Claiborne Miller-Davis

[18F]Fluorodeoxyglucose Single Photon Emission Computed Tomography Can It Replace PET and Thallium SPECT for the Assessment of Myocardial Viability?

Background —New high-energy collimators for single photon emission computed tomography (SPECT) cameras have made imaging of positron-emitting tracers, such as [ 18 F]fluorodeoxyglucose ( 18 FDG), possible. We examined differences between SPECT and PET technologies and between 18 FDG and thallium tracers to determine whether 18 FDG SPECT could be adopted for assessment of myocardial viability. Methods and Results —Twenty-eight patients with chronic coronary artery disease (mean left ventricular ejection fraction [LVEF]=33±15% at rest) underwent 18 FDG SPECT, 18 FDG PET, and thallium SPECT studies. Receiver operating characteristic curves showed overall good concordance between SPECT and PET technologies and thallium and 18 FDG tracers for assessing viability regardless of the level of 18 FDG PET cutoff used (40% to 60%). However, in the subgroup of patients with LVEF≤25%, at 60% 18 FDG PET threshold value, thallium tended to underestimate myocardial viability. In a subgroup of regions with severe asynergy, there were considerably more thallium/ 18 FDG discordances in the inferior wall than elsewhere (73% versus 27%, P 18 FDG by SPECT and PET was compared in 137 segments exhibiting severely irreversible thallium defects (scarred by thallium), 59 (43%) were viable by 18 FDG PET, of which 52 (88%) were also viable by 18 FDG SPECT. However, of the 78 segments confirmed to be nonviable by 18 FDG PET, 57 (73%) were nonviable by 18 FDG SPECT ( P Conclusions —Although 18 FDG SPECT significantly increases the sensitivity for detection of viable myocardium in tissue declared nonviable by thallium (to 88% of the sensitivity achievable by PET), it will occasionally (27% of the time) result in falsely identifying as viable tissue that has been identified as nonviable by both PET and thallium.BACKGROUND New high-energy collimators for single photon emission computed tomography (SPECT) cameras have made imaging of positron-emitting tracers, such as [18F]fluorodeoxyglucose (18FDG), possible. We examined differences between SPECT and PET technologies and between 18FDG and thallium tracers to determine whether 18FDG SPECT could be adopted for assessment of myocardial viability. METHODS AND RESULTS Twenty-eight patients with chronic coronary artery disease (mean left ventricular ejection fraction [LVEF]=33+/-15% at rest) underwent 18FDG SPECT, 18FDG PET, and thallium SPECT studies. Receiver operating characteristic curves showed overall good concordance between SPECT and PET technologies and thallium and 18FDG tracers for assessing viability regardless of the level of 18FDG PET cutoff used (40% to 60%). However, in the subgroup of patients with LVEF< or =25%, at 60% 18FDG PET threshold value, thallium tended to underestimate myocardial viability. In a subgroup of regions with severe asynergy, there were considerably more thallium/18FDG discordances in the inferior wall than elsewhere (73% versus 27%, P<.001), supporting attenuation of thallium as a potential explanation for the discordant observations. When uptake of 18FDG by SPECT and PET was compared in 137 segments exhibiting severely irreversible thallium defects (scarred by thallium), 59 (43%) were viable by 18FDG PET, of which 52 (88%) were also viable by 18FDG SPECT. However, of the 78 segments confirmed to be nonviable by 18FDG PET, 57 (73%) were nonviable by 18FDG SPECT (P<.001). CONCLUSIONS Although 18FDG SPECT significantly increases the sensitivity for detection of viable myocardium in tissue declared nonviable by thallium (to 88% of the sensitivity achievable by PET), it will occasionally (27% of the time) result in falsely identifying as viable tissue that has been identified as nonviable by both PET and thallium.

Validating the Clinical Research Nursing Domain of Practice

PURPOSE/OBJECTIVES To develop and validate a taxonomy for the domain of clinical research nursing. DESIGN Survey. SETTING Clinical research settings in the United States. SAMPLE A purposefully selected expert panel of 22 nurses who were actively practicing or supervising in a clinical research environment. METHODS A study team consisting of nurses with experience in clinical research synthesized peer-reviewed articles, academic curricula, professional guidelines, position descriptions, and expert opinion. Using the Delphi technique, three rounds of surveys were conducted to validate the taxonomy. The three sequential questionnaires were completed over five months. MAIN RESEARCH VARIABLES Activities performed by nurses in a clinical research setting. FINDINGS A taxonomy for clinical research nursing was validated with five dimensions and 52 activities: Clinical Practice (4 activities), Study Management (23 activities), Care Coordination and Continuity (10 activities), Human Subjects Protection (6 activities), and Contributing to the Science (9 activities). CONCLUSIONS This study validated activities for direct care providers and nurses with the primary focus of research coordination. The findings identify a variety of activities that are unique to nurses in a clinical research setting. IMPLICATIONS FOR NURSING Nurses play an integral role in the clinical research enterprise. Validating a taxonomy for the specialty of clinical research nursing allows for roles to be compared across settings, competency requirements to be defined, and nursing organizations to be guided in the development of specialty certification.

Defining Clinical Research Nursing Practice: Results of a Role Delineation Study

Clinical research nursing is a specialty nursing practice focused on the care of research subjects and implementation of clinical research. A five‐dimensional model (Clinical Practice [CP], Study Management, Care Coordination and Continuity, Contributing to the Science [CS], Human Subjects Protection) has been validated nationally to represent the domain of clinical research nursing practice. The purpose of this study was to describe the frequency and importance of activities within each dimension as performed by nurses in clinical research and to describe differences between roles. One thousand and four nurses from the NIH Intramural Campus in Bethesda, Maryland, were invited to participate in an anonymous web‐based survey. Participants (N = 412) were predominantly female (90%) with ≥11 years research experience (70%). Two hundred eighty‐eight respondents (70%) identified themselves as clinical research nurses (CRNs) and 74 (18%) as research nurse coordinators (RNCs). CP activities were reported most frequent and important whereas CS activities were least frequent and important. CRN and RNC activity frequency differed across all dimensions (p < 0.001) with CRNs reporting significantly higher levels of CP activities and significantly lower levels in other dimensions. Delineating specialty activities and practice across roles enhances the understanding of nurses’ role in clinical research and provides groundwork for role‐based training. Clin Trans Sci 2011; Volume 4: 421–427

Developing a Model of the Benefits and Burdens of Research Participation in Cancer Clinical Trials

Background: Recruiting and retaining human participants in cancer clinical trials is challenging for many investigators. Although we expect participants to identify and weigh the benefits and burdens of research participation for themselves, it is not clear what burdens adult cancer participants perceive in relation to benefits. We identify key attributes and develop an initial conceptual framework of benefit and burden based on interviews with individuals enrolled in cancer clinical research. Methods: Semistructured interviews were conducted with a purposive sample of 32 patients enrolled in cancer clinical trials at a large northeastern cancer center. Kruegers guidelines for qualitative methodology were followed. Results: Respondents reported a range of benefits and burdens associated with research participation. Benefits such as access to needed medications that subjects otherwise might not be able to afford, early detection and monitoring of the disease, potential for remission or cure, and the ability to take control of their lives through actively participating in the trial were identified. Burdens included the potentiality of side effects, worry and fear of the unknown, loss of job support, and financial concerns. Conclusions: Both benefit and burden influence research participation, including recruitment and retention in clinical trials. Dimensions of benefit and burden include physical, psychological, economic, familial, and social. Understanding the benefit–burden balance involved in the voluntary consent of human subjects is a fundamental tenet of research and important to ensure that subjects have made an informed decision regarding their decision to participate in clinical research.

[18F]Fluorodeoxyglucose Single Photon Emission Computed Tomography

Background —New high-energy collimators for single photon emission computed tomography (SPECT) cameras have made imaging of positron-emitting tracers, such as [ 18 F]fluorodeoxyglucose ( 18 FDG), possible. We examined differences between SPECT and PET technologies and between 18 FDG and thallium tracers to determine whether 18 FDG SPECT could be adopted for assessment of myocardial viability. Methods and Results —Twenty-eight patients with chronic coronary artery disease (mean left ventricular ejection fraction [LVEF]=33±15% at rest) underwent 18 FDG SPECT, 18 FDG PET, and thallium SPECT studies. Receiver operating characteristic curves showed overall good concordance between SPECT and PET technologies and thallium and 18 FDG tracers for assessing viability regardless of the level of 18 FDG PET cutoff used (40% to 60%). However, in the subgroup of patients with LVEF≤25%, at 60% 18 FDG PET threshold value, thallium tended to underestimate myocardial viability. In a subgroup of regions with severe asynergy, there were considerably more thallium/ 18 FDG discordances in the inferior wall than elsewhere (73% versus 27%, P 18 FDG by SPECT and PET was compared in 137 segments exhibiting severely irreversible thallium defects (scarred by thallium), 59 (43%) were viable by 18 FDG PET, of which 52 (88%) were also viable by 18 FDG SPECT. However, of the 78 segments confirmed to be nonviable by 18 FDG PET, 57 (73%) were nonviable by 18 FDG SPECT ( P Conclusions —Although 18 FDG SPECT significantly increases the sensitivity for detection of viable myocardium in tissue declared nonviable by thallium (to 88% of the sensitivity achievable by PET), it will occasionally (27% of the time) result in falsely identifying as viable tissue that has been identified as nonviable by both PET and thallium.BACKGROUND New high-energy collimators for single photon emission computed tomography (SPECT) cameras have made imaging of positron-emitting tracers, such as [18F]fluorodeoxyglucose (18FDG), possible. We examined differences between SPECT and PET technologies and between 18FDG and thallium tracers to determine whether 18FDG SPECT could be adopted for assessment of myocardial viability. METHODS AND RESULTS Twenty-eight patients with chronic coronary artery disease (mean left ventricular ejection fraction [LVEF]=33+/-15% at rest) underwent 18FDG SPECT, 18FDG PET, and thallium SPECT studies. Receiver operating characteristic curves showed overall good concordance between SPECT and PET technologies and thallium and 18FDG tracers for assessing viability regardless of the level of 18FDG PET cutoff used (40% to 60%). However, in the subgroup of patients with LVEF< or =25%, at 60% 18FDG PET threshold value, thallium tended to underestimate myocardial viability. In a subgroup of regions with severe asynergy, there were considerably more thallium/18FDG discordances in the inferior wall than elsewhere (73% versus 27%, P<.001), supporting attenuation of thallium as a potential explanation for the discordant observations. When uptake of 18FDG by SPECT and PET was compared in 137 segments exhibiting severely irreversible thallium defects (scarred by thallium), 59 (43%) were viable by 18FDG PET, of which 52 (88%) were also viable by 18FDG SPECT. However, of the 78 segments confirmed to be nonviable by 18FDG PET, 57 (73%) were nonviable by 18FDG SPECT (P<.001). CONCLUSIONS Although 18FDG SPECT significantly increases the sensitivity for detection of viable myocardium in tissue declared nonviable by thallium (to 88% of the sensitivity achievable by PET), it will occasionally (27% of the time) result in falsely identifying as viable tissue that has been identified as nonviable by both PET and thallium.

Patients' and Community Leaders' Perceptions Regarding Conducting Health Behavior Research in a Diverse, Urban Clinic Specializing in Rheumatic Diseases

Background: Disparities in the incidence, prevalence, severity, care, and outcomes for rheumatic diseases exist among racial and ethnic groups compared with White Americans. Objective: This paper describes a community-based participatory research (CBPR) approach engaging researchers, community leaders, and patients in purposeful dialogues related to the implementation of health behavior research in an urban rheumatic disease clinic. Methods: Seven focused discussions were led in either English or Spanish. Discussions were audiotaped and transcribed verbatim. Results: Six community leaders and nine patients participated in the seven scheduled focused discussions. Transcripts uncovered five major themes that assisted with study design: trust, patient–provider relationship, study implementation suggestions, decreased functional capacity, and access to healthcare. Conclusions: Engaging community partners and patients in informal and formal discussions from early phases of research design through implementation, followed by systematic application of these insights, may serve to accelerate the potential for translation from findings into improved clinical practice and optimal outcomes.

Naturopathic management of females with cervical atypia: a delphi process to explore current practice.

Background Human papillomavirus is the most significant factor contributing to cervical cancer. Naturopathic doctors (NDs) implement an integrative approach to treat cervical atypia. This study explored practice consensus and variance among NDs. Methods A purposefully selected panel of six NDs participated in a modified Delphi study to validate practice. Three electronic web-based surveys were completed over nine months. Results Local and systemic treatments were included in all ND protocols. Six protocols included cervical cancer screening guidelines, green tea suppositories, and oral folic acid. Five protocols included oral green tea, diindoylemethane (DIM), and cartenoids. Four protocols incorporated Vitamin C. Two NDs considered escharotics when managing cervical atypia. All NDs included health behavior management in their protocols. Conclusion Naturopathic management of cervical atypia varies across practitioners. However, in general, elements of management include (1) cervical cancer screening guidelines, (2) local and systemic treatments, (3) health behavior/lifestyle recommendations, and (4) immune system support.

[ 18 F]Fluorodeoxyglucose Single Photon Emission Computed Tomography

Background —New high-energy collimators for single photon emission computed tomography (SPECT) cameras have made imaging of positron-emitting tracers, such as [ 18 F]fluorodeoxyglucose ( 18 FDG), possible. We examined differences between SPECT and PET technologies and between 18 FDG and thallium tracers to determine whether 18 FDG SPECT could be adopted for assessment of myocardial viability. Methods and Results —Twenty-eight patients with chronic coronary artery disease (mean left ventricular ejection fraction [LVEF]=33±15% at rest) underwent 18 FDG SPECT, 18 FDG PET, and thallium SPECT studies. Receiver operating characteristic curves showed overall good concordance between SPECT and PET technologies and thallium and 18 FDG tracers for assessing viability regardless of the level of 18 FDG PET cutoff used (40% to 60%). However, in the subgroup of patients with LVEF≤25%, at 60% 18 FDG PET threshold value, thallium tended to underestimate myocardial viability. In a subgroup of regions with severe asynergy, there were considerably more thallium/ 18 FDG discordances in the inferior wall than elsewhere (73% versus 27%, P 18 FDG by SPECT and PET was compared in 137 segments exhibiting severely irreversible thallium defects (scarred by thallium), 59 (43%) were viable by 18 FDG PET, of which 52 (88%) were also viable by 18 FDG SPECT. However, of the 78 segments confirmed to be nonviable by 18 FDG PET, 57 (73%) were nonviable by 18 FDG SPECT ( P Conclusions —Although 18 FDG SPECT significantly increases the sensitivity for detection of viable myocardium in tissue declared nonviable by thallium (to 88% of the sensitivity achievable by PET), it will occasionally (27% of the time) result in falsely identifying as viable tissue that has been identified as nonviable by both PET and thallium.BACKGROUND New high-energy collimators for single photon emission computed tomography (SPECT) cameras have made imaging of positron-emitting tracers, such as [18F]fluorodeoxyglucose (18FDG), possible. We examined differences between SPECT and PET technologies and between 18FDG and thallium tracers to determine whether 18FDG SPECT could be adopted for assessment of myocardial viability. METHODS AND RESULTS Twenty-eight patients with chronic coronary artery disease (mean left ventricular ejection fraction [LVEF]=33+/-15% at rest) underwent 18FDG SPECT, 18FDG PET, and thallium SPECT studies. Receiver operating characteristic curves showed overall good concordance between SPECT and PET technologies and thallium and 18FDG tracers for assessing viability regardless of the level of 18FDG PET cutoff used (40% to 60%). However, in the subgroup of patients with LVEF< or =25%, at 60% 18FDG PET threshold value, thallium tended to underestimate myocardial viability. In a subgroup of regions with severe asynergy, there were considerably more thallium/18FDG discordances in the inferior wall than elsewhere (73% versus 27%, P<.001), supporting attenuation of thallium as a potential explanation for the discordant observations. When uptake of 18FDG by SPECT and PET was compared in 137 segments exhibiting severely irreversible thallium defects (scarred by thallium), 59 (43%) were viable by 18FDG PET, of which 52 (88%) were also viable by 18FDG SPECT. However, of the 78 segments confirmed to be nonviable by 18FDG PET, 57 (73%) were nonviable by 18FDG SPECT (P<.001). CONCLUSIONS Although 18FDG SPECT significantly increases the sensitivity for detection of viable myocardium in tissue declared nonviable by thallium (to 88% of the sensitivity achievable by PET), it will occasionally (27% of the time) result in falsely identifying as viable tissue that has been identified as nonviable by both PET and thallium.

Qualitative inquiry: a method for validating patient perceptions of palliative care while enrolled on a cancer clinical trial

BackgroundPalliative care is a vital component of patient-centered care. It has increasingly become central to the management and care of seriously ill patients by integrating physical, psychosocial, and spiritual supportive services. Through qualitative inquiry, this paper examines cancer patients’ perceptions of the process and outcomes of the pain and palliative care consultative services they received while enrolled in a clinical trial.MethodsA qualitative analysis of open-ended questions was conducted from a sub-sample of patients (n = 34) with advanced cancers enrolled in a randomized controlled trial exploring the efficacy of a palliative care consult service. Two open-ended questions focused on patient perceptions of continued participation on their primary cancer clinical trials and their perceptions of interdisciplinary communication.ResultsThree overarching themes emerged when asked whether receiving pain and palliative care services made them more likely to remain enrolled in their primary cancer clinical trial: patients’ past experiences with care, self-identified personal characteristics and reasons for participation, and the quality of the partnership. Four themes emerged related to interdisciplinary communication including: the importance of developing relationships, facilitating open communication, having quality communication, and uncertainty about communication between the cancer clinical trial and palliative care teams.ConclusionsOur findings suggest the importance of qualitative inquiry methods to explore patient perceptions regarding the efficacy of palliative care services for cancer patients enrolled in a cancer clinical trial. Validation of patient perceptions through qualitative inquiry regarding their pain and palliative care needs can provide insight into areas for future implementation research.Trial registrationNIH Office of Human Subjects Research Protection OHSRP5443 and University of Pennsylvania 813365