AAPM Medical Physics Practice Guideline 1.b: CT protocol management and review practice guideline.

The American Association of Physicists in Medicine (AAPM) is a nonprofit professional society whose primary purposes are to advance the science, education and professional practice of medical physics. The AAPM has more than 8000 members and is the principal organization of medical physicists in the United States. The AAPM will periodically define new practice guidelines for medical physics practice to help advance the science of medical physics and to improve the quality of service to patients throughout the United States. Existing medical physics practice guidelines will be reviewed for the purpose of revision or renewal, as appropriate, on their fifth anniversary or sooner. Each medical physics practice guideline represents a policy statement by the AAPM, has undergone a thorough consensus process in which it has been subjected to extensive review, and requires the approval of the Professional Council. The medical physics practice guidelines recognize that the safe and effective use of diagnostic and therapeutic radiology requires specific training, skills, and techniques, as described in each document. Reproduction or modification of the published practice guidelines and technical standards by those entities not providing these services is not authorized. The following terms are used in the AAPM practice guidelines: (a) Must and Must Not: Used to indicate that adherence to the recommendation is considered necessary to conform to this practice guideline. (b) Should and Should Not: Used to indicate a prudent practice to which exceptions may occasionally be made in appropriate circumstances.

AAPM medical physics practice guideline 10.a.: Scope of practice for clinical medical physics.

The American Association of Physicists in Medicine (AAPM) is a nonprofit professional society whose primary purposes are to advance the science, education, and professional practice of medical physics. The AAPM has more than 8000 members and is the principal organization of medical physicists in the United States. The AAPM will periodically define new practice guidelines for medical physics practice to help advance the science of medical physics and to improve the quality of service to patients throughout the United States. Existing medical physics practice guidelines will be reviewed for the purpose of revision or renewal, as appropriate, on their fifth anniversary or sooner. Each medical physics practice guideline (MPPG) represents a policy statement by the AAPM, has undergone a thorough consensus process in which it has been subjected to extensive review, and requires the approval of the Professional Council. The medical physics practice guidelines recognize that the safe and effective use of diagnostic and therapeutic radiation requires specific training, skills, and techniques as described in each document. As the review of the previous version of AAPM Professional Policy (PP)-17 (Scope of Practice) progressed, the writing group focused on one of the main goals: to have this document accepted by regulatory and accrediting bodies. After much discussion, it was decided that this goal would be better served through a MPPG. To further advance this goal, the text was updated to reflect the rationale and processes by which the activities in the scope of practice were identified and categorized. Lastly, the AAPM Professional Council believes that this document has benefitted from public comment which is part of the MPPG process but not the AAPM Professional Policy approval process. The following terms are used in the AAPM's MPPGs: Must and Must Not: Used to indicate that adherence to the recommendation is considered necessary to conform to this practice guideline. Should and Should Not: Used to indicate a prudent practice to which exceptions may occasionally be made in appropriate circumstances.

Safety and Effectiveness of Whole Body Cooling Therapy for Neonatal Encephalopathy on Transport.

OBJECTIVE: The purpose of this study was to evaluate the safety and effectiveness of a transport protocol using active and passive methods for therapeutic whole body cooling of the neonate with hypoxic-ischemic encephalopathy. METHODS: A retrospective study of neonates who received whole body cooling during transport by our pediatric/neonatal transport team between December 2008 and April 2012 was conducted. RESULTS: Sixty-three of 66 (95%) neonates arrived within a safety temperature range of 33.0°C-37°C, and 3 (5%) were hypothermic (31.9°C-32.8°C). No clinical complications of cooling during transport were identified. Twenty-five (38%) and 57(86%) achieved therapeutic cooling upon admission and ≤ 6 hours after birth, respectively. Factors associated with cooling > 6 hours included a later time of initial referral (2.44 vs. 1.07 hours, P = .01), a later rendezvous time (4.17 vs. 1.92 hours, P = .002), and a later admission time (6.46 vs. 3.99 hours, P = .001). CONCLUSION: Whole body cooling of neonates with hypoxic-ischemic encephalopathy can be effectively and safely performed during interfacility transport.

Preferences for results delivery from exome sequencing/genome sequencing.

PURPOSE: The aim of this study was to explore the implications of sequencing information and stated preferences for return of results among research participants. METHODS: Six focus groups were held with 39 ClinSeq participants. The groups included participants who had received results, those who had not, those affected with cardiovascular disease, and healthy adults. Audio recordings of the sessions were transcribed and coded and analyzed for themes. RESULTS: All participants expressed interest in receiving results that are medically actionable, nonactionable, carrier, and less so variants that cannot be interpreted. Most participants preferred to receive results in person, although several endorsed use of Internet-based resources that they could return to. Participants identified benefits for health management along with satisfying curiosity, making scientific contributions, and partnering in research. Value was seen in gaining control over health risks. Concerns were distress and/or fear that may result. Some participants were opposed to or ambivalent about learning certain types of results, particularly those having to do with diseases that were incurable or that might have implications for the health of their children. CONCLUSION: There was relative enthusiasm about the value of learning sequencing information, yet it was tempered by concern about negative feeling responses and aversion to learning about incurable conditions.

How do research participants perceive "uncertainty" in genome sequencing?

PURPOSE: The scope of uncertainty in genome sequence information has no rival in health-care delivery. We present data from adults participating in a National Institutes of Health study using this technology, in which perceptions of uncertainty are hypothesized to be key in predicting decisions to learn and act on genome health information. METHODS: We conducted six professionally moderated focus groups with 39 randomly selected ClinSeq participants varying on whether they had coronary heart disease and had received prior sequence results. We elicited perceptions of the uncertainties associated with genome sequencing using written prompts. RESULTS: Participants perceived uncertainty as a quality of genome information. The majority of participants characterized uncertainty of sequencing information as "changing, fluid, developing, or ground breaking." These responses led to anticipation of more optimistic future outcomes. Fewer participants described uncertainty as "questionable, less accurate, limited, or poorly understood." These perceptions seemed to undermine participants' faith in genome information, leading to feelings of disillusionment. CONCLUSION: Our findings suggest that perceptions of uncertainty are related to epistemological beliefs that inform expectations for the information. Interventions that promote realistic expectations of genome sequencing may mitigate negative responses to uncertainty.

Expectations and experiences of investigators and parents involved in a clinical trial for Duchenne/Becker muscular dystrophy.

BACKGROUND: The social context of rare disease research is changing, with increased community engagement around drug development and clinical trials. This engagement may benefit patients and families but may also lead to heightened trial expectations and therapeutic misconception. Clinical investigators are also susceptible to harboring high expectations. Little is known about parental motivations and expectations for clinical trials for rare pediatric disorders. PURPOSE: We describe the experience of parents and clinical investigators involved in a phase II clinical trial for Duchenne and Becker muscular dystrophy: their expectations, hopes, motivations, and reactions to the termination of the trial. METHODS: This qualitative study was based on interviews with clinical investigators and parents of sons with Duchenne and Becker muscular dystrophy (DBMD) who participated in the phase IIa or IIb ataluren clinical trial in the United States. Interviews were transcribed and coded for thematic analysis. RESULTS: Participants were 12 parents of affected boys receiving active drug and 9 clinical investigators. High trial expectations of direct benefit were reported by parents and many clinicians. Investigators described monitoring and managing parents' expectations; several worried about their own involvement in increasing parents' expectations. Most parents were able to differentiate their expectations from their optimistic hopes for a cure. Parents' expectations arose from other parents, advocacy organizations, and the sponsor. All parents reported some degree of clinical benefit to their children. Secondary benefits were hopefulness and powerful feelings associated with active efforts to affect the disease course. Parents and clinical investigators reported strong, close relationships that were mutually important. Parents and clinicians felt valued by the sponsor for the majority of the trial. When the trial abruptly stopped, they described loss of engagement, distress, and feeling unprepared for the possibility of trial termination. LIMITATIONS: This was a retrospective study of one clinical trial. We were unable to recruit participants whose children received placebo. The interviews occurred during a time of significant uncertainty and distress for many of the participants. CONCLUSION: This pilot study reflects complex outcomes of strong community engagement. The findings highlight a need for renewed education about, and support for, clinical trial termination and loss of drug access. The primary positive outcome was demonstration of strong relationships among committed parents and study teams. These relationships were highly valued by both parties and may suggest an ideal intervention opportunity for efforts to improve psychological well-being. A negative outcome attributed, in part, to community engagement was inappropriately high trial expectations. More optimistically, high expectations were attributed, in part, to the importance of hope and powerful feelings associated with active efforts to affect the disease course.

Cytochrome P450 (CYP2D6) genotype is associated with elevated systolic blood pressure in preterm infants after discharge from the neonatal intensive care unit.

OBJECTIVE: To determine genetic and clinical risk factors associated with elevated systolic blood pressure (ESBP) in preterm infants after discharge from the neonatal intensive care unit (NICU). STUDY DESIGN: A convenience cohort of infants born at <32 weeks gestational age was followed after NICU discharge. We retrospectively identified a subgroup of subjects with ESBP (systolic blood pressure [SBP] >90th percentile for term infants). Genetic testing identified alleles associated with ESBP. Multivariate logistic regression analysis was performed for the outcome ESBP, with clinical characteristics and genotype as independent variables. RESULTS: Predictors of ESBP were cytochrome P450, family 2, subfamily D, polypeptide 6 (CYP2D6) (rs28360521) CC genotype (OR, 2.92; 95% CI, 1.48-5.79), adjusted for outpatient oxygen therapy (OR, 4.53; 95% CI, 2.23-8.81) and history of urinary tract infection (OR, 4.68; 95% CI, 1.47-14.86). Maximum SBP was modeled by multivariate linear regression analysis: maximum SBP=84.8 mm Hg + 6.8 mm Hg if cytochrome P450, family 2, subfamily D, polypeptide 6 (CYP2D6) CC genotype + 6.8 mm Hg if discharged on supplemental oxygen + 4.4 mm Hg if received inpatient glucocorticoids (P=.0002). CONCLUSIONS: ESBP is common in preterm infants with residual lung disease after discharge from the NICU. This study defines clinical factors associated with ESBP, identifies a candidate gene for further testing, and supports the recommendation to monitor blood pressure before age 3 years, as is suggested for term infants.

Intentions to receive individual results from whole-genome sequencing among participants in the ClinSeq study.

Genome sequencing has been rapidly integrated into clinical research and is currently marketed to health-care practitioners and consumers alike. The volume of sequencing data generated for a single individual and the wide range of findings from whole-genome sequencing raise critical questions about the return of results and their potential value for end-users. We conducted a mixed-methods study of 311 sequential participants in the NIH ClinSeq study to assess general preferences and specific attitudes toward learning results. We tested how these variables predicted intentions to receive results within four categories of findings ranging from medically actionable to variants of unknown significance. Two hundred and ninety-four participants indicated a preference to learn their genome sequencing results. Most often, participants cited disease prevention as their reason, including intention to change their lifestyle behaviors. Participants held positive attitudes, strongly perceived social norms and strong intentions to learn results, although there were significant mean differences among four categories of findings (P<0.01). Attitudes and social norms for medically actionable and carrier results were most similar and rated the highest. Participants distinguished among the types and quality of information they may receive, despite strong intentions to learn all results presented. These intentions were motivated by confidence in their ability to use the information to prevent future disease and a belief in the value of even uninterpretable information. It behooves investigators to facilitate participants' desire to learn a range of information from genomic sequencing while promoting realistic expectations for its clinical and personal utility.

US screening of international travelers for radioactive contamination after the Japanese nuclear plant disaster in March 2011.

On March 11, 2011, a magnitude 9.0 earthquake and subsequent tsunami damaged nuclear reactors at the Fukushima Daiichi complex in Japan, resulting in radionuclide release. In response, US officials augmented existing radiological screening at its ports of entry (POEs) to detect and decontaminate travelers contaminated with radioactive materials. During March 12 to 16, radiation screening protocols detected 3 travelers from Japan with external radioactive material contamination at 2 air POEs. Beginning March 23, federal officials collaborated with state and local public health and radiation control authorities to enhance screening and decontamination protocols at POEs. Approximately 543 000 (99%) travelers arriving directly from Japan at 25 US airports were screened for radiation contamination from March 17 to April 30, and no traveler was detected with contamination sufficient to require a large-scale public health response. The response highlighted synergistic collaboration across government levels and leveraged screening methods already in place at POEs, leading to rapid protocol implementation. Policy development, planning, training, and exercising response protocols and the establishment of federal authority to compel decontamination of travelers are needed for future radiological responses. Comparison of resource-intensive screening costs with the public health yield should guide policy decisions, given the historically low frequency of contaminated travelers arriving during radiological disasters.

Concurrent task effects on memory encoding and retrieval: further support for an asymmetry.

Several studies have demonstrated that divided attention at encoding significantly reduces memory performance, whereas divided attention at retrieval affects memory performance only minimally. However, the possibility exists that retrieval processes have shown such resilience because the concurrent tasks used have often not been very demanding. To assess this possibility, we used independent manipulations of the concurrent task during either encoding or retrieval that included stimulus-response compatibility and participant- versus experimenter-controlled pace. In addition, we manipulated the distribution of practice that the participants received with the primary and the concurrent tasks. The results replicated and extended those recently reported by Rohrer and Pashler (2003), indicating that although memory performance is negatively affected by divided attention at retrieval, especially with noncompatible stimulus-response mapping in the concurrent task, this effect was much smaller than that at encoding, in line with the asymmetry notion. Furthermore, experimenter versus participant control of the concurrent task had no effect on memory retrieval. Finally, under conditions of equal practice with both the memory and the concurrent tasks, memory retrieval was affected only to a small degree. In contrast to encoding processes, the processes involved in retrieval accuracy appear, in many cases, to be less interrupted by divided attention, although this protection requires substantial resources.