The provision of dental sleep medicine (DSM) has caused the rapid growth and expansion of an industry that includes health care providers, manufacturers, and retailers. Sleep is used as a vital sign by health care providers to screen and test for sleep disorders and to prevent future health issues, disease, and catastrophic events. Professional services and devices continue to be developed to enhance and foster better sleep hygiene and environment and to encourage improved sleep by building a comprehensive portfolio of sleep solutions, including DSM. However, the provision of DSM requires compliance with applicable state and federal regulations.

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Buprenorphine is a highly effective treatment for opioid use disorder (OUD) and a critical tool for addressing the worsening US overdose crisis. However, multiple barriers to treatment-including stringent federal regulations-have historically made this medication hard to reach for many who need it. In 2020, under the COVID-19 public health emergency, federal regulators substantially changed access to buprenorphine by allowing prescribers to initiate patients on buprenorphine via telehealth without first evaluating them in person. As the public health emergency has been set to expire in May of 2023, Congress and federal agencies can leverage extensive evidence from studies conducted during the wake of the pandemic to make evidence-based decisions on the regulation of buprenorphine going forward. To aid policy makers, this narrative review synthesizes and interprets peer-reviewed research on the effect of buprenorphine flexibilities on the uptake and implementation of telehealth, and its impact on OUD patient and prescriber experiences, access to treatment, and health outcomes. Overall, our review finds that many prescribers and patients took advantage of telehealth, including the audio-only option, with a wide range of benefits and few downsides. As a result, federal regulators-including agencies and Congress-should continue nonrestricted use of telehealth for buprenorphine initiation.

Buprenorphine is a highly effective treatment for opioid use disorder and a critical tool for addressing the worsening U.S. overdose crisis. However, multiple barriers to treatment - including stringent federal regulations - have historically made this medication hard to reach for many who need it. In 2020, under the COVID-19 Public Health Emergency, federal regulators substantially changed access to buprenorphine by allowing prescribers to initiate patients on buprenorphine via telehealth without first evaluating them in person. As the Public Health Emergency is set to expire in May of 2023, Congress and federal agencies can leverage extensive evidence from studies conducted during the wake of the pandemic to make evidence-based decisions on the regulation of buprenorphine going forward. To aid policy makers, this review synthesizes and interprets peer-reviewed research on the effect of buprenorphine flexibilities on uptake and implementation of telehealth, and its impact on OUD patient and prescriber experiences, access to treatment and health outcomes. Overall, our review finds that many prescribers and patients took advantage of telehealth, including the audio-only option, with a wide range of benefits and few downsides. As a result, federal regulators-including agencies and Congress-should continue non-restricted use of telehealth for buprenorphine initiation.

Institutional review boards play a crucial role in initiating clinical trials. Although many multicenter clinical trials use an individual institutional review board model, where each institution uses their local institutional review board, it is unknown if a shared (single institutional review board) model would reduce the time required to approve a standard institutional review board protocol.
This study aimed to compare processing times and other processing characteristics between sites using a single institutional review board model and those using their individual site institutional review board model in a multicenter clinical trial.
This was a retrospective study of sites in an open-label, multicenter randomized control trial from 2014 to 2021. Participating sites in the multicenter Chronic Hypertension and Pregnancy trial were asked to complete a survey collecting data describing their institutional review board approval process.
A total of 45 sites participated in the survey (7 used a shared institutional review board model and 38 used their individual institutional review board model). Most sites (86%) using the shared institutional review board model did not require a full-board institutional review board meeting before protocol approval, compared with 1 site (3%) using the individual institutional review board model (P<.001). Median total approval times (41 vs 56 days; P=.42), numbers of submission rounds (1 vs 2; P=.09), and numbers of institutional review board stipulations (1 vs 4; P=.12) were lower for the group using the shared institutional review board model than those using the individual site institutional review board model; however, these differences were not statistically significant.
The findings supported the hypothesis that the shared institutional review board model for multicenter studies may be more efficient in terms of cumulative time and effort required to obtain approval of an institutional review board protocol than the individual institutional review board model. Given that these data have important implications for multicenter clinical trials, future research should evaluate these findings using larger or multiple multicenter trials.

UNASSIGNED: Critical for advancing a Learning Health System (LHS) in the U.S., a regulatory safe harbor for deidentified data reduces barriers to learning from care at scale while minimizing privacy risks. We examine deidentified data policy as a mechanism for synthesizing the ethical obligations underlying clinical care and human subjects research for an LHS which conceptually and practically integrates care and research, blurring the roles of patient and subject.
UNASSIGNED: First, we discuss respect for persons vis-a-vis the systemic secondary use of data and tissue collected in the fiduciary context of clinical care. We argue that, without traditional informed consent or duty to benefit the individual, deidentification may allow secondary use to supersede the primary purpose of care. Next, we consider the effectiveness of deidentification for minimizing harms via privacy protection and maximizing benefits via promoting learning and translational care. We find that deidentification is unable to fully protect privacy given the vastness of health data and current technology, yet it imposes limitations to learning and barriers for efficient translation. After that, we evaluate the impact of deidentification on distributive justice within an LHS ethical framework in which patients are obligated to contribute to learning and the system has a duty to translate knowledge into better care. Such a system may permit exacerbation of health disparities as it accelerates learning without mechanisms to ensure that individuals\' contributions and benefits are fair and balanced.
UNASSIGNED: We find that, despite its established advantages, system-wide use of deidentification may be suboptimal for signaling respect, protecting privacy or promoting learning, and satisfying requirements of justice for patients and subjects.
UNASSIGNED: Finally, we highlight ethical, socioeconomic, technological and legal challenges and next steps, including a critical appreciation for novel approaches to realize an LHS that maximizes efficient, effective learning and just translation without the compromises of deidentification.

Relaxation of federal regulations for methadone take-out dosing during the COVID-19 pandemic is unprecedented. The impact of this change on drug use is unknown. This study explores the impact of the federal take-out variance on drug use in one urban opioid treatment program as measured by drug testing.
This study collected drug test results from 613 patients receiving methadone from July 2020, following COVID-19-related take-out dose adjustments, and July 2019 for comparison. Using a generalized linear mixed model, we computed the average estimated probability of a positive drug test for each year for each take-out phase. To isolate the effect of changing take-out, we removed the main effect of year, while retaining the main effect of take-out phase and the interaction between year and phase.
The percent of drug tests positive for opiates, benzodiazepines, and methamphetamine was greater in July 2020 than in July 2019 (p < 0.001 for each), while the percent of tests negative for methadone increased (p < 0.001). Oxycodone, barbiturate, and cocaine positive tests remained stable. In a separate analysis of opioid and non-opioid test results, take-out phase was associated with both opioid and non-opioid positive results (p < 0.001, each outcome). The association of take-out phase with opioid and non-opioid positive results differed in the two years (year-by-phase interaction p < 0.025, each outcome). After removing the year main effect, the rate of positive tests was lower in 2020 for the smallest number of take-out doses, higher for a moderate number of take-out doses, and about the same for the highest number of take-out doses.
Positive opioid and non-opioid drug tests increased following the federal variance allowing more methadone take-out doses, but these findings cannot fully be attributed to alterations in the take-out schedule.

We aimed to identify and characterize barriers faced by researchers studying abortion in academic medical centers in the United States. We specifically focused on regulatory restrictions on abortion research related to institutional review board (IRB) or research ethics committee interpretations of Subpart B of the 2001 Code of Federal Regulations, which states that researchers cannot take part in decisions involving the timing, method, or procedures used to terminate a pregnancy. We aimed to document investigators\' experiences obtaining approval from their IRBs and to identify obstacles that prevent investigators from generating evidence related to abortion care.
We conducted semistructured telephone interviews with family planning researchers at 15 US academic institutions across the country. We coded transcripts using an iterative process, and analyzed the data for content and themes.
Interviewees reported significant variations in the way that IRBs at their institutions applied federal regulations to abortion research. At several institutions, the regulations represented barriers to conducting abortion research and discouraged some investigators from conducting such research altogether. At other institutions, interviewees did not face significant barriers related to their IRB\'s interpretation of Subpart B. Many interviewees discussed creating and maintaining positive professional relationships with members of their IRB as a way to overcome barriers and successfully conduct abortion research.
Our study suggests that IRBs interpret Subpart B in varying ways. At some institutions, this creates barriers to conducting abortion research. However, abortion researchers have also found ways to navigate these challenges successfully.
This exploratory study identified barriers that may constrain the generation of evidence in abortion care at some academic institutions, and can inform future endeavors to overcome limitations to abortion research.

OBJECTIVE: To explore the federal regulations governing clinical trials and human subject protection, the importance of research participant\'s informed consent, and the role the oncology clinical research nurse has within the clinical trial setting.
METHODS: Peer-reviewed journal articles, internet, book chapters, white papers.
CONCLUSIONS: Federal regulations mandate the conduct of a clinical research trial, human research participant protection, and the informed consent process.
CONCLUSIONS: The oncology nurse supports the autonomy and safe conduct of the human research participant during a clinical research trial and provides education and support through the informed consent process.

A cancer patient who uses heroin can\'t gain reasonable access to methadone to treat his disorder until he qualifies for hospice.