Hearing intervention versus health education control to reduce cognitive decline in older adults with hearing loss in the USA (ACHIEVE): a multicentre, randomised controlled trial.

BACKGROUND: Hearing loss is associated with increased cognitive decline and incident dementia in older adults. We aimed to investigate whether a hearing intervention could reduce cognitive decline in cognitively healthy older adults with hearing loss. METHODS: The ACHIEVE study is a multicentre, parallel-group, unmasked, randomised controlled trial of adults aged 70-84 years with untreated hearing loss and without substantial cognitive impairment that took place at four community study sites across the USA. Participants were recruited from two study populations at each site: (1) older adults participating in a long-standing observational study of cardiovascular health (Atherosclerosis Risk in Communities [ARIC] study), and (2) healthy de novo community volunteers. Participants were randomly assigned (1:1) to a hearing intervention (audiological counselling and provision of hearing aids) or a control intervention of health education (individual sessions with a health educator covering topics on chronic disease prevention) and followed up every 6 months. The primary endpoint was 3-year change in a global cognition standardised factor score from a comprehensive neurocognitive battery. Analysis was by intention to treat. This trial was registered at ClinicalTrials.gov, NCT03243422. FINDINGS: From Nov 9, 2017, to Oct 25, 2019, we screened 3004 participants for eligibility and randomly assigned 977 (32·5%; 238 [24%] from ARIC and 739 [76%] de novo). We randomly assigned 490 (50%) to the hearing intervention and 487 (50%) to the health education control. The cohort had a mean age of 76·8 years (SD 4·0), 523 (54%) were female, 454 (46%) were male, and most were White (n=858 [88%]). Participants from ARIC were older, had more risk factors for cognitive decline, and had lower baseline cognitive scores than those in the de novo cohort. In the primary analysis combining the ARIC and de novo cohorts, 3-year cognitive change (in SD units) was not significantly different between the hearing intervention and health education control groups (-0·200 [95% CI -0·256 to -0·144] in the hearing intervention group and -0·202 [-0·258 to -0·145] in the control group; difference 0·002 [-0·077 to 0·081]; p=0·96). However, a prespecified sensitivity analysis showed a significant difference in the effect of the hearing intervention on 3-year cognitive change between the ARIC and de novo cohorts (pinteraction=0·010). Other prespecified sensitivity analyses that varied analytical parameters used in the total cohort did not change the observed results. No significant adverse events attributed to the study were reported with either the hearing intervention or health education control. INTERPRETATION: The hearing intervention did not reduce 3-year cognitive decline in the primary analysis of the total cohort. However, a prespecified sensitivity analysis showed that the effect differed between the two study populations that comprised the cohort. These findings suggest that a hearing intervention might reduce cognitive change over 3 years in populations of older adults at increased risk for cognitive decline but not in populations at decreased risk for cognitive decline. FUNDING: US National Institutes of Health.

Hearing loss and cognition: A protocol for ensuring speech understanding before neurocognitive assessment.

INTRODUCTION: Many neurocognitive evaluations involve auditory stimuli, yet there are no standard testing guidelines for individuals with hearing loss. The ensuring speech understanding (ESU) test was developed to confirm speech understanding and determine whether hearing accommodations are necessary for neurocognitive testing. METHODS: Hearing was assessed using audiometry. The probability of ESU test failure by hearing status was estimated in 2679 participants (mean age: 81.4 ± 4.6 years) using multivariate logistic regression. RESULTS: Only 2.2% (N = 58) of participants failed the ESU test. The probability of failure increased with hearing loss severity; similar results were observed for those with and without mild cognitive impairment or dementia. DISCUSSION: The ESU test is appropriate for individuals who have variable degrees of hearing loss and cognitive function. This test can be used prior to neurocognitive testing to help reduce the risk of hearing loss and compromised auditory access to speech stimuli causing poorer performance on neurocognitive evaluation.

Everyday Clinical Ethics: Essential Skills and Educational Case Scenarios.

Bioethics conjures images of dramatic healthcare challenges, yet everyday clinical ethics issues unfold regularly. Without sufficient ethical awareness and a relevant working skillset, clinicians can feel ill-equipped to respond to the ethical dimensions of everyday care. Bioethicists were interviewed to identify the essential skills associated with everyday clinical ethics and to identify educational case scenarios to illustrate everyday clinical ethics. Individual, semi-structured interviews were conducted with a convenience sample of bioethicists. Bioethicists were asked: (1) What are the essential skills required for everyday clinical ethics? And (2) What are potential educational case scenarios to illustrate and teach everyday clinical ethics? Participant interviews were analyzed using qualitative content analysis. Twenty-five (25) bioethicists completed interviews (64% female; mean 14.76 years bioethics experience; 80% white). Five categories of general skills and three categories of ethics-specific skills essential for everyday clinical ethics were identified. General skills included: (1) Awareness of Core Values and Self-Reflective Capacity; (2) Perspective-Taking and Empathic Presence; (3) Communication and Relational Skills; (4) Cultural Humility and Respect; and (5) Organizational Understanding and Know-How. Ethics-specific skills included: (1) Ethical Awareness; (2) Ethical Knowledge and Literacy; and (3) Ethical Analysis and Interaction. Collectively, these skills comprise a Toolbox of Everyday Clinical Ethics Skills. Educational case scenarios were identified to promote everyday ethics. Bioethicists identified skills essential to everyday clinical ethics. Educational case scenarios were identified for the purpose of promoting proficiency in this domain. Future research could explore the impact of integrating educational case scenarios on clinicians' ethical competencies.

A Multicenter Observational Study Comparing Virtual with In-Person Morning Reports during the COVID-19 Pandemic.

OBJECTIVES: The coronavirus disease 2019 (COVID-19) pandemic disrupted how educational conferences were delivered, leaving programs to choose between in-person and virtual morning report formats. The objective of our study was to describe morning reports during the COVID-19 pandemic, including the use of virtual formats, attendance, leadership, and content. METHODS: A prospective observational study of morning reports was conducted at 13 Internal Medicine residency programs between September 1, 2020 and March 30, 2021, including a follow-up survey of current morning report format in January 2023. RESULTS: In total, 257 reports were observed; 74% used virtual formats, including single hospital, multiple hospital, and a hybrid format with both in-person and virtual participants. Compared with in-person reports, virtual reports had more participants, with increased numbers of learners (median 21 vs 7; P < 0.001) and attendings (median 4 vs 2; P < 0.001), and they were more likely to involve medical students (83% vs 40%; P < 0.001), interns (99% vs 53%; P < 0.001), and program directors (68% vs 32%; P < 0.001). Attendings were less likely to lead virtual reports (3% vs 28%, P < 0.001). Virtual reports also were more likely to be case based (88% vs 69%; P < 0.001) and to use digital presentation slides (91% vs 36%; P < 0.001). There was a marked increase in the number of slides (median 20 vs 0; P < 0.001). As of January 2023, all 13 programs had returned to in-person reports, with only 1 program offering an option to participate virtually. CONCLUSIONS: During the COVID-19 pandemic, virtual morning report formats predominated. Compared with traditional in-person reports, virtual report increased attendance, favored resident leadership, and approached a similar range of patient diagnoses with a greater number of case-based presentations and slides. In spite of these characteristics, all programs returned to an in-person format for morning report as pandemic restrictions waned.

What internal medicine attendings talk about at morning report: a multicenter study.

BACKGROUND: Morning report is a core educational activity in internal medicine resident education. Attending physicians regularly participate in morning report and influence the learning environment, though no previous study has described the contribution of attending physicians to this conference. This study aims to describe attending comments at internal medicine morning reports. METHODS: We conducted a prospective, observational study of morning reports conducted at 13 internal medicine residency programs between September 1, 2020, and March 30, 2021. Each attending comment was described including its duration, whether the comment was teaching or non-teaching, teaching topic, and field of practice of the commenter. We also recorded morning report-related variables including number of learners, report format, program director participation, and whether report was scripted (facilitator has advance knowledge of the case). A regression model was developed to describe variables associated with the number of attending comments per report. RESULTS: There were 2,344 attending comments during 250 conferences. The median number of attendings present was 3 (IQR, 2-5). The number of comments per report ranged across different sites from 3.9 to 16.8 with a mean of 9.4 comments/report (SD, 7.4). 66% of comments were shorter than one minute in duration and 73% were categorized as teaching by observers. The most common subjects of teaching comments were differential diagnosis, management, and testing. Report duration, number of general internists, unscripted reports, and in-person format were associated with significantly increased number of attending comments. CONCLUSIONS: Attending comments in morning report were generally brief, focused on clinical teaching, and covered a wide range of topics. There were substantial differences between programs in terms of the number of comments and their duration which likely affects the local learning environment. Morning report stakeholders that are interested in increasing attending involvement in morning report should consider employing in-person and unscripted reports. Additional studies are needed to explore best practice models of attending participation in morning report.

The effects of vitamin D supplementation on frailty in older adults at risk for falls.

BACKGROUND: Low serum 25-hydroxyvitamin D [25(OH)D] level is associated with a greater risk of frailty, but the effects of daily vitamin D supplementation on frailty are uncertain. This secondary analysis aimed to examine the effects of vitamin D supplementation on frailty using data from the Study To Understand Fall Reduction and Vitamin D in You (STURDY). METHODS: The STURDY trial, a two-stage Bayesian, response-adaptive, randomized controlled trial, enrolled 688 community-dwelling adults aged ≥ 70 years with a low serum 25(OH)D level (10-29 ng/mL) and elevated fall risk. Participants were initially randomized to 200 IU/d (control dose; n = 339) or a higher dose (1000 IU/d, 2000 IU/d, or 4000 IU/d; n = 349) of vitamin D3. Once the 1000 IU/d was selected as the best higher dose, other higher dose groups were reassigned to the 1000 IU/d group and new enrollees were randomized 1:1 to 1000 IU/d or control group. Data were collected at baseline, 3, 12, and 24 months. Frailty phenotype was based on number of the following conditions: unintentional weight loss, exhaustion, slowness, low activity, and weakness (≥ 3 conditions as frail, 1 or 2 as pre-frail, and 0 as robust). Cox proportional hazard models estimated the risk of developing frailty, or improving or worsening frailty status at follow-up. All models were adjusted for demographics, health conditions, and further stratified by baseline serum 25(OH)D level (insufficiency (20-29 ng/mL) vs. deficiency (10-19 ng/mL)). RESULTS: Among 687 participants (mean age 77.1 ± 5.4, 44% women) with frailty assessment at baseline, 208 (30%) were robust, 402 (59%) were pre-frail, and 77 (11%) were frail. Overall, there was no significant difference in risk of frailty outcomes comparing the pooled higher doses (PHD; ≥ 1000 IU/d) vs. 200 IU/d. When comparing each higher dose vs. 200 IU/d, the 2000 IU/d group had nearly double the risk of worsening frailty status (HR = 1.89, 95% CI: 1.13-3.16), while the 4000 IU/d group had a lower risk of developing frailty (HR = 0.22, 95% CI: 0.05-0.97). There were no significant associations between vitamin D doses and frailty status in the analyses stratified by baseline serum 25(OH)D level. CONCLUSIONS: High dose vitamin D supplementation did not prevent frailty. Significant subgroup findings might be the results of type 1 error. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02166333 .

The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults : A Response-Adaptive, Randomized Clinical Trial.

BACKGROUND: Vitamin D supplementation may prevent falls in older persons, but evidence is inconsistent, possibly because of dosage differences. OBJECTIVE: To compare the effects of 4 doses of vitamin D3 supplements on falls. DESIGN: 2-stage Bayesian, response-adaptive, randomized trial. (ClinicalTrials.gov: NCT02166333). SETTING: 2 community-based research units. PARTICIPANTS: 688 participants, aged 70 years and older, with elevated fall risk and a serum 25-hydroxyvitamin D [25-(OH)D] level of 25 to 72.5 nmol/L. INTERVENTION: 200 (control), 1000, 2000, or 4000 IU of vitamin D3 per day. During the dose-finding stage, participants were randomly assigned to 1 of the 4 vitamin D3 doses, and the best noncontrol dose for preventing falls was determined. After dose finding, participants previously assigned to receive noncontrol doses received the best dose, and new enrollees were randomly assigned to receive 200 IU/d or the best dose. MEASUREMENTS: Time to first fall or death over 2 years (primary outcome). RESULTS: During the dose-finding stage, the primary outcome rates were higher for the 2000- and 4000-IU/d doses than for the 1000-IU/d dose, which was selected as the best dose (posterior probability of being best, 0.90). In the confirmatory stage, event rates were not significantly different between participants with experience receiving the best dose (events and observation time limited to the period they were receiving 1000 IU/d; n = 308) and those randomly assigned to receive 200 IU/d (n = 339) (hazard ratio [HR], 0.94 [95% CI, 0.76 to 1.15]; P = 0.54). Analysis of falls with adverse outcomes suggested greater risk in the experience-with-best-dose group versus the 200-IU/d group (serious fall: HR, 1.87 [CI, 1.03 to 3.41]; fall with hospitalization: HR, 2.48 [CI, 1.13 to 5.46]). LIMITATIONS: The control group received 200 IU of vitamin D3 per day, not a placebo. Dose finding ended before the prespecified thresholds for dose suspension and dose selection were reached. CONCLUSION: In older persons with elevated fall risk and low serum 25-(OH)D levels, vitamin D3 supplementation at doses of 1000 IU/d or higher did not prevent falls compared with 200 IU/d. Several analyses raised safety concerns about vitamin D3 doses of 1000 IU/d or higher. PRIMARY FUNDING SOURCE: National Institute on Aging.

Improving Mental Health Communication From the Pediatric Emergency Department to Primary Care.

OBJECTIVES: Suicide is a leading cause of adolescent death, and emergency department (ED) visits are recognized as an opportunity to identify at-risk youth. For patients screening positive for mental health concerns, we implemented a quality improvement initiative to enhance documentation of results and interventions in the ED, increase communication between the ED and primary care providers (PCPs), and increase PCP follow-up. METHODS: Interventions included education, feedback, and an alert in our electronic health record. Completion of a Behavioral Health Screen (BHS-ED) initiates an alert that reminds ED providers how to document and communicate results and needed follow-up to the PCP. We reviewed a random monthly sample of ED charts for adolescents 14 to 19 years old presenting with nonpsychiatric complaints who screened positive for severe depression or suicidality. Outcome measures included documentation of BHS-ED results in the ED note, communication of positive results to the PCP, PCP follow-up of results, and ED return visits. RESULTS: Documentation of BHS-ED results increased from 73% at baseline to 88% of patients after the intervention. For patients discharged from the ED with nonpsychiatric chief complaints, communication to PCPs increased from 1% at baseline to 40% during the final 3 months of the study. When PCP communication occurred, 67% of in-network PCPs followed up with patients versus 5% when no communication took place from the ED. CONCLUSIONS: A multifaceted intervention including education and an electronic health record alert improved ED documentation, communication, and PCP follow-up of issues identified during ED-based mental health screens.

An Integrated Review of Cannabis and Cannabinoids in Adult Oncologic Pain Management.

OBJECTIVE: The objective of this paper is to review the available literature regarding the use of cannabis and cannabinoids in adult oncologic pain management. DESIGN AND DATA SOURCES: A integrative review was conducted on March 1, 2018 using PubMed, MEDLINE, CINAHL, Embase, and Scopus. A snowball method was used to extract studies included in systematic reviews that were not included in the primary literature search. REVIEW METHOD: Articles reviewed address the use of cannabinoids or cannabis for pain management in oncology patients, either as stand- alone or adjuvant therapy. RESULTS: The final number of articles included is nine articles. Of the nine studies reviewed, eight reviewed the effect of the cannabinoid THC on cancer pain, and one study reviewed the use of medicinally available whole plant cannabis. The following study types were included: multiple multi-center, randomized, placebo- controlled trials and two prospective observational survey studies. RESULTS AND CONCLUSIONS: Of the eight studies that reviewed the effect of the cannabinoid THC, five found THC to be more effective than placebo, one found THC to be more effective than placebo in American patients but ineffective in patients from other countries, and two found THC to be no more effective than placebo. The study that reviewed the effect of the whole plant cannabis found that there was a significant decrease in pain among those patients smoking cannabis. NURSING PRACTICE IMPLICATIONS: The lack of evidence in this field of research suggests a need to change policy surrounding cannabis research.

Comparisons of IQ in Children With and Without Cochlear Implants: Longitudinal Findings and Associations With Language.

OBJECTIVES: To make longitudinal comparisons of intelligence quotient (IQ) in children with cochlear implants (CIs) and typical hearing peers from early in development to the school-age period. Children with additional comorbidities and CIs were also evaluated. To estimate the impact of socioeconomic status and oral language on school-age cognitive performance. DESIGN: This longitudinal study evaluated nonverbal IQ in a multicenter, national sample of 147 children with CIs and 75 typically hearing peers. IQ was evaluated at baseline, prior to cochlear implantation, using the Bayley Scales of Infant and Toddler Development and the Leiter International Performance Scale. School-age IQ was assessed using the Wechsler Intelligence Scales for Children. For the current study, only the Perceptual Reasoning and Processing Speed indices were administered. Oral language was evaluated using the Comprehensive Assessment of Spoken Language. RESULTS: Children in the CI group scored within the normal range of intelligence at both time points. However, children with additional comorbidities scored significantly worse on the Processing Speed, but not the Perceptual Reasoning Index. Maternal education and language were significantly related to school-age IQ in both groups. Importantly, language was the strongest predictor of intellectual functioning in both children with CIs and normal hearing. CONCLUSION: These results suggest that children using cochlear implants perform similarly to hearing peers on measures of intelligence, but those with severe comorbidities are at-risk for cognitive deficits. Despite the strong link between socioeconomic status and intelligence, this association was no longer significant once spoken language performance was accounted for. These results reveal the important contributions that early intervention programs, which emphasize language and parent training, contribute to cognitive functioning in school-age children with CIs. For families from economically disadvantaged backgrounds, who are at-risk for suboptimal outcomes, these early intervention programs are critical to improve overall functioning.

The Effects of Closed-Loop Medical Devices on the Autonomy and Accountability of Persons and Systems.

Closed-loop medical devices such as brain-computer interfaces are an emerging and rapidly advancing neurotechnology. The target patients for brain-computer interfaces (BCIs) are often severely paralyzed, and thus particularly vulnerable in terms of personal autonomy, decisionmaking capacity, and agency. Here we analyze the effects of closed-loop medical devices on the autonomy and accountability of both persons (as patients or research participants) and neurotechnological closed-loop medical systems. We show that although BCIs can strengthen patient autonomy by preserving or restoring communicative abilities and/or motor control, closed-loop devices may also create challenges for moral and legal accountability. We advocate the development of a comprehensive ethical and legal framework to address the challenges of emerging closed-loop neurotechnologies like BCIs and stress the centrality of informed consent and refusal as a means to foster accountability. We propose the creation of an international neuroethics task force with members from medical neuroscience, neuroengineering, computer science, medical law, and medical ethics, as well as representatives of patient advocacy groups and the public.

Whose role? Oncology practitioners' perceptions of their role in providing spiritual care to advanced cancer patients.

PURPOSE: The purpose of this study is to determine how oncology nurses and physicians view their role in providing spiritual care (SC), factors influencing this perception, and how this belief affects SC provision. METHODS: This is a survey-based, multisite study conducted from October 2008 to January 2009. All oncology physicians and nurses caring for advanced cancer patients at four Boston, MA cancer centers were invited to participate; 339 participated (response rate = 63 %). RESULTS: Nurses were more likely than physicians to report that it is the role of medical practitioners to provide SC, including for doctors (69 vs. 49 %, p < 0.001), nurses (73 vs. 49 %, p < 0.001), and social workers (81 vs. 63 %, p = 0.001). Among nurses, older age was the only variable that was predictive of this belief [adjusted odds ratio (AOR) 1.08; 1.01-1.16, p = 0.02]. For nurses, role perception was not related to actual SC provision to patients. In contrast, physicians' role perceptions were influenced by their intrinsic religiosity (AOR, 1.44; 95 % CI, 1.09-1.89; p = 0.01) and spirituality (AOR, 6.41; 95 % CI, 2.31-17.73, p < 0.001). Furthermore, physicians who perceive themselves as having a role in SC provision reported greater SC provision to their last advanced cancer patients seen in clinic, 69 % compared to 31 %, p < 0.001. CONCLUSIONS: Nurses are more likely than physicians to perceive medical practitioners as having a role in SC provision. Physicians' perceptions of their role in SC provision are influenced by their religious/spiritual characteristics and are predictive of actual SC provision to patients. Spiritual care training that includes improved understanding of clinicians' appropriate role in SC provision to severely ill patients may lead to increased SC provision.

The Value of Virginity.

Hymen reconstruction surgery is a simple procedure to repair a woman's hymen, requested by women who, for religious and cultural reasons, believe they must appear to have an intact hymen on their wedding night. Debates surrounding possible ethical justification for the procedure are complex and heated. These articles from the Harvard Ethics Consortium present and explore the case of a young woman who asked a young female physician on call for a referral for the procedure.

Hinduism and death with dignity: historic and contemporary case examples.

An estimated 1.2 to 2.3 million Hindus live in the United States. End-of-life care choices for a subset of these patients may be driven by religious beliefs. In this article, we present Hindu beliefs that could strongly influence a devout person's decisions about medical care, including end-of-life care. We provide four case examples (one sacred epic, one historical example, and two cases from current practice) that illustrate Hindu notions surrounding pain and suffering at the end of life. Chief among those is the principle of karma, through which one reaps the benefits and penalties for past deeds. Deference to one's spouse or family is another important Hindu value, especially among Hindu women, which can impact the decision-making process and challenge the Western emphasis on autonomy. In addition, the Hindu embrace of astrology can lead to a desire to control the exact time of death. Confounding any generalizations, a Hindu patient may reject or accept treatments based on the individual patient's or family's interpretation of any given tradition. Through an awareness of some of the fundamental practices in Hinduism and the role of individual interpretation within the tradition, clinicians will be better able to support their Hindu patients and families at the end of life.

Does professional orientation predict ethical sensitivities? Attitudes of paediatric and obstetric specialists toward fetuses, pregnant women and pregnancy termination.

BACKGROUND: To determine (1) whether fetal care paediatric (FCP) and maternal-fetal medicine (MFM) specialists harbour differing attitudes about pregnancy termination for congenital fetal conditions, their perceived responsibilities to pregnant women and fetuses, and the fetus as a patient and (2) whether self-perceived primary responsibilities to fetuses and women and views about the fetus as a patient are associated with attitudes about clinical care. METHODS: Mail survey of 434 MFM and FCP specialists (response rates 60.9% and 54.2%, respectively). RESULTS: MFMs were more likely than FCPs to disagree with these statements (all p values<0.005): (1) 'the presence of a fetal abnormality is not an appropriate reason for a couple to consider pregnancy termination' (MFM : FCP-78.4% vs 63.5%); (2) 'the effects that a child born with disabilities might have on marital and family relationships is not an appropriate reason for a couple to consider pregnancy termination' (MFM : FCP-80.5% vs 70.2%); and (3) 'the cost of healthcare for the future child is not an appropriate reason for a couple to consider pregnancy termination' (MFM : FCP-73.5% vs 55.9%). 65% MFMs versus 47% FCPs disagreed that their professional responsibility is to focus primarily on fetal well-being (p<0.01). Specialists did not differ regarding the fetus as a separate patient. Responses about self-perceived responsibility to focus on fetal well-being were associated with clinical practice attitudes. CONCLUSIONS: Independent of demographic and sociopolitical characteristics, FCPs and MFMs possess divergent ethical sensitivities regarding pregnancy termination, pregnant women and fetuses, which may influence clinical care.