Moral distress among clinicians working in US safety net practices during the COVID-19 pandemic: a mixed methods study

Objective To explore the causes and levels of moral distress experienced by clinicians caring for the low-income patients of safety net practices in the USA during the COVID-19 pandemic. Design Cross-sectional survey in late 2020, employing quantitative and qualitative analyses. Setting Safety net practices in 20 US states. Participants 2073 survey respondents (45.8% response rate) in primary care, dental and behavioural health disciplines working in safety net practices and participating in state and national education loan repayment programmes. Measures Ordinally scaled degree of moral distress experienced during the pandemic, and open-ended response descriptions of issues that caused most moral distress. Results Weighted to reflect all surveyed clinicians, 28.4% reported no moral distress related to work during the pandemic, 44.8% reported ‘mild’ or ‘uncomfortable’ levels and 26.8% characterised their moral distress as ‘distressing’, ‘intense’ or ‘worst possible’. The most frequently described types of morally distressing issues encountered were patients not being able to receive the best or needed care, and patients and staff risking infection in the office. Abuse of clinic staff, suffering of patients, suffering of staff and inequities for patients were also morally distressing, as were politics, inequities and injustices within the community. Clinicians who reported instances of inequities for patients and communities and the abuse of staff were more likely to report higher levels of moral distress. Conclusions During the pandemic’s first 9 months, moral distress was common among these clinicians working in US safety net practices. But for only one-quarter was this significantly distressing. As reported for hospital-based clinicians during the pandemic, this study’s clinicians in safety net practices were often morally distressed by being unable to provide optimal care to patients. New to the literature is clinicians’ moral distress from witnessing inequities and other injustices for their patients and communities

A national study of moral distress among U.S. internal medicine physicians during the COVID-19 pandemic

Background There have been no studies to date of moral distress during the COVID-19 pandemic in national samples of U.S. health workers. The purpose of this study was to determine, in a national sample of internal medicine physicians (internists) in the U.S.: 1) the intensity of moral distress; 2) the predictors of moral distress; 3) the outcomes of moral distress. Methods We conducted a national survey with an online panel of internists, representative of the membership of the American College of Physicians, the largest specialty organization of physicians in the United States, between September 21 and October 8, 2020. Moral distress was measured with the Moral Distress Thermometer, a one-item scale with a range of 0 (“none”) to 10 (“worst possible”). Outcomes were measured with short screening scales. Results The response rate was 37.8% (N = 810). Moral distress intensity was low (mean score = 2.4, 95% CI, 2.2–2.6); however, 13.3% (95% CI, 12.1% - 14.5%) had a moral distress score greater than or equal to 6 (“distressing”). In multiple linear regression models, perceived risk of death if infected with COVID-19 was the strongest predictor of higher moral distress (β (standardized regression coefficient) = 0.26, p < .001), and higher perceived organizational support (respondent belief that their health organization valued them) was most strongly associated with lower moral distress (β = -0.22, p < .001). Controlling for other factors, high levels of moral distress, but not low levels, were strongly associated (adjusted odds ratios 3.0 to 11.5) with screening positive for anxiety, depression, posttraumatic stress disorder, burnout, and intention to leave patient care. Conclusions The intensity of moral distress among U.S. internists was low overall. However, the 13% with high levels of moral distress had very high odds of adverse mental health outcomes. Organizational support may lower moral distress and thereby prevent adverse mental health outcomes

Phase 1b/2a trial of the superoxide dismutase mimetic GC4419 to reduce chemoradiotherapy-induced oral mucositis in patients with oral cavity or oropharyngeal carcinoma

PURPOSE: To assess the safety of the superoxide dismutase mimetic GC4419 in combination with radiation and concurrent cisplatin for patients with oral cavity or oropharyngeal cancer (OCC) and to assess the potential of GC4419 to reduce severe oral mucositis (OM). PATIENTS AND METHODS: Patients with locally advanced OCC treated with definitive or postoperative intensity modulated radiation therapy (IMRT) plus cisplatin received GC4419 by 60-minute intravenous infusion, ending \u3c60 minutes before IMRT, Monday through Friday for 3 to 7 weeks, in a dose and duration escalation study. Oral mucositis was assessed twice weekly during and weekly after IMRT. RESULTS: A total of 46 patients received GC4419 in 11 separate dosing and duration cohorts: dose escalation occurred in 5 cohorts receiving 15 to 112 mg/d over 3 weeks (n=20), duration escalation in 3 cohorts receiving 112 mg/d over 4 to 6 weeks (n=12), and then 3 additional cohorts receiving 30 or 90 mg/d over 6 to 7 weeks (n=14). A maximum tolerated dose was not reached. One dose-limiting toxicity (grade 3 gastroenteritis and vomiting with hyponatremia) occurred in each of 2 separate cohorts at 112 mg. Nausea/vomiting and facial paresthesia during infusion seemed to be GC4419 dose-related. Severe OM occurred through 60 Gy in 4 of 14 patients (29%) dosed for 6 to 7 weeks, with median duration of only 2.5 days. CONCLUSIONS: The safety of GC4419 concurrently with chemoradiation for OCC was acceptable. Toxicities included nausea/vomiting and paresthesia. Doses of 30 and 90 mg/d administered for 7 weeks were selected for further study. In an exploratory analysis, severe OM seemed less frequent and briefer than expected

Moral distress among clinicians working in US safety net practices during the COVID-19 pandemic: a mixed methods study

Objective To explore the causes and levels of moral distress experienced by clinicians caring for the low-income patients of safety net practices in the USA during the COVID-19 pandemic. Design Cross-sectional survey in late 2020, employing quantitative and qualitative analyses. Setting Safety net practices in 20 US states. Participants 2073 survey respondents (45.8% response rate) in primary care, dental and behavioural health disciplines working in safety net practices and participating in state and national education loan repayment programmes. EMPAVELI® (pegcetacoplan) - Official Physician Website See Prescribing Info & Boxed Warning. Read What to Know Before Prescribing EMPAVELI. empavelihcp.com Measures Ordinally scaled degree of moral distress experienced during the pandemic, and open-ended response descriptions of issues that caused most moral distress. Results Weighted to reflect all surveyed clinicians, 28.4% reported no moral distress related to work during the pandemic, 44.8% reported ‘mild’ or ‘uncomfortable’ levels and 26.8% characterised their moral distress as ‘distressing’, ‘intense’ or ‘worst possible’. The most frequently described types of morally distressing issues encountered were patients not being able to receive the best or needed care, and patients and staff risking infection in the office. Abuse of clinic staff, suffering of patients, suffering of staff and inequities for patients were also morally distressing, as were politics, inequities and injustices within the community. Clinicians who reported instances of inequities for patients and communities and the abuse of staff were more likely to report higher levels of moral distress. Conclusions During the pandemic’s first 9 months, moral distress was common among these clinicians working in US safety net practices. But for only one-quarter was this significantly distressing. As reported for hospital-based clinicians during the pandemic, this study’s clinicians in safety net practices were often morally distressed by being unable to provide optimal care to patients. New to the literature is clinicians’ moral distress from witnessing inequities and other injustices for their patients and communities

Psychological treatments for adults with posttraumatic stress disorder: A systematic review and meta-analysis

Numerous guidelines have been developed over the past decade regarding treatments for Posttraumatic stress disorder (PTSD). However, given differences in guideline recommendations, some uncertainty exists regarding the selection of effective PTSD therapies. The current manuscript assessed the efficacy, comparative effectiveness, and adverse effects of psychological treatments for adults with PTSD. We searched MEDLINE, Cochrane Library, PILOTS, Embase, CINAHL, PsycINFO, and the Web of Science. Two reviewers independently selected trials. Two reviewers assessed risk of bias and graded strength of evidence (SOE). We included 64 trials; patients generally had severe PTSD. Evidence supports efficacy of exposure therapy (high SOE) including the manualized version Prolonged Exposure (PE); cognitive therapy (CT), cognitive processing therapy (CPT), cognitive behavioral therapy (CBT)-mixed therapies (moderate SOE); eye movement desensitization and reprocessing (EMDR) and narrative exposure therapy (low-moderate SOE). Effect sizes for reducing PTSD symptoms were large (e.g., Cohen's d ~-1.0 or more compared with controls). Numbers needed to treat (NNTs) were <4 to achieve loss of PTSD diagnosis for exposure therapy, CPT, CT, CBT-mixed, and EMDR. Several psychological treatments are effective for adults with PTSD. Head-to-head evidence was insufficient to determine these treatments' comparative effectiveness, and data regarding adverse events was absent from most studies

Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer

PURPOSE: Oral mucositis (OM) remains a common, debilitating toxicity of radiation therapy (RT) for head and neck cancer. The goal of this phase IIb, multi-institutional, randomized, double-blind trial was to compare the efficacy and safety of GC4419, a superoxide dismutase mimetic, with placebo to reduce the duration, incidence, and severity of severe OM (SOM). PATIENTS AND METHODS: A total of 223 patients (from 44 institutions) with locally advanced oral cavity or oropharynx cancer planned to be treated with definitive or postoperative intensity-modulated RT (IMRT; 60 to 72 Gy [≥ 50 Gy to two or more oral sites]) plus cisplatin (weekly or every 3 weeks) were randomly assigned to receive 30 mg (n = 73) or 90 mg (n = 76) of GC4419 or to receive placebo (n = 74) by 60-minute intravenous administration before each IMRT fraction. WHO grade of OM was assessed biweekly during IMRT and then weekly for up to 8 weeks after IMRT. The primary endpoint was duration of SOM tested for each active dose level versus placebo (intent-to-treat population, two-sided α of .05). The National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03, was used for adverse event grading. RESULTS: Baseline patient and tumor characteristics as well as treatment delivery were balanced. With 90 mg GC4419 versus placebo, SOM duration was significantly reduced (P = .024; median, 1.5 v 19 days). SOM incidence (43% v 65%; P = .009) and severity (grade 4 incidence, 16% v 30%; P = .045) also were improved. Intermediate improvements were seen with the 30-mg dose. Safety was comparable across arms, with no significant GC4419-specific toxicity nor increase of known toxicities of IMRT plus cisplatin. The 2-year follow-up for tumor outcomes is ongoing. CONCLUSION: GC4419 at a dose of 90 mg produced a significant, clinically meaningful reduction of SOM duration, incidence, and severity with acceptable safety

Approval processes in evidence-based clinical practice guidelines sponsored by medical specialty societies.

OBJECTIVE:To determine the approval processes for evidence-based Clinical Practice Guidelines sponsored by medical specialty societies in the United States. STUDY DESIGN AND SETTING:Cross-sectional analysis of published Clinical Practice Guidelines and Guideline procedure manuals, sponsored by the 43 members of the Council of Medical Specialty Societies in the United States. Approval processes were measured by written evidence in the specialty society's guideline procedure manual or published guidelines, through May 2017. RESULTS:Among the 36 (of 43) specialty societies that published evidence-based Clinical Practice Guidelines, 27 (75%) required approval by a committee representing the society as a whole. None specified the criteria used for approval decisions. Six specialty societies (17%) required approval but included procedures to maintain some editorial independence for the guideline development group, such as approval by a guideline committee not an executive committee or approval dependent on fidelity to established guideline methodology, not content. One society required Board review, but not approval. The approval process was not reported by 2 (6%) of the specialty societies. CONCLUSIONS:Most medical specialty societies in the U.S. require approval of guidelines by a board that represents the society as whole. Since medical specialty societies have loyalties to the patients they serve and to their physician members, and because the interests of those two groups may differ, such an approval process introduces a potential conflict of interest into the guideline development process

Extreme response style bias in burn survivors.

This paper explores extreme response style to the Life Impact Burn Recovery Evaluation (LIBRE) Profile, a measure of social participation in burn survivors. We fit a Multidimensional Generalized Partial Credit Model (MGPCM) with a positive extreme response style (PERS) factor and compared this model with the original MGPCM, estimated the impact that PERS has on scores, and examined the personal characteristics that may result in an individual more likely to respond in a fashion that would inflate their true low scores. The average impact of the PERS, based upon the root mean squared bias, ranged from 0.27 to 0.50 of a standard deviation of the scale. Individuals who were older, had participated in a burn survivor support group, and had selected to self-administer the measure were less likely to have a high PERS bias that masks low scores. Future work can consider PERS when measuring the psychosocial impacts of burn injuries and other health conditions