Geographic Variation in Informed Consent Law: Two Standards for Disclosure of Treatment Risks

We analyzed 714 jury verdicts in informed consent cases tried in 25 states in 1985–2002 to determine whether the applicable standard of care (“patient” vs. “professional” standard) affected the outcome. Verdicts for plaintiffs were significantly more frequent in states with a patient standard than in states with a professional standard (27 percent vs. 17 percent, P = 0.02). This difference in outcomes did not hold for other types of medical malpractice litigation (36 percent vs. 37 percent, P = 0.8). The multivariate odds of a plaintiff’s verdict were more than twice as high in states with a patient standard than in states with a professional standard (odds ratio = 2.15, 95% confidence interval = 1.32–3.50). The law’s expectations of clinicians with respect to risk disclosure appear to vary geographically

How and Why to Do Things with Eighteenth-Century Manuscripts

This Element examines eighteenth-century manuscript forms, their functions in the literary landscape of their time, and the challenges and practices of manuscript study today. Drawing on both literary studies and book history, Levy and Schellenberg offer a guide to the principal forms of literary activity carried out in handwritten manuscripts produced in the first era of print dominance, 1730-1820. After an opening survey of sociable literary culture and its manuscript forms, numerous case studies explore what can be learned from three manuscript types: the verse miscellany, the familiar correspondence, and manuscripts of literary works that were printed. A final section considers issues of manuscript remediation up to the present, focusing particularly on digital remediation. The Element concludes with a brief case study of the movement of Phillis Wheatley\u27s poems between manuscript and print. This title is also available as Open Access on Cambridge Core

Frailty and the psychosocial components of the edmonton frail scale are most associated with patient experience in older kidney transplant candidates – a secondary analysis within the kidney transplantation in older people (KTOP) study

© 2023 Thind, Levy, Wellsted, Willicombe and Brown. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). https://creativecommons.org/licenses/by/4.0/Background: Older people with end-stage kidney disease (ESKD) are vulnerable to frailty, which impacts on clinical and experiential outcomes. With kidney transplantation in older people increasing, a better understanding of patient experiences is necessary for guiding decision making. The Kidney Transplantation in Older People (KTOP):impact of frailty on outcomes study aims to explore this. We present a secondary analysis of the Edmonton Frail Scale (EFS) and its relationship with patient experience scores. Methods: The KTOP study is a single centre, prospective study, which began in October 2019. All ESKD patients aged ≥60 considered for transplantation at Imperial College Renal and Transplant Centre were eligible. Frailty was assessed using the EFS and 5 questionnaires assessed patient experience and quality of life (QoL) (Short Form-12(v2), Palliative Care Outcome Scale–Symptoms Renal, Depression Patient Health Questionnaire-9, Illness Intrusiveness Ratings Scale, Renal Treatment Satisfaction Questionnaire). The EFS was divided into 4 subdomains (psychosocial, physical function, medical status, and general health) and then compared with the questionnaire scores. Results: 210 patients have been recruited (aged 60-78), 186 of whom completed EFS assessments. 118 (63.4%) participants were not frail, 36 (19.4%) vulnerable, and 32 (17.2%) were frail. Worse frailty scores were associated with poorer patient experience and QoL scores across all questionnaires. Severe deficits in the EFS psychosocial subdomain showed a statistically significant association with higher depression screen scores (coefficient 4.9, 95% CI 3.22 to 6.59), lower physical (coefficient -4.35, 95% CI -7.59 to -1.12) and mental function scores (coefficient -8.33, 95% CI -11.77 to -4.88) from the Short Form-12(v2), and lower renal treatment satisfaction scores (coefficient -5.54, 95% CI -10.70 to -0.37). Deficits in the physical function and medical status EFS subdomians showed some association with patient experience scores. Conclusion: In the KTOP study cohort at recruitment vulnerable and frail candidates reported worse QoL and patient experiences. Severe deficits in the psychosocial subdomains of the EFS showed a strong association with patient experience and QoL, whilst physical function and medical status deficits showed a lesser association. This has highlighted specific EFS domains that may be suitable for targeted interventions to improve experiences and optimise outcomes.Peer reviewe

Delivering the Strengthening Families Program to Native American Families During COVID-19: Lessons & Next Steps

The COVID-19 pandemic (COVID) of 2020 has forced adaptation for all Americans. Programs that serve Native American children and families are particularly critical during this time due to the disproportionate risks and disparities faced by this population. The objective of this qualitative evaluation is to gather adult participant feedback on strengths and needed changes with a telehealth adaptation of the Strengthening Families Program. This evaluation builds on previous knowledge of SFP group leadership which suggests that supportive helping relationships paired with dynamic flexibility are facilitators of effective family engagement. Participant feedback suggests that caregiver’s felt comfort, care, and genuine concern. In addition all participants noticed a difference in their families’ communication and relationships. Although tragic and challenging, the COVID-19 pandemic, forced a spotlight on barriers (limited internet access, social services, and food resources) that were needed to sustain participation and increase resilience among Native American residents in this mid-western state.  The individualized planning and checking in on every level which started out as a “how do we replicated this service” became about building resilience strategies for Native American families in this critical time in history

Surveillance for Waterborne-Disease Outbreaks -- United States, 1995-1996

PROBLEM/CONDITION: Since 1971, CDC and the U.S. Environmental Protection Agency have maintained a collaborative surveillance system for collecting and periodically reporting data that relate to occurrences and causes of waterborne-disease outbreaks (WBDOs). REPORTING PERIOD COVERED: This summary includes data for January 1995 through December 1996 and previously unreported outbreaks in 1994. DESCRIPTION OF THE SYSTEM: The surveillance system includes data about outbreaks associated with drinking water and recreational water. State, territorial, and local public health departments are primarily responsible for detecting and investigating WBDOs and for voluntarily reporting them to CDC on a standard form. RESULTS: For the period 1995-1996, 13 states reported a total of 22 outbreaks associated with drinking water. These outbreaks caused an estimated total of 2,567 persons to become ill. No deaths were reported. The microbe or chemical that caused the outbreak was identified for 14 (63.6%) of the 22 outbreaks. Giardia lamblia and Shigella sonnei each caused two (9.1%) of the 22 outbreaks; Escherichia coli O157:H7, Plesiomonas shigelloides, and a small round structured virus were implicated for one outbreak (4.5%) each. One of the two outbreaks of giardiasis involved the largest number of cases, with an estimated 1,449 ill persons. Seven outbreaks (31.8% of 22) of chemical poisoning, which involved a total of 90 persons, were reported. Copper and nitrite were associated with two outbreaks (9.1% of 22) each and sodium hydroxide, chlorine, and concentrated liquid soap with one outbreak (4.5%) each. Eleven (50.0%) of the 22 outbreaks were linked to well water, eight in noncommunity and three in community systems. Only three of the 10 outbreaks associated with community water systems were caused by problems at water treatment plants; the other seven resulted from problems in the water distribution systems and plumbing of individual facilities (e.g., a restaurant). Six of the seven outbreaks were associated with chemical contamination of the drinking water; the seventh outbreak was attributed to a small round structured virus. Four of the seven outbreaks occurred because of backflow or backsiphonage through a cross-connection, and two occurred because of high levels of copper that leached into water after the installation of new plumbing. For three of the four outbreaks caused by contamination from a cross-connection, an improperly installed vacuum breaker or a faulty backflow prevention device was identified; no protection against backsiphonage was found for the fourth outbreak. Thirty-seven outbreaks from 17 states were attributed to recreational water exposure and affected an estimated 9,129 persons, including 8,449 persons in two large outbreaks of cryptosporidiosis. Twenty-two (59.5%) of these 37 were outbreaks of gastroenteritis; nine (24.3%) were outbreaks of dermatitis; and six (16.2%) were single cases of primary amebic meningoencephalitis caused by Naegleria fowleri, all of which were fatal. The etiologic agent was identified for 33 (89.2%) of the 37 outbreaks. Six (27.3%) of the 22 outbreaks of gastroenteritis were caused by Cryptosporidium parvum and six (27.3%) by E. coli O157:H7. All of the latter were associated with unchlorinated water (i.e., in lakes) or inadequately chlorinated water (i.e., in a pool). Thirteen (59.1%) of these 22 outbreaks were associated with lake water, eight (36.4%) with swimming or wading pools, and one(4.5%) with a hot spring. Of the nine outbreaks of dermatitis, seven (77.8%) were outbreaks of Pseudomonas dermatitis associated with hot tubs, and two (22.2%) were lake-associated outbreaks of swimmer\u27s itch caused by Schistosoma species. INTERPRETATION: WBDOs caused by E. coli O157:H7 were reported more frequently than in previous years and were associated primarily with recreational lake water. This finding suggests the need for better monitoring of water quality and identification of sources of contamination. Although protozoan parasites, especially Cryptosporidium and Giardia, were associated with fewer reported outbreaks than in previous years, they caused large outbreaks that affected a total of approximately 10,000 persons; all of the outbreaks of cryptosporidiosis were associated with recreational water, primarily swimming pools. Prevention of pool-associated outbreaks caused by chlorine-resistant parasites (e.g., Cryptosporidium and to a lesser extent Giardia) is particularly difficult because it requires improved filtration methods as well as education of patrons about hazards associated with fecal accidents, especially in pools frequented by diaper-aged children. The proportion of reported drinking water outbreaks associated with community water systems that were attributed to problems at water treatment plants has steadily declined since 1989 (i.e., 72.7% for 1989-1990, 62.5% for 1991-1992, 57.1% for 1993-1994, and 30.0% for 1995-1996). This decrease might reflect improvements in water treatment and in operation of plants. The outbreaks attributed to contamination in the distribution system suggest that efforts should be increased to prevent cross-connections, especially by installing and monitoring backflow prevention devices. Actions Taken: Surveillance data that identify the types of water systems, their deficiencies, and the etiologic agents associated with outbreaks are used to evaluate the adequacy of current technologies for providing safe drinking and recreational water. In addition, they are used to establish research priorities and can lead to improved water-quality regulations

Predictors of IAPT psychological well-being practitioners’ intention to use CBT self-help materials routinely in their clinical practice

Despite efficacy and effectiveness evidence, and recommendations from the National Institute for Health and Care Excellence (NICE), use of CBT self-help materials remains inconsistent in UK mental health services. Since 2006, the Improving Access to Psychological Therapies (IAPT) programme has provided standardized training and mandates routine use of CBT self-help materials by their trainee psychological well-being practitioners (PWPs). This study tested whether the main constructs of the theory of planned behaviour (TPB; attitudes, subjective norms, and perceived behavioural control), past use, prior training and demographic characteristics, would predict PWPs’ intention to use self-help materials routinely in their clinical practice. Stage 1 utilized a standardized procedure to create measures for the constructs of TPB, before the design and testing of a web-based, cross-sectional questionnaire. In stage 2, the questionnaire was administered to a convenience sample of trainee PWPs (n = 94). Data was analysed using multiple linear regression, mediation analyses, and content analysis. TPB constructs predicted intention to use self-help materials, with only direct attitude contributing significantly to 70% of the variance in intention. Past use of materials predicted intention, via direct and indirect mediation. Qualitative data from 43 trainees highlighted clients’ experience of self-help materials as positive, albeit with some practical constraints. The results suggest that the main constructs of TPB have some utility in predicting trainee PWPs’ intention to use self-help materials routinely. Future prospective, longitudinal research could investigate actual use of self-help materials to elucidate cognitive factors involved in trainees’ clinical decision-making post-qualification

Acoustic and perceptual consequences of speech cues for children with dysarthria

Purpose: Reductions in articulatory working space and vocal intensity have been linked to intelligibility deficits in children with dysarthria due to cerebral palsy. However, few studies have examined the outcomes of behavioral treatments aimed at these underlying impairments or investigated which treatment cues might best facilitate improved intelligibility. This study assessed the effects of cues targeting clear speech (i.e., “Speak with your big mouth”) and greater vocal intensity (i.e., “Speak with your strong voice”) on acoustic measures of speech production and intelligibility. Method: Eight children with spastic dysarthria due to cerebral palsy repeated sentence- and word-level stimuli across habitual, big mouth, and strong voice conditions. Acoustic analyses were conducted, and 48 listeners completed orthographic transcription and scaled intelligibility ratings. Results: Both cues resulted in significant changes to vocal intensity and speech rate although the degree of change varied by condition. In a similar manner, perceptual analysis revealed significant improvements to intelligibility with both cues; however, at the single-word level, big mouth outperformed strong voice. Conclusion: Children with dysarthria are capable of changing their speech styles differentially in response to cueing. Both the big mouth and strong voice cues hold promise as intervention strategies to improve intelligibility in this population. Supplemental Material: https://doi.org/10.23641/asha.511684

Frailty and the psychosocial components of the edmonton frail scale are most associated with patient experience in older kidney transplant candidates – a secondary analysis within the kidney transplantation in older people (KTOP) study

BackgroundOlder people with end-stage kidney disease (ESKD) are vulnerable to frailty, which impacts on clinical and experiential outcomes. With kidney transplantation in older people increasing, a better understanding of patient experiences is necessary for guiding decision making. The Kidney Transplantation in Older People (KTOP):impact of frailty on outcomes study aims to explore this. We present a secondary analysis of the Edmonton Frail Scale (EFS) and its relationship with patient experience scores.MethodsThe KTOP study is a single centre, prospective study, which began in October 2019. All ESKD patients aged ≥60 considered for transplantation at Imperial College Renal and Transplant Centre were eligible. Frailty was assessed using the EFS and 5 questionnaires assessed patient experience and quality of life (QoL) (Short Form-12(v2), Palliative Care Outcome Scale–Symptoms Renal, Depression Patient Health Questionnaire-9, Illness Intrusiveness Ratings Scale, Renal Treatment Satisfaction Questionnaire). The EFS was divided into 4 subdomains (psychosocial, physical function, medical status, and general health) and then compared with the questionnaire scores.Results210 patients have been recruited (aged 60-78), 186 of whom completed EFS assessments. 118 (63.4%) participants were not frail, 36 (19.4%) vulnerable, and 32 (17.2%) were frail. Worse frailty scores were associated with poorer patient experience and QoL scores across all questionnaires. Severe deficits in the EFS psychosocial subdomain showed a statistically significant association with higher depression screen scores (coefficient 4.9, 95% CI 3.22 to 6.59), lower physical (coefficient -4.35, 95% CI -7.59 to -1.12) and mental function scores (coefficient -8.33, 95% CI -11.77 to -4.88) from the Short Form-12(v2), and lower renal treatment satisfaction scores (coefficient -5.54, 95% CI -10.70 to -0.37). Deficits in the physical function and medical status EFS subdomians showed some association with patient experience scores.ConclusionIn the KTOP study cohort at recruitment vulnerable and frail candidates reported worse QoL and patient experiences. Severe deficits in the psychosocial subdomains of the EFS showed a strong association with patient experience and QoL, whilst physical function and medical status deficits showed a lesser association. This has highlighted specific EFS domains that may be suitable for targeted interventions to improve experiences and optimise outcomes

Improvements in health-related quality of life with belimumab, a B-lymphocyte stimulator-specific inhibitor, in patients with autoantibody-positive systemic lupus erythematosus from the randomised controlled BLISS trials

OBJECTIVE: Assess the effects of belimumab treatment plus standard systemic lupus erythematosus (SLE) therapy on health-related quality of life (HRQOL) in patients with active, autoantibody-positive SLE. METHODS: Patients received standard therapy plus placebo or belimumab 1 or 10 mg/kg in two multicentre, randomised controlled trials of 52 (BLISS-52; N=865) and 76 (BLISS-76; N=819) weeks' duration. Responders were evaluated by SLE Responder Index at week 52. Patient-reported outcome assessments included SF-36, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, and EQ-5D. RESULTS: Mean SF-36 Physical Component Summary (PCS) scores at week 24 was a major secondary endpoint. Baseline SF-36 scores were 1.5 SDs below age-/sex-matched US norms with similar improvement at week 24 across treatment groups. Mean changes from baseline in PCS scores were significantly (p<0.05) greater with belimumab 1 mg/kg (4.20) and 10 mg/kg (4.18) versus placebo (2.96) in BLISS-52, week 52. In BLISS-76, significantly (p<0.05) greater improvements were seen with belimumab 1 mg/kg in PCS (belimumab 1 mg/kg=4.37, 10 mg/kg=3.41 vs placebo=2.85) and Mental Component Summary (MCS) scores (belimumab 1 mg/kg=3.14, 10 mg/kg=2.70 vs placebo=1.40) at week 52, and in MCS score at week 76 (belimumab 1 mg/kg=3.05, 10 mg/kg=2.28 vs placebo=1.36). In pooled analysis, significantly greater improvements in PCS, SF-36 vitality domain, and FACIT-Fatigue scores at week 52 were evident with both belimumab doses. CONCLUSIONS: The clinically meaningful improvements in HRQOL in autoantibody-positive patients with active SLE treated with belimumab and standard therapy are consistent with the reductions in disease activity observed in these trials

Developing a Common Framework for Evaluating the Implementation of Genomic Medicine Interventions in Clinical Care: The IGNITE Network’s Common Measures Working Group

Purpose Implementation research provides a structure for evaluating the clinical integration of genomic medicine interventions. This paper describes the Implementing GeNomics In PracTicE (IGNITE) Network’s efforts to promote: 1) a broader understanding of genomic medicine implementation research; and 2) the sharing of knowledge generated in the network. Methods To facilitate this goal the IGNITE Network Common Measures Working Group (CMG) members adopted the Consolidated Framework for Implementation Research (CFIR) to guide their approach to: identifying constructs and measures relevant to evaluating genomic medicine as a whole, standardizing data collection across projects, and combining data in a centralized resource for cross network analyses. Results CMG identified ten high-priority CFIR constructs as important for genomic medicine. Of those, eight didn’t have standardized measurement instruments. Therefore, we developed four survey tools to address this gap. In addition, we identified seven high-priority constructs related to patients, families, and communities that did not map to CFIR constructs. Both sets of constructs were combined to create a draft genomic medicine implementation model. Conclusion We developed processes to identify constructs deemed valuable for genomic medicine implementation and codified them in a model. These resources are freely available to facilitate knowledge generation and sharing across the field