Glutathione sensitive vesicles prepared from supramolecular amphiphiles.

Glutathione (GSH) sensitive vesicles were prepared by the self-assembly of amphiphilic inclusion complexes. These novel chemically sensitive supramolecular amphiphiles are anticipated to have applications in drug delivery; the nanocarriers can protect the encapsulated cargo and release it via triggered degradation in high concentrations of GSH. Additionally, the sensitivity of the vesicles to GSH indicates that the dynamic covalent disulfide bond at the vesicle surface can be used for post-modification of the nanocarrier via a thiol-disulfide exchange, a strategy that can be exploited to introduce targeting moieties to increase treatment specificity. Supramolecular amphiphiles containing a dynamic covalent disulfide bond were prepared via the host-guest inclusion complexes between alkylated ß-cyclodextrin (ß-CD) hosts and adamantane terminated polyethylene glycol derivatives. The significant difference between the critical micelle concentrations of the supramolecular amphiphiles and the individual host and guest components confirmed that a unique supramolecular amphiphile was formed. Fluorescence experiments and dynamic light scattering (DLS) revealed that the supramolecular amphiphiles self-assembled into vesicles of 130 nm diameter which were stable for 8 months. Degradation of the vesicles after incubation with GSH was monitored using DLS and by the release of encapsulated 5,6-carboxyfluorescein (CF), observed by an increase in fluorescence intensity. Degradation of the nanocarrier was faster at intracellular GSH concentrations than at extracellular GSH concentrations.

One-Year Linear Trajectories of Symptoms, Physical Functioning, Cognitive Functioning, Emotional Well-being, and Spiritual Well-being Among Patients Receiving Dialysis.

BACKGROUND: This study evaluated 1-year linear trajectories of patient-reported dimensions of quality of life among patients receiving dialysis. STUDY DESIGN: Longitudinal observational study. SETTING & PARTICIPANTS: 227 patients recruited from 12 dialysis centers. FACTORS: Sociodemographic and clinical characteristics. MEASUREMENTS/OUTCOMES: Participants completed an hour-long interview monthly for 12 months. Each interview included patient-reported outcome measures of overall symptoms (Edmonton Symptom Assessment System), physical functioning (Activities of Daily Living/Instrumental Activities of Daily Living), cognitive functioning (Patient's Assessment of Own Functioning Inventory), emotional well-being (Center for Epidemiologic Studies Depression Scale, State Anxiety Inventory, and Positive and Negative Affect Schedule), and spiritual well-being (Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale). For each dimension, linear and generalized linear mixed-effects models were used. Linear trajectories of the 5 dimensions were jointly modeled as a multivariate outcome over time. RESULTS: Although dimension scores fluctuated greatly from month to month, overall symptoms, cognitive functioning, emotional well-being, and spiritual well-being improved over time. Older compared with younger participants reported higher scores across all dimensions (all P<0.05). Higher comorbidity scores were associated with worse scores in most dimensions (all P<0.01). Nonwhite participants reported better spiritual well-being compared with their white counterparts (P<0.01). Clustering analysis of dimension scores revealed 2 distinctive clusters. Cluster 1 was characterized by better scores than those of cluster 2 in nearly all dimensions at baseline and by gradual improvement over time. LIMITATIONS: Study was conducted in a single region of the United States and included mostly patients with high levels of function across the dimensions of quality of life studied. CONCLUSIONS: Multidimensional patient-reported quality of life varies widely from month to month regardless of whether overall trajectories improve or worsen over time. Additional research is needed to identify the best approaches to incorporate patient-reported outcome measures into dialysis care.

Randomized controlled trial of a brief cognitive-behavioral strategies intervention for the pain, fatigue, and sleep disturbance symptom cluster in advanced cancer.

OBJECTIVE: Patients receiving treatment for advanced cancer suffer significant symptom burden, including co-occurring pain, fatigue, and sleep disturbance. There is limited evidence for effective interventions targeting this common symptom cluster. METHODS: A randomized controlled trial of a brief cognitive-behavioral strategies (CBS) intervention was conducted. A sample of 164 patients with advanced cancer receiving chemotherapy practiced imagery, relaxation, and distraction exercises or listened to cancer education recordings (attention-control) to manage co-occurring pain, fatigue, and sleep disturbance over a 9-week period. Symptom cluster severity, distress, and interference with daily life were measured at baseline and 3, 6, and 9 weeks. We also evaluated the moderating influence of imaging ability and number of concurrent symptoms, and mediating effects of changes in stress, anxiety, outcome expectancy, and perceived control over symptoms. RESULTS: Compared with the cancer education condition, participants receiving the CBS intervention reported less symptom cluster distress at week 6 (M = 1.82 vs 2.15 on a 0-4 scale, P < .05). No other group differences were statistically significant. The number of concurrent symptoms moderated the intervention effect on symptom cluster interference. Changes in stress, outcome expectancy, and perceived control mediated the extent of intervention effects on symptom outcomes, primarily at weeks 6 and 9. CONCLUSIONS: The brief CBS intervention had limited effects in this trial. However, findings regarding potential mediators affirm hypothesized mechanisms and provide insight into ways to strengthen future interventions to reduce the suffering associated with co-occurring pain, fatigue, and sleep disturbance.

Receptor-independent, direct membrane binding leads to cell-surface lipid sorting and Syk kinase activation in dendritic cells.

Binding of particulate antigens by antigen-presenting cells is a critical step in immune activation. Previously, we demonstrated that uric acid crystals are potent adjuvants, initiating a robust adaptive immune response. However, the mechanisms of activation are unknown. By using atomic force microscopy as a tool for real-time single-cell activation analysis, we report that uric acid crystals could directly engage cellular membranes, particularly the cholesterol components, with a force substantially stronger than protein-based cellular contacts. Binding of particulate substances activated Syk kinase-dependent signaling in dendritic cells. These observations suggest a mechanism whereby immune cell activation can be triggered by solid structures via membrane lipid alteration without the requirement for specific cell-surface receptors, and a testable hypothesis for crystal-associated arthropathies, inflammation, and adjuvanticity.

Process and impact of an advance care planning intervention evaluated by bereaved surrogate decision-makers of dialysis patients.

BACKGROUND: Few studies have examined the process and impact of an advance care planning intervention experienced by surrogate decision-makers of dialysis patients. AIM: To explore the perspectives of the bereaved surrogates of dialysis patients on the process and impact of an advance care planning intervention and to compare the perceived impacts of the intervention between African Americans and Whites. DESIGN: Qualitative interviews and thematic analysis. SETTING/PARTICIPANTS: 24 bereaved surrogates of patients from outpatient dialysis centers were interviewed. Both patients and surrogates had been participants in a larger efficacy study and had received an advance care planning intervention, SPIRIT (Sharing Patient's Illness Representations to Increase Trust). RESULTS: Two themes related to the process of SPIRIT were as follows: (1) SPIRIT provided a welcome opportunity to think about and discuss topics that had been avoided and (2) SPIRIT helped patients and surrogates to share their feelings. Four themes of the SPIRIT's impact were as follows: (1) SPIRIT was an eye-opening experience, acquiring knowledge and understanding of the patient's illness and end-of-life care, (2) SPIRIT helped strengthen relationships between patients and surrogates, (3) SPIRIT helped surrogates feel prepared during the time leading up to end-of-life decision-making, and (4) SPIRIT helped surrogates have peace of mind during and after actual end-of-life decision-making. Themes related to SPIRIT's impact on feeling prepared for end-of-life decision-making and the actual decision-making experience more frequently occurred in African Americans than in Whites. CONCLUSION: Our data may help explain the beneficial effects of SPIRIT on surrogates, but future trials should include data on control surrogates' perspectives.

Beliefs About Dysmenorrhea and Their Relationship to Self-Management.

Dysmenorrhea is highly prevalent and is the leading cause of work and school absences among women of reproductive age. However, self-management of dysmenorrhea is not well understood in the US, and little evidence is available on factors that influence dysmenorrhea self-management. Guided by the Common Sense Model, we examined women's representations of dysmenorrhea (beliefs about causes, symptoms, consequences, timeline, controllability, coherence, and emotional responses), described their dysmenorrhea self-management behaviors, and investigated the relationship between representations and self-management behaviors. We conducted a cross-sectional, web-based survey of 762 adult women who had dysmenorrhea symptoms in the last six months. Participants had varied beliefs about the causes of their dysmenorrhea symptoms, which were perceived as a normal part of life. Dysmenorrhea symptoms were reported as moderately severe, with consequences that moderately affected daily life. Women believed they understood their symptoms moderately well and perceived them as moderately controllable but them to continue through menopause. Most women did not seek professional care but rather used a variety of pharmacologic and complementary health approaches. Care-seeking and use of self-management strategies were associated with common sense beliefs about dysmenorrhea cause, consequences, timeline, and controllability. The findings may inform development and testing of self-management interventions that address dysmenorrhea representations and facilitate evidence-based management. © 2016 Wiley Periodicals, Inc.

A SMART design to optimize treatment strategies for patient and family caregiver outcomes.

Sequential multiple randomization trial (SMART) designs are experimental designs used to identify treatment strategies that maximize targeted health outcomes. SMART designs are receiving greater attention in nursing and other health disciplines to develop multicomponent interventions that are tailored to the patient's (or family caregiver's) needs and preferences. A SMART design resembles a traditional randomized controlled trial (RCT) design in that it scientifically examines intervention effects with randomization. However, the two designs address very different research inquiries. In this article, we compare traditional RCT designs and SMART designs, describe the adaptive treatment framework that underlies SMART designs and key features of SMART designs, and illustrate the application of a SMART design to develop an adaptive palliative care treatment to improve patient and caregiver outcomes.

Advance care planning and end-of-life decision making in dialysis: a randomized controlled trial targeting patients and their surrogates.

BACKGROUND: Few trials have examined long-term outcomes of advance care planning (ACP) interventions. We examined the efficacy of an ACP intervention on preparation for end-of-life decision making for dialysis patients and surrogates and for surrogates' bereavement outcomes. STUDY DESIGN: A randomized trial compared an ACP intervention (Sharing Patient's Illness Representations to Increase Trust [SPIRIT]) to usual care alone, with blinded outcome assessments. SETTING & PARTICIPANTS: 420 participants (210 dyads of prevalent dialysis patients and their surrogates) from 20 dialysis centers. INTERVENTION: Every dyad received usual care. Those randomly assigned to SPIRIT had an in-depth ACP discussion at the center and a follow-up session at home 2 weeks later. PRIMARY OUTCOMES: preparation for end-of-life decision making, assessed for 12 months, included dyad congruence on goals of care at end of life, patient decisional conflict, surrogate decision-making confidence, and a composite of congruence and surrogate decision-making confidence. SECONDARY OUTCOMES: bereavement outcomes, assessed for 6 months, included anxiety, depression, and posttraumatic distress symptoms completed by surrogates after patient death. PRIMARY OUTCOMES: adjusting for time and baseline values, dyad congruence (OR, 1.89; 95% CI, 1.1-3.3), surrogate decision-making confidence (ß=0.13; 95% CI, 0.01-0.24), and the composite (OR, 1.82; 95% CI, 1.0-3.2) were better in SPIRIT than controls, but patient decisional conflict did not differ between groups (ß=-0.01; 95% CI, -0.12 to 0.10). SECONDARY OUTCOMES: 45 patients died during the study. Surrogates in SPIRIT had less anxiety (ß=-1.13; 95% CI, -2.23 to -0.03), depression (ß=-2.54; 95% CI, -4.34 to -0.74), and posttraumatic distress (ß=-5.75; 95% CI, -10.9 to -0.64) than controls. LIMITATIONS: Study was conducted in a single US region. CONCLUSIONS: SPIRIT was associated with improvements in dyad preparation for end-of-life decision making and surrogate bereavement outcomes.

Making Visible a Theory-Guided Advance Care Planning Intervention.

PURPOSE: In reports of end-of-life communication interventions, it is difficult to find sufficient detail about the intervention to allow replication, extension, and translation into practice. The purpose of this article is to provide details about a theory-guided advance care planning intervention, sharing the patient's illness representations to increase trust (SPIRIT), an intervention that has been shown to be efficacious for patients and their surrogates with respect to preparation for end-of-life decision making. METHODS AND DESIGN: The description of SPIRIT is based on an intervention description checklist by Conn (2012), the Intervention Taxonomy from Schulz, Czaja, McKay, Ory, and Belle (2010) and on relevant segments of Consolidated Standards of Reporting Trials. DISCUSSION: The SPIRIT intervention was developed based on sound theoretical underpinnings and pilot tested with target patient populations and racial or ethnic groups. We describe details about the intervention's theoretical basis, requisite intervener training, implementation of each intervention component, and fidelity monitoring. CLINICAL RELEVANCE: The details about the components of a theory-guided advance care planning intervention may facilitate translation of the intervention to practice settings.

Quality pain management practices in a university hospital.

Despite available guidelines and efforts to improve pain management, pain remains prevalent in hospitals. The aim of this study was to explore whether pain management practices in a university hospital were in line with guidelines on acute, geriatric, and cancer pain. This was a descriptive, correlational, and point-prevalence study conducted at a university hospital with 282 adults, who were hospitalized for 24 hours and were alert and able to participate. Patient self-report data were collected with the American Pain Society questionnaire and pain management data were collected from medical records. Adequacy of treatment was measured with the Pain Management Index, calculated for prescribed and administered treatments. The mean age of participants was 68.9 years (SD = 17; range 18-100); 49% were women; and 72% were on medical services. Pain assessment was documented for 57% of patients, of those, 27% had pain severity documented with a standardized scale. Most patients (85%) were prescribed analgesics and multimodal therapy was prescribed for 60%. Prescribed treatment was adequate for 78% of patients, whereas 64% were administered adequate treatment. The odds of receiving adequate treatment were higher (odds ratio, 3.44; 95% confidence interval, 1.38-8.60) when pain severity was documented. Nonpharmacologic methods were used by 34% of patients. Although the majority of patients had an analgesic prescription, many did not receive adequate treatment. The use of pain severity scales was associated with the provision of more adequate pain treatment. To provide quality pain management, pain assessment needs to be improved and available treatments used to meet patient needs.

Assessment effects in educational and psychosocial intervention trials: an important but often-overlooked problem.

Baseline assessments and repeated measures are an essential part of educational and psychosocial intervention trials, but merely measuring an outcome of interest can modify that outcome, either by the measurement process alone or by interacting with the intervention to strengthen or weaken the intervention effects. Assessment effects can result in biased estimates of intervention effects and may not be controlled by the usual two-group randomized controlled trial design. In this paper, we review the concept of assessment effects and other related phenomena, briefly describe study designs that estimate assessment effects separately from intervention effects and discuss their strengths and limitations, review evidence regarding the strength of assessment effects in intervention trials targeting behavior change, and discuss implications for intervention research.

Quality pain management in the hospital setting from the patient's perspective.

BACKGROUND: Pain management is a crucial issue for patients, and patients' perception of care is an important quality outcome criterion for health care institutions. Pain remains a common problem in hospitals, with subsequent deleterious effects on well-being. OBJECTIVES: To assess the epidemiology of pain (frequency, severity, and interference), patient participation in pain treatment decisions, and patient satisfaction with care in a hospital setting. METHODS: A point-prevalence study was conducted. Data were collected with the American Pain Society Patient Outcome Questionnaire (Icelandic version). Participants (n = 308) were ≥ 18 years old, alert, and hospitalized for ≥ 24 hours. RESULTS: The response rate was 73%. The mean age of participants was 67.5 (SD = 17.4; range 18 to 100) years, and 49% were men. Pain prevalence in the past 24 hours was 83%, mean worst pain severity was 4.6 (SD = 3.1), and 35% experienced severe pain (≥ 7 on 0 to 10 scale). Moderate to severe interference with activities and sleep was experienced by 36% and 29% of patients respectively. Patient participation in decision making was weakly associated with spending less time in severe pain and better pain relief. Patient satisfaction was related to spending less time in severe pain, better pain relief, and lower pain severity (P < 0.05). CONCLUSIONS: Pain was both prevalent and severe in the hospital, but patient participation in decision making was related to better outcomes. Optimal pain management, with emphasis on patient participation in decision making, should be encouraged in an effort to improve the quality of care in hospitals.

Ion-gated synthetic photosystems.

Herein, molecular strings of ions built along charge-transporting channels are shown to dramatically increase photocurrents and enable charge transport over long distances, thus confirming the existence and significance of ion-gated photosystems. For their synthesis, ordered and oriented stacks of naphthalenediimides were grown on indium tin oxide by ring-opening disulfide-exchange polymerization. To these charge-transporting channels, coaxial strings of anions or cations-fixed, mobile, complete, partial, pure, or mixed-were added by orthogonal hydrazone exchange. The presence of partially protonated carboxylates was found to most significantly increase activity, implying that they both attract holes and repel electrons, that is, facilitate photoinduced charge separation and hinder charge recombination at the same time. As a result of this quite remarkable situation, photocurrents increased rather than decreased with increasing charge stabilization on their "stepping stones." The presence of mobile anions facilitated long-distance charge transport through thick films. Turned off by inhibited anion mobility, that is, proton hopping, hole/proton antiport is identified to account for long-distance charge transport in ion-gated photosystems.

Cellular uptake of substrate-initiated cell-penetrating poly(disulfide)s.

Substrate-initiated, self-inactivating, cell-penetrating poly(disulfide)s (siCPDs) are introduced as general transporters for the covalent delivery of unmodified substrates of free choice. With ring-opening disulfide-exchange polymerization, we show that guanidinium-rich siCPDs grow on fluorescent substrates within minutes under the mildest conditions. The most active siCPD transporters reach the cytosol of HeLa cells within 5 min and depolymerize in less than 1 min to release the native substrate. Depolymerized right after use, the best siCPDs are nontoxic under conditions where cell-penetrating peptides (CPPs) are cytotoxic. Intracellular localization (cytosol, nucleoli, endosomes) is independent of the substrate and can be varied on demand, through choice of polymer composition. Insensitivity to endocytosis inhibitors and classical structural variations (hydrophobicity, aromaticity, branching, boronic acids) suggest that the best siCPDs act differently. Supported by experimental evidence, a unique combination of the counterion-mediated translocation of CPPs with the underexplored, thiol-mediated covalent translocation is considered to account for this decisive difference.

Evaluating the quality of pain management in a hospital setting: testing the psychometric properties of the Icelandic version of the revised American Pain Society patient outcome questionnaire.

Pain management is an important aspect of providing quality health care, and monitoring patient-related outcomes is a recommended quality improvement practice. Valid and reliable tools are needed for this purpose. The American Pain Society Patient Outcome Questionnaire (APS-POQ) is widely used to measure quality of pain management. The APS-POQ was recently revised to reflect advances in pain management. The purpose of this study was to test the psychometric properties of the revised version in Icelandic patients in the hospital setting. The questionnaire was translated according to an adaptation of Brislin's model. Data were collected from 143 patients on 23 wards in a university hospital. Participants were ≥ 18 years old, hospitalized for >24 hours, alert, not too ill to participate, and in pain ≥ 1 on a 0-10 scale in the past 24 hours. Mean (SD) age was 66 (18) years, 51.4% were women, 48.6% men. Principal component analysis with varimax rotation confirmed a five-component structure, but four items lowered reliability and were removed from the scales. The final version consists of four components, with Cronbach α >.70, explaining 64.2% of the variance. Participants had little difficulty in answering the questionnaire, but two additional items about participation in decisions and pain medications were added in response to patients' comments and suggestions. Administering the Icelandic version of the APS-POQ-R was found to be feasible, and the questionnaire has acceptable construct validity and reliability. The results support the use of the APS-POQ-R-I to evaluate the quality of pain management in hospitals in Iceland.

Pandemic Effects on Stability of End-of-Life Preferences and Patient-Surrogate Dyad Congruence.

CONTEXT: Whether a largescale disaster alters people's previous decisions about their end-of-life care is unknown. OBJECTIVES: We examined the effects of a disaster, the COVID-19 pandemic, on stability of end-of-life care preferences among dialysis patients and on patient-surrogate goals-of-care congruence. METHODS: We used a natural experimental design to examine goals-of-care preferences pre- and postexposure to the pandemic during a pragmatic trial testing SPIRIT (sharing patient's illness representations to increase trust), an evidence-based advance care planning (ACP) intervention. There were 151 patient-surrogate dyads who prior to the pandemic lockdown had completed baseline (T1) and postintervention assessments (T2) regarding their goals-of-care preferences in two end-of-life scenarios. Of those 151 dyads, 59 intervention, and 51 usual care dyads consented to be in the present study and completed the goals-of-care tool two additional times, at enrollment (T3) and six months later (T4), along with the COVID stress scale (CSS). Dyad congruence was ascertained by comparing patient and surrogate responses to the goals-of-care tool. RESULTS: There were no changes over time in the proportions of patients who chose comfort-care-only in the goals-of-care tool. The proportion of patients who chose comfort-care-only and dyad congruence were higher in SPIRIT compared to usual care, but there was no interaction between that treatment effect and exposure to the pandemic. CSS was associated with neither patients' preferences nor dyad congruence. CONCLUSIONS: The pandemic alone did not appear to influence patients' goals-of-care preferences or dyad congruence. This finding supports the stability of value-based end-of-life preferences in general, even during a disaster.

Measures of Patient and Surrogate Preparedness for End-of-Life Decision-Making.

CONTEXT: Reliable and valid measures are critical in accurately assessing outcomes of advance care planning interventions (ACP) for end-of-life (EOL) decision-making. OBJECTIVES: To develop measures of preparedness for EOL decision-making for patients with end-stage renal disease and their surrogates (an exemplar population). METHODS: In this 3-phase study, Phases 1 and 2 included a cross-discipline concept analysis of the preparedness construct, item generation for patient and surrogate scales (82 items), evaluation of content validity and readability, cognitive interviewing, and item reduction. In phase 3, the retained 26 patient and 25 surrogate items were administered to 426 patients and 426 surrogates during a multisite trial of an ACP intervention versus care-as-usual and evaluated internal consistency, 2-week test-retest reliability, and construct validity. RESULTS: Scales were reduced to 20 patient and 19 surrogate items during phase 3. Cronbach's alphas were 0.86 (patient) and 0.90 (surrogate). There was a strong correlation between preparedness at baseline and two weeks for both scales (r = 0.66-0.69, P < 0.001). Confirmatory factor analysis and item-response analyses suggested unidimensionality. A significant correlation was shown between patient preparedness and patient decisional conflict (r = -0.53, P < 0.001), and surrogate preparedness and surrogate decision-making confidence (r = 0.44, P < 0.001). Among those who received the ACP intervention, the effect size of change was medium: Cohen's d = 0.54, P < 0.001 for patients and d = 0.57, P < 0.001 for surrogates. CONCLUSIONS: The preparedness scales demonstrated strong psychometric properties. Future studies should examine scale performance in other populations.

Effectiveness of an Advance Care Planning Intervention in Adults Receiving Dialysis and Their Families: A Cluster Randomized Clinical Trial.

Importance: Evidence of effectiveness of advance care planning (ACP) strategies for patients receiving dialysis and their families is needed. Objectives: To test the effectiveness of an ACP intervention to prepare patients and their surrogates for end-of-life (EOL) decision-making and to improve surrogate bereavement outcomes. Design, Setting, and Participants: This cluster randomized clinical trial, An Effectiveness-Implementation Trial of SPIRIT (Sharing Patients' Illness Representations to Increase Trust) in ESRD, was conducted from December 2017 to March 2023 and included 42 dialysis clinics in 5 US states (Georgia, New Mexico, North Carolina, Pennsylvania, and Virginia) randomized to provide intervention or usual care. Recruitment was from February 15, 2018, to January 31, 2022, and patient-surrogate dyads were followed up for 21 months (until January 17, 2023) or until patient death. Intervention: Each clinic selected 1 or 2 health care workers (eg, nurse practitioner, registered nurse, or social worker) to conduct 45- to 60-minute ACP discussions with dyads in the clinic or remotely. After March 13, 2020 (commencement of the COVID-19 emergency declaration), all discussions were conducted remotely. An ACP summary was placed in patients' medical records. Main Outcomes and Measures: The primary, 2-week preparedness outcomes were dyad congruence on EOL goals of care, patient decisional conflict, surrogate decision-making confidence, and a composite of dyad congruence and surrogate decision-making confidence. Secondary bereavement outcomes were anxiety, depression, and posttraumatic distress 3 months after patient death. To adjust for COVID-19 pandemic effects on bereavement outcomes, a variable to indicate the timing of baseline and 3-month assessment relative to the COVID-19 emergency declaration was created. Results: Of the 426 dyads enrolled, 231 were in the intervention clinics, and 195 were in the control clinics. Among all dyads, the mean (SD) patient age was 61.9 (12.7) years, and the mean (SD) surrogate age was 53.7 (15.4) years. At 2 weeks, after adjusting for baseline values, dyad congruence (odds ratio [OR], 1.61; 95% CI, 1.12-2.31; P = .001), decisional conflict scores (ß, -0.10; 95% CI, -0.13 to -0.07; P < .001), and the composite (OR, 1.57; 95% CI, 1.06-2.34; P = .03) were higher in the intervention group than in the control group. Surrogate decision-making confidence was similar between groups (ß, 0.06; 95% CI, -0.01 to 0.13; P = .12). Among 77 bereaved surrogates, after adjusting for baseline values and assessment timing, intervention group anxiety was lower than control group anxiety (ß, -1.55; 95% CI, -3.08 to -0.01; P = .05); however, depression (ß, -0.18; 95% CI, -2.09 to 1.73; P = .84) and posttraumatic distress (ß, -0.96; 95% CI, -7.39 to 5.46; P = .75) were similar. Conclusions and Relevance: In this randomized clinical trial, the ACP intervention implemented by health care workers at dialysis centers improved preparation for EOL decision-making but showed mixed effectiveness on bereavement outcomes. The ACP intervention implemented in dialysis centers may be an effective strategy to the dyad preparation for end-of-life care as opposed to the current focus on advance directives. Trial Registration: ClinicalTrials.gov Identifier: NCT03138564.

Laxative use in adults with intellectual disabilities: development of prescribing guidelines.

BACKGROUND: Constipation is overrepresented in people with intellectual disabilities. Around 40% of people with intellectual disabilities who died prematurely were prescribed laxatives. A quarter of people with intellectual disabilities are said to be on laxatives. There are concerns that prescribing is not always effective and appropriate. There are currently no prescribing guidelines specific to this population. AIMS: To develop guidelines to support clinicians with their decision-making when prescribing laxatives to people with intellectual disabilities. METHOD: A modified Delphi methodology, the RAND/UCLA Appropriateness Method, was used. Step 1 comprised development of a bespoke six-item, open-ended questionnaire from background literature and its external validation. Relevant stakeholders, including a range of clinical experts and experts by experience covering the full range of intellectual disability and constipation, were invited to participate in an expert panel. Panel members completed the questionnaire. Responses were divided into 'negative consensus' and 'positive consensus'. Members were then invited to two panel meetings, 2 weeks apart, held virtually over Microsoft Teams, to build consensus. The expert-by-experience group were included in a separate face-to-face meeting. RESULTS: A total of 20 people (ten professional experts and ten experts by experience, of whom seven had intellectual disability) took part. There were five main areas of discussion to reach a consensus i.e. importance of diagnosis, the role of prescribing, practicalities of medication administration, importance of reviewing and monitoring, and communication. CONCLUSIONS: Laxative prescribing guidelines were developed by synthesising the knowledge of an expert panel including people with intellectual disabilities with the existing evidence base, to improve patient care.

Patient perspectives on informed decision-making surrounding dialysis initiation.

BACKGROUND: Careful patient-clinician shared decision-making about dialysis initiation has been promoted, but few studies have addressed patient perspectives on the extent of information provided and how decisions to start dialysis are made. METHODS: Ninety-nine maintenance dialysis patients recruited from 15 outpatient dialysis centers in North Carolina completed semistructured interviews on information provision and communication about the initiation of dialysis. These data were examined with content analysis. In addition, informed decision-making (IDM) scores were created by summing patient responses (yes/no) to 10 questions about the decision-making. RESULTS: The mean IDM score was 4.4 (of 10; SD = 2.0); 67% scored 5 or lower. Age at the time of decision-making (r = -0.27, P = 0.006), years of education (r = 0.24, P = 0.02) and presence of a warning about progressing to end-stage kidney disease (t = 2.9, P = 0.005) were significantly associated with IDM scores. Nearly 70% said that the risks and burdens of dialysis were not mentioned at all, and only one patient recalled that the doctor offered the option of not starting dialysis. While a majority (67%) said that they felt they had no choice about starting dialysis (because the alternative would be death) or about dialysis modality, only 21.2% said that they had felt rushed to make a decision. About one-third of the patients perceived that the decision to start dialysis and modality was already made by the doctor. CONCLUSIONS: A majority of patients felt unprepared and ill-informed about the initiation of dialysis. Improving the extent of IDM about dialysis may optimize patient preparation prior to starting treatment and their perceptions about the decision-making process.