Diagnosing the "master mechanism of the universe" in interwar and war-era America.

Drawing on personal testimonials and questions addressed to psychiatric hospital officials, this article explores how patients and their loved ones engaged with the idea of diagnosis in interwar and war-era America. I argue that diagnosis had synergies with intellectual sensibilities of American modernity, among them an enthusiasm for science and newness, a modernist sense of time that could be both forward- and backward-looking, and a knowable, interpreted self. While self-understanding and the creation of life narratives were more often considered the bailiwick of psychoanalysis in this period, understanding subjectivity and self-interpretation were not solely expressed in its conceptual vocabulary. Patient and family dialogs with diagnosis and psychiatric authorities allow for an illumination of the interaction between domestic intuitions, common sense, and folk wisdom, on the one hand, and institutional taxonomy, categorization, and scientific terminology on the other, or more broadly, between dispositions that are ostensibly antimodern and more modern ideas. I suggest that the protean and wide-ranging intellectual origins of the discipline of psychiatry, along with the inherent ambiguity of psychiatric diagnosis during the early 20th century, allowed patients to participate in their own medicalization in the most capacious way possible: by combining biology with diagnostic narrative capacities, as well as broader perceptions of morality and character. In the concluding reflection, I speculate about why it is that late 20th-century American critics and activists have tended to view diagnosis and medicalization as coercive and threatening, in contrast to earlier 20th-century patients and their intimate observers.

Measuring the effects of listening for leisure on outcome after stroke (MELLO): A pilot randomized controlled trial of mindful music listening.

BACKGROUND: Cognitive deficits and low mood are common post-stroke. Music listening is suggested to have beneficial effects on cognition, while mindfulness may improve mood. Combining these approaches may enhance cognitive recovery and improve mood early post-stroke. AIMS: To assess the feasibility and acceptability of a novel mindful music listening intervention. METHODS: A parallel group randomized controlled feasibility trial with ischemic stroke patients, comparing three groups; mindful music listening, music listening and audiobook listening (control group), eight weeks intervention. Feasibility was measured using adherence to protocol and questionnaires. Cognition (including measures of verbal memory and attention) and mood (Hospital Anxiety and Depression Scale) were assessed at baseline, end of intervention and at six-months post-stroke. RESULTS: Seventy-two participants were randomized to mindful music listening (n = 23), music listening (n = 24), or audiobook listening (n = 25). Feasibility and acceptability measures were encouraging: 94% fully consistent with protocol; 68.1% completing ≥6/8 treatment visits; 80-107% listening adherence; 83% retention to six-month endpoint. Treatment effect sizes for cognition at six month follow-up ranged from d = 0.00 ([-0.64,0.64], music alone), d = 0.31, ([0.36,0.97], mindful music) for list learning; to d = 0.58 ([0.06,1.11], music alone), d = 0.51 ([-0.07,1.09], mindful music) for immediate story recall; and d = 0.67 ([0.12,1.22], music alone), d = 0.77 ([0.16,1.38]mindful music) for attentional switching compared to audiobooks. No signal of change was seen for mood. A definitive study would require 306 participants to detect a clinically substantial difference in improvement (z-score difference = 0.66, p = 0.017, 80% power) in verbal memory (delayed story recall). CONCLUSIONS: Mindful music listening is feasible and acceptable post-stroke. Music listening interventions appear to be a promising approach to improving recovery from stroke.

Intravenous Iron in Patients Undergoing Maintenance Hemodialysis.

BACKGROUND: Intravenous iron is a standard treatment for patients undergoing hemodialysis, but comparative data regarding clinically effective regimens are limited. METHODS: In a multicenter, open-label trial with blinded end-point evaluation, we randomly assigned adults undergoing maintenance hemodialysis to receive either high-dose iron sucrose, administered intravenously in a proactive fashion (400 mg monthly, unless the ferritin concentration was >700 µg per liter or the transferrin saturation was ≥40%), or low-dose iron sucrose, administered intravenously in a reactive fashion (0 to 400 mg monthly, with a ferritin concentration of <200 µg per liter or a transferrin saturation of <20% being a trigger for iron administration). The primary end point was the composite of nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure, or death, assessed in a time-to-first-event analysis. These end points were also analyzed as recurrent events. Other secondary end points included death, infection rate, and dose of an erythropoiesis-stimulating agent. Noninferiority of the high-dose group to the low-dose group would be established if the upper boundary of the 95% confidence interval for the hazard ratio for the primary end point did not cross 1.25. RESULTS: A total of 2141 patients underwent randomization (1093 patients to the high-dose group and 1048 to the low-dose group). The median follow-up was 2.1 years. Patients in the high-dose group received a median monthly iron dose of 264 mg (interquartile range [25th to 75th percentile], 200 to 336), as compared with 145 mg (interquartile range, 100 to 190) in the low-dose group. The median monthly dose of an erythropoiesis-stimulating agent was 29,757 IU in the high-dose group and 38,805 IU in the low-dose group (median difference, -7539 IU; 95% confidence interval [CI], -9485 to -5582). A total of 320 patients (29.3%) in the high-dose group had a primary end-point event, as compared with 338 (32.3%) in the low-dose group (hazard ratio, 0.85; 95% CI, 0.73 to 1.00; P<0.001 for noninferiority; P=0.04 for superiority). In an analysis that used a recurrent-events approach, there were 429 events in the high-dose group and 507 in the low-dose group (rate ratio, 0.77; 95% CI, 0.66 to 0.92). The infection rate was the same in the two groups. CONCLUSIONS: Among patients undergoing hemodialysis, a high-dose intravenous iron regimen administered proactively was superior to a low-dose regimen administered reactively and resulted in lower doses of erythropoiesis-stimulating agent being administered. (Funded by Kidney Research UK; PIVOTAL EudraCT number, 2013-002267-25 .).

Randomized Trial Comparing Proactive, High-Dose versus Reactive, Low-Dose Intravenous Iron Supplementation in Hemodialysis (PIVOTAL): Study Design and Baseline Data.

BACKGROUND: Intravenous (IV) iron supplementation is a standard maintenance treatment for hemodialysis (HD) patients, but the optimum dosing regimen is unknown. METHODS: PIVOTAL (Proactive IV irOn Therapy in hemodiALysis patients) is a multicenter, open-label, blinded endpoint, randomized controlled (PROBE) trial. Incident HD adults with a serum ferritin < 400 µg/L and transferrin saturation (TSAT) levels < 30% receiving erythropoiesis-stimulating agents (ESA) were eligible. Enrolled patients were randomized to a proactive, high-dose IV iron arm (iron sucrose 400 mg/month unless ferritin > 700 µg/L and/or TSAT ≥40%) or a reactive, low-dose IV iron arm (iron sucrose administered if ferritin <200 µg/L or TSAT < 20%). We hypothesized that proactive, high-dose IV iron would be noninferior to reactive, low-dose IV iron for the primary outcome of first occurrence of nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization for heart failure or death from any cause. If noninferiority is confirmed with a noninferiority limit of 1.25 for the hazard ratio of the proactive strategy relative to the reactive strategy, a test for superiority will be carried out. Secondary outcomes include infection-related endpoints, ESA dose requirements, and quality-of-life measures. As an event-driven trial, the study will continue until at least 631 primary outcome events have accrued, but the expected duration of follow-up is 2-4 years. RESULTS: Of the 2,589 patients screened across 50 UK sites, 2,141 (83%) were randomized. At baseline, 65.3% were male, the median age was 65 years, and 79% were white. According to eligibility criteria, all patients were on ESA at screening. Prior stroke and MI were present in 8 and 9% of the cohort, respectively, and 44% of patients had diabetes at baseline. Baseline data for the randomized cohort were generally concordant with recent data from the UK Renal Registry. CONCLUSIONS: PIVOTAL will provide important information about the optimum dosing of IV iron in HD patients representative of usual clinical practice. TRIAL REGISTRATION: EudraCT number: 2013-002267-25.

Participants' experiences of music, mindful music, and audiobook listening interventions for people recovering from stroke.

Existing research evidence suggests that both music listening and mindfulness interventions may have beneficial effects on mood and cognition poststroke. This mixed-methods study, nested within a pilot randomized controlled trial investigating the feasibility and acceptability of combining music listening and brief mindfulness training poststroke, explored study participants' experiences of engaging in the interventions. Fifty-six stroke survivors who were randomized to receive an 8-week intervention of mindful music listening (n = 15), music listening (n = 21), or audiobook listening (n = 20, control) using self-selected material participated in a postintervention individual semistructured interview with a researcher not involved in their intervention delivery. Interview questions focused on affective, cognitive, and physical experiences. Data were coded and analyzed using thematic analysis. Across groups, listening was associated with positive distraction from thoughts and worries. Mindful music listening was most strongly associated with relaxation and concentration, improved attentional control, and emotion regulation, as well as enjoyment. Music listening was most strongly associated with increased activity, memory reminiscence, and improved mood. In addition, participants provided valuable feedback on intervention feasibility and acceptability. The findings suggest that the interventions were feasible and enjoyable for people recovering from stroke.