Objective: Disruptions in biological rhythms and sleep are a core aspect of mood disorders, with sleep and rhythm changes frequently occurring prior to and during mood episodes. Wrist-worn actigraphs are increasingly utilized to measure ambulatory activity rhythm and sleep patterns. Methods: A comprehensive study using subjective and objective measures of sleep and biological rhythms was conducted in 111 participants (40 healthy volunteers [HC], 38 with major depressive disorder [MDD] and 33 with bipolar disorder [BD]). Participants completed 15-day actigraphy and first-morning urine samples to measure 6-sulfatoxymelatonin levels. Sleep and biological rhythm questionnaires were administered: Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN), Munich Chronotype Questionnaire (MCTQ), Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS). Actigraph data were analyzed for sleep and daily activity rhythms, light exposure and likelihood of transitioning between rest and activity states. Results: Mood groups had worse subjective sleep quality (PSQI) and biological rhythm disruption (BRIAN) and higher objective mean nighttime activity than controls. Participants with BD had longer total sleep time, higher circadian quotient and lower 6-sulfatoxymelatonin levels than HC group. The MDD group had longer sleep onset latency and higher daytime probability of transitioning from rest to activity than HCs. Mood groups displayed later mean timing of light exposure. Multiple linear regression analysis with BRIAN scores, circadian quotient, mean nighttime activity during rest and daytime probability of transitioning from activity to rest explained 43% of variance in quality-of-life scores. BRIAN scores, total sleep time and probability of transitioning from activity to rest explained 52% of variance in functioning (all p < 0.05). Conclusions: Disruption in biological rhythms is associated with poorer functioning and quality of life in bipolar and MDD. Investigating biological rhythms and sleep using actigraphy variables, urinary 6-sulfatoxymelatonin and subjective measures provide evidence of widespread sleep and circadian system disruptions in mood disorders.
Background: Femoroacetabular impingement (FAI) is a condition known to cause hip pain in young adults. Purpose: To evaluate the efficacy of the surgical correction of FAI via arthroscopic osteochondroplasty with or without labral repair compared with arthroscopic lavage of the hip joint with or without labral repair. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 220 male and female participants aged 18 to 50 years with nonarthritic FAI suitable for surgical treatment were recruited for the trial at 10 clinical centers in Canada, Finland, and Denmark between October 2012 and November 2017, of whom 214 were included in the final analysis. In the osteochondroplasty group, cam- and/or pincer-type lesions were resected using fluoroscopic guidance. In the lavage group, the joint was washed out with 3 L of normal saline. Surgeons were instructed to repair the labrum in both groups if it was mechanically unstable once probed, showing visible displacement or chondrolabral separation. The primary outcome was patient-reported pain (using the 100-point visual analog scale [VAS]) at 12 months. Secondary outcomes included hip function (Hip Outcome Score [HOS] and International Hip Outcome Tool), physical and mental health (12-Item Short Form Health Survey), and health utility (EuroQol–5 Dimensions) at 12 months as well as any reoperations and other hip-related adverse events at 24 months. Results: At 12 months, there was no difference in pain (VAS) between the groups (mean difference [MD], 0.11 [95% CI, –7.22 to 7.45]; P = .98). Also, 88.3% (189/214) of participants had a labral tear, of which 60.3% were repaired. For the secondary outcomes, there were no significant differences between treatment groups, with the exception of the HOS activities of daily living domain in which lavage showed significant improvement compared with osteochondroplasty (MD, –5.03 [95% CI, −10.40 to −0.03]; P = .049). By 24 months, there were significantly fewer reoperations reported in the osteochondroplasty group (8/105) than the lavage group (19/104) (odds ratio, 0.37 [95% CI, 0.15-0.89]; P = .026). The primary reasons for a reoperation included hip pain (15/27; 55.6%) and a reinjury of the labrum (11/27; 40.7%). Conclusion: Both the osteochondroplasty and the lavage groups with or without labral repair for FAI had significantly improved pain or function significantly at 1 year. By 2 years, the reoperation rate was significantly lower in the osteochondroplasty group. Registration: NCT01623843 ( ClinicalTrials.gov identifier)
ImportanceUnstable chest wall injuries have high rates of mortality and morbidity. In the last decade, multiple studies have reported improved outcomes with operative compared with nonoperative treatment. However, to date, an adequately powered, randomized clinical trial to support operative treatment has been lacking.ObjectiveTo compare outcomes of surgical treatment of acute unstable chest wall injuries with nonsurgical management.Design, Setting, and ParticipantsThis was a multicenter, prospective, randomized clinical trial conducted from October 10, 2011, to October 2, 2019, across 15 sites in Canada and the US. Inclusion criteria were patients between the ages of 16 to 85 years with displaced rib fractures with a flail chest or non–flail chest injuries with severe chest wall deformity. Exclusion criteria included patients with significant other injuries that would otherwise require prolonged mechanical ventilation, those medically unfit for surgery, or those who were randomly assigned to study groups after 72 hours of injury. Data were analyzed from March 20, 2019, to March 5, 2021.InterventionsPatients were randomized 1:1 to receive operative treatment with plate and screws or nonoperative treatment.Main Outcomes and MeasuresThe primary outcome was ventilator-free days (VFDs) in the first 28 days after injury. Secondary outcomes included mortality, length of hospital stay, intensive care unit stay, and rates of complications (pneumonia, ventilator-associated pneumonia, sepsis, tracheostomy).ResultsA total of 207 patients were included in the analysis (operative group: 108 patients [52.2%]; mean [SD] age, 52.9 [13.5] years; 81 male [75%]; nonoperative group: 99 patients [47.8%]; mean [SD] age, 53.2 [14.3] years; 75 male [76%]). Mean (SD) VFDs were 22.7 (7.5) days for the operative group and 20.6 (9.7) days for the nonoperative group (mean difference, 2.1 days; 95% CI, −0.3 to 4.5 days; P = .09). Mortality was significantly higher in the nonoperative group (6 [6%]) than in the operative group (0%; P = .01). Rates of complications and length of stay were similar between groups. Subgroup analysis of patients who were mechanically ventilated at the time of randomization demonstrated a mean difference of 2.8 (95% CI, 0.1-5.5) VFDs in favor of operative treatment.Conclusions and RelevanceThe findings of this randomized clinical trial suggest that operative treatment of patients with unstable chest wall injuries has modest benefit compared with nonoperative treatment. However, the potential advantage was primarily noted in the subgroup of patients who were ventilated at the time of randomization. No benefit to operative treatment was found in patients who were not ventilated.Trial RegistrationClinicalTrials.gov Identifier: NCT01367951
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