and related disorders (PDRD) have consequences for quality of life (QoL) and are the 14th leading cause of death in the United States. Despite growing interest in palliative care (PC) for persons with PDRD, few studies are available supporting its effectiveness. OBJECTIVE To determine if outpatient PC is associated with improvements in patient-centered outcomes compared with standard care among patients with PDRD and their caregivers. DESIGN, SETTING, AND PARTICIPANTS This randomized clinical trial enrolled participants at 3 academic tertiary care centers between November 1, 2015, and September 30, 2017, and followed them up for 1 year. A total of 584 persons with PDRD were referred to the study. Of those, 351 persons were excluded by phone and 23 were excluded during in-person screenings. Patients were eligible to participate if they had PDRD and moderate to high PC needs. Patients were excluded if they had urgent PC needs, another diagnosis meriting PC, were already receiving PC, or were unable or unwilling to follow the study protocol. Enrolled participants were assigned to receive standard care plus outpatient integrated PC or standard care alone. Data were analyzed between November 1, 2018, and December 9, 2019. INTERVENTIONS Outpatient integrated PC administered by a neurologist, social worker, chaplain, and nurse using PC checklists, with guidance and selective involvement from a palliative medicine specialist. Standard care was provided by a neurologist and a primary care practitioner. MAIN OUTCOMES AND MEASURES The primary outcomes were the differences in patient quality of life (QoL; measured by the Quality of Life in Alzheimer Disease scale) and caregiver burden (measured by the Zarit Burden Interview) between the PC intervention and standard care groups at 6 months. RESULTS A total of 210 patients with PDRD (135 men [64.3%]; mean [SD] age, 70.1 [8.2] years) and 175 caregivers (128 women [73.1%]; mean [SD] age, 66.1 [11.1] years) were enrolled in the study; 193 participants (91.9%) were white and non-Hispanic. Compared with participants receiving standard care alone at 6 months, participants receiving the PC intervention had better QoL (mean [SD], 0.66 [5.5] improvement vs 0.84 [4.2] worsening; treatment effect estimate, 1.87; 95% CI, 0.47-3.27; P = .009). No significant difference was observed in caregiver burden (mean [SD], 2.3 [5.0] improvement vs 1.2 [5.6] improvement in the standard care group; treatment effect estimate, −1.62; 95% CI, −3.32 to 0.09; P = .06). Other significant differences favoring the PC intervention included nonmotor symptom burden, motor symptom severity, completion of advance directives, caregiver anxiety, and caregiver burden at 12 months. No outcomes favored standard care alone. Secondary analyses suggested that benefits were greater for persons with higher PC needs. CONCLUSIONS AND RELEVANCE Outpatient PC is associated with benefits among patients with PDRD compared with standard care alone. This study supports efforts to integrate PC into PDRD care. The lack of diversity a...
Summary Background Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled trial, we enrolled patients aged 50 years or older with a low-energy hip fracture requiring fracture fixation from 81 clinical centres in eight countries. Patients were assigned by minimisation with a centralised computer system to receive a single large-diameter screw with a side-plate (sliding hip screw) or the present standard of care, multiple small-diameter cancellous screws. Surgeons and patients were not blinded but the data analyst, while doing the analyses, remained blinded to treatment groups. The primary outcome was hip reoperation within 24 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function. Analyses followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT00761813. Findings Between March 3, 2008, and March 31, 2014, we randomly assigned 1108 patients to receive a sliding hip screw (n=557) or cancellous screws (n=551). Reoperations within 24 months did not differ by type of surgical fixation in those included in the primary analysis: 107 (20%) of 542 patients in the sliding hip screw group versus 117 (22%) of 537 patients in the cancellous screws group (hazard ratio [HR] 0.83, 95% CI 0.63–1.09; p=0.18). Avascular necrosis was more common in the sliding hip screw group than in the cancellous screws group (50 patients [9%] vs 28 patients [5%]; HR 1.91, 1.06–3.44; p=0.0319). However, no significant difference was found between the number of medically related adverse events between groups (p=0.82; appendix); these events included pulmonary embolism (two patients [<1%] vs four [1%] patients; p=0.41) and sepsis (seven [1%] vs six [1%]; p=0.79). Interpretation In terms of reoperation rates the sliding hip screw shows no advantage, but some groups of patients (smokers and those with displaced or base of neck fractures) might do better with a sliding hip screw than with cancellous screws. Funding National Institutes of Health, Canadian Institutes of Health Research, Stichting NutsOhra, Netherlands Organisation for Health Research and Development, Physicians’ Services Incorporated.
Background: The Integra Cadence total ankle replacement (TAR) is a fourth-generation anatomic, fixed-bearing implant requiring minimal tibial and talar resection, which has been in clinical use since June 2016. The primary purpose of this study is to assess its short-term clinical and radiographic outcomes after TAR using this prosthesis. Methods: This is a prospective case series of consecutive patients that underwent TAR using this novel fourth-generation prosthesis between June 2016 and November 2017. The primary outcome of interest was the Ankle Osteoarthritis Scale (AOS). Secondary outcomes included Short Form Health Survey–36 (SF-36) scores, radiographic alignment, complications, reoperations, and revisions. Results: In total, 69 patients were included in our study. Fifty-one patients (73.9%) required a total of 91 ancillary procedures. Postoperatively, AOS pain scores decreased significantly by an average of 17.8±30.1 points from 45.9±18.2 to 28.4±27.3 ( P < .001). AOS disability scores also decreased significantly following surgery by an average of 22.0±30.5 points from 53.9±18.5 to 32.5±27.9 ( P < .001). The SF-36 physical component summary score improved 10.4±9.8 points from 33.1±9.1 to 42.6±9.1 ( P < .001). Radiographic analysis demonstrated significant improvement to neutral coronal plane alignment, which was achieved in 97% of patients ( P < .01) with no cyst formation at 2 years. There was 1 reported complication, 9 reoperations, and no metal or polyethylene component revisions. Overall, the 2-year implant survivorship was 100% in our cohort. Eighteen patients (26.1%) demonstrated fibrous ingrowth of the tibial component. However, outcome scores for these patients did not demonstrate any negative effects. Conclusions: In our hands, this TAR system demonstrated excellent early clinical and radiographic outcomes. Patients reported improved physical health status, pain, and disability in the postoperative period. Total ankle instrumentation allowed for accurate and reproducible implantation with correction of coronal and sagittal plane deformities. Early results for the clinical use of this TAR system are promising, but further long-term prospective outcome studies are necessary. Level of Evidence: Level IV, case series.
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)
Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.
BackgroundTens of thousands of cardiac and vascular surgeries (CaVS) are performed on seniors in Canada and the United Kingdom each year to improve survival, relieve disease symptoms, and improve health-related quality of life (HRQL). However, chronic postsurgical pain (CPSP), undetected or delayed detection of hemodynamic compromise, complications, and related poor functional status are major problems for substantial numbers of patients during the recovery process. To tackle this problem, we aim to refine and test the effectiveness of an eHealth-enabled service delivery intervention, TecHnology-Enabled remote monitoring and Self-MAnagemenT—VIsion for patient EmpoWerment following Cardiac and VasculaR surgery (THE SMArTVIEW, CoVeRed), which combines remote monitoring, education, and self-management training to optimize recovery outcomes and experience of seniors undergoing CaVS in Canada and the United Kingdom.ObjectiveOur objectives are to (1) refine SMArTVIEW via high-fidelity user testing and (2) examine the effectiveness of SMArTVIEW via a randomized controlled trial (RCT).MethodsCaVS patients and clinicians will engage in two cycles of focus groups and usability testing at each site; feedback will be elicited about expectations and experience of SMArTVIEW, in context. The data will be used to refine the SMArTVIEW eHealth delivery program. Upon transfer to the surgical ward (ie, post-intensive care unit [ICU]), 256 CaVS patients will be reassessed postoperatively and randomly allocated via an interactive Web randomization system to the intervention group or usual care. The SMArTVIEW intervention will run from surgical ward day 2 until 8 weeks following surgery. Outcome assessments will occur on postoperative day 30; at week 8; and at 3, 6, 9, and 12 months. The primary outcome is worst postop pain intensity upon movement in the previous 24 hours (Brief Pain Inventory-Short Form), averaged across the previous 14 days. Secondary outcomes include a composite of postoperative complications related to hemodynamic compromise—death, myocardial infarction, and nonfatal stroke— all-cause mortality and surgical site infections, functional status (Medical Outcomes Study Short Form-12), depressive symptoms (Geriatric Depression Scale), health service utilization-related costs (health service utilization data from the Institute for Clinical Evaluative Sciences data repository), and patient-level cost of recovery (Ambulatory Home Care Record). A linear mixed model will be used to assess the effects of the intervention on the primary outcome, with an a priori contrast of weekly average worst pain intensity upon movement to evaluate the primary endpoint of pain at 8 weeks postoperation. We will also examine the incremental cost of the intervention compared to usual care using a regression model to estimate the difference in expected health care costs between groups.ResultsStudy start-up is underway and usability testing is scheduled to begin in the fall of 2016.ConclusionsGiven our experience, dedicated industry partners, an...
Background Multiligament knee injuries, though rare, can be profoundly disabling. Surgeons disagree about when to initiate rehabilitation after surgical reconstruction due to the conflicting priorities of postoperative stability and motion. Questions/purposes (1) Does early or late initiation of physical therapy after multiligament knee surgery result in fewer postoperative manipulations? (2) Does early versus late physical therapy compromise stability postoperatively? (3) Does early initiation of physical therapy result in improved patient-reported outcomes, as measured by the Multi-ligament Quality of Life (ML-QOL) score? Methods Between 2011 and 2016, 36 adults undergoing multiligament repair or reconstruction were prospectively enrolled in a randomized controlled trial and randomized 1:1 to either early rehabilitation or late rehabilitation after surgery. Eligibility included those with an injury to the posterior cruciate ligament (PCL) and at least one other ligament, as well as the ability to participate in early rehabilitation. Patients who were obtunded or unable to adhere to the protocols for other reasons were excluded. Early rehabilitation consisted of initiating a standardized physical therapy protocol on postoperative day 1 involving removal of the extension splint for quadriceps activation and ROM exercises. Late rehabilitation consisted of full-time immobilization in an extension splint for 3 weeks. Following this 3-week period, both groups engaged in the same standardized physical therapy protocol. All surgical reconstructions were performed at a single center by one of two fellowship-trained sports orthopaedic surgeons, and all involved allograft Achilles tendon PCL reconstruction. When possible, hamstring autograft was used for ACL and medial collateral ligament reconstructions, whereas lateral collateral ligament and posterolateral reconstruction was performed primarily with allograft. The primary outcome was the number of patients undergoing manipulation during the first 6 months. Additional outcomes added after trial registration were patient-reported quality of life scores (ML-QOL) at 1 year and an objective assessment of laxity through a physical examination and stress radiographs at 1 year. One patient from each group was not assessed for laxity or ROM at 1 year, and one patient from each group did not complete the ML-QOL questionnaires. No patient crossover was observed. Results With the numbers available, there was no difference in the use of knee manipulation during the first 6 months between the rehabilitation groups: 1 of 18 patients in the early group and 4 of 18 patients in the late group (p = 0.34). Similarly, there were no differences in knee ROM, stability, or patient-reported quality of life (ML-QOL) between the groups at 1 year. Conclusion With the numbers available in this study, we were unable to demonstrate a difference between early and late knee rehabilitation with regard to knee stiffness, laxity, or patient-reported quality of life outcomes. The results of this small, randomized pilot study suggest a potential role for early rehabilitation after multiligament reconstruction for knee dislocation, which should be further explored in larger multi-institutional studies. Level of Evidence Level II, therapeutic study.
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