Median PCS Research Articles

Spinal Cord Stimulation with Implantation of Surgical Leads is a Sufficient Salvage Therapy for Patients Suffering from Persistent Spinal Pain Syndrome—A Retrospective Single-center Experience

ObjectivePersistent spinal pain syndrome (PSPS) poses a significant medical challenge, often leading to diminished quality of life for affected individuals. In response to this clinical dilemma, Spinal Cord Stimulation (SCS) has emerged as a promising intervention aimed at improving the functional outcomes and overall well-being of patients suffering from these debilitating syndrome. In case a therapy with percutaneous lead fails, e.g. due to a dislocation, surgical lead can be used as a stable alternative. This is resulting in a more invasive procedure and does not allow for intraoperative monitoring. The aim of the study is to investigate the efficacy and safety of the use of surgical leads, as there have been only a few case series published so far. MethodsWe included PSPS patients that gave consent to a SCS therapy and were treated with Surgical Leads. Outcome scores concerning the quality of life (SF-36), pain related disability (Oswestry disability index [ODI]), sleeping quality (Pittsburgh Sleep Quality Index [PSQI]), and pain intensity (NRS) were obtained prior surgery and at outpatient visits after permanent implantation. ResultsIn this study, 36 patients were implanted with a Surgical Lead SCS system. One patient developed a new neurological deficit characterized by left-sided leg paresis attributable to postoperative hemorrhage, and another patient experienced a wound infection. These complications contributed to an overall morbidity rate of 5.6%. In overall 5 patients (20.8%) the electrodes were explanted within the first month. Follow-up data of 24 subjects with a median time of 21 [15-47] months were available. The mean pain intensity at rest and in motion was reduced. Further pain depending disability improved from a median ODIpreop=38 [30-57]% to ODIfollow-up =21 [9-35]% (p<0.01). Additionally the Sleeping Quality and the Quality of Life improved concerning the physical (Median PCS preop=22.5 [20.4-30.4] vs. PCSfollow-up = 41.8 [35.2-47.0], p < 0.01).) and mental (Median MCSpreop=45.4 [31.1-55.5] vs. MCSfollow-up=58.1 [47.6-59.8], p=0.018). component. ConclusionSCS with surgical leads is a safe secondary technique to treat PSPS, where treatment with percutaneous leads fail. The results show a promising long-term effect concerning pain intensity and functional outcome.

Long-term patient reported outcomes after revision surgery for lower extremity nonunion: A retrospective cohort study

IntroductionOngoing lower extremity long-bone nonunion is a devastating condition and associated with substantial patient morbidity. There is limited evidence regarding physical and mental function after surgical management of lower extremity nonunions. The purpose of this study was to assess general physical and mental health and lower extremity specific physical function of patients that underwent surgery for a lower extremity long-bone nonunion. MethodsOne-hundred and twenty-four adult patients who underwent successful surgical management for a lower extremity long-bone nonunion between June 2002 and December 2021 were evaluated at an average follow-up of 8.6 years (interquartile range [IQR]: 4 – 12). General physical and mental health was assessed with the Short-Form 12 (SF-12) physical (PCS) and mental (MCS) component summaries, and lower extremity specific physical function with the Lower Extremity Functional Scale (LEFS). Multivariable linear regression was performed to identify variables that were independently associated with outcomes. ResultsThe median LEFS was 50 (IQR: 37 – 63) and the median SF-12 PCS was 43 (IQR: 33 – 52), which are both lower than normative population scores (LEFS: 77 and PCS: 51, p < 0.0001). The median SF-12 MCS was 50, which was comparable to the normative population score of 51 (p < 0.0001). The number of previous surgeries before the index nonunion treatment (p = 0.018 and p = 0.041) and the number of revision surgeries after the index nonunion treatment (p = 0.022 and p = 0.041) were associated with lower LEFS and SF-12 PCS scores. ConclusionAt an average of 8.6 years after lower extremity nonunion surgery that led to bone healing, patients continue to report lower general and lower extremity specific physical functioning compared to the normative population. The number of surgical attempts to obtain definitive healing was associated with compromised physical function scores. Mental health scores may return close to normative population scores. These results can be used to inform patients and guide treatment strategies and healthcare policies.

Quality of Life After Early Clot Removal for Acute Iliofemoral Deep Vein Thrombosis

To evaluate patient reported outcome measures after early clot removal for acute deep vein thrombosis (DVT), using the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) and the Short Form Health Survey (SF-36). Cross sectional design. Patients who underwent early clot removal between June 2012 and November 2021 were asked to complete the two questionnaires once. Lower CIVIQ-20 and higher SF-36 scores indicate better quality of life (QoL). Primary endpoints were the median scores. The one sample Wilcoxon signed rank test was used to compare SF-36 physical and mental component summary (PCS and MCS) to the normative and CIVIQ-20 to the minimum. Secondary, non-parametric independent t test or Fisher's exact test examined how age, sex, body mass index, stent placement, re-intervention, and time of questionnaire completion related to QoL. Multivariable linear regression tested whether various variables were associated with QoL. The response rate was 73.5% (n= 39). Median time of questionnaire completion was 1.8 years (interquartile range [IQR] 3.1) after clot removal. The median CIVIQ-20 of 29.0 (IQR 28.0) was slightly higher than the minimum value 20.0 (p < .001). The median PCS (50.5, IQR 16.6) and median MCS (50.2, IQR 14.2) did not differ from the normative of 50.0. However, wide IQRs indicated impairments for a subgroup of patients. None of the tested variables affected QoL except for the finding that re-interventions had a significantly negative impact on the SF-36 MCS (standardised β coefficient of-0.4, p= .030). Overall patient reported outcome measures were satisfactory after early clot removal, but impaired physical and mental functioning levels were present in a subgroup of patients. Re-interventions were found to have a negative impact on mental QoL. This finding was independent of time that had passed between the procedure and questionnaire completion. This study emphasises that mental functioning deserves attention, besides the widely recognised physical consequences after invasive acute iliofemoral DVT treatment.

An investigation into perceived autonomy support, motivation and competence in chronic pain patients in Ireland: A cross-sectional study.

Autonomy supportive healthcare settings are associated with enhanced behaviour change and self-management strategies in individuals living with chronic disease. The level of autonomy support provided by healthcare professionals to individuals living with chronic pain in Ireland is unknown. A cross-sectional study was completed on participants living with chronic pain (>3 months) in Ireland. Participants (n = 389) completed an anonymous survey constructed of patient reported outcome measures relating to autonomy support (HCCQ), motivation (TSRQ), competence in physical activity (PCS), pain interference (BPI) and psychological factors (PHQ-9, GAD-7). Results showed the median HCCQ (H = 39.287, p < .001), Autonomous Motivation (H = 13.568, p = 0.019) and PCS (H = 30.701, p < .001) scores were significantly different when patients received care from different healthcare professionals. There was a negative correlation between PCS and pain severity (r = -0.32, <0.01), pain interference (r = -0.44, p = <0.01), PHQ-9 (r = -0.50, p = <0.01) and GAD-7 (r = -0.34, p = <0.01). This study has identified that perceived healthcare support in Ireland varies according to the healthcare professional leading pain care. Furthermore, higher levels of self-determination were associated with decreased depression and anxiety in individuals with chronic pain. Given the limited number of multidisciplinary team clinics to provide pain management programs, an alternative cost-effective community led solution is required. The results of this study indicate that allied health professionals may be well placed to fill this void. Future research exploring the barriers to providing healthcare supportive settings is required.

Quality of Life after Venous Stenting for Post-thrombotic Syndrome and the Effect of Inflow Disease.

Patients with PTS experience an impaired quality of life (QoL). We aimed to study QoL in patients stented for post thrombotic syndrome (PTS) and analyze the influence of different parameters. Patients stented for PTS after iliofemoral deep vein thrombosis were asked to complete the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) and the Short Form Health Survey (SF-36) in this cross-sectional study. All other data were collected retrospectively. Primary endpoints were median CIVIQ-20 and physical (PCS) and mental (MCS) component summary SF-36 scores. The influence of age, sex, and years between the procedure and completion of questionnaire were investigated using a multivariate linear regression model. Wilcoxon signed rank test compared the PCS and MCS with the normative. Effects of inflow from the deep femoral vein (DFV) and/or the femoral vein (FV) on QoL was analyzed in patients with patent stents. The response rate was 70.3% (n = 45/64). Time period (median) from stenting to questionnaire completion was 6.6 years (IQR: 8.0). Most stents were placed unilateral left-sided (73.3%). For patients with patent stents (n = 42) median CIVIQ-20 was 35.5 (IQR: 17.3), higher than the minimum of 20.0 (P < .001). Median PCS of 44.7 (IQR: 14.2) was lower (P < .001), and MCS of 55.9 (IQR: 7.1) higher (P = .001) than the normative (50.0). Time since stenting and sex were not associated with QoL. Age was a significant predictor [standardized coefficient ß = .36, P = .04] for QoL using the CIVIQ-20, but not for the SF-36. Inflow disease did not impact QoL, but patients with occluded stents (n = 3) had poor functioning levels. Quality of life is impaired after venous stenting for PTS, particularly physical functioning, among patients with an open stent, but was similar between patients with good and impaired inflow. Patients with a permanent stent occlusion had the lowest QoL.

Comparable Outcomes of Cartiva Implant, Cheilectomy, and Fusion for Hallux Rigidus of the 1st Metatarsophalangeal Joint: A Matched Cohort Study

Category: Midfoot/Forefoot; Other Introduction/Purpose: The primary goal of treating hallux rigidus of the 1st metatarsophalangeal (MTP) joint of the foot is to reduce pain. Treatment options include cheilectomy, interposition arthroplasty, and arthrodesis for more severe disease. Recently, the use of a synthetic cartilage implant (Cartiva, Stryker Inc., MI, USA) has been introduced with the advantage of motion preservation. While a Level 1 study has demonstrated similar outcomes of fusion and Cartiva, other comparative studies have shown less favorable results for the Cartiva implant. The purpose of this study was to evaluate minimum 2-year patient reported outcomes (PROs) of the Cartiva implant for the treatment of hallux rigidus in the 1st MTP joint in comparison to a matched cohort of patients treated with fusion or cheilectomy. Methods: Patients &gt;18 years old who underwent surgery for treatment of 1st MTP joint hallux rigidus with Cartiva implant, cheilectomy, or fusion performed by two surgeons (T.O.C. or C.T.H.) between January 2009 and January 2020 were identified. A 2:1 matched control cohort of patients who underwent cheilectomy or fusion was constructed using a nearest neighbor, greedy algorithm based on age, sex, prior surgery, and Coughlin osteoarthritis grade. Minimum 2-year follow-up was obtained with patients completing subjective questionnaires including Foot and Ankle Ability Measure (FAAM) with Activities of Daily Living (ADL) and Sport subscales, Short Form-12 (SF-12), Tegner activity scale, and patient satisfaction with surgical outcome. Demographics and patient-reported outcomes were compared between groups. Results: Follow-up was obtained for 22/27 (82%) Cartiva patients (mean age 54±19) at median 4.3 years and 41/49 (84%) control patients (mean age 58±11) at median 3.5 years. Prevalence of Coughlin grade was similar between Cartiva and control groups (6 vs 10 grade 1, 8 vs 15 grade 2, 2 vs 6 grade 4, 6 vs 10 grade 5; p=.93), respectively. There was no significant difference in median post-operative FAAM-ADL (96 vs 95, p=.53), FAAM-Sport (92 vs 89, p=.89), SF-12 PCS (56 vs 51, p=.054), SF-12 MCS (56.3 vs 57.5, p=.50), Tegner score (4 vs 3, p=.30), or patient satisfaction (9 vs 9, p=.91) between Cartiva and control cohorts, respectively. Revision surgery was required for 3 (14%) Cartiva patients and 4 (10%) control patients (p=.70). Conclusion: Patients treated with a Cartiva synthetic cartilage implant for 1st MTP joint hallux rigidus had similar patient-reported outcomes and revision rate compared to patients treated with cheilectomy or fusion for Coughlin grade 2-5 osteoarthritis.

Broström Repair With and Without Augmentation: Comparison of Outcomes at Median Follow-up of 5 Years.

An augmented Broström repair with nonabsorbable suture tape has demonstrated strength and stiffness more similar to the native anterior talofibular ligament (ATFL) compared to Broström repair alone at the time of repair in cadaveric models for the treatment of lateral ankle instability. The study purpose was to compare minimum 2-year patient-reported outcomes (PROs) following treatment of ATFL injuries with Broström repair with vs without suture tape augmentation. Between 2009 and 2018, patients >18 years old who underwent primary surgical treatment for an ATFL injury with either a Broström repair alone (BR Cohort) or Broström repair with suture tape augmentation (BR-ST Cohort) were identified. Demographic data and PROs, including Foot and Ankle Ability Measure (FAAM) with activities of daily living (ADL) and sport subscales, 12-Item Short Form Health Survey (SF-12), Tegner Activity Scale, and patient satisfaction with surgical outcome, were compared between groups, and proportional odds ordinal logistic regression was used. Ninety-one of 102 eligible patients were available for follow-up at median 5 years. The BR cohort had 50 of 53 patients (94%) completed follow-up at a median of 7 years. The BR-ST cohort had 41 of 49 (84%) complete follow-up at a median of 5 years. There was no significant difference in median postoperative FAAM ADL (98% vs 98%, P = .67), FAAM sport (88% vs 91%, P = .43), SF-12 PCS (55 vs 54, P = .93), Tegner score (5 vs 5, P = .64), or patient satisfaction (9 vs 9, P = .82). There was significantly higher SF-12 MCS (55.7 vs 57.6, P = .02) in the BR-ST group. Eight patients underwent subsequent ipsilateral ankle surgery, of which one patient (BR-ST group) was revised for recurrent lateral ankle instability. At median 5 years, patients treated for ATFL injury of the lateral ankle with Broström repair with suture tape augmentation demonstrated similar patient-reported outcomes to those treated with Broström repair alone. Level II, retrospective cohort study.

Association of Frailty With Health-Related Quality of Life in Liver Transplant Recipients

Frailty has been recognized as a risk factor for mortality after liver transplant (LT) but little is known of its association with functional status and health-related quality of life (HRQL), termed global functional health, in LT recipients. To evaluate the association between pre-LT and post-LT frailty with post-LT global functional health. This prospective cohort study was conducted at 8 US LT centers and included adults who underwent LT from October 2016 to February 2020. Frail was defined by a pre-LT Liver Frailty Index (LFI) score of 4.5 or greater. Global functional health at 1 year after LT, assessed using surveys (Short Form-36 [SF-36; summarized by physical component scores (PFC) and mental component summary scores (MCS)], Instrumental Activities of Daily Living scale) and performance-based tests (LFI, Fried Frailty Phenotype, and Short Physical Performance Battery). Of 358 LT recipients (median [IQR] age, 60 [53-65] years; 115 women [32%]; 25 [7%] Asian/Pacific Islander, 21 [6%] Black, 54 [15%] Hispanic White, and 243 [68%] non-Hispanic White individuals), 68 (19%) had frailty pre-LT. At 1 year post-LT, the median (IQR) PCS was lower in recipients who had frailty vs those without frailty pre-LT (42 [31-53] vs 50 [38-56]; P = .002), but the median MCS was similar. In multivariable regression, pre-LT frailty was associated with a -5.3-unit lower post-LT PCS (P < .001), but not MCS. The proportion who had difficulty with 1 or more Instrumental Activities of Daily Living (21% vs 10%) or who were unemployed/receiving disability (38% vs 29%) was higher in recipients with vs without frailty. In a subgroup of 210 recipients with LFI assessments 1 year post-LT, 13% had frailty at 1 year post-LT. Recipients who had frailty post-LT reported lower adjusted SF-36-PCS scores (coefficient, -11.4; P < .001) but not SF-36-MCS scores. Recipients of LT who had frailty vs those without frailty 1 year post-LT also had worse median (IQR) Fried Frailty Phenotype scores (1 [1-2] vs 1 [0-1]) and higher rates of functional impairment by a Short Physical Performance Battery of 9 or less (42% vs 20%; P = .01). In this cohort study, pre-LT frailty was associated with worse global functional health 1 year after LT. The presence of frailty after LT was also associated with worse HRQL in physical, but not mental, subdomains. These data suggest that interventions and therapeutics that target frailty that are administered before and/or early post-LT may help to improve the health and well-being of LT recipients.

Mindfulness Practices for Chronic Pain in Sickle Cell Disease

Background: Patients with sickle cell disease (SCD) suffer from both acute and chronic pain that severely affects their quality of life. Pain is largely managed with opioids, which have significant side effects including dependence, adverse mood effects, and potential for opioid-induced hyperalgesia. The 2020 American Society of Hematology guidelines for SCD suggests cognitive and behavioral pain management strategies (including mind-body interventions). However, there remains low certainty in the evidence of these modalities. We chose to pursue mindfulness-based interventions given their proven efficacy in other chronic pain syndromes and associated mental health disorders. Objective: The purpose of our pilot study was to assess the feasibility and acceptability of weekly group yoga therapy sessions conducted virtually via videoconferencing software in patients with sickle cell disease and chronic pain, defined as pain on more than 15 days per month for the last 6 months. Design: Twenty patients with SCD were recruited for weekly virtual group yoga therapy sessions, which incorporated aspects of mindfulness meditation and low impact movements synchronized with breathing exercises (see Table 1). Results: Twenty out of 22 patients (92%) approached for the study agreed to participate. The median age of participants was 35 (IQR 26-43), with the majority being female (n=13 out of 19, 68%). The baseline survey revealed participants had frequent Emergency Department visits (median 3, IQR 1.25-4) and hospitalizations (median 2, IQR 0-2) in the 6 months prior to the intervention. The study population exhibited high levels of pain catastrophizing (median PCS 40.5, IQR 27.25-52.5, 93%tile), anxiety (median GAD-7 18.5, IQR 10.25-21.5), and depression (median PHQ-9 17, IQR 13.25-22.5). On average, 15% of participants (range 2-32%) attended each session. Barriers to participation included technologic difficulties, time conflicts, and inability to contact participants. The participants who consistently attended the sessions had positive feedback. One participant stated, "It went well for me. Meditation was helpful...[and] the yoga helped with my knee." Another participant commented, "I liked having a community with the other patients." Conclusions and Future Directions: This pilot study was among the first of its kind to examine mindfulness practices for chronic pain in adults with SCD. While there was a high rate of agreement to participate in the study, indicating a willingness and receptiveness to the study intervention, the overall participation per session was low. The study population had high rates of health care utilization despite most participants being on chronic opioid therapy and disease modifying medications, which illustrates the need for additional therapeutic strategies. A striking aspect of the baseline survey was the high rates of pain catastrophizing, anxiety, and depression, which directly impact chronic pain and thus require a holistic approach that includes mindfulness-based interventions. Our future research will draw upon lessons learned from the pilot study to address barriers to participation. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Is Ankle Arthrodesis With an Ilizarov External Fixator an Effective Treatment for Septic Ankle Arthritis? A Study With a Minimum of 6 Years of Follow-up.

Septic ankle arthritis is a devastating clinical problem with a high potential for permanent disability and amputation. Successful treatment of septic ankle arthritis remains a challenge for the surgeon and patient. Ankle arthrodesis combined with radical debridement may be an effective option to eradicate infection and salvage the limb. Although numerous fusion methods have been proposed, there is controversy about the most effective technique. At a minimum follow-up of 6 years after ankle arthrodesis performed using an Ilizarov external fixator, we asked, (1) In what proportion of patients was bony fusion achieved? (2) What complications were observed, and what reoperations were performed in these patients? (3) How much did patient-reported outcomes improve from before surgery to the most recent follow-up in this group? Between April 2010 to March 2015, we treated 59 patients for septic ankle arthritis. Of those, we considered patients who were at least 18 years of age with irreversible destruction of the joint as potentially eligible. During that time period, all patients met the prespecified criteria and were treated with ankle arthrodesis using an Ilizarov external fixator. Two percent (one of 59) of patients were excluded because they died in the second year after surgery for reasons unrelated to the procedure, and another 7% (four of 59) of patients were excluded because they were lost before the minimum study follow-up interval of 6 years. Finally, 92% (54 of 59) of patients were analyzed at a mean follow-up time of 9 ± 1 years. A total of 61% (33 of 54) were men, and they had a mean age of 48 ± 12 years. Forty-six percent (25 of 54) of patients were smokers, and 13% (seven of 54) of patients had Type 2 diabetes mellitus. All patients received radical debridement and primary arthrodesis with an Ilizarov external fixator, followed by antibiotic therapy. Postoperatively, patients were instructed to perform lower extremity functional exercises and external fixator care; weightbearing ambulation as tolerated was encouraged as early as possible. Fusion was assessed with a radiographic review that was performed by an individual who was not involved in the surgical care of these patients. We defined bony fusion as continuous trabeculae and complete cortical bridging in the fusion interface achieved before 9 months; delayed union was defined as fusion achieved by 9 to 12 months; and nonunion was defined as patients in whom fusion was not achieved by 12 months. Complications and reoperations were tallied through a record review that was performed by an individual who was not involved in the surgical care of these patients. We defined complications as any deviation from the expected postoperative course. We used the American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot score, the VAS active pain score, and the SF-12 questionnaire (including the physical component summary [PCS] score and mental component summary [MCS] score) to assess patient-reported outcomes. The minimum clinically important difference (MCID) for the AOFAS score was 30 points of 100, the MCID for the VAS active pain score was 2 points of 10, and the MCID of PCS and MCS scores was 7 points and 9 points, respectively. Primary bony fusion was achieved in 94% (51 of 54) of patients. Delayed union was found in 2% (one of 54) of patients. Nonunion was found in 6% (three of 54); one of these patients underwent autologous bone grafting during revision, and bony fusion was ultimately achieved. Final bony fusion was achieved in 96% (52 of 54) of patients. Recurrent infection was found in 2% (one of 54). The median (range) AOFAS score improved from 28 points (8 to 59) before surgery to 80 points (52 to 86) at the most recent follow-up (median difference 52; p < 0.001). The median (range) VAS active pain score decreased from 8 points (6 to 9) before surgery to 2 points (0 to 5) at the most recent follow-up (median difference -6; p < 0.001). For the Short Form 12-item score, the median (range) PCS score improved from 0 points (0 to 30) before surgery to 70 points (40 to 95) at the most recent follow-up (median difference 70; p < 0.001), and the median (range) MCS score improved from 46 points (21 to 75) before surgery to 75 points (50 to 92) at the most recent follow-up (median difference 29; p < 0.001). Ankle arthrodesis with Ilizarov external fixation might eradicate an infection and restore foot function in patients with septic ankle arthritis. However, patients should be fully informed of the complications related to the external fixator, such as pin-tract infections, recurrent infection, and nonunion. Standardized and professional pin care is important. Additionally, because Ilizarov external fixators can be inconvenient to the patients' daily lives, future studies should explore how psychologic support affects patients who undergo ankle arthrodesis with these devices. Level IV, therapeutic study.

Impact of advances in therapy on survival in patients with de novo metastatic prostate cancer.

e17052 Background: The approval of newer therapies including novel androgen pathway inhibitors (abiraterone [2011], enzalutamide [2012], apalutamide [2018]), and radium 223 dichloride [2013]) in the past decade has expanded the therapeutic landscape for patients with metastatic prostate cancer (mPCa). Such therapies have demonstrated a consistent benefit on survival in clinical trials including highly selected patients. However, the benefit on survival at the population level is unknown. This study aims to evaluate the impact of therapeutic advancements in the past decade on survival in patients with de novo mPCa using the SEER database. Methods: We included males with de novo mPCa ≥18 years of age in the SEER database from 2000 to 2018. Patients with missing survival data and those diagnosed at autopsy were excluded. Using the year of diagnosis, patients were categorized into two therapeutic periods: 2000-2010 (period A) and 2011-2018 (period B). The period 2011 to 2018 corresponds to the timeline of approval for novel antiandrogens and radium 223. Kaplan-Meier was used to estimate prostate cancer-specific survival (pCS) and overall survival (OS). Log-rank test was used to compare pCS and OS between the two periods. Univariate and multivariate cox regression models were performed to determine the significant covariates for pCS and OS. Results: A total of 33,969 patients were included in the analysis; 15,433 in period A (45.4%) and 18,536 in period B (54.6%). The mean age was 70.9(SD:10.5) and 61% were Caucasian. No significant difference was noted in the clinicopathologic and socioeconomic characteristics in both periods. The median pCS (36 vs. 30 months, p &lt; 0.001) and OS (30 vs. 25 months, p &lt; 0.001) were longer in period B compared to period A. In the multivariate model for pCS, diagnosis during period B was associated with a significantly decreased hazard of death from prostate cancer (HR:0.89, CI: 0.85-0.94, p &lt; 0.001). Age &gt; 80 years (HR:1.6, p &lt; 0.001), PSA &gt; 50 ng/mL (HR:1.3, p &lt; 0.001), and poorly differentiated histology (HR:2.0, p &lt; 0.001) were significant predictors of worse pCS. Hispanic origin (HR:0.94, p = 0.02) and median household income &gt; $75000 (HR:0.86, p = 0.007) were associated with better pCS. In the multivariate model for OS, diagnosis in period B was associated with a decreased hazard of death from any cause (HR:0.89, CI:0.85-0.93, p &lt; 0.001). Age &gt; 65 years (HR:1.26, p &lt; 0.001), PSA &gt; 50 ng/mL (HR:1.30, p &lt; 0.001), and poorly differentiated histology (HR:1.6, p &lt; 0.001) were associated with worse OS. Hispanic origin (HR:0.94, p = 0.01) and median household income &gt; $75000 (HR:0.81, p &lt; 0.001) were associated with better OS. Conclusions: The diagnosis of de novo mPCa during the period of the therapeutic advancement (2011-2018) was associated with improved pCS and OS. However, the observed 11% reduction in the risk of death from any cause in this population-based study was smaller than the reported 20 to 38% in clinical trials.

Long-stay medical-surgical intensive care unit patients in South Africa: Quality of life and mortality 1 year after discharge

Background. Although mortality is the primary measure of critical care outcome, the health-related quality of life (HRQOL) of survivors is often diminished. There is a paucity of South African research on HRQOL in intensive care unit (ICU) survivors. Objectives. To evaluate the 1-year post-discharge data of long-stay ICU patients, a group known to consume 20 - 40% of ICU resources. Methods. A 1-year prospective observational study was conducted in a multidisciplinary medical-surgical ICU. Adult patients who were mechanically ventilated beyond 6 days were included. Clinical and mortality data were collected. Pre-admission and 6- and 12-month HRQOL were measured with the Short Form-36 questionnaire. Physical and mental component summary scores (PCS and MCS) were calculated. Associations between 12-month mortality and poor HRQOL scores were determined. Results. Of 119 patients enrolled, 40.3% had sustained trauma, 19.3% were post-surgical and 40.3% had medical conditions; 29.2% were HIV-positive (HIV status was known for 74.8% of the cohort). The hospital and 12-month mortality rates were 42.9% and 57.4% (n=66/115), respectively. Age, longer ICU stay, higher disease severity scores and vasopressor use were associated with 12-month mortality. The survivors’ median PCS and MCS at 6 and 12 months were significantly lower compared with pre-admission scores (both p&lt;0.001). At 12 months, 53.1% of survivors demonstrated a poor PCS and 42.9% a poor MCS. Associations with poor 12-month PCS included longer ICU stay, male gender and trauma, while trauma and sepsis were associated with a poor 12-month MCS. Among the 19 trauma survivors, 78.9% had a poor MCS and/or PCS. Of previously employed patients, 54.8% were unemployed at 12 months. Conclusions. Patients ventilated beyond 6 days in a multidisciplinary ICU had a high mortality. Poor HRQOL at 12 months post discharge was frequently observed among survivors. Trauma was associated with poor 12-month outcomes. These findings highlight the need to further explore the outcomes of long-stay ICU patients in Africa.

Associations between the Composite Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS), survival and other disease measures

ObjectiveDiffuse cutaneous systemic sclerosis (dcSSc) is a multifaceted disease for which the Composite Response Index in dcSSc (CRISS) was developed as a global outcome measure. We aimed to further validate the CRISS by examining its association with other disease measures, patient reported quality of life (QoL), and mortality. MethodsDcSSc patients with ≤5 year disease duration were recruited from multinational registries. CRISS improvers (score ≥0.6) and non-improvers (score <0.6) were identified after one year. Median changes in European Scleroderma Group Activity Index (EScSG-AI), Medsger Disease Severity Scale (DSS), Scleroderma Clinical Trials Consortium Damage Index (SCTC-DI), and Short Form 36 physical component score (SF-36 PCS) after one year was compared between CRISS groups. Kaplan Meier and adjusted Cox analyses compared SCTC-DI damage accrual and mortality between CRISS groups. ResultsOf 212 patients, 68 (32.1%) were CRISS improvers. CRISS improvers had improved median EScSG-AI (-1.1 points [IQR -2.6, -0.3] vs. 0 [-1.1, 1.0], p<0.001), DSS (-1 [-3, 1] vs. 0 [-2, 2], p = 0.015), and SF-36 PCS (+3.6 [-1.0, 8.9] vs. -0.3 [-5.9, 4.5], p<0.001) compared to non-improvers. CRISS improvers were less likely to accumulate damage on the SCTC-DI (hazard ratio [95% confidence interval] 0.68 [0.47, 0.96]) adjusting for age, sex, disease duration, and immunosuppression use. CRISS improvers had a trend towards better survival. ConclusionCRISS improvers had more favourable changes in measures of disease activity, disease severity, and QoL compared to non-improvers. These findings support the construct validity of a CRISS outcome after one year in early dcSSc.

Distress, Health-Related Quality of Life (HQOL) and Confidence in Survivorship Information (CSI) in Older (≥60 Years) Hematopoietic Cell Transplant (HCT) Patients

Background: The use of HCT to treat older (≥60 years) patients with hematological malignancies has markedly increased in recent years, however, the long-term effects of HCT on distress, psychosocial functioning, and HQOL in older HCT survivors is largely unknown. Though older HCT survivors have a higher risk of disease recurrence, they may have less access to resources and subsequently experience more pronounced late effects of disease and treatment. Confidence in Survivorship Information (CSI) in this specific age group has not been reported.Methods: We conducted a secondary analysis on a subgroup of patients enrolled in INSPIRE (NCT01602211) and PCORI-SCP (NCT02200133) clinical trials. Eligibility criteria for inclusion include HCT patients who were ≥ 60 years at time of transplant performed in 2003-2014, survived ≥ 1 year post-transplant with no evidence of disease relapse or secondary cancers. Patients were eligible for inclusion irrespective of transplant type (autologous or allogeneic), diagnosis, donor source or conditioning regimen. Primary endpoint was distress level in older HCT survivors; secondary endpoints included CSI and HQOL outcomes. We collected baseline distress level as measured by Cancer and Treatment Distress (CTXD) score, HQOL (measured by SF-12 Mental and Physical Component Summaries (PCS/MCS) and CSI (measured by a 15-item CSI questionnaire). Sociodemographic, disease and transplant factors were extracted from medical databases. Nonparametric (Wilcoxon rank sum/Kruskal-Wallis) test was conducted for comparing 2 or 3 groups. Spearman correlation and univariate linear regression model were used to evaluate associations between CTXD/CSI and PCS/MCS. Bonferroni correlation was used to adjust for multiple pairwise comparisons within age group.Results: A total of 567 patients satisfied the eligibility criteria and were included in this analysis. Median age at time of HCT was 69 years with 57% male; two-thirds were autologous HCT recipients. Table 1 details patient characteristics. The median CTXD score for older HCT survivors was 0.7 (range 0-2.7, SD 0.6) indicating low/insignificant level of distress post-HCT. 20-30% of HCT survivors reported moderate distress when asked about concerns regarding relapse risk, loss of energy and functional decline. Type of transplant (auto vs allo), age group (<65 years, 65-70 years, ≥70 years), and time from HCT (≤2 years vs > 2 years) showed no apparent effect on reported distress level. CSI median score was 1.4 (range 0-2) which remains consistent with the score reported previously by the original trial including all age groups, indicating that older HCT survivors may have similar level of confidence in their survivorship information as their younger counterparts. Of note, close to 20% of the older HCT survivors reported poor CSI when asked about strategies for prevention and treatment of long-term effects of HCT and when asked about their confidence in availability of community resources to deal with long-term HCT complications. No statistically significant correlation was identified between CSI in older survivors and transplant type, time from HCT, or age group. HQOL outcomes indicated a median PCS of 48.2 (range 21.1 - 62.9) and a median MCS of 54.7 (range of 14.9 - 67.2). Interestingly, even though not reflected on the overall median CTXD and CSI scores for this cohort, a significant individual association between CTXD/CSI and PCS/MCS measures of HQOL was found (Figure 1). A subgroup analysis conducted on older alloHCT recipients confirmed the same findings of clinically insignificant distress level (mean CTXD ≤1.1) while having a similar level of CSI when compared to all age groups. Interestingly, time from HCT (≤2 years vs > 2 years) showed no significant effect on distress level reported by older alloHCT survivors, and cGVHD status did not correlate with CTXD or CSI scores nor with PCS/MCS in older alloHCT survivors.Conclusion: This is the largest study to date to investigate patient-reported distress, CSI and HQOL in older HCT survivors. Our data indicate that older HCT survivors have low levels of stress after HCT and had confidence in survivorship information in most aspects of their care. However, targeted interventions should focus on improving strategies for prevention, treatment and availability of community resources to deal with late effects of HCT; aspects reported as points of low CSI by older HCT survivors. [Display omitted] DisclosuresFarhadfar: Incyte: Consultancy. Shaw: Orca bio: Consultancy; mallinkrodt: Other: payments. Devine: Be the Match: Current Employment; Orca Bio: Consultancy, Research Funding; Johnsonand Johnson: Consultancy, Research Funding; Sanofi: Consultancy, Research Funding; Magenta Therapeutics: Current Employment, Research Funding; Tmunity: Current Employment, Research Funding; Vor Bio: Research Funding; Kiadis: Consultancy, Research Funding. Majhail: Anthem, Inc: Consultancy; Incyte Corporation: Consultancy. Wingard: Merck: Consultancy; AlloVir: Consultancy; Celgene: Consultancy; Shire: Consultancy; Janssen: Consultancy; Cidara Therapeutics: Consultancy.

Evidence supporting the use of a subjective staff evaluation to assess the benefit of rehabilitation in hemodialysis patients undergoing inpatient rehabilitation

BackgroundWe questioned whether the introduction of a subjective evaluation of patient-specific goals, could be used as a valid method to assess the effectiveness of inpatient rehabilitation.MethodsIn this prospective cohort study, all admissions to the UHN hemodialysis rehabilitation service between April 2013 and August 2016 were included. We introduced a system of subjective assessment, performed by the team at the time of admission and discharge. We evaluated Functional Independence Measure (FIM®) score and KDQoL for objective measures of physical function and patient-reported quality of life.ResultsA total of 201 patients were included. The median FIM score at discharge correlated well with the subjective staff evaluation. FIM score changes for those with evaluations for Success, Partial success, and Not Successful were 28 [interquartile range (IQR) 20–34], 24 [IQR18–31], 16 [IQR 11–34] respectively. The median PCS at discharge for those deemed to have Success was 37.4 [IQR31.0, 44.7], and for those with Partial success & Not Successful 28.8 [IQR 22.4, 39.2]. There was no correlation with MCS scores (55.2 [IQR 51.2, 60.2], 58.4 [IQR 50.1, 63.1] respectively).ConclusionsThese results suggest the subjective staff evaluation is a brief but valid assessment of patient outcome for dialysis patients undergoing inpatient rehabilitation.

Efficacy Analyses from the Immune Thrombocytopenia (ITP) Clinical Development Program for Avatrombopag: Comparisons with Placebo and Eltrombopag

Efficacy Analyses from the Immune Thrombocytopenia (ITP) Clinical Development Program for Avatrombopag: Comparisons with Placebo and Eltrombopag

Chronic Hip Injury Has a Negative Emotional Impact on the Male Athlete With Femoroacetabular Impingement

To evaluate the impact of hip arthroscopy for femoroacetabular impingement (FAI) on both the physical and mental components of the 36-Item Short Form (SF-36) and assess how changes in health status compare with improvements in physical function and ability to continue to play (CTP) 2 years after surgery. Data collected prospectively from male athletes undergoing primary arthroscopic correction of FAI between November 2008 and October 2016 were analyzed. Physical (PCS) and mental (MCS) component scores of the SF-36 were assessed preoperatively and 2 years postoperatively. The minimal clinical important difference (MCID) was calculated using an anchor-based percentage of possible improvement technique, and the proportion of athletes achieving MCID was established. Logistic regression analysis was used to identify predictors of achieving MCID. CTP was assessed at 2-year follow-up. 486 cases were included, age 25.9 ± 5.6 years. Median PCS improved from baseline 69.4 (51.9 to 85.0) to 91.9 (81.9 to 97.5) at 2 years (P < .001). Median MCS remained unchanged-preoperative, 88 (76 to 92); postoperative, 88 (80 to 96)-although the difference in the distribution of scores was statistically significant (P < .001). Calculated MCID was 60.1% (PCS) and 58.1% (MCS). Mean improvement was significantly higher for PCS compared with MCS (17.4 versus 3.7, P < .001) The proportion of cases achieving MCID was 56.9% and 28.7% for PCS and MCS, respectively, and the difference was statistically significant (P < .001). Lower Tonnis grade (odds ratio [OR] 0.601, 95% confidence interval [CI] 0.377 to 0.958; P= .032) and symptom duration <2 years (OR 0.624, 95% CI 0.406 to 0.960; P= .032) were predictive of achieving PCS MCID. Higher preoperative scores decreased the odds of achieving MCID (OR 0.965, 95% CI 0.955 to 0.975; P < .001; OR 0.972, 95% CI 0.958 to 0.986; P < .001 for PCS and MCS, respectively). 77.3% continued to play their main preinjury sport. Where CTP was not achieved, a significantly higher proportion of cases failed to meet MCID for the MCS compared with PCS (85% versus 60%, P < .001). Arthroscopic management of sports-related FAI results in excellent overall clinical outcome and high levels of satisfaction and CTP at 2 years. Chronic hip injury has a significant negative effect on the physical and mental well-being of athletes; corrective surgery may restore physical function but is more limited in its ability to improve mental health status in this athletic cohort. IV, therapeutic case series.

Community health status and outcomes after allogeneic hematopoietic cell transplantation in the United States.

The association of community factors and outcomes after hematopoietic cell transplantation (HCT) has not been comprehensively described. Using the County Health Rankings and Roadmaps (CHRR) and the Center for International Blood and Marrow Transplant Research (CIBMTR), this study evaluated the impact of community health status on allogeneic HCT outcomes. This study included 18,544 adult allogeneic HCT recipients reported to the CIBMTR by 170 US centers in 2014-2016. Sociodemographic, environmental, and community indicators were derived from the CHRR, an aggregate community risk score was created, and scores were assigned to each patient (patient community risk score [PCS]) and transplant center (center community risk score [CCS]). Higher scores indicated less healthy communities. The impact of PCS and CCS on patient outcomes after allogeneic HCT was studied. The median age was 55 years (range, 18-83 years). The median PCS was -0.21 (range, -1.37 to 2.10; standard deviation [SD], 0.42), and the median CCS was -0.13 (range, -1.04 to 0.96; SD, 0.40). In multivariable analyses, a higher PCS was associated with inferior survival (hazard ratio [HR] per 1 SD increase, 1.04; 99% CI, 1.00-1.08; P = .0089). Among hematologic malignancies, a tendency toward inferior survival was observed with a higher PCS (HR, 1.04; 99% CI, 1.00-1.08; P = .0102); a higher PCS was associated with higher nonrelapse mortality (NRM; HR, 1.08; 99% CI, 1.02-1.15; P = .0004). CCS was not significantly associated with survival, relapse, or NRM. Patients residing in counties with a worse community health status have inferior survival as a result of an increased risk of NRM after allogeneic HCT. There was no association between the community health status of the transplant center location and allogeneic HCT outcomes.

Quality of life analysis after stereotactic radiofrequency ablation of liver tumors

The purpose of this study was to evaluate the health-related quality of life (HRQoL) after stereotactic radiofrequency ablation (SRFA) of liver tumors and identify variables associated with decreased HRQoL and to compare it to other treatments in case of concurrency. From 2011 to 2017 577 patients underwent SRFA for liver tumors in 892 ablation sessions. 303 (52.5%) patients completed a HRQoL questionnaire once after the ablation. HRQoL was assessed by the Short Form (SF)-12 health survey with mental and physical component scales and by a general questionnaire to assess disease and treatment-specific items as well as to compare tolerability of SRFA to transarterial chemoembolization (TACE), hepatic resection (HR) and chemotherapy (CTX). The median SF-12 PCS was 46.6 and MCS was 53.2. Patients experiencing pain or complications and patients refusing repeat SRFA showed significantly lower PCS (43.2 vs 48.6, p = 0.0003; 32.8 vs 46.9, p = 0.005 and 40.6 vs 46.9, p = 0.009). 355 (97.8%) patients indicated willingness to undergo repeat SRFA with little to no fear in 292 (80.7%) patients. Among patients with multiple therapies, SRFA was rated by 40 (90.9%) as preferred re-treatment, HR by 1 (2.3%) and CTX by 3 (6.8%). In conclusion, we have shown that SRFA has good HRQoL-outcomes and reported low morbidity rates. Consequently the vast majority of study patients would accept a repeated SRFA if necessary (97.8%), without fear (80.7%). SRFA was preferred among patients who experienced concurrent treatments, such as HR or CTX.

Health-related quality of life and flourishing in current and former recreational and elite cricketers

BackgroundHealth related quality of life (HRQoL) and flourishing are constructs that encompasses a holistic representation of physical, psychological, and social health. The underlying psychological factors that can affect HRQoL and flourishing in sports participants is poorly understood. The purpose of this study was to i) evaluate HRQoL (physical and mental-components) and flourishing in recreational and elite and current and former cricketers; ii) determine the effect of resilience, playing-standard, and playing status on HRQoL and flourishing in cricketers.MethodsThe Cricket Health and Wellbeing Study (n = 2598 current and former cricketers, aged ≥18 years) collected cross-sectional questionnaire data including the Flourishing Scale, Short Form-8 (physical (PCS) and mental (MCS) component scores), resilience (European Social Survey), highest standard-of-play, and playing status. Multivariable linear regressions with fractional polynomials were utilised, adjusted for age, gender, total cricket-seasons, comorbidity, ≥ 4-week time-loss injury, and orthopaedic surgery.ResultsTwo thousand two hundred eighty individuals (aged (mean (SD)) 51.7(14.7) years, 61% played recreationally, 37% former cricketers) were included in analyses. The median (IQR) PCS was 51.4(46.9–55.9), MCS was 54.3(50.0–58.6), and Flourishing Scale score was 48 [ (1–7)] .Greater resilience was associated with better PCS (effect (95% CI) 1.41(0.70–2.11)), MCS (4.78(4.09–5.48)), and flourishing (2.07(2.55–3.59)) compared to less resilience. Playing standard was not associated with HRQoL. Playing at an elite standard was associated with greater flourishing (1.21(0.68, 1.73)), compared with playing recreationally. Current cricket participation was associated with better PCS (3.61(2.92–4.30)) and flourishing scores (0.53(0.02–1.04)), compared to former cricket participation.ConclusionCricketers reported high levels of mental-components of HRQoL and flourishing, and this was similar in recreational, elite, current and former cricketers. Current cricket participation and a higher standard-of-play was associated with greater flourishing. Current cricket participation was also associated with better PCS, however playing-status was not related to MCS. Further research is needed to understand if cricket participation may have psychological benefits that persist beyond cricket retirement.