Improvements In Outcome Measures Research Articles

Barriers and new opportunities in developing effective therapies for diabetic neuropathy: International expert consensus recommendations.

Diabetic neuropathy (DN) affects up to half of individuals with type 1 and type 2 diabetes. Despite evidence that improving metabolic and cardiovascular health can slow its progression, DN remains a significant clinical challenge due to the lack of disease-modifying therapies and effective pain management strategies. This consensus aimed to identify gaps and recommend strategies to address these challenges. A workshop, initiated by Steno Diabetes Centre Copenhagen and the Danish Diabetes and Endocrinology Academy, conducted a gap analysis based on insights from clinical studies, observational cohorts, and clinical practice. Online invitations targeted experienced clinicians, researchers, and drug developers committed to improving DN treatment through innovative clinical trials. Thirty-five participants from six countries reached consensus via a Delphi process on key steps to advance DN therapy. Four critical barriers and needs were addressed: (1) Translating bench research to clinical practice, (2) Enhancing clinical trial design, (3) Improving outcome measures, and (4) Identifying effective treatments for painful DN. Successful interventional trials require robust outcome measures to capture clinically meaningful changes in DN phenotypes, providing the basis for developing effective, disease-modifying treatments.

Comparison of the effectiveness of nurse-led preoperative counseling and postoperative follow-up care vs standard care for patients with gastric cancer.

Radical gastrectomy is generally prefered for gastric cancer but has postoperative complications. The objectives of the study are to evaluate the effectiveness of three different models of preoperative counseling and postoperative follow-up care in patients who underwent radical gastrectomy for gastric cancer. In retrospective medical record analyses, patients received nurse-led preoperative counseling and postoperative follow-up care (NC cohort, n = 105) or surgeon-led preoperative counseling and surgeon-led follow-up (SC cohort, n = 140), or did not receive counseling and aftercare (RC cohort, n = 160). Patients had a postoperative intensive care unit (PICU) stay of 24 (26-22) h/patient and postoperative pain of 6 (6-5)/ patient. The frequencies of nausea, vomiting, medical intensive care unit admission(s), dizziness, length of PICU stay, and intensity of postoperative pain were lower among patients in the NC cohort, followed by those in the SC and RC cohorts. A higher number of patients in the RC cohort died when compared to the NC (25 [16%) vs 2 [2%], p = 0.0458) and the SC (25 [16%] vs 11 [8%], p = 0.0001) cohorts in follow-up. Patients who undergo radical gastrectomy for gastric cancer require healthcare professional-led preoperative counseling and postoperative aftercare. Nurse-led preoperative counseling and postoperative aftercare, could improve outcome measures in patients who underwent radical gastrectomy for gastric cancer.

Variations in caesarean section outcome reporting in low- and middle-income countries: A systematic review.

To explore the variation and quality of the outcomes reported using descriptive analysis and interactive network visualisation of CS outcomes of comparative studies conducted in low-and middle-income settings. Systematic review of comparative studies to reduce caesarean section complications in low- and middle-income countries and outcome assessment using the modified Harman questionnaire, assessing for the presence of a clear primary outcome, an explanation of how the outcomes were analysed and a description of the methods used to enhance the quality of these measures. 102 comparative studies were included. Studies of interventions to improve maternal and perinatal outcomes after caesarean section reported 466 outcomes with 15% of these outcomes appearing only once across the outcomes reviewed (n=73). The most common outcome categories reported were maternal death, disability and bleeding. Psychological and injury outcomes were less commonly reported. The overall quality of outcome reporting varied between studies but was particularly low for reporting on methods to improve outcome measures. Very few outcomes scored a maximum of three points when assessed according to the modified Harman score, with only 15 of the primary outcomes (16%) achieving 3 points and 40 of the secondary outcomes (11%) achieving 3 points. The median quality of reporting was 2 (range 0, 3) for all outcomes, for a maximum score of 3. Quality of outcome reporting was associated with the type of outcome (primary or secondary), the region in which the study was conducted in, and journal characteristics such as impact factor and journal type. There was wide variability in both the outcomes reported and the frequency in which they were reported. Overall, very few primary and secondary outcomes achieved the maximum score of three on the modified Harman score, highlighting the need for a core outcome set for caesarean section intervention trials to improve the consistency and synergy of future research outcome definition, measurement and synthesis. The protocol was registered (PROSPERO CRD42022353939).

OGC SO29 - Patient perceptions survey on the best timed oesophago-gastric dietetic pathway

Abstract Background It is well established that patients with oesophago-gastric (OG) cancer often present with malnutrition and impact symptoms such as anorexia, dysphagia and abdominal symptoms. Dietetic input is imperative in assessing and managing these symptoms early to improve outcome measures such as nutritional status, clinical outcomes and quality of life. A service evaluation was conducted to explore patient perceptions of early dietetic intervention in the Greater Manchester OG two week wait (TWW) pathway. There is no known prior research exploring the aims of this project. The results provide a novel insight into patient perceptions. Method A mixed methods survey using Microsoft Forms including open and close-ended questions was completed using transcription of responses via telephone consultation for 8 participants. For multiple choice responses, quantitative analysis was undertaken utilising Microsoft Forms analytics. Thematic analysis was completed with the use of computer assisted qualitative data analysis software (CAQDAS). Results 100% of respondents strongly agreed that receiving information about eating and drinking during investigations was important to them. 100% of respondents disagreed that dietetic advice was difficult to understand and follow. 75% of respondents felt dietetic input to be helpful in managing nutritional impact symptoms. 25% of participants responded neutrally. 100% of respondents felt their individual needs and concerns were addressed and would recommend the service to friends/family (88% strongly agreed; 12% agreed respectively). Conclusion Dietetic input was viewed positively by service users undergoing the OG TWW pathway. Patients reported feeling reassured, and valued communication, accessibility, and a personal approach. Some patients experienced delays in receiving prescribed nutritional supplements. Consistency of nutritional information requires improvement across the multidisciplinary team. Unfamiliarity with dietetic input limits the ability of participants to provide perspectives on service improvement. These findings suggest that specialist nutritional assessment and advice is beneficial to patients. Future research should be conducted to explore the long-term impact of early dietetic interventions on health outcomes in OG cancer patients.

Improving outcome measures in late onset Pompe disease: Modified Rasch-Built Pompe-Specific Activity scale.

The Rasch-Built Pompe-Specific Activity (R-PAct) scale is a patient-reported outcome measure specifically designed to quantify the effects of Pompe disease on daily life activities, developed for use in Dutch- and English-speaking countries. This study aimed to validate the R-PAct for use in other countries. Four other language versions (German, French, Italian, and Spanish) of the R-PAct were created and distributed among Pompe patients (≥16 years old) in Germany, France, Spain, Italy, and Switzerland and pooled with data of newly diagnosed patients from Australia, Belgium, Canada, the Netherlands, New Zealand, the USA, and the UK and the original validation cohort (n = 186). The psychometric properties of the scale were assessed by exploratory factor analysis and Rasch analysis. Data for 520 patients were eligible for analysis. Exploratory factor analysis suggested that the items separated into two domains: Activities of Daily Living and Mobility. Both domains independently displayed adequate Rasch model measurement properties, following the removal of one item ("Are you able to practice a sport?") from the Mobility domain, and can be added together to form a "higher order" factor as well. Differential item functioning (DIF)-by-language assessment indicated DIF for several items; however, the impact of accounting for DIF was negligible. We recalibrated the nomogram (raw score interval-level transformation) for the updated 17-item R-PAct scale. The minimal detectable change value was 13.85 for the overall R-PAct. After removing one item, the modified-R-PAct scale is a valid disease-specific patient-reported outcome measure for patients with Pompe disease across multiple countries.

Outcome Measures for Sjögren Disease-Novel Developments and Further Needs.

Sjögren disease (SjD) is a systemic autoimmune disorder affecting both children and adults, with a wide range of clinical phenotypes. It remains a challenging condition to recognise and diagnose early and manage effectively. The heterogeneous nature of the presentation, variable disease course and overlapping symptoms with other autoimmune conditions often result in delayed diagnosis. This, coupled with the lack of licensed effective therapies frequently leads to suboptimal patient outcomes. Improved outcome measures are crucial for advancing our understanding of SjD pathogenesis and developing effective treatments. They can help ensure that clinical trials are accurately capturing the impact of potential therapies on the disease and the quality of life of people with SjD. Further developments are needed in the areas of age and developmentally appropriate disease and patient-reported outcome measures, with adequate sensitivity to evaluate treatment efficacy, as well as predictor biomarkers for both treatment response and poor prognostic outcomes associated with SjD. Advancing these areas will help ensure that clinical trials adequately select the most suitable SjD cohorts to treat with a certain therapy, as well as accurately reflect the impact of a certain intervention on disease activity, progression, and quality of life, ultimately leading to better care for people with SjD.

A Dedicated Multidisciplinary Growth and Feeding Clinic for Infants with Cleft Lip and/or Palate Demonstrates Need for Intervention

Objective A Growth and Feeding Clinic (GFC) focused on early intervention around feeding routines in patients with cleft lip and/or palate (CL/P) was implemented. Design This study assessed the effect of preoperative feeding interventions provided by the GFC. Setting Tertiary academic center. Methods This study evaluated patients with CL/P who were cared for by the GFC and a control group of patients with CL/P. Weight-for-age (WFA) Z-score of less than −2.00 was used as a cutoff to classify patients who were underweight during the preoperative period. Main Outcome Measure The number of underweight patients who were able to reach normal weight by the time of their cleft lip repair was used as the primary outcome measure. Results Within both the GFC and control groups, 25% of patients with CL/P were underweight as determined by WFA Z-score. GFC patients who were underweight received more clinic visits ( P < .001) and GFC interventions ( P < .001) compared to GFC patients who were normal weight. At the time of cleft lip surgery, 64.1% of GFC underweight patients were normal weight compared to 31.8% of control group underweight patients ( P = .0187). Conclusion This study showed that multidisciplinary care provided by the GFC was able to target preoperative nutritional interventions to the highest-risk patients, resulting in double the percentage of patients who were of normal weight at the time of their cleft lip repair. These results provide objective proof supporting the assertion that multidisciplinary team care of the infant with cleft leads to measurable improvement in outcomes.

Abstract PO5-26-08: Caveats behind the improved outcomes observed in recent clinical trials for women with breast cancer: Korean breast cancer consensus meeting 2023

Abstract Introduction Korean Breast Cancer Society has organized the biennial Korean Breast Cancer Consensus Conference to find solutions to clinical situations that cannot be answered by randomized clinical trials or other definitive treatment research data. Unlike guidelines which are designed to apply to the majority of patients with early or advanced breast cancer encountered in daily practice, consensus meetings yield answers from clinicians’ perspectives and experiences. Therefore, this meeting aimed to integrate patient preferences, treatment availability, or other individual circumstances upon recent medical advances and available evidence. Materials and methods. Panelists were invited from various filed, such as medical oncology, surgical oncology, radiation oncology, pathology, radiology, nuclear medicine, hereditary cancer specialist. Results. 1. caveats behind optimizing treatment There had been strong interests in refinening thresholes for treatment and it can be more or less than previous standard treatment. Some patients clearly required escalated treatment, such as ovarian function suppression, combined HER2-targeted treatment, and utilization of immunotherapy during neoadjuvant systemic treatment. However, even same agent which showed great success for high risk patients showed Disappointing results and even failure. Furthermore, we need more sophisticated decision even for successful stories which introduced above, because of their serious adverse events. AntiPd-1/PD-L1 showed different serious adverse events profiles and Trastuzumab-deruxtecan is related with life-threatening pulmonary complication. Therefore, there is a clinical equipoise for an appropriate therapeutic threshold not only for low-risk patients but also high-risk patients who can safely forgo recommend treatment escalation in the newly introduced clinical trials. 2. Completely new serious adverse events observed in new drugs. Unlike chemotherapy, most targeted therapies cause lethal damage that clinicians may not have experienced. Some, such as pulmonary complications from trastuzumab deruxtecan, can be fatal if not treated immediately. Even if patients survive, they may suffer catastrophic outcomes because these agents leave a fatal disability that is too great for the patient's quality of life. Moreover, in South Korea, where government-run health insurance is the only payer and at the same time policy maker, non-medical constraints such as passive reimbursement plans, value-based medicine, and intentional delay or denial of certain drugs, panelist delivered varing opinions on the extent to which new agents can be utilized and which treatment plan could offer equal clinical benefit with less toxicity, or provide for a measurable improvement in outcomes. 3. utilizing genomic signatures Panelist raised issues genetic assay which analyzed genes currently we do not have treatment options which can modify disease process. Many questions were addressed such as, appropriate sampling time, which sample, liquid or tumor, can yield meaningful information. Conclusion Korean Breast Cancer consensus meeting highlighted important caveats behinds new promising findings. Clinical unmet need and uncertainty should be disclosed before patients because what clinician and patients work with is their life. Shared decision making is essential and patients should become well aware of science and medicine. Proactive approach of clinician is critical for these movements. Citation Format: Airi Han, Young-Joon Kang, Sei Hyun Kim, Eui Su Chae, Han Cho Kim, Kyong Hwa Park. Caveats behind the improved outcomes observed in recent clinical trials for women with breast cancer: Korean breast cancer consensus meeting 2023 [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-26-08.

Assessment of global antimicrobial resistance campaigns conducted to improve public awareness and antimicrobial use behaviours: a rapid systematic review

IntroductionPublic health campaigns with a well-defined outcome behaviour have been shown to successfully alter behaviour. However, the complex nature of antimicrobial resistance (AMR) creates challenges when evaluating campaigns aimed at raising awareness and changing behaviour.AimsTo determine what campaigns have been conducted and which reported being effective at improving awareness of antimicrobial resistance and changing behaviour around antimicrobial use in members of the public. It also sought to determine the outcome measures studies have used to assess campaign effectiveness.MethodsA systematic search of Ovid MEDLINE and Embase, was conducted in October 2022 using a predefined search strategy. Studies which were published between 2010 and September 2022 that outlined a campaign or invention aimed at the public and focusing on AMR or antibiotic usage were eligible for inclusion and studies which solely targeted healthcare professionals (HCP) were excluded.ResultsLiterature searches retrieved 6961 results. De-duplication and screening removed 6925 articles, five articles from grey literature and reference screening were included, giving a total of 41 studies and 30 unique interventions. There was a distribution of campaigns globally with the majority run in Europe (n = 15) with most campaigns were conducted nationally (n = 14). Campaigns tended to focus on adult members of the public (n = 14) or targeted resources towards both the public and HCPs (n = 13) and predominately assessed changes in knowledge of and/or attitudes towards AMR (n = 16). Campaigns where an improvement was seen in their primary outcome measure tended to use mass media to disseminate information, targeted messaging towards a specific infection, and including the use of HCP-patient interactions.DiscussionThis review provides some evidence that campaigns can significantly improve outcome measures relating to AMR and antibiotic usage. Despite a lack of homogeneity between studies some common themes emerged between campaigns reported as being effective. However, the frequent use of observational study designs makes it difficult to establish causation between the campaign and changes seen in the studies outcome measures. It is important that clear evaluation processes are embedded as part of the design process for future campaigns; a campaign evaluation framework for use by campaign developers may facilitate this.

Workflow and Recommendations for Lateral Position Spinal Surgery With Robotics and Navigation

Recent decades have seen numerous significant advancements in the field of spinal and lumbar fusion surgeries, including the augmentation of surgical precision with robotic navigation. Use of robotic navigation in single-position lumbar fusion surgery (SPLS), which utilizes a lateral approach and requires no mid-procedure repositioning of the patient, has been shown to improve outcome measures and overall operative efficiency in addition to reducing patient time under anesthesia. Despite indications that robotically-assisted SPLS is superior to more traditional approaches in terms of cost and outcomes, relatively few surgeons currently utilize this innovative combination. This is largely attributed to the well-documented learning curve associated with robotically assisted surgery. In an attempt to mitigate this and reduce the barrier to entry for robotically-assisted spinal surgery, this report will give a detailed description of the workflow for SPLS procedures using robotic navigation. The authors will also give best-practice recommendations applicable for spine surgeons and surgical residents unfamiliar with surgical robotics systems.

Categories of the Patient-Specific Functional Scale Activities in Chronic Neck Pain and Their Relationship to the Neck Disability Index.

Intoduction: Common outcome measures for chronic neck pain are the Patient-Specific Functional Scale (PSFS) and the neck disability index (NDI). The primary aim was to categorize the top-rated, patient-selected functional activity limitations of the PSFS to determine if there were consistent limited functional activities for individuals with chronic neck pain and how these compared to the constructs of activities on the NDI. The secondary aim was to determine the relationship between scores for individuals who completed both the NDI and PSFS. Design: A retrospective review of data extracted from the electronic medical record, EPIC, within two hospital-based outpatient physical therapy clinics within a health care system. Methods: Retrospective analysis was performed on individual's characteristics, self-selected functional activity limitations, and total scores of the PSFS and NDI. Most common categories of self-selected functional activity limitations were developed by practicing physical therapists. These functional activity limitation categories of the PSFS were compared to the activities of the NDI. Mean PSFS total scores were correlated with the NDI total scores with Spearman's test. Results: Participants were individuals with chronic neck pain from January 2013-September 2018 (n = 2283). Movement-based activities accounted for 60.8% of the functional activity limitations of the PSFS with the top functional activity limitations being cervical motion and exercise (32%). The PSFS total score moderately correlated with NDI (r = -0.50, p = <0.01) which may relate to the differences in constructs of the NDI and the top patient-selected PSFS functional activity limitations found in this analysis. Conclusion: The results suggest that individuals with chronic neck pain present with similar categories of self-selected functional activity limitations that differ from activities of the NDI. Additional research is needed to improve outcome measures to capture patient-selected functional activity limitations and an individual's pain experience.

Evaluating motor progression of juvenile-onset Huntington's Disease: An Enroll-HD analysis

IntroductionJuvenile-onset Huntington's disease (JOHD) is characterized by a unique motor phenotype relative to patients with adult-onset Huntington's Disease (AOHD). This study characterized motor progression of JOHD to propose improved outcome measures for this group. MethodsWe used linear mixed effect regression models to compare progression of the Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS) and the chorea score between patients with JOHD and AOHD. We then evaluated all 31 subscales that make up the UHDRS over time within patients with JOHD to identify measures that may be used to track motor progression most reliably. ResultsThe JOHD cohort had faster TMS progression compared to AOHD (p = 0.006) but no group difference in the rate of change of chorea. Patients with JOHD did not show significant change in any of the chorea subscales. The subscales that changed most reliably over time amongst patients with JOHD were dysarthria, upper extremity dystonia, tandem walking, gait, bilateral pronate/supinate, bilateral finger-tapping, and tongue protrusion. When these subscales were summed, they progressed at a faster rate (7.07%, 95% CI [5.96–8.18]) than the TMS (4.92%, 95% CI [3.95–5.89]). ConclusionWhile the TMS changes at a significant rate in JOHD subjects, not all subscales that make up the TMS accurately represent the unique motor features of JOHD. A JOHD-specific scale performed better at tracking motor progression relative to the TMS. This scale may improve clinical care for patients with JOHD and allow for the development of more efficient clinical trials.

From Animal Models to Clinical Trials: The Potential of Antimicrobials in Multiple Sclerosis Treatment.

Multiple sclerosis (MS) is a chronic, autoimmune, demyelinating disease of the central nervous system (CNS). Microbes, including bacteria and certain viruses, particularly Epstein-Barr virus (EBV), have been linked to the pathogenesis of MS. While there is currently no cure for MS, antibiotics and antivirals have been studied as potential treatment options due to their immunomodulatory ability that results in the regulation of the immune process. The current issue addressed in this systematic review is the effect of antimicrobials, including antibiotics, antivirals, and antiparasitic agents in animals and humans. We performed a comprehensive search of PubMed, Google Scholar, and Scopus for articles on antimicrobials in experimental autoimmune encephalomyelitis animal models of MS, as well as in people with MS (pwMS). In animal models, antibiotics tested included beta-lactams, minocycline, rapamycin, macrolides, and doxycycline. Antivirals included acyclovir, valacyclovir, and ganciclovir. Hydroxychloroquine was the only antiparasitic that was tested. In pwMS, we identified a total of 24 studies, 17 of them relevant to antibiotics, 6 to antivirals, and 1 relevant to antiparasitic hydroxychloroquine. While the effect of antimicrobials in animal models was promising, only minocycline and hydroxychloroquine improved outcome measures in pwMS. No favorable effect of the antivirals in humans has been observed yet. The number and size of clinical trials testing antimicrobials have been limited. Large, multicenter, well-designed studies are needed to further evaluate the effect of antimicrobials in MS.

Conservative Approach to Treating American Football Players With Medial Collateral Ligament Grade 2 Sprain During the Season.

The medial collateral ligament is the most commonly injured ligament in the knee. The high-speed pivoting and agility movements that are common in the sport of American Football put participants at an increased risk for a valgus force stress from contact or noncontact injuries. Positional release therapy (PRT) also considered strain/counterstrain focuses on releasing the tension in a tissue through unloading the involved body part. Two male student-athletes participating in football with a mean age of 20.5years were diagnosed by a physician with medial collateral ligament grade 2 sprain. Both patients sustained their injuries in a regular season game with a contact valgus force from an opposing player. After the initial 72hours of compression, elevation, and cryotherapy, the patients were both treated with PRT followed by progressive loading exercises. Following 4 treatment sessions of PRT over the next 6days, the patients started with quadriceps engagement exercises, single-leg squats to 60° knee flexion, side steps, triceps dips, slow controlled lunges, and toe walk. The patients progressed to full body weight squats, single-leg landing, step-up tri-extension, and sidekicks with a leg on table. Then, the patients completed function movements and sports-specific exercises. In this case series, 2 patients competing in intercollege American Football were treated with PRT and progressive loading exercises to facilitate return to unrestricted activities and improve outcome measures. Commonly, a grade 2 medial collateral ligament sprain is conservatively treated with return to sport taking 20days on average. In this type 2 case series, the clinician found success utilizing PRT early in the recovery process, which in these 2 cases lead to restoration of function, outcome measure improvement, and an expedited return to sport. The expedited return to sport occurred at an average of 18days for these patients.

Long-Term Follow-Up of Critically Ill Patients With Traumatic Brain Injury: From Intensive Care Parameters to Patient and Caregiver-Reported Outcome.

Abstract Traumatic brain injury (TBI) is associated with a high social and financial burden due to persisting (severe) disabilities. The consequences of TBI after intensive care unit (ICU) admission are generally measured with global disability screeners such as the Glasgow Outcome Scale-Extended (GOSE), which may lack precision. To improve outcome measurement after brain injury, a comprehensive clinical outcome assessment tool called the Minimal Dataset for Acquired Brain Injury (MDS-ABI) was recently developed. The MDS-ABI covers 12 life domains (demographics, injury characteristics, comorbidity, cognitive functioning, emotional functioning, energy, mobility, self-care, communication, participation, social support, and quality of life), as well as informal caregiver capacity and strain. In this cross-sectional study, we used the MDS-ABI among formerly ICU admitted patients with TBI to explore the relationship between dichotomized severity of TBI and long-term outcome. Our objectives were to: 1) summarize demographics, clinical characteristics, and long-term outcomes of patients and their informal caregivers, and 2) compare differences between long-term outcomes in patients with mild-moderate TBI and severe TBI based on Glasgow Coma Scale (GCS) scores at admission. Participants were former patients of a Dutch university hospital (total n = 52; mild-moderate TBI n = 23; severe TBI n = 29) and their informal caregivers (n = 45). Hospital records were evaluated, and the MDS-ABI was administered during a home visit. On average 3.2 years after their TBI, 62% of the patients were cognitively impaired, 62% reported elevated fatigue, and 69% experienced restrictions in ≥2 participation domains (most frequently work or education and going out). Informal caregivers generally felt competent to provide necessary care (81%), but 31% experienced a disproportionate caregiver burden. All but four patients lived at home independently, often together with their informal caregiver (81%). Although the mild-moderate TBI group and the severe TBI group had significantly different clinical trajectories, there were no persisting differences between the groups for patient or caregiver outcomes at follow-up. As a large proportion of the patients experienced long-lasting consequences beyond global disability or independent living, clinicians should implement a multi-domain outcome set such as the MDS-AB to follow up on their patients.

Outcomes after Bipolar Osteochondral Allograft Transplantation in the Ankle

Category: Ankle Arthritis; Ankle Introduction/Purpose: Surgical treatment options for symptomatic, full-thickness articular cartilage loss in the ankle are not consistently effective in restoring ankle function. Osteochondral allograft transplantation provides a standard-of-care alternative for patients, however, outcomes reported to date have been only fair, with a high incidence of reoperation and revision. However, recent cartilage storage and preservation techniques have significantly improved the percent viable chondrocytes at the time of implantation in OCAs. These high-chondrocyte-viability allografts should lead to improved survivability of OCAs and improved outcome measures. This study aimed to document the initial outcomes for patients undergoing bipolar OCA transplantation in the ankle after advances in tissue preservation, transplantation techniques, and patient management strategies. Methods: Patients with symptomatic tibiotalar arthritis were prospectively enrolled into a registry designed to follow outcomes after OCA surgeries in the ankle. All patients underwent complete OCA replacement of their tibial plafond and talar dome, with most undergoing fibular articular resurfacing. All OCA were size and side matched and preserved in Missouri Osteochondral Allograft Preservation System (MOPS). Patients followed a standardized, procedure-specific rehabilitation protocol after surgery, including remaining non-weight bearing for 8 weeks, weekly therapy visits, limited step count during recovery, and avoidance of high impact activities until 1 year after surgery. Patients followed-up with their physician at regular post-operative timepoints. Radiographs and patient reported outcome measures (VAS, AAOS Foot and Ankle, PROMIS PF, PROMIS Mobility) were obtained at each follow-up visit. Demographic and operative data were collected from the electronic medical record. All reported complications, reoperations, revisions, and failures were recorded in the EMR. Results: 14 patients were included for analyses with 12 undergoing primary OCA transplantation, and 2 undergoing revision OCA transplantation. Mean age and follow up was 36 and 44.1 months, respectively. All patients underwent tibia and talus OCA transplantation, with 10/14 including a fibula OCA transplantation. Initial success was 92.9% with one documented failure (tibial OCA collapse). Radiographic assessments indicated OCA integration and maintenance of joint space in 12 patients (85.7%). AAOS and VAS pain scores improved significantly from preoperative measures at each timepoint (p=.002, p=.03), while postoperative improvements in PROMIS Mobility and PROMIS Physical Function scores did not reach significance (p&gt;0.15) (Table 1). Patients that were non-adherent to postoperative restriction and rehabilitation protocols, all 1-year postoperative PROs were significantly lower than for patients who were adherent. Conclusion: Ankle osteoarthritis in young patients continues to present a challenging dilemma. Previous attempts at large bipolar OCAs in the ankle have yielded fair, to poor, results. However, recent advances in bulk osteochondral allograft preservation has improved chondrocyte viability. Based on the results of our study, the use of high-chondrocyte-viability allografts for OCA transplantation is a viable option for the treatment of symptomatic bipolar osteochondral defects in the ankle joint. However, post operative rehab protocols are equally important in determining outcomes, and patient selection and education is key to ensuring successful outcomes. Longer term follow up is ongoing.

Complications in adult spinal deformity: Current concepts

Surgical treatment for adult spinal deformity is associated with improved surgical alignment and improved outcome measures. Unfortunately, complications are a common consequence following surgery for adult spinal deformity. This article reviews the current concepts in complications including trends in complication profile over the past decade, classification of complications and risk calculators to help with complication stratification. The goal of this article is to identify the current best practices and to provide the reader with objective information to identify risk factors for complications and their prevention.

Outcomes ofcompleted quality activities inan Australian tertiary hospital, 2015-2019.

Quality activities including quality assurance and quality improvement are an integral part of safety and quality governance for hospitals. Previous studies identified that (i) majority are for quality assurance and knowledge-acquiring purposes and (ii) adherence to the quality cycle as well as impact on patient-related outcomes at the hospital level are unclear, neither associated with costs. This study aims to (i) assess adherence to the quality cycle for quality activities in a large Australian tertiary hospital; (ii) report outcomes of quality activities at the hospital level, including impact on patient-related outcomes measured by the occurrence of hospital-acquired complications; and (iii) estimate time and costs for data collection. This quantitative study utilized three data sources. First is the hospital's electronic quality management system, Governance, Evidence, Knowledge and Outcome that identifies completed quality activities over a 5-year period; second is Tableau dashboards for hospital-acquired complication performance; third is Microsoft Teams Forms used to capture time of data collection for bedside observations and retrospective notes reviews. Median sample size and median hourly rates in 2018 were used for calculations. A total of 1768 quality activities were completed over a 5-year period representing an average of 353 quality activities per year, of which 87.8% were initiated by clinicians and 12.2% planned and coordinated by safety and quality or equivalent. The activity reports indicated that less than a fifth (17.1%) brought about improvement in process measures and only 7.1% improved outcome measures. Two-thirds of the quality activities (66.3%) provided recommendations based on their findings, but evidence of action plan was available in 14.1% of the reports only. No association was found between the number of activities completed and overall hospital-acquired complication performance. Retrospective data collection (64.7%) was common. The estimated time and cost for data collection averaged at 3490h/year, equivalent to 1.8 full-time employees, for a cost of $171 000 at the nursing rate (A$49.0), $280 000 at the medical rate (A$79.5), and $200 000 at the Health Service Union rate (A$58.9). Most quality activities were clinician-initiated. Implementing change and achieving and sustaining improvement were the two challenging stages in the quality cycle. No clear association was observed between activities completed and improvement in patient-related outcomes although some improvement in processes. A paradigm shift may be needed to engineer quality activities in hospitals to be more outcome-oriented. Opportunities exist for hospitals to consider how quality activities can be organized to maximize returns from investment.

Pulmonary rehabilitation and risk of fall in elderly with chronic obstructive pulmonary disease.

Few data are available on the effects of pulmonary rehabilitation (PR) on risk of fall in over 80 individuals with chronic obstructive pulmonary disease (COPD). We investigated the effectiveness of PR on the risk of fall in older as compared to younger than 80 individuals. Parallel-group retrospective exploratory study of individuals undergone in-hospital PR. The risk of fall was defined as a gait speed ≤0.8 m/s (primary outcome). Outcome measures (exercise capacity, physical performance, symptoms, and health status) were also assessed. As compared to younger, individuals over 80 suffered from more severe symptoms, a reduction in physical performance and in exercise capacity and greater risk of fall (P=0.0001). The proportion of participants at risk of fall increased with age, and after PR decreased significantly without any significant difference between age groups. However, 53.4% of older individuals were still at risk of fall, as compared to 17.5% of those under 80 (P=0.0001). After PR, both populations had improved outcomes measures, without any significant between group differences. In individuals with COPD pulmonary rehabilitation reduced the risk of fall, while improving outcome measures independent of age, however, more than 50% of those over 80 were still at risk of fall. The pulmonary rehabilitation programs for individuals over 80 should include strategies effective in reducing the risk of fall.

Adaptive assistive robotics: a framework for triadic collaboration between humans and robots.

Robots and other assistive technologies have a huge potential to help society in domains ranging from factory work to healthcare. However, safe and effective control of robotic agents in these environments is complex, especially when it involves close interactions and multiple actors. We propose an effective framework for optimizing the behaviour of robots and complementary assistive technologies in systems comprising a mix of human and technological agents with numerous high-level goals. The framework uses a combination of detailed biomechanical modelling and weighted multi-objective optimization to allow for the fine tuning of robot behaviours depending on the specification of the task at hand. We illustrate our framework via two case studies across assisted living and rehabilitation scenarios, and conduct simulations and experiments of triadic collaboration in practice. Our results indicate a marked benefit to the triadic approach, showing the potential to improve outcome measures for human agents in robot-assisted tasks.