Improvements In Other Outcomes Research Articles

Transcutaneous electrical acupoint stimulation to prevent dizziness after microvascular decompression for hemifacial spasm: A randomized controlled trial

BackgroundDizziness often occurs after microvascular decompression (MVD), and therapeutic options are limited. The aim of this trial was to determine the potential efficacy of transcutaneous electrical acupoint stimulation (TEAS), against dizziness and its safety in patients undergoing MVD. MethodsAdult patients scheduled to undergo MVD for hemifacial spasm under total intravenous anesthesia were randomized at a 1:1 ratio to receive, after extubation, 30-min TEAS in the mastoid region as well as Fengchi acupoints (GB20) and Neiguan acupoints (PC6) or 30-min sham stimulation. The primary outcome was the incidence of dizziness at 2 h after surgery. Secondary outcomes included dizziness, postoperative nausea and vomiting (PONV) or headache severity, rescue medication, changes in intraocular pressure before and after surgery, length of stay, dizziness symptoms 4 weeks after discharge, and surgical complications. ResultsA total of 86 patients (51.9 ± 9.4 years of age; 67 women) were enrolled. One patient (in the TEAS arm) was excluded from analysis due to conversion to sevoflurane anesthesia. The rate of dizziness at 2 h after surgery was 31.0 % (13/42) in the TEAS arm vs. 53.5 % (23/43) in the sham control arm (P = 0.036). TEAS was also associated with significantly lower severity of dizziness, based on a 10-point scale, during the first 24 h after surgery. None of the other secondary efficacy outcomes differed significantly between the two arms. All postoperative complications were Clavien-Dindo grade I or II. The rate of postoperative complications was 21.4 % (9/42) in the TEAS arm vs. 16.3 % (7/43) in the sham control arm (P = 0.544). ConclusionsCompared with sham control, TEAS was associated with a lower incidence of dizziness within 2 h and lower severity of dizziness within 24 h post-operatively, but no improvement in other outcomes, in adult patients undergoing MVD for hemifacial spasm.

Abstract PO2-25-12: Production of a bespoke muscle resistance exercise (MRE) programme for use in a future clinical trial, following a detailed patient engagement program (PEP) in patients with advanced breast cancer (ABC)

Abstract Background: MRE investigations in early breast cancer have been undertaken but there has been little evaluation in ABC. Cancer guidelines suggest the use of physical activity, including MRE, to improve fatigue (National Comprehensive Cancer Network, 2.2020; European Society of Medical Oncology 2020) but improvement in other outcomes in ABC is less clear. In clinical trials, adherence to exercise intervention has been a challenge and has hampered investigation of other outcomes and little data exists evaluating the possible reasons for this poor adherence and compliance. In preparation for an exercise component as part of lifestyle intervention trial in ABC, a PEP was undertaken to evaluate an on-line web-based exercise program. Results would support continued usage of the program or creation of a new program. Methods: A commercially available program was used containing a library of exercises created for multiple disease types. There was no voice over. Using an exercise science professional, 2 sets of muscular resistance exercise programmes were created (A &B), selecting exercises for upper and lower limb major muscle groups. Set A and B differed , with A involving younger leaner demonstrators and B older, less lean. Volunteers were asked to view the sets and complete a survey. The results of the survey, involving 21 volunteers of which 43% were over 60 years and presented previously, indicated that the following main modifications were needed to a program: use of demonstrators similar to patient's habitus and use of a voice-over to guide exercises. A short test video was produced incorporating these and other visual changes and viewed by a focus group of four volunteers. Results: The focus group concluded that the new visual and audio changes would allow them to more easily perform the exercises and increase the likelihood of compliance compared to the on-line program. The group advised involvement of a more diverse demonstrator group and further improvements to the voice-over. A professionally produced video has now been made with all the above changes. Conclusions: This PEP indicates that is necessary to review exercise programmes with patients and not assume they are all suitable for use in clinical trials. We believe a PEP of this kind with the resultant bespoke video is the first produced involving patients with ABC. This video will now be evaluated in a much larger diverse PPE which will help the development of a national UK clinical trial of exercise in ABC. Citation Format: Amanda Clarke, Jennifer Glendenning, Glen Davison, Catherine Harper-Wynne. Production of a bespoke muscle resistance exercise (MRE) programme for use in a future clinical trial, following a detailed patient engagement program (PEP) in patients with advanced breast cancer (ABC) [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 PO2-25-12.

Compression Therapy after Thermal Ablation of Varicose Veins: A Meta-Analysis.

To investigate whether compression therapy after thermal ablation of varicose veins can improve the prognosis of patients. Systematic research were applied for Chinese and English electronic databases(PubMed, Web of Science, Cochrane Library, CNKI, Wanfang, VIP Databases). Eligible prospective studies that comparing the efficacy of compression therapy and non-compression therapy on patients after thermal ablation of varicose veins were included. The interest outcome such as pain, quality of life (QOL), venous clinical severity score (VCSS), time to return to work and complications were analyzed. 10 studies were of high quality, and randomized controlled trials involving 1,545 patients met the inclusion criteria for this study. At the same time, the meta-analysis showed that the application of compression therapy improved pain (SMD: -0.51, 95% CI: -0.95, -0.07) but exhibited no statistically significant effect on QOL (SMD: 0.04, 95% CI: -0.08, 0.16), VCSS (MD: -0.05, 95% CI: -1.19, 1.09), time to return to work (MD: -0.43, 95% CI: -0.90, 0.03), total complications (RR: 0.54, 95% CI: 0.27, 1.09), and thrombosis (RR: 0.71, 95% CI: 0.31, 1.62). Compression therapy after thermal ablation of varicose veins can slightly relieve pain, but it has not been found to be associated with improvement in other outcomes.

Impact of Preoperative Weight Loss on 30-Day Complication Rate after Bariatric Surgery.

The aim of this study is to evaluate the impact of preoperative weight loss on surgical outcomes and operating room (OR) times after primary bariatric procedures, including laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (RYGB). A retrospective cohort study uses the 2021 MBSAQIP dataset. Preoperative total weight loss (TWL)% was calculated. Patients were then divided in to 4 groups: those with no weight loss, lost <0 to <5%, lost ≥5% to <10%, or lost ≥10% TWL preoperatively. These groups were then stratified into those with BMI less than 50 kg/m 2 and those with BMI 50 kg/m 2 or more and 30-day outcomes and OR times were compared. Analysis included 171,010 patients. For BMI less than 50 kg/m 2 , preoperative weight loss led to no consistent improvement in surgical outcomes. Although >0% to <5% TWL led to a decrease in intra- and postoperative occurrences after RYGB and a decrease in reoperation rates after LSG, these observations were not seen in those with higher degree of weight loss. In patients with BMI 50 kg/m 2 or more, preoperative weight loss showed a consistent improvement in reintervention rates after LSG, and readmission rates after RYGB. There was no improvement in other outcomes, however, irrespective of degree of preoperative weight loss. In patients undergoing primary bariatric surgery, preoperative weight loss does not lead to a consistent improvement in outcomes or OR times. In those with BMI 50 kg/m 2 or more, there may be improvement in select outcomes that is procedure-specific. Overall, these data do not support a uniform policy of preoperative weight loss, although selective use in some high-risk patients may be appropriate.

Effects of Walking-Only Intervention on Physical Function, Fall-Related Outcomes, and Health-Related Quality of Life in Community-Dwelling Older Adults: A Systematic Review and Meta-Analysis.

This study aimed to determine the effects of walking-only intervention (walking was the only exercise in which people participated) on physical function, fall-related outcomes, and health-related quality of life in community-dwelling older adults. We conducted a systematic search across five electronic databases, assessing risk of bias using Minds Manual for Guideline Development. Meta-analyses were performed, and pooled standardized mean differences were calculated. Nine studies (a total of 1,309 participants) were included, showing that walking-only interventions improved walking endurance (standardized mean difference: 1.11, 95% confidence interval: [0.08, 2.15]) and health-related quality of life (standardized mean difference: 0.71, 95% confidence interval: [0.18, 1.25]). However, there were no significant improvements in other outcomes. The certainty of the evidence based on the Grading of Recommendations, Assessment, Development, and Evaluation approach for all outcomes was graded as very low, primarily due to significant inconsistency and imprecision. Our results suggest that walking-only intervention can be effective for enhancing walking endurance and health-related quality of life for community-dwelling older adults. Further studies are required to investigate the effects of walking-only intervention. This need stems from the limited number of randomized controlled trials, heterogeneous intervention settings and results, and the very low certainty of the evidence.

Dupilumab demonstrated efficacy and was well tolerated regardless of prior use of swallowed topical corticosteroids in adolescent and adult patients with eosinophilic oesophagitis: a subgroup analysis of the phase 3 LIBERTY EoE TREET study

ObjectiveTo assess the effect of long-term dupilumab on histological, symptomatic and endoscopic aspects of eosinophilic oesophagitis (EoE) in adolescent and adult patients with and without prior use of swallowed topical...

Peer-led safer supply and opioid agonist treatment medication distribution: a case study from rural British Columbia

BackgroundBritish Columbia (BC) has been facing a public health emergency of overdose since 2016, with rural regions of the province facing the highest rates of death. Peers (in this case, people with lived experience of substance use) are known to be effective patient navigators in health systems and can play a role in connecting patients to care and reducing overdose risk.Case presentationWe outline a peer-led program focused on opioid agonist treatment and prescribed safe supply medication delivery that began in March 2020 at a clinic in rural BC. The peer takes an Indigenous harm reduction approach and is focused on meeting the needs of the whole person. The peer has regular contact with approximately 50 clients and navigates medication delivery and appointments for approximately 10–15 people each day. Clients have been retained on the medication, and experienced improvement in other outcomes, including securing housing, employment and managing acute and chronic health conditions. The peer has established contact with clients since March 2020 to support engagement with health care and continuity of medication access. This program highlights the importance and value of peer-led work and need for further investments in peer-led programs to respond to the unregulated drug poisoning crisis.ConclusionsThis peer-led intervention is a promising approach to engaging people who remain disconnected from health services in care in a rural community. This model could be adapted to other settings to support patient contact with the health system and medication access and continuity, with the ultimate goal of reducing overdose risk.

Training for walking through an opening improves collision avoidance behavior in subacute patients with stroke: a randomized controlled trial

Purpose Paretic side collisions frequently occur in stroke patients, especially while walking through narrow spaces. We determined whether training for walking through an opening (T-WTO) while entering from the paretic side would improve collision avoidance behavior and prevent falls after 6 months. Materials and Methods Thirty-eight adults with moderate-to-mild hemiparetic gait after stroke who were hospitalized in a rehabilitation setting were randomly allocated to the T-WTO (n = 20) or regular rehabilitation (R-Control; n = 18) program. Both groups received five sessions of 40 min per week, for three weeks total. T-WTO included walking through openings of various widths while rotating with the paretic side in front, and R-Control involved normal walking without body rotation. Obstacle avoidance ability, 10-m walking test, timed Up and Go test, Berg Balance Scale, Activities-specific Balance Confidence, the perceptual judgment of passability, and fall incidence were assessed. Results Collision rate and time to passage of the opening in obstacle avoidance task significantly improved in the T-WTO group compared with those in the R-Control group. Contrast, T-WTO did not lead to significant improvements in other outcomes. Conclusions T-WTO improved efficiency and safety in managing subacute stroke patients. Such training could improve patient outcomes/safety because of the paretic body side during walking. Clinical Trial Registration No. R000038375 UMIN000033926

Usability and Satisfaction Outcomes from a Pilot Open Trial Examining Remote Patient Monitoring to Treat Pediatric Obesity during the COVID-19 Pandemic.

Pediatric obesity is common and a significant burden. Supplementing pediatric obesity treatment with technology is needed. This manuscript examines the usability and satisfaction, as well as explores initial effectiveness, of a remote patient monitoring system (RPMS) designed for youth presenting for pediatric weight management treatment. 47 youth, 10 to 17 years old, with obesity and a caregiver participated. For three months, families received treatment via the RPMS. Usability and satisfaction outcomes were examined. Exploratory analyses were conducted to examine initial effectiveness from baseline and post-treatment (month 3) assessments. More than 80% of patients used the RPMS, and overall, patients completed 27 out of 90 daily sessions (30%). Youth and caregivers reported high satisfaction. Non-parametric tests revealed no significant improvements for youth or caregiver weight status after the RPMS treatment. Significant improvements in other outcomes examined were limited. Families were satisfied with the RPMS, but use of the system was limited. Initial effectiveness was not able to be determined due to the amount of missing data, which was impacted by the COVID-19 pandemic. Modifications of the RPMS and future evaluation of usability and effectiveness are warranted to determine utility in supplementing pediatric obesity clinical treatment.

Associations of Annual Hospital and Surgeon Volume with Patient Outcomes After Gastrectomy: A Systematic Review and Meta-analysis.

Procedural volume is an important determinant of outcomes in cancer surgery. There is a lack of a comprehensive and updated assessment of hospital and surgeon volumes in relation to short- and long-term outcomes after gastrectomy for cancer. The PubMed and Embase databases were searched on January 2021. We conducted meta-analyses and meta-regressions assuming a random effects model to assess the associations of procedural volumes with outcomes after gastrectomy. Effect sizes included hazard ratios (HRs), odds ratios (ORs), and standardized mean differences (SMDs). Heterogeneity was evaluated with the I2 statistic and explored by subgroup analyses. The risk of publication bias, risk of bias, and certainty of evidence were also assessed. We identified 53 primary publications on the effect of hospital (n=48) or surgeon (n=11) volume on 11 gastrectomy outcomes. Patients operated on in high-volume centers had better overall survival (HR 0.82, 95% confidence interval [CI] 0.75-0.90), lower short-term mortality (OR 0.66, 95% CI 0.58-0.75), more adequate lymphadenectomy (OR 2.14, 95% CI 1.76-2.59), and shorter length of stay (SMD -0.08, 95% CI -0.12 to -0.04). The meta-analysis showed no significant associations of hospital volume with surgical complications, R0 or negative margin resection, or disease-free survival (all p>0.05). A higher surgeon volume was associated with lower 30-day mortality (OR 0.94, 95% CI 0.90-0.97). The current study suggested with high confidence that gastric cancer patients operated on in high-volume centers had better overall survival. Centralization of gastrectomy in high-volume centers might lead to an overall improvement in other outcomes, but more studies, especially on surgeon volume, are needed.

Residual Effect of Texting to Promote Medication Adherence for Villagers with Schizophrenia in China: 18-Month Follow-up Survey After the Randomized Controlled Trial Discontinuation.

BackgroundReducing the treatment gap for mental health in low- and middle-income countries is a high priority. Even with treatment, adherence to antipsychotics is rather low. Our integrated intervention package significantly improved medication adherence within 6 months for villagers with schizophrenia in resource-poor communities in rural China. However, considering the resource constraint, we need to test whether the effect of those behavior-shaping interventions may be maintained even after the suspension of the intervention.ObjectiveThe aim of this study is to explore the primary outcome of adherence and other outcomes at an 18-month follow-up after the intervention had been suspended.MethodsIn a 6-month randomized trial, 277 villagers with schizophrenia were randomized to receive either a government community mental health program (686 Program) or the 686 Program plus Lay health supporters, e-platform, award, and integration (LEAN), which included health supporters for medication or care supervision, e-platform access for sending mobile SMS text messaging reminders and education message, a token gift for positive behavior changes (eg, continuing taking medicine), and integrating the e-platform with the existing 686 Program. After the 6-month intervention, both groups received only the 686 Program for 18 months (phase 2). Outcomes at both phases included antipsychotic medication adherence, functioning, symptoms, number of rehospitalization, suicide, and violent behaviors. The adherence and functioning were assessed at the home visit by trained assessors. We calculated the adherence in the past 30 days by counting the percentage of dosages taken from November to December 2018 by unannounced home-based pill counts. The functioning was assessed using the World Health Organization Disability Assessment Schedule 2.0. The symptoms were evaluated using the Clinical Global Impression–Schizophrenia during their visits to the 686 Program psychiatrists. Other outcomes were routinely collected in the 686 Program system. We used intention-to-treat analysis, and missing data were dealt with using multiple imputation. The generalized estimating equation model was used to assess program effects on adherence, functioning, and symptoms.ResultsIn phase 1, antipsychotic adherence and rehospitalization incidence improved significantly. However, in phase 2, the difference of the mean of antipsychotic adherence (adjusted mean difference 0.05, 95% CI −0.06 to 0.16; P=.41; Cohen d effect size=0.11) and rehospitalization incidence (relative risk 0.65, 95% CI 0.32-1.33; P=.24; number needed to treat 21.83, 95% CI 8.30-34.69) was no longer statistically significant, and there was no improvement in other outcomes in either phase (P≥.05).ConclusionsThe simple community-based LEAN intervention could not continually improve adherence and reduce the rehospitalization of people with schizophrenia. Our study inclined to suggest that prompts for medication may be necessary to maintain medication adherence for people with schizophrenia, although we cannot definitively exclude other alternative interpretations.

Brain-In-Hand technology for adults with acquired brain injury: A convergence of mixed methods findings.

IntroductionIndividuals with acquired brain injury may find it difficult to self-manage and live independently. Brain-in-Hand is a smartphone app designed to support psychological problems and encourage behaviour change, comprised of a structured diary, reminders, agreed solutions, and traffic light monitoring system.AimTo evaluate the potential use and effectiveness of Brain-in-Hand for self-management in adults with acquired brain injury.MethodsA-B mixed-methods case-study design. Individuals with acquired brain injury (n = 10) received Brain-in-Hand for up to 12 months. Measures of mood, independence, quality of life, cognition, fatigue, goal attainment, participation administered at baseline, 6 and 12 months. Semi-structured interviews conducted with acquired brain injury participants (n = 9) and healthcare workers (n = 3) at 6 months.ResultsSignificant increase in goal attainment after 6 months use (t(7) = 4.20, p = .004). No significant improvement in other outcomes. Qualitative data suggested improvement in anxiety management. Contextual (personal/environmental) factors were key in influencing the use and effectiveness of Brain-in-Hand. Having sufficient insight, appropriate support and motivation facilitated use.ConclusionsBrain-in-Hand shows potential to support acquired brain injury, but further work is required to determine its effectiveness. Context played a pivotal role in the effectiveness and sustained use of Brain-in-Hand, and needs to be explored to support implementation.

Dementia Early-Stage Cognitive Aids New Trial (DESCANT) of memory aids and guidance for people with dementia: randomised controlled trial

BackgroundCommon memory aids for people with dementia at home are recommended. However, rigorous evaluation is lacking, particularly what guidance or support is valued.ObjectiveTo investigate effects of memory aids and guidance...

Examining the impact of a community-based exercise intervention on cardiorespiratory fitness, cardiovascular health, strength, flexibility and physical activity among adults living with HIV: A three-phased intervention study.

Our aim was to examine the impact of a community-based exercise (CBE) intervention on cardiorespiratory fitness, cardiovascular health, strength, flexibility, and physical activity outcomes among adults living with HIV. We conducted a longitudinal intervention study with community-dwelling adults living with HIV in Toronto, Canada. We measured cardiopulmonary fitness (V̇O2peak (primary outcome), heart rate, blood pressure), strength (grip strength, vertical jump, back extension, push-ups, curl ups), flexibility (sit and reach test), and self-reported physical activity bimonthly across three phases. Phase 1 included baseline monitoring (8 months); Phase 2 included the CBE Intervention (6 months): participants were asked to exercise (aerobic, strength, balance and flexibility training) for 90 minutes, 3 times/week, with weekly supervised coaching at a community-based fitness centre; and Phase 3 included follow-up (8 months) where participants were expected to continue with thrice weekly exercise independently. We used segmented regression (adjusted for baseline age and sex) to assess the change in trend (slope) among phases. Our main estimates of effect were the estimated change in slope, relative to baseline values, over the 6 month CBE intervention. Of the 108 participants who initiated Phase 1, 80 (74%) started and 67/80 (84%) completed the intervention and 52/67 (77%) completed the study. Most participants were males (87%), with median age of 51 years (interquartile range (IQR): 45, 59). Participants reported a median of 4 concurrent health conditions in addition to HIV (IQR: 2,7). Participants attended a median of 18/25 (72%) weekly supervised sessions. Change in V̇O2peak attributed to the six-month Phase 2 CBE intervention was 0.56 ml/kg/min (95% Confidence Interval (CI): -1.27, 2.39). Significant effects of the intervention were observed for systolic blood pressure (-5.18 mmHg; 95% CI: -9.66, -0.71), push-ups (2.30 additional push-ups; 95% CI: 0.69, 3.91), curl ups (2.89 additional curl ups; 95% CI: 0.61, 5.17), and sit and reach test (1.74 cm; 95% CI: 0.21, 3.28). More participants engaged in self-reported strength (p<0.001) and flexibility (p = 0.02) physical activity at the end of intervention. During Phase 3 follow-up, there was a significant reduction in trend of benefits observed during the intervention phase for systolic blood pressure (1.52 mmHg/month; 95% CI: 0.67, 2.37) and sit and reach test (-0.42 cm/month; 95% CI: -0.68, -0.16). Adults living with HIV who engaged in this six-month CBE intervention demonstrated inconclusive results in relation to V̇O2peak, and potential improvements in other outcomes of cardiovascular health, strength, flexibility and self-reported physical activity. Future research should consider features tailored to promote uptake and sustained engagement in independent exercise among adults living with HIV. NCT02794415. https://clinicaltrials.gov/ct2/show/record/NCT02794415.

Guselkumab demonstrated an independent treatment effect in reducing fatigue after adjustment for clinical response\u2014results from two phase 3 clinical trials of 1120 patients with active psoriatic arthritis

BackgroundThe interleukin-23p19-subunit inhibitor guselkumab effectively treats signs and symptoms of psoriatic arthritis (PsA). We evaluated the effect of guselkumab on fatigue.MethodsAcross two phase 3 trials of guselkumab (DISCOVER-1, DISCOVER-2), patients with active PsA despite standard therapy were randomized to subcutaneous injections of guselkumab 100 mg every 4 weeks (Q4W, N = 373); guselkumab 100 mg at week 0, week 4, and then Q8W (N = 375); or placebo (N = 372) through week 24, after which patients in the placebo group crossed over to guselkumab Q4W. Fatigue was measured as a secondary endpoint using the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue instrument (range 0–52, higher scores indicate less fatigue). Least-squares mean changes in FACIT-Fatigue scores were compared between treatments using a mixed-effect model for repeated measures. Mediation analysis was used to adjust for indirect effects on fatigue deriving from improvement in other outcomes, including ≥20% improvement in American College of Rheumatology criteria (ACR20; prespecified), minimal disease activity (MDA; post hoc), or C-reactive protein (CRP; post hoc).ResultsBaseline mean (SD) FACIT-Fatigue scores in DISCOVER-1 (N = 381) and DISCOVER-2 (N = 739), ranging from 29.1 (9.5) to 31.4 (10.1), indicated substantial levels of fatigue relative to the United States general population (43.6 [9.4]). Across studies, mean improvements, and proportions of patients with ≥4-point improvements, in FACIT-Fatigue scores at week 24 with guselkumab Q4W and Q8W (5.6–7.6 and 54–63%, respectively) were larger vs placebo (2.2–3.6 and 35–46%). Improvement in FACIT-Fatigue scores with guselkumab was sustained from week 24 to week 52, with moderate-to-large effect sizes (Cohen’s d = 0.52–0.81 at week 24; 0.66–0.91 at week 52). Mediation analyses demonstrated that substantial proportions of the effects of guselkumab vs placebo on fatigue were direct effect, after adjusting for achievement of ACR20 (Q4W 69–70%, Q8W 12–36% direct effect) or MDA (72–92% across dosing regimens) response or for change in serum CRP concentrations (82–88% across dosing regimens).ConclusionsIn patients with active PsA, guselkumab 100 mg Q4W or Q8W led to clinically meaningful and sustained improvements in fatigue through 1 year. A substantial portion of the improvement in FACIT-Fatigue scores induced by guselkumab was independent of effects on the achievement of other select outcomes.Trial registrationName of the registry: ClinicalTrials.govTrial registrations: DISCOVER-1, NCT03162796; DISCOVER-2, NCT03158285Date of registration: DISCOVER-1, May 22, 2017; DISCOVER-2, May 18, 2017URLs of the trial registry record:DISCOVER-1, https://clinicaltrials.gov/ct2/show/NCT03162796?term=NCT03162796&draw=1&rank=1DISCOVER-2, https://clinicaltrials.gov/ct2/show/NCT03158285?term=NCT03158285&draw=2&rank=1

POS0435 CHARACTERISTICS AND 6-MONTH OUTCOMES AMONG REAL-WORLD PATIENTS WITH RHEUMATOID ARTHRITIS INITIATING UPADACITINIB: ANALYSIS FROM THE CORRONA REGISTRY

Background:Upadacitinib (UPA) has demonstrated efficacy in randomized controlled trials1-3; however, few data are available from patients with rheumatoid arthritis (RA) who have been treated with UPA in real-world clinical practice.Objectives:Describe the characteristics and 6-month outcomes in patients with RA initiating UPA in a real-world setting.Methods:We identified adults with RA enrolled in the Corrona RA Registry through October 31, 2020 who initiated UPA during or after August 2019 and had a follow-up visit 6 (±3) months after initiation of UPA. Descriptive statistics were used to summarize characteristics in all patients initiating UPA who had a 6-month follow-up visit. Outcomes (CDAI, modified HAQ-DI, pain, and fatigue) were described at the 6-month visit for all UPA initiators regardless of UPA use at 6 months and for the subset of patients who continued UPA through the 6-month visit. Patients who discontinued UPA before the 6-month visit were considered non-responders for dichotomous variables and were assigned the value at the time of discontinuation for continuous variables. Mean change from baseline in continuous variables was analyzed with one-sample t tests or one-sample Wilcoxon rank sum tests. Minimum clinically important difference (MCID) in HAQ-DI is defined as an improvement of 0.22 units or more. MCID in CDAI is an improvement of at least 2, 7, and 13 units for patients in low, moderate and severe disease at initiation, respectively. MCID for 100-point VAS is an improvement of ≥10 points. Percentages of patients achieving MCID thresholds were calculated.Results:We identified 181 patients who initiated UPA and had a 6-month follow-up visit. Mean±SD age was 58.6±12.1 years, 81% were female. Patients had RA for a mean of 11.5±9.8 years. At UPA initiation, 45% of patients were on monotherapy. Prior use of one or more TNFi and JAKi was 79% and 52%, respectively. Seventy-two percent of patients (n=130) initiated UPA as the third or higher line of therapy. Mean CDAI was 18.7±11.6 and mean HAQ-DI was 1.1±0.8 at initiation. Based on CDAI (n=155), 29%, 52%, and 15% of patients had high, moderate, and low disease activity, respectively; 4.5% were in remission at initiation. At 6 months (n=158), 22%, 39%, and 28% had high, moderate, and low disease activity, respectively; 11% were in remission. Among 138 initiators with valid CDAI measures at initiation and 6 months, mean change in CDAI was –4.8±11.8, P&lt;0.01. At 6 months, 46% (63/138) maintained and 39% (54/138) achieved improvement in any CDAI category. Improvements in other outcomes were significantly different from zero. Improvements &gt;=MCID in CDAI, HAQ-DI, pain, and fatigue were achieved in 36–44% of UPA initiators. Improvements were similar, but larger in the subset of patients (n=122) who continued UPA through the 6-month visit (Table 1).Conclusion:Among patients in the Corrona RA Registry, UPA is frequently started in those who failed multiple previous therapies. UPA initiators responded to therapy in the first 6 months with improvements in several disease activity measures including CDAI and HAQ-DI, as well as patient-reported pain and fatigue.

Robot-assisted training compared with an enhanced upper limb therapy programme and with usual care for upper limb functional limitation after stroke: the RATULS three-group RCT.

Loss of arm function is common after stroke. Robot-assisted training may improve arm outcomes. The objectives were to determine the clinical effectiveness and cost-effectiveness of robot-assisted training, compared with an enhanced upper limb therapy programme and with usual care. This was a pragmatic, observer-blind, multicentre randomised controlled trial with embedded health economic and process evaluations. The trial was set in four NHS trial centres. Patients with moderate or severe upper limb functional limitation, between 1 week and 5 years following first stroke, were recruited. Robot-assisted training using the Massachusetts Institute of Technology-Manus robotic gym system (InMotion commercial version, Interactive Motion Technologies, Inc., Watertown, MA, USA), an enhanced upper limb therapy programme comprising repetitive functional task practice, and usual care. The primary outcome was upper limb functional recovery 'success' (assessed using the Action Research Arm Test) at 3 months. Secondary outcomes at 3 and 6 months were the Action Research Arm Test results, upper limb impairment (measured using the Fugl-Meyer Assessment), activities of daily living (measured using the Barthel Activities of Daily Living Index), quality of life (measured using the Stroke Impact Scale), resource use costs and quality-adjusted life-years. A total of 770 participants were randomised (robot-assisted training, n = 257; enhanced upper limb therapy, n = 259; usual care, n = 254). Upper limb functional recovery 'success' was achieved in the robot-assisted training [103/232 (44%)], enhanced upper limb therapy [118/234 (50%)] and usual care groups [85/203 (42%)]. These differences were not statistically significant; the adjusted odds ratios were as follows: robot-assisted training versus usual care, 1.2 (98.33% confidence interval 0.7 to 2.0); enhanced upper limb therapy versus usual care, 1.5 (98.33% confidence interval 0.9 to 2.5); and robot-assisted training versus enhanced upper limb therapy, 0.8 (98.33% confidence interval 0.5 to 1.3). The robot-assisted training group had less upper limb impairment (as measured by the Fugl-Meyer Assessment motor subscale) than the usual care group at 3 and 6 months. The enhanced upper limb therapy group had less upper limb impairment (as measured by the Fugl-Meyer Assessment motor subscale), better mobility (as measured by the Stroke Impact Scale mobility domain) and better performance in activities of daily living (as measured by the Stroke Impact Scale activities of daily living domain) than the usual care group, at 3 months. The robot-assisted training group performed less well in activities of daily living (as measured by the Stroke Impact Scale activities of daily living domain) than the enhanced upper limb therapy group at 3 months. No other differences were clinically important and statistically significant. Participants found the robot-assisted training and the enhanced upper limb therapy group programmes acceptable. Neither intervention, as provided in this trial, was cost-effective at current National Institute for Health and Care Excellence willingness-to-pay thresholds for a quality-adjusted life-year. Robot-assisted training did not improve upper limb function compared with usual care. Although robot-assisted training improved upper limb impairment, this did not translate into improvements in other outcomes. Enhanced upper limb therapy resulted in potentially important improvements on upper limb impairment, in performance of activities of daily living, and in mobility. Neither intervention was cost-effective. Further research is needed to find ways to translate the improvements in upper limb impairment seen with robot-assisted training into improvements in upper limb function and activities of daily living. Innovations to make rehabilitation programmes more cost-effective are required. Pragmatic inclusion criteria led to the recruitment of some participants with little prospect of recovery. The attrition rate was higher in the usual care group than in the robot-assisted training or enhanced upper limb therapy groups, and differential attrition is a potential source of bias. Obtaining accurate information about the usual care that participants were receiving was a challenge. Current Controlled Trials ISRCTN69371850. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 54. See the NIHR Journals Library website for further project information.

A gender-sensitised weight-loss and healthy living program for men with overweight and obesity in Australian Football League settings (Aussie-FIT): A pilot randomised controlled trial.

Recent evidence shows that sport settings can act as a powerful draw to engage men in weight loss. The primary objective of this pilot study was to test the feasibility of delivering and to evaluate preliminary efficacy of Aussie-FIT, a weight-loss program for men with overweight/obesity delivered in Australian Football League (AFL) settings, in preparation for a future definitive trial. This 6-month pilot trial took place in Perth, Australia. Participants were overweight/obese (Body Mass Index [BMI] ≥ 28 kg/m2), middle-aged (35-65 years old) men. Participants were recruited in May 2018, and the intervention took place between June and December 2018. The intervention involved 12 weekly 90-min face-to-face sessions, incorporating physical activity, nutrition, and behaviour change information and practical activities delivered by coaches at 2 clubs. Data were collected at baseline and immediately postintervention. For trial feasibility purposes, 6-month follow-ups were completed. Outcomes were differences in weight loss (primary outcome) and recruitment and retention rates, self-reported measures (for example, psychological well-being), device-measured physical activity, waist size, and blood pressure at 3 months. Within 3 days of advertising at each club, 426 men registered interest; 306 (72%) were eligible. Men were selected on a first-come first-served basis (n = 130; M age = 45.8, SD = 8; M BMI = 34.48 kg/m2, SD = 4.87) and randomised by a blinded researcher. Trial retention was 86% and 63% at 3- and 6-month follow-ups (respectively). No adverse events were reported. At 3 months, mean difference in weight between groups, adjusted for baseline weight and group, was 3.3 kg (95% CI 1.9, 4.8) in favour of the intervention group (p < 0.001). The intervention group's moderate-to-vigorous physical activity (MVPA) was higher than the control group by 8.54 min/day (95% CI 1.37, 15.71, p = 0.02). MVPA among men attracted to Aussie-FIT was high at baseline (intervention arm 35.61 min/day, control arm 38.38 min/day), which may have limited the scope for improvement. Aussie-FIT was feasible to deliver; participants increased physical activity, decreased weight, and reported improvements in other outcomes. Issues with retention were a limitation of this trial. In a future, fully powered randomised controlled trial (RCT), retention could be improved by conducting assessments outside of holiday seasons. Australian New Zealand Clinical Trials Registry: ACTRN12617000515392.

Respiratory Muscle Strength Training to Improve Vocal Function in Patients with Presbyphonia

The effects of presbyphonia are compounded by the decline in respiratory function that occurs with age. Commonly recommended exercises to optimize the use of respiratory muscles during speech, such as diaphragmatic breathing, are unlikely to be intensive enough to induce respiratory changes and impact vocal function. The objective of this study was to assess the effect of adding a targeted intervention, respiratory muscle strength training, to voice exercises in a sample of patients with presbyphonia. In this prospective, randomized-controlled trial, 12 participants received either (1) vocal function exercises (VFE), (2) VFE combined with inspiratory muscle strength training (IMST), or (3) VFE combined with expiratory muscle strength training (EMST). Data collected prior to and following 4 weekly intervention sessions included respiratory measures (pulmonary function and respiratory muscle strength) and voice measures (videostroboscopy, acoustic, auditory-perceptual, aerodynamic, and self-assessment measures). Participants who received IMST improved their voice quality during connected speech (smoothed cepstral peak prominence and ratings of overall voice quality) and their scores on the three self-assessment questionnaires with large to very large within-group effect sizes (|d|=0.82-1.61). In addition, participants in the IMST group reduced their subglottal pressure with a large effect size (d=-0.92). Participants who received EMST improved their maximum expiratory strength and smoothed cepstral peak prominence with large effect sizes (d=0.80 and 0.99, respectively) but had limited improvements in other outcomes. Participants who received only VFE decreased their amount of vocal fold bowing, improved their voice quality on a sustained vowel (amplitude perturbation quotient), and improved their Glottal Function Index score with large effect sizes (|d|=0.74-1.00). Preliminary data indicate that adding IMST to voice exercises may lead to the greatest benefits in patients with presbyphonia by promoting improved subglottal pressure control as well as increasing air available for phonation, resulting in improved self-assessment outcomes.

Tofacitinib in the treatment of Indian patients with rheumatoid arthritis: A post hoc analysis of efficacy and safety in Phase 3 and long-term extension studies over 7years.

ObjectivesTofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We characterized tofacitinib efficacy/safety in Indian vs rest of the world (ROW; excluding India) RA patients.MethodsEfficacy data were pooled for disease‐modified antirheumatic drug (DMARD) inadequate responders from Phase (P)3 studies. For Indian patients, ORAL Solo and ORAL Scan; ROW (excluding India), these studies plus ORAL Step, ORAL Sync, and ORAL Standard. Safety data also included ORAL Start (P3; methotrexate‐naïve) and ORAL Sequel (long‐term extension [LTE] study; data cut‐off March 2017) for Indian patients, and these studies plus A3921041 (LTE study; Japanese study) for ROW. Efficacy outcomes at months 3/6: American College of Rheumatology (ACR)20/50/70; Disease Activity Score in 28 joints, erythrocyte sedimentation rate remission/low disease activity; change from baseline in Health Assessment Questionnaire‐Disability Index. Incidence rates (IRs; patients with events/100 patient‐years) for adverse events of special interest (AESIs) were assessed throughout. Descriptive data underwent no formal comparison.ResultsOne‐hundred‐and‐ninety‐seven Indian and 3879 ROW patients were included. Compared with ROW patients, Indian patients were younger, had lower body mass index, shorter RA duration, and higher baseline disease activity; most Indian patients were non‐smokers and all were biologic DMARD (bDMARD)‐naïve. Month 3 ACR20 rates with tofacitinib 5 mg twice daily/10 mg twice daily/placebo were 67.4%/82.1%/40.9% (India) and 59.0%/66.1%/28.2% (ROW), and month 6 rates were 76.2%/92.1%/88.9% (India) and 69.0%/74.2%/66.5% (ROW). Month 3/6 improvements in other outcomes were generally numerically greater with tofacitinib vs placebo, and similar in both populations. Compared with ROW, Indian patients had numerically fewer AEs/serious AEs, and similar IRs for discontinuations due to AEs and AESIs, except that tuberculosis (TB) IR was higher in Indian (IR = 1.21; 95% CI 0.49, 2.49) vs ROW patients (IR = 0.17; 95% CI 0.11, 0.25).ConclusionsTofacitinib efficacy/safety were similar in both populations, except TB IR, which was higher in Indian patients but in line with those in bDMARD‐treated RA patients from high‐risk countries (IR = 0.00‐2.56; TB IR >0.05 [World Health Organization]). Limitations included the small Indian population and baseline differences between populations.