Intervention-related Adverse Events Research Articles (Page 3)

Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is a common surgical procedure for ulcerative colitis and familial adenomatous polyposis. IPAA strictures are a known complication, often requiring surgical intervention. Endoscopic interventions offer a less invasive alternative, but their safety and efficacy remain uncertain. A comprehensive literature search was performed to identify pertinent studies. Outcomes assessed were technical success, clinical success (immediate and end of follow up), pouch failure rate and adverse events. Pooled estimates were calculated using random effects models with a 95% confidence interval. A total of 607 patients from 9 studies were included. Technical success, defined as the ability to pass the endoscope through the stricture, was achieved in 97.4% of patients. Immediate clinical success, defined as symptom improvement post-intervention, was seen in 44.5% of patients. Clinical success at the end of follow up was observed in 81.7% of patients. However, 6.8% of patients experienced pouch failure and ultimately 14.5% required surgical intervention for refractory strictures or complications. Endoscopic intervention-related serious adverse events occurred in 3.9% of patients, including perforation and major post-procedural bleeding. Endoscopic interventions for IPAA strictures demonstrate high technical success rates, providing a less invasive option for managing this complication. While clinical success rates immediately post-procedure and at end of follow up are promising, a significant proportion of patients ultimately require surgical intervention for pouch failure or refractory strictures.

Abstract Older adults who experience a slip, trip, or fall may experience preclinical mobility limitation (PCML), where individuals report modifications but not difficulty in mobility tasks and are at increased risk for future functional decline. Functional decline may be prevented with exercise. The purpose of this pilot trial was to determine the feasibility (adherence, recruitment, retention, safety) and preliminary outcomes (physical functioning, cognitive functioning, enjoyment) of home-based 12-week high-intensity functional strength training (HIFST) for community-dwelling older adults (≥ 55 years) with PCML who have had an injury from a slip, trip, or fall in the previous year. The trial is currently underway (target completion spring 2023). Participants are stratified by sex and randomized (1:1) to HIFST or a stretching program, both delivered by a physiotherapist via videoconferencing. Feasibility will be assessed based on predetermined criteria and reported using descriptive statistics. Preliminary effects will be reported as between group differences. To date, 20 participants (11 HIFST, 9 stretch) have enrolled (target n=24). Six participants have completed the HIFST intervention, and 2 have withdrawn before completion (reasons: mental health crisis and acute knee pain episode) with a total adherence rate of 85.8% of sessions completed (97.7% for the 6 participants who did not withdraw) which exceeds our threshold for feasibility (≥ 70%). No serious intervention-related adverse events have been reported. The results of this pilot will provide essential information for future research regarding the process, resources, and potential effects of home-based HIFST in a PCML post-injury older adult population.

ABSTRACT Poor sleep quality is highly prevalent among individuals with mild cognitive impairment (MCI). Further, poor sleep quality is associated with reduced quality of life, increased stress response, memory impairments, and progression to dementia among individuals with MCI. Pharmacological treatments for sleep have mixed efficacy and can lead to dependency. Therefore, alternatives to pharmacological treatments for improving sleep among individuals with MCI are needed. The present study reports on the feasibility of a non-pharmacological self-administered hypnosis intervention focused on sleep quality in adults with MCI. It was hypothesized that the hypnosis intervention program would be feasible and have acceptable levels of adherence to daily hypnosis practice. A two-armed randomized controlled pilot trial was conducted using a sample of 21 adults with MCI. Eligible participants were randomly assigned to listen to either hypnosis audio recordings or sham hypnosis recordings for five weeks. Program feasibility, program adherence, pain intensity, stress, and sleep quality were measured using a daily home practice log, questionnaires, and wrist actigraphy. The results found mid or higher levels of treatment satisfaction, ease of use, and perceived effectiveness at one-week follow-up, with participants in the hypnosis arm reporting greater perceived benefit. Adherence to assigned audio recordings and meetings were likewise within acceptable margins in both groups. No intervention-related adverse events were reported in either treatment condition. Significant improvements in sleep quality, sleep duration, and daytime sleepiness were found for the hypnosis intervention. The results of this study can be used to inform future research on the effects of hypnosis on sleep quality in adults with MCI.

Incentives-based strategies can improve health behaviour. Public transport use confers individual- and societal-level public health gain but incentivising public transport has been under-explored. The study objective was to assess the effectiveness of financially incentivising public transport use from a public health perspective. trips4health was a single-blinded parallel group randomised controlled trial (RCT) conducted in Hobart, Australia. Participants were 18 + years and infrequent (<3 times/week) bus users who completed surveys and attended study clinics at baseline and post-intervention. Intervention group participants were set weekly bus use targets increasing over 16-weeks. Smartcard credit was awarded if targets were attained. Weekly text messages and educational materials supported incentives. An active control group received educational materials. 110 participants had been randomised to the control (n = 55) or intervention (n = 55) group when the trial was abandoned due to the COVID-19 pandemic; 65 % (n = 71; 34 intervention, 38 control) completed a 16-week intervention period. The percentage of participants using the bus during the 16-week intervention period was higher in the intervention (69 %) than the control (49 %) group, target attainment (intervention) or their equivalent (control) was higher in the intervention (22 %) than the control (15 %) group, and average weekly bus use was higher in the intervention (2.4 bus trips) compared to the control group (1.7). No intervention related adverse events were reported. Preliminary data from this COVID-impacted RCT to increase bus use through incentives demonstrated some evidence of effectiveness. A sufficiently powered trial that broadens participant reach and examines maintenance of longer-term behaviour change is warranted.

Methotrexate is the first-line treatment for immune-mediated inflammatory diseases and reduces vaccine-induced immunity. We evaluated if a 2-week interruption of methotrexate treatment immediately after COVID-19 booster vaccination improved antibody response against the S1 receptor binding domain (S1-RBD) of the SARS-CoV-2 spike protein and live SARS-CoV-2 neutralisation compared with uninterrupted treatment in patients with immune-mediated inflammatory diseases. We did a multicentre, open-label, parallel-group, randomised, superiority trial in secondary-care rheumatology and dermatology clinics in 26 hospitals in the UK. Adults (aged ≥18 years) with immune-mediated inflammatory diseases taking methotrexate (≤25 mg per week) for at least 3 months, who had received two primary vaccine doses from the UK COVID-19 vaccination programme were eligible. Participants were randomly assigned (1:1) using a centralised validated computer program, to temporarily suspend methotrexate treatment for 2 weeks immediately after COVID-19 booster vaccination or continue treatment as usual. The primary outcome was S1-RBD antibody titres 4 weeks after COVID-19 booster vaccination and was assessed masked to group assignment. All randomly assigned patients were included in primary and safety analyses. This trial is registered with ISRCTN, ISRCTN11442263; following a pre-planned interim analysis, recruitment was stopped early. Between Sept 30, 2021, and March 7, 2022, we screened 685 individuals, of whom 383 were randomly assigned: to either suspend methotrexate (n=191; mean age 58·8 years [SD 12·5], 118 [62%] women and 73 [38%] men) or to continue methotrexate (n=192; mean age 59·3 years [11·9], 117 [61%] women and 75 [39%] men). At 4 weeks, the geometric mean S1-RBD antibody titre was 25 413 U/mL (95% CI 22 227-29 056) in the suspend methotrexate group and 12 326 U/mL (10 538-14 418) in the continue methotrexate group with a geometric mean ratio (GMR) of 2·08 (95% CI 1·59-2·70; p<0·0001). No intervention-related serious adverse events occurred. 2-week interruption of methotrexate treatment in people with immune-mediated inflammatory diseases enhanced antibody responses after COVID-19 booster vaccination that were sustained at 12 weeks and 26 weeks. There was a temporary increase in inflammatory disease flares, mostly self-managed. The choice to suspend methotrexate should be individualised based on disease status and vulnerability to severe outcomes from COVID-19. National Institute for Health and Care Research.

The Impact of Pausing Bruton Tyrosine Kinase Inhibitor Therapy and Responsiveness of Vaccination in Blood Cancer Patients: Primary Outcome Result for the Randomised Improve Trial

The objective of this study was to determine the feasibility of low-load resistance training with blood flow restriction (BFR) for people with advanced disability due to multiple sclerosis (MS). In this prospective cohort study, 14 participants with MS (Expanded Disability Status Scale [EDSS] score = 6.0 to 7.0; mean age = 55.4 [SD = 6.2] years; 71% women) were asked to perform 3 lower extremity resistance exercises (leg press, calf press, and hip abduction) bilaterally twice weekly for 8weeks using BFR. Feasibility criteria were as follows: enrollment of 20 participants, ≥80% retention and adherence, ≥90% satisfaction, and no serious adverse events related to the intervention. Other outcomes included knee extensor, ankle plantar flexor, and hip abductor muscle strength, 30-Second Sit-to-Stand Test, Berg Balance Scale, Timed 25-Foot Walk Test, 12-Item MS Walking Scale, Modified Fatigue Impact Scale, Patient-Specific Functional Scale, and daily step count. Sixteen participants consented, and 14 completed the intervention, with 93% adherence overall. All participants were satisfied with the intervention. A minor hip muscle strain was the only intervention-related adverse event. There were muscle strength improvements on the more-involved (16%-28%) and less-involved (12%-19%) sides. There were also changes in the 30-Second Sit-to-Stand Test (1.9 repetitions; 95% CI = 1.0 to 2.8), Berg Balance Scale (5.3 points; 95% CI = 3.2 to 7.4), Timed 25-Foot Walk Test (-3.3seconds; 95% CI = -7.9 to 1.3), Modified Fatigue Impact Scale (-8.8 points; 95% CI = -16.5 to -1.1), 12-Item MS Walking Scale (-3.6 points; 95% CI = -11.5 to 4.4), Patient-Specific Functional Scale (2.9 points; 95% CI = 1.9 to 3.8), and daily step count (333 steps; 95% CI = -191 to 857). Low-load resistance training using BFR in people with MS and EDSS scores of 6.0 to 7.0 appears feasible, and subsequent investigation into its efficacy is warranted. Although efficacy data are needed, combining BFR with low-load resistance training may be a viable alternative for people who have MS and who do not tolerate conventional moderate- to high-intensity training because of more severe symptoms, such as fatigue and weakness. Low-load strength training with BFR was feasible in people who have advanced disability due to MS. Using BFR may provide an alternative for people with MS who do not tolerate higher intensity training due to more severe symptoms, such as fatigue and weakness.

Dyslipidemia, a condition implying high cardiovascular risks, has been widely studied on its potential nutrition interventions, including functional foods. This study aims to examine the effect of nattokinase monascus supplements (NMSs) on cardiovascular biomarkers and carotid intima-media thickness (CIMT) in patients with dyslipidemia. A total of 113 eligible subjects were randomly assigned to receive either NMSs or a placebo (55 and 58, respectively). After a 120-day intervention, there were significant mean absolute changes in total cholesterol (TC), low-density cholesterol (LDL-C), non-high-density cholesterol (non-HDL-C), and low-density cholesterol to high-density cholesterol ratio (LDL-C to HDL-C ratio), with values of −0.52 (95% CI: −0.51 to −0.54) mmol/L, −0.43 (95% CI: −0.45 to −0.41) mmol/L, −0.52 (95% CI: −0.52 to −0.52) mmol/L, and −0.29 (95% CI: −0.30 to −0.28) mmol/L, respectively, between the two groups. However, no significant differences were found in triglycerides (TGs), high-density cholesterol (HDL-C), and CIMT. Furthermore, the results for lipids and CIMT remained essentially unchanged after adjusting for various confounding factors using the analysis of covariance model. There were no significant differences in coagulation, liver function, renal function, or other indicators. No intervention-related adverse events, such as mouth ulcers, drooling, and stomach pain, were reported. The study results demonstrate that NMSs can ameliorate lipid levels (TC, LDL-C, non-HDL-C, and the LDL-C to HDL-C ratio) without the occurrence of adverse events. However, it did not significantly affect serum TG, HDL-C, and CIMT.

Background: Patient non-adherence to antihypertensive (AH) drugs impacts achieving treatment goals, highlighting the need for adjunctive therapies such as radiofrequency renal denervation (RDN). Patient preference for an intervention vs. drug therapy is poorly understood. We assessed patient treatment preferences at different stages of HTN management using a calculator derived from a discrete choice experiment (DCE) study. Methods: Preferences in 3 different clinical scenarios in the natural course of HTN management were evaluated: (1) initiating AH drugs vs. interventional treatment in untreated patients with mild-moderate HTN; (2) increasing drugs vs. interventional treatment with no drug change in patients with mild-moderate HTN; (3) increasing drugs vs. interventional treatment with no drug change in patients with severe resistant HTN. The predicted probability of choosing one treatment vs. the other was calculated based on preference-weighted treatment attributes (type of treatment, changes in AH drugs, BP reduction, effect duration, risk of drug side effects, intervention related adverse events). The values chosen for each scenario were derived from published RDN studies, the literature, and expert opinion. Results: Comparing scenario 1 to 2 to 3, the preference to select an intervention without drugs or change in drugs increased from 17% to 24% to 45%. Conversely, the preference to select either initiation or an increase in drugs decreased from 83% to 76% to 55%. The magnitude of BP reduction was the major driver of calculated patient preferences while drug and interventional treatment-related adverse events had a smaller impact on calculated patient preferences. Conclusions: Using preference-weights derived from a discrete choice experiment, a model predicting patient choice for drug vs. interventional treatment was applied to clinical scenarios derived from the natural course of management of patients with uncontrolled HTN. Preference for an interventional treatment increased from 17% in treatment naïve patients to 45% in patients with severe resistant HTN. Patient preference was driven predominantly by efficacy outcomes and minimally by safety concerns.

81 Background: Exercise is now considered an important therapy to ameliorate treatment side effects, improve quality of life and physical function however, causation of survival benefit and the underlying mechanisms is not yet established. In 2015, the Intense Exercise for Survival among Men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL-GAP4) – a worldwide multicentre phase III trial – was launched to determine if high-intensity combined resistance and aerobic exercise plus psychosocial support improves overall survival in men with metastatic prostate cancer. Here, while exercise delivery and follow-up assessments are still taking place in 6 different countries, we aim to examine the feasibility, exercise compliance and safety of a 12-month exercise medicine program in patients with mCRPC. Methods: Experimental design was a longitudinal analysis of attrition rates, exercise attendance and compliance metrics and programme safety over the initial 12 months of patients participating in the INTERVAL-GAP4 trial at the Edith Cowan University site in Perth, Australia. Results: 201 patients were screened for participation and 46 patients (22.9%) were randomly assigned to the two study arms. Median time since prostate cancer diagnosis was 72.0 (interquartile range (IQR): 19.5-118.5) months. Most patients were previously treated with radiotherapy (53.3%). Metastases present mostly in the lymph nodes (53.3%), followed by bones (51.1%), lungs (2.2%) and bladder (2.2%). Participants attended a total of 2,907 out of 3,744 exercise sessions scheduled, with a median exercise attendance of 78.8% (IQR: 71.6%-82.7%) per participant. Majority of sessions were performed at an RPE of 7-8 indicating “vigorous intensity” or at an RPE of 5-6 indicating “moderate intensity” (67.2%). Tolerance was moderate-to-high in most sessions (83.0%). 191 adverse events (AEs) were observed throughout the study period. A total of 136 adverse events were reported by 19 participants from the exercise group, and these were mainly disease related (n= 69, 50.7%). Most AEs were grade 1 and 2 (n= 126, 92.7%). In the control group, 55 AEs were observed, and these were mainly disease related (n= 22, 40.0%) and grade 1 and 2 (n= 51, 92.7%). The most common intervention-related adverse events experienced in the exercise group were pain (n= 6, 50.0%; i.e., back pain, bone pain, lymph node pain, and general pain). Conclusions: Patients with mCPRC can participate in high-intensity aerobic and resistance training with moderate to high attendance and tolerance. The exercise intervention appears safe with limited intervention-related adverse events experienced and mostly minor and expected. However, with only 22.9% of screened patients deemed suitable and willing, this aspect of feasibility requires attention. Clinical trial information: NCT02730338 .

BackgroundExercise is an effective adjuvant therapy that can alleviate treatment-related toxicities for men with prostate cancer (PC). However, the feasibility of delivering exercise training to men with advanced disease and the wider impact on clinical outcomes remain unknown. The purpose of the EXACT trial was to determine the feasibility and effects of home-based exercise training in men with metastatic castrate-resistant prostate cancer (mCRPC).MethodsPatients with mCRPC receiving ADT + an androgen receptor pathway inhibitor (ARPI) were prescribed 12 weeks of home-based, remotely monitored, moderate intensity, aerobic and resistance exercise. Feasibility was assessed using recruitment, retention and adherence rates. Safety and adverse events were monitored throughout, with functional and patient-reported outcomes captured at baseline, post-intervention and at 3-month follow-up.ResultsFrom the 117 screened, 49 were deemed eligible and approached, with 30 patients providing informed consent (61% recruitment rate). Of those who consented, 28 patients completed baseline assessments, with 24 patients completing the intervention and 22 completing follow-up (retention rates: 86% and 79% respectively). Task completion was excellent throughout, with no intervention-related adverse events recorded. Self-reported adherence to the overall intervention was 82%. Exercise training decreased mean body mass (−1.5%), improved functional fitness (> 10%) and improved several patient-reported outcomes including clinically meaningful changes in fatigue (p = 0.042), FACT-G (p = 0.054) and FACT-P (p = 0.083), all with moderate effect sizes.ConclusionHome-based exercise training, with weekly remote monitoring, was feasible and safe for men with mCRPC being treated with an ARPI. Given that treatment-related toxicities accumulate throughout the course of treatment, and as a result, negatively impact functional fitness and health-related quality of life (HRQoL), it was positive that exercise training improved or prevented a decline in these clinically important variables and could better equip patients for future treatment. Collectively, these preliminary feasibility findings support the need for a definitive, larger RCT, which downstream may lead to the inclusion of home-based exercise training as part of adjuvant care for mCRPC.

BackgroundA tele-emergency medical service with a remote emergency physician for severe prehospital emergencies may overcome the increasing number of emergency calls and shortage of emergency medical service providers. We analysed whether routine use of a tele-emergency medical service is non-inferior to a conventional physician-based one in the occurrence of intervention-related adverse events.MethodsThis open-label, randomised, controlled, parallel-group, non-inferiority trial included all routine severe emergency patients aged ≥ 18 years within the ground-based ambulance service of Aachen, Germany. Patients were randomised in a 1:1 allocation ratio to receive either tele-emergency medical service (n = 1764) or conventional physician-based emergency medical service (n = 1767). The primary outcome was the occurrence of intervention-related adverse events with suspected causality to the group assignment. The trial was registered with ClinicalTrials.gov (NCT02617875) on 30 November 2015 and is reported in accordance with the CONSORT statement for non-inferiority trials.ResultsAmong 3531 randomised patients, 3220 were included in the primary analysis (mean age, 61.3 years; 53.8% female); 1676 were randomised to the conventional physician-based emergency medical service (control) group and 1544 to the tele-emergency medical service group. A physician was not deemed necessary in 108 of 1676 cases (6.4%) and 893 of 1544 cases (57.8%) in the control and tele-emergency medical service groups, respectively. The primary endpoint occurred only once in the tele-emergency medical service group. The Newcombe hybrid score method confirmed the non-inferiority of the tele-emergency medical service, as the non-inferiority margin of − 0.015 was not covered by the 97.5% confidence interval of − 0.0046 to 0.0025.ConclusionsAmong severe emergency cases, tele-emergency medical service was non-inferior to conventional physician-based emergency medical service in terms of the occurrence of adverse events.

Low-energy diets are used to treat obesity and diabetes, but there are fears that they may worsen liver disease in patients with nonalcoholic steatohepatitis (NASH) and significant-to-advanced fibrosis. In this 24-week single-arm trial, 16 adults with NASH, fibrosis, and obesity received one-to-one remote dietetic support to follow a low-energy (880 kcal/d) total diet replacement program for 12 weeks and stepped food reintroduction for another 12 weeks. Liver disease severity was blindly evaluated (magnetic resonance imaging proton density fat fraction [MRI-PDFF], iron-corrected T1 [cT1], liver stiffness on magnetic resonance elastography [MRE], and liver stiffness on vibration-controlled transient elastography [VCTE]). Safety signals included liver biochemical markers and adverse events. A total of 14 participants (87.5%) completed the intervention. Weight loss was 15% (95% CI: 11.2%-18.6%) at 24 weeks. Compared with baseline, MRI-PDFF reduced by 13.1% (95% CI: 8.9%-16.7%), cT1 by 159 milliseconds (95% CI: 108-216.5), MRE liver stiffness by 0.4 kPa (95% CI: 0.1-0.8), and VCTE liver stiffness by 3.9 kPa (95% CI: 2.6-7.2) at 24 weeks. The proportions with clinically relevant reductions in MRI-PDFF (≥30%), cT1 (≥88 milliseconds), MRE liver stiffness (≥19%), and VCTE liver stiffness (≥19%) were 93%, 77%, 57%, and 93%, respectively. Liver biochemical markers improved. There were no serious intervention-related adverse events. The intervention demonstrates high adherence, favorable safety profile, and promising efficacy as a treatment for NASH.

12023 Background: Older cancer survivors consistently express the need for interventions to reduce fatigue and maintain quality of life (QOL). We previously showed that yoga, compared to standard care, effectively improved fatigue and QOL among older survivors. Whether yoga is superior to a rigorous behavioral placebo for improving fatigue and QOL in older survivors is unknown. To examine the efficacy of yoga vs a behavioral placebo for improving fatigue and QOL in older survivors. Methods: Older cancer survivors (age 60+) 2-60 months post-treatment were randomized to receive Yoga for Cancer Survivors (YOCAS; 75-minute sessions 2x/week for 4 weeks) or a behavioral placebo (Survivorship Health Education – SHE; 75-minute sessions 2x/week for 4 weeks). The YOCAS intervention includes breathing exercises, yoga poses, and mindfulness activities. The SHE placebo includes education based on ASCO cancer survivorship recommendations. Fatigue and QOL (i.e., overall, physical, emotional, and functional) were assessed pre- and post-intervention with the Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F). The within-group and between-group intervention effects on fatigue were examined by 2-tailed t tests and ANCOVAs. Results: 173 older survivors were enrolled (91% women, mean age 67 [range=60-85], 90% White, 10% racial minority, 2.3% Hispanic, 71% breast cancer). On average, participants completed 6 in-person yoga sessions and 1 additional weekly, home-based yoga practice, for an average of 183 minutes of yoga/week with no intervention-related adverse events. There were significant between group differences on fatigue, where yoga participants reported significantly more improvement in fatigue than controls (1.6±0.9, p&lt;0.05). There were also significant between group differences on the emotional component of QOL, where yoga participants reported significant improvement in the emotional component of QOL but controls did not (0.8±0.4, p&lt;0.045). Moreover, there were statistical trends for between group differences on the physical and functional component of QOL, where yoga participants reported improvements in the physical (0.8±0.4, p&lt;0.063) and functional components of QOL (0.9±0.5, p&lt;0.089) but controls did not. There were significant between group differences on overall QOL, where yoga participants reported significant improvement in overall QOL but controls did not (3.8±1.4, p&lt;0.007). 94% of participants reported the intervention useful for symptom management and would recommend it to others. Conclusions: Results suggest that older survivors: 1) can safely utilize yoga for treating side effects, 2) experience improvements in fatigue and QOL via yoga therapy, and 3) find yoga a useful treatment for side effects and recommend it to others. Future research is needed to confirm these results and increase uptake by older, and ethnically and racially diverse survivors. Clinical trial information: NCT02613364 .

BackgroundPulmonary rehabilitation (PR) decreases rehospitalization for people with COPD. However, less than 2% receive PR, partly due to lack of referral and sparsity of PR facilities. This disparity is particularly pronounced in African American and Hispanic persons with COPD. Telehealth-provided PR could increase access and improve health outcomes.MethodsWe applied the RE-AIM framework in a post-hoc analysis of our mixed methods RCT comparing referral to Telehealth-delivered PR (TelePR) versus standard PR (SPR) for African American and Hispanic COPD patients hospitalized for COPD exacerbation. Both arms received a referral to PR for 8 weeks, social worker follow-up, and surveys administered at baseline, 8 weeks, 6, and 12 months. PR sessions were conducted twice a week for 90 min each (16 sessions total). Quantitative data were analyzed using 2-sample t tests or nonparametric Wilcoxon tests for continuous data and χ2/Fisher exact tests for categorical data. Logistic regression–estimated odds ratios (ORs) were used for the intention-to-treat primary outcome. Qualitative interviews were conducted at the end of the study to assess adherence and satisfaction and were analyzed using inductive and deductive methods. The goal was to understand Reach (whether the target population was able to be enrolled), Effectiveness (primary outcome was a composite of 6-month COPD rehospitalization and death), Adoption (proportion of people willing to initiate the program), Implementation (whether the program was able to be executed as intended, and Maintenance (whether the program was continued).ResultsTwo hundred nine people enrolled out of a 276-recruitment goal. Only 85 completed at least one PR session 57/111 (51%) TelePR; 28/98 (28%) SPR. Referral to TelePR compared to SPR did not decrease the composite outcome of 6-month COPD-readmission rate/death (OR1.35;95%CI 0.69,2.66). There was significant reduction in fatigue (PROMIS® scale) from baseline to 8-weeks in TelePR compared to SPR (MD-1.34; ± SD4.22; p = 0.02). Participants who received TelePR experienced improvements from baseline in several outcomes (ie, before and after 8 weeks of PR) in the following: COPD symptoms, knowledge about COPD management, fatigue, and functional capacity. Among the patients who had 1 initial visit, adherence rates were similar (TelePR arm, 59% of sessions; SPR arm, 63%). No intervention-related adverse events occurred. Barriers to PR adoption included difficulty or reluctance to complete medical clearances and beliefs about PR efficacy. Notably, only 9 participants sustained exercise after program completion. Maintenance of the program was not possible due to low insurance reimbursement and sparsity of Respiratory Therapists.ConclusionsTelePR can reach COPD patients with health disparities and can be successfully implemented. The small sample size and large confidence intervals prevent conclusion about the relative effectiveness of participating in TelePR compared to SPR. However, improved outcomes were seen for those in TelePR as well as in SPR. Increasing adoption of PR and TelePR requires consideration of comorbidity burden, and perception of PR utility, and must facilitate medical clearances. Given the sparsity of SPR locations, TelePR can overcome at least the barrier of access. However, given the challenges to the uptake and completion of PR - many of the additional barriers in PR (both in TelePR and SPR) need to be addressed. Awareness of these real-world challenges will not only inform implementation of TelePR for clinicians seeking to adopt this platform but will also inform study designers and reviewers regarding the feasibility of approaches to patient recruitment and retention.

Lack of consistently reported outcomes limits progress in evidence-based implant dentistry and quality of care. The objective of this initiative was to develop a core outcome set (COS) and measurements for implant dentistry clinical trials (ID-COSM). This Core Outcome Measures in Effectiveness Trials (COMET)-registered international initiative comprised six steps over 24 months: (i) systematic reviews of outcomes reported in the last 10 years; (ii) international patient focus groups; (iii) a Delphi project with a broad range of stakeholders (care providers, clinical researchers, methodologists, patients and industry representatives); (iv) expert group discussions organizing the outcomes in domains using a theoretical framework and identifying the COSs; (v) identification of valid measurement systems to capture the different domains and (vi) final consensus and formal approval involving experts and patients. The methods were modified from the best practice approach following the Outcome Measures in Rheumatoid Arthritis Clinical Trial and COMET manuals. The systematic reviews and patient focus groups identified 754 (665 + 89, respectively) relevant outcome measures. After elimination of redundancies and duplicates, 111 were formally assessed in the Delphi project. By applying pre-specified filters, the Delphi process identified 22 essential outcomes. These were reduced to 13 after aggregating alternative assessments of the same features. The expert committee organized them into four core outcome areas: (i) pathophysiology, (ii) implant/prosthesis lifespan, (iii) life impact and (iv) access to care. In each area, core outcomes were identified to capture both the benefits and harms of therapy. Mandatory outcome domains included assessment of surgical morbidity and complications, peri-implant tissue health status, intervention-related adverse events, complication-free survival and overall patient satisfaction and comfort. Outcomes deemed mandatory in specific circumstances comprised function (mastication, speech, aesthetics and denture retention), quality of life, effort for treatment and maintenance and cost effectiveness. Specialized COSs were identified for bone and soft-tissue augmentation procedures. The validity of measurement instruments ranged from international consensus (peri-implant tissue health status) to early identification of important outcomes (patient-reported outcomes identified by the focus groups). The ID-COSM initiative reached a consensus on a core set of mandatory outcomes for clinical trials in implant dentistry and/or soft tissue/bone augmentation. Adoption in future protocols and reporting on the respective domain areas by currently ongoing trials will contribute to improving evidence-informed implant dentistry and quality of care.

Lack of consistently reported outcomes limits progress in evidence-based implant dentistry and quality of care. The objective of this initiative was to develop a core outcome set (COS) and measurements for implant dentistry clinical trials (ID-COSM). This Core Outcome Measures in Effectiveness Trials (COMET)-registered international initiative comprised six steps over 24 months: (i) systematic reviews of outcomes reported in the last 10 years; (ii) international patient focus groups; (iii) a Delphi project with a broad range of stakeholders (care providers, clinical researchers, methodologists, patients and industry representatives); (iv) expert group discussions organizing the outcomes in domains using a theoretical framework and identifying the COSs; (v) identification of valid measurement systems to capture the different domains and (vi) final consensus and formal approval involving experts and patients. The methods were modified from the best practice approach following the Outcome Measures in Rheumatoid Arthritis Clinical Trial and COMET manuals. The systematic reviews and patient focus groups identified 754 (665 + 89, respectively) relevant outcome measures. After elimination of redundancies and duplicates, 111 were formally assessed in the Delphi project. By applying pre-specified filters, the Delphi process identified 22 essential outcomes. These were reduced to 13 after aggregating alternative assessments of the same features. The expert committee organized them into four core outcome areas: (i) pathophysiology, (ii) implant/prosthesis lifespan, (iii) life impact and (iv) access to care. In each area, core outcomes were identified to capture both the benefits and harms of therapy. Mandatory outcome domains included assessment of surgical morbidity and complications, peri-implant tissue health status, intervention-related adverse events, complication-free survival and overall patient satisfaction and comfort. Outcomes deemed mandatory in specific circumstances comprised function (mastication, speech, aesthetics and denture retention), quality of life, effort for treatment and maintenance and cost effectiveness. Specialized COSs were identified for bone and soft-tissue augmentation procedures. The validity of measurement instruments ranged from international consensus (peri-implant tissue health status) to early identification of important outcomes (patient-reported outcomes identified by the focus groups). The ID-COSM initiative reached a consensus on a core set of mandatory outcomes for clinical trials in implant dentistry and/or soft tissue/bone augmentation. Adoption in future protocols and reporting on the respective domain areas by currently ongoing trials will contribute to improving evidence-informed implant dentistry and quality of care.

TP53 mutation is associated with cancer progression. Novel strategies to reboot p53 are required to stabilize the disease and improve survival. This randomized placebo-controlled trial investigated safety and efficacy of Nutri-PEITC Jelly (a texture-modified nutritious diet fortified with β-phenethyl isothiocyanate (PEITC) on oral cancer. Seventy-two patients with advanced-staged oral or oropharyngeal cancer were randomly assigned to study and control groups, who consumed 200 g of Nutri-Jelly with and without 20 mg of PEITC, respectively, 5 days/week for 12 weeks. Outcomes, including adverse events, health-related quality of life (HRQOL), progression-free survival (PFS), tumor response, serum p53, and cytochrome c, were measured at 0, 1, and 3 months. Results show that the study group had a higher proportion of participants with improved HRQOL, stable disease, and increased serum p53 levels than those in the control group (p < 0.001). The PFS time in the study group was significantly longer than that of the control group (p < 0.05). Serum cytochrome c levels were non-significantly decreased in the study group. No serious intervention-related adverse events occurred in either group. In conclusion, Nutri-PEITC Jelly intake for 3 months is safe, stabilizes the disease, improves quality of life and progression-free survival, and might re-activate p53 in advanced-stage oral and oropharyngeal cancer patients.

Coffee cherry pulp, a major waste product from coffee manufacturing, contains polyphenols with antioxidant activity. However, its clinical safety and health benefits are unclear. This randomized, double-blinded, placebo-controlled trial evaluated the safety and potential efficacy of coffee cherry pulp juice concentrate. A total of 61 participants were randomly divided into a study group (n = 30), receiving the juice, and a control group (n = 31), receiving a placebo drink of 14 g twice daily for 12 weeks. Adverse symptoms, changes in body weight, hematological and biochemical parameters, vital signs, and heart function were evaluated using subject diaries, interviews, blood and urine tests, and electrocardiograms. The results showed no intervention-related adverse events. Body weight, liver, renal function, complete blood counts, blood glucose, urinalysis, and electrocardiograms were not significantly altered throughout the study. Consuming the juice for at least 8 weeks significantly decreased cholesterol and LDL levels. The glucose levels were maintained significantly better than those of the placebo group. The findings suggest that continuously consuming 28 g/day of coffee pulp juice concentrate for 12 weeks is safe in healthy volunteers. Future studies could employ a dose of ≤28 g/day to investigate the efficacy of this novel food, especially for preventing dyslipidemia and diabetes.

Tissue buccal fat pad–stromal vascular fraction as a safe source in maxillofacial bone regeneration: A clinical pilot study