Monthly Phone Calls Research Articles

Effectiveness of a Sugar Consumption Prevention Program in the First Year of Life on the Occurrence of Early Childhood Caries: A Multicentric Randomized Trial in Brazil.

This study aims to investigate the effectiveness of a nutritional counseling program for mothers of newborns to prevent sugar consumption in the first year of the child's life on the occurrence of Early Childhood Caries (ECC). A multicentric randomized clinical trial (ClinicalTrials.gov NCT03841123) was conducted in three state capitals of Brazil (n=516). Mothers were randomly assigned to the intervention group (IG) or control group (CG) after delivery. The IG received face-to-face nutritional counseling based on UNICEF dietary guidelines, followed by monthly phone calls. The CG received standard counseling. Dietary intake was measured through structured questionnaires and 24-hour recalls at six and 12 months. Calibrated dentists performed a dental clinical examination for ECC diagnosis after the children completed their first year of life. The prevalence of ECC was 17.4% in the overall sample (49/290). The number of affected teeth ranged from 0 to 6 (mean 0.43). The IG had a 2.4 times probability of not consuming sugar in the first six months of the child's life (RR 2.44; 95% CI 1.18-5.00) and they had Fa significantly lower mean number of sweet items consumed at 12 months (p=0.016). No significant differences between groups were found concerning the occurrence of ECC (RR 1.33; 95% CI 0.79-2.25) or the number of teeth affected by caries (p=0.273). The intervention to prevent and reduce sugar intake in the first year of life was not effective at reducing the occurrence of early childhood caries or the number of teeth with carious lesions.

Mothers’ experiences of a lifestyle intervention for weight reduction 12 months after gestational diabetes mellitus: Qualitative findings from the PAIGE2 study

The standardised pooled prevalence of gestational diabetes mellitus (GDM) globally is approximately 14 %, a reflection of increasing rates of obesity in women of childbearing age. Lifestyle interventions to reduce GDM and subsequent type 2 diabetes (T2D) have been deemed a research priority but are challenging to perform and have variable success rates. The PAIGE2 study was a pragmatic lifestyle randomised controlled trial for women with GDM and body mass index ≥25 kg/m2, which began during pregnancy and continued for one year postnatally. The primary outcome was weight loss 12 months postnatally compared with mothers receiving standard maternity care. Qualitative results are presented from end of study focus groups conducted amongst intervention mothers to gather feedback and determine acceptability of the PAIGE2 intervention. In total, 19 mothers participated in five virtual focus groups. Content analysis explored general study experience, longer term changes to lifestyle and suggested improvements of intervention components including monthly phone calls, motivational text messages, Fitbit experience, Slimming World, and study contact timings. Overall, most mothers found the individual PAIGE2 intervention components enjoyable, although opinions differed as to which were the most effective. Several mothers claimed the intervention helped them make long-term changes to their behaviours. A common suggested improvement was the establishment of a local group where mothers could share their experiences. In conclusion, most mothers deemed the intervention acceptable, and felt that with minor enhancements, it could be utilised as an effective tool to support weight loss after pregnancy and reduce future risk of obesity and T2D.

Active cycle of breathing technique versus oscillating PEP therapy versus walking with huffing during an acute exacerbation of bronchiectasis: a randomised, controlled trial protocol

BackgroundAirway clearance techniques (ACTs) for individuals with bronchiectasis are routinely prescribed in clinical practice and recommended by international guidelines, especially during an acute exacerbation. However, there is limited evidence of the efficacy of these techniques during an exacerbation to improve sputum expectoration, health-related quality-of-life (HRQOL) or exercise tolerance. The primary aim of this study is to compare the effects of the active cycle of breathing technique (ACBT), oscillating positive expiratory pressure (O-PEP) therapy, and walking with huffing on sputum expectoration for adults hospitalised with an acute exacerbation of bronchiectasis. Secondary aims are to compare the effects of these interventions on HRQOL, health status, exacerbation rates and hospital admissions in a six-month period following hospital discharge.MethodsThis multi-centre randomised controlled trial will recruit adults with an acute exacerbation of bronchiectasis requiring hospital admission. Participants will be randomised to receive one of three interventions: ACBT, O-PEP therapy, and walking with huffing. Outcome measures including sputum volume during and 1-h post ACT session, and 24-h sputum, as well as health status, HRQOL and exercise capacity will be completed during inpatient stay on day 2 and day 6 of admission, and within 24 h of hospital discharge. Time to first exacerbation, and time to first hospitalisation will be monitored via monthly phone calls for six months post hospital discharge. Health status and HRQOL will be assessed after discharge at two and six months, and exercise capacity will be assessed at six months post hospital discharge.DiscussionDespite recommendations regarding the importance of ACT for individuals with bronchiectasis during an acute exacerbation, there is a gap in the literature regarding effectiveness of ACT when undertaken by individuals in this clinical state. This study will add to the evidence base regarding the effectiveness of commonly implemented ACTs during a hospital admission with an exacerbation of bronchiectasis. Additionally, it will contribute to knowledge of the long term effects on important and patient-centred outcomes, including incidence of future exacerbations, and HRQOL, which has not been previously established.Trial registration Registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12621000428864).

Early Experience and Patient Characteristics from Opera: A Real-World Study of Pegcetacoplan Treatment

Background Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, acquired life-threatening disease characterized by complement-mediated hemolysis and thrombosis. Chronic hemolysis leads to anemia, which can result in persistent fatigue and dependance on transfusions, affecting the overall quality of life (QOL) of patients with PNH. Pegcetacoplan (PEG; US brand name Empaveli®) is the first approved C3 inhibitor for US adults with PNH. Although clinical trials have assessed the efficacy of PEG, which include patient-reported outcomes, there is no information on the use of PEG in a real-world setting. Aims To provide the first report of trends in hemoglobin (Hb) values and baseline QOL (measured by patient-reported fatigue and cognitive impairment) from OPERA, a descriptive, observational exploratory outcomes study, presenting the first real-world data describing PEG treatment for adults with PNH post-approval. Methods This single site opt-in study recruited patients in the US, following a valid PEG prescription from a licensed medical professional. Patients ≥18 years of age, diagnosed with PNH and prescribed PEG, were electronically consented and then enrolled to participate in the OPERA study, as approved by the internal review board. OPERA collected information from routine care and did not direct or suggest any medical interventions. In this observational setting, Hb lab values were reported (by the patient/site) at varying timepoints when available. Participants self-reported QOL status from baseline over a 12-month period through monthly phone calls and quarterly online patient-reported outcome measures (PROMs). During monthly phone calls, participants were asked to report their most recent Hb levels (typical normal range: male, 13.6-18 g/dL; female, 12-16 g/dL) if available from their regular primary care visits in the previous month. Online PROMs collected data using validated QOL instruments including the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale (0-52 total score) and the Patient-Reported Outcomes Measurement Information System (PROMIS) scale for Cognitive Abilities (23.27-67.09 t-score). Lower scores on each measure represent greater levels of fatigue or cognitive impairment. Results Participants enrolled in OPERA with a 30-70% monthly range to opt-in. Of 17 participants enrolled with available baseline Hb values, mean (range) age was 45.76 (20-70) years, and 8 were female. No OPERA participants were previously enrolled in a PEG clinical trial. All participants were prescribed and received the label recommended dose of PEG (1080 mg, twice weekly). All participants reported prior treatment with either eculizumab, ravulizumab or both, before starting PEG. Additional dosing information and time since PNH diagnosis can be found in the Table. The mean (SD) baseline Hb levels from 17 OPERA participants was 8.90 (2.19) g/dL, which was similar to the mean (SD) baseline Hb levels (8.69 [1.08] g/dL) for 41 patients in the previously published phase 3 PEGASUS (NCT03500549) trial. Among 4 participants with available data after 1 month of PEG use, mean (SD) Hb levels increased to 11.95 (1.84) g/dL (mean change from baseline +2.83 (1.35) g/dL) which was similar to the mean (SD) Hb levels of 11.55 (1.62) g/dL seen in 40 PEGASUS participants after 1 month of treatment. QOL data was available at baseline in 12 participants and the mean (SD) baseline FACIT-Fatigue score was 30.25 (15.63), which was similar to the mean (SD) baseline FACIT-Fatigue score of 32.2 (11.4) from the PEGASUS trial, but below the reported mean FACIT-Fatigue population norm of 43.6 (Cella, et al. Cancer. 2002). Additionally, the mean (SD) PROMIS-Cognitive Abilities t-score for patients with available QOL data (n=12) was 43.57 (9.11), which is lower than the published population norm of 50 (Saffer, et al. Psychiatry Research 2015). Conclusions This first real-world study of adults with PNH receiving PEG indicates a positive trend in Hb levels in participants after 1 month of use. These early experiences are similar to previously reported changes in Hb levels after PEG treatment in phase 3 clinical trials (Hillmen et al, NEJM 2021). At baseline, participants with PNH report a considerable amount of fatigue and cognitive impairment, indicating poor QOL with previous C5 inhibitor treatment. More research is needed to corroborate the findings of this first analysis. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Efficacy of a multiple-component and multifactorial personalized fall prevention program in a mixed population of community-dwelling older adults with stroke, Parkinson's Disease, or frailty compared to usual care: The PRE.C.I.S.A. randomized controlled trial.

BackgroundFall risk in the elderly is a major public health issue due to the injury-related consequences and the risk of associated long-term disability. However, delivering preventive interventions in usual clinical practice still represents a challenge.AimTo evaluate the efficacy of a multiple-component combined with a multifactorial personalized intervention in reducing fall rates in a mixed population of community-dwelling elderly compared to usual care.DesignRandomized Controlled Trial (NCT03592420, clinicalTrials.gov).SettingOutpatients in two Italian centers.Population403 community-dwelling elderly at moderate-to-high fall risk, including subjects with Parkinson's Disease and stroke.MethodsAfter the randomization, the described interventions were administered to the intervention group (n = 203). The control group (n = 200) received usual care and recommendations to minimize fall risk factors. In addition, each participant received a fall diary, followed by 12 monthly phone calls. The primary endpoint was the total number of falls in each group over 12 months, while the secondary endpoints were other fall-related indicators recorded at one year. In addition, participants' functioning was assessed at baseline (T1) and 3-month (T3).Results690 falls were reported at 12 months, 48.8% in the intervention and 51.2% in the control group, with 1.66 (± 3.5) and 1.77 (± 3.2) mean falls per subject, respectively. Subjects with ≥ 1 fall and ≥2 falls were, respectively, 236 (58.6%) and 148 (36.7%). No statistically significant differences were observed between groups regarding the number of falls, the falling probability, and the time to the first fall. According to the subgroup analysis, no significant differences were reported. However, a statistically significant difference was found for the Mini-BESTest (p = 0.004) and the Fullerton Advanced Balance Scale (p = 0.006) for the intervention group, with a small effect size (Cohen's d 0.26 and 0.32, respectively), at T1 and T3 evaluations.ConclusionsThe intervention was ineffective in reducing the number of falls, the falling probability, and the time to the first fall at 12 months in a mixed population of community-dwelling elderly. A significant improvement for two balance indicators was recorded in the intervention group. Future studies are needed to explore different effects of the proposed interventions to reduce falls and consequences.

The relationship between physical activity intensity and volume on prospective falls in older adults

Obesity remains one of the leading risk factors for aging and age-related diseases such as Alzheimer’s and type II diabetes, and effects 40% of the US population. The occurrence of obesity has been closely tied to an increase in sugar consumption with chronic hyperglycemia enhancing glycolysis. One of the byproducts of glycolysis is methylglyoxal (MGO), a reactive precursor for advanced glycation end-products (AGEs), which drives type II diabetes and its complications. We hypothesize that an MGO-derived AGE, MG-H1, affects hypothalamic regulation of food consumption and metabolism parallel to the leptin pathway in mice fed a high carbohydrate diet. Exogenous supplementation of MG-H1 increased food consumption rates and weight gain. Conversely, glycation byproduct lowering compounds (GLY-LOW), a customized chemical cocktail that blocks the production of MGO, rescued over-feeding phenotypes in wild-type mice. Furthermore, GLY-LOW treatment in a leptin receptor deficient mouse model rescued weight gain, diabetic phenotypes and lifespan. RNA sequencing of the hypothalamus of leptin receptor deficient mice treated with GLY-LOW showed significant downregulation of Rax, a gene responsible for tanycyte differentiation, and several genes involved in feeding and aging. We propose that specific cells in the hypothalamus both make and respond to MG-H1. We will also discuss evidence for the potential of GLY-LOW as a new class of therapeutics that reduce the effects of glycation to reduce food intake and slow aging.

Results of a Multicenter Diagnostic Stewardship Collaborative to Optimize Blood Culture Use in Critically Ill Children

Group Name: Bright STAR Authorship GroupBackground: Blood cultures are fundamental in the diagnosis and treatment of sepsis. Culture practices vary widely, and overuse can lead to false-positive results and unnecessary antibiotics. Our objective was to describe the implementation of a multisite quality improvement collaborative to reduce unnecessary blood cultures in pediatric intensive care unit (PICU) patients, and its 18-month impact on blood culture rates and safety metrics. Methods: In 2018, 14 PICUs joined the Blood Culture Improvement Guidelines and Diagnostic Stewardship for Antibiotic Reduction in Critically Ill Children (Bright STAR) Collaborative, designed to understand and improve blood culture practices in critically ill children. Guided by a centralized multidisciplinary study team, sites first reviewed existing evidence for safe reduction of unnecessary blood cultures and assessed local practices and barriers to change. Subsequently, local champions developed and implemented clinical decision-support tools informed by local patient needs to guide new blood-culture practices. The coordinating study team facilitated regular evaluations and discussions of project progress through monthly phone calls, site visits if requested by sites or the study team, and collaborative-wide teleconferences. The study team collected monthly blood culture rates and monitored for possible delays in obtaining blood cultures using a standardized review process as a safety balancing metric. We compared 24 months of baseline data to 18 months of postimplementation using a Poisson regression model accounting for the site-specific patient days and correlation of culture use within a site over time. Results: Across the 14 sites, before implementation, 41,768 blood cultures were collected over 259,701 PICU patient days. The mean preimplementation site-specific blood culture rate was 15.7 cultures per 100 patient days (rate range, 9.6–48.2 cultures per 100 patient days). After implementation, 22,397 blood cultures were collected over 208,171 PICU patient days. The mean postimplementation rate was 10.4 cultures per 100 patient days (rate range, 4.7–28.3 cultures per 100 patient days), which was 33.6% lower than the preimplementation (relative rate 0.66; 95% CI, 0.65–0.68 p <0.01). In 18 months post-implementation, sites reviewed 793 positive blood cultures, and identified only one suspected delay in culture collection possibly attributable to the site’s blood culture reduction program. Conclusions: Multidisciplinary quality improvement teams safely facilitated a 33.6% average reduction in blood culture use in critically ill children at 14 hospitals. Future collaborative work will determine the impact of blood culture diagnostic stewardship on antibiotic use and other important patient safety outcomes.Funding: NoDisclosures: None

Comprehensive geriatric assessment and management for Canadian elders with Cancer: The 5C study.

12011 Background: Comprehensive Geriatric Assessment (CGA) is recommended by ASCO for older adults with cancer undergoing chemotherapy to identify issues that can interfere with treatment delivery and optimize functional status and quality of life. However, few randomized controlled trials have been completed so far. Our objective is to evaluate the effectiveness of CGA on improving quality of life for older adults receiving cancer treatment. Methods: Eligible patients were aged 70+, diagnosed with a solid tumour, lymphoma or myeloma, referred for first/second line chemotherapy, speaking English/French, and with an Eastern Collaborative Oncology Group Performance Status 0–2. The CGA was done by a nurse and geriatrician followed by monthly phone calls by the study nurse for 6 months. Patients were randomly assigned (1:1) to receive either the intervention (CGA plus follow-up by geriatric trained team in addition to usual oncology care) or usual care alone. All participants received a monthly healthy aging booklet for attention control. Randomization was stratified by center and treatment intent (curative/adjuvant versus palliative). Our primary outcome was health-related quality of life (HRQOL) assessed with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 global health scale (items 29 and 30). Secondary outcomes include functional status (Instrumental Activities of Daily Living). Outcome data collection was completed monthly for the first 6 months, then at 9 and 12 months. For the primary outcome we used a pattern mixture model using an intent-to-treat approach (at 0, 3, and 6 months). The last data collection took place March 8 2021. Results: From May 2017 to March 2020, 351 participants from 8 hospitals across Canada were enrolled. All patients were seen on or after day 1 of treatment for the intervention per patient request. Patient characteristics at baseline were similar in both arms. The average age was 75.7 (SD = 4.8), 60.4% was male and 54.3% had treatment with palliative intent. Change in HRQOL scores did not differ by arm (p =.80). Neither group exceeded the MCID of 10 points. There was also no difference in IADL between the groups (p = 0.82). Conclusion: CGA was not effective in improving quality of life for older adults receiving cancer treatment in this study. CGA may need to be performed prior to treatment initiation to achieve benefits. Clinical trial information: NCT03154671.

Abstract 15644: Proinflammatory Diet Independently Predicts Shorter Event-free Survival in Patients With Heart Failure

Introduction: Inflammation is a common biological process accompanying chronic conditions, such as heart failure (HF) that can be moderated by diet. The association between foods thought to promote inflammation and event-free survival in patients with HF has not been investigated. Hypothesis: The inflammatory potential of individuals’ diets, measured using the dietary inflammatory index (DII), will be associated with event-free survival in patients with HF. Methods: The DII scores were calculated from 4-day food diaries recorded at baseline by 213 patients with HF (age 61±12years, 35% female, 43% NYHA III/IV). Patients were followed for a median of 365 days by monthly phone calls, medical record review, and death records to determine time to all cause-hospitalization or death. The DII scores were dichotomized using median value for the Cox regression model. Hierarchical multivariate Cox proportional hazards model was used to determine whether DII scores predicted event-free survival after controlling for age, gender, body mass index, prescribed angiotensin-converting-enzyme inhibitor, beta-blocker, cholesterol lowering agent, antiinflammatory agent, N-terminal pro B-type natriuretic peptide, comorbidity, depressive symptoms, and the New York Heart Association functional classification. Results: The DII scores independently predicted event-free survival in the model constant ( p = 0.012). Higher DII scores were associated with more than double the risk of an event compared to lower DII scores (HR: 2.28, 95% Confidence Interval =1.21-4.36). Conclusions: Greater intake of foods considered to promote inflammation was associated with shorter event-free survival in patients with HF. These results provide further evidence of the importance of diet to HF outcomes.

Efficacy of motivational-interviewing and guided opioid tapering support for patients undergoing orthopedic surgery (MI-Opioid Taper): A prospective, assessor-blind, randomized controlled pilot trial.

BackgroundPostoperative opioid use can lead to chronic use and misuse. Few studies have examined effective approaches to taper postoperative opioid use while maintaining adequate analgesia.MethodsThis randomized, assessor-blinded, pilot trial of postoperative motivational interviewing and guided opioid tapering support (MI-Opioid Taper) added to usual care (UC) enrolled patients undergoing total hip or knee arthroplasty at a single U.S. academic medical center. MI-Opioid Taper involved weekly (to seven weeks) and monthly (to one year) phone calls until patient-reported opioid cessation. Opioid tapering involved 25% weekly dose reductions. The primary feasibility outcome was study completion in the group to which participants were randomized. The primary efficacy outcome, time to baseline opioid use, was the first of five consecutive days of return to baseline preoperative dose. Intention-to-treat analysis with Cox proportional hazards regression was adjusted for operation. ClinicalTrials.gov registration: NCT02070003.FindingsFrom November 26, 2014, to April 27, 2018, 209 patients were screened, and 104 patients were assigned to receive MI-Opioid Taper (49 patients) or UC only (55 patients). Study completion after randomization was similar between groups (96.4%, 53 patients receiving UC, 91.8%, 45 patients receiving MI-Opioid Taper). Patients receiving MI-Opioid Taper had a 62% increase in the rate of return to baseline opioid use after surgery (HR 1.62; 95%CI 1.06–2.46; p = 0•03). No trial-related adverse events occurred.InterpretationIn patients undergoing total joint arthroplasty, MI-Opioid Taper is feasible and future research is needed to establish the efficacy of MI-Opioid Taper to promote postoperative opioid cessation.FundingNational Institute on Drug Abuse

Telemedicine for Disparity Patients With Diabetes: The Feasibility of Utilizing Telehealth in the Management of Uncontrolled Type 2 Diabetes in Black and Hispanic Disparity Patients; A Pilot Study.

Non-Hispanic Black (NHB) and Hispanic/Latinx (H/L) patients bear a disproportionate burden of type 2 diabetes and associated complications. Regular visits to a primary care doctor or diabetes specialist are warranted to maintain glycemic control, but for a myriad of reasons disparity populations may have difficulties receiving diabetes care. We seek to determine the feasibility of telehealth added to care as usual and secondarily to improve health outcomes (hemoglobin A1c [HbA1c]) in NHB and H/L with uncontrolled type 2 diabetes managed with two or three noninsulin agents. Twenty-nine patients were randomized to monthly phone calls or weekly to biweekly telehealth visits. Feasibility outcomes were summarized descriptively for the telehealth arm. Differences scores for A1C level and surveys were computed between baseline and three months and compared across arms using a two-sample t test or Mann-Whitney U test. Patients in the telehealth arm completed a median of eight visits (IQR: 5, 8), and 53% of those in the telephone arm completed 100% of their calls. Change in HbA1c was greater for those in the telephone arm (-2.57 vs -2.07%, P = .70) but the mean baseline HbA1c was higher in the telephone group (11.1% vs 10.3%). Although the change in HbA1c was not statistically different across arms, it was clinically significant. Augmenting care as usual with telehealth provided by telephone or tablet can be of benefit in improving glycemic control in NHB and H/L with type 2 diabetes. Larger studies need to explore this further.

The transition from acute to persistent pain: the identification of distinct trajectories among women presenting to an emergency department.

Posttraumatic stress disorder (PTSD) symptoms and other negative psychosocial factors have been implicated in the transition from acute to persistent pain. Women (N = 375) who presented to an inner-city emergency department (ED) with complaints of acute pain were followed up for 3 months. They completed a comprehensive battery of questionnaires at an initial visit and provided ratings of pain intensity at the site of pain presented in the ED during 3 monthly phone calls. Latent class growth analyses were used to detect possible trajectories of change in pain intensity from the initial visit to 3 months later. A 3-trajectory solution was found, which identified 3 groups of participants. One group (early recovery; n = 93) had recovered to virtually no pain by the initial visit, whereas a second group (delayed recovery; n = 120) recovered to no pain only after 1 month. A third group (no recovery; n = 162) still reported elevated pain at 3 months after the ED visit. The no recovery group reported significantly greater PTSD symptoms, anger, sleep disturbance, and lower social support at the initial visit than both the early recovery and delayed recovery groups. Results suggest that women with high levels of PTSD symptoms, anger, sleep disturbance, and low social support who experience an acute pain episode serious enough to prompt an ED visit may maintain elevated pain at this pain site for at least 3 months. Such an array of factors may place women at an increased risk of developing persistent pain following acute pain.

Describing the resource utilisation and costs associated withvertebral fractures: the Build Better Bones with Exercise (B3E) Pilot Trial

This exploratory economic analysis examined the health resource utilisation and costs experienced by women with vertebral fractures, and explored the effects of home exercise on those costs. Women ≥ 65years with one or more X-ray-confirmed vertebral fractures were randomised 1:1 to a 12-month home exercise programme or equal attention control group. Clinical and health system resources were collected during monthly phone calls and daily diaries completed by participants. Intervention costs were included. Unit costs were applied to health system resources. Quality of life (QoL) information was collected via EQ-5D-5L at baseline, 6 and 12months. One hundred and forty-one women were randomised. Overall total costs(CAD 2018) were $664,923 (intervention) and $614,033 (control), respectively. The top three cost drivers were caregiver time ($250,269 and $240,811), medications ($151,000 and $122,145) and AEs ($58,807 and $71,981). The mean cost per intervention participant of $9365 ± $9988 was higher compared with the mean cost per control participant of $8772 ± $9718. The mean EQ-5D index score was higher for the intervention participants (0.81 ± 0.11) compared with that of controls (0.79 ± 0.13). The differences in quality-adjusted life year (QALY) (0.02) and mean cost ($593) were used to calculate the ICER of $29,650. Women with osteoporosis with a previous fracture experience a number of resources and associated costs that impact their care and quality of life. Caregiver time, medications and AEs are the biggest cost drivers for this population. The next steps would be to expand this feasibility study with more participants, longer-term follow-up and more regional variability.

Potential long-term impact of \u201cOn The Move\u201d group-exercise program on falls and healthcare utilization in older adults: an exploratory analysis of a randomized controlled trial

BackgroundWellness program participation may reduce the risk of falling, emergency department-use, and hospitalization among older adults. “On the Move” (OTM), a community-based group exercise program focused on the timing and coordination of walking, improved mobility in older adults, but its impact on falls, emergency department-use, and hospitalizations remains unclear. The aim of this preliminary study was to investigate the potential long-term effects that OTM may have on downstream, tertiary outcomes.MethodsWe conducted a secondary analysis of a cluster-randomized, single-blind intervention trial, which compared two community-based, group exercise programs: OTM and a seated exercise program on strength, endurance, and flexibility (i.e. ‘usual-care’). Program classes met for 50 min/session, 2 sessions/week, for 12 weeks. Older adults (≥65 years), with the ability to ambulate independently at ≥0.60 m/s were recruited. Self-reported incidence of falls, emergency department visitation, and hospitalization were assessed using automated monthly phone calls for the year following intervention completion. Participants with ≥1 completed phone call were included in the analyses. Incidence rate ratios (IRRs) and 95% confidence intervals (CIs) were calculated (reference = usual-care).ResultsParticipants (n = 248) were similar on baseline characteristics and number of monthly phone calls completed. Participants in the seated exercise program attended an average of 2.9 more classes (p = .017). Of note, all results were not statistically significant (i.e. 95% CI overlapped a null value of 1.0). However, point estimates suggest OTM participation resulted in a decreased incidence rate of hospitalization compared to usual-care (IRR = 0.88; 95% CI = 0.59–1.32), and the estimates strengthened when controlling for between-group differences in attendance (adjusted IRR = 0.82; 95% CI = 0.56–1.21). Falls and emergency department visit incidence rates were initially greater for OTM participants, but decreased after controlling for attendance (adjusted IRR = 1.08; 95% CI = 0.72–1.62 and adjusted IRR = 0.96; 95% CI = 0.55–1.66, respectively).ConclusionCompared to a community-based seated group exercise program, participation in OTM may result in a reduced risk of hospitalization. When OTM is adhered to, the risk for falling and hospitalizations are attenuated. However, definitive conclusions cannot be made. Nevertheless, it appears that a larger randomized trial, designed to specifically evaluate the impact of OTM on these downstream health outcomes is warranted.Trial registrationClinical trials.gov (NCT01986647; prospectively registered on November 18, 2013).

What types of dissemination of information occurred between researchers, providers and clinical staff while implementing an asthma shared decision-making intervention: a directed content analysis

ObjectiveTo qualitatively analyse different types of dissemination of information during monthly group calls between researchers, providers and clinical staff used to establish best practices for implementing an asthma shared decision-making...

Abstract TP132: Intensive Medical Management and Life-Style Modifications Can Be Successfully Applied in Combination With Indirect Surgical Revascularization for Symptomatic Intracranial Atherosclerotic Disease

Introduction: We present the results of using the strict model of intensive medical management (IMM) and life-style modification of SAMMPRIS in a phase 2 study of EDAS revascularization in patients with symptomatic intracranial atherosclerosis (ERSIAS). Methods: ERSIAS was a mid-development, single surgical arm trial that enrolled patients closely matched to those recruited in SAMMPRIS with the exception of including also individuals with occlusions of the intracranial arteries. In addition to surgery, primary and secondary risk factors were strictly managed and a life-style modification program with monthly phone calls to encourage adherence to medication, diet, physical activity, and smoking cessation was applied. Every 3 months, patients were clinically evaluated and data of adherence to medical regimen was collected. Results: As previously reported, the rate of recurrent stroke in ERSIAS at one year was 7.7%. ERSIAS required patients to have ceased smoking for at least 6 months before enrollment. Of the 52 patients enrolled only 5 had a relapse in their smoking habit (9.6%). At the end of the study four stopped smoking, representing a failure on smoking control of only 2%. Patient’s engagement in vigorous physical activity increased from 43% at baseline to 84% at follow-up (p=0.03). Median LDL values at baseline, 6 months, and 12 months were 83.9 (IQR 65.2), 70.9 (IQR 38.8), and 77 (IQR 78.25), respectively. At an individual level 75.6% of patients had improvement in LDL control. The SBP goal (<160mmHg) was achieved in 91% of patients, and a reduction of SBP was observed in 65.9% at either 6 or 12 months. Median HbA1c values in diabetic (DM2) patients were 6.3% (QR 2.5) at baseline, 5.1% (IQR 2.5) at 6 months, and 5.9% (IQR 2.8) at 12 months, accounting for an improvement in 60% of patients at either 6 or 12 months. Conclusion: A dedicated follow-up program optimized medical adherence and results in ERSIAS. The surgery did not affect the ability of patients to engage in exercise or adhere to medical management. The IMM model of SAMMPRIS was successfully applied in this surgical trial. Strict observance of the improvements in medical management should be integrated in future interventional studies for ICAD.

1851 The Ever-Mysterious Cyclical Vomiting Syndrome (CVS) and Abdominal Migraine: Recognition and Successful Management Strategies Illustrated by a Case Report

INTRODUCTION: Cyclical vomiting syndrome (CVS) is a medically and socially disabling, idiopathic disorder characterized by recurrent, stereotypical bouts of vomiting with periods of normal health, occurring in children, adolescents, and recognized in adults. CVS is associated with substantial morbidity. Lack of awareness and recognition leads to tremendous anxiety, cost burden, and delay in diagnosis. Recently updated, Rome IV classification has attempted to highlight the issue to promote early recognition and diagnosis. We present a case of CVS and abdominal migraine in a 27-year-old female whose illness went unrecognized for 8 years and discuss successful management strategies. CASE DESCRIPTION/METHODS: A 27-year-old female with an 8-year history of recurrent episodic abdominal pains, nausea, vomiting, incidental superior mesenteric artery syndrome, status post laparoscopic duodenojejunostomy at 24, after which she had an apparent 6-month relief of symptoms, and history of anxiety and depression was seen for persistent diffuse abdominal pain, nausea, and 7-8 daily episodes of emesis for 3 weeks. Family history was significant for migraines in her mother. Since her initial symptoms at the age of 19, she experienced episodes of incapacitating nausea, vomiting, and abdominal pain lasting 3-4 weeks followed by symptom-free periods of 2-3 months. She had visited many hospitals, primary care physicians, psychiatrists, and gastroenterologists, and undergone repeated work-ups from basic to complex. Treatment with SSIRs, anti-emetics, valproic acid and even marijuana showed no or minimal benefit. Following thorough history and obtainment of records from other institutions, she was diagnosis and started on a combination of amitriptyline, propranolol, and Co-enzyme Q/L-Carnitine. She has been followed by monthly phone calls for about 1-year, remains symptom-free, and compliant with the regimen. DISCUSSION: Cyclic vomiting syndrome (CVS) is characterized by recurrent bouts of nausea and vomiting with periods of normal health. The pathogenesis is multifactorial, with multiple genetic, autonomic, and environmental factors. Often a great delay in diagnosis, on average 2.6 years in children and 8 years in adults leads to unnecessary testing and cumbersome procedures. In the case of our patient, her illness was unrecognized for many years and her symptoms often dismissed, pushing her into anxiety and depression. A multidisciplinary approach as well as prophylactic and abortive pharmacotherapy is needed to address the issue.

Incidence and associated risk factors for falls in adults with intellectual disability.

People with intellectual disability (ID) experience age-related changes earlier in life, and as such, falls among people with ID are of serious concern. Falls can cause injury and consequently reduce quality of life. Limited studies have investigated the incidence of falls among people with ID and the associated risk factors. The purpose of this study was to investigate the incidence of falls and risk factors for falling in people with ID living in the community. A prospective observational cohort (n=78) of community-dwelling adults with ID. Characteristics measured at baseline included falls history, medication use, balance and mobility. Falls were reported for 6months using monthly calendars and phone calls. Data were analysed using univariate and multivariate logistic regression to identify risk factors associated with falling. Participants [median (interquartile range) age 49 (43-60) years, female n=32 (41%)] experienced 296 falls, with 36 (46.2%) participants having one or more falls. The incidence of falls was 5.7 falls (injurious falls=0.8) per person year (one outlier removed from analysis). A history of falls [adjusted odds ratio (OR): 6.37, 95% confidence interval (CI) (1.90-21.34)] and being ambulant [adjusted OR: 4.50, 95% CI (1.15-17.67)] were associated with a significantly increased risk of falling. Falls were significantly less frequent among participants taking more than four medications [adjusted OR: 0.22, 95% CI (0.06-0.83)] and participants who were continent [adjusted OR: 0.25, 95% CI (0.07-0.91)]. People with ID fall at a younger age compared with the broader community. The associated falls risk factors also differ to older community-dwelling adults. Health professionals should prioritise assessment and management of falls risk in this population.

Long-term tolerability, safety and efficacy of rituximab in neuromyelitis optica spectrum disorder: a prospective study.

Neuromyelitis optica spectrum disorder (NMOSD) is a B-cell-mediated disease with autoimmunity towards the astrocyte water channel aquaporin-4 (AQP-4) in the central nervous system. To assess the long-term safety and efficacy in NMOSD patients receiving maintenance therapy with B-cell-depleting agent rituximab for more than 2years. NMOSD patients were included prospectively from 2014 to 2018 and received continuous cycles of rituximab infusions biannually. Incidence of adverse events (AE), serious AEs (SAE), and infusion-related AEs were evaluated through monthly phone calls and neurological examination every 4 months. A total of 44 NMOSD patients were included, of those 30 were treatment naive (68%). The mean age was 37.2years with 79.5% females. With overall observation period of 31.6 ± 7.3months (24-48months), tolerability was assessed as satisfactory in most cases. We observed infusion reactions (mostly mild) in 31.8% of patients and 31.8% never experienced any AEs after a mean 5.1 cycles of rituximab therapy. Rituximab was also beneficial in terms of improvement in relapse rate (from 0.26 ± 0.54 to 0, P = 0.003) and Expanded Disability Status Scale (from 4.1 ± 1.8 to 3.1 ± 1.8, P < 0.001). Stratification according to AQP4-IgG serostatus showed no difference between groups. Rituximab treatment is well tolerated, safe, and efficacious with a minor risk of mild infusion reactions for NMOSD patients.

Build better bones with exercise (B3E pilot trial): results of a feasibility study of a multicenter randomized controlled trial of 12months of home exercise in older women with vertebral fracture.

Osteoporotic fragility fractures create a substantial human and economic burden. There have been calls for a large randomized controlled trial examining the effect of exercise on fracture incidence. The B3E pilot trial was designed to evaluate the feasibility of a large trial examining the effects of home exercise on individuals at high risk of fracture. Community-dwelling women ≥ 65years with radiographically confirmed vertebral compression fractures were recruited at seven sites in Canada and Australia. We randomized participants in a 1:1 ratio to a 12-month home exercise program or equal attention control group, both delivered by a physiotherapist (PT). Participants received six PT home visits in addition to monthly phone calls from the PT and a blinded research assistant. The primary feasibility outcomes of the study were recruitment rate (20 per site in 1year), retention rate (75% completion), and intervention adherence rate (60% of weeks meeting exercise goals). Secondary outcomes included falls, fractures and adverse events. One hundred forty-one participants were recruited; an average of 20 per site, though most sites took longer than anticipated. Retention and adherence met the criteria for success: 92% of participants completed the study; average adherence was 66%. The intervention group did not differ significantly in the number of falls (IRR 0.97, 95% CI 0.58 to 1.63)or fragilityfractures (OR 1.11, 95% CI 0.60 to 2.05) compared to the control group. There were 18 serious adverse events in the intervention group and 12 in the control group. An RCT of home exercise in women with vertebral fractures is feasible butrecruitment was a challenge. Suggestions are made for the conduct of future trials.