scholarly journals P220 Patient-entered symptoms scores collected using a new IBD patient portal correlate closely with clinical assessment and can optimise delivery of IBD care

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S274-S275
Author(s):  
S Carlson ◽  
P Harrow ◽  
S McCartney
Keyword(s):  
Disease Activity ◽  
Severe Disease ◽  
Healthcare Delivery ◽  
Clinic Visit ◽  
Clinical Impression ◽  
Patient Portal ◽  
Face To Face ◽  
Patient Reported ◽  
Symptom Scores

Abstract Background Patient healthcare portals can empower IBD patients by allowing access to their electronic health record and provide opportunities for active participation in their care. We built 3 patient-entered symptom questionnaires in EPIC MyChart using existing validated IBD symptom scores (HBI, SCCAI, IBD Control). Patients were invited to complete these prior to clinic using the MyChart patient portal. In this study we examine the feasibility and accuracy of patient entered scores compared to the physician’s impression of disease activity and the potential impact on healthcare delivery. Methods Between September 2020 and January 2021 consecutive patients were invited to complete 2 questionnaires reporting disease activity on the EPIC MyChart portal using the IBD Control (Bodger et al. 2014) and either HBI or SCCAI (for Crohn’s disease and UC respectively). Only patients who completed these scores were included in this study. A retrospective review of the notes was completed to determine the physician’s impression of disease activity and actions taken by the physician in the outpatient clinic. Results 107 patients with Crohn’s and 80 with UC were included in the study. 60% of CD and 56% of UC patients were in remission by HBI (<5) or SCCAI (<3). Patient reported disease activity correlated well with clinical impression of disease activity. 88% of CD patients and 98% of UC patients in HBI or SCCAI remission were also deemed to be in remission on physician’s clinical impression (r= 0.54, p <0.001 and r= 0.74, p <0.001). Both CD and UC had lower rates of remission by IBD Control (49% and 53%). This score also captures fatigue and mood. Furthermore, the IBD Control identified a specific question to be addressed at the upcoming clinic visit for 76% of patients with CD and 64% with UC. Importantly, 24% of all UC patients (n=19) in remission by SCCAI and IBD Control, had no questions they wanted addressed, and all of these patients had no further actions triggered by clinic attendance. Conversely in the 18% patients with moderate to severe disease by HBI or SCCAI, 50% required a blood test or calprotectin prior to further clinical decisions. Conclusion Patient-entered symptom scores correlate closely with physician’s impression of disease activity and patients are able to accurately record these using the EPIC MyChart portal. Importantly, it is possible to identify a cohort of patients who are well, where there are opportunities to optimise follow-up, and conversely a group of patients with active disease where key investigations can be arranged prior to clinical review to prevent delays in treatment. These patients can also be prioritised for face-to-face clinics, at a time when reducing social contacts is imperative.

scholarly journals AB0369 EFFICACY AND SAFETY OF RITUXIMAB ORIGINATOR AND BIOSIMILAR IN PRIMARY SJÖGREN’S SYNDROME IN A REAL-LIFE SETTING

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1485.3-1485
Author(s):  
F. Carubbi ◽  
A. Alunno ◽  
P. Cipriani ◽  
V. Pavlych ◽  
C. DI Muzio ◽  
...  
Keyword(s):  
Disease Activity ◽  
Real Life ◽  
Primary Sjögren’S Syndrome ◽  
Efficacy And Safety ◽  
Research Support ◽  
Treatment Groups ◽  
Real Life Setting ◽  
Patient Reported ◽  
Time Point

Background:Over the last 2 decades rituximab (RTX) has been widely used, albeit off-label, in primary Sjögren’s syndrome (pSS). Several studies reported that B-lymphocyte depletion with RTX is effective in this disease not only by reducing disease activity but also by affecting the inflammation and the lymphoid organization that occur in target tissues. With the recent release of several RTX biosimilars (bRTX) on the market, the demonstration of their interchangeability with RTX originator (oRTX) is required.Objectives:To compare efficacy and safety of oRTX and bRTX in pSS patients in a real-life setting.Methods:Clinical records of pSS patients referring to a tertiary rheumatology clinic were retrospectively evaluated. Patients having received at least 2 courses of either oRTX or bRTX (1000 mg IV infusion, repeated after 2 weeks -1 course- and the course repeated after 24 weeks) with complete data at baseline and after 3, 6, 9 and 12 months of treatment were enrolled. Disease activity was assessed with the EULAR SS disease activity index (ESSDAI) and its clinical version without the biological domain (ClinESSDAI). Patient-reported symptoms were assessed with the EULAR SS Patient Reported Index (ESSPRI).Results:Seven patients that received oRTX and 7 patients that received bRTX were enrolled. Baseline clinical features, including ESSDAI and ESSPRI were similar in the 2 treatment groups. Both compounds significantly reduced ESSDAI and ESSPRI as early as 3 months and no difference between the groups was observed at any time point (Figure 1). Of interest, ESSDAI slowly decreased until month 6 when the most pronounced reduction was observed. Conversely, ESSPRI dropped to its lowest values already at month 3. With regard to safety, at 12 months of follow-up no adverse event was observed in any of the treatment groups.Conclusion:At 12 months of follow-up, oRTX and bRTX display similar efficacy and safety profiles. The improvement of patient reported outcomes is faster than the improvement of disease activity with both compounds. Our data support interchangeability of oRTX and bRTX in pSS.References:[1]Carubbi F et al. Arthritis Res Ther. 2013;15(5):R172[2]Carubbi F et al. Lupus. 2014;23(13):1337-49Figure 1 ESSDAI and ESSPRI values at every time point in the 2 treatment groups. Asterisks indicate p values <0.05 compared to the other treatment group at the same time pointDisclosure of Interests:Francesco Carubbi Speakers bureau: Francesco Carubbi received speaker honoraria from Abbvie and Celgene outside this work., Alessia Alunno: None declared, Paola Cipriani Grant/research support from: Actelion, Pfizer, Speakers bureau: Actelion, Pfizer, Viktoriya Pavlych: None declared, claudia di muzio: None declared, Roberto Gerli: None declared, Roberto Giacomelli Grant/research support from: Actelion, Pfizer, Speakers bureau: Abbvie, Roche, Actelion, BMS, MSD, Ely Lilly, SOBI, Pfizer

scholarly journals AB0330 HIGH REMISSION RATES IN RA – REAL LIFE DATA FROM BARITICINIB

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1463.2-1464
Author(s):  
S. Bayat ◽  
K. Tascilar ◽  
V. Kaufmann ◽  
A. Kleyer ◽  
D. Simon ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Cox Regression ◽  
Real Life ◽  
Inadequate Response ◽  
Research Support ◽  
Das 28 ◽  
Patient Reported ◽  
One Year

Background:Recent developments of targeted treatments such as targeted synthetic DMARDs (tsDMARDs) increase the chances of a sustained low disease activity (LDA) or remission state for patients suffering rheumatoid arthritis (RA). tsDMARDs such as baricitinib, an oral inhibitor of the Janus Kinases (JAK1/JAK2) was recently approved for the treatment of RA with an inadequate response to conventional (cDMARD) and biological (bDMARD) therapy. (1, 2).Objectives:Aim of this study is to analyze the effect of baricitinb on disease activity (DAS28, LDA) in patients with RA in real life, to analyze drug persistance and associate these effects with various baseline characteristics.Methods:All RA patients were seen in our outpatient clinic. If a patient was switched to a baricitinib due to medical reasons, these patients were included in our prospective, observational study which started in April 2017. Clinical scores (SJC/TJC 76/78), composite scores (DAS28), PROs (HAQ-DI; RAID; FACIT), safety parameters (not reported in this abstract) as well as laboratory biomarkers were collected at each visit every three months. Linear mixed effects models for repeated measurements were used to analyze the time course of disease activity, patient reported outcomes and laboratory results. We estimated the probabilities of continued baricitinib treatment and the probabilities of LDA and remission by DAS-28 as well as Boolean remission up to one year using survival analysis and explored their association with disease characteristics using multivariable Cox regression. All patients gave informed consent. The study is approved by the local ethics.Results:95 patients were included and 85 analyzed with available follow-up data until November 2019. Demographics are shown in table 1. Mean follow-up duration after starting baricitinib was 49.3 (28.9) weeks. 51 patients (60%) were on monotherapy. Baricitinib survival (95%CI) was 82% (73% to 91%) at one year. Cumulative number (%probability, 95%CI) of patients that attained DAS-28 LDA at least once up to one year was 67 (92%, 80% to 97%) and the number of patients attaining DAS-28 and Boolean remission were 31 (50%, 34% to 61%) and 12(20%, 9% to 30%) respectively. Median time to DAS-28 LDA was 16 weeks (Figure 1). Cox regression analyses did not show any sufficiently precise association of remission or LDA with age, gender, seropositivity, disease duration, concomitant DMARD use and number of previous bDMARDs. Increasing number of previous bDMARDs was associated with poor baricitinib survival (HR=1.5, 95%CI 1.1 to 2.2) while this association was not robust to adjustment for baseline disease activity. Favorable changes were observed in tender and swollen joint counts, pain-VAS, patient and physician disease assessment scores, RAID, FACIT and the acute phase response.Conclusion:In this prospective observational study, we observed high rates of LDA and DAS-28 remission and significant improvements in disease activity and patient reported outcome measurements over time.References:[1]Keystone EC, Taylor PC, Drescher E, Schlichting DE, Beattie SD, Berclaz PY, et al. Safety and efficacy of baricitinib at 24 weeks in patients with rheumatoid arthritis who have had an inadequate response to methotrexate. Annals of the rheumatic diseases. 2015 Feb;74(2):333-40.[2]Genovese MC, Kremer J, Zamani O, Ludivico C, Krogulec M, Xie L, et al. Baricitinib in Patients with Refractory Rheumatoid Arthritis. The New England journal of medicine. 2016 Mar 31;374(13):1243-52.Figure 1.Cumulative probability of low disease activity or remission under treatment with baricitinib.Disclosure of Interests:Sara Bayat Speakers bureau: Novartis, Koray Tascilar: None declared, Veronica Kaufmann: None declared, Arnd Kleyer Consultant of: Lilly, Gilead, Novartis,Abbvie, Speakers bureau: Novartis, Lilly, David Simon Grant/research support from: Else Kröner-Memorial Scholarship, Novartis, Consultant of: Novartis, Lilly, Johannes Knitza Grant/research support from: Research Grant: Novartis, Fabian Hartmann: None declared, Susanne Adam: None declared, Axel Hueber Grant/research support from: Novartis, Lilly, Pfizer, EIT Health, EU-IMI, DFG, Universität Erlangen (EFI), Consultant of: Abbvie, BMS, Celgene, Gilead, GSK, Lilly, Novartis, Speakers bureau: GSK, Lilly, Novartis, Georg Schett Speakers bureau: AbbVie, BMS, Celgene, Janssen, Eli Lilly, Novartis, Roche and UCB

scholarly journals POS0942 THE NEGATIVE IMPACT OF UNDIAGNOSED DEPRESSION IN AXIAL SPONDYLOARTHROPARTHY: RESULTS OF A SCREENING STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 734.1-734
Author(s):  
S. Maguire ◽  
F. B. O’shea
Keyword(s):  
Disease Activity ◽  
Negative Impact ◽  
Depression Scale ◽  
Clinic Visit ◽  
Categorical Variables ◽  
P Value ◽  
Continuous Variables ◽  
Numerical Result ◽  
Co Morbidity ◽  
Patient Reported

Background:Previous research in axial spondyloarthropathy(axSpA) has shown this population to have a high prevalence of depression. This co-morbidity has been previously shown to impact disease activity in patients with rheumatic disease.Objectives:The purpose of this study was to screen for early signs of depression using two validated tools, the Patient Health Questionaire-9 (PHQ-9) and the Hospital Anxiety and Depression Scale for depression (HADs-D) in patients with known axSpA.Methods:AxSpA patients attending the Rheumatology department in St James’ Hospital between February and October 2020 were invited to take a self-administered survey which included the PHQ-9 and the HADs-D. Scores from the HADs-D yielded a numerical result which was then categorised as normal, borderline or abnormal. PHQ-9 numerical results were categorised as normal, mild, moderate, moderate/severe or severe. Patients with a known diagnosis of depression were excluded. In addition to baseline demographics, patient reported outcomes from the clinic visit were also recorded.Data analysis was performed using IBM SPSS version 26. Continuous variables were recorded as means, categorical variables as frequencies with percentages. A one-way analysis of variance analysis (ANOVA) was used to determine significance of variation in outcomes between patient outcomes as determined by the HADs-D and PHQ-9. A p-value of <0.05 was deemed significant. Consent was obtained prior to participation. Approval was received from the St James’/Tallaght Hospital Joint Ethics Committee.Results:In total 71 axSpA patients took part in the survey. The population was 70.4%(50) males and 29.5%(21) female, with an average age 47.9 years and mean disease duration 19.7 years (mean outcomes: BASDAI 4.08, BASFI 3.62, BASMI 3.54, ASQoL 6.79). Overall, 7 (9.9%) participants recorded abnormal HADs-D scores, while 17 (23.9%) recorded moderate to severe PHQ-9 scores indicative of underlying depression. AxSpA females had higher mean HADs-D scores (7.5 vs 4.8, p=0.01) than males, with abnormal scores in 19%(4) of females and 6% (3) of males. No significant differences were found in PHQ-9 scores between genders.Analysis revealed significantly worse BASDAI (6.27 vs 3.42, p<0.01) and AQoL scores (12.57 vs 5.26, p<0.01) in axSpA patients with abnormal compared to normal HADs-D scores. No significant differences were noted in BASFI, BASMI or baseline demographics. A similar pattern was noted on analysis of PHQ-9 scores, with significantly worse BASDAI (7.9 vs 2.55, p<0.01), BASFI (8.05 vs 2.33, p<0.01) and ASQoL (19.5 vs 2.62, p<0.01) noted in those scoring as severe compared to normal. No significant differences were detected in BASMI scores or baseline demographics.Conclusion:A high percentage of axSpA patients recorded high HADs-D and PHQ-9 scores concerning for undiagnosed depression. These patients were noted to have significantly worse disease activity and quality of life as compared to patients with normal scores. Clinicians treating axSpA should consider screening for depression in this population.Disclosure of Interests:Sinead Maguire Speakers bureau: Speaker fee from Jassen, Grant/research support from: Recipient of the Gilead Inflammation Fellowship Grant, Finbar Barry O’Shea: None declared

scholarly journals The Heart Failure Readmission Intervention by Variable Early Follow-up (THRIVE) Study

2020 ◽  
Vol 13 (10) ◽  
Author(s):  
Keane K. Lee ◽  
Rachel C. Thomas ◽  
Thida C. Tan ◽  
Thomas K. Leong ◽  
Anthony Steimle ◽  
...  
Keyword(s):  
Heart Failure ◽  
Primary Care Physicians ◽  
Care Delivery ◽  
Healthcare Delivery ◽  
Clinic Visit ◽  
Heart Failure Hospitalization ◽  
Healthcare Delivery System ◽  
Unique Identifier ◽  
Clinic Visits

Background: In-person clinic follow-up within 7 days after discharge from a heart failure hospitalization is associated with lower 30-day readmission. However, health systems and patients may find it difficult to complete an early postdischarge clinic visit, especially during the current pandemic. We evaluated the effect on 30-day readmission and death of follow-up within 7 days postdischarge guided by an initial structured nonphysician telephone visit compared with follow-up guided by an initial clinic visit with a physician. Methods and Results: We conducted a pragmatic randomized trial in a large integrated healthcare delivery system. Adults being discharged home after hospitalization for heart failure were randomly assigned to either an initial telephone visit with a nurse or pharmacist to guide follow-up or an initial in-person clinic appointment with primary care physicians providing usual care within the first 7 days postdischarge. Telephone appointments included a structured protocol enabling medication titration, laboratory ordering, and booking urgent clinic visits as needed under physician supervision. Outcomes included 30-day readmissions and death and frequency and type of completed follow-up within 7 days of discharge. Among 2091 participants (mean age 78 years, 44% women), there were no significant differences in 30-day heart failure readmission (8.6% telephone, 10.6% clinic, P =0.11), all-cause readmission (18.8% telephone, 20.6% clinic, P =0.30), and all-cause death (4.0% telephone, 4.6% clinic, P =0.49). Completed 7-day follow-up was higher in 1027 patients randomized to telephone follow-up (92%) compared with 1064 patients assigned to physician clinic follow-up (79%, P <0.001). Overall frequency of clinic visits during the first 7 days postdischarge was lower in participants assigned to nonphysician telephone guided follow-up (48%) compared with physician clinic-guided follow-up (77%, P <0.001). Conclusions: Early, structured telephone follow-up after hospitalization for heart failure can increase 7-day follow-up and reduce in-person visits with comparable 30-day clinical outcomes within an integrated care delivery framework. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03524534.

P121 REAL WORLD PREVALENCE OF BOWEL MOVEMENT URGENCY – A SNAPSHOT OF SYMPTOM EXPERIENCE REPORTED BY PATIENTS WITH ULCERATIVE COLITIS PARTICIPATING IN SPARC IBD

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S44-S45
Author(s):  
April Naegeli ◽  
Yan Dong ◽  
Xian Zhou ◽  
Nathan Morris ◽  
Vipin Arora ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Disease Activity ◽  
Real World ◽  
Ad Hoc ◽  
Bowel Movement ◽  
Severe Disease ◽  
Symptom Experience ◽  
Biologic Treatment ◽  
Patient Reported ◽  
Bowel Movements

Abstract Background Urgency, also referred to as bowel movement urgency or bowel urgency, is the sudden need for a bowel movement. Bowel urgency is one of the most bothersome and important symptoms experienced by patients with ulcerative colitis (UC), contributing to decrements in quality of life. Bowel urgency is distinct from the common symptoms associated with UC, namely stool frequency and rectal bleeding, however patients often experience all symptoms, urgent, frequent bowel movements with bleeding, concurrently. Bowel movement urgency is a key symptom for triggering clinical consideration of UC diagnosis and for defining more severe disease activity in clinical practice. Methods The results published here are based on data obtained from the IBD Plexus program of the Crohn’s & Colitis Foundation. To better understand the prevalence of bowel movement urgency in patients with UC, an ad hoc analysis was performed using data from a Study of a Prospective Adult Research Cohort with IBD (SPARC IBD), a multicenter longitudinal study of adult patients with IBD that collects and links clinical data, patient-reported outcome (PRO) data, and serial bio-samples throughout the course of the patients’ disease. The enrollment visit was defined as 7 days from the patients’ date of enrollment in SPARC IBD. At study enrollment, patients were asked to answer questions based on their symptom experiences. Patients reported how much urgency they experienced before bowel movements on average during the past 3 days (none, mild, moderate, moderately severe, severe, not applicable). Descriptive analyses for patient demographic and disease characteristics were conducted. Additionally, contingency table analyses were conducted exploring the association of urgency with other UC symptoms and other measures of UC disease severity. Results Of 1,833 patients included in the SPARC IBD data cutoff of May 13, 2019 (Enrolled from 08 November 2016 to 15 May 2019), 582 were patients with UC, of which 514 had urgency data available. Overall, 51.8% of patients were male, and the mean age is 42.4 years (Table 1). At enrollment, 59.7% of patients reported some level (mild, moderate, moderately severe/severe) of urgency. Forty-six percent of UC patients with urgency data were receiving biologic treatment with 31% still reporting mild urgency, and 32% reporting moderate to severe urgency (Table 1). The severity of urgency was associated with patient reported severity of other UC symptoms and disease activity (Table 2). Conclusion Results from ad hoc analyses using a real-world sample of patients with UC suggest that bowel movement urgency is a prevalent symptom of UC which varies with disease activity.

Implementing routine assessment of patient-reported outcomes in cancer care.

2017 ◽  
Vol 35 (8_suppl) ◽  
pp. 229-229 ◽  
Author(s):  
Kathi Mooney ◽  
Joshua Biber ◽  
Rachel Hess ◽  
Howard Weeks ◽  
John W. Sweetenham
Keyword(s):  
Cancer Care ◽  
Patient Reported Outcomes ◽  
Clinic Visit ◽  
Computer Assisted ◽  
Patient Reported ◽  
Reported Data ◽  
Time Critical ◽  
Anxiety Depression ◽  
Routine Assessment

229 Background: Value based cancer care includes measurement of value to the patient. Patient reported outcomes (PRO) are central to assessing outcomes of cancer care but systematically measuring them creates adoption and work flow issues. We report the Huntsman Cancer Institute’s (HCI) experience implementing routine collection of PROs. Methods: Patients on a quarterly basis either prior to a scheduled visit via email or at the visit via tablet, complete 5 PROMIS measures (fatigue, pain interference, anxiety, depression and physical function) administered in computer-assisted test (CAT) format. Patients also complete a current health visual analog scale and general health question. Data are automatically and seamlessly populated to the electronic health record (EHR) for clinician review at the visit and are stored within the data warehouse. Results: Roll-out began sequentially to all HCI oncology outpatient clinics in July 2016, with a new clinic added every 2 weeks. To date PRO assessment is operational in every HCI clinic with over 9,800 assessments completed by 8,600 patients. Most assessments have been completed in the clinic as at-home completion was a recent option. Time to complete assessments average 5 minutes. Findings to date demonstrate that HCI patients are within average norms for cancer patients on the measures. Approximately 3% of depression assessments were at an elevated level and automatically routed to social work for follow-up. Initial assessments will serve as the basis for tracking quality improvement initiatives in the future. Missed assessments were common during initial startup. Completion was more likely when the clinicians valued having the data during the clinic visit and made it an expectation for collection by front end staff at visit registration. Conclusions: Technology-aided patient reported outcomes can be systematically and successfully collected during outpatient care, with triage of scores beyond acceptable thresholds for follow-up. Baseline scores will serve to evaluate improvements in care over time. Critical to success are clinical champions who value and understand the scoring and interpretation of patient reported data and make staff facilitation of data collection an expectation.

scholarly journals Emicizumab Outcomes in Hemophilia A Using Real-World Data from the Canadian Hemophilia Bleeding Disorder Registry

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 347-347
Author(s):  
Man-Chiu Poon ◽  
Adrienne Lee ◽  
Federico Germini ◽  
Arun Keepanasseril ◽  
Quazi Ibrahim ◽  
...  
Keyword(s):  
Stock Options ◽  
Research Funding ◽  
Patient Reported Outcomes ◽  
Hemophilia A ◽  
Severe Disease ◽  
Mild Disease ◽  
Patient Reported ◽  
Privately Held ◽  
Mcmaster University

Abstract Background: The Canadian Hemophilia Bleeding Disorders Registry (CBDR) is a clinical database including data from all Canadian Hemophilia Treatment Centers (HTCs) to assist in the management of hemophilia and other bleeding disorders. The CBDR launched on July 1, 2015 and integrates the data entry platform for patients, myCBDR, allowing direct entry of treatments, bleeding events, and other patient reported outcomes (PRO) data. Health Canada approved emicizumab in August 2018 for the treatment of persons with hemophilia A (PwHA) with factor (F)VIII inhibitors, and for PwHA without FVIII inhibitors in 2019, enabling some patients without FVIII inhibitors to be provided compassionate access beginning November 2019. Our aim for this analysis was to use the CBDR data to describe the demographics of the emicizumab-treated PwHA population and assess its effectiveness, safety, treatment patterns, and the impact on disease burden. Methods: De-identified data were extracted from the CBDR database for all registered PwHA who had received emicizumab at least once up to December 31, 2020. Disease severity is defined by the level of endogenous clotting FVIII activity. Effectiveness outcomes include number of patients (%) with zero treated bleeds, joint bleeds, and spontaneous bleeds; annualized bleeding rates (ABR) for any bleeds and treated bleeds; Hemophilia Joint Health Score (HJHS); Patient Reported Outcomes Burdens and Experiences (PROBE); and EQ-5D-5L index and visual analog scale (VAS). ABRs were calculated as (total number of bleeds/duration of follow-up [days])*365.25. All analyses were performed based on the observed values, without imputation. This study was approved by the research ethics board of McMaster University and other participating centers, and abides by the guiding principles of the Declaration of Helsinki. Results: 73 PwHA who received emicizumab at least once up to December 31, 2020 were identified. Demographic characteristics, severity, inhibitor status, and treatments are described in Table 1. Median (IQR) age for the entire cohort was 19.7 (10.0, 40.6) years with 45.2% ≤18 years. There were 64 PwHA with severe disease, 7 with moderate disease and 2 with mild disease; both cases with mild disease had current FVIII inhibitors. 49 PwHA had current FVIII inhibitors, 12 had a history of FVIII inhibitors, and 12 had no FVIII inhibitors. 5/73 (6.8%) received immune tolerance induction (ITI) treatment while on emicizumab. Two cases of rash (allergic or acute reactions) were reported (2/73, 2.7%) of which one (reported 6 days after administration) was possibly related to emicizumab according to the reporting HTC. No thromboembolisms or thrombotic microangiopathies were observed. Median ABR (IQR) for the entire study population was 0.0 (0, 0) and 59/73 (80.8%) had no recorded bleeds. In the 14/73 (19.2%) with recorded bleeds, median ABR (IQR) was 2 (1, 3); 8 of those 14 had joint bleeds and 7 had spontaneous bleeds. HJHS was recorded for 23, PROBE Score for 9, EQ-5D-5L for 9 and EQ-5D-5L VAS for 4 PwHA (Table 2). Conclusions: The Canadian population treated with emicizumab had severe disease and current or historical FVIII inhibitors. The bleed outcomes are consistent with earlier publications, showing 80.8% had no recorded bleeds. The CBDR will allow for longitudinal follow-up of this patient population. Our results can inform healthcare practitioners and regulatory authorities on the real-world safety and effectiveness outcomes of emicizumab in PwHA with and without FVIII inhibitors. Figure 1 Figure 1. Disclosures Poon: Roche: Honoraria; Pfizer: Honoraria; Novo Nordisk: Honoraria; Bioverativ/Sanofi: Honoraria; CSL-Behring: Honoraria, Research Funding; Bayer: Honoraria, Research Funding; University of Calgary: Current Employment; Takeda: Honoraria. Lee: Roche: Honoraria; Pfizer: Honoraria, Speakers Bureau; Novo Nordisk: Honoraria, Speakers Bureau; CSL Behring: Honoraria; Biovertiv/Sanofi: Honoraria, Research Funding; Bayer: Research Funding, Speakers Bureau; Takeda: Honoraria. Keepanasseril: McMaster University: Current Employment; NovoNordisk Canada: Consultancy. Ibrahim: McMaster University: Current Employment. Nissen: F. Hoffmann-La Roche Ltd: Current Employment, Current holder of stock options in a privately-held company; Novartis: Consultancy; Actelion: Consultancy. Sanabria: F. Hoffmann-La Roche Ltd: Current Employment, Current holder of individual stocks in a privately-held company. Santos: F. Hoffmann-La Roche Ltd.: Current Employment; Roche: Current holder of individual stocks in a privately-held company, Current holder of stock options in a privately-held company; Baxter: Current holder of individual stocks in a privately-held company, Current holder of stock options in a privately-held company; Takeda: Current holder of individual stocks in a privately-held company, Current holder of stock options in a privately-held company. Iorio: McMaster University: Current Employment; Bayer (funding to the institution): Research Funding; BioMarin (funding to the institution): Research Funding; NovoNordisk (funding to the institution): Research Funding; Octapharma (funding to the institution): Research Funding; Pfizer (funding to the institution): Research Funding; Roche (funding to the institution): Research Funding; Sanofi (funding to the institution): Research Funding; Sobi (funding to the institution): Research Funding; Takeda (funding to the institution): Research Funding.

scholarly journals An Overview of Tools to Score Severity in Pediatric Inflammatory Bowel Disease

2021 ◽  
Vol 9 ◽  
Author(s):  
Ron Shaoul ◽  
Andrew S. Day
Keyword(s):  
Disease Activity ◽  
Age Groups ◽  
Scoring Systems ◽  
Clinical Findings ◽  
Response To Treatment ◽  
Cochrane Library ◽  
Optimal Care ◽  
Patient Reported ◽  
Assessment Of Disease Activity

Background and Aims: The management of IBD entails the use of various treatments (nutrition, medications, and surgery) in order to induce and maintain remission. The assessment of IBD disease activity is based on a combination of symptoms, clinical findings, imaging, and endoscopic procedures. As in any disease, reliable assessment of disease activity or severity is required in order to plan relevant follow-up, decide on appropriate investigations, determine the best treatment option and subsequently assess response to treatment. It is important for proper documentation, follow-up, assessment of response to treatment and communication, especially in patients with IBD, to talk the same language by using validated and widely used scores for disease activity, endoscopic and radiologic activity, and patient reported outcomes both for clinical practice and research. This review aims to highlight key tools available for the assessment of disease activity or severity in individuals (especially children) with IBD.Methods: A literature search was performed using MEDLINE, Pubmed, and the Cochrane Library with the last search date of August 2020. Tools evaluating disease severity across various aspects (clinical, endoscopic, and radiological) were identified and discussed. Those tools validated and specific for children with IBD were included were available.Results: Over time a number of scoring systems have been developed to quantify clinical, endoscopic and imaging assessments in individuals with IBD. While some are exclusively for children or adults, others appear to have relevance to all age groups. In addition, some tools developed in adult populations are utilized in children, but have not expressly been validated in this age group.Conclusions: Although some available scoring tools are appropriate for children with IBD, others require consideration. The development and use of pediatric-specific tools is relevant and appropriate to optimal care of children and adolescents with IBD.

scholarly journals Does a Multidisciplinary Menopausal Symptoms after Cancer Clinic Reduce Symptoms?

2021 ◽  
Author(s):  
Jade Hollingworth ◽  
Lucy Walsh ◽  
Stephanie Tran ◽  
Lesley Ramage ◽  
Shavita Patel-Brown ◽  
...  
Keyword(s):  
Management Strategies ◽  
Significant Proportion ◽  
Patient Reported Outcome ◽  
Clinic Visit ◽  
Menopausal Symptoms ◽  
Care Clinic ◽  
Patient Reported ◽  
After Cancer ◽  
Multidisciplinary Model

Abstract PurposeThis study aimed to measure the prevalence of menopausal symptoms in patients attending a multidisciplinary model of care clinic at their initial clinic visit and their subsequent follow-up consultation using a validated patient reported outcome measure to assess whether menopausal symptoms after cancer had improved.MethodsA retrospective review was conducted of patients attending the clinic in a 12-month period in 2017 (n=189). Recorded variables included patient demographics, details of index cancer, previous treatments and menopausal symptom management strategies. Severity of menopausal symptoms was evaluated using the Greene Climacteric Scale. The extent to which patients were bothered by symptoms were combined into two categories and dichotomized (present/absent). Differences in symptom prevalence between the initial consultation and first follow-up visit were examined using McNemar’s Test. ResultsThe majority of patients attending the clinic had a history of breast cancer (72%). 55% of patients were prescribed a non-hormonal therapy at their initial visit, most commonly gabapentin. Significantly fewer patients reported being bothered by hot flushes, fatigue, sleep difficulties and loss of interest in sex, anxiety or troubles concentrating at the first follow-up visit compared to their initial consultation (p < 0.01). ConclusionIn this study there was an improvement in self-reported menopausal symptoms in a significant proportion of cancer survivors attending a multidisciplinary menopause clinic between their initial and first subsequent follow-up consultations.

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