Using oral morphine-equivalent values to track the analgesic effect of treatments in clinical trials.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14075-e14075
Author(s):  
Stephen A Raymond ◽  
John F Hutchin ◽  
Arnold Degboe ◽  
Kenneth G Faulkner
Keyword(s):  
Oral Morphine ◽  
Route Of Administration ◽  
Handheld Device ◽  
Analgesic Effects ◽  
Pain Medications ◽  
Patient Reported ◽  
Strong Opioids ◽  
Oral Morphine Equivalent ◽  
The Impact ◽  
Time Dose

e14075 Background: Patient reported pain is subjective, requiring individuals to grade the feeling of pain as “high” or “low”, typically using a numeric scale. As a supplement to self-reported pain, monitoring the dosage and type of treatment needed to keep pain at a tolerable or comfortable level has been suggested. However, differences in treatments can complicate the ability to compare analgesic effects. One approach to this problem uses a 30 mg oral dose of morphine as a standard to quantify the relative analgesic strength of different pain medications. Methods: For use in clinical research, we developed an application on a handheld device for logging opioid consumption and supporting automated determination of oral morphine equivalents (OME) for commonly prescribed analgesics. We reviewed the literature to prepare a comprehensive database of OMEs for more than 450 commonly prescribed pain medications. From treatment logs (time, dose, and route of administration), the application determines a daily “OME Score” in standardized units of mg of oral morphine. Results: As prescriptions change, the daily OME Score gives a comparable measure to track the utilization of diverse analgesic medications. OME Scores can be categorized using the Analgesic Quantification Algorithm (AQA scale) developed by Chung (1). The AQA scale has eight categories and provides 5 gradations for patients in advanced pain who receive strong opioids, each gradation reflecting adoubling in the daily OME Score. The impact of a therapy on pain may be considered clinically significant depending on the changes in self-reported pain and AQA scores related to the treatment. Conclusions: We have developed a method and associated application for easily logging the time, dose, and route of administration of analgesic treatments. This information can be used to compute the daily OME Score for a wide variety of analgesics. The daily OME score can then be tracked and used to report the AQA score alongside self-reported pain for evaluating pain relief in clinical studies. Reference: 1) Chung KC, Barlev A, Braun AH, Qian Y, Zagari M. Pain Medicine 2014; 15:225-232.

2 Impact of Multimodal Analgesia on Critically Ill Burn Patients

2020 ◽  
Vol 41 (Supplement_1) ◽  
pp. S5-S5
Author(s):  
Sierra R Young ◽  
Jeremiah Duby ◽  
Erin Louie
Keyword(s):  
Pain Control ◽  
Total Body Surface Area ◽  
Oral Morphine ◽  
Multimodal Analgesia ◽  
Power Calculation ◽  
Opioid Use ◽  
Icu Discharge ◽  
Opioid Medications ◽  
Oral Morphine Equivalent ◽  
The Impact

Abstract Introduction Opioids are considered the cornerstone of treatment for post-operative burn pain. However, detrimental adverse effects of opioid use include over-sedation, respiratory depression and dependence. Multimodal analgesia is an alternative method of pain control that utilizes a combination of opioid and non-opioid medications. Multimodal analgesia offers different mechanisms of action which may be beneficial in burn-injured patients. This study examines the impact of multimodal therapy for post-operative pain control in a burn intensive care unit (BICU). Methods This retrospective cohort study was performed at an academic burn center between 2012 and 2018. Consecutively admitted patients with burns greater than or equal to 10% total body surface area (TBSA) and BICU length of stay (LOS) greater than seven days were eligible for inclusion. Patients were excluded if they received an opioid continuous infusion greater than 48 hours. Patients treated with multimodal analgesia were compared to those treated with opioids alone. The total oral morphine equivalent (OME) dose was calculated for each 24-hour period for 5 days after a grafting surgery. Secondary endpoints included pain scores, BICU LOS, and ventilator days. Data analysis was performed with descriptive statistics. A power calculation determined that 60 patients per group were needed to detect a 30% difference in the primary endpoint. Results There were 100 patients in the non-multimodal group and 100 patients in the multimodal group. Mean cumulative OME dose was significantly lower in the multimodal group (1,028 mg vs. 1,438 mg, P < 0.002). Patients with over 20% TBSA burns had a larger reduction in mean OME doses in the multimodal group (1,097 mg vs. 1,624 mg, P = 0.0049) compared to patients with 10% to 20% TBSA burns (949 mg vs 1,282 mg, P = 0.057). Utilizing more multimodal agents was not associated with lower OME doses. There was no difference in pain score on post-operative day 5 (5.5 + 2.3 vs. 6.2 + 2.2, P=0.07) or at ICU discharge (4.7 + 2.4 vs 4.7 + 2.8, P = 0.99). There was no difference in other secondary outcomes. Conclusions The use of multimodal analgesia significantly reduced cumulative OME doses without compromising pain control. Applicability of Research to Practice Multimodal analgesia may be a beneficial adjunct to burn pain management to mitigate opioid use without compromising pain control.

scholarly journals Does scrolling affect measurement equivalence of electronic patient-reported outcome measures (ePROM)? Results of a quantitative equivalence study

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Saeid Shahraz ◽  
Tan P. Pham ◽  
Marc Gibson ◽  
Marie De La Cruz ◽  
Munther Baara ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Measurement Equivalence ◽  
Intraclass Correlation ◽  
Bodily Pain ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Measurement Properties ◽  
Handheld Device ◽  
Patient Reported ◽  
The Impact

Abstract Background Scrolling is a perceived barrier in the use of bring your own device (BYOD) to capture electronic patient reported outcomes (ePROs). This study explored the impact of scrolling on the measurement equivalence of electronic patient-reported outcome measures (ePROMs) in the presence and absence of scrolling. Methods Adult participants with a chronic condition involving daily pain completed ePROMs on four devices with different scrolling properties: a large provisioned device not requiring scrolling; two provisioned devices requiring scrolling – one with a “smart-scrolling” feature that disabled the “next” button until all information was viewed, and a second without this feature; and BYOD with smart-scrolling. The ePROMs included were the SF-12, EQ-5D-5L, and three pain measures: a visual analogue scale, a numeric response scale and a Likert scale. Participants completed English or Spanish versions according to their first language. Associations between ePROM scores were assessed using intraclass correlation coefficients (ICCs), with lower bound of 95% confidence interval (CI) > 0.7 indicating comparability. Results One hundred fifteen English- or Spanish-speaking participants (21-75y) completed all four administrations. High associations between scrolling and non-scrolling were observed (ICCs: 0.71–0.96). The equivalence threshold was met for all but one SF-12 domain score (bodily pain; lower 95% CI: 0.65) and two EQ-5D-5L item scores (pain/discomfort, usual activities; lower 95% CI: 0.64/0.67). Age, language, and device size produced insignificant differences in scores. Conclusions The measurement properties of PROMs are preserved even in the presence of scrolling on a handheld device. Further studies that assess scrolling impact over long-term, repeated use are recommended.

Effect of inpatient palliative care on supportive care measures in patients undergoing hematopoietic cell transplantation (HCT).

2019 ◽  
Vol 37 (31_suppl) ◽  
pp. 70-70
Author(s):  
Areej El-Jawahri ◽  
Harry VanDusen ◽  
Alyssa L. Fenech ◽  
Alison Kavanaugh ◽  
Vicki A. Jackson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Palliative Care ◽  
Supportive Care ◽  
Atypical Antipsychotics ◽  
Hematopoietic Cell Transplantation ◽  
Care Intervention ◽  
Pain Medications ◽  
Patient Reported ◽  
Care Practices ◽  
The Impact

70 Background: Inpatient palliative care integrated with transplant care has been shown to improve patient-reported quality of life (QOL), symptom burden, and psychological distress during hospitalization for HCT. However, the impact of palliative care on supportive care practices during HSCT remains unknown. Methods: This secondary analysis is based on a single-site randomized clinical trial of 160 patients with hematologic malignancies undergoing HSCT between 8/2014 and 1/2016. Participants received either inpatient palliative care integrated with transplant care (n = 81) or transplant care alone (n = 79). We used the electronic health record to obtain data on supportive care measures during HSCT including the use of patient-controlled analgesia (PCA), intravenous pain medications, atypical antipsychotics (used to treat nausea/anxiety), psychostimulants, antidepressants, hypnotics, and the use of standing orders (as opposed to as needed ‘PRN’) for supportive care medications. We compared the proportion of subjects in each group receiving these supportive care measures using Fisher’s exact test. Results: Patients randomized to the palliative care intervention were more likely to use PCA (32.1% vs. 15.19%, P = 0.015), and atypical antipsychotics (35.8% vs. 17.7%, P = 0.012) compared to those receiving transplant care alone. Intervention participants were also more likely to have standing orders for their supportive care medications (74.1% vs. 56.9%, P = 0.030) compared to those receiving transplant care alone. Study groups did not differ in the of intravenous pain medications, psychostimulants, antidepressants, or hypnotics. Conclusions: Patients receiving inpatient integrated palliative and transplant care were more likely to utilize PCA and atypical antipsychotics during HCT compared to those receiving transplant care alone. Future work should examine whether these differences in supportive care practices mediate the effect of the palliative care intervention on patient-reported outcomes. Clinical trial information: NCT02207322.

Rescue-free laxation response with methylnaltrexone treatment in cancer patients with opioid-induced constipation: The impact of baseline ECOG status.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e24083-e24083
Author(s):  
Scott Boniol ◽  
Neal E. Slatkin ◽  
Nancy Stambler ◽  
Robert J. Israel
Keyword(s):  
Cancer Patients ◽  
Eastern Cooperative Oncology Group ◽  
Oral Morphine ◽  
Common Side Effect ◽  
Significant Treatment ◽  
Institutional Review ◽  
Number Of Patients ◽  
Daily Dose ◽  
Oral Morphine Equivalent ◽  
The Impact

e24083 Background: Opioid-induced constipation (OIC) is a common side effect of opioid treatment for cancer-related pain. Methylnaltrexone (MNTX) is a peripherally active µ-opioid receptor antagonist indicated for OIC that does not affect opioid central analgesia. We assessed if baseline Eastern Cooperative Oncology Group (ECOG) status impacted the rescue-free laxation (RFL) responses among cancer patients with OIC treated with repeated doses of MNTX. Methods: This pooled post hoc analysis from 2 randomized, placebo-controlled, institutional review board–approved clinical studies included cancer patients with OIC (study 302, NCT00402038; study 4000, NCT00672477). Study 302 compared subcutaneous MNTX 0.15 mg/kg vs placebo and study 4000 compared body weight‒based subcutaneous MNTX 8 mg (38–< 62 kg) or 12 mg (³ 62 kg) vs placebo. The data were stratified by baseline ECOG status (< 2 vs ≥ 2). Endpoints included the number of patients with RFL responses within 4 hours after ≥ 2 of the first 4 doses and the number of patients with RFL response within 4 hours of treatment for patients who received all 7 doses. Results: The intent-to-treat analysis included 43 patients with an ECOG < 2 (placebo = 20; MNTX = 23) and 187 patients with an ECOG ≥ 2 (placebo = 94; MNTX = 93). Those with an ECOG < 2 were younger (mean age 58 vs 65 years), predominantly male (60.5% vs 51.3%), and used a higher daily dose of oral morphine equivalent (190.7 vs 180.0 mg/d) compared with those with an ECOG ≥ 2. Cancer patients with an ECOG < 2 treated with MNTX had a significantly greater RFL response within 4 hours after ≥ 2 of the first 4 doses compared with placebo (56.5% vs 5.0%, P = 0.0003). Similar results were reported for patients with an ECOG ≥ 2 (57.0% vs 5.3%, P < 0.0001). Compared with placebo, the MNTX group had a greater proportion of patients with an RFL response, whether they had at least 1 RFL response or up to 7 RFL responses out of 7 doses, with significant treatment differences with each additional RFL per 7 doses among cancer patients with an ECOG ≥ 2 (Table). Conclusions: RFL response rates in cancer patients were significantly greater in the MNTX group vs the placebo group regardless of baseline ECOG status; responses were similar between the 2 groups despite a higher daily dose of opioids in the group with an ECOG > 2. Clinical trial information: NCT00402038; NCT00672477. [Table: see text]

Predictors of nonroutine discharge among patients undergoing surgery for grade I spondylolisthesis: insights from the Quality Outcomes Database

2020 ◽  
Vol 32 (4) ◽  
pp. 523-532 ◽  
Author(s):  
Praveen V. Mummaneni ◽  
Mohamad Bydon ◽  
John Knightly ◽  
Mohammed Ali Alvi ◽  
Anshit Goyal ◽  
...  
Keyword(s):  
Body Mass Index ◽  
Acute Care ◽  
Body Mass ◽  
Care Facility ◽  
Older Age ◽  
Quality Outcomes ◽  
Acute Care Facility ◽  
Factors Associated ◽  
Patient Reported ◽  
The Impact

OBJECTIVEDischarge to an inpatient rehabilitation facility or another acute-care facility not only constitutes a postoperative challenge for patients and their care team but also contributes significantly to healthcare costs. In this era of changing dynamics of healthcare payment models in which cost overruns are being increasingly shifted to surgeons and hospitals, it is important to better understand outcomes such as discharge disposition. In the current article, the authors sought to develop a predictive model for factors associated with nonroutine discharge after surgery for grade I spondylolisthesis.METHODSThe authors queried the Quality Outcomes Database for patients with grade I lumbar degenerative spondylolisthesis who underwent a surgical intervention between July 2014 and June 2016. Only those patients enrolled in a multisite study investigating the impact of fusion on clinical and patient-reported outcomes among patients with grade I spondylolisthesis were evaluated. Nonroutine discharge was defined as those who were discharged to a postacute or nonacute-care setting in the same hospital or transferred to another acute-care facility.RESULTSOf the 608 patients eligible for inclusion, 9.4% (n = 57) had a nonroutine discharge (8.7%, n = 53 discharged to inpatient postacute or nonacute care in the same hospital and 0.7%, n = 4 transferred to another acute-care facility). Compared to patients who were discharged to home, patients who had a nonroutine discharge were more likely to have diabetes (26.3%, n = 15 vs 15.7%, n = 86, p = 0.039); impaired ambulation (26.3%, n = 15 vs 10.2%, n = 56, p < 0.001); higher Oswestry Disability Index at baseline (51 [IQR 42–62.12] vs 46 [IQR 34.4–58], p = 0.014); lower EuroQol-5D scores (0.437 [IQR 0.308–0.708] vs 0.597 [IQR 0.358–0.708], p = 0.010); higher American Society of Anesthesiologists score (3 or 4: 63.2%, n = 36 vs 36.7%, n = 201, p = 0.002); and longer length of stay (4 days [IQR 3–5] vs 2 days [IQR 1–3], p < 0.001); and were more likely to suffer a complication (14%, n = 8 vs 5.6%, n = 31, p = 0.014). On multivariable logistic regression, factors found to be independently associated with higher odds of nonroutine discharge included older age (interquartile OR 9.14, 95% CI 3.79–22.1, p < 0.001), higher body mass index (interquartile OR 2.04, 95% CI 1.31–3.25, p < 0.001), presence of depression (OR 4.28, 95% CI 1.96–9.35, p < 0.001), fusion surgery compared with decompression alone (OR 1.3, 95% CI 1.1–1.6, p < 0.001), and any complication (OR 3.9, 95% CI 1.4–10.9, p < 0.001).CONCLUSIONSIn this multisite study of a defined cohort of patients undergoing surgery for grade I spondylolisthesis, factors associated with higher odds of nonroutine discharge included older age, higher body mass index, presence of depression, and occurrence of any complication.

Optimizing electronic capture of patient-reported outcome measures in oncology clinical trials: lessons learned from a qualitative study

2020 ◽  
Vol 9 (17) ◽  
pp. 1195-1204
Author(s):  
Florence D Mowlem ◽  
Brad Sanderson ◽  
Jill V Platko ◽  
Bill Byrom
Keyword(s):  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Lessons Learned ◽  
Structured Interviews ◽  
Patient Reported ◽  
Oncology Clinical Trials ◽  
Anticancer Treatment ◽  
Fit For Purpose ◽  
The Impact ◽  
Electronic Implementation

Aim: To understand the impact of anticancer treatment on oncology patients’ ability to use electronic solutions for completing patient-reported outcomes (ePRO). Materials & methods: Semi-structured interviews were conducted with seven individuals who had experienced a cancer diagnosis and treatment. Results: Participants reported that the following would impact the ability to interact with an ePRO solution: peripheral neuropathy of the hands (4/7), fatigue and/or concentration and memory issues (6/7), where they are in a treatment cycle (5/7). Approaches to improve usability included: larger, well-spaced buttons to deal with finger numbness, the ability to pause a survey and complete at a later point and presenting the recall period with every question to reduce reliance on memory. Conclusion: Symptoms associated with cancers and anticancer treatments can impact the use of technologies. The recommendations for optimizing the electronic implementation of patient-reported outcome instruments in this population provides the potential to improve data quality in oncology trials and places patient needs at the forefront to ensure ‘fit-for-purpose’ solutions.

The effect of surgery in tenosynovial giant cell tumours as measured by patient-reported outcomes on quality of life and joint function

2019 ◽  
Vol 101-B (3) ◽  
pp. 272-280 ◽  
Author(s):  
F. G. M. Verspoor ◽  
M. J. L. Mastboom ◽  
G. Hannink ◽  
W. T. A. van der Graaf ◽  
M. A. J. van de Sande ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Giant Cell ◽  
Diffuse Type ◽  
Joint Function ◽  
Population Means ◽  
Sf 36 ◽  
Patient Reported ◽  
The Impact

Aims The aim of this study was to evaluate health-related quality of life (HRQoL) and joint function in tenosynovial giant cell tumour (TGCT) patients before and after surgical treatment. Patients and Methods This prospective cohort study run in two Dutch referral centres assessed patient-reported outcome measures (PROMs; 36-Item Short-Form Health Survey (SF-36), visual analogue scale (VAS) for pain, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)) in 359 consecutive patients with localized- and diffuse-type TGCT of large joints. Patients with recurrent disease (n = 121) and a wait-and-see policy (n = 32) were excluded. Collected data were analyzed at specified time intervals preoperatively (baseline) and/or postoperatively up to five years. Results A total of 206 TGCT patients, 108 localized- and 98 diffuse-type, were analyzed. Median age at diagnosis of localized- and diffuse-type was 41 years (interquartile range (IQR) 29 to 49) and 37 years (IQR 27 to 47), respectively. SF-36 analyses showed statistically significant and clinically relevant deteriorated preoperative and immediate postoperative scores compared with general Dutch population means, depending on subscale and TGCT subtype. After three to six months of follow-up, these scores improved to general population means and continued to be fairly stable over the following years. VAS scores, for both subtypes, showed no statistically significant or clinically relevant differences pre- or postoperatively. In diffuse-type patients, the improvement in median WOMAC score was statistically significant and clinically relevant preoperatively versus six to 24 months postoperatively, and remained up to five years’ follow-up. Conclusion Patients with TGCT report a better HRQoL and joint function after surgery. Pain scores, which vary hugely between patients and in patients over time, did not improve. A disease-specific PROM would help to decipher the impact of TGCT on patients’ daily life and functioning in more detail. Cite this article: Bone Joint J 2019;101-B:272–280.

scholarly journals Patient-reported effectiveness and safety of Pamidronate in NSAIDs-refractory chronic recurrent multifocal osteomyelitis in children

2021 ◽  
Author(s):  
Bartłomiej Juszczak ◽  
Jerzy Sułko
Keyword(s):  
Adverse Drug Reactions ◽  
Social Life ◽  
Chronic Recurrent Multifocal Osteomyelitis ◽  
Daily Activities ◽  
Drug Reactions ◽  
Patient Reported ◽  
Multifocal Osteomyelitis ◽  
Drug Dependent ◽  
Treatment Onset ◽  
The Impact

AbstractTo evaluate patient-reported effectiveness, safety and social influence of Pamidronate in the therapy of NSAIDs-refractory Chronic Recurrent Multifocal Osteomyelitis in children. Authors reviewed self-created questionnaires, which asked patients for symptoms alleviation, adverse drug reactions frequency and degree of severity and daily activities self-reliance. Only surveys with complete answers, which were returned to authors by an e-mail from juvenile patients treated for NSAIDs-refractory Chronic Recurrent Multifocal Osteomyelitis at the University Children’s Hospital of Cracow were analyzed. Between 2010 and 2019, 61 children were diagnosed with NSAIDs-refractory Chronic Recurrent Multifocal Osteomyelitis at our department. Out of 61 requests sent, 42 complete replies (33 females, 9 males) were gathered and analyzed. All patients included in this research were administered with at least one set of Pamidronate intravenously in the dose of 1 mg/kg/day for 3 consecutive days. Our analysis shows remarkable in terms of patient’s impressions decrease of pain intensity after 2.5 series of Pamidronate on average, and total pain resolution after 5.9 series on average. Overall number of adverse drug reaction events reported by responders was 105. One patient developed drug-dependent renal insufficiency in the course of therapy. Outcome assessment indicates that nearly 50% of the studied population was more eager to participate in social life just after the first infusion of the drug. 95% of the surveyed unanimously agreed to recommend Pamidronate therapy to cure NSAIDs-refractory CRMO. 39 out of 42 (93%) patients considered Pamidronate effective at the end of the treatment. Onset of Pamidronate’s action is gradual and differs in terms of symptoms alleviation between sexes. The therapy can induce considerable number of adverse drug reactions (2.5 per patient). Only 3 out of 42 (7%) patients were free from any ADRs. To demonstrate the impact of the use of Pamidronate on daily activities more precisely, further research with quantification of the quality of life is warranted.

scholarly journals POS1234 IMPACT OF THE CHANGE IN ADMINISTRATION ROUTE OF TOCILIZUMAB AND ABATACEPT, DUE TO THE COVID-19 LOCKDOWN ON DISEASE ACTIVITY IN PATIENTS WITH RHEUMATOID ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 900.1-900
Author(s):  
L. Diebold ◽  
T. Wirth ◽  
V. Pradel ◽  
N. Balandraud ◽  
E. Fockens ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Physical Activity ◽  
Disease Activity ◽  
Univariate Analysis ◽  
Route Of Administration ◽  
Anxiety And Depression ◽  
Administration Route ◽  
Factors Associated ◽  
The Impact

Background:Among therapeutics used to treat rheumatoid arthritis (RA), Tocilizumab (TCZ) and Abatacept (ABA) are both biologic agents that can be delivered subcutaneously (SC) or intravenously (IV). During the first COVID-19 lockdown in France, all patients treated with IV TCZ or IV ABA were offered the option to switch to SC administration.Objectives:The primary aim was to assess the impact of changing the route of administration on the disease activity. The second aim was to assess whether the return to IV route at the patient’s request was associated with disease activity variation, flares, anxiety, depression and low physical activity during the lockdown.Methods:We conducted a prospective monocentric observational study. Eligibility criteria: Adult ≥ 18 years old, RA treated with IV TCZ or IV ABA with a stable dose ≥3 months, change in administration route (from IV to SC) between March 16, 2020, and April 17, 2020. The following data were collected at baseline and 6 months later (M6): demographics, RA characteristics, treatment, history of previous SC treatment, disease activity (DAS28), self-administered questionnaires on flares, RA life repercussions, physical activity, anxiety and depression (FLARE, RAID, Ricci &Gagnon, HAD).The primary outcome was the proportion of patients with a DAS28 variation>1.2 at M6. Analyses: Chi2-test for quantitative variables and Mann-Whitney test for qualitative variables. Factors associated with return to IV route identification was performed with univariate and multivariate analysis.Results:Among the 84 patients who were offered to switch their treatment route of administration, 13 refused to change their treatment. Among the 71 who switched (48 TCZ, 23 ABA), 58 had a M6 follow-up visit (13 lost of follow-up) and DAS28 was available for 49 patients at M6. Main baseline characteristics: female 81%, mean age 62.7, mean disease duration: 16.0, ACPA positive: 72.4%, mean DAS28: 2.01, previously treated with SC TCZ or ABA: 17%.At M6, the mean DAS28 variation was 0.18 ± 0.15. Ten (12.2%) patients had a DAS28 worsening>1.2 (ABA: 5/17 [29.4%] and TCZ: 5/32 [15.6%], p= 0.152) and 19 patients (32.8%) had a DAS28 worsening>0.6 (ABA: 11/17 [64.7%] and TCZ: 8/32 [25.0%], p= 0.007).At M6, 41 patients (77.4%) were back to IV route (26 TCZ, 15 ABA) at their request. The proportion of patients with a DAS28 worsening>1.2 and>0.6 in the groups return to IV versus SC maintenance were 22.5%, 42.5% versus 11.1% and 22.2% (p=0.4), respectively. The univariate analysis identified the following factors associated with the return to IV route: HAD depression score (12 vs 41, p=0.009), HAS anxiety score (12 vs 41, p=0.047) and corticosteroid use (70% vs 100%, p=0.021), in the SC maintenance vs return to IV, respectively.Conclusion:The change of administration route of TCZ and ABA during the first COVID-19 lockdown was infrequently associated with a worsening of RA disease. However, the great majority of the patients (77.4%) request to return to IV route, even without disease activity worsening. This nocebo effect was associated with higher anxiety and depression scores.Disclosure of Interests:None declared

Patients With a History of Oronasal Fistula Repair Exhibit Lower Oral Health Measured With Patient-Centric Outcomes Measures

2020 ◽  
pp. 105566562098133
Author(s):  
Alyssa Fritz ◽  
Diana S. Jodeh ◽  
Fatima Qamar ◽  
James J. Cray ◽  
S. Alex Rottgers
Keyword(s):  
Quality Of Life ◽  
Oral Health ◽  
Cleft Palate ◽  
Fistula Repair ◽  
Old Patients ◽  
Oronasal Fistula ◽  
Patient Reported ◽  
History Of ◽  
The Impact

Introduction: Oronasal fistulae following palatoplasty may affect patients’ quality of life by impacting their ability to eat, speak, and maintain oral hygiene. We aimed to quantify the impact of previous oronasal fistula repair on patients’ quality of life using patient-reported outcome psychometric tools. Methods: A cross-sectional study of 8- to 9-year-old patients with cleft palate and/or lip was completed. Patients who had a cleft team clinic between September 2018 and August 2019 were recruited. Participants were divided into 2 groups (no fistula, prior fistula repair). Differences in the individual CLEFT-Q and Child Oral Health Impact Profile-Short Form 19 (COHIP-SF 19) Oral Health scores between the 2 groups were evaluated using a multivariate analysis controlling for Veau classification and syndromic diagnosis. Results: Sixty patients with a history of cleft palate were included. Forty-two (70%) patients had an associated cleft lip. Thirty-two (53.3%) patients had no history of fistula and 28 (46.7%) patients had undergone a fistula repair. CLEFT-Q Dental, Jaw, and Speech Function were all higher in patients without a history of a fistula repair; however, none of these differences were statistically significant. The COHIP-SF 19 Oral Health score demonstrated a significantly lower score in the fistula group, indicating poorer oral health ( P = .05). Conclusions: One would expect that successful repair of a fistula would result in improved function and patient satisfaction, but the consistent trend toward lower CLEFT-Q scores and significantly increased COHIP-SF 19 Oral Health scores in our study group suggests that residual effects linger and that the morbidity of a fistula may not be completely treated with a secondary correction.

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