scholarly journals SAT0150 CHANGES IN PATIENT-REPORTED OUTCOME (PRO) SCORES FOR NAUSEA AND FATIGUE FOLLOWING WEEKLY METHOTREXATE DOSE IN A REAL-WORLD SAMPLE OF RA AND PSA PATIENTS IN THE ARTHRITISPOWER REGISTRY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1014-1015
Author(s):  
W. B. Nowell ◽  
E. Karis ◽  
K. Gavigan ◽  
L. Stradford ◽  
S. Stryker ◽  
...  

Background:Methotrexate (MTX) is frequently used in patients with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) because of its beneficial effects in both populations1-3. Despite the well-known benefits of MTX, it is associated with a number of potential side effects4-6These include nausea and fatigue, are often temporally related to the timing of weekly MTX administration, and can be severe. The combined patient-reported side effects, along with potential of long-term toxicity, may make use of MTX more burdensome. Currently, there is a gap in patient-centered studies that focus on patients’ experience with MTX.Objectives:Examine patient temporal experience of fatigue and nausea relating to oral MTX therapy for the treatment of RA and PsA.Methods:Adult US patients in the ArthritisPower registry with self-reported RA or PsA taking MTX for less than 10 years were invited to participate in the study via email invitation. Participants (pts) completed a screener and brief online survey. In an ancillary study to the ArthritisPower registry and using a self-controlled case series study design where pts serve as their own control to avoid between-person confounding, pts were asked to complete a set of up to 8 assessments within 6-36 hours (‘risk’) and 96-144 hours (‘control’) after taking their oral dose of MTX each week, for up to 4 weeks. Risk and control windows were selected based on the expected temporal relationship between MTX use and peak onset of these symptoms. Assessments included PROMIS short forms for same-day Fatigue, same-day Nausea/Vomiting, and Patient Global. Descriptive statistics were conducted using paired t-tests two-way comparisons. Within-person change in PROMIS scores between the risk (1-2 days after MTX) and control (4-6 days after MTX) windows were analyzed using mixed models for repeated measures, stratified on whether pts reported fatigue or nausea with MTX at baseline. Recruitment for this study is ongoing.Results:As of December 2019, 91 pts had participated, of whom 76.9% were living with RA and 28.6% with PsA, with mean baseline PROMIS Patient Global score (SD) of 39.5 (7.1). Mean age (SD) was 50.9 (12.0) years, 84.6% female, 92.3% White, with mean BMI 33.7 (8.8). Mean duration of MTX treatment among current users was 2.1 (2.8) years. Among pts, 41.8% were on a biologic DMARD and 58.2% on non-biologic DMARDs only. Among pts reporting baseline nausea (n=30, 33.0%) where paired within-week measures were observed (n=64 observations among 20 pts), the mean increase in the PROMIS Nausea score was 4.5 units (adjusted p=0.003). Among those reporting MTX-associated fatigue (n=39, 42.9%) as a side effect of MTX on their baseline survey where paired within-week measures were observed (n=96 observations among 28 pts), the mean increase in PROMIS Fatigue was 4.7 (adjusted p=0.004) units. In those pts, the proportion of pts with worsened nausea and fatigue with minimally important difference of >5 units7-8was 40.0% (nausea), and 60.7% (fatigue) [Figures 1 and 2].Conclusion:People taking MTX to manage RA or PsA commonly experience bothersome side effects, notably fatigue and nausea, that are temporally related to weekly MTX dosing. In this sample, one-third or more of pts were bothered by nausea or fatigue shortly after MTX dosing, many of them with clinically meaningful symptoms.References:[1]Singh JA, et al.Arthritis Rheumatol. 2016;68:1-26.[2]Singh JA, et al.Arthritis Rheumatol. 2019;71:5-32.[3]Mease P.Bull NYU Hosp Jt Dis. 2013;71.(suppl 1):S41.[4]Wang W, et al.Eur J Med Chem. 2018;158:502-516.[5]Wilsdon TD, et al.Cochrane Database Syst Rev. 2019;1:CD012722.[6]Husted JA, et al.Ann Rheum Dis. 2009;68:1553-1558.[7]Norman GR, et al.Med Care. 2003;41:582-92.[8]Bingham CO, et al.J Patient Rep Outcomes. 2019;3:14.Disclosure of Interests:W. Benjamin Nowell: None declared, Elaine Karis Shareholder of: Amgen Inc., Employee of: Amgen Inc., Kelly Gavigan: None declared, Laura Stradford: None declared, Scott Stryker Shareholder of: Amgen Inc., Employee of: Amgen Inc., Huifeng Yun Grant/research support from: Bristol-Myers Squibb and Pfizer, Shilpa Venkatachalam: None declared, Greg Kricorian Shareholder of: Amgen Inc., Employee of: Amgen Inc., Lang Chen: None declared, Hong Zhao: None declared, Fenglong Xie: None declared, Jeffrey Curtis Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, UCB, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, UCB

Author(s):  
Mohei M. Fadel ◽  
Hesham M. Gawish ◽  
Mohamed A. Elsheikh

<p class="abstract"><strong>Background:</strong> Idiopathic subcoracoid impingement is considered now as a well-established cause of anterior shoulder pain. There are multiple techniques reported for management of subcoracoid impingement. Open decompression and reattachment of conjoint tendon as well as arthroscopic resection of coracoid tip. The aim of this study was to evaluate the results of arthroscopic stepwise approach for management of idiopathic coracoid impingment.</p><p class="abstract"><strong>Methods:</strong> This prospective therapeutic case series study included 26 consecutive patients suffering from anterior shoulder pain and were diagnosed as subcoracoid impingement. All cases were evaluated preoperatively and followed up for 12 months after surgery both clinically and radiologically. Arthroscopic subcoracoid decompression, coracoplasty and arthroscopic repair of partial subscapularis tear if present were done for all cases.<strong></strong></p><p class="abstract"><strong>Results:</strong> The mean age at the time of surgery was 45.3±5.4years. At the final follow up, the mean VAS score improved significantly to 0.8±0.8points postoperatively (p&lt;0.01). The mean Constant score improved significantly to 87.8±7.8 at the final follow-up (p&lt;0.001). The mean UCLA score improved significantly to 32.1±2.4 at the end of follow-up (P&lt;0.001)</p><p class="abstract"><strong>Conclusions:</strong> Coracoid impingement should be in mind when evaluating any patient with anterior shoulder pain. The arthroscopic management in form of bone, bursal and tendon procedures (triple attack) is a good treatment to relieve clinical symptoms with excellent patient reported outcomes.</p><p class="abstract"> </p>


2021 ◽  
Vol 9 (2) ◽  
pp. 232596712098187
Author(s):  
Justus Gille ◽  
Ellen Reiss ◽  
Moritz Freitag ◽  
Jan Schagemann ◽  
Matthias Steinwachs ◽  
...  

Background: Autologous matrix-induced chondrogenesis (AMIC) is a well-established treatment for full-thickness cartilage defects. Purpose: To evaluate the long-term clinical outcomes of AMIC for the treatment of chondral lesions of the knee. Study Design: Case series; Level of evidence, 4. Methods: A multisite prospective registry recorded demographic data and outcomes for patients who underwent repair of chondral defects. In total, 131 patients were included in the study. Lysholm, Knee injury and Osteoarthritis Outcome Score (KOOS), and visual analog scale (VAS) score for pain were used for outcome analysis. Across all patients, the mean ± SD age of patients was 36.6 ± 11.7 years. The mean body weight was 80.0 ± 16.8 kg, mean height was 176.3 ± 7.9 cm, and mean defect size was 3.3 ± 1.8 cm2. Defects were classified as Outerbridge grade III or IV. A repeated-measures analysis of variance was used to compare outcomes across all time points. Results: The median follow-up time for the patients in this cohort was 4.56 ± 2.92 years. Significant improvement ( P < .001) in all scores was observed at 1 to 2 years after AMIC, and improved values were noted up to 7 years postoperatively. Among all patients, the mean preoperative Lysholm score was 46.9 ± 19.6. At the 1-year follow-up, a significantly higher mean Lysholm score was noted, with maintenance of the favorable outcomes at 7-year follow-up. The KOOS also showed a significant improvement of postoperative values compared with preoperative data. The mean VAS had significantly decreased during the 7-year follow-up. Age, sex, and defect size did not have a significant effect on the outcomes. Conclusion: AMIC is an effective method of treating chondral defects of the knee and leads to reliably favorable results up to 7 years postoperatively.


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Carlos Ramírez-Paesano ◽  
Albert Juanola Galceran ◽  
Claudia Rodiera Clarens ◽  
Vicenҫ Gilete García ◽  
Bartolomé Oliver Abadal ◽  
...  

Abstract Background Patients with Ehlers-Danlos Syndrome/Hypermobility Type (EDS-HT/JHS) and Craneo-Cervical Instability frequently suffer from severe widespread pain which is difficult to control. Chronic neuroinflammation, opioid-induced hyperalgesia, and central sensitization may explain this painful condition. The aim of this study was to determine if opioid-free anesthesia plus the postoperative administration of lidocaine, ketamine and dexmedetomidine can reduce postoperative pain and the need of methadone rescues in comparison with opioid-based management in these patients undergoing Craneo-Cervical Fixation (CCF). The secondary aim was to assess the needs of opioids at hospital-discharge, incidence of gastrointestinal complications and the requirement of anxiolytic. Methods A retrospective, consecutive case series study was designed. 42 patients with EDS-HT/JHS undergoing CCF were enrolled in two groups: an OFA-plus Group that received opioid-free anesthesia with propofol, lidocaine, ketamine and dexmedetomidine, and OP Group, opioid-based anesthesia-analgesia. The main variables: Preoperative Visual Analogue Score (VAS), postoperative VAS on the 1st, 2nd, 4th and 6th days, sufentanil or morphine requirements, need for methadone rescue, and VAS at hospital-discharge. Data was presented by mean ± SD, percentage, median or interquartile range. Chi-squared or Fisher’s test. 95% C.I and P values < 0.05. Results Nineteen patients in OFA-plus, and 23 patients in OP group. VAS was lower in OFA-plus on the postoperative days evaluated (p < 0.001).VAS at hospital-discharge was lower in OFA-plus: 4.96 (4.54–5.37) vs. OP 6.39 (6.07–6.71) (p < 0.001). Methadone requirement was lower in the OFA-plus (p < 0.001). 78% of patients in OFA-plus didn’t need methadone rescue. 95% in OP group needed methadone rescues at high doses(> 15 mg/day). No differences regarding equivalent doses of sufentanil or morphine consumption on the 2nd, 4th, and 6th postoperative days were found. OFA-plus decreased ileus, nausea and vomiting (p < 0.001). 60.9% in OFA-plus group decreased opioid requirements at hospital-discharge compared with preoperative values. A 77% reduction of anxiolytics requirements was shown. Conclusion OFA-plus management for patients undergoing CCF with EDS-HT/JHS shows significant reduction in postoperative pain and at hospital-discharge compared with opioid-based anesthesia. OFA-plus management decreases the total doses of methadone rescues, reduces anxiolytic requirements and gastrointestinal side-effects, except for constipation. OFA-plus management is a feasible option to improve postoperative pain control, reducing the opioids’ use and their postoperative side-effects in patients undergoing CCF with EDS-HT/JHS.


2019 ◽  
Vol 98 (5) ◽  
pp. 291-294 ◽  
Author(s):  
Saudamini J. Lele ◽  
Mickie Hamiter ◽  
Torrey Louise Fourrier ◽  
Cherie-Ann Nathan

Sialendoscopy has emerged as a safe, effective and minimally invasive technique for management of obstructive and inflammatory salivary gland disease. The aim of our study was to analyze outcomes of sialendoscopy and steroid irrigation in patients with sialadenitis without sialoliths. We performed a retrospective analysis of patients who underwent interventional sialendoscopy with steroid irrigation from 2013 to 2016, for the treatment of sialadenitis without sialolithiasis. Twenty-two patients underwent interventional sialendoscopy with ductal dilation and steroid irrigation for the treatment of sialadenitis without any evidence of sialolithiasis. Conservative measures had failed in all. Eleven patients had symptoms arising from the parotid gland, 4 patients had symptoms arising from the submandibular gland, while 6 patients had symptoms in both parotid and submandibular glands. One patient complained of only xerostomia without glandular symptoms. The mean age of the study group which included 1 male and 21 females was 44.6 years (range: 3-86 years). Four patients had autoimmune disease, while 7 patients had a history of radioactive iodine therapy. No identifiable cause for sialadenitis was found in the remaining 11 patients. The mean follow-up period was 378.9 days (range: 16-1143 days). All patients underwent sialendoscopy with ductal dilation and steroid irrigation. Twelve patients showed a complete response and 9 patients had a partial response, while 1 patient reported no response. Only 3 patients required repeat sialendoscopy. The combination of sialendoscopy with ductal dilation and steroid irrigation is a safe and effective treatment option for patients with sialadenitis without sialoliths refractory to conservative measures. Prospective studies with a larger case series are needed to establish its role as a definitive treatment option.


2018 ◽  
Vol 30 (1) ◽  
pp. 40-47 ◽  
Author(s):  
Islam SH Ahmed ◽  
Ahmed MA Hadi ◽  
Hassan H Hassan

Aim: To report the results of treatment of type 1 prethreshold retinopathy of prematurity using intravitreal injection of ultra-low dose of ranibizumab (0.1 mg in 0.01 mL). Design: A retrospective observational case series study. Methods: Review of files of eligible infants who received this form of treatment to determine the outcome of treatment and any associated ocular or systemic side effects. Results: The study included 24 eyes of 12 preterm infants with mean gestational age of 29.75 ± 1.54 weeks and mean birth weight of 1074.58 ± 320.59 g. A total of 22 eyes (91.67%) had zone II disease while 2 eyes of one infant (8.33%) had zone I disease. All cases showed regression of the signs of the active retinopathy of prematurity with complete retinal vascularization. None of the cases required retreatment. Three eyes developed ocular complications. Apart from mild feeding intolerance that lasted for 24 h after injection in one infant, none of the cases developed systemic side effects. Conclusion: Intravitreal injection of ultra-low-dose ranibizumab showed promising efficacy and good ocular safety. However, further large-scale studies are required to give stronger evidence about the efficacy and safety of ultra-low-dose ranibizumab.


2013 ◽  
Vol 5 ◽  
pp. OED.S12672
Author(s):  
Kagmeni Giles ◽  
Moukouri Ernest ◽  
Domngang Christelle ◽  
Nguefack-Tsague Georges ◽  
Cheuteu Raoul ◽  
...  

We assessed the outcomes of the use of anterior chamber foldable lens for unilateral aphakia correction at the University Teaching Hospital of Yaounde. In this retrospective, non-comparative, consecutive case series study, we reviewed the records of patients who underwent an operation for aphakia correction by the means of injection of an angular supported foldable lens between January 2009 and December 2011 in the University Teaching Hospital Yaounde. Student's paired t-test was carried out to compare preoperative and postoperative visual acuity (VA) and intraocular pressure (TOP). P-values less than 0.05 were considered statistically significant. Twenty-one patients were included in the study; twelve were male (57.1%) and nine were female (42.9%). The mean age was 55.38 ± 17.67 years (range 9–75 years). The mean follow-up duration was 5.95 ± 3.14 months (range 2–12 months). The mean logMAR visual acuity was 1.26 ± 0.46 pre-operatively and 0.78 ± 0.57 post-operatively ( P = 0.003). The change in intraocular pressure was not statistically significant. Complications included intraocular hypertension (over 21 mmHg) in 3 patients (14.3%) and macular edema, pupillar ovalization, and retinal detachment in one patient each. The results indicate that injection of an angular support foldable lens in the anterior chamber is a useful technique for the correction of aphakia in eyes without capsular support. More extended follow-up, however, and a larger series of patients are needed to ascertain the effectiveness and safety of this procedure.


2022 ◽  
Author(s):  
Mahmoud Ekram ◽  
Ahmed Mohamed Kamal Elshafei ◽  
Asmaa Anwar Mohamed ◽  
Mohamed Farouk Sayed Othman Abdelkader

Abstract Purpose: To evaluate the anatomical effects of implantable phakic contact lens (IPCL) (Care Group, India) on anterior segment and its visual outcomes .Patients and methods: In a prospective interventional case series study, 60 highly myopic eyes of 32 patients were subjected to IPCL implantation in the Ophthalmology Department of Minia University Hospital, Egypt from January 2019 to June 2021. All patients had complete ophthalmic examination and were followed up for 1 year. Pentacam was used for preoperative and postoperative estimation of anterior chamber depth (ACD), anterior chamber angle (ACA), anterior chamber volume (ACV) and IPCL vault in the 1st, 3rd, and 12th months. Assessment of corneal endothelium was done using specular microscope preoperatively and after 12 months. Preoperative and postoperative refraction and visual acuity were measured. Results: There was a statistically significant decrease in ACD, ACA, and ACV. There was no significant difference between preoperative and postoperative mean intraocular pressure (IOP) by the 12th month (P=0.163). The mean preoperative endothelial cell count (ECD) was significantly reduced from 2929.3±248 cells/mm2 to 2737.9±303 cells/mm2 at the 12th month (P<0.001). with a statistically highly significant improvement of mean Log Mar uncorrected visual acuity (UCVA) from 1.48±0.19 preoperatively to 0.46±0.11 by the end of follow up (P<0.001) with insignificant difference between preoperative best corrected visual acuity (BCVA) and postoperative UCVA (P=0.209). In the 12th month, the mean vault was 240±540 μm. No sight threatening complications occurred.Conclusion: Although IPCL induced anatomical changes, it was safe and effective for correction of high myopia.


Author(s):  
Manoochehr Ghorbanpour ◽  
Mohammad Ali Seyfrabie ◽  
Babak Yousefi

Objective. Patients undergoing Soave surgery for Hirschsprung's disease are at risk for some complications. The aim of this study was to investigate such short-term and long-term complications and evaluate the outcome of the operation in these patients. Methods. A case series study was carried out during the last 12 years, during 2007 to 2018 in Besat hospital of Hamadan. Data collection conducted using a checklist includes questions about demographic information, clinical features, and short-term and long-term complications, and consequences of post-operative surgery. The findings of the study were analyzed using SPSS software version 20 and appropriate statistical tests. P-value less than 0.05 was considered statistically significant. Results. A total of 55 children underwent Soave surgery during the last 12 years in Besat Hospital Hamadan, Iran. The mean age of the patients was 38±10 days during surgery, of which 56.4% were female. The mean hospital stay was 7.3 days. Also, the mean weight of children at birth was 2970±447 gr. Most of the patients were born as NVD (52.7%) and term (74.5%). The most common comorbidity was congenital heart disease. The most common short-term complication was intestinal obstruction in 14 patients (25.5%) and the most frequent long-term complication was intestinal obstruction and constipation (27.3% each cases). The mortality rate of patients in this study was 14.5% in total. Conclusions. One stage surgical procedure in Hirschsprung's disease is a safe and effective method, but care should be taken in choosing patients and patients should be monitored for possible complications, so that they can be considered and implemented for proper treatment.


2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0032
Author(s):  
Thomas L. Lewis ◽  
Robbie Ray; David Gordon

Category: Bunion Introduction/Purpose: Minimally invasive surgery for hallux valgus has significantly increased in popularity recently due to smaller incisions, reduced soft tissue trauma, and the ability to achieve large deformity corrections compared to traditional treatments. This study aimed to investigate the radiological outcomes and degree of deformity correction of the intermetatarsal angle (IMA) and the hallux valgus angle (HVA) following third generation (using screw fixation) Minimally Invasive Chevron and Akin Osteotomies (MICA) for hallux valgus. Methods: A single surgeon case series of patients with hallux valgus underwent primary, third generation MICA for hallux valgus. Pre- and post-operative (6 weeks after surgery) radiological assessments of the IMA and HVA were based on weight-bearing dorso-plantar radiographs. Radiographic measurements were conducted by two foot & ankle fellowship trained consultant surgeons (RR, DG). Paired t-tests were used to determine the statistically significant difference between pre- and post-operative measurements. Results: Between January 2017 and December 2019, 401 MICAs were performed in 274 patients. Pre- and post-operative radiograph measurements were collected for 348 feet in 232 patients (219 female; 13 male). The mean age was 54.4 years (range 16.3-84.9, standard deviation (s.d.) 13.2). Mean pre-operative IMA was 15.3° (range 6.5°-27.0°, s.d. 3.4°) and HVA was 33.8° (range 9.3°-63.9°, s.d. 9.7°). Post-operatively, there was a statistically significant improvement in radiological deformity correction; mean IMA was 5.3° (range -1.2°-16.5°, s.d. 2.7°, p<0.001) and mean HVA was 8.8° (range -5.2°-24.0°, s.d. 4.5°, p<0.001). The mean post-operative reduction in IMA and HVA was 10.0° and 25.0° respectively. Conclusion: This is the largest case series demonstrating radiological outcomes following third generation Minimally Invasive Chevron and Akin Osteotomies (MICA) for hallux valgus to date. These data show that this is an effective approach at correcting both mild and severe hallux valgus deformities. Longer term radiological outcome studies are needed to investigate whether there is any change in radiological outcomes. Correlation with patient reported outcomes is planned.


2019 ◽  
Vol 267 (1) ◽  
pp. 239-243 ◽  
Author(s):  
Y. Sammaraiee ◽  
G. Banerjee ◽  
S. Farmer ◽  
B. Hylton ◽  
P. Cowley ◽  
...  

Abstract Objective Deferiprone is an iron chelator that has recently been used to treat patients with infratentorial superficial siderosis (iSS). It is considered to have a generally favourable safety profile but concerns have been raised due to the risk of agranulocytosis. We aimed to evaluate the safety and tolerability of oral deferiprone as a treatment for patients with iSS. Methods We present a case series of 10 consecutive patients presenting with classical iSS treated with deferiprone. Results Ten patients were followed up for a mean period of 2.3 years (range 0.5–5.5 years). Four patients (40%) were withdrawn from treatment because of treatment-related side effects. The reasons for treatment discontinuation were neutropenic sepsis (n = 3) and fatigue (n = 1). In 2 out of the 3 cases of neutropenic sepsis, patients initially developed neutropenia without sepsis. The mean time to neutropenic sepsis following deferiprone was 1.2 years (range 0.3–2.5) with mean neutrophil count of 0.4 (range 0.3–0.5). Six patients (60%) reported no change in neurological function while on treatment, and four patients (40%) reported that their condition deteriorated. Conclusions Deferiprone was poorly tolerated, with 40% of patients withdrawing from treatment, most commonly due to neutropenic sepsis, after an average of 2 years on treatment. This study increases the number of reported cases of agranulocytosis in patients with iSS treated with deferiprone. Clinicians treating iSS patients with deferiprone should be aware that this drug has a potentially life-threatening side effect of neutropenic sepsis, and should ensure that appropriate haematological monitoring is in place.


Sign in / Sign up

Export Citation Format

Share Document