scholarly journals Evaluating Time to Pain Progression in Multiple Myeloma

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2299-2299
Author(s):  
Jessica K Roydhouse ◽  
Vishal Bhatnagar ◽  
Mallorie H. Fiero ◽  
Bellinda L King-Kallimanis ◽  
Daniel L. Suzman ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Pain Score ◽  
Rating Scale ◽  
Palliative Radiotherapy ◽  
Brief Pain Inventory ◽  
Numeric Rating Scale ◽  
Lower Threshold ◽  
Opioid Analgesia ◽  
Threshold Levels ◽  
Patient Reported

Abstract Patient-reported outcomes (PROs) are increasingly assessed as part of trials for new medical treatments for multiple myeloma. Pain, particularly bone pain, is an important symptom for patients with myeloma. Although time to pain progression has been evaluated as an endpoint in prostate cancer trials, this endpoint has yet to be applied in multiple myeloma despite the importance of this symptom. We sought to evaluate key issues for defining time to pain progression endpoints using two trials of anti-myeloma products submitted to the FDA. We combined data from two trials, each of which used the 0-10 point worst pain intensity numeric rating scale (0=best, 10=worst) from the Brief Pain Inventory (BPI). We evaluated changes of +1 to +5 points from pre-treatment baseline as deterioration thresholds. We considered deterioration events to be durable if patient scores did not improve by the threshold at the next visit. Event timing and frequency were evaluated using descriptive statistics. Opioid analgesia and pain-relieving procedures such as palliative radiotherapy were also assessed. We evaluated data from 1,368 patients in the pooled intention-to-treat (ITT) populations. At lower threshold levels (+2 to +3 points), 37 - 49% of patients experienced deterioration events. Of the patients with deterioration at lower threshold levels (+2 to +3 points), 39% - 44% had durable deterioration. Deterioration was less durable at higher threshold levels (+4 to +5 points), where 28% - 33% of patients with deterioration had durable deterioration. Additionally, fewer patients had deterioration events at higher threshold levels (16% - 25%). However, even if patients improved by the next visit and did not have durable deterioration, they often deteriorated again at a later timepoint; at a threshold of +5 points, >40% of patients experienced a second deterioration of +5 points after improving. Among those patients who deteriorated but then subsequently improved, pain relief through either opioid analgesia or pain-relieving procedures was used by 52% - 63% in the ITT population. For patients with minimal pain (score of <=4) or no pain (score of 0) at baseline, pain-relieving measures were used less frequently at lower deterioration thresholds (<50% of patients in either population for thresholds of +1 to +3), but more frequently at higher deterioration thresholds (47% - 62%). In conclusion, lower deterioration thresholds result in more frequent and durable events. However, patients often deteriorate, improve, and then deteriorate again. As patients may remain on clinical trials for long periods, researchers interested in assessing time to the first (durable) deterioration should clearly justify this approach. Additionally, the assessment of deterioration durability may be complicated by measures such as the use of opioid analgesia, vertebroplasty, and palliative radiotherapy. As pain is an important myeloma symptom and capturing the patient's experience while on therapy is critical, further research to better characterize patient pain while on trial is needed. Disclosures King-Kallimanis: Pharmerit International: Employment.

scholarly journals Comparison of Pregabalin and Placebo Effects in Treating Eye Pain Following Cataract Surgery by Phacoemulsification Method

2021 ◽  
Author(s):  
Fardin Yousefshahi ◽  
Hossein Majedi Ardakani ◽  
Mehdi Sanatkar ◽  
Reza Atef Yekta ◽  
Alireza Takzare ◽  
...  
Keyword(s):  
Cataract Surgery ◽  
Pain Score ◽  
Rating Scale ◽  
Brief Pain Inventory ◽  
Numeric Rating Scale ◽  
Double Blind ◽  
Eye Pain ◽  
Double Blind Clinical Trial ◽  
Corneal Damage ◽  
The Impact

Cataract surgery sometimes is associated with adverse effects, such as dryness, burning, and patient discomfort. This study evaluates the treatment of dry eye syndrome and pain caused by corneal damage following cataract surgery with pregabalin compared to placebo. In our double-blind clinical trial, a total of 60 cases were divided into two groups. The pain score was assessed by the Numeric Rating Scale (NRS), and the impact of pain and dryness on the patient's performance was evaluated by the Brief Pain Inventory (BPI). The patient's pain score was evaluated postoperatively and followed for six weeks after the procedure. After the sixth week of the study, NRS, BPI, and photophobia in the pregabalin group were significantly different from the placebo group. Pregabalin can significantly reduce chronic and resistant eye pain after cataract surgery.

scholarly journals Trajectories of fatigue in actively treated patients with established rheumatoid arthritis starting biologic DMARD therapy

RMD Open ◽  
2020 ◽  
Vol 6 (3) ◽  
pp. e001372
Author(s):  
Sella Aarrestad Provan ◽  
Brigitte Michelsen ◽  
Joseph Sexton ◽  
Tillmann Uhlig ◽  
Hilde Berner Hammer
Keyword(s):  
Rheumatoid Arthritis ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Tender Joint Count ◽  
Tender Joint ◽  
Logistic Regression Models ◽  
Patient Reported ◽  
Biologic Dmard ◽  
Clinically Significant

ObjectivesTo define fatigue trajectories in patients with rheumatoid arthritis (RA) who initiate biological DMARD (bDMARD) treatment, and explore baseline predictors for a trajectory of continued fatigue.MethodsOne-hundred and eighty-four patients with RA initiating bDMARDs were assessed at 0, 1, 2, 3, 6 and 12 months. Swollen and tender joint counts, patient reported outcomes (PROMs), blood samples and ultrasound examinations were collected at each time point. Fatigue was assessed by the fatigue Numeric Rating Scale (0–10) from the Rheumatoid Arthritis Impact of Disease (RAID) questionnaire. Clinically significant fatigue was predefined as fatigue ≥4. Three trajectories of interest were defined according to level of RAID fatigue: no fatigue (≤3 at 5/6 visits), improved fatigue (≥4 at start, but ≤3 at follow-up) and continued fatigue (≥4 at 5/6 visits). Baseline variables were compared between groups by bivariate analyses, and logistic regression models were used to explore baseline predictors of continued vs improved fatigue.ResultsThe majority of patients starting bDMARD therapy followed one of three fatigue trajectories, (no fatigue; n=61, improved; n=33 and continued fatigue; n=53). Patients with continued fatigue were more likely to be anti–citrullinated protein antibody and/or rheumatoid factor positive and had higher baseline PROMs compared to the other groups, while there were no differences between the groups for variables of inflammation including. Patient global, tender joint count and anxiety were predictors for the continued fatigue trajectory.DiscussionA trajectory of continued fatigue was determined by PROMs and not by inflammatory RA disease activity.

Differences in calculated percentage improvement versus patient-reported percentage improvement in pain scores: a review of spinal cord stimulation trials

2021 ◽  
pp. rapm-2020-102238
Author(s):  
Jonathan M Hagedorn ◽  
Timothy R Deer ◽  
Nicholas C Canzanello ◽  
Stephen M Covington ◽  
Darrell R Schroeder ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Pain Scale ◽  
Concordance Correlation ◽  
Percentage Improvement ◽  
Patient Reported ◽  
The Mean ◽  
Numeric Rating

IntroductionSpinal cord stimulation is frequently used for the treatment of intractable chronic pain conditions. Trialing of the spinal cord stimulator device is recommended to assess the patient’s response to neurostimulation before permanent implantation. The trial response is often assessed by Numeric Rating Scale changes and patient-reported percentage pain improvement. Using number rating scale changes between prespinal and postspinal cord stimulation trial, a calculated percentage pain improvement can be obtained. The aim of this study was to assess the difference between calculated and patient-reported percentage improvement in pain scale during spinal cord stimulation trials.MethodsThis study was a retrospective single center review of all spinal cord stimulation trials from January 1 2017 to July 1 2019. A total of 174 patients were included. The paired t-test was used to compare numeric pain scores obtained prestimulation versus poststimulation. The mean difference between methods (patient-reported minus calculated) was compared with zero using the 1-sample t-test. Lin’s concordance correlation coefficient was computed with a 95% CI, calculated using Fisher z-transformation; and a bootstrapping approach was used to compare the concordance correlation coefficient between groups. In all cases, two-tailed tests were used with p<0.05 considered statistically significant.ResultsBased on prestimulation and poststimulation numeric rating scale scores, the mean±SD calculated percentage improvement in pain scale was 54±28. The mean±SD patient-reported percentage improvement in pain scale was 59±25. The overall 95% limits of agreement for the two methods are −30% to +41%. The overall concordance correlation coefficient was 0.76 (95% CI 0.69 to 0.81).ConclusionAlthough the two methods are highly correlated, there is substantial lack of agreement between patient-reported and calculated percentage improvement in pain scale, suggesting that these measures should not be used interchangeably for spinal cord stimulator trial outcome assessment. This emphasizes the need for improved metrics to better measure patient response to neuromodulation therapies. Additionally, patient-reported percentage improvement in pain was found to be higher than calculated percentage improvement in pain, potentially highlighting the multidimensional experience of pain and the unpredictability of solely using Numeric Rating Scale scores to assess patient outcomes.

scholarly journals Patient-reported outcome measurement compared with professional judgment of cosmetic results after breast-conserving therapy

2018 ◽  
Vol 25 (6) ◽  
Author(s):  
A.T.P.M. Brands-Appeldoorn ◽  
A.J.G. Maaskant-Braat ◽  
W.A.R Zwaans ◽  
J.P. Dieleman ◽  
K.E. Schenk ◽  
...  
Keyword(s):  
Rating Scale ◽  
Outcome Measurement ◽  
Intraclass Correlation ◽  
Scoring Systems ◽  
Breast Conserving Therapy ◽  
Numeric Rating Scale ◽  
Cosmetic Outcome ◽  
Professional Judgment ◽  
Size And Shape ◽  
Patient Reported

Background In the present study, we set out to compare patient reported outcomes with professional judgment about cosmesis after breast-conserving therapy (bct) and to evaluate which items (position of the nipple, color, scar, size, shape, and firmness) correlate best with subjective outcome.Methods Dutch patients treated with bct between 2008 and 2009 were analyzed. Exclusion criteria were prior amputation or bct of the contralateral breast, metastatic disease, local recurrence, or any prior cosmetic breast surgery. Structured questionnaires and standardized six-view photographs were obtained with a minimum of 3 years’ follow-up. Cosmetic outcome was judged by the patients and, based on photographs, by 5 different medical professionals using 3 different scoring systems: the Harvard scale, the Sneeuw questionnaire, and a numeric rating scale. Agreement was scored using the intraclass correlation coefficient (icc). The association between items of the Sneeuw questionnaire and a fair–poor Harvard score was estimated using logistic regression analysis.Results The study included 108 female patients (age: 40–91 years). Based on the Harvard scale, agreement on cosmetic outcome between the professionals was good (icc: 0.78). In contrast, agreement between professionals as a group compared with the patients was found to be fair to moderate (icc range: 0.38–0.50). The items “size” and “shape” were identified as the strongest determinants of cosmetic outcome.Conclusions Cosmetic outcome was scored differently by patients and professionals. Agreement was greater between the professionals than between the patients and the professionals as a group. In general, size and shape were the most prominent items on which cosmetic outcome was judged by patients and professionals alike.

Exploration of pain management following implementation of WHO pain guidelines

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19646-19646
Author(s):  
S. Subongkot ◽  
S. Khounnikhom ◽  
N. Pratheepawanit Johns ◽  
A. Sookprasert
Keyword(s):  
Pain Management ◽  
Pain Score ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Cross Sectional Study ◽  
P Value ◽  
Cross Sectional ◽  
Daily Life Activities ◽  
Naive Group ◽  
Who Guideline

19646 Background: Pain is among the most common symptoms encountered in cancer patients and remains the first priority of care. Methods: This cross sectional study aimed to explore a pattern of pain management at KKU Hospital by utilizing a numeric rating scale (0–10). Cancer pain patients were categorized based on prior analgesic exposure into two groups; Naïve group, and Routine group. Treatments were defined according to WHO as 1) drug treatment relevant to pain severity, 2) analgesics being prescribed as around-the- clock and 3) analgesics used for break-through pain for patients receiving strong opioid. Results: From Dec 2005 to Jul 2006, 261 patients were enrolled. 93.1% (n=243) were in advanced stages and 88.5% (n=231) were in moderate to severe pain. This pain interfered with patient’s daily life activities mildly to moderately as each pain score increased (p-value<0.01). In Naive group (n=159), 32.7% (n=52) were given analgesics following the WHO on both days 1 and day 3 of admission whereas 40.2% (n=64) patients were not. A decreased pain score was greater (2.61, SD±1.5) in a group following the WHO on day 1. Additionally, a decreased pain score was greater (3.91, SD±1.8) in a group following the WHO on day 3 (p-value <0.0001). This pain score decreased was also clinically significant as pain score reduced more than 3 points. In Routine group (n=102), 32 (31.4%) were given analgesics following the WHO guideline on both day 1 and day 3 of admission. In contrast, 36 (35.3%) were not. A decreased pain score was greater (2.59, SD±1.8) in a routine group following the WHO on day 1. Moreover, a decreased pain score was greater (3.95, SD±1.8) in a group following the WHO on day 3. The clinical significance of pain score reduced was also found on day 3. Of the 261 evaluable patients, the pattern of analgesics usage following the WHO guideline was increased in both groups comparing to at the beginning of the study. Conclusions: The results demonstrated that patients who received pain management following the WHO guideline reported significantly lower pain intensity than those not following the WHO. No significant financial relationships to disclose.

Oral mucositis is associated with increased resource use among patients receiving treatment for cancers of the head and neck

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6070-6070
Author(s):  
D. M. Keefe ◽  
A. Garden ◽  
A. Barasch ◽  
R. Tischler ◽  
M. Brennan ◽  
...  
Keyword(s):  
Head And Neck ◽  
Oral Mucositis ◽  
Resource Use ◽  
Rating Scale ◽  
Mucosal Injury ◽  
Numeric Rating Scale ◽  
Oral Manifestation ◽  
Validated Questionnaire ◽  
Patient Reported ◽  
Multicenter Prospective Study

6070 Background: Oral mucositis (OM) is the oral manifestation of mucosal injury (MUI), and is a common, bothersome, and treatment-interrupting toxicity of chemoradiation therapy for squamous cell cancers (SCC) of the head and neck. Retrospective studies have reported that OM increases healthcare resource use. We present interim results of an international, multicenter, prospective study undertaken to characterize the clinical and economic burden of OM in patients with cancers of the oral cavity (OC), oropharynx (OP), larynx (L) and hypopharynx (HP). Methods: Patients (pts) with histologically proven SCC of the designated anatomical sites, whose planned treatment included full-cycle conventional or intensity modulated (IM) radiation therapy (RT) with or without chemotherapy, were enrolled at least one week prior to the start of treatment. Pts completed the Oral Mucositis Daily Questionnaire (OMDQ), a validated questionnaire developed to document patient-reported symptoms of OM and MUI including mouth and throat soreness (MTS), at baseline and daily throughout RT. MTS was assessed using a 5-point numeric rating scale, ranging from 0 (“no soreness”) to 4 (“extreme soreness”). Results: Of the first 61 pts to complete RT, 72% had cancers of the OC or OP, 49% received IMRT with concomitant chemotherapy, and 68% were male. 95% of pts reported OM symptoms (MTS>0); 80% had one or more scores =2. Pts with OC or OP cancers reported more symptoms than those with L or HP tumors (mean maximum score: 3.3 vs 2.8; p= 0.12). MTS scores were positively related to levels of resource use. Conclusions: Symptoms of radiation-induced OM are positively correlated with levels of resource utilization in patients with head and neck cancers. No significant financial relationships to disclose. [Table: see text]

scholarly journals PENGARUH MADU TERHADAP TINGKAT NYERI DISMENORE DAN KUALITAS HIDUP MAHASISWI FAKULTAS KEDOKTERAN UNIVERSITAS PEMBANGUNAN NASIONAL VETERAN JAKARTA

2021 ◽  
Vol 12 (1) ◽  
pp. 39-50
Author(s):  
Nurfitri - Bustamam ◽  
Cut - Fauziah ◽  
Meiskha - Bahar
Keyword(s):  
Scoring System ◽  
Rating Scale ◽  
Brief Pain Inventory ◽  
Numeric Rating Scale ◽  
Consecutive Sampling ◽  
Numeric Rating

Latar belakang: Prevalensi dismenore diperkirakan berkisar antara 45–95 persen dan 10–25 persen diantaranya merupakan dismenore primer berat. Dismenore dapat menimbulkan sejumlah masalah, antara lain limitasi aktivitas, penurunan prestasi akademik, dan kesulitan tidur. Saat ini, terdapat kecenderungan penggunaan herbal dan pengobatan alternatif untuk mengatasi dismenore primer. Tujuan: Penelitian ini bertujuan untuk mengetahui pengaruh madu terhadap tingkat nyeri dismenore dan kualitas hidup mahasiswi Fakultas Kedokteran Universitas Pembangunan Nasional Veteran Jakarta (FKUPNVJ). Metode: Penelitian menggunakan one group pretest-posttest design. Sebanyak 30 subjek yang ditentukan dengan consecutive sampling  diminta minum madu sebanyak dua sendok makan yang dimulai dari dua hari sebelum menstruasi hingga hari ketiga menstruasi. Data diambil menggunakan kuesioner, Numeric Rating Scale, Verbal Multidimensional Scoring System, dan Brief Pain Inventory. Hasil: Hasil uji Wilcoxon menunjukkan madu dapat menurunkan intensitas nyeri (p = 0,000) dan grade dismenore (p = 0,001). Selain mengurangi derajat nyeri, madu dapat mengurangi lama waktu nyeri menstruasi dari 2 hari menjadi 1 hari (p = 0,001). Hasil uji Wilcoxon juga menunjukkan madu dapat mengurangi gangguan dismenore terhadap aktivitas secara umum, suasana hati, kemampuan berjalan, pekerjaan, hubungan dengan orang lain, tidur, dan menikmati hidup (p ≤ 0,001). Kesimpulan: madu dapat menurunkan tingkat nyeri dan meningkatkan kualitas hidup mahasiswi FKUPNVJ dengan dismenore primer.  Kata kunci: dismenore primer, kualitas hidup, madu, mahasiswi

Predictors of the Best Outcomes Following Minimally Invasive Surgery for Grade 1 Degenerative Lumbar Spondylolisthesis

Neurosurgery ◽  
2020 ◽  
Author(s):  
Andrew K Chan ◽  
Erica F Bisson ◽  
Mohamad Bydon ◽  
Steven D Glassman ◽  
Kevin T Foley ◽  
...  
Keyword(s):  
Minimally Invasive Surgery ◽  
Back Pain ◽  
Minimally Invasive ◽  
Invasive Surgery ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Leg Pain ◽  
Degenerative Lumbar Spondylolisthesis ◽  
Patient Reported ◽  
Lumbar Spondylolisthesis

Abstract BACKGROUND The factors driving the best outcomes following minimally invasive surgery (MIS) for grade 1 degenerative lumbar spondylolisthesis are not clearly elucidated. OBJECTIVE To investigate the factors that drive the best 24-mo patient-reported outcomes (PRO) following MIS surgery for grade 1 degenerative lumbar spondylolisthesis. METHODS A total of 259 patients from the Quality Outcomes Database lumbar spondylolisthesis module underwent single-level surgery for degenerative grade 1 lumbar spondylolisthesis with MIS techniques (188 fusions, 72.6%). Twenty-four-month follow-up PROs were collected and included the Oswestry disability index (ODI) change (ie, 24-mo minus baseline value), numeric rating scale (NRS) back pain change, NRS leg pain change, EuroQoL-5D (EQ-5D) questionnaire change, and North American Spine Society (NASS) satisfaction questionnaire. Multivariable models were constructed to identify predictors of PRO change. RESULTS The mean age was 64.2 ± 11.5 yr and consisted of 148 (57.1%) women and 111 (42.9%) men. In multivariable analyses, employment was associated with superior postoperative ODI change (β-7.8; 95% CI [−12.9 to −2.6]; P = .003), NRS back pain change (β −1.2; 95% CI [−2.1 to −0.4]; P = .004), EQ-5D change (β 0.1; 95% CI [0.01-0.1]; P = .03), and NASS satisfaction (OR = 3.7; 95% CI [1.7-8.3]; P &lt; .001). Increasing age was associated with superior NRS leg pain change (β −0.1; 95% CI [−0.1 to −0.01]; P = .03) and NASS satisfaction (OR = 1.05; 95% CI [1.01-1.09]; P = .02). Fusion surgeries were associated with superior ODI change (β −6.7; 95% CI [−12.7 to −0.7]; P = .03), NRS back pain change (β −1.1; 95% CI [−2.1 to −0.2]; P = .02), and NASS satisfaction (OR = 3.6; 95% CI [1.6-8.3]; P = .002). CONCLUSION Preoperative employment and surgeries, including a fusion, were predictors of superior outcomes across the domains of disease-specific disability, back pain, leg pain, quality of life, and patient satisfaction. Increasing age was predictive of superior outcomes for leg pain improvement and satisfaction.

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