scholarly journals Development and content validation of a symptom assessment for eosinophilic gastritis and eosinophilic gastroenteritis in adults and adolescents

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Calvin N. Ho ◽  
Sean O’Quinn ◽  
Julie Bailey ◽  
Oren Meyers ◽  
Ashley F. Slagle ◽  
...  
Keyword(s):  
Rating Scale ◽  
Numerical Rating Scale ◽  
Symptom Assessment ◽  
Eosinophilic Gastroenteritis ◽  
Symptom Improvement ◽  
Cognitive Debriefing ◽  
Validity And Reliability ◽  
Treatment Benefit ◽  
Eosinophilic Gastritis ◽  
Patient Reported

Abstract Background A patient reported outcome (PRO) instrument with evidence of validity and reliability for assessing symptoms of eosinophilic gastritis (EG) and eosinophilic gastroenteritis (EGE) is needed to measure treatment benefit in clinical trials. The aim of this research is to develop an EG/EGE symptom PRO instrument for patients aged 12 and above. Methods The Symptom Assessment for Gastrointestinal Eosinophilic Diseases (SAGED) was developed through a literature review, discussions with expert clinicians, and concept elicitation and cognitive debriefing interviews with patients. Patients (n = 28) were recruited based on confirmed diagnosis and self-reported symptoms. The final instrument was translated and linguistically validated with additional cognitive debriefing interviews (n = 105). Results SAGED is a 24-h recall questionnaire consisting of eight items evaluating the core symptoms of EG and EGE (abdominal pain, nausea, bloating, early satiety, loss of appetite, vomiting, and diarrhea). Seven of the eight items are evaluated on an 11-point numerical rating scale ranging from ‘none’ to ‘worst imaginable’. Cognitive debriefing interviews showed that adults and adolescents understand the content and are able to select a response that reflects their experience. The linguistic validation process produced 21 translations that are understandable to patients and conceptually equivalent to the source version. Conclusions SAGED is suitable for measuring symptom improvement in adult and adolescent patients with EG and/or EGE. The content validity of SAGED has been established through best practices in qualitative research for PRO instrument development. The psychometric properties of SAGED will be evaluated in a future study.

scholarly journals Development of symptom-focused outcome measures for advanced and indolent systemic mastocytosis: the AdvSM-SAF and ISM-SAF©

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Fiona Taylor ◽  
Cem Akin ◽  
Roger E. Lamoureux ◽  
Brad Padilla ◽  
Tanya Green ◽  
...  
Keyword(s):  
Systemic Mastocytosis ◽  
Signs And Symptoms ◽  
Symptom Assessment ◽  
Patient Reported Outcome ◽  
Therapeutic Area ◽  
Cognitive Debriefing ◽  
Treatment Benefit ◽  
Patient Reported ◽  
Symptom Level ◽  
Indolent Systemic Mastocytosis

Abstract Background Advanced systemic mastocytosis (AdvSM), indolent systemic mastocytosis (ISM), and smoldering systemic mastocytosis (SSM) are rare diseases characterized by neoplastic mast cell infiltration of more than one organ. A content-valid patient-reported outcome (PRO) questionnaire that assesses relevant signs and symptoms that are important and understandable to individuals with a condition is critical for assessing new treatment benefit as well as supporting product labeling claims. Notably, no such PRO questionnaire has been developed in accordance with regulatory and scientific guidelines for use in AdvSM, ISM, and SSM patient populations. To fill that gap, this study documents the development and content validity of instruments evaluating signs and symptoms of systemic mastocytosis. Methods A review of peer-reviewed literature, advice meetings with clinical therapeutic area experts, patient concept elicitation interviews, concept selection and questionnaire construction meetings, and patient cognitive debriefing interviews were conducted, and regulatory feedback was incorporated. Results For AdvSM, 26 sign- and symptom-level concepts were identified in literature, 39 by clinicians, and 33 by patients. For ISM/SSM, 38 sign- and symptom-level concepts were identified in the literature, 39 by clinicians, and 57 by patients. Two patient-reported instruments, the Advanced Systemic Mastocytosis Symptom Assessment Form (AdvSM-SAF) and Indolent Systemic Mastocytosis Symptom Assessment Form (ISM-SAF)(©Blueprint Medicines Corporation), were developed based on consolidated findings. Cognitive debriefing interviews with AdvSM and ISM patients showed the AdvSM-SAF and ISM-SAF were understood and interpreted as intended by the majority of patients. Conclusion The AdvSM-SAF and ISM-SAF are content-valid tools measuring symptoms from AdvSM and ISM patients’ perspective.

Cancer symptom scale preferences: does one size fit all?

2016 ◽  
Vol 8 (2) ◽  
pp. 198-203 ◽  
Author(s):  
Kirby Jeter ◽  
Siobhan Blackwell ◽  
Lucy Burke ◽  
David Joyce ◽  
Catherine Moran ◽  
...  
Keyword(s):  
Rating Scale ◽  
Numerical Rating Scale ◽  
Eastern Cooperative Oncology Group ◽  
Symptom Assessment ◽  
Response Scale ◽  
Symptom Scale ◽  
Appetite Loss ◽  
Cancer Symptoms ◽  
Individual Scale ◽  
Loss Of Appetite

ObjectivesPatients with advanced cancer do not report all symptoms, so assessment is best done systematically. However, for such patients, completion rates of some symptom instruments are <50%. Symptoms can be quantified by various scales including the Categorical Response Scale (CRS), Numerical Rating Scale (NRS) and Visual Analogue Scale (VAS). Patient preferences for CRS, NRS and VAS in symptom assessment and their clinical utility in 3 cancer symptoms: pain, tiredness and appetite loss were determined.MethodsA prospective survey was conducted involving cancer admissions to a 36-bed palliative care unit.Results100 inpatients were recruited, aged 38–93 years (x̅ =71 years; SD=11.6), with median Eastern Cooperative Oncology Group (ECOG) scores of 2 (range 0–4). VAS was the least preferred measure. 52% of patients choose the same scale for all 3 symptoms and 44% for 2, with 4% choosing a different individual scale per symptom. There was moderate agreement between participant scale preference and observer determined ease of scale completion (loss of appetite: κ=0.36; pain: κ=0.49; tiredness: κ=0.45). Participants preferred CRS for appetite loss (48%) and tiredness (40%) and NRS for pain (44%).ConclusionsVAS was the least favoured scale and should be used cautiously in this population. Most participants had a scale preference with high intrapatient consistency between scales. CRS was preferred for appetite loss and tiredness and NRS for pain. Consideration should be given to individualised cancer symptom assessment according to patient scale preference.

scholarly journals Effect of Mirogabalin on Chemotherapy-Induced Peripheral Neuropathy Caused by Gemcitabine Plus Nab-Paclitaxel Therapy in Pancreatic Cancer Patients: A Pilot Study

2021 ◽  
Author(s):  
Yusuke Takasaki ◽  
Toshio Fujisawa ◽  
Mako Ushio ◽  
Sho Takahashi ◽  
Wataru Yamagata ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Peripheral Neuropathy ◽  
Pilot Study ◽  
Adverse Events ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Sensory Neuropathy ◽  
Life Questionnaire ◽  
European Organization ◽  
Patient Reported

Abstract Purpose: Gemcitabine/nab-paclitaxel (GnP) therapy is widely used to treat pancreatic cancer (PC), but chemotherapy-induced peripheral neuropathy (CIPN) is common. Mirogabalin is a novel drug for treating peripheral neuropathy. We investigated the effects of mirogabalin on CIPN due to GnP therapy in PC patients.Methods: This was a single-center retrospective pilot study. Patients who had previously received or were currently receiving GnP for PC and had taken mirogabalin for at least 2 weeks for CIPN, were included. Patients completed a questionnaire about their symptoms before and after taking mirogabalin. The primary outcome was the change in numbness and tingling scores on the patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Secondary outcomes were the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire–Chemotherapy-Induced Peripheral Neuropathy (QLQ-CIPN20) (Japanese version) score, numerical rating scale (NRS) pain score, and adverse events (AEs).Results: Increased numbness and tingling severity (1.84 vs. 1.76; P=0.63) and interference with daily life (1.42 vs. 1.44; P=0.80) were not seen in any of the 25 enrolled patients. The scores on the sensory subscale of the QLQ-CIPN improved significantly after treatment (17.5 vs. 15.7; P=0.02). AEs occurred in 22 patients (88%), but there were no serious AEs (≥ grade 3).Conclusions: Mirogabalin may control the progression of CIPN caused by GnP therapy in PC patients, and improved sensory neuropathy significantly in our patients. However, since the incidence of AEs is high, mirogabalin should be used with caution.

scholarly journals 12-Month Cohort Study to Investigate Changes in Patient-Reported Outcomes Pain after Intra-articular Injection of Micro-Fragmented Adipose Tissue for Knee Osteoarthritis

2021 ◽  
Vol 3 (1) ◽  
pp. e19-e28
Author(s):  
Nathan Hogaboom ◽  
Ella D'Amico ◽  
Ken Mautner ◽  
Christopher Rogers ◽  
Gerard Malanga
Keyword(s):  
Quality Of Life ◽  
Adipose Tissue ◽  
Knee Osteoarthritis ◽  
Outcome Measures ◽  
Knee Pain ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Symptomatic Knee ◽  
Patient Reported

BackgroundTo evaluate changes in pain, function, and quality of life after treatment with injected micro-fragmented adipose tissue (MFAT) for knee osteoarthritis in a large cohort of individuals treated at multiple centers. MethodsOne hundred ten individuals were recruited from three private outpatient clinics. Participants had to be diagnosed with symptomatic knee OA (defined by persistent knee pain associated with clinical symptoms of OA and/ or classic imaging findings) and who had not received prior knee surgery or treatment with platelet-rich plasma, cortisone, or hyaluronic acid within the previous 6 weeks. Data from 120 knees were included in the analysis. Outcome measures included Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales (pain, symptoms, activities of daily living [ADL], sports and recreation, quality of life [QOL]) and an 11-point Numerical Rating Scale (NRS) for average knee pain over the past week. Outcomes were collected at baseline and 3, 6, and 12 months. ResultsSignificant increases and decreases in KOOS subscale and NRS scores were observed, respectively, in the cohort as a whole (p< .05). Lower BMI was associated with more significant improvements in pain, sports/recreation, and ADL KOOS subscale scores (p< .05). Greater age was associated with more significant improvements in symptoms and QOL subscale scores (p< .05). ConclusionsA single injection of MFAT improved pain, function, and QOL outcome measures up to 12 months in this cohort for more than half of the participants. Greater BMI and lower age negatively influenced outcomes. It is not known whether improvements continue after this timeframe or why many participants reported little-to-no improvement.

scholarly journals Addition of Fusion to Decompression for Grade I Degenerative Lumbar Spondylolisthesis is Associated With Greater Patient-Reported Outcome Improvements at Twenty-Four-Month Follow-Up: A Multicenter Study Using the Quality Outcomes Database

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Jian Guan ◽  
Erica F Bisson ◽  
Mohamad Bydon ◽  
Mohammed A Alvi ◽  
Steven D Glassman ◽  
...  
Keyword(s):  
Rating Scale ◽  
Numerical Rating Scale ◽  
Primary Outcome Measure ◽  
Patient Reported Outcome ◽  
Leg Pain ◽  
Quality Outcomes ◽  
Degenerative Lumbar Spondylolisthesis ◽  
Patient Reported ◽  
Lumbar Spondylolisthesis

Abstract INTRODUCTION Extensive investigation has not ascertained the ideal surgical management of grade 1 lumbar spondylolisthesis. Using the large, multicenter, prospectively collected Quality Outcomes Database (QOD), we compared 24-mo outcomes for patients undergoing decompression alone vs decompression and fusion. METHODS Patients undergoing single-level surgery from 7/1/2014 to 6/30/2016 were identified. The primary outcome measure, 24-mo Oswestry Disability Index (ODI) change, was analyzed with univariate and multivariable linear regression. EQ-5D scores, numerical rating scale (NRS) back and leg pain scores, and North American Spine Society patient satisfaction scores were also analyzed. RESULTS Of the 608 patients (85.5% with at least 24-mo follow-up) who met the inclusion criteria, 140 (23.0%) underwent decompression alone and 468 (77.0%) underwent decompression and fusion. The 24-mo change in ODI was significantly greater in the fusion group than the decompression-only group (−25.8 ± 20.0 vs −15.2 ± 19.8, P < .001). Fusion remained independently associated with 24-mo ODI change in our multivariable model (B = −7.05, 95% CI 10.70-3.39, P = < .001). Patients in the fusion group were significantly more likely to reach minimal clinically important difference (MCID, 12.8 points) in ODI at 24 mo (73.3% vs 56.0%, P = < .001), and to experience significantly greater NRS back pain improvement at 24-mo follow-up (3.8 ± 3.1 vs −1.8 ± 3.9, P < .001). Fusion was also independently associated with achieving MCID for ODI at 24 mo in our logistic regression model (OR 1.767, 95% CI 1.058-2.944, P = .029). CONCLUSION The results of our study suggest that decompression plus fusion may offer superior outcomes to decompression alone in patients with grade 1 lumbar spondylolisthesis at 24 mo. Longer-term follow-up is warranted to assess whether this effect is sustained.

A Clinical Case Demonstrating the Effectiveness of an Individualized Multimodal Intervention for Chronic Pain and Cognitive Sequelae Secondary to Traumatic Brain Injury

2019 ◽  
Vol 18 (5) ◽  
pp. 344-360
Author(s):  
Rosanna Scott ◽  
Megan Sherod
Keyword(s):  
Traumatic Brain Injury ◽  
Chronic Pain ◽  
Brain Injury ◽  
Cognitive Rehabilitation ◽  
Satisfaction With Life ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Satisfaction With Life Scale ◽  
Pain Rating ◽  
Patient Reported

Chronic pain and cognitive difficulties are common secondary to traumatic brain injury (TBI); however, given the vast heterogeneity in TBI presentation, no empirically supported treatments specific to TBI exist. This case demonstrates the effectiveness of an empirically informed multimodal treatment, in which treatment components were selected based on the patient’s individual symptoms and delivered in a manner cognizant of the patient’s cognitive profile. Treatment incorporated components of cognitive behavioral therapy, physical intervention, mindfulness, sleep hygiene, distress tolerance, and cognitive rehabilitation. Pain, sleep, and therapy-related activities were logged daily. Treatment progress was further measured with the Beck Depression Inventory–II, Beck Anxiety Inventory, Satisfaction With Life Scale, and Insomnia Severity Index. The patient reported a significant reduction in pain (average pain rating reduced from 8.5-9 to 6.90 on the numerical rating scale [NRS]) and reported experiencing his least painful day in “years” (i.e., pain rating of 3). The patient reported improvements in mood and sleep, increased engagement in physical/other pleasant activities, and improved academic performance. The patient is currently not pursuing opioids or surgical intervention for pain. This case demonstrates the importance of utilization of neuropsychological data in the identification of treatment goals, appropriate treatment selection, and implementation of suitable techniques. This approach can provide neurologically atypical individuals with interventions that better address their symptom presentation and maximize prognosis.

Approach to the Assessment and Management of Adult Patients With Atopic Dermatitis: A Consensus Document. Section II: Tools for Assessing the Severity of Atopic Dermatitis

2018 ◽  
Vol 22 (1_suppl) ◽  
pp. 10S-16S ◽  
Author(s):  
Melinda J. Gooderham ◽  
Robert Bissonnette ◽  
Parbeer Grewal ◽  
Perla Lansang ◽  
Kim A. Papp ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Disease Severity ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Life Quality ◽  
Severity Index ◽  
Adult Patients ◽  
Physician Global Assessment ◽  
Atopic Dermatitis Severity ◽  
Patient Reported

Clinicians rely on clinical measures to define the severity of atopic dermatitis and assess outcomes of therapy. These measures can be objective (ie, physician assessments of disease severity) or subjective (ie, patient-reported symptoms and quality of life outcomes). In this review, the most commonly used tools for assessing atopic dermatitis severity in adult patients are presented and compared. These include Eczema Area and Severity Index (EASI); SCORing Atopic Dermatitis (SCORAD); Physician Global Assessment (PGA); body surface area (BSA); Atopic Dermatitis Severity Index (ADSI); Six Area, Six Sign Atopic Dermatitis (SASSAD); Patient Oriented Eczema Measure (POEM); Dermatology Life Quality Index (DLQI); and pruritus Numerical Rating Scale (NRS). Available severity strata for the tools are summarized, although the use of severity strata in clinical practice is not recommended. Since both objective and subjective assessments of disease severity are important to assess, consideration of clinical characteristics such as disease recurrence or persistence, as well as location of the affected areas, should be considered in the overall judgement of disease severity and consideration of therapy choice.

scholarly journals Pain Predicts Function One Year Later: A Comparison across Pain Measures in a Rheumatoid Arthritis Sample

2016 ◽  
Vol 2016 ◽  
pp. 1-8
Author(s):  
Vivian Santiago ◽  
Karen Raphael ◽  
Betty Chewning
Keyword(s):  
Rheumatoid Arthritis ◽  
Pain Intensity ◽  
Severe Pain ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Functional Limitations ◽  
Measurement Scale ◽  
Impact Measurement ◽  
Patient Reported ◽  
One Year

Background. Guidance is limited on best measures and time periods to reference when measuring pain in order to predict future function. Objective. To examine how different measures of pain predict functional limitations a year later in a sample of rheumatoid arthritis patients. Methods. Logistic regression analyses were conducted using baseline and one-year data (n=262). Pain intensity in the last 24 hours was measured on a 0–10 numerical rating scale and in the last month using an item from the Arthritis Impact Measurement Scale 2 (AIMS2). AIMS2 also provided frequency of severe pain, pain composite scores, and patient-reported limitations. Physician-rated function was also examined. Results. Composite AIMS2 pain scale performed best, predicting every functional outcome with the greatest magnitude, a one-point increase in pain score predicting 21% increased odds of limitations (combined patient and physician report). However, its constituent item—frequency of severe pain in the last month—performed nearly as well (19% increased odds). Pain intensity measures in last month and last 24 hours yielded inconsistent findings. Conclusion. Although all measures of pain predicted some functional limitations, predictive consistency varied by measure. Frequency of severe pain in the last month provided a good balance of brevity and predictive power.

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