Creating a personalized evaluation framework for patient-reported outcomes: an illustration using the EQ-5D visual analogue scale

2018 ◽  
Vol 19 (1) ◽  
pp. 97-104 ◽  
Author(s):  
M. Reaney ◽  
L. Stassek ◽  
M. Martin ◽  
K. McCarrier ◽  
A. Slagle ◽  
...  
Rheumatology ◽  
2020 ◽  
Vol 59 (9) ◽  
pp. 2381-2391 ◽  
Author(s):  
Lewis Carpenter ◽  
Elena Nikiphorou ◽  
Patrick D W Kiely ◽  
David A Walsh ◽  
Adam Young ◽  
...  

Abstract Objectives To examine secular trends in the progression of clinical and patient-reported outcomes in early RA. Methods A total of 2701 patients recruited to the Early Rheumatoid Arthritis Study or Early Rheumatoid Arthritis Network with year of diagnosis from 1986 to 2011. The 5-year progression rates for patients diagnosed at different points in time were modelled using mixed-effects regression; 1990, 2002 and 2010, were compared. Clinical markers of disease included the 28-joint count DAS and the ESR. Patient-reported markers included the HAQ, visual analogue scale of pain and global health, and the Short-Form 36. Results Statistically significant improvements in both 28-joint count DAS and ESR were seen over the 5 years in patients diagnosed with RA compared with those diagnosed earlier. By 5 years, 59% of patients with diagnosis in 2010 were estimated to reach low disease activity compared with 48% with diagnosis in 2002 and 32% with diagnosis in 1990. Whilst HAQ demonstrated statistically significant improvements, these improvements were small, with similar proportions of patients achieving HAQ scores of ≤1.0 by 5 years with a diagnosis in 1990 compared with 2010. Levels of the visual analogue scale and the Mental Component Scores of the Short-Form 36 indicated similar, statistically non-significant levels over the 5 years, irrespective of year diagnosed. Conclusion This study demonstrates improvements in inflammatory markers over time in early RA, in line with improved treatment strategies. These have not translated into similar improvements in patient-reported outcomes relating to either physical or mental health.


2019 ◽  
Vol 90 (3) ◽  
pp. e42.1-e42
Author(s):  
JMW Robins ◽  
L Luo ◽  
F Mallallah ◽  
J Timothy ◽  
D Pal ◽  
...  

ObjectivesTo compare clinical, radiological and complication results between skip laminectomy and cervical laminectomy for posterior cervical decompression for cervical spondylotic myelopathy.DesignRetrospective single institution cohort study.SubjectsSubjects underwent primary skip or cervical laminectomy between 2008–2016.MethodsStatistical analysis compared pre- and post-operative differences in Visual Analogue Scale, Neck Disability Index and radiological differences in sagittal alignment of the vertebral bodies. Analysis of re-operation rates was performed.ResultsA total of 42 and 29 patients had skip and cervical laminectomy respectively. Median follow up was 32±23.1 (Range: 1–325) weeks. Post-operatively there was no difference in patient reported outcomes namely Visual Analogue Scale and Neck Disability Index between skip laminectomy and cervical laminectomy groups compared to pre-operatively (p=0.64, p=0.75). No difference was seen in sagittal alignment between both groups following surgery (p=0.65). Three patients (7.1%) in the skip laminectomy group and two patients (6.9%) in the cervical laminectomy group required revision surgery to the cervical spinal region at a different level to the original surgery. No patients needed further instrumentation.ConclusionsBoth skip laminectomy and cervical laminectomy appear to deliver similar outcomes with regards to patient reported outcomes, preserving sagittal alignment and re-operation rates over this short follow-up period.


2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 167-167
Author(s):  
Eric Van Cutsem ◽  
Prianka Singh ◽  
James M. Cleary ◽  
Ronan Joseph Kelly ◽  
Markus H. Moehler ◽  
...  

167 Background: NIVO is the first adjuvant therapy to provide a statistically significant and clinically meaningful improvement in disease-free survival (DFS) versus PBO in resected EC/GEJC following neoadjuvant chemoradiotherapy as demonstrated by CheckMate 577. NIVO was well tolerated with an acceptable safety profile. This analysis provides additional information on the exploratory HRQoL endpoints in this clinical trial. Methods: The effect of NIVO versus PBO on HRQoL, including general and disease-related symptoms, functioning, disease burden, and overall QoL, was assessed using FACT-E and EQ-5D-3L patient-reported outcome (PRO) questionnaires administered at baseline (BL), every 4 weeks during the 12-month treatment period, and at post-treatment follow-up visits (up to 2 years after last dose). Longitudinal change from BL in PRO scores over 12 months was assessed using descriptive statistics. Additionally, mixed model for repeated measures and time to deterioration analyses evaluated the difference between treatment with NIVO and PBO (data not shown). Results: 794 pts with EC/GEJC were randomized 2:1 to NIVO (n = 532) or PBO (n = 262). PRO completion rates were ≥ 95% at BL and ~ 90% at 12 months on treatment. Mean (SD) BL HRQoL scores were similar between treatment arms for the FACT-E total score (NIVO: 133.40 [20.97]; PBO: 134.03 [20.40]); esophageal cancer subscale (ECS; NIVO: 50.2 [9.3]; PBO: 50.1 [8.9]); EQ-5D Visual Analogue Scale (NIVO: 70.4 [22.3]; PBO: 69.1 [24.1]); and EQ-5D Utility Index (NIVO: 0.820 [0.179]; PBO: 0.831 [0.163]) based on the UK value set. Descriptive analyses showed a trend for increases from baseline at most time points through week 49 for both NIVO and PBO treatment groups for FACT-E total score, ECS, and EQ-5D Visual Analogue Scale and Utility Index. Conclusions: Preliminary results from CheckMate 577 demonstrated that pts on NIVO treatment showed trends of improvement in both esophageal-specific and general HRQoL. Similar trends were also observed in pts treated with PBO over 1 year. Pts treated with NIVO did not experience a reduction in HRQoL, further supporting clinical data to demonstrate treatment benefit and tolerability for adjuvant NIVO in pts with resected EC/GEJC. Clinical trial information: NCT02743494.


Author(s):  
Erika Michele dos Santos Araújo ◽  
Bárbara Fávero Araújo Lima ◽  
Júlia Gomes Lúcio de Araújo ◽  
Fernanda Cristina Nogueira Rodrigues ◽  
Stella Ferreira do Amaral ◽  
...  

Objective: This case report proposes a treatment for dentin hypersensitivity (DH) using photobiomodulation (PBT) with low power diode laser. Methods and Results: Male patient, 28 years old, reporting “dental sensitivity,” diagnosed by anamnesis and intraoral examination, with non-carious cervical lesions (NCCL) and DH on teeth 15 to 25, with different pain intensities, measured with visual analogue scale (VAS). For DH treatment, a PBT was proposed, with 808nm, 100mW, 20s and 2J of energy, applied during 3 sessions, with one-week interval and reevaluation after 30 days. After the first session, the patient reported improvement of sensitivity in all teeth, except for 15, that remained sensitive even during the reevaluation. Conclusion: PBT was effective in DH treatment, with desensitization being observed for 30 days in 90% of treated teeth.


Neurospine ◽  
2021 ◽  
Vol 18 (4) ◽  
pp. 882-888
Author(s):  
Dong-Ho Lee ◽  
Gian Karlo P. Dadufalza ◽  
Jong-Min Baik ◽  
Sehan Park ◽  
Jae Hwan Cho ◽  
...  

Objective: To introduce a new surgical technique - double dome laminoplasty for decompression of the entire C2 lamina and preservation of an extensor muscle insertion.Methods: Eleven consecutive cervical myelopathy patients due to ossification of the posterior longitudinal ligament involving the Axis (C2) area were contained at this study. Direct decompression was evaluated as an increasing rate in space available cord (%) and posterior cord shift (mm) at C2 level. The Japanese Orthopaedic Association (JOA) score, visual analogue scale, and C2–7 Cobb angle in a neutral lateral x-ray were analyzed.Results: The mean increase in space available for spinal cord at the C2 level, average posterior cord shift, and JOA recovery rate were 69.7%, 5.3 ± 0.15 mm, and 58.0%, respectively. Cervical lordotic angle was maintained in all patients. One patient reported neck pain (visual analogue scale 6) postoperatively. No specific complications such as C2 laminar fracture or insufficient decompression were observed.Conclusion: We recommend double dome laminoplasty for treating patients with cervical myelopathy involving the C2 area to avoid C2 laminectomy, reduce postoperative neck pain, and maintain lordotic cervical spine alignment.


2014 ◽  
Vol 20 (1) ◽  
pp. 6-13
Author(s):  
Zuh S.G ◽  
Nagy Ö. ◽  
Zazgyva Ancuța ◽  
Russu O.M. ◽  
Gergely I. ◽  
...  

ABSTRACT Total hip replacement is one of the most frequently performed orthopaedic interventions that can significantly improve the functional status and the quality of life of patients suffering from hip arthrosis. Recently patient satisfaction and patient-reported results of total hip arthroplasty are increasingly emphasised as important tools for the assessments of these interventions. For patients with arthrosis secondary to hip dysplasia, these evaluations can be more difficult, due to younger age and higher functional demands. In this study we compared the Visual Analogue Scale and the Harris Hip Score in order to determine the correlations between these instruments and analyse the possibility of replacing the Harris Score with the Visual Analogue Scale in evaluating the results of hip surgery in patients with dysplastic hips. Our study included 37 women and 4 men (53 hips), with a mean age of 50.96 years (35-58 years), followed for a mean of 4 years postoperatively. Both assessment instruments were used preoperatively and at the follow-up visits. We observed a positive correlation of the values of the Visual Analogue Scale and the Harris Hip Score both preoperatively and postoperatively, with correlation coefficients of +0.71(P <0.001) and +0.77 (P <0.001) respectively. Given these positive correlations, we assumed that the Visual Analogue Scale could replace the Harris Hip Score in the evaluation of patients after total hip replacement. Still it is recommended to combine the Visual Analogue Scale with objective measurements and radiological examination in order to identify significant postoperative changes.


2021 ◽  
Vol 6 (3) ◽  
pp. 300-309
Author(s):  
Iu. O. Pavlova ◽  
◽  
O. B. Fedorovych ◽  
A. V. Perederiy ◽  
K. A. Tymruk-Skoropad

Tools based on patient assessment (Patient-Reported Outcome Measures, PROMs) have significant interest in rehabilitation practice. Nowadays, this approach is considered reliable, trustworthy, and reasonable. Tools that have undergone all stages of adaptation and validation are highly proven and meet international standards, which, in particular, is a guarantee of high-quality survey results. The purpose of the study was to conduct an intercultural adaptation of the Oswestry Disability Index to the Ukrainian language and further verify the validity of this version of the instrument. Materials and methods. The study included individuals who had complaints of back pain (n = 104, 60.6 % females; age (M±SE) – 36.9±1.6 years old). Three different tools were used to assess pain (Oswestry Disability Index, Visual Analogue Scale) and various parameters of life quality (“The MOS 36-Item Short-Form Health Survey”). The internal consistency of the Oswestry Disability Index questionnaire was evaluated (the α-Cronbach’s index was determined), its reliability was studied (according to the test-retest procedure), and correlation and regression analyzes were used to check the constructive validity. The structure of the questionnaire was studied using exploratory factor analysis. Results and discussion. The proposed Ukrainian version of the questionnaire passed all stages of translation and intercultural adaptation, which meets the international standards and requirements of the MAPI Research Trust. In addition to the scientific coordinators, a sufficient number of translators, editor of the scientific literature, and a group of patients were involved in these processes. The questionnaire has high internal consistency (α-Cronbach = 0.931) and reliability (Spearman’s rho = 0.94, p < 0.01). In the structure of the tool, two factors explain 69.165% of the total variance. Issues related to walking and social life were related to the first factor, sitting, standing, traveling – to the second factor, the intensity of pain, self-care, lifting objects, and sex life – were related to both the first and second factors. The questionnaire has a sufficient level of constructive validity. An average correlation with the value of the Visual Analogue Scale (r = 0.547, p < 0.001), a strong correlation with the life quality scale “Physical Functioning” (r = -0.871, p < 0.001) were identified. Conclusion. The Ukrainian version of the Oswestry Disability Index questionnaire can be used to assess the level of pain, physical well-being, and physical component of the life quality of patients who have complaints of back pain


2021 ◽  
pp. 175857322110481
Author(s):  
Gray Alexander Edwards ◽  
Jennifer Coghlan ◽  
Jeff Hughes ◽  
Warwick Wright ◽  
Richard Dallalana ◽  
...  

Background: We report the radiological and functional outcomes at five years in patients with severe osteoarthritis of the glenohumeral joint and a Walch type B glenoid who have undergone stemless anatomic total shoulder replacement. Methods: A retrospective analysis of case notes, computed tomography scans and plain radiographs of patients undergoing anatomic total shoulder replacement for primary glenohumeral osteoarthritis were performed. Patients were grouped by the severity of their osteoarthritis using the modified Walch classification, glenoid retroversion and posterior humeral head subluxation. An evaluation was made using modern planning software. Functional outcomes were assessed using the American shoulder and elbow surgeons score, shoulder pain and disability index and visual analogue scale. Annual Lazarus scores were reviewed as regard to glenoid loosening. Results: Thirty patients were reviewed at 5 years. Analysis of all patient-reported outcome measures demonstrated significant improvement at 5-year review, American shoulder and elbow surgeons ( p = <0.0001), shoulder pain and disability index ( p = 0.0001), visual analogue scale ( p = 0.0001). Radiological associations between Walch scores and Lazarus scores were not statistically significant ( p = 0.1251) at 5 years. There were no associations between features of glenohumeral osteoarthritis and patient-reported outcome measures. Discussion: The severity of osteoarthritis did not show any association with glenoid component survivorship or with patient-reported outcome measures at 5 years review. Level of evidence: IV.


2019 ◽  
Vol 13 (3) ◽  
pp. 207-210
Author(s):  
Calvin J. Rushing ◽  
Steven M. Spinner ◽  
Patrick Hardigan

Background. Recent studies have raised concerns regarding the usefulness of the visual analogue scale (VAS) as an effective outpatient patient-reported outcome measure (PROM), with disparate scores reported during the same encounter to a nurse versus physician. The purpose of present study was to assess the VAS reported by new patient referrals to 2 different physicians of varying training levels (resident, attending), during the same initial outpatient encounter. Methods. One hundred and one patients treated by a single foot and ankle surgeon were included in the retrospective cohort. Each patient was asked to rate their pain intensity by a resident, and then by the attending surgeon using a standard horizontal VAS 0 to 10, from “no pain” to the “worst pain.” Differences in reported scores were analyzed. Results. Overall, the mean VAS reported to the residents (4.97 ± 2.75) and the attending surgeon (5.02 ± 2.71) were not significantly different ( P = .61). On the 11-point scale, the mean difference accounted for only 0.05 points. Conclusion. Taken into consideration with previous studies, the data suggest collection personnel may influence the reported VAS, possibly owing to patients’ preferences and perception of their care. Although the exact reasons remain unclear, our findings lend credence to the previous concerns expressed regarding the subjective nature of the VAS. Levels of Evidence: Level III: Comparative study


2020 ◽  
pp. 175857322091324
Author(s):  
Fabrizio Brindisino ◽  
Tiziana Indaco ◽  
Giuseppe Giovannico ◽  
Diego Ristori ◽  
Lorenza Maistrello ◽  
...  

Background Health-related patient reported outcome measures are considered essential to determine the impact of disease on the life of individuals. Aim of this study is to culturally adapt the Italian version of the Shoulder Pain and Disability Index (SPADI). The secondary aim is to evaluate psychometric proprieties in patients with non-specific shoulder pain. Methods The current study is an analysis of a sample of 59 adult patients with non-specific shoulder pain. The SPADI was translated and cross-culturally adapted, and then psychometric properties were tested. Participants completed the Shoulder Pain and Disability Index-Italian (SPADI-I), 36-item short form health survey, the Oxford Shoulder Score, the Disability of Arm, Shoulder, and Hand scale and a pain intensity visual analogue scale. Results SPADI-I included two domains. Internal consistency analysis showed good values for total (α = 0.84) and subscales (α = 0.94 and α = 0.76). For construct validity, there was good correlation between the visual analogue scale, the Oxford Shoulder Score, the DASH and the SPADI-I total score and subscales. Standard error of measurement and minimally detectable change were calculated. Conclusions The SPADI-I was culturally adapted into Italian. SPADI-I is centred on pain and disability of the shoulder only and can be considered as a useful tool in daily clinical practice for assessing musculoskeletal non-specific shoulder pain because of its good internal consistency and validity. Further studies should focus on other psychometric proprieties such as test re-test reliability, responsiveness and clinical interpretability to improve the available clinimetrics of the tool.


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