Development and validation of a tool for patient reporting of symptoms and signs of the post-thrombotic syndrome

2016 ◽  
Vol 115 (02) ◽  
pp. 361-367 ◽  
Author(s):  
Kristin Kornelia Utne ◽  
Waleed Ghanima ◽  
Siv Foyn ◽  
Susan Kahn ◽  
Per Morten Sandset ◽  
...  

SummaryPost-thrombotic syndrome (PTS) is a long-term complication of deepvein thrombosis (DVT). The Villalta scale is the recommended tool for diagnosing PTS, but requires a clinician’s assessment in addition to patient self-assessment. In the present study, we validated a self-administered tool for patient reporting of leg symptoms and signs as a mean to assess PTS. We first validated a form for patient self-reported Villalta (PRV1), then developed and validated a visually assisted form (PRV2). The validity of PRV1 and PRV2 was assessed in patients diagnosed with DVT between 2004 and 2012. Median time from DVT to inclusion was 5.1 and 3.5 years for PRV1 (n=162) and PRV2 (n=94), respectively. Patients were requested to complete the PRV form before a scheduled visit. PTS diagnosed by the original Villalta scale during the visit served as the reference method. PRV1 showed only moderate agreement for diagnosing PTS compared with the original Villalta scale (kappa agreement 0.60, 95 % CI 0.48–0.72), whereas PRV2 showed very good agreement (0.82, 95 % CI 0.71–0.94). In the validation of PRV2, PTS was diagnosed in 54 (57 %) patients according to the original Villalta scale and in 60 (64 %) by PRV2. The sensitivity of PRV2 to detect PTS was 98 % and the specificity was 83 %. We conclude that the visually assisted form for PRV is a valid and sensitive tool for diagnosing PTS. Such a tool could be applied in further clinical studies of PTS, making studies less resource demanding by reducing the need for in-person clinic visits.Supplementary Material to this article is available online at www.thrombosis-online.com.

1980 ◽  
Vol 8 (6) ◽  
pp. 375-381 ◽  
Author(s):  
A J Gordon ◽  
T F Estabrooks ◽  
P Dessain

Thirty-eight investigators in Belgium, Finland, Germany, Italy and The Netherlands participated in a long-term follow-up of 154 patients who had shown adequate response without toleration problems in a short-term multicentre trial in osteoarthrosis. Patients were from 37 to 85 years of age (mean 63) and 68% were female. They received piroxicam from 92 to 344 days (mean 182). The starting dose of 20 mg once daily was maintained throughout for 69% of patients; for 12% the final dose was 30 mg, for 16% it was 10 mg, and for 3% it was 40 mg. Forty-seven per cent of patients reported they were taking concurrent anti-inflammatory/analgesic medication at baseline but by the end of therapy only 18% were. Most patients had moderate or severe involvement in one or more of the knee, hip, spine, shoulder, and finger joints. By the final visit, between 84% and 94% showed marked or moderate improvement in the physician's assessment of joint tenderness and limitation of motion. These results were in good agreement with patient self assessment: 83% to 90% reported marked or moderate improvement in ability to move and use joints and in their general overall feeling (‘quality of life’ measurement). Furthermore, steady improvement was observed throughout therapy in patient self-assessment of pain and stiffness relative to baseline. The 50% to 60% pain reduction recorded over the short-term (6 to 12 weeks) reached 70% at the end of therapy. The figures for stiffness were 50% to 55% short-term and 61% long-term. Onset of morning pain which occurred on the average within 1 hour of waking at baseline had risen to 8.4 hours (740% increase) by the end of therapy. The drug was well tolerated with sixteen patients (10%) reporting side-effects attributed to piroxicam. Nearly all were mild or moderate and occurred without disruption of therapy during the first 1 or 2 months of treatment. Most adverse reactions were upper gastro-intestinal but there were no reports of ulceration. One patient, with gastro-intestinal pain after 99 days on drug, was discontinued. In their global evaluation, physicians judged the efficacy of piroxicam as marked in 71%, moderate in 24%, slight in 4%, and not effective in 1% of patients. Toleration was considered excellent in 83%, good in 14 %, fair in 2%, and poor in only 1%. Compared to prior therapy, piroxicam was rated by the investigators as better in 90% of the 114 assessable cases. The results suggest that patients with osteoarthrosis who respond well to piroxicam during a short course of treatment are likely to continue their good response and possibly obtain increased relief of symptoms during longer treatment periods.


2012 ◽  
pp. 19-25
Author(s):  
Mikhail Mikhailovsky ◽  
◽  
Elena Gubina ◽  
Aleksandr Sergunin ◽  
Vyacheslav Novikov ◽  
...  

Author(s):  
Kenneth P. De Meuse ◽  
Guangrong Dai ◽  
Selamawit Zewdie ◽  
Ronald C. Page ◽  
Larry Clark ◽  
...  

Author(s):  
Behnam Jahangiri ◽  
Punyaslok Rath ◽  
Hamed Majidifard ◽  
William G. Buttlar

Various agencies have begun to research and introduce performance-related specifications (PRS) for the design of modern asphalt paving mixtures. The focus of most recent studies has been directed toward simplified cracking test development and evaluation. In some cases, development and validation of PRS has been performed, building on these new tests, often by comparison of test values to accelerated pavement test studies and/or to limited field data. This study describes the findings of a comprehensive research project conducted at Illinois Tollway, leading to a PRS for the design of mainline and shoulder asphalt mixtures. A novel approach was developed, involving the systematic establishment of specification requirements based on: 1) selection of baseline values based on minimally acceptable field performance thresholds; 2) elevation of thresholds to account for differences between short-term lab aging and expected long-term field aging; 3) further elevation of thresholds to account for variability in lab testing, plus variability in the testing of field cores; and 4) final adjustment and rounding of thresholds based on a consensus process. After a thorough evaluation of different candidate cracking tests in the course of the project, the Disk-shaped Compact Tension—DC(T)—test was chosen to be retained in the Illinois Tollway PRS and to be presented in this study for the design of crack-resistant mixtures. The DC(T) test was selected because of its high degree of correlation with field results and its excellent repeatability. Tailored Hamburg rut depth and stripping inflection point thresholds were also established for mainline and shoulder mixes.


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