External validation of the patient reported Villalta scale for the diagnosis of post-thrombotic syndrome.

Abstract The absence of a specific tool to evaluate the impact of Supportive care in general and socioesthetics in particular as a rendered medical service is undoubtedly at the origin of the lack of published research based on scientific standards.In this context, we developed one supportive-care patient-reported outcome [PRO] using the multistep methods following COSMIN recommendations. Its construction followed all recommended steps: elaboration of the questionnaire, measurement properties of the questionnaire, internal and external validation, test-retest validation and translation, cross-cultural adaptation and cognitive debriefing. In total, our questionnaire includes11 items. It is scored by adding each VAS, making it range from 0 to 110, with a higher benefit when the score is higher. The Cronbach’s α coefficient is 0.88 for the entire questionnaire. The questionnaire thus constructed is a reflection of the patient's feelings, and it is quite natural that the name The “patient centricity questionnaire” (PCQ) was retained and validated by the Scientific Committee. The PCQ correlated negatively and moderately with the PSS, positively and moderately with the mental dimension of the and poorly with the WB12, the physical dimension of the SF-12 and the satisfaction EVA. Constructed according to the recommendations, the PCQ meets the prerequisite for this type of questionnaire. Its short format (11 questions) and simplicity of use allow it to be used by a large number of people and provides an pragmatic answer by making available to research teams a simple, reliable, easy-to-use and validated tool. It makes possible randomized studies to prove the impact on quality of life of the Supportive care in general and socioesthetics" in particular.

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PO-0712 A new prediction model for patient reported xerostomia; external validation in postoperative setting

Radiotherapy and Oncology ◽

10.1016/s0167-8140(19)31132-6 ◽

2019 ◽

Vol 133 ◽

pp. S365-S366

Author(s):

H.P. Van der Laan ◽

L. Van den Bosch ◽

A. Van der Schaaf ◽

R.J.H.M. Steenbakkers ◽

H.P. Bijl ◽

...

Keyword(s):

Prediction Model ◽

External Validation ◽

Patient Reported ◽

Postoperative Setting

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Novel patient-specific visual analogue survey (PVS) is validated in patients treated with collagenase injection for Dupuytren’s disease

Journal of ISAKOS Joint Disorders & Orthopaedic Sports Medicine ◽

10.1136/jisakos-2019-000301 ◽

2019 ◽

Vol 5 (1) ◽

pp. 3-9

Author(s):

Stephen L Lyman ◽

Jayme Burket Kotsov ◽

Chisa Hidaka ◽

Quynh Tran ◽

Naomi Roselaar ◽

...

Keyword(s):

Effect Size ◽

External Validation ◽

Patient Specific ◽

Dupuytren’S Contracture ◽

Post Injection ◽

Retest Reliability ◽

Dupuytren's Contracture ◽

Number Of Patients ◽

Patient Reported ◽

Test Retest Reliability

ObjectivesWe developed and validated an electronically administered patient-specific visual analogue survey (PVS) to evaluate changes in hand function after treatment with injectable collagenase clostridium histolyticum (CCH) in Dupuytren’s contracture. The items in the PVS were authored and ranked in importance by the patients.MethodsIn an open-label trial for patients with Dupuytren’s contracture receiving CCH injection, 109 patients completed the PVS on the day of injection, day of manipulation and 30-day follow-up. For external validation, patients also completed standard patient-reported outcome measures, the Overall Treatment Effects Scale and QuickDASH, and underwent physician assessment of contracture via goniometry and the table top test.ResultsResponses were highly individualised with no single activity being chosen as important by more than 8% of patients. Sports-related activities were mentioned most often (23%). The PVS was highly responsive to changes in patients’ conditions with CCH injection (effect size=1.49), much more so than the QuickDASH (effect size=0.50). Additionally, the PVS had no floor or ceiling effects, whereas the QuickDASH ceiling approached 20% post-injection. The PVS had excellent internal consistency (Cronbach’s α=0.95) and correlated strongly with the QuickDASH post-injection (Spearman’s=−0.67). PVS scores were significantly higher for patients reporting their condition had improved versus those reporting no change after injection. The test–retest reliability of the PVS was poor to fair, in part due to allowing patients to choose different activities at test and retest. However, test–retest reliability was good (intraclass correlation coefficient >0.7) and better than QuickDASH among patients who rated the same activities at test and retest.ConclusionsThe PVS is simple to administer and enables individualised assessment in a large number of patients. It is also readily adaptable for use in other diseases, particularly within musculoskeletal medicine.Level of evidenceTherapeutic II: Prospective cohort.

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Initial experience with a new pharmacomechanical thrombectomy device for deep venous thrombosis: Report of 91 cases

Phlebology The Journal of Venous Disease ◽

10.1177/0268355519833235 ◽

2019 ◽

Vol 34 (10) ◽

pp. 707-714

Author(s):

Şahin Bozok ◽

Kaptanıderya Tayfur

Keyword(s):

Venous Thrombosis ◽

Deep Venous Thrombosis ◽

Color Doppler ◽

Early Period ◽

Efficacy And Safety ◽

Duration Of Symptoms ◽

Post Thrombotic Syndrome ◽

Tertiary Center ◽

Patient Reported ◽

Thrombectomy Device

Background To evaluate the efficacy and safety of pharmacomechanical thrombectomy using a new rotational thrombectomy device with additional thrombus-removal methods for deep venous thrombosis. Methods A total of 91 patients admitted to our tertiary center with symptomatic iliac, ilio-femoral, femoro-popliteal deep venous thrombosis and who underwent hybrid pharmacomechanical thrombectomy constituted the study group. Postinterventional color Doppler ultrasonography was repeated at 1st, 6th, and 12th months. Villalta scoring system was used to evaluate the patients for the development of post-thrombotic syndrome after deep venous thrombosis. The patient-reported severity of pain in the index leg was measured on a Likert scale. Results Of the 91 patients whose charts were reviewed, the location of thrombus was iliofemoral in 60 (65.9%) and femoropopliteal in 31 (34.1%) patients, respectively. Duration of symptoms was 5.62 ± 3.43 (range, 2–15) days. Technical success was observed in 82 patients (90.1%) at 3 months, in 77 patients (84.6%) at 6 months, and in 74 patients (81.3%) at 12 months. Villalta score was over 10 points in 15 of 17 patients whose Doppler US revealed venous occlusions, at 12 months, and in 8 patients with recurrent deep venous thrombosis. Post-thrombotic syndrome was detected in 18 patients in our study. Twelve (13.2%) of these 18 patients had mild, 5 (5.5%) moderate, and 1 (1.1%) severe PTS. In predicting predisposing factors in 18 patients with PTS, 13 patients (72.2%) had a Villalta score ≥10, 10 patients (55.6%) had experienced a delayed endovascular procedure (≥10 days), and 8 patients (44.4%) had recurrent deep venous thrombosis. Conclusion The endovenous pharmacomechanical thrombectomy with the Mantis thrombectomy device in the treatment of acute and subacute iliofemoral deep venous thrombosis is a promising approach in terms of efficacy and safety in the early period regarding reasonable and long-term prevention of post-thrombotic syndrome, development of pulmonary thromboembolism, and adequate venous system patency.

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Construct Validity of DSM-5 Level 2 Assessments (PROMIS Depression, Anxiety, and Anger): Evidence From the MMPI-2-RF

Assessment ◽

10.1177/1073191120911092 ◽

2020 ◽

pp. 107319112091109

Author(s):

Anthony M. Tarescavage ◽

Emma H. Forner ◽

Yossef Ben-Porath

Keyword(s):

Construct Validity ◽

Convergent Validity ◽

Minnesota Multiphasic Personality Inventory ◽

Outcome Measurement ◽

External Validation ◽

Patient Reported Outcome ◽

Measurement Information ◽

Short Forms ◽

Patient Reported ◽

Future Revision

The Patient Reported Outcome Measurement Information System (PROMIS) is a NIH-funded measure that has item banks assessing a variety of physical, social, and mental health domains. Short forms from the emotional distress item bank (which includes measures of Depression, Anxiety, and Anger) were included in the Diagnostic and Statistical Manual for Mental Disorders–Fifth edition as emerging measures to be administered at intake to aid diagnosis and throughout treatment to track progress. The purpose of the current study was to further investigate the PROMIS distress item bank’s construct validity using the Minnesota Multiphasic Personality Inventory–2–Restructured Form (MMPI-2-RF). The sample included 344 college students (119 males, 225 females) who were administered the MMPI-2-RF and the PROMIS Anxiety, Anger, and Depression short forms. Zero-order correlations between the PROMIS scales and the Restructured Clinical Scales and Internalizing Specific Problems Scales were examined. Overall, these results suggest that scores from the PROMIS Anxiety, Anger, and Depression scales evidence convergent validity but have problematic construct validity (particularly for Depression). Future revision of the scales should be considered and sufficient external validation evidence should be available for review before psychological assessments are recommended and distributed for widespread clinical use.

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Comparison of Performance of Two Clinical Scales To Diagnose the Post-Thrombotic Syndrome: Correlation with Patient-Reported Disease Burden and Valvular Reflux.

Blood ◽

10.1182/blood.v106.11.4114.4114 ◽

2005 ◽

Vol 106 (11) ◽

pp. 4114-4114

Author(s):

Susan R. Kahn ◽

Sylvie Desmarais ◽

Thierry Ducruet ◽

Louise Arsenault ◽

Jeffrey S. Ginsberg ◽

...

Keyword(s):

Severe Disease ◽

Chronic Venous Disease ◽

Leg Pain ◽

Venous Disease ◽

Objective Criterion ◽

Clinical Scales ◽

Post Thrombotic Syndrome ◽

Sf 36 ◽

Patient Reported ◽

Disease Specific

Abstract Background and Objectives: There is no objective, criterion standard test to diagnose the post thrombotic syndrome (PTS). Two clinical scales have been used to classify deep vein thrombosis (DVT) patients as having or not having the PTS: the Villalta scale and the Ginsberg measure. Differences in test characteristics of these measures could help explain differing rates of PTS reported after DVT. During a Canadian prospective cohort study of long-term outcomes after DVT (The VETO Study), we carried out a substudy to evaluate agreement between the Villalta and Ginsberg measures with regard to (1) proportion of patients classified as having PTS; (2) relation to patient-reported quality of life (QOL); and (3) correlation with venous valvular reflux, a physiological indicator of chronic venous disease. Methods: For this substudy, 259 VETO patients were assessed for ipsilateral PTS at the 1 year follow-up visit using both the Villalta scale (grades the severity of 5 symptoms and 6 signs from 0–3; a summed total score of ≥5 indicates PTS, and >14 or presence of ulcer indicates severe PTS) and the Ginsberg PTS measure (PTS defined by the presence of daily leg pain and swelling for ≥ 1 month, occurring 6 months or more after DVT, made worse by standing/walking and relieved by rest/leg elevation). Patients also completed generic (SF-36) and disease-specific (VEINES-QOL) QOL questionnaires and underwent a standardized ultrasound assessment for ipsilateral popliteal venous valvular reflux. We compared the proportion of patients classified as having PTS with each measure and assessed associations with QOL and valvular reflux. Results: Proportion of patients classified as having PTS was 96/259 (37%) (5/96 severe) with the Villalta scale and 21/259 (8.1%) with the Ginsberg measure (kappa 0.22; 95% CI 0.13, 0.32). Agreement between measures was better for severe PTS than for any PTS. For both measures, generic and disease specific-QOL scores were significantly lower (i.e. poorer QOL) in patients with vs. without PTS; however, QOL was worse in patients with Ginsberg-PTS than in patients with Villalta-PTS. Reflux was not significantly associated with PTS for either measure. Conclusions: The proportion of patients classified as having PTS was more than 4-fold higher with the Villalta measure than with the Ginsberg measure. While both measures showed a graded association with QOL, patients with Ginsberg-PTS had poorer QOL and higher mean Villalta scores, indicating that the Ginsberg measure identifies more severe disease. The presence of reflux was not discriminating for the diagnosis of PTS with either measure. Comparison of Villalta and Ginsberg PTS measures Villalta PTS Ginsberg PTS Mean (SD) YES NO p YES NO p Villalta score 8.3 (3.1) 1.6 (1.4) <.0001 9.2 (3.5) 3.6 (3.4) <.0001 SF-36 MCS (mental) 49.5 (12.1) 54.2 (8.3) .0007 47.3 (12.6) 52.9 (9.7) 0.01 SF-36 PCS (physical) 39.7 (11.0) 49.1 (10.0) <.0001 35.0 (12.4) 46.8 (10.8) <.0001 VEINES-QOL 48.6 (6.1) 56.2 (2.5) <.0001 44.1 (5.6) 54.2 (5.1) <.0001 Reflux present (%) 54.6% 44.0% 0.12 52.6% 46.2% 0.59

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Predictors Of The Post-Thrombotic Syndrome In a Large Cohort Of Patients With Proximal DVT: Secondary Analysis Of The Sox Trial

Blood ◽

10.1182/blood.v122.21.460.460 ◽

2013 ◽

Vol 122 (21) ◽

pp. 460-460

Author(s):

Susan R. Kahn ◽

Stan Shapiro ◽

Philip S. Wells ◽

Marc A Rodger ◽

Michael J. Kovacs ◽

...

Keyword(s):

Intervention Group ◽

Secondary Analysis ◽

Iliac Vein ◽

Study Endpoint ◽

Primary Study ◽

Reference Category ◽

Post Thrombotic Syndrome ◽

Patient Reported ◽

Category Score

Background The post-thrombotic syndrome (PTS) is a frequent complication of deep venous thrombosis (DVT). Identifying predictors of PTS is important to counsel DVT patients on their expected prognosis and to identify patients who may benefit from closer monitoring or preventive strategies. Objective In a secondary analysis of the SOX Trial, we aimed to identify predictors of developing PTS during 2 years follow-up after a first episode of proximal DVT. Methods The study cohort consisted of participants in the SOX Trial, a multicenter (24 centres in Canada and U.S.) randomized placebo controlled trial of active elastic compression stockings vs. placebo stockings worn for 2 years after a first, symptomatic proximal DVT. PTS, the primary study endpoint, was diagnosed at or after the 6 month visit based on patient-reported pain and swelling of ≥ 1 month duration that were typical in character, i.e. worse at end of day or after prolonged sitting/standing and improved after rest/leg elevation (Ginsberg criteria). Cumulative incidences of PTS were compared in subgroups defined by sex, age category, body mass index (BMI) category, anatomic extent of index DVT, type of DVT (cancer-associated, secondary risk factor-associated, unprovoked) and 1-month Villalta score category (score 0-4: none; 5-9, mild; 10-14, moderate; >14, severe), using Cox regression. Losses to follow-up, withdrawals and deaths were censored as of last date of follow-up. Results are presented as cumulative incidence by 750 days follow-up and hazard ratios (HR) with 95% confidence intervals (CI). Results Among the 803 participants in the SOX Trial, 60% were male, mean age was 55.1 years, and 87% were out-patients. In analyses adjusted for intervention group (i.e. allocation to active vs. placebo stockings), iliac vein DVT (HR 2.26 [95% CI 1.12, 4.53]; reference category: popliteal DVT) and Villalta score category at 1 month after DVT (score 5-9, HR 2.74 [95% CI 1.62, 4.64]; score 10-14, HR 5.81[95% CI 2.99, 11.29]; score >14, HR 7.59 [95% CI 3.31, 17.44]; reference category: score <5) were significant predictors of PTS. In analyses adjusted for intervention group and all predictor variables of interest, Villalta score category at 1 month was a highly statistically significant, independent predictor of PTS (see Table). Age, sex, BMI and type of DVT did not predict development of PTS. Conclusions In a large prospective cohort of patients with proximal DVT who were participants in the SOX Trial, Villalta score category (which reflects severity of venous symptoms and signs) at 1 month after DVT was strongly predictive of development of PTS during 2 years follow-up. This confirms a similar finding that we first observed in the VETO cohort study (Kahn SR et. al., Annals Intern Med 2008). More extensive DVT was also associated with PTS. Patients with these risk factors may benefit from closer monitoring after proximal DVT, and in the case of iliac vein DVT, from more aggressive strategies to treat acute DVT. Disclosures: No relevant conflicts of interest to declare.

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Evaluating Methodological Quality of Prognostic Prediction Models on Patient Reported Outcome Measurements after Total Hip Replacement and Total Knee Replacement Surgery: a systematic review protocol

10.21203/rs.3.rs-903247/v1 ◽

2021 ◽

Author(s):

Wei-Ju Chang ◽

Justine Naylor ◽

Pragadesh Natarajan ◽

Spiro Menounos ◽

Masiath Monuja ◽

...

Keyword(s):

Systematic Review ◽

Knee Osteoarthritis ◽

Prediction Model ◽

Methodological Quality ◽

Prediction Models ◽

External Validation ◽

Model Development ◽

Patient Reported ◽

Modelling Studies

Abstract Background Prediction models for poor patient-reported surgical outcomes after total hip replacement (THR) and total knee replacement (TKR) may provide a method for improving appropriate surgical care for hip and knee osteoarthritis. There are concerns about methodological issues and the risk of bias of studies producing prediction models. A critical evaluation of the methodological quality of prediction modelling studies in THR and TKR is needed to ensure their clinical usefulness. This systematic review aims to: 1) evaluate and report the quality of risk stratification and prediction modelling studies that predict patient-reported outcomes after THR and TKR; 2) identify areas of methodological deficit and provide recommendations for future research; and 3) synthesise the evidence on prediction models associated with post-operative patient-reported outcomes after THR and TKR surgeries. Methods MEDLINE, EMBASE and CINAHL electronic databases will be searched to identify relevant studies. Title and abstract and full-text screening will be performed by two independent reviewers. We will include: 1) prediction model development studies without external validation; 2) prediction model development studies with external validation of independent data; 3) external model validation studies; and 4) studies updating a previously developed prediction model. Data extraction spreadsheets will be developed based on the CHARMS checklist and TRIPOD statement and piloted on two relevant studies. Study quality and risk of bias will be assessed using the PROBAST tool. Prediction models will be summarised qualitatively. Meta-analyses on the predictive performance of included models will be conducted if appropriate. Discussion This systematic review will evaluate the methodological quality and usefulness of prediction models for poor outcomes after THR or TKR. This information is essential to provide evidence-based healthcare for end-stage hip and knee osteoarthritis. Findings of this review will contribute to the identification of key areas for improvement in conducting prognostic research in this field and facilitate the progress in evidence-based tailored treatments for hip and knee osteoarthritis. Systematic review registration: Submitted to PROSPERO on 30 August 2021.

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Development and Validation of a Practical Two-Step Prediction Model and Clinical Risk Score for Post-Thrombotic Syndrome

Thrombosis and Haemostasis ◽

10.1055/s-0038-1655743 ◽

2018 ◽

Vol 118 (07) ◽

pp. 1242-1249 ◽

Cited By ~ 8

Author(s):

Elham Amin ◽

Sander van Kuijk ◽

Manuela Joore ◽

Paolo Prandoni ◽

Hugo ten Cate ◽

...

Keyword(s):

Deep Vein Thrombosis ◽

Acute Phase ◽

External Validation ◽

Individual Risk ◽

Baseline Model ◽

Vein Thrombosis ◽

Clinical Risk ◽

Post Thrombotic Syndrome ◽

The Individual ◽

Deep Vein

Background Post-thrombotic syndrome (PTS) is a common chronic consequence of deep vein thrombosis that affects the quality of life and is associated with substantial costs. In clinical practice, it is not possible to predict the individual patient risk. We develop and validate a practical two-step prediction tool for PTS in the acute and sub-acute phase of deep vein thrombosis. Methods Multivariable regression modelling with data from two prospective cohorts in which 479 (derivation) and 1,107 (validation) consecutive patients with objectively confirmed deep vein thrombosis of the leg, from thrombosis outpatient clinic of Maastricht University Medical Centre, the Netherlands (derivation) and Padua University hospital in Italy (validation), were included. PTS was defined as a Villalta score of ≥ 5 at least 6 months after acute thrombosis. Results Variables in the baseline model in the acute phase were: age, body mass index, sex, varicose veins, history of venous thrombosis, smoking status, provoked thrombosis and thrombus location. For the secondary model, the additional variable was residual vein obstruction. Optimism-corrected area under the receiver operating characteristic curves (AUCs) were 0.71 for the baseline model and 0.60 for the secondary model. Calibration plots showed well-calibrated predictions. External validation of the derived clinical risk scores was successful: AUC, 0.66 (95% confidence interval [CI], 0.63–0.70) and 0.64 (95% CI, 0.60–0.69). Conclusion Individual risk for PTS in the acute phase of deep vein thrombosis can be predicted based on readily accessible baseline clinical and demographic characteristics. The individual risk in the sub-acute phase can be predicted with limited additional clinical characteristics.

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P193 Validation of the two-item UC patient-reported outcome (PRO2) against the simple clinical colitis activity index (SCCAI), measures of biochemical disease activity and quality of life

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.322 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S234-S235

Author(s):

M Samaan ◽

G Cunningham ◽

G Tamilarasan ◽

S Ray ◽

J Mawdsley ◽

...

Keyword(s):

Quality Of Life ◽

Disease Activity ◽

Induction Therapy ◽

Activity Index ◽

External Validation ◽

Clinical Disease ◽

Predictive Values ◽

Clinical Disease Activity ◽

Patient Reported

Abstract Background Patient-reported outcomes (PRO) have an increasingly important role in IBD. This is true of monitoring of disease activity in clinical practice and as well as the evaluation of new therapies, when used as clinical trial endpoints. An interim two-item PRO (PRO2) has been developed for UC that ranges from 0–6 and consist of the patient-derived items from the Mayo score (rectal bleeding and stool frequency). PRO2 was internally validated against endoscopic outcomes. We aimed to add external validation across a range of clinical, biochemical and quality of life outcomes. Methods Data were collected as part of the GO-LEVEL study, an open-label, phase IV, investigator-initiated study (NCT03124121) which included a prospective cohort of UC patients commencing golimumab induction therapy, as well as a cross-sectional cohort receiving maintenance treatment. Patients commencing induction therapy all had disease activity objectively confirmed and were evaluated at weeks 6, 10 and 14. Patients receiving maintenance therapy were recruited either at the point of flare or during stable remission. Clinical disease activity was evaluated using PRO2 and SCCAI, quality of life using IBD-Control as well as a 100mm visual analogue scale (IBD-Control-VAS), and biochemical activity using FC and CRP. Clinical remission was defined as a score of <3 using SCCAI, or 0 using PRO2. Correlations were calculated using Spearman’s correlation coefficient (rs) and contingency table analyses using Chi-square. Results GO-LEVEL included a total of 112 patients across the two study cohorts. A total of 217 PRO2 assessments were made with concurrent SCCAI and IBD-Control scores available at all timepoints. CRP measurements were available at 214 of these and FC at 207. Strong correlations were observed between PRO2 and SCCAI (rs = 0.94, p < 0.0001), as well as with IBD-Control (rs=−0.82, p < 0.0001) and IBD-Control-VAS (rs = −0.78, p < 0.0001). Significant correlations were also seen between PRO2 and FC (rs = 0.38, p < 0.0001) as well as PRO2 and CRP (rs=0.31, p < 0.0001). Of the 217 assessments, 109 were in SCCAI defined remission, 95 were in PRO2 defined remission and the two were highly contingent (p < 0.0001). The sensitivity and specificity of disease activity assessments made with PRO2 vs. SCCAI were 0.85 and 0.98, respectively. The positive and negative predictive values were 0.98 and 0.87, respectively. Conclusion The PRO2 performs well when validated against an established clinical disease activity index (SCCAI), quality-of-life assessments and biochemical markers of disease activity. PRO2 assessments have the benefit of being more rapid to administer (comprising of only two items) than SCCAI (6 items), whilst providing similar and accurate evaluations of remission status.

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