The Post-VTE Functional Status Scale for assessment of functional limitations in patients with venous thromboembolism: construct validity and responsiveness in a prospective cohort study

Introduction Venous thromboembolism (VTE) is a common disease with various long-term sequelae such as impaired quality of life and psychosocial consequences. Additionally, a large proportion of patients experience functional limitations after an acute episode of VTE. Recently, the post-VTE functional status (PVFS) scale was proposed to capture these limitations. [1] We performed a prospective cohort study to validate this scale.

Method The PVFS scale, PROMIS physical function short form 10a, EQ-5D-5L, and disease-specific quality of life (VEINES-QOL/Sym, PEmb-QoL) were assessed within three weeks of VTE diagnosis and after a median (IQR) follow-up of 13.4 (12.7-15.9) weeks. To evaluate construct validity of the PVFS scale, we determined correlations of PVFS scale with the other health measurements and investigated differences in patients above and below 70 years of age. Responsiveness was evaluated with a linear regression model, predicting change in PROMIS with change in PVFS scale.

Results We included 211 patients (median (IQR) age: 55.1 (44.1-67.6) years, 40% women). Pulmonary embolism was diagnosed in 105 (49.8%) patients and 62.6% of events were unprovoked (Table 1). The PVFS scale correlated with PROMIS physical function (Spearman’s rho (r): -0.67 and -0.63, p<0.001; [Tab. 1]) and EQ-5D-5L index (r=-0.61 and -0.61, p<0.001) at baseline and follow-up. Furthermore, PVFS correlated moderately to strongly with disease-specific quality of life. Patients above 70 years of age had significantly higher PVFS grades at follow-up (median (IQR): 2 (0-3) vs. 1 (0-2), p=0.010). Changes in PVFS scale over time were significantly associated with changes in PROMIS physical function, and for every unit decrease in PFVS scale grade, the PROMIS T-score increased by approximately half a standard deviation. This association remained significant after adjusting for age, sex, type of event, and comorbidities ([Fig. 1]).

Tab. 1 PROMIS physical function T-score according to PVFS scale grade at baseline and follow-up.; Legend to Figure 1: Grid A depicts baseline values, grid B follow-up values. Higher PVFS scale grade values indicate more functional limitations, lower PROMIS T-scores indicate worse physical function. Bold line represents median, upper and lower hinge represent third and first quartile, respectively, and outliers (distance to hinge >1.5x interquartile range) are plotted individually. PROMIS, Patient Reported Outcome Measurement Information System; PVFS, post-VTE functional status.

Fig. 1 Baseline characteristics; Legend to Table 1: ^*Some patients had more than one risk factor. ^**No data available for 6 patients.

Conclusion The PVFS scale showed adequate construct validity and responsiveness in a prospective cohort study of patients with VTE. These results suggest that it can be incorporated as additional health measurement and outcome parameter in research and clinical practice.

 

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Conflict of Interest

DS, SN, and BW have no potential conflicts of interest do declare. OS received personal fees from Abbott, BARD/BD, Bayer, Biotronik, and Optimed, outside the submitted work. OK received personal fees for lectures and/or participation in advisory boards from BMS. FAK received research support from Bayer, BMS, BSCI, MSD, Leo Pharma, Actelion, The Netherlands Organisation for Health Research and Development, The Dutch Thrombosis Association, The Dutch Heart Foundation, and the Horizon Europe Program, all paid to his institution and outside the current work. IP received personal fees for lectures and/or participation in advisory boards from Bayer, BMS, Pfizer, and Sanofi. CA received personal fees for lectures and/or participation in advisory boards from Bayer, BMS, Daiichi-Sankyo, Pfizer, and Sanofi.

• References

• 1 Klok FA, Barco S, Siegerink B. Measuring functional limitations after venous thromboembolism: A call to action. Thrombosis Research 2019; 178: 59-62

Publication History

Article published online:
20 February 2023