What is the effect of venous thromboembolism and related complications on patient reported health-related quality of life?

Bart Lubberts; Nuno Rui Paulino Pereira; Christopher Kabrhel; David J. Kuter; Christopher W. DiGiovanni

doi:10.1160/TH16-02-0152

Thrombosis and Haemostasis, Inhaltsverzeichnis

Thromb Haemost 2016; 116(03): 417-431
DOI: 10.1160/TH16-02-0152

Coagulation and Fibrinolysis

Schattauer GmbH

What is the effect of venous thromboembolism and related complications on patient reported health-related quality of life?

A meta-analysis

Bart Lubberts

¹Orthopaedic Foot and Ankle Service, Massachusetts General Hospital – Harvard Medical School, Boston, Massachusetts, USA

,

Nuno Rui Paulino Pereira

²Orthopaedic Spine and Oncology Service, Massachusetts General Hospital – Harvard Medical School, Boston, Massachusetts, USA

,

Christopher Kabrhel

³Department of Emergency Medicine, Massachusetts General Hospital – Harvard Medical School, Boston, Massachusetts, USA

,

David J. Kuter

⁴Clinical Hematology, Massachusetts General Hospital – Harvard Medical School, Boston, Massachusetts, USA

,

Christopher W. DiGiovanni

¹Orthopaedic Foot and Ankle Service, Massachusetts General Hospital – Harvard Medical School, Boston, Massachusetts, USA

› Institutsangaben

Abstract

Summary

We conducted a meta-analysis of the literature to 1) assess the health-related quality of life for patients with a minimum follow-up of one year after an episode of pulmonary embolism (PE) or deep-vein thrombosis (DVT), and 2) to assess the HRQOL for patients who develop chronic thromboembolic pulmonary hypertension (CTEPH) and post thrombotic syndrome (PTS). PubMed, EMBASE, and the Cochrane Library were searched from inception to March 30, 2016. Data were pooled using random-effects meta-analysis, and heterogeneity was assessed with I² and Tau² tests. SF-12, SF-36, and VEINES-QOL were evaluated with pooled standardised mean difference (SMD) and 95% confidence intervals (CI). Fourteen studies were included for meta-analysis. In patients who sustain a PE, physical health becomes impaired (p<0.001, 2 studies) but mental health appears to remain similar to population norms (p=0.069, 2 studies) after at least one year. Patients who develop CTEPH report worse physical (p<0.001, 1 study) and mental health (p=0.009, 1 study). In patients who suffer from a DVT, physical health (p=0.19, 9 studies), mental health (p=0.67, 9 studies), and disease specific quality of life (p=0.61, 8 studies) remain similar to population norms after at least one year. Patients who develop PTS, however, report worse physical health (p<0.001, 7 studies), mental health (p<0.001, 7 studies), and disease specific quality of life (p<0.001, 10 studies). These data can be used to educate patients during the shared decision making process that increasingly governs medical care today. Level of Evidence: II.

Supplementary Material to this article is available online at www.thrombosis-online.com.

Keywords

Quality of life - meta-analysis - chronic thromboembolic pulmonary hypertension - post-thrombotic syndrome - venous thromboembolism

Volltext

Referenzen

References
1 Revicki DA.. FDA draft guidance and health-outcomes research. Lancet 2007; 369: 540-542.
2 Porter ME.. What is value in health care?. N Engl J Med 2010; 363: 2477-2481.
3 Enden T. et al. Symptom burden and job absenteeism after treatment with additional catheter-directed thrombolysis for deep vein thrombosis. Patient Rel Outc Meas 2013; 4: 55-59.
4 Hogg K. et al. Validity of standard gamble estimated quality of life in acute venous thrombosis. Thromb Res 2014; 134: 819-825.
5 Kline JA. et al. Treatment of submassive pulmonary embolism with tenecteplase or placebo: Cardiopulmonary outcomes at 3 months: Multicenter double-blind, placebo-controlled randomized trial. J Thromb Haemost 2014; 12: 459-468.
6 Mathias SD. et al. A health-related quality of life measure in patients with deep vein thrombosis: A validation study. Drug Inform J 1999; 33: 1173-1187.
7 O'Brien B. et al. Economic evaluation of outpatient treatment with low-molecular-weight heparin for proximal vein thrombosis. Arch Intern Med 1999; 159: 2298-2304.
8 Shrier I, Kahn SR.. Effect of physical activity after recent deep venous thrombosis: a cohort study. Med Science Sports Exercise 2005; 37: 630-634.
9 MacLean S. et al. Patient values and preferences in decision making for antithrombotic therapy: a systematic review: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (Suppl. 02) e1S-23S.
10 Liberati A. et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. PLoS Med 2009; 6: e1000100.
11 Lamping DL. et al. Evaluation of outcomes in chronic venous disorders of the leg: development of a scientifically rigorous, patient-reported measure of symptoms and quality of life. J Vasc Surg 2003; 37: 410-419.
12 Cohn DM. et al. Quality of life after pulmonary embolism: the development of the PEmb-QoL questionnaire. J Thromb Haemost 2009; 7: 1044-1046.
13 Launois R, Reboul-Marty J, Henry B.. Construction and validation of a quality of life questionnaire in chronic lower limb venous insufficiency (CIVIQ). Quality Life Res 1996; 5: 539-554.
14 Ware Jr. JE, Sherbourne CD.. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992; 30: 473-483.
15 Ware Jr. J. et al. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996; 34: 220-233.
16 EuroQol Group. EuroQol – a new facility for the measurement of health-related quality of life. Health Policy 1990; 16: 199-208.
17 Bergner M. et al. The Sickness Impact Profile: development and final revision of a health status measure. Med Care 1981; 19: 787-805.
18 The World Health Organization Quality of Life Assessment (WHOQOL). development and general psychometric properties. Social Sci Med 1998; 46: 1569-1585.
19 Anderson JP. et al. Interday reliability of function assessment for a health status measure. The Quality of Well-Being scale. Med Care 1989; 27: 1076-1083.
20 Cella D. et al. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care 2007; 45 (05) (Suppl. 01) S3-s11.
21 McQueen DA. et al. Selecting a subjective health status measure for optimum utility in everyday orthopaedic practice. J Eval Clin Pract 2005; 11: 45-51.
22 Kahn SR.. The post-thrombotic syndrome. Hematology 2010; 2010: 216-220.
23 McNeil K, Dunning J.. Chronic thromboembolic pulmonary hypertension (CTEPH). Heart 2007; 93: 1152-1158.
24 Shrier I. et al. Effect of early physical activity on long-term outcome after venous thrombosis. Clin J Sport Med 2009; 19: 487-493.
25 Hedner E. et al. An instrument for measuring health-related quality of life in patients with Deep Venous Thrombosis (DVT): development and validation of Deep Venous Thrombosis Quality of Life (DVTQOL) questionnaire. Health Qual Life Outc 2004; 2: 30.
26 Stewart LK. et al. Contribution of fibrinolysis to the physical component summary of the SF-36 after acute submassive pulmonary embolism. J Thromb Thrombol 2015; 40: 161-166.
27 Harzheim D. et al. Anxiety and depression disorders in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. Resp Res 2013; 14: 104.
28 Roman A. et al. Health-related quality of life in a national cohort of patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Arch Bronconeumol 2013; 49: 181-188.
29 Marvig CL. et al. Quality of life in patients with venous thromboembolism and atrial fibrillation treated with coumarin anticoagulants. Thromb Res 2015; 136: 69-75.
30 Ashrani AA. et al. Impact of venous thromboembolism, venous stasis syndrome, venous outflow obstruction and venous valvular incompetence on quality of life and activities of daily living: a nested case-control study. Vasc Med 2010; 15: 387-397.
31 Halank M. et al. Exercise capacity affects quality of life in patients with pulmonary hypertension. Lung 2013; 191: 337-343.
32 Kukkonen M. et al. Quality of life among pulmonary hypertension patients in Finland. Eur Clin Resp J 2016; 3: 26405.
33 Catarinella F. et al. Quality-of-life in interventionally treated patients with post-thrombotic syndrome. Phlebology 2015; 30 (Suppl. 01) 89-94.
34 Comerota AJ. et al. Catheter-directed thrombolysis for iliofemoral deep venous thrombosis improves health-related quality of life. J Vasc Surg 2000; 32: 130-137.
35 Archibald CJ. et al. Long-term outcome after pulmonary thromboendarterectomy. Am J Resp Crit Care Med 1999; 160: 523-528.
36 Yoshimi S. et al. Survival and quality of life for patients with peripheral type chronic thromboembolic pulmonary hypertension. Circulation J 2008; 72: 958-965.
37 Tian Y. et al. Life quality changes within 26 month after the non-surgical treatment in patients with deep vein thrombosis. Intern J Clin Exp Med 2015; 8: 5999-6007.
38 Enden T. et al. Assessing burden of illness following acute deep vein thrombosis: Data quality, reliability and validity of the Norwegian version of VEINES-QOL/ Sym, a disease-specific questionnaire. Scand J Caring Sci 2009; 23: 369-374.
39 Kahn SR. et al. VEINES-QOL/Sym questionnaire was a reliable and valid disease-specific quality of life measure for deep venous thrombosis. J Clin Epidemiol 2006; 59: 1049-1056.
40 Kahn SR. et al. Determinants of health-related quality of life during the 2 years following deep vein thrombosis. J Thromb Haemost 2008; 6: 1105-1112.
41 Kahn SR. et al. Post-thrombotic syndrome, functional disability and quality of life after upper extremity deep venous thrombosis in adults. Thromb Haemost 2005; 93: 499-502.
42 Klok FA. et al. Quality of life after pulmonary embolism: Validation of the PEmb-QoL Questionnaire. J Thromb Haemost 2010; 8: 523-532.
43 Klok FA. et al. Quality of life in long-term survivors of acute pulmonary embolism. Chest 2010; 138: 1432-1440.
44 Enden T, Wik HS, Kvam AK. et al. Health-related quality of life after catheter-directed thrombolysis for deep vein thrombosis: secondary outcomes of the randomised, non-blinded, parallel-group CaVenT study. Br Med J Open 2013; 3: e002984.
45 Haig Y. et al. Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis (CaVenT): 5-year follow-up results of an open-label, randomised controlled trial. Lancet Haematol 2016; 3: e64-71.
46 Catarinella F. et al. Short-term follow-up of Quality-of-Life in interventionally treated patients with post-thrombotic syndrome after deep venous occlusion. Phlebology 2014; 29 (Suppl. 01) 104-111.
47 Stewart LK. et al. Contribution of fibrinolysis to the physical component summary of the SF-36 after acute submassive pulmonary embolism. J Thromb Thrombol 2015; 40: 161-166.
48 van Es J. et al. Quality of life after pulmonary embolism as assessed with SF-36 and PEmb-QoL. Thromb Res 2013; 132: 500-505.
49 Ware Jr JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). Conceptual framework and item selection. Med Care 1992; 30: 473-483.
50 Brazier J. et al. Testing the validity of the Euroqol and comparing it with the SF-36 health survey questionnaire. Qual Life Res 1993; 2: 169-180.
51 Kahn SR. et al. Prospective evaluation of health-related quality of life in patients with deep venous thrombosis. Arch Intern Med 2005; 165: 1173-1178.
52 van Korlaar IM. et al. The impact of venous thrombosis on quality of life. Thromb Res 2004; 114: 11-18.
53 Grewal NK. et al. Quantity of clot lysed after catheter-directed thrombolysis for iliofemoral deep venous thrombosis correlates with postthrombotic morbidity. J Vasc Surg 2010; 51: 1209-1214.
54 Ware JE. et al. SF-36 physical and mental summary measures: A user's manual. The Health Institute, New England Medical Center; Boston (MA): 1994
55 Stolk E. et al. Using the Internet to collect EQ-5D norm scores: a valid alternative?. 4th Scientific Plenary Meeting of the EuroQol Group – Proceedings: 153–1K5 ©. 2009. EuroQol Group.;
56 van der Zee KI, Sanderman R. Het meten van de algemene gezondheidstoestand met de RAND-36: een handleiding [Assessing Quality of Life With the RAND-36: A Manual]. Groningen, The Netherlands: Noordelijk Centrum voor Gezondheidsvraagstukken; 1993
57 Hanmer J. et al. Report of nationally representative values for the noninstitutionalized US adult population for 7 health-related quality-of-life scores. Med Decision Making 2006; 26: 391-400.
58 Hopman WM. et al. Canadian normative data for the SF-36 health survey. Canadian Multicentre Osteoporosis Study Research Group. Canad Med Assoc J 2000; 163: 265-271.
59 Sorensen J. et al. Danish EQ-5D population norms. Scand J Public Health 2009; 37: 467-474.
60 Wang R. et al. Health related quality of life measured by SF-36: a population-based study in Shanghai, China. BMC Public Health 2008; 8: 292.
61 Suzukamo Y. et al. Validation testing of a three-component model of Short Form-36 scores. J Clin Epidemiol 2011; 64: 301-308.
62 Czihal M. et al. Impact of the postthrombotic syndrome on quality of life after primary upper extremity deep venous thrombosis. Vasa 2012; 41: 200-204.
63 Delis KT. et al. Venous Claudication in Iliofemoral Thrombosis: Long-term Effects on Venous Hemodynamics, Clinical Status, and Quality of Life. Ann Surg 2004; 239: 118-126.
64 Urushibara T. et al. Effects of Surgical and Medical Treatment on Quality of Life for Patients With Chronic Thromboembolic Pulmonary Hypertension. Circ J 2015; 79: 2696-2702.
65 Berzaczy D. et al. Quality of life in patients with idiopathic subclavian vein thrombosis. Thromb Res 2010; 125: 25-28.
66 Broholm R. et al. Postthrombotic syndrome and quality of life in patients with iliofemoral venous thrombosis treated with catheter-directed thrombolysis. J Vasc Surg 2011; 54 (Suppl. 06) 18S-25S.
67 Holmes CE. et al. Efficacy of a short course of complex lymphedema therapy or graduated compression stocking therapy in the treatment of post-thrombotic syndrome. Vasc Med 2014; 19: 42-48.
68 Kahn SR. et al. Effect of postthrombotic syndrome on health-related quality of life after deep venous thrombosis. Arch Intern Med 2002; 162: 1144-1148.
69 Kahn SR. et al. Predictors of the post-thrombotic syndrome during long-term treatment of proximal deep vein thrombosis. J Thromb Haemost 2005; 3: 718-723.
70 Kahn SR. et al. Six-month exercise training program to treat post-thrombotic syndrome: A randomized controlled two-centre trial. Canad Med Assoc J 2011; 183: 37-44.
71 Lukas PS. et al. Association of fatigue and psychological distress with quality of life in patients with a previous venous thromboembolic event. Thromb Haemost 2009; 102: 1219-1226.
72 O'Donnell MJ. et al. Evaluation of a venous-return assist device to treat severe post-thrombotic syndrome (VENOPTS): A randomized controlled trial. Thromb Haemost 2008; 99: 623-629.
73 Zhang X. et al. A prospective randomized trial of catheter-directed thrombolysis with additional balloon dilatation for iliofemoral deep venous thrombosis: A single-center experience. Cardiovasc Interv Radiol 2014; 37: 958-968.
74 Estimation of a single effect size: parametric and nonparametric methods. In: Hedges LV, Olkin I. Statistical methods for meta-analysis. Orlando, Fla: Academic Press; 1985: 75-106.
75 DerSimonian R, Laird N.. Meta-analysis in clinical trials. Contr Clin Trials 1986; 7: 177-188.
76 Rucker G. et al. Undue reliance on I(2) in assessing heterogeneity may mislead. BMC Med Res Methodol 2008; 8: 79.
77 Higgins JP. et al. Measuring inconsistency in meta-analyses. Br Med J Clin Res 2003; 327: 557-560.
78 Egger M. et al. Bias in meta-analysis detected by a simple, graphical test. Br Med J Clin Res 1997; 315: 629-634.
79 Bosma J. et al. Primary subclavian vein thrombosis and its long-term effect on quality of life. Vascular 2011; 19: 327-332.
80 Stewart AL. et al. Functional status and well-being of patients with chronic conditions. Results from the Medical Outcomes Study. J Am Med Assoc 1989; 262: 907-913.
81 Kahn SR. et al. Long-term outcomes after deep vein thrombosis: postphlebitic syndrome and quality of life. J Gen Intern Med 2000; 15: 425-429.
82 van Korlaar I. et al. Quality of life in venous disease. Thromb Haemost 2003; 90: 27-35.
83 Voller H. et al. ProTime self-management yielding improvement of fluency and quality of life. Thromb Haemost 2007; 98: 889-895.
84 Simonneau G. et al. Updated clinical classification of pulmonary hypertension. J Am Coll Cardiol 2013; 62 (Suppl. 25) D34-41.
85 Hull RD. et al. Effect of long-term LMWH on post-thrombotic syndrome in patients with iliac/noniliac venous thrombosis: a subanalysis from the home-LITE study. Clin Appl Thromb Hemost 2013; 19: 476-481.

Zusatzmaterial

Zusatzmaterial