Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach) for improving walking impairment in peripheral artery disease: study protocol for a randomised controlled trial and economic evaluation

Farhad Rezvani, Dirk Heider, Martin Härter, Hans-Helmut König, Frank Bienert, Julia Brinkmann, Lutz Herbarth, Edith Kramer, Patrick Steinisch, Frank Freudenstein, René Terhalle, Yvonne Grosse, Susanne Bock, Jacqueline Posselt, Corinna Beutel, Franziska Reif, Florian Kirchhoff, Carolin Neuschwander, Franziska Löffler, Lisa Brunner, Patrick Dickmeis, Thomas Heidenthal, Lara Schmitz, Daniela Patricia Chase, Claudia Seelenmeyer, Mark Dominik Alscher, Uwe Tegtbur, Jörg Dirmaier, Farhad Rezvani, Dirk Heider, Martin Härter, Hans-Helmut König, Frank Bienert, Julia Brinkmann, Lutz Herbarth, Edith Kramer, Patrick Steinisch, Frank Freudenstein, René Terhalle, Yvonne Grosse, Susanne Bock, Jacqueline Posselt, Corinna Beutel, Franziska Reif, Florian Kirchhoff, Carolin Neuschwander, Franziska Löffler, Lisa Brunner, Patrick Dickmeis, Thomas Heidenthal, Lara Schmitz, Daniela Patricia Chase, Claudia Seelenmeyer, Mark Dominik Alscher, Uwe Tegtbur, Jörg Dirmaier

Abstract

Introduction: Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide, with smoking and diabetes being the strongest risk factors. The most prominent symptom is leg pain while walking, known as intermittent claudication. To improve mobility, first-line treatment for intermittent claudication is supervised exercise programmes, but these remain largely unavailable and economically impractical, which has led to the development of structured home-based exercise programmes. This trial aims to determine the effectiveness and cost advantage of TeGeCoach, a 12-month long home-based exercise programme, compared with usual care of PAD. It is hypothesised that TeGeCoach improves walking impairment and lowers the need of health care resources that are spent on patients with PAD.

Methods and analysis: The investigators conduct a prospective, pragmatic randomised controlled clinical trial in a health insurance setting. 1760 patients diagnosed with PAD at Fontaine stage II are randomly assigned to either TeGeCoach or care-as-usual. TeGeCoach consists of telemonitored intermittent walking exercise with medical supervision by a physician and telephone health coaching. Participants allocated to the usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle. The primary outcome is patient reported walking ability based on the Walking Impairment Questionnaire. Secondary outcome measures include quality of life, health literacy and health behaviour. Claims data are used to collect total health care costs, healthcare resource use and (severe) adverse events. Outcomes are measured at baseline, 12 and 24 months.

Ethics and dissemination: Ethical approval has been obtained from the Medical Association Hamburg. Findings are disseminated through peer-reviewed journals, reports to the funding body, conference presentations and media press releases. Data from this trial are made available to the public and researchers upon reasonable request.NCT03496948 (www.clinicaltrials.gov), Pre-results.

Keywords: VASCULAR MEDICINE; clinical trials; health economics; health services administration & management; peripheral artery disease.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Prospective flow chart of the study design. CAU, usual care of PAD; PAD, peripheral artery disease; TeGeCoach, telemonitored intermittent walking exercise with medical supervision by a physician and telephone health coaching.

References

    1. Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res 2015;116:1509–26. 10.1161/CIRCRESAHA.116.303849
    1. Fowkes FGR, Rudan D, Rudan I, et al. . Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. The Lancet 2013;382:1329–40. 10.1016/S0140-6736(13)61249-0
    1. McDermott MM, Liu K, Greenland P, et al. . Functional decline in peripheral arterial disease: associations with the ankle brachial index and leg symptoms. JAMA 2004;292:453–61. 10.1001/jama.292.4.453
    1. Nehler MR, Duval S, Diao L, et al. . Epidemiology of peripheral arterial disease and critical limb ischemia in an insured national population. J Vasc Surg 2014;60:686–95. 10.1016/j.jvs.2014.03.290
    1. Criqui MH, McClelland RL, McDermott MM, et al. . The Ankle-brachial index and incident cardiovascular events in the MESA (multi-ethnic study of atherosclerosis). J Am Coll Cardiol 2010;56:1506–12. 10.1016/j.jacc.2010.04.060
    1. Criqui MH, Ninomiya JK, Wingard DL, et al. . Progression of peripheral arterial disease predicts cardiovascular disease morbidity and mortality. J Am Coll Cardiol 2008;52:1736–42. 10.1016/j.jacc.2008.07.060
    1. Malyar N, Fürstenberg T, Wellmann J, et al. . Recent trends in morbidity and in-hospital outcomes of in-patients with peripheral arterial disease: a nationwide population-based analysis. Eur Heart J 2013;34:2706–14. 10.1093/eurheartj/eht288
    1. Eraso LH, Fukaya E, Mohler ER, et al. . Peripheral arterial disease, prevalence and cumulative risk factor profile analysis. Eur J Prev Cardiol 2014;21:704–11. 10.1177/2047487312452968
    1. Joosten MM, Pai JK, Bertoia ML, et al. . Associations between conventional cardiovascular risk factors and risk of peripheral artery disease in men. JAMA 2012;308:1660–7. 10.1001/jama.2012.13415
    1. Hamburg NM, Creager MA. Pathophysiology of intermittent claudication in peripheral artery disease. Circ J 2017;81:281–9. 10.1253/circj.CJ-16-1286
    1. Hiatt WR, Armstrong EJ, Larson CJ, et al. . Pathogenesis of the limb manifestations and exercise limitations in peripheral artery disease. Circ Res 2015;116:1527–39. 10.1161/CIRCRESAHA.116.303566
    1. Gardner AW, Montgomery PS, Wang M, et al. . Predictors of health-related quality of life in patients with symptomatic peripheral artery disease. J Vasc Surg 2018;68:1126–34. 10.1016/j.jvs.2017.12.074
    1. Maksimovic M, Vlajinac H, Marinkovic J, et al. . Health-Related quality of life among patients with peripheral arterial disease. Angiology 2014;65:501–6. 10.1177/0003319713488640
    1. Regensteiner JG, Hiatt WR, Coll JR, et al. . The impact of peripheral arterial disease on health-related quality of life in the peripheral arterial disease awareness, risk, and treatment: new resources for survival (partners) program. Vasc Med 2008;13:15–24. 10.1177/1358863X07084911
    1. Smolderen KG, Hoeks SE, Pedersen SS, et al. . Lower-leg symptoms in peripheral arterial disease are associated with anxiety, depression, and anhedonia. Vasc Med 2009;14:297–304. 10.1177/1358863X09104658
    1. Haas TL, Lloyd PG, Yang H-T, et al. . Exercise training and peripheral arterial disease. Compr Physiol 2012;2:2933–3017. 10.1002/cphy.c110065
    1. Hamburg NM, Balady GJ. Exercise rehabilitation in peripheral artery disease: functional impact and mechanisms of benefits. Circulation 2011;123:87–97. 10.1161/CIRCULATIONAHA.109.881888
    1. Guidon M, McGee H. Exercise-based interventions and health-related quality of life in intermittent claudication: a 20-year (1989–2008) review. Eur J Cardio Prevention Rehabilitation 2010;17:140–54. 10.1097/HJR.0b013e3283377f08
    1. Lane R, Harwood A, Watson L, et al. . Exercise for intermittent claudication. Cochrane Database Syst Rev 2017;12:CD000990. 10.1002/14651858.CD000990.pub4
    1. Gerhard-Herman MD, Gornik HL, Barrett C, et al. . 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: Executive summary: a report of the American College of Cardiology/American heart association Task force on clinical practice guidelines. Circulation 2017;135:e686–725. 10.1161/CIR.0000000000000470
    1. Lawall H, Huppert P, Espinola-Klein C, et al. . The diagnosis and treatment of peripheral arterial vascular disease. Dtsch Arztebl Int 2016;113:729–36. 10.3238/arztebl.2016.0729
    1. Aboyans V, Ricco J-B, Bartelink M-LEL, et al. . 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). European Heart Journal 2017;39:763–816.
    1. Harwood A-E, Smith GE, Cayton T, et al. . A systematic review of the uptake and adherence rates to supervised exercise programs in patients with intermittent claudication. Ann Vasc Surg 2016;34:280–9. 10.1016/j.avsg.2016.02.009
    1. Makris GC, Lattimer CR, Lavida A, et al. . Availability of supervised exercise programs and the role of structured home-based exercise in peripheral arterial disease. Eur J Vasc Endovasc Surg 2012;44:569–75. 10.1016/j.ejvs.2012.09.009
    1. McDermott MM, Polonsky TS. Home-Based exercise: a therapeutic option for peripheral artery disease. Circulation 2016;134:1127–9. 10.1161/CIRCULATIONAHA.116.023691
    1. Golledge J, Singh TP, Alahakoon C, et al. . Meta-Analysis of clinical trials examining the benefit of structured home exercise in patients with peripheral artery disease. Br J Surg 2019;106:319–31. 10.1002/bjs.11101
    1. Harwood AE, Hitchman LH, Ingle L, et al. . Preferred exercise modalities in patients with intermittent claudication. Journal of Vascular Nursing 2018;36:81–4. 10.1016/j.jvn.2017.12.002
    1. Hageman D, Fokkenrood HJ, Gommans LN, et al. . Supervised exercise therapy versus home-based exercise therapy versus walking advice for intermittent claudication. Cochrane Database Syst Rev 2018;4:CD005263. 10.1002/14651858.CD005263.pub4
    1. Al-Jundi W, Madbak K, Beard JD, et al. . Systematic review of home-based exercise programmes for individuals with intermittent claudication. Eur J Vasc Endovasc Surg 2013;46:690–706. 10.1016/j.ejvs.2013.09.004
    1. Bäck M, Jivegård L, Johansson A, et al. . Home-Based supervised exercise versus hospital-based supervised exercise or unsupervised walk advice as treatment for intermittent claudication: a systematic review. J Rehabil Med 2015;47:801–8. 10.2340/16501977-2012
    1. McDermott MM, Liu K, Guralnik JM, et al. . Home-Based walking exercise intervention in peripheral artery disease: a randomized clinical trial. JAMA 2013;310:57–65. 10.1001/jama.2013.7231
    1. McDermott MM, Guralnik JM, Criqui MH, et al. . Home‐Based walking exercise in peripheral artery disease: 12‐Month Follow‐up of the goals randomized trial. J Am Heart Assoc 2014;3:e000711 10.1161/JAHA.113.000711
    1. Collins TC, Lunos S, Carlson T, et al. . Effects of a home-based walking intervention on mobility and quality of life in people with diabetes and peripheral arterial disease: a randomized controlled trial. Diabetes Care 2011;34:2174–9. 10.2337/dc10-2399
    1. Cunningham MA, Swanson V, O'Carroll RE, et al. . Randomized clinical trial of a brief psychological intervention to increase walking in patients with intermittent claudication. Br J Surg 2012;99:49–56. 10.1002/bjs.7714
    1. Cunningham MA, Swanson V, Holdsworth RJ, et al. . Late effects of a brief psychological intervention in patients with intermittent claudication in a randomized clinical trial. Br J Surg 2013;100:756–60. 10.1002/bjs.9100
    1. Mays RJ, Hiatt WR, Casserly IP, et al. . Community-Based walking exercise for peripheral artery disease: an exploratory pilot study. Vasc Med 2015;20:339–47. 10.1177/1358863X15572725
    1. Gardner AW, Parker DE, Montgomery PS, et al. . Step‐Monitored home exercise improves ambulation, vascular function, and inflammation in symptomatic patients with peripheral artery disease: a randomized controlled trial. J Am Heart Assoc 2014;3:e001107 10.1161/JAHA.114.001107
    1. Gardner AW, Parker DE, Montgomery PS, et al. . Efficacy of quantified home-based exercise and supervised exercise in patients with intermittent claudication. Circulation 2011;123:491–8. 10.1161/CIRCULATIONAHA.110.963066
    1. Duscha BD, Piner LW, Patel MP, et al. . Effects of a 12-week mHealth program on FunctionalCapacity and physical activity in patients with PeripheralArtery disease. Am J Cardiol 2018;122:879–84. 10.1016/j.amjcard.2018.05.018
    1. Tew GA, Humphreys L, Crank H, et al. . The development and pilot randomised controlled trial of a group education programme for promoting walking in people with intermittent claudication. Vascular Medicine 2015;20:348–57. 10.1177/1358863X15577857
    1. Mays RJ, Rogers RK, Hiatt WR, et al. . Community walking programs for treatment of peripheral artery disease. J Vasc Surg 2013;58:1678–87. 10.1016/j.jvs.2013.08.034
    1. Ware JH, Hamel MB. Pragmatic trials — guides to better patient care? N Engl J Med 2011;364:1685–7. 10.1056/NEJMp1103502
    1. Dwinger S, Dirmaier J, Herbarth L, et al. . Telephone-based health coaching for chronically ill patients: study protocol for a randomized controlled trial. Trials 2013;14:337 10.1186/1745-6215-14-337
    1. Härter M, Dirmaier J, Dwinger S, et al. . Effectiveness of Telephone-Based health coaching for patients with chronic conditions: a randomised controlled trial. PLoS One 2016;11:e0161269 10.1371/journal.pone.0161269
    1. Härter M, Dwinger S, Seebauer L, et al. . Evaluation of telephone health coaching of German health insurants with chronic conditions. Health Educ J 2013;72:622–34. 10.1177/0017896912453990
    1. Dennis SM, Harris M, Lloyd J, et al. . Do people with existing chronic conditions benefit from telephone coaching? a rapid review. Australian Health Review 2013;37:381–8. 10.1071/AH13005
    1. Eakin EG, Lawler SP, Vandelanotte C, et al. . Telephone interventions for physical activity and dietary behavior change. Am J Prev Med 2007;32:419–34. 10.1016/j.amepre.2007.01.004
    1. McDermott MM, Spring B, Berger JS, et al. . Effect of a home-based exercise intervention of wearable technology and telephone coaching on walking performance in peripheral artery disease. JAMA 2018;319:1665–76. 10.1001/jama.2018.3275
    1. Parmenter BJ, Dieberg G, Smart NA. Exercise training for management of peripheral arterial disease: a systematic review and meta-analysis. Sports Med 2015;45:231–44. 10.1007/s40279-014-0261-z
    1. Lewis ZH, Lyons EJ, Jarvis JM, et al. . Using an electronic activity monitor system as an intervention modality: a systematic review. BMC Public Health 2015;15:585 10.1186/s12889-015-1947-3
    1. Bravata DM, Smith-Spangler C, Sundaram V, et al. . Using Pedometers to increase physical activity and improve health. JAMA 2007;298:2296–304. 10.1001/jama.298.19.2296
    1. Harris T, Limb ES, Hosking F, et al. . Effect of pedometer-based walking interventions on long-term health outcomes: prospective 4-year follow-up of two randomised controlled trials using routine primary care data. PLoS Med 2019;16:e1002836 10.1371/journal.pmed.1002836
    1. Haveman ME, Kleiss SF, Ma KF, et al. . Telemedicine in patients with peripheral arterial disease: is it worth the effort? Expert Rev Med Devices 2019;16:777–86. 10.1080/17434440.2019.1649595
    1. O'Brien T, Troutman-Jordan M, Hathaway D, et al. . Acceptability of wristband activity trackers among community dwelling older adults. Geriatr Nurs 2015;36:S21–5. 10.1016/j.gerinurse.2015.02.019
    1. Cadmus-Bertram LA, Marcus BH, Patterson RE, et al. . Randomized trial of a Fitbit-based physical activity intervention for women. Am J Prev Med 2015;49:414–8. 10.1016/j.amepre.2015.01.020
    1. Ehn M, Eriksson LC, Åkerberg N, et al. . Activity monitors as support for older persons’ physical activity in daily life: qualitative study of the users’ experiences. JMIR mHealth and uHealth 2018;6:e34 10.2196/mhealth.8345
    1. Kononova A, Li L, Kamp K, et al. . The use of wearable activity trackers among older adults: focus group study of tracker perceptions, motivators, and barriers in the maintenance stage of behavior change. JMIR mHealth and uHealth 2019;7:e9832 10.2196/mhealth.9832
    1. Normahani P, Kwasnicki R, Bicknell C, et al. . Wearable sensor technology efficacy in peripheral vascular disease (wSTEP): a randomized controlled trial. Ann Surg 2018;268:1113–8. 10.1097/SLA.0000000000002300
    1. Lyons EJ, Swartz MC, Lewis ZH, et al. . Feasibility and acceptability of a wearable technology physical activity intervention with telephone counseling for mid-aged and older adults: a randomized controlled pilot trial. JMIR Mhealth Uhealth 2017;5:e28 10.2196/mhealth.6967
    1. Loudon K, Treweek S, Sullivan F, et al. . The PRECIS-2 tool: designing trials that are fit for purpose. BMJ 2015;350:h2147 10.1136/bmj.h2147
    1. Deshpande P, Sudeepthi BLakshmi, Rajan S, et al. . Patient-Reported outcomes: a new era in clinical research. Perspect Clin Res 2011;2:137–44. 10.4103/2229-3485.86879
    1. Schulz KF, Altman DG, Moher D. Consort 2010 statement: updated guidelines for reporting parallel group randomised trials. BMC Med 2010;8:18 10.1186/1741-7015-8-18
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . Spirit 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Calvert M, Kyte D, Mercieca-Bebber R, et al. . Guidelines for inclusion of patient-reported outcomes in clinical trial protocols. JAMA 2018;319:483–94. 10.1001/jama.2017.21903
    1. Hoffmann TC, Glasziou PP, Boutron I, et al. . Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ 2014;348:g1687 10.1136/bmj.g1687
    1. Guidon M, McGee H. Recruitment to clinical trials of exercise: challenges in the peripheral arterial disease population. Physiotherapy 2013;99:305–10. 10.1016/j.physio.2012.12.010
    1. Rahman S, Majumder A, Shaban S, et al. . Physician participation in clinical research and trials: issues and approaches. Adv Med Educ Pract 2011;2:85 10.2147/AMEP.S14103
    1. Polit DF. Blinding during the analysis of research data. Int J Nurs Stud 2011;48:636–41. 10.1016/j.ijnurstu.2011.02.010
    1. Regensteiner JG, Steiner JF, Panzer RJ, et al. . Evaluation of walking impairment by questionnaire in patients with peripheral Arterial-Disease. Clin Res 1990;38:A515–A15.
    1. McDermott MM, Liu K, Guralnik JM, et al. . Measurement of walking endurance and walking velocity with questionnaire: validation of the walking impairment questionnaire in men and women with peripheral arterial disease. J Vasc Surg 1998;28:1072–81. 10.1016/S0741-5214(98)70034-5
    1. Sagar SP, Brown PM, Zelt DT, et al. . Further clinical validation of the walking impairment questionnaire for classification of walking performance in patients with peripheral artery disease. Int J Vasc Med 2012;2012:1–10. 10.1155/2012/190641
    1. Nicolaï SPA, Kruidenier LM, Rouwet EV, et al. . The walking impairment questionnaire: an effective tool to assess the effect of treatment in patients with intermittent claudication. J Vasc Surg 2009;50:89–94. 10.1016/j.jvs.2008.12.073
    1. Herdman M, Gudex C, Lloyd A, et al. . Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011;20:1727–36. 10.1007/s11136-011-9903-x
    1. Ware J, Kosinski M, Keller SD. A 12-Item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996;34:220–33. 10.1097/00005650-199603000-00003
    1. Gandek B, Ware JE, Aaronson NK, et al. . Cross-Validation of item selection and scoring for the SF-12 health survey in nine countries: results from the IQOLA project. International quality of life assessment. J Clin Epidemiol 1998;51:1171–8. 10.1016/s0895-4356(98)00109-7
    1. Hinz A, Kohlmann T, Stöbel-Richter Y, et al. . The quality of life questionnaire EQ-5D-5L: psychometric properties and normative values for the general German population. Qual Life Res 2014;23:443–7. 10.1007/s11136-013-0498-2
    1. Morgan MBF, Crayford T, Murrin B, et al. . Developing the vascular quality of life questionnaire: a new disease-specific quality of life measure for use in lower limb ischemia. J Vasc Surg 2001;33:679–87. 10.1067/mva.2001.112326
    1. Mehta T, Venkata Subramaniam A, Chetter I, et al. . Assessing the validity and responsiveness of disease-specific quality of life instruments in intermittent claudication. Eur J Vasc Endovasc Surg 2006;31:46–52. 10.1016/j.ejvs.2005.08.028
    1. Kroenke K, Spitzer RL. The PHQ-9: a new depression diagnostic and severity measure. Psychiatr Ann 2002;32:509–15. 10.3928/0048-5713-20020901-06
    1. Spitzer RL, Kroenke K, Williams JBW, et al. . A brief measure for assessing generalized anxiety disorder. Arch Intern Med 2006;166:1092–7. 10.1001/archinte.166.10.1092
    1. Löwe B, Decker O, Müller S, et al. . Validation and standardization of the generalized anxiety disorder screener (GAD-7) in the general population. Med Care 2008;46:266–74. 10.1097/MLR.0b013e318160d093
    1. Bush K, Kivlahan DR, McDonell MB, et al. . The audit alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. ambulatory care quality improvement project (ACQUIP). alcohol use disorders identification test. Arch Intern Med 1998;158:1789–95. 10.1001/archinte.158.16.1789
    1. Bradley KA, DeBenedetti AF, Volk RJ, et al. . AUDIT-C as a brief screen for alcohol misuse in primary care. Alcoholism: Clinical and Experimental Research 2007;31:1208–17. 10.1111/j.1530-0277.2007.00403.x
    1. Dybek I, Bischof G, Grothues J, et al. . The reliability and validity of the alcohol use disorders identification test (audit) in a German general practice population sample. J Stud Alcohol 2006;67:473–81. 10.15288/jsa.2006.67.473
    1. Heatherton TF, Kozlowski LT, Frecker RC, et al. . The Fagerstrom test for nicotine dependence: a revision of the Fagerstrom tolerance questionnaire. Addiction 1991;86:1119–27. 10.1111/j.1360-0443.1991.tb01879.x
    1. Osborne RH, Batterham RW, Elsworth GR, et al. . The grounded psychometric development and initial validation of the health literacy questionnaire (HLQ). BMC Public Health 2013;13:658 10.1186/1471-2458-13-658
    1. Nolte S, Osborne RH, Dwinger S, et al. . German translation, cultural adaptation, and validation of the health literacy questionnaire (HLQ). PLoS One 2017;12:e0172340 10.1371/journal.pone.0172340
    1. Hibbard JH, Mahoney ER, Stockard J, et al. . Development and testing of a short form of the patient activation measure. Health Serv Res 2005;40:1918–30. 10.1111/j.1475-6773.2005.00438.x
    1. Zill JM, Dwinger S, Kriston L, et al. . Psychometric evaluation of the German version of the patient activation measure (PAM13). BMC Public Health 2013;13:1027 10.1186/1471-2458-13-1027
    1. Scholl I, Hölzel L, Härter M, et al. . Fragebogen Zur zufriedenheit in Der ambulanten versorgung–schwerpunkt patientenbeteiligung (ZapA). Klinische Diagnostik und Evaluation 2011;4:50–62.
    1. Gardner AW, Montgomery PS, Wang M. Minimal clinically important differences in treadmill, 6-minute walk, and patient-based outcomes following supervised and home-based exercise in peripheral artery disease. Vasc Med 2018;23:349–57. 10.1177/1358863X18762599
    1. Asch DA, Jedrziewski MK, Christakis NA. Response rates to mail surveys published in medical journals. J Clin Epidemiol 1997;50:1129–36. 10.1016/S0895-4356(97)00126-1
    1. Deutsche Forschungsgemeinschaft Sicherung guter wissenschaftlicher Praxis. Sicherung Guter Wissenschaftlicher Praxis: Empfehlungen der Kommission “Selbstkontrolle in der Wissenschaft”. Weinheim, Germany: Wiley-VCH Verlag GmbH & Co. KGaA, 2013: 1–109.
    1. Chakraborty H, Gu H. A mixed model approach for intent-to-treat analysis in longitudinal clinical trials with missing values 2009.
    1. Twisk J, de Boer M, de Vente W, et al. . Multiple imputation of missing values was not necessary before performing a longitudinal mixed-model analysis. J Clin Epidemiol 2013;66:1022–8. 10.1016/j.jclinepi.2013.03.017
    1. Collins LM, Schafer JL, Kam CM. A comparison of inclusive and restrictive strategies in modern missing data procedures. Psychol Methods 2001;6:330–51. 10.1037/1082-989X.6.4.330
    1. Hainmueller J. Entropy balancing for causal effects: a multivariate reweighting method to produce balanced samples in observational studies. Political Analysis 2012;20:25–46. 10.1093/pan/mpr025

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel