Measuring Health-Related Quality of Life in Randomised Controlled Trials: Expected and Reported Results Do Not Match

References

• Robert Koch-Institut (Hrsg.). Allgemeines zu Gesundheitsbezogener Lebensqualität. Avaialable from: https://www.rki.de/DE/Content/Gesundheitsmonitoring/Gesundheitsberichterstattung/GesundAZ/Content/G/Gesbez_Lebensqualitaet/Inhalt/Lebensqualitaet.html. Accessed May 1, 2019.
   Google Scholar
• Reeve BB, Wyrwich KW, Wu AW, et al. ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Qual Life Res. 2013;22(8):1889–1905. doi:10.1007/s11136-012-0344-y
   PubMed Web of Science ®Google Scholar
• Ahmed S, Berzon RA, Revicki DA, et al. International society for quality of life research: the use of patient-reported outcomes (PRO) within comparative effectiveness research: implications for clinical practice and health care policy. Med Care. 2012;50(12):1060–1070. doi:10.1097/MLR.0b013e318268aaff
   PubMed Web of Science ®Google Scholar
• Kaplan RM, Hays RD. Health-related quality of life measurement in public health. Annu Rev Public Health. 2021. doi:10.1146/annurev-publhealth-052120-012811
   PubMed Web of Science ®Google Scholar
• Katz S. The science of quality of life. J Chronic Dis. 1987;40(6):459–463. doi:10.1016/0021-9681(87)90001-4
   PubMedGoogle Scholar
• Statistisches Bundesamt (Hrsg.). Gesundheitsbericht für Deutschland. Available from: http://www.gbe-bund.de/gbe10/abrechnung.prc_abr_test_logon?p_uid=gast&p_aid=0&p_knoten=FID&p_sprache=D&p_suchstring=819. Accessed January 20, 2020.
   Google Scholar
• Bullinger M. Das Konzept der Lebensqualität in der Medizin – Entwicklung und heutiger Stellenwert. Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheitswesen. 2014;108(2–3):97–103. doi:10.1016/j.zefq.2014.02.006
   PubMedGoogle Scholar
• Gill TM, Feinstein AR. A critical appraisal of the quality of quality-of-life measurements. JAMA. 1994;272(8):619–626. doi:10.1001/jama.1994.03520080061045
   PubMed Web of Science ®Google Scholar
• Haraldstad K, Wahl A, Andenaes R, et al. Quality of life research: an international journal of quality of life aspects of treatment, care and rehabilitation. JAMA. 2019;271:2641–2650.
   Google Scholar
• Kohlmann T. Measuring quality of life: as simple as possible and as detailed as necessary. Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheitswesen. 2014;108(2–3):104–110. doi:10.1016/j.zefq.2014.03.015
   PubMedGoogle Scholar
• Moons P, Budts W, De Geest S. Critique on the conceptualisation of quality of life: a review and evaluation of different conceptual approaches. Int J Nurs Stud. 2006;43(7):891–901. doi:10.1016/j.ijnurstu.2006.03.015
   PubMed Web of Science ®Google Scholar
• Radoschewski M. Gesundheitsbezogene Lebensqualität - Konzepte und Maße. Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz. 2000;43(3):165–189. doi:10.1007/s001030050033
   Google Scholar
• Osoba D. Effect of Cancer on Quality of Life. Boca Raton, Florida: CRC Press Inc; 1991.
   Google Scholar
• Porzsolt F, Wiedemann F, Phlippen M, et al. The terminology conflict on efficacy and effectiveness in healthcare. J Comp Eff Res. 2020;9(17):1171. doi:10.2217/cer-2020-0149
   PubMed Web of Science ®Google Scholar
• Haynes B. Can it work? Does it work? Is it worth it? The testing of healthcare interventions is evolving. BMJ. 1999;319(7211):652–653. doi:10.1136/bmj.319.7211.652
   PubMed Web of Science ®Google Scholar
• Wiedemann F. Potential mistakes in clinical trials that use health-related quality of life as outcome. Medical thesis for the Medical Faculty of the Ulm University; 2020.
   Google Scholar
• Edmonds SW, Cram P, Lou Y, et al. Effects of a DXA result letter on satisfaction, quality of life, and osteoporosis knowledge: a randomized controlled trial. BMC Musculoskelet Disord. 2016;17(1). doi:10.1186/s12891-016-1227-0
   PubMed Web of Science ®Google Scholar
• Slok AH, Kotz D, van Breukelen G, et al. Effectiveness of the Assessment of Burden of COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled trial in primary and hospital care. BMJ Open. 2016;6(7):e011519–2016–011519. doi:10.1136/bmjopen-2016-011519
   PubMed Web of Science ®Google Scholar
• Espie CA, Luik AI, Cape J, et al. Digital Cognitive Behavioural Therapy for Insomnia versus sleep hygiene education: the impact of improved sleep on functional health, quality of life and psychological well-being. Study protocol for a randomised controlled trial. Trials. 2016;17(1). doi:10.1186/s13063-016-1364-7
   PubMed Web of Science ®Google Scholar
• Klinkhammer-Schalke M, Lindberg P, Koller M, et al. Direct improvement of quality of life in colorectal cancer patients using a tailored pathway with quality of life diagnosis and therapy (DIQOL): study protocol for a randomised controlled trial. Trials. 2015;16(1). doi:10.1186/s13063-015-0972-y
   PubMed Web of Science ®Google Scholar
• Coulton S, Clift S, Skingley A, Rodriguez J. Effectiveness and cost-effectiveness of community singing on mental health-related quality of life of older people: randomised controlled trial. Br J Psychiatry J Ment Sci. 2015;207(3):250–255. doi:10.1192/bjp.bp.113.129908
   PubMed Web of Science ®Google Scholar
• Braamse AM, van Meijel B, Visser OJ, et al. A randomized clinical trial on the effectiveness of an intervention to treat psychological distress and improve quality of life after autologous stem cell transplantation. Ann Hematol. 2016;95(1):105–114. doi:10.1007/s00277-015-2509-6
   PubMed Web of Science ®Google Scholar
• Porzsolt F, Wiedemann F, Becker SI, Rhoads CJ. Inclusion and exclusion criteria and the problem of describing homogeneity of study populations in clinical trials. BMJ Evid Based Med. 2018;24(3):92–94. doi:10.1136/bmjebm-2018-111115
   PubMedGoogle Scholar
• Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Clin Epidemiol. 2009;62(5):499–505. doi:10.1016/j.jclinepi.2009.01.012
   PubMed Web of Science ®Google Scholar
• Grimes DA, Schulz KF. An overview of clinical research: the lay of the land. Lancet. 2002;359(9300):57–61. doi:10.1016/S0140-6736(02)07283-5
   PubMed Web of Science ®Google Scholar
• Thiese MS. Observational and interventional study design types; an overview. Biochemia Medica. 2014;24(2):199–210. doi:10.11613/BM.2014.022
   PubMed Web of Science ®Google Scholar
• Porzsolt F, Weiß C, Weiß M, et al. Versorgungsforschung braucht dreidimensionale Standards zur Beschreibung von Gesundheitsleistungen – teil 2. Monitor Versorgungsforschung. 2019;12(04/2019):53–60. doi:10.24945/MVF.04.19.1866-0533.2163
   Google Scholar
• Porzsolt F, Eisemann M, Habs M, Wyer P. Form follows function: pragmatic controlled trials (PCTs) have to answer different questions and require different designs than randomized controlled trials (RCTs). Zeitschrift für Gesundheitswissenschaften. 2013;21(3):307–313. doi:10.1007/s10389-012-0544-5
   Google Scholar
• Porzsolt F, Rocha NG, Toledo-Arruda AC, et al. Efficacy and effectiveness trials have different goals, use different tools, and generate different messages. Pragmatic Observ Res. 2015;6:47–54. doi:10.2147/POR.S89946
   PubMedGoogle Scholar
• Burches E, Burches M. Efficacy, effectiveness and efficiency in the health care: the need for an agreement to clarify its meaning. Int Arch Public Health Community Med. 2020;4:35.
   Google Scholar