Skip to main content
Mijn bibliotheek
Shop
Nieuws Boeken Tijdschriften E-learning Web-tv Video Audio
Tips voor Mijn BSL
UITGEBREID ZOEKEN
Inloggen
Top
Quality of Life Research
Gepubliceerd in: Quality of Life Research 3/2022

20-07-2021 | Review

Impact of open-label versus blinded study design on patient-reported outcomes data in randomized clinical trials of immunotherapy in advanced or metastatic cancer patients: a systematic review

Auteurs: Amélie Anota, Astrid Pozet, Hervé Lemasson, Francois-Emery Cotté, Antoine Falcoz, Guillaume Eberst, Guillaume Mouillet, Stéphane Guerzider, Émilie Charton, Virginie Westeel

Gepubliceerd in: Quality of Life Research | Uitgave 3/2022

Log in om toegang te krijgen
share
DELEN

Deel dit onderdeel of sectie (kopieer de link)

  • Optie A:
    Klik op de rechtermuisknop op de link en selecteer de optie “linkadres kopiëren”
  • Optie B:
    Deel de link per e-mail
    Link delen
publish
Publiceer nu

Abstract

Aim

A systematic literature review of immuno-oncology trials was conducted to assess the potential impact of open-label vs double-blind trial design on patient-reported outcome (PRO) data.

Methods

A systematic search of indexed literature published from January 2009 to May 2019 was conducted using PubMed/MEDLINE, Cochrane Library, and EMBASE database. All randomized clinical trials (RCTs) of immuno-oncology therapies on advanced cancer patients reporting PRO data were identified. Descriptive analyses were performed to quantify differences at baseline and over time, by the type of study, regarding questionnaire completion rate and PRO scores.

Results

In total, 23 studies were retained (15 open-label, 8 blinded). At baseline, no difference in completion rate was observed between arms irrespective of trial design (absolute mean difference of 2.8% and 2.2% for open label and blinded studies, respectively). No clinically significant difference in baseline PRO scores was observed between arms. Over time, impact on PRO scores could not be identified due to the limited number of studies, heterogeneity of questionnaires and tumor types.

Conclusions

Trial design had no impact on PRO completion rate or baseline scores. Future research should involve analyses by specific cancer types and ideally compare individual data from two similar RCTs (blinded vs. open-label).
volgende artikel Comparing the use of patient-reported outcomes in clinical studies in Europe in 2008 and 2018: a literature review
Bijlagen
Alleen toegankelijk voor geautoriseerde gebruikers
Literatuur
1.
Jardim, D. L., de Melo Gagliato, D., Giles, F. J., & Kurzrock, R. (2018). Analysis of Drug Development Paradigms for Immune Checkpoint Inhibitors. Clinical Cancer Research, 24(8), 1785–1794.CrossRef
2.
Secord, A. A., Coleman, R. L., Havrilesky, L. J., Abernethy, A. P., Samsa, G. P., & Cella, D. (2015). Patient-reported outcomes as end points and outcome indicators in solid tumours. Nature Reviews Clinical Oncology, 12(6), 358–370.CrossRef
3.
4.
Sridhara, R., Mandrekar, S. J., & Dodd, L. E. (2013). Missing data and measurement variability in assessing progression-free survival endpoint in randomized clinical trials. Clinical Cancer Research, 19(10), 2613–2620.CrossRef
5.
Roydhouse, J. K., Fiero, M. H., & Kluetz, P. G. (2019). Investigating potential bias in patient-reported outcomes in open-label cancer trials. JAMA Oncology, 5(4), 457–458.CrossRef
6.
Atkinson, T. M., Wagner, J. S., & Basch, E. (2017). Trustworthiness of patient-reported outcomes in unblinded cancer clinical trials. JAMA Oncology, 3(6), 738–739.CrossRef
7.
FDA, U. (2009). Patient reported outcome measures: Use in medical product development to support labeling claims. Guidance for Industry.
8.
Gnanasakthy, A., Barrett, A., Evans, E., D’Alessio, D., & Romano, C. D. (2019). A Review of patient-reported outcomes labeling for oncology drugs approved by the FDA and the EMA (2012–2016). Value Health, 22(2), 203–209.CrossRef
9.
Gnanasakthy, A., DeMuro, C., Clark, M., Haydysch, E., Ma, E., & Bonthapally, V. (2016). Patient-reported outcomes labeling for products approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010–2014). Journal of Clinical Oncology, 34(16), 1928–1934.CrossRef
10.
Roydhouse, J. K., King-Kallimanis, B. L., Howie, L. J., Singh, H., & Kluetz, P. G. (2019). Blinding and patient-reported outcome completion rates in US Food and drug administration cancer trial submissions, 2007–2017. Journal of The National Cancer Institute, 111(5), 459–464.CrossRef
11.
Barlesi, F., Garon, E. B., Kim, D. W., Felip, E., Han, J. Y., Kim, J. H., Ahn, M. J., Fidler, M. J., Gubens, M. A., de CastroSurmont, G. V., Jr., Li, Q., Deitz, A. C., Lubiniecki, G. M., & Herbst, R. S. (2019). Health-related quality of life in KEYNOTE-010: A phase II/III study of pembrolizumab versus docetaxel in patients with previously treated advanced, programmed death ligand 1-expressing NSCLC. Journal of Thoracic Oncology, 14(5), 793–801.CrossRef
12.
Reck, M., Brahmer, J., Bennett, B., Taylor, F., Penrod, J. R., DeRosa, M., Dastani, H., Spigel, D. R., & Gralla, R. J. (2018). Evaluation of health-related quality of life and symptoms in patients with advanced non-squamous non-small cell lung cancer treated with nivolumab or docetaxel in CheckMate 057. European Journal of Cancer, 102, 23–30.CrossRef
13.
Reck, M., Taylor, F., Penrod, J. R., DeRosa, M., Morrissey, L., Dastani, H., Orsini, L., & Gralla, R. J. (2018). Impact of nivolumab versus docetaxel on health-related quality of life and symptoms in patients with advanced squamous non-small cell lung cancer: Results from the CheckMate 017 study. Journal of Thoracic Oncology, 13(2), 194–204.CrossRef
14.
Andre, T., Amonkar, M., Norquist, J. M., Shiu, K. K., Kim, T. W., Jensen, B. V., Jensen, L. H., Punt, C. J. A., Smith, D., Garcia-Carbonero, R., Sevilla, I., De La Fouchardiere, C., Rivera, F., Elez, E., Diaz, L. A., Jr., Yoshino, T., Van Cutsem, E., Yang, P., Farooqui, M., & Le, D. T. (2021). Health-related quality of life in patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer treated with first-line pembrolizumab versus chemotherapy (KEYNOTE-177): An open-label, randomised, phase 3 trial. The Lancet Oncology, 22(5), 665–677.CrossRef
15.
Long, G. V., Atkinson, V., Ascierto, P. A., Robert, C., Hassel, J. C., Rutkowski, P., Savage, K. J., Taylor, F., Coon, C., Gilloteau, I., Dastani, H. B., Waxman, I. M., & Abernethy, A. P. (2016). Effect of nivolumab on health-related quality of life in patients with treatment-naive advanced melanoma: Results from the phase III CheckMate 066 study. Annals of Oncology, 27(10), 1940–1946.CrossRef
16.
Moher, D., Liberati, A., Tetzlaff, J., Altman, D. G., & Prisma Group. (2009). Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Medicine, 6(7), e1000097.CrossRef
17.
Wolchok, J. D., Neyns, B., Linette, G., Negrier, S., Lutzky, J., Thomas, L., Waterfield, W., Schadendorf, D., Smylie, M., Guthrie, T., Jr., Grob, J. J., Chesney, J., Chin, K., Chen, K., Hoos, A., O’Day, S. J., & Lebbe, C. (2010). Ipilimumab monotherapy in patients with pretreated advanced melanoma: A randomised, double-blind, multicentre, phase 2, dose-ranging study. The Lancet Oncology, 11(2), 155–164.CrossRef
18.
Higgins, J. P., Altman, D. G., Gotzsche, P. C., Juni, P., Moher, D., Oxman, A. D., Savovic, J., Schulz, K. F., Weeks, L., & Sterne, J. A. (2011). The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ, 343, 5928.CrossRef
19.
Ascierto, P. A., Del Vecchio, M., Robert, C., Mackiewicz, A., Chiarion-Sileni, V., Arance, A., Lebbe, C., Bastholt, L., Hamid, O., Rutkowski, P., McNeil, C., Garbe, C., Loquai, C., Dreno, B., Thomas, L., Grob, J. J., Liszkay, G., Nyakas, M., Gutzmer, R …Maio, M(2017). Ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with unresectable or metastatic melanoma: a randomised, double-blind, multicentre, phase 3 trial. The Lancet Oncology, 18(5), 611–622
20.
Bordoni, R., Ciardiello, F., von Pawel, J., Cortinovis, D., Karagiannis, T., Ballinger, M., Sandler, A., Yu, W., He, P., Matheny, C., Felizzi, F., & Rittmeyer, A. (2018). Patient-reported outcomes in OAK: A phase III study of atezolizumab versus docetaxel in advanced non-small-cell lung cancer. Clinical Lung Cancer, 19(5), 441–449.CrossRef
21.
Brahmer, J. R., Rodriguez-Abreu, D., Robinson, A. G., Hui, R., Csoszi, T., Fulop, A., Gottfried, M., Peled, N., Tafreshi, A., Cuffe, S., O’Brien, M., Rao, S., Hotta, K., Zhang, J., Lubiniecki, G. M., Deitz, A. C., Rangwala, R., & Reck, M. (2017). Health-related quality-of-life results for pembrolizumab versus chemotherapy in advanced, PD-L1-positive NSCLC (KEYNOTE-024): A multicentre, international, randomised, open-label phase 3 trial. The Lancet Oncology, 18(12), 1600–1609.CrossRef
22.
Cella, D., Grunwald, V., Escudier, B., Hammers, H. J., George, S., Nathan, P., Grimm, M. O., Rini, B. I., Doan, J., Ivanescu, C., Paty, J., Mekan, S., & Motzer, R. J. (2019). Patient-reported outcomes of patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib (CheckMate 214): A randomised, phase 3 trial. The Lancet Oncology, 20(2), 297–310.CrossRef
23.
Cella, D., Grunwald, V., Nathan, P., Doan, J., Dastani, H., Taylor, F., Bennett, B., DeRosa, M., Berry, S., Broglio, K., Berghorn, E., & Motzer, R. J. (2016). Quality of life in patients with advanced renal cell carcinoma given nivolumab versus everolimus in CheckMate 025: A randomised, open-label, phase 3 trial. The lancet Oncology, 17(7), 994–1003.CrossRef
24.
Coens, C., Suciu, S., Chiarion-Sileni, V., Grob, J. J., Dummer, R., Wolchok, J. D., Schmidt, H., Hamid, O., Robert, C., Ascierto, P. A., Richards, J. M., Lebbe, C., Ferraresi, V., Smylie, M., Weber, J. S., Maio, M., Bottomley, A., Kotapati, S., de Pril, V., … Eggermont, A. M. M. (2017). Health-related quality of life with adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): Secondary outcomes of a multinational, randomised, double-blind, phase 3 trial. The Lancet Oncology, 18(3), 393–403.CrossRef
25.
Ferris, R. L., Blumenschein, G., Jr., Fayette, J., Guigay, J., Colevas, A. D., Licitra, L., Harrington, K., Kasper, S., Vokes, E. E., Even, C., Worden, F., Saba, N. F., Iglesias Docampo, L. C., Haddad, R., Rordorf, T., Kiyota, N., Tahara, M., Monga, M., Lynch, M., … Gillison, M. L. (2016). Nivolumab for recurrent squamous-cell carcinoma of the head and neck. New England Journal of Medicine, 375(19), 1856–1867.CrossRef
26.
Harrington, K. J., Ferris, R. L., Blumenschein, G., Jr., Colevas, A. D., Fayette, J., Licitra, L., Kasper, S., Even, C., Vokes, E. E., Worden, F., Saba, N. F., Kiyota, N., Haddad, R., Tahara, M., Grunwald, V., Shaw, J. W., Monga, M., Lynch, M., Taylor, F., … Guigay, J. (2017). Nivolumab versus standard, single-agent therapy of investigator’s choice in recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141): Health-related quality-of-life results from a randomised, phase 3 trial. The Lancet Oncology, 18(8), 1104–1115.CrossRef
27.
Motzer, R. J., Escudier, B., McDermott, D. F., George, S., Hammers, H. J., Srinivas, S., Tykodi, S. S., Sosman, J. A., Procopio, G., Plimack, E. R., Castellano, D., Choueiri, T. K., Gurney, H., Donskov, F., Bono, P., Wagstaff, J., Gauler, T. C., Ueda, T., Tomita, Y., … CheckMate, I. (2015). Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. New England Journal of Medicine, 373(19), 1803–1813.CrossRef
28.
Motzer, R. J., Tannir, N. M., McDermott, D. F., Frontera, O. A., Melichar, B., Choueiri, T. K., ... Checkmate. (2018). Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma. New England Journal of Medicine 378(14) 1277–1290
29.
Larkin, J., Minor, D., D'Angelo, S., Neyns, B., Smylie, M., Miller Jr, W. H., ... Weber, J. (2018). Overall survival in patients with advanced melanoma who received nivolumab versus investigator’s choice chemotherapy in CheckMate 037: A randomized, controlled, open-label phase III trial. Journal of clinical oncology, 36(4), 383.
30.
Lebbe, C., Meyer, N., Mortier, L., Marquez-Rodas, I., Robert, C., Rutkowski, P., Menzies, A. M., Eigentler, T., Ascierto, P. A., Smylie, M., Schadendorf, D., Ajaz, M., Svane, I. M., Gonzalez, R., Rollin, L., Lord-Bessen, J., Saci, A., Grigoryeva, E., & Pigozzo, J. (2019). Evaluation of two dosing regimens for nivolumab in combination with Ipilimumab in patients with advanced melanoma: Results from the Phase IIIb/IV CheckMate 511 Trial. Journal of Clinical Oncology, 37(11), 867–875.CrossRef
31.
Maio, M., Scherpereel, A., Calabro, L., Aerts, J., Perez, S. C., Bearz, A., Nackaerts, K., Fennell, D. A., Kowalski, D., Tsao, A. S., Taylor, P., Grosso, F., Antonia, S. J., Nowak, A. K., Taboada, M., Puglisi, M., Stockman, P. K., & Kindler, H. L. (2017). Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): A multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial. The Lancet Oncology, 18(9), 1261–1273.CrossRef
32.
Petrella, T. M., Robert, C., Richtig, E., Miller, W. H., Jr., Masucci, G. V., Walpole, E., Lebbe, C., Steven, N., Middleton, M. R., Hille, D., Zhou, W., Ibrahim, N., & Cebon, J. (2017). Patient-reported outcomes in KEYNOTE-006, a randomised study of pembrolizumab versus ipilimumab in patients with advanced melanoma. European Journal of Cancer, 86, 115–124.CrossRef
33.
Powles, T., Durán, I., Van Der Heijden, M. S., Loriot, Y., Vogelzang, N. J., De Giorgi, U., ... Ravaud, A. (2018). Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): A multicentre, open-label, phase 3 randomised controlled trial. The Lancet, 391(10122), 748–757.
34.
Pujol, J. L., Greillier, L., Audigier-Valette, C., Moro-Sibilot, D., Uwer, L., Hureaux, J., Guisier, F., Carmier, D., Madelaine, J., Otto, J., Gounant, V., Merle, P., Mourlanette, P., Molinier, O., Renault, A., Rabeau, A., Antoine, M., Denis, M. G., Bommart ... Souquet, P. J. (2019). A randomized non-comparative phase II study of anti-programmed cell death-ligand 1 atezolizumab or chemotherapy as second-line therapy in patients with small cell lung cancer: Results from the IFCT-1603 trial. Journal of Thoracic Oncology, 14(5), 903–913.
35.
Revicki, D. A., van den Eertwegh, A. J., Lorigan, P., Lebbe, C., Linette, G., Ottensmeier, C. H., Safikhani, S., Messina, M., Hoos, A., Wagner, S., & Kotapati, S. (2012). Health related quality of life outcomes for unresectable stage III or IV melanoma patients receiving ipilimumab treatment. Health and Quality of Life Outcomes, 10, 66.CrossRef
36.
Ribas, A., Puzanov, I., Dummer, R., Schadendorf, D., Hamid, O., Robert, C., Hodi, F. S., Schachter, J., Pavlick, A. C., Lewis, K. D., Cranmer, L. D., Blank, C. U., O'Day, S. J., Ascierto, P. A., Salama, A. K., Margolin, K. A., Loquai, C., Eigentler, T. K., Gangadhar, T ... Daud, A. (2015). Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): A randomised, controlled, phase 2 trial. The Lancet Oncology, 16(8), 908–918.
37.
Schadendorf, D., Dummer, R., Hauschild, A., Robert, C., Hamid, O., Daud, A., van den Eertwegh, A., Cranmer, L., O’Day, S., Puzanov, I., Schachter, J., Blank, C., Salama, A., Loquai, C., Mehnert, J. M., Hille, D., Ebbinghaus, S., Kang, S. P., Zhou, W., & Ribas, A. (2016). Health-related quality of life in the randomised KEYNOTE-002 study of pembrolizumab versus chemotherapy in patients with ipilimumab-refractory melanoma. European Journal of Cancer, 67, 46–54.CrossRef
38.
Schadendorf, D., Larkin, J., Wolchok, J., Hodi, F. S., Chiarion-Sileni, V., Gonzalez, R., Rutkowski, P., Grob, J. J., Cowey, C. L., Lao, C., Wagstaff, J., Callahan, M. K., Postow, M. A., Smylie, M., Ferrucci, P. F., Dummer, R., Hill, A., Taylor, F., Sabater, J. ... Long, G. V. (2017). Health-related quality of life results from the phase III CheckMate 067 study. European Journal of Cancer, 82, 80–91.
39.
Scherpereel, A., Mazieres, J., Greillier, L., Lantuejoul, S., Dô, P., Bylicki, O., ... Carmier, D. (2019). Nivolumab or nivolumab plus ipilimumab in patients with relapsed malignant pleural mesothelioma (IFCT-1501 MAPS2): A multicentre, open-label, randomised, non-comparative, phase 2 trial. The Lancet Oncology, 20(2), 239–253.
40.
Vaughn, D. J., Bellmunt, J., Fradet, Y., Lee, J. L., Fong, L., Vogelzang, N. J., Climent, M. A., Petrylak, D. P., Choueiri, T. K., Necchi, A., Gerritsen, W., Gurney, H., Quinn, D. I., Culine, S., Sternberg, C. N., Mai, Y., Li, H., Perini, R. F., Bajorin, D. F., & de Wit, R. (2018). Health-related Quality-of-Life Analysis from KEYNOTE-045: A phase III study of pembrolizumab versus chemotherapy for previously treated advanced urothelial cancer. Journal of Clinical Oncology, 36(16), 1579–1587.CrossRef
41.
Weber, J., Mandala, M., Del Vecchio, M., Gogas, H. J., Arance, A. M., Cowey, C. L., Dalle, S., Schenker, M., Chiarion-Sileni, V., Marquez-Rodas, I., Grob, J. J., Butler, M. O., Middleton, M. R., Maio, M., Atkinson, V., Queirolo, P., Gonzalez, R., Kudchadkar, R. R., Smylie … CheckMate.2017)Adjuvant nivolumab versus Ipilimumab in resected stage III or IV melanoma.New England Journal of Medicine377(19), 1824–1835
42.
Calvert, M., Blazeby, J., Altman, D. G., Revicki, D. A., Moher, D., Brundage, M. D., & CONSORT PRO Group FT. (2013). Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA, 309(8), 814–822.CrossRef
43.
Kiebert, G. M., Curran, D., & Aaronson, N. K. (1998). Quality of life as an endpoint in EORTC clinical trials. Statistics in Medicine, 17(5–7), 561–569.CrossRef
44.
Kluetz, P. G., Slagle, A., Papadopoulos, E. J., Johnson, L. L., Donoghue, M., Kwitkowski, V. E., Chen, W. H., Sridhara, R., Farrell, A. T., Keegan, P., Kim, G., & Pazdur, R. (2016). Focusing on core patient-reported outcomes in cancer clinical trials: Symptomatic adverse events, physical function, and disease-related symptoms. Clinical Cancer Research, 22(7), 1553–1558.CrossRef
45.
Hall, E. T., Singhal, S., Dickerson, J., Gabster, B., Wong, H. N., Aslakson, R. A., & Schapira, L. (2019). Patient-reported outcomes for cancer patients receiving checkpoint inhibitors: Opportunities for palliative care: A systematic review. Journal of Pain and Symptom Management, 58(1), 137–156.CrossRef
46.
Colomer-Lahiguera, S., Bryant-Lukosius, D., Rietkoetter, S., Martelli, L., Ribi, K., Fitzpatrick-Lewis, D., Sherifali, D., Orcurto, A., Juergens, R., & Eicher, M. (2020). Patient-reported outcome instruments used in immune-checkpoint inhibitor clinical trials in oncology: A systematic review. Journal of Patient-Reported Outcomes, 4(1), 58.CrossRef
47.
King-Kallimanis, B. L., Howie, L. J., Roydhouse, J. K., Singh, H., Theoret, M. R., Blumenthal, G. M., & Kluetz, P. G. (2019). Patient reported outcomes in anti-PD-1/PD-L1 inhibitor immunotherapy registration trials: FDA analysis of data submitted and future directions. Clinical Trials, 16(3), 322–326.CrossRef
48.
49.
Hui, R., Ozguroglu, M., Villegas, A., Daniel, D., Vicente, D., Murakami, S., Yokoi, T., Chiappori, A., Lee, K. H., de Wit, M., Cho, B. C., Gray, J. E., Ryden, A., Viviers, L., Poole, L., Zhang, Y., Dennis, P. A., & Antonia, S. J. (2019). Patient-reported outcomes with durvalumab after chemoradiotherapy in stage III, unresectable non-small-cell lung cancer (PACIFIC): A randomised, controlled, phase 3 study. The Lancet Oncology, 20(12), 1670–1680.CrossRef
Metagegevens
Titel
Impact of open-label versus blinded study design on patient-reported outcomes data in randomized clinical trials of immunotherapy in advanced or metastatic cancer patients: a systematic review
Auteurs
Amélie Anota
Astrid Pozet
Hervé Lemasson
Francois-Emery Cotté
Antoine Falcoz
Guillaume Eberst
Guillaume Mouillet
Stéphane Guerzider
Émilie Charton
Virginie Westeel
Publicatiedatum
20-07-2021
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 3/2022
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-021-02945-8

Andere artikelen Uitgave 3/2022

Quality of Life Research 3/2022 Naar de uitgave

OriginalPaper

BEAUTY and the breast: is adjuvant chemotherapy the right time for a beauty boost? Lessons learned from a large randomized controlled trial

OriginalPaper

The impact of CNS-directed treatment on quality of life in childhood cancer survivors

OriginalPaper

Equivalence testing of a newly developed interviewer-led telephone script for the EORTC QLQ-C30

OriginalPaper

The expanded prostate cancer index composite short form (EPIC-26) for measuring health-related quality of life: content analysis of patients’ spontaneous comments written in survey margins

Review

Measurement properties of patient-reported outcome measures (PROMs) in hyperhidrosis: a systematic review

OriginalPaper

Assessing anger and irritability in children: psychometric evaluation and normative data for the German version of the PROMIS® Parent Proxy Anger Scale