Acceptability of the method of administration of a patient-reported outcome measure (PROM) with stroke survivors, a randomised controlled trial protocol

Alexander Smith, Anna Pennington, Ben Carter, Stephanie Gething, Michelle Price, James White, Richard Dewar, Jonathan Hewitt, Alexander Smith, Anna Pennington, Ben Carter, Stephanie Gething, Michelle Price, James White, Richard Dewar, Jonathan Hewitt

Abstract

Background: UK-wide national clinical guidelines promote routine 6-month post-stroke follow-up assessment. However, as part of this 6-month assessment little information is gathered from the patient's perspective. The means of collecting this patient-centred information might be served best by a patient-reported outcome measure (PROM) at the 6-month assessment time point. Currently, four different methods of 6-month follow-up assessment occur; the most common being face-to-face interview followed by telephone interview, postal questionnaire and online questionnaire. Therefore, this study will investigate if the acceptability of telephone, online or postal administration of a PROM at the 6-month post-stoke time point is not inferior to face-to-face administration.

Methods/design: A UK multicentre, blinded (analyst and researcher), pragmatic, non-inferiority study, with 80% power using a 2.5% non-inferiority margin was designed to compare the acceptability of three modes of administration (telephone interview, postal questionnaire and online questionnaire) compared with face-to-face interview administration of a PROM. We plan to approach and randomise a minimum of 808 potentially eligible participants, 202 participants per group.

Discussion: The aim of this ongoing research is to understand if there is a difference between face-to-face administration and the other three methods of administering a PROM as a patient-centred supplement to the 6-month review for stroke survivors. In utilising a pragmatic design, it is believed that this study will offer UK wide generalisable results, of the acceptability of the methods under investigation, to inform clinicians and commissioners of stroke services.

Trials registration: ClinicalTrials.gov: NCT03177161 . Registered on 6 June 2017.

Keywords: CVA; Face-to-face; Non-inferiority; Online; PROM; Postal; Questionnaire; Response rate; Stroke; Telephone.

Conflict of interest statement

Ethics approval and consent to participate

Ethical approval was obtained from the North West – Greater Manchester South Research Ethics Committee via the Health Research Authority (HRA) Central Booking Service as a member panel of the NHS Research Ethics Committees (IRAS ID – 222,226 - REC ID – 17/NW/0269). All potentially eligible participants will be approached to offer their informed consent.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Participant flow diagram
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure

References

    1. Dawson J, Doll H, Fitzpatrick R, Jenkinson C, Carr AJ. The routine use of patient reported outcome measures in healthcare settings. BMJ. 2010;340:c186. doi: 10.1136/bmj.c186.
    1. Greenhalgh J. The applications of PROs in clinical practice: what are they, do they work, and why? Qual Life Res. 2009;18:115–123. doi: 10.1007/s11136-008-9430-6.
    1. Snyder CF, Aaronson NK, Choucair AK, Elliott TE, Greenhalgh J, Halyard MY, et al. Implementing patient-reported outcomes assessment in clinical practice: a review of the options and considerations. Qual Life Res. 2012;21:1305–1314. doi: 10.1007/s11136-011-0054-x.
    1. Higginson IJ, Carr AJ. Measuring quality of life: using quality of life measures in the clinical setting. BMJ. 2001;322:1297–1300. doi: 10.1136/bmj.322.7297.1297.
    1. Alonso J, Bartlett SJ, Rose M, Aaronson NK, Chaplin JE, Efficace F, Leplège A, Lu A, Tulsky DS, Raat H, Ravens-Sieberer U, Revicki D, Terwee CB, Valderas JM, Cella D, Forrest CB. The case for an international patient-reported outcomes measurement information system (PROMIS®) initiative Health Qual Life Outcomes. 2013;11(1), p. 210. doi: 10.1186/1477-7525-11-210.
    1. Devlin NJ, Brooks R. EQ-5D and the EuroQol group: past, present and future. Appl Health Econ Health Policy. 2017:1–11. 10.1007/s40258-017-0310-5.
    1. Hays RD, Sherbourne CD, Mazel RM. The Rand 36-item health survey 1.0. Health Econ. 1993;2(3):217–227. doi: 10.1002/hec.4730020305.
    1. Cogger H, Worthington E, Lincoln NB. Cognitive rehabilitation for memory deficits after stroke. Cochrane Database Syst Rev. 2016; 10.1002/14651858.cd002293.pub3.
    1. Sentinel Stroke National Audit Programme (SSNAP) SSNAP Portfolio for April–July 2016 admissions and discharges – Wales. 2016.
    1. Lannin N, Anderson C, Lim J, Paice K, Price C, Faux S, Levi C, Donnan G, Cadilhac D. Telephone follow-up was more expensive but more efficient than postal in a national stroke registry. J Clin Epidemiol. 2013. 66(8):896–902.
    1. Duncan P, Reker D, Kwon S, Lai S, Studenski S, Perera S, Alfrey C, Marquez J. Measuring stroke impact with the stroke impact scale. Med Care. 2005;43(5):507–515. doi: 10.1097/.
    1. Duncan P, Bode R, Min Lai S, Perera S. Rasch analysis of a new stroke-specific outcome scale: the Stroke Impact Scale. Arch Phys Med Rehabil. 2003;84(7):950–963. doi: 10.1016/S0003-9993(03)00035-2.
    1. Peters M, Crocker H, Jenkinson C, Doll H, Fitzpatrick R. The routine collection of patient-reported outcome measures (PROMs) for long-term conditions in primary care: a cohort survey. BMJ Open. 2014;4(2):e003968. doi: 10.1136/bmjopen-2013-003968.
    1. Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, DeVellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai J-S, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R. The patient-reported outcomes measurement information system (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008. J Clin Epidemiol. 2010;63(11):1179–1194. doi: 10.1016/j.jclinepi.2010.04.011.
    1. International Consortium for Health Outcomes Measurement (ICHOM) Stroke: Data Collection Reference Guide − Version 2.0. 2015.
    1. Salinas J, Sprinkhuizen SM, Ackerson T, Bernhardt J, Davie C, George MG, Gething S, Kelly AG, Lindsay P, Liu L, Martins SCO, Morgan L, Norrving B, Ribbers GM, Silver FL, Smith EE, Williams LS, Schwamm LH. An international standard set of patient-centered outcome measures after stroke. Stroke. 2015;47(1):180–186. doi: 10.1161/STROKEAHA.115.010898.
    1. Asplund K, Hulter Åsberg K, Appelros P, Bjarne D, Eriksson M, Johansson Å, Jonsson F, Norrving B, Stegmayr B, Terént A, Wallin S, Wester PO. The Riks-Stroke story: building a sustainable national register for quality assessment of stroke care. Int J Stroke. 2011;6(2):99–108. doi: 10.1111/j.1747-4949.2010.00557.x.
    1. Söderholm A, Stegmayr B, Glader E-L, Asplund K. Validation of hospital performance measures of acute stroke care quality. RiksStroke, the Swedish Stroke Register. Neuroepidemiology. 2016;46(4):229–234. doi: 10.1159/000444679.
    1. Adamson J, Cockayne S, Puffer S, Torgerson DJ. Review of randomised trials using the post-randomised consent (Zelen’s) design. Contemp Clin Trials. 2006;27(4):305–319. doi: 10.1016/j.cct.2005.11.003.
    1. Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin J, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleža-Jerić K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi: 10.1136/bmj.e7586.
    1. Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin J, Doré C, Parulekar W, Summerskill W, Groves T, Schulz K, Sox H, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. World Health Organization . The ICD-10 classification of mental and behavioural disorders: clinical descriptions and diagnostic guidelines. Geneva: World Health Organization; 1992.
    1. Great Britain Data Protection Act. London: Stationery Office [Online] 1998. Available at: Accessed 2 Mar 2017.
    1. Holm S. A simple sequentially rejective multiple test procedure. Scand J Stat. 1979;6(2):65–70.
    1. Intercollegiate Stroke Working Party . National clinical guideline for stroke. 5. London: Royal College of Physicians; 2016.
    1. Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Ann Int Med. 2010;152 Epub 24 March
    1. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epi. 2010;63(8):e1–e37. doi: 10.1016/j.jclinepi.2010.03.004.
    1. Piaggio G, Elbourne DR, Pocock SJ, Evans SJW, Altman DG, for the CONSORT group Reporting of noninferiority and equivalence randomized trials. Extension of the CONSORT 2010 statement. JAMA. 2012;308(24):2594–2604. doi: 10.1001/jama.2012.87802.
    1. Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D, for the CONSORT and Pragmatic Trials in Healthcare (Practihc) Group Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390. doi: 10.1136/bmj.a2390.

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