Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Health and Quality of Life Outcomes
Published in: Health and Quality of Life Outcomes 1/2015

Open Access 01-12-2015 | Research article

Development and validation of a patient-reported outcome measure for stroke patients

Authors: Yanhong Luo, Jie Yang, Yanbo Zhang

Published in: Health and Quality of Life Outcomes | Issue 1/2015

Login to get access

Abstract

Background

Family support and patient satisfaction with treatment are crucial for aiding in the recovery from stroke. However, current validated stroke-specific questionnaires may not adequately capture the impact of these two variables on patients undergoing clinical trials of new drugs. Therefore, the aim of this study was to develop and evaluate a new stroke patient-reported outcome measure (Stroke-PROM) instrument for capturing more comprehensive effects of stroke on patients participating in clinical trials of new drugs.

Methods

A conceptual framework and a pool of items for the preliminary Stroke-PROM were generated by consulting the relevant literature and other questionnaires created in China and other countries, and interviewing 20 patients and 4 experts to ensure that all germane parameters were included. During the first item-selection phase, classical test theory and item response theory were applied to an initial scale completed by 133 patients with stroke. During the item-revaluation phase, classical test theory and item response theory were used again, this time with 475 patients with stroke and 104 healthy participants. During the scale assessment phase, confirmatory factor analysis was applied to the final scale of the Stroke-PROM using the same study population as in the second item-selection phase. Reliability, validity, responsiveness and feasibility of the final scale were tested.

Results

The final scale of Stroke-PROM contained 46 items describing four domains (physiology, psychology, society and treatment). These four domains were subdivided into 10 subdomains. Cronbach’s α coefficients for the four domains ranged from 0.861 to 0.908. Confirmatory factor analysis supported the validity of the final scale, and the model fit index satisfied the criterion. Differences in the Stroke-PROM mean scores were significant between patients with stroke and healthy participants in nine subdomains (P < 0.001), indicating that the scale showed good responsiveness.

Conclusions

The Stroke-PROM is a patient-reported outcome multidimensional questionnaire developed especially for clinical trials of new drugs and is focused on issues of family support and patient satisfaction with treatment. Extensive data analyses supported the validity, reliability and responsiveness of the Stroke-PROM.
Appendix
Available only for authorised users
Literature
1.
Kaste M. Every day is a world stroke day act now, be a stroke champion and a torchbearer. Stroke. 2010;41:2449–50.CrossRefPubMed
2.
3.
Claiborne Johnston S, Shanthi M, Mathers CD. Global variation in stroke burden and mortality: estimates from monitoring, surveillance, and modeling. Lancet Neurol. 2009;8:345–54.CrossRefPubMed
4.
Cerebrovascular disease group of the neurology branch of Chinese medical association for writing ischemic stroke secondary prevention guidelines. The secondary prevention guidelines of Chinese ischemic stroke and transient ischemic attack. Chin J Neurol. 2010;43(2):154–60.
5.
Jones P, Harding G, Wiklund I, Berry P, Leidy N. Improving the process and outcome of care in COPD:development of a standardised assessment tool. Prim Care Respir J. 2009;18(3):208–15.CrossRefPubMed
6.
Rinu Susan R, Sarma PS, Pandian JD. Psychosocial problems, quality of life, and functional independence among Indian stroke survivors. Stroke. 2010;41:2932–7.CrossRef
7.
Björn S, Mika N, Per-Olof E, Paul H, Eva Wikström J. Validation of the clinical COPD questionnaire (CCQ) in primary care. Health Qual Life Outcomes. 2009;7:26.CrossRef
8.
9.
Deshpande PR, Surulivel R, Lakshmi Sudeepthi B, Abdul Nazir CP. Patient-reported outcomes: a new era in clinical research. Perspect Clin Res. 2011;2(4):136–44.CrossRef
10.
Reda AA, Daniel K, Janwillem WH K, Geertjan W, Constant P, van Schayck N. Reliability and validity of the clinical COPD questionniare and chronic respiratory questionnaire. Respir Med. 2010;104:1675–82.CrossRefPubMed
11.
Windisch W, Budweiser S, Heinemann F, Pfeiferb M, Rzehak P. The severe respiratory insufficiency questionnaire was valid for COPD patients with severe chronic respiratory failure. J Clin Epidemiol. 2008;61:848–53.CrossRefPubMed
12.
13.
Buck D, Jacoby A, Massey A, Steen N, Sharma A, Ford GA. Development and validation of NEWSQOL, the Newcastle stroke-specific quality of life measure. Cerebrovasc Dis. 2004;17:143–52.CrossRefPubMed
14.
Hilari K, Byng S, Lamping DL, Smith SC. Stroke and aphasia quality of life scale-39 (SAQOL-39) evaluation of acceptability, reliability, and validity. Stroke. 2003;34:1944–50.CrossRefPubMed
15.
Duncan PW, Dennis W, Sue Min L, Dallas J, Susan E, Louise Jacobs L. The stroke impact scale version 2.0: evaluation of reliability, validity, and sensitivity to change. Stroke. 1999;30:2131–40.CrossRefPubMed
16.
Xiaoxv Y, Xiaochen T, Yeqing T, Rui Y, Yunxia W, Shiyi C, et al. Development and validation of a tuberculosis medication adherence scale. Plos One. 2012;7(12):e50328.CrossRef
17.
Richieri R, Boyer L, Reine G, Loundou A, Auquier P, Lançon C, et al. The schizophrenia caregiver quality of life questionnaire (S-CGQoL): development and validation of an instrument to measure quality of life of caregivers of individuals with schizophrenia. Schizophr Res. 2011;126:192–201.CrossRefPubMed
18.
Polit DF, Cheryl Tatano B, Owen SV. Is the CVI an acceptable indicator of content validity? appraisal and recommendations. Res Nurs Health. 2007;30:459–67.CrossRefPubMed
19.
Wynd CA, Bruce S, Michelle Atkins S. Two quantitative approaches for estimating content validity. West J Nurs Res. 2003;25(5):508–18.CrossRefPubMed
20.
Yusoff MSB. The Dundee ready educational environment measure: a confirmatory factor analysis in a sample of Malaysian medical students. Int J Humanities Social Sci. 2012;2(16):313–21.
21.
Steven DM. Reliability: on the reproducibility of assessment data. Metric Med Educ. 2004;38:1006–12.CrossRef
22.
Muhamad Saiful Bahri Yusoff, Ahmad Fuad Abdul Rahim, Mohd Jamil Yaacob: The development and validity of the medical student stressor questionnaire(MSSQ). ASEAN Journal of Psychiatry 2010, 11 (1): Jan – June 2010: XX XX.
23.
tot van Nispen Pannerden SC, Candel MJJM, Zwakhalen SMG, Hamers JPH, Curfs LMG, Berger MPF. An item response theory-based assessment of the pain assessment checklist for seniors with limited ability to communicate (PACSLAC). J Pain. 2009;10(8):844–53.CrossRef
24.
U.S. Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health. Guidance for industry patient-reported outcome measures: Use in medical product development to support labeling claims. Clin/Med. 2009;12:1–39.
25.
van der Molen T, Brigitte WM W, Siebrig S, ten Hacken NHT, Postma DS, Juniper EF. Development, validity and responsiveness of the Clinical COPD Questionnaire. Health Qual Life Outcomes. 2003;1:13.CrossRefPubMedCentralPubMed
26.
van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988;19:604–7.CrossRefPubMed
27.
Lyden PD, Mei L, Levine SR, Brott TG, Broderick J. A modified national institutes of health stroke scale for use in stroke clinical trials. Stroke. 2001;32:1310–7.CrossRefPubMed
28.
Cote R, Hachinski VC, Shurvell BL, Norris JW, Wolfson C. The Canadian neurological scale: a preliminary study in acute stroke. Stroke. 1986;17:731–7.CrossRefPubMed
29.
Williams LS, Weinberger M, Harris LE, Clark DO, Biller J´. Development of a stroke-specific quality of life scale. Stroke. 1999;30:1362–9.CrossRefPubMed
30.
Wang Y, Zhao H, Liu Z, Liu B. Reliability, validity and response of patient reported outcome scale in stroke patients with spastic paralysis. Chinese General Practice. 2009;12:1168–70.
31.
Buck D, Jacoby A, Massey A, Ford G. Evaluation of measures used to assess quality of life after stroke. Stroke. 2000;31:2004–10.CrossRefPubMed
32.
Watanabe Y, Araki S, Kurihara M. Health-related quality of life of stroke patients’ families during the patients’ hospitalization: a pilot study in Japan. Int J Rehabil Res. 2003;26(1):43–5.CrossRefPubMed
33.
Palmer S, Glass TA. Family function and stroke recovery: a review. Rehabil Psychol. 2003;48(4):255–65.CrossRef
34.
Cameron JI, Gary N, Gignac MAM, Mark B, Grace W, Theresa G, et al. Randomized clinical trial of the timing it right stroke family support program: research protocol. Health Serv Res. 2014;14:18.CrossRef
35.
Clark MS, Sally R, Adrian W. A randomized controlled trial of an education and counselling intervention for families after stroke. Clin Rehabil. 2003;17:703–12.CrossRefPubMed
36.
Clark PC, Dunbar SB, Shields CG, Viswanathan B, Aycock DM, Wolf SL. Influence of stroke survivor characteristics and family conflict surrounding recovery on Caregivers’ mental and physical health. Nurs Res. 2004;53(6):406–13.CrossRefPubMed
37.
Lawrence M, Kinn S. Needs, priorities, and desired rehabilitation outcomes of family members of young adults who have had a stroke: findings from a phenomenological study. Disabil Rehabil. 2013;35(7):586–95.CrossRefPubMed
38.
Anne V-M, Marcel P, Jan Willem G, Berlekom SBV, Trudi Van Den B, Eline L. Rehabilitation of stroke patients needs a family-centred approach. Disabil Rehabil. 2006;28(24):1557–61.CrossRef
39.
Han B, Haley WE. Family caregiving for patients with stroke review and analysis. Stroke. 1999;30:1478–85.CrossRefPubMed
40.
Francesco M, Harin Padma N, Andrew M, Brock GB, Gregory B, Sanjeev A, et al. Tadalafil in the treatment of erectile dysfunction following bilateral nerve sparing radical retropubic prostatectomy: a randomized, double-blind, placebo controlled trial. J Urol. 2004;172:1036–41.CrossRef
41.
Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008;9(2):105–21.CrossRefPubMed
42.
Burgio KL, Locher JL, Goode PS, Michael Hardin J, Joan McDowell B, Marianne D, et al. Behavioral vs drug treatment for urge urinary incontinence in older women a randomized controlled trial. JAMA. 1998;280(23):1995.CrossRefPubMed
43.
Linda A, Krithika R, Polyxane M, Carolyn B, Rod B, Robin C. Development and validation of the Impact of Dry Eye on Everyday Life (IDEEL) questionnaire, a patient-reported outcomes (PRO) measure for the assessment of the burden of dry eye on patients. Health Qual Life Outcomes. 2011;9:111.CrossRef
44.
Hagman BT, Kuerbis AN, Morgenstern J, Bux DA, Parsons JT, Heidinger BE. An item response theory (IRT) analysis of the short inventory of problems-alcohol and drugs (SIP-AD) among non-treatment seeking men-who-have-sex-with-men: evidence for a shortened 10-item SIP-AD. Addict Behav. 2009;34:948–54.CrossRefPubMedCentralPubMed
Metadata
Title
Development and validation of a patient-reported outcome measure for stroke patients
Authors
Yanhong Luo
Jie Yang
Yanbo Zhang
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2015
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/s12955-015-0246-0

Other articles of this Issue 1/2015

Health and Quality of Life Outcomes 1/2015 Go to the issue

Research

Differential item functioning (DIF) of SF-12 and Q-LES-Q-SF items among french substance users

Research Article

Impact of overactive bladder on quality of life and resource use: results from Korean Burden of Incontinence Study (KOBIS)

Research

Effects of social activity on health-related quality of life according to age and gender: an observational study

Research

“Married with children” the influence of significant others in TTO exercises

Research

Shoulder pain and disability index: cross cultural validation and evaluation of psychometric properties of the Spanish version

Research Article

Mobility predicts change in older adults’ health-related quality of life: evidence from a Vancouver falls prevention prospective cohort study