Evidence map›Paper›PMID 25953508›Full record

ArticleHealth and quality of life outcomes2015

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

Yanhong Luo, Jie Yang, Yanbo Zhang

Abstract read
In one paragraph

Article in Health and quality of life outcomes, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  5. Understanding data visualization techniques in qualitative studies used to develop and validate patient-reported outcome measures: a targeted literature review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025
    Review
  6. A scoping review of patient and public involvement in empirical stroke research.International journal of stroke : official journal of the International Stroke Society · 2024
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Yanhong LuoDepartment of Health Statistics, School of Public Health, Shanxi Medical University, 56 South XinJian Road, Taiyuan, Shanxi Province, 030001, People's Republic of China. lifearena@163.com.
Jie YangDepartment of Health Statistics, School of Public Health, Shanxi Medical University, 56 South XinJian Road, Taiyuan, Shanxi Province, 030001, People's Republic of China. 617802126@qq.com.
Yanbo ZhangDepartment of Health Statistics, School of Public Health, Shanxi Medical University, 56 South XinJian Road, Taiyuan, Shanxi Province, 030001, People's Republic of China. sxmuzyb@126.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFamily 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.

methodsA 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.

resultsThe 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.

conclusionsThe 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.

Indexed as

AdultAgedAnticoagulantsChinaClinical Trials as TopicFactor Analysis, StatisticalFemaleHumansMaleMiddle AgedPatient Outcome AssessmentPatient SatisfactionPersonal SatisfactionQuality of LifeReproducibility of ResultsSelf ReportAnticoagulants

Identifiers

PMID25953508
PMCPMC4489208

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.