Core Outcomes in Aphasia Treatment Research: An e-Delphi Consensus Study of International Aphasia Researchers

2016 ◽  
Vol 25 (4S) ◽  
Author(s):  
Sarah J. Wallace ◽  
Linda Worrall ◽  
Tanya Rose ◽  
Guylaine Le Dorze
Keyword(s):  
Rating Scale ◽  
Core Outcome Set ◽  
International Classification Of Functioning ◽  
Delphi Consensus ◽  
Specific Patient ◽  
Patient Reported ◽  
Delphi Exercise ◽  
Related Quality ◽  
Treatment Research ◽  
Aphasia Treatment

Purpose The purpose of this article is to identify outcome constructs that aphasia researchers consider essential to measure in all aphasia treatment research. Method Purposively sampled researchers were invited to participate in a 3-round e-Delphi exercise. In Round 1, an open-ended question was used to elicit important outcome constructs; responses were analyzed using inductive content analysis. In Rounds 2 and 3, participants rated the importance of each outcome using a 9-point rating scale. Outcomes reaching predefined consensus criteria were further analyzed using International Classification of Functioning, Disability and Health coding. Results Eighty researchers commenced Round 1, with 72 completing the entire survey. High response rates (≥ 85%) were achieved in subsequent rounds. Consensus was reached on 6 outcomes: (a) language functioning in modalities relevant to study aims, (b) impact of treatment from the perspective of the person with aphasia (PWA), (c) communication-related quality of life, (d) satisfaction with intervention from the perspective of the PWA, (e) satisfaction with ability to communicate from the perspective of the PWA, and (f) satisfaction with participation in activities from the perspective of the PWA. Conclusions Consensus was reached that it is essential to measure language function and specific patient-reported outcomes in all aphasia treatment research. These results will contribute to the development of a core outcome set.

The ICF, Relationship-Centred Care and Research Outcome Measurement: Carol Frattali's Impact on Aphasia Research

2015 ◽  
Vol 25 (3) ◽  
pp. 107-113 ◽  
Author(s):  
Linda Worrall ◽  
Sarah Wallace
Keyword(s):  
Outcome Measurement ◽  
Core Outcome Set ◽  
World Health ◽  
International Classification Of Functioning ◽  
International Consensus ◽  
Treatment Research ◽  
Aphasia Treatment ◽  
Health Organization ◽  
Qualitative Methodologies ◽  
Measurement Practices

Outcome measurement was a major focus of Carol Frattali's work. This article describes three aphasia research initiatives that have followed from her early publications. The first is the application of the World Health Organization (WHO) International Classification of Functioning, Disability and Health (ICF) to aphasia. The Living with Aphasia: A Framework for Outcome Measurement (A-FROM) is a reinterpretation of the ICF specifically as it applies to aphasia. The Assessment for Living with Aphasia (ALA) is an assessment that is derived from the A-FROM. The second initiative is the program of research that has described aphasia and aphasia rehabilitation from the patient perspective. Using qualitative methodologies, this research has highlighted the need for relationship-centred care in aphasia services. Finally, a current project is described that seeks to gain international consensus on a core outcome set for aphasia treatment research. This will help researchers combine data in effectiveness studies. To achieve the best outcomes for people with aphasia, there is a need to realize Carol Frattali's vision and ensure the continued use of unifying frameworks, relationship-centered practice, consumer-focused research, and consistent outcome measurement practices.

scholarly journals A core outcome set for aphasia treatment research: The ROMA consensus statement

2018 ◽  
Vol 14 (2) ◽  
pp. 180-185 ◽  
Author(s):  
Sarah J Wallace ◽  
Linda Worrall ◽  
Tanya Rose ◽  
Guylaine Le Dorze ◽  
Caterina Breitenstein ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Consensus Statement ◽  
Outcome Measurement ◽  
Core Outcome Set ◽  
Core Outcome ◽  
International Consensus ◽  
Patient Reported ◽  
Treatment Research ◽  
Aphasia Treatment

Background A core outcome set (COS; an agreed, minimum set of outcomes) was needed to address the heterogeneous measurement of outcomes in aphasia treatment research and to facilitate the production of transparent, meaningful, and efficient outcome data. Objective The Research Outcome Measurement in Aphasia (ROMA) consensus statement provides evidence-based recommendations for the measurement of outcomes for adults with post-stroke aphasia within phases I–IV aphasia treatment studies. Methods This statement was informed by a four-year program of research, which comprised investigation of stakeholder-important outcomes using consensus processes, a scoping review of aphasia outcome measurement instruments, and an international consensus meeting. This paper provides an overview of this process and presents the results and recommendations arising from the international consensus meeting. Results Five essential outcome constructs were identified: Language, communication, patient-reported satisfaction with treatment and impact of treatment, emotional wellbeing, and quality of life. Consensus was reached for the following measurement instruments: Language: The Western Aphasia Battery Revised (WAB-R) (74% consensus); emotional wellbeing: General Health Questionnaire (GHQ)-12 (83% consensus); quality of life: Stroke and Aphasia Quality of Life Scale (SAQOL-39) (96% consensus). Consensus was unable to be reached for measures of communication (where multiple measures exist) or patient-reported satisfaction with treatment or impact of treatment (where no measures exist). Discussion Harmonization of the ROMA COS with other core outcome initiatives in stroke rehabilitation is discussed. Ongoing research and consensus processes are outlined. Conclusion The WAB-R, GHQ-12, and SAQOL-39 are recommended to be routinely included within phases I–IV aphasia treatment studies. This consensus statement has been endorsed by the Collaboration of Aphasia Trialists, the British Aphasiology Society, the German Society for Aphasia Research and Therapy, and the Royal College of Speech Language Therapists.

Core Outcome Set for Reporting Outcomes of Interventions for Velopharyngeal Dysfunction: Final Results of the COS-VPD Initiative

2021 ◽  
pp. 105566562110350
Author(s):  
Catherine de Blacam ◽  
Adriane L. Baylis ◽  
Richard E. Kirschner ◽  
Susan Smith ◽  
Debbie Sell ◽  
...  
Keyword(s):  
Core Outcome Set ◽  
A Priori ◽  
Delphi Panel ◽  
Core Outcome ◽  
Delphi Consensus ◽  
Assessment Development ◽  
Comparison Of Results ◽  
Outcome Set ◽  
Patient Reported ◽  
Panel Rating

Objective To date, the recording of outcomes of interventions for velopharyngeal dysfunction (VPD) has not been standardized. This makes a comparison of results between studies challenging. The aim of this study was to develop a core outcome set (COS) for reporting outcomes in studies examining the management of VPD. Design A two-round Delphi consensus process was used to develop the COS. Patients, Participants The expert Delphi panel comprised patients and caregivers of patients with VPD, surgeons and speech and language therapists specializing in cleft palate, and researchers with expertise in VPD. Interventions A long list of outcomes was derived from the published literature. In each round of a Delphi survey, participants were asked to score outcomes using the Grading of Recommendations, Assessment, Development, and Evaluations scale of 1 to 9, with 1 to 3 labeled “not important,” 4 to 6 labeled “important but not critical,” and 7 to 9 labeled “critical.” Main outcome measure Consensus criteria were specified a priori. Outcomes with a rating of 75% or more of the panel rating 7 to 9 and 25% or fewer rating 1 to 3 were included in the COS. Results A total of 31 core outcomes were identified from the Delphi process. This list was condensed to combine topic areas to produce a final COS of 10 outcomes, including both processes of care and patient-reported outcomes that should be considered for reporting in future studies of VPD. Conclusions Implementation of the COS-VPD will facilitate consistency of outcomes data collection and comparison of results across studies.

scholarly journals Development of a patient-reported outcome questionnaire for aplastic anemia and paroxysmal nocturnal hemoglobinuria (PRO-AA/PNH)

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Kimmo Weisshaar ◽  
Hannah Ewald ◽  
Jörg Halter ◽  
Sabine Gerull ◽  
Sandra Schönfeld ◽  
...  
Keyword(s):  
Aplastic Anemia ◽  
Paroxysmal Nocturnal Hemoglobinuria ◽  
Patient Reported Outcome ◽  
Phase Iii ◽  
Specific Patient ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related ◽  
Core Symptoms ◽  
Missing Items

Abstract Background The introduction of new therapy modalities has significantly improved the outcome of aplastic anemia (AA) and paroxysmal nocturnal hemoglobinuria (PNH) patients. However, relatively little is known about the exact disease burden of AA/PNH since standardized assessments of symptoms including health-related quality of life (HRQoL) are frequently missing or inadequately designed for this rare patient group. We aimed to develop AA/PNH-specific questionnaires for self-reporting of symptoms, which could be included in electronic platforms for data collection and patient care. Methods By scoping review, we extracted any reported symptoms in AA/PNH and their prevalence from the literature (Phase I). Consensus rounds with patients and medical experts were conducted to identify core symptoms reported in the literature and to add missing items (Phase II). Ultimately, AA/PNH-specific patient-reported outcome (PRO) questionnaires including the selected measures were designed (Phase III). Results AA symptoms from 62 and PNH symptoms from 45 observational studies were extracted from the literature. Twenty-four patients and seven medical experts identified 11 core symptoms including HRQoL issues after three consensus rounds. Significant differences in the symptom ranking of patients versus medical experts could be observed. Therefore, patient- as well as expert-centered PRO questionnaires in AA and PNH were created following the concepts of validated instruments. Conclusion The development of symptom self-reporting questionnaires for AA and PNH was feasible and the disease-specific PRO questionnaires can now be validated within a web-based workflow in a subsequent feasibility study.

scholarly journals Development of a patient-reported outcome questionnaire for aplastic anemia and paroxysmal nocturnal hemoglobinuria (PRO-AA/PNH)

2020 ◽  
Author(s):  
Kimmo Weisshaar ◽  
Hannah Ewald ◽  
Jörg P. Halter ◽  
Sabine Gerull ◽  
Sandra Schönfeld ◽  
...  
Keyword(s):  
Aplastic Anemia ◽  
Paroxysmal Nocturnal Hemoglobinuria ◽  
Patient Reported Outcome ◽  
Phase Iii ◽  
Specific Patient ◽  
Physical Constraints ◽  
Patient Reported ◽  
Related Quality ◽  
Core Symptoms ◽  
Self Reporting Questionnaire

Abstract Background: The introduction of new therapy modalities has significantly improved the outcome of aplastic anemia (AA) and paroxysmal nocturnal hemoglobinuria (PNH) patients. However, relatively little is known about the exact disease burden of AA/PNH since standardized assessments of symptoms including health-related quality of life (HRQoL) are frequently missing or inadequately designed for this rare patient group. We aimed to develop an AA/PNH-specific questionnaire for self-reporting of symptoms, which could be included in electronic platforms for data collection and patient care. Methods: By scoping review, we extracted any reported symptoms in AA/PNH and their prevalence from the literature (Phase I). Consensus rounds with patients and medical experts were conducted to identify core symptoms reported in the literature and to add missing items (Phase II). Ultimately, an AA/PNH-specific patient-reported outcome (PRO) questionnaire including the selected measures was designed (Phase III). Results: Sixty-one symptoms in AA and 45 symptoms in PNH were extracted from the literature. Twenty-four patients and seven medical experts identified 11 core symptoms including HRQoL issues after three consensus rounds. Significant differences in the symptom ranking of patients versus medical experts could be observed. We determined a compromise between experts’ opinions on physical constraints and patients’ frequent demands on HRQoL. These items built the basis for the development of two PRO questionnaires separate for AA and PNH following the concepts of validated instruments. Conclusion: The development of a symptom self-reporting questionnaire for AA and PNH was feasible and the PRO questionnaire can now be validated within a web-based workflow in a subsequent feasibility study.

A core outcome set for aphasia treatment research: Obstacles, risks, and benefits

Aphasiology ◽  
2014 ◽  
Vol 28 (11) ◽  
pp. 1396-1399 ◽  
Author(s):  
William D. Hula ◽  
Gerasimos Fergadiotis ◽  
Patrick J. Doyle
Keyword(s):  
Core Outcome Set ◽  
Core Outcome ◽  
Risks And Benefits ◽  
Outcome Set ◽  
Treatment Research ◽  
Aphasia Treatment

scholarly journals Identification and categorisation of relevant outcomes for symptomatic uncomplicated gallstone disease: in-depth analysis to inform the development of a core outcome set

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e045568
Author(s):  
Moira Cruickshank ◽  
Rumana Newlands ◽  
Jane Blazeby ◽  
Irfan Ahmed ◽  
Mohamed Bekheit ◽  
...  
Keyword(s):  
Core Outcome Set ◽  
Gallstone Disease ◽  
Patient Reported Outcome Measures ◽  
Qualitative Studies ◽  
Core Outcome ◽  
Systematic Map ◽  
Specific Patient ◽  
Outcome Set ◽  
Depth Analysis ◽  
Patient Reported

BackgroundMany completed trials of interventions for uncomplicated gallstone disease are not as helpful as they could be due to lack of standardisation across studies, outcome definition, collection and reporting. This heterogeneity of outcomes across studies hampers useful synthesis of primary studies and ultimately negatively impacts on decision making by all stakeholders. Core outcome sets offer a potential solution to this problem of heterogeneity and concerns over whether the ‘right’ outcomes are being measured. One of the first steps in core outcome set generation is to identify the range of outcomes reported (in the literature or by patients directly) that are considered important.ObjectivesTo develop a systematic map that examines the variation in outcome reporting of interventions for uncomplicated symptomatic gallstone disease, and to identify other outcomes of importance to patients with gallstones not previously measured or reported in interventional studies.ResultsThe literature search identified 794 potentially relevant titles and abstracts of which 137 were deemed eligible for inclusion. A total of 129 randomised controlled trials, 4 gallstone disease specific patient-reported outcome measures (PROMs) and 8 qualitative studies were included. This was supplemented with data from 6 individual interviews, 1 focus group (n=5 participants) and analysis of 20 consultations. A total of 386 individual recorded outcomes were identified across the combined evidence: 330 outcomes (which were reported 1147 times) from trials evaluating interventions, 22 outcomes from PROMs, 17 outcomes from existing qualitative studies and 17 outcomes from primary qualitative research. Areas of overlap between the evidence sources existed but also the primary research contributed new, unreported in this context, outcomes.ConclusionsThis study took a rigorous approach to catalogue and map the outcomes of importance in gallstone disease to enhance the development of the COS ‘long’ list. A COS for uncomplicated gallstone disease that considers the views of all relevant stakeholders is needed.

scholarly journals Obtaining Patient-Reported Outcomes Electronically With “OncoFunction” in Head and Neck Cancer Patients During Aftercare

2020 ◽  
Vol 10 ◽  
Author(s):  
Veit Zebralla ◽  
Juliane Müller ◽  
Theresa Wald ◽  
Andreas Boehm ◽  
Gunnar Wichmann ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Patient Reported Outcomes ◽  
Psychosocial Problems ◽  
Patient Reported Outcome ◽  
International Classification Of Functioning ◽  
Patient Reported ◽  
Related Quality ◽  
Time Required

The disease and treatment of patients with head and neck cancer can lead to multiple late and long-term sequelae. Especially pain, psychosocial problems, and voice issues can have a high impact on patients’ health-related quality of life. The aim was to show the feasibility of implementing an electronic Patient-Reported Outcome Measure (PROM) in patients with head and neck cancer (HNC). Driven by our department’s intention to assess Patient-Reported Outcomes (PRO) based on the International Classification of Functioning during tumor aftercare, the program “OncoFunction” has been implemented and continuously refined in everyday practice. The new version of “OncoFunction” was evaluated by 20 head and neck surgeons and radiation oncologists in an interview. From 7/2013 until 7/2017, 846 patients completed the PROM during 2,833 of 3,610 total visits (78.5%). The latest software version implemented newly developed add-ins and increased the already high approval ratings in the evaluation as the number of errors and the time required decreased (6 vs. 0 errors, 1.35 vs. 0.95 min; p<0.01). Notably, patients had different requests using PRO in homecare use. An additional examination shows that only 59% of HNC patients use the world wide web. Using OncoFunction for online-recording and interpretation of PROM improved data acquisition in daily HNC patients’ follow-up. An accessory timeline grants access to former consultations and their visualization supported and simplified structured examinations. This provides an easy-to-use representation of the patient’s functional outcome supporting comprehensive aftercare, considering all aspects of the patient’s life.

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