Applying cognitive debriefing to pre-test patient-reported outcomes in older people with multiple sclerosis

Ploughman, Michelle; Austin, Mark W.; Stefanelli, Mark; Godwin, Marshall

doi:10.1007/s11136-010-9602-z

Cited by 36 publications

(35 citation statements)

References 16 publications

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“…To create a profile of ageing with MS in Canada, we developed a national cross-sectional survey, based on previous qualitative research,5 6 using validated patient-reported outcome measures 9. We focused on health and lifestyle factors, disability, participation and quality of life, targeting people 55 years of age and older with MS symptoms for 20 or more years.…”

Section: Introductionmentioning

confidence: 99%

The Canadian survey of health, lifestyle and ageing with multiple sclerosis: methodology and initial results

Ploughman

Beaulieu²,

Harris

et al. 2014

BMJ Open

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ObjectivePeople with multiple sclerosis (MS) are living longer so strategies to enhance long-term health are garnering more interest. We aimed to create a profile of ageing with MS in Canada by recruiting 1250 (5% of the Canadian population above 55 years with MS) participants and focusing data collection on health and lifestyle factors, disability, participation and quality of life to determine factors associated with healthy ageing.DesignNational multicentre postal survey.SettingRecruitment from Canadian MS clinics, MS Society of Canada chapters and newspaper advertisements.ParticipantsPeople aged 55 years or older with MS symptoms more than 20 years.Outcome measuresValidated outcome measures and custom-designed questions examining MS disease characteristics, living situation, disability, comorbid conditions, fatigue, health behaviours, mental health, social support, impact of MS and others.ResultsOf the 921 surveys, 743 were returned (80.7% response rate). Participants (mean age 64.6±6.2 years) reported living with MS symptoms for an average of 32.9±9.5 years and 28.6% were either wheelchair users or bedridden. There was only 5.4% missing data and 709 respondents provided optional qualitative information. According to data derived from the 2012 Canadian Community Health Survey of Canadians above 55 years of age, older people with MS from this survey sample are about eight times less likely to be employed full-time. Older people with MS were less likely to engage in regular physical activity (26.7%) compared with typical older Canadians (45.2%). However, they were more likely to abstain from alcohol and smoking.ConclusionsDespite barriers to participation, we were able to recruit and gather detailed responses (with good data quality) from a large proportion of older Canadians with MS. The data suggest that this sample of older people with MS is less likely to be employed, are less active and more disabled than other older Canadians.

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Section: Introductionmentioning

confidence: 99%

The Canadian survey of health, lifestyle and ageing with multiple sclerosis: methodology and initial results

Ploughman

Beaulieu²,

Harris

et al. 2014

BMJ Open

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“…[4,24,25]. Others have developed overview tables to identify the initial text, the final text, and the stage of the process in which the revision occurred.…”

Section: Good Practice 5: Document Cognitive Interview Results For Evmentioning

confidence: 99%

Content Validity—Establishing and Reporting the Evidence in Newly Developed Patient-Reported Outcomes (PRO) Instruments for Medical Product Evaluation: ISPOR PRO Good Research Practices Task Force Report: Part 2—Assessing Respondent Understanding

et al. 2011

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The importance of content validity in developing patient reported outcomes (PRO) instruments is stressed by both the US Food and Drug Administration and the European Medicines Agency. Content validity is the extent to which an instrument measures the important aspects of concepts developers or users purport it to assess. A PRO instrument measures the concepts most relevant and important to a patient's condition and its treatment. For PRO instruments, items and domains as reflected in the scores of an instrument should be important to the target population and comprehensive with respect to patient concerns. Documentation of target population input in item generation, as well as evaluation of patient understanding through cognitive interviewing, can provide the evidence for content validity. Part 1 of this task force report covers elicitation of key concepts using qualitative focus groups and/or interviews to inform content and structure of a new PRO instrument. Building on qualitative interviews and focus groups used to elicit concepts, cognitive interviews help developers craft items that can be understood by respondents in the target population and can ultimately confirm that the final instrument is appropriate, comprehensive, and understandable in the target population. Part 2 details: 1) the methods for conducting cognitive interviews that address patient understanding of items, instructions, and response options; and 2) the methods for tracking item development through the various stages of research and preparing this tracking for submission to regulatory agencies. The task force report's two parts are meant to be read together. They are intended to offer suggestions for good practice in planning, executing, and documenting qualitative studies that are used to support the content validity of PRO instruments to be used in medical product evaluation.

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“…Cognitive debriefing is a qualitative interview method in which the patient's understanding and interpretation of items and answer options of the questionnaire are assessed [38,39]. A separate classification task was used to assess the appropriateness of the body categories.…”

Section: Content Validationmentioning

confidence: 99%

“…Immediately thereafter, a semi-structured interview was conducted using a topic list based on the ''question-and-answer'' model [38,39]. A subset of patients was asked to do a classification task, for which all ADEs were randomly split into five lists.…”

Section: Study Proceduresmentioning

confidence: 99%

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Development and Initial Validation of a Patient-Reported Adverse Drug Event Questionnaire

et al. 2013

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Background Direct patient reporting of adverse drug events (ADEs) is relevant for the evaluation of drug safety. To collect such data in clinical trials and postmarketing studies, a valid questionnaire is needed that can measure all possible ADEs experienced by patients. Objective Our aim was to develop and test a generic questionnaire to identify ADEs and quantify their nature and causality as reported by patients. Methods We created a draft list of common ADEs in layterms, which were classified in body categories and mapped to the Medical Dictionary for Regulatory Activities (MedDRA Ò ) terminology. Questions about the nature and causality were derived from existing questionnaires and causality scales. Content validity was tested through cognitive debriefing, revising the questionnaire in an iterative process. Feasibility and reliability were assessed using a Web-based version of the questionnaire. Patients received the questionnaire twice. Feasibility was assessed by the reported time needed for completion and ease of use. Reliability was calculated using Cohen's kappa and proportion of positive agreement (PPA) on: (1) any ADE at patient level; (2) similar ADEs at MedDRA Ò System Organ Class level; and (3) the same ADE at ADE-specific level.Results In the development phase, 28 patients with type 2 diabetes or asthma/chronic obstructive pulmonary disease (COPD) participated. Questions and answer options were rephrased, layout was improved, and changes were made in the classification of ADEs. The final questionnaire consisted of 252 ADEs organized in 16 body categories, and included 14 questions per reported ADE. A total of 135 patients using a median of five different drugs completed the Web-based questionnaire twice. The median completion time was 15 min for patients not reporting any ADE, and 30 min for patients reporting at least one ADE. Three quarters of the patients found the questionnaire easy to use. Test-retest reliability was acceptable at patient level (j = 0.50, PPA 0.64) and at MedDRA Ò System Organ Class level (j = 0.52, PPA 0.54), but was low at ADEspecific level (j = 0.38, PPA 0.38). Conclusion We developed a generic patient-reported ADE questionnaire and confirmed its content validity. The questionnaire was feasible and reliable for reporting any ADE and similar ADEs at MedDRA Ò System Organ Class level. Additional work is, however, needed to reliably quantify specific ADEs reported by patients.

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Applying cognitive debriefing to pre-test patient-reported outcomes in older people with multiple sclerosis

Abstract: Our findings support the notion that methods such as cognitive debriefing help improve precision of self-reported measures in a special population such as ours.

Cited by 36 publications

References 16 publications

The Canadian survey of health, lifestyle and ageing with multiple sclerosis: methodology and initial results

The Canadian survey of health, lifestyle and ageing with multiple sclerosis: methodology and initial results

Content Validity—Establishing and Reporting the Evidence in Newly Developed Patient-Reported Outcomes (PRO) Instruments for Medical Product Evaluation: ISPOR PRO Good Research Practices Task Force Report: Part 2—Assessing Respondent Understanding

Development and Initial Validation of a Patient-Reported Adverse Drug Event Questionnaire

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