Dataset Information

Developing a patient-centered outcome measure for complementary and alternative medicine therapies II: refining content validity through cognitive interviews.

ABSTRACT:

Background

Available measures of patient-reported outcomes for complementary and alternative medicine (CAM) inadequately capture the range of patient-reported treatment effects. The Self-Assessment of Change questionnaire was developed to measure multi-dimensional shifts in well-being for CAM users. With content derived from patient narratives, items were subsequently focused through interviews on a new cohort of participants. Here we present the development of the final version in which the content and format is refined through cognitive interviews.

Methods

We conducted cognitive interviews across five iterations of questionnaire refinement with a culturally diverse sample of 28 CAM users. In each iteration, participant critiques were used to revise the questionnaire, which was then re-tested in subsequent rounds of cognitive interviews. Following all five iterations, transcripts of cognitive interviews were systematically coded and analyzed to examine participants' understanding of the format and content of the final questionnaire. Based on this data, we established summary descriptions and selected exemplar quotations for each word pair on the final questionnaire.

Results

The final version of the Self-Assessment of Change questionnaire (SAC) includes 16 word pairs, nine of which remained unchanged from the original draft. Participants consistently said that these stable word pairs represented opposite ends of the same domain of experience and the meanings of these terms were stable across the participant pool. Five pairs underwent revision and two word pairs were added. Four word pairs were eliminated for redundancy or because participants did not agree on the meaning of the terms. Cognitive interviews indicate that participants understood the format of the questionnaire and considered each word pair to represent opposite poles of a shared domain of experience.

Conclusions

We have placed lay language and direct experience at the center of questionnaire revision and refinement. In so doing, we provide an innovative model for the development of truly patient-centered outcome measures. Although this instrument was designed and tested in a CAM-specific population, it may be useful in assessing multi-dimensional shifts in well-being across a broader patient population.

SUBMITTER: Thompson JJ

PROVIDER: S-EPMC3439682 | biostudies-literature | 2011 Dec

REPOSITORIES: biostudies-literature

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Publications

Developing a patient-centered outcome measure for complementary and alternative medicine therapies II: refining content validity through cognitive interviews.

Thompson Jennifer J JJ Kelly Kimberly L KL Ritenbaugh Cheryl C Hopkins Allison L AL Sims Colette M CM Coons Stephen J SJ

BMC complementary and alternative medicine 20111229

<h4>Background</h4>Available measures of patient-reported outcomes for complementary and alternative medicine (CAM) inadequately capture the range of patient-reported treatment effects. The Self-Assessment of Change questionnaire was developed to measure multi-dimensional shifts in well-being for CAM users. With content derived from patient narratives, items were subsequently focused through interviews on a new cohort of participants. Here we present the development of the final version in which ...[more]

PMID: 22206409

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Project description:BackgroundPersonalised (or individualised) medicine in the days of genetic research refers to molecular biologic specifications in individuals and not to a response to individual patient needs in the sense of person-centred medicine. Studies suggest that patients often wish for authentically person-centred care and personal physician-patient interactions, and that they therefore choose Complementary and Alternative medicine (CAM) as a possibility to complement standard care and ensure a patient-centred approach. Therefore, to build on the findings documented in these qualitative studies, we investigated the various concepts of individualised medicine inherent in patients' reasons for using CAM.MethodsWe used the technique of meta-ethnography, following a three-stage approach: (1) A comprehensive systematic literature search of 67 electronic databases and appraisal of eligible qualitative studies related to patients' reasons for seeking CAM was carried out. Eligibility for inclusion was determined using defined criteria. (2) A meta-ethnographic study was conducted according to Noblit and Hare's method for translating key themes in patients' reasons for using CAM. (3) A line-of-argument approach was used to synthesize and interpret key concepts associated with patients' reasoning regarding individualized medicine.Results(1) Of a total of 9,578 citations screened, 38 studies were appraised with a quality assessment checklist and a total of 30 publications were included in the study. (2) Reasons for CAM use evolved following a reciprocal translation. (3) The line-of-argument interpretations of patients' concepts of individualised medicine that emerged based on the findings of our multidisciplinary research team were "personal growth", "holism", "alliance", "integrative care", "self-activation" and "wellbeing".ConclusionsThe results of this meta-ethnographic study demonstrate that patients' notions of individualised medicine differ from the current idea of personalised genetic medicine. Our study shows that the "personal" patients' needs are not identified with a specific high-risk group or with a unique genetic profile in the sense of genome-based "personalised" or "individualised" medicine. Thus, the concept of individualised medicine should include the humanistic approach of individualisation as expressed in concepts such as "personal growth", "holistic" or "integrative care", doctor-patient "alliance", "self-activation" and "wellbeing" needs. This should also be considered in research projects and the allocation of healthcare resources.

Project description:BackgroundThe quality of life of patients at all stages of hematological malignancy is greatly affected by the disease and its treatment. There is a wide range of health-related quality of life (HRQoL) issues important to these patients. Any new instrument developed to measure HRQoL of such patients should be content valid, i.e., the items should be comprehensively relevant to the patients and their health condition. The aim of the present study was to examine content validity of a hematological malignancy specific patient reported outcome measure (HM-PRO) developed for use in routine clinical practice.MethodsFollowing literature review and semi-structured interviews, the generated themes and sub-themes were discussed to develop the prototype version of the HM-PRO. A 4-step approach was used for content validation: initial testing and cognitive interviewing; item rating; content validity panel meeting; final field testing and cognitive interviewing. Additional questions related to patients' perception of recall period and preferred sentence structure (i.e., question or statement) of the items were also asked during cognitive interviews.ResultsThe content analysis of 129 transcribed semi-structured interviews resulted in the prototype version of the instrument consisting of 58 items grouped into two parts: Part A (impact/HRQoL - 34 items) and Part B (signs and symptoms - 24 items). The initial testing showed intra-class correlation coefficient (ICC) of >0.8 for both Part A and Part B. Item rating for language clarity, completeness, relevance, and response scale by experts and patients showed content validity index for scales average >0.8 for both Part A and Part B, except 0.64 for relevance for Part A by the patient panel. The final testing of the revised version of the instrument showed the Cronbach's alpha value of 0.91 for Part A and 0.76 for Part B, suggesting high internal consistency, and ICC of 0.91 for Part A and 0.76 for Part B. The recall period of "today" for Part-A and "last 3 days" for Part-B were the patients' preferred "recall period." Furthermore, the patients expressed preference to the HM-PRO items as statements.ConclusionThe findings of this study confirm that the HM-PRO possesses a strong content validity, includes all the issues important to patients and is easy to read, understand and respond to spontaneously.

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Project description:BackgroundThe identification of eligible controlled trials for systematic reviews of complementary and alternative medicine (CAM) interventions can be difficult. To increase access to these difficult to locate trials, the Cochrane Collaboration Complementary Medicine Field (CAM Field) has established a specialized register of citations of CAM controlled trials. The objective of this study is to describe the sources and characteristics of citations included in the CAM Field specialized register.MethodsBetween 2006 and 2011, regular searches for citations of CAM trials in MEDLINE and the Cochrane Central Register of Controlled Trials (CENTRAL) were supplemented with contributions of controlled trial citations from international collaborators. The specialized register was 'frozen' for analysis in 2011, and frequencies were calculated for publication date, language, journal, presence in MEDLINE, type of intervention, and type of medical condition.ResultsThe CAM Field specialized register increased in size from under 5,000 controlled trial citations in 2006 to 44,840 citations in 2011. Most citations (60%) were from 2000 or later, and the majority (71%) were reported in English; the next most common language was Chinese (23%). The journals with the greatest number of citations were CAM journals published in Chinese and non-CAM nutrition journals published in English. More than one-third of register citations (36%) were not indexed in MEDLINE. The most common CAM intervention type in the register was non-vitamin, non-mineral dietary supplements (e.g., glucosamine, fish oil) (34%), followed by Chinese herbal medicines (e.g., Astragalus membranaceus, Schisandra chinensis) (27%).ConclusionsThe availability of the CAM Field specialized register presents both opportunities and challenges for CAM systematic reviewers. While the register provides access to thousands of difficult to locate trial citations, many of these trials are of low quality and may overestimate treatment effects. When including these trials in systematic reviews, adequate analysis of their risk of bias is of utmost importance.

Dataset Information

Developing a patient-centered outcome measure for complementary and alternative medicine therapies II: refining content validity through cognitive interviews.

Background

Methods

Results

Conclusions

Publications

Developing a patient-centered outcome measure for complementary and alternative medicine therapies II: refining content validity through cognitive interviews.

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