Dataset Information

Mixed methods study to develop the content validity and the conceptual framework of the electronic patient-reported outcome measure for vascular conditions.

ABSTRACT: OBJECTIVE:The aim of this paper is to describe the stages undertaken to generate the items and conceptual framework of a new electronic personal assessment questionnaire for vascular conditions. DESIGN:A mixed methods study: First a survey of vascular clinicians was completed to identify the most common conditions treated in vascular clinics and wards. Quantitative systematic reviews were done to identify validated patient-reported outcome measures (PROMs) for direct inclsuion in the new instrument. However, due to scarcity of validated PROMs, the items of the new instrument were mainly based on a large qualitative study of patients and systematic reviews of the qualitative evidence . This was followed by a quantitative clinicians' consensus study and, finally, a qualitative face validity study with patients. PARTICIPANTS:Vascular patients participated in the primary qualitative study and the face validity study. In the qualitative study, 55 patients were interviewed, and for the face validity, 19 patients gave feedback. Twelve clinicians completed the survey and 13 completed two cycles of the clinicians' consensus study. RESULTS:The items and scales in the electronic personal assessment questionnaire for vascular conditions (ePAQ-VAS) were generated based on the results of five systematic reviews evaluating existing PROMs for possible inclusion in ePAQ-VAS, five systematic reviews of qualitative evidence, a primary qualitative study involving 55 patients and clinicians' input. One hundred and sixty-eight items were initially generated, of which 59 were eliminated by the expert panel due to repetition. The instrument was divided into one generic and three disease-specific sections (abdominal aortic aneurysm, carotid artery disease and lower limb vascular conditions). In each section, items were grouped together into putative scales. Fifty-five items were grouped across eight scales; the remaining items were kept as individual items, because of relevance to service users. CONCLUSIONS:This multidimensional electronic questionnaire covers the most common vascular conditions. This is particularly important for patients presenting with mixed symptoms or multiple conditions. This tool captures symptomatology, health related quality of life (HRQoL) and other clinically relevant data, such as experience with services and comorbidities.

SUBMITTER: Aber A

PROVIDER: S-EPMC7418769 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Mixed methods study to develop the content validity and the conceptual framework of the electronic patient-reported outcome measure for vascular conditions.

Aber Ahmed A Phillips Patrick P Lumley Elizabeth E Radley Stephen S Thomas Steven M SM Nawaz Shah S Jones Georgina G Michaels Jonathan J

BMJ open 20200811 8

<h4>Objective</h4>The aim of this paper is to describe the stages undertaken to generate the items and conceptual framework of a new electronic personal assessment questionnaire for vascular conditions.<h4>Design</h4>A mixed methods study: First a survey of vascular clinicians was completed to identify the most common conditions treated in vascular clinics and wards. Quantitative systematic reviews were done to identify validated patient-reported outcome measures (PROMs) for direct inclsuion in ...[more]

PMID: 32784253

Similar Datasets

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.

Project description:BackgroundPatient-reported experience measures aim to capture the patient's perspective of what happened during a care encounter and how it happened. However, due to a lack of guidance to support patient-reported experience measure development and reporting, the content validity of many instruments is unclear and ambiguous. Thus, the aim of this study was to establish the content validity of a newly developed Emergency Department Patient-Reported Experience Measure (ED PREM).MethodsED PREM items were developed based on the findings of a systematic mixed studies review, and qualitative interviews with Emergency Department patients that occurred during September and October, 2020. Individuals who participated in the qualitative interviews were approached again during August 2021 to participate in the ED PREM content validation study. The preliminary ED PREM comprised 37 items. A two-round modified, online Delphi study was undertaken where patient participants were asked to rate the clarity, relevance, and importance of ED PREM items on a 4-point content validity index scale. Each round lasted for two-weeks, with 1 week in between for analysis. Consensus was a priori defined as item-level content validity index scores of ≥0.80. A scale-level content validity index score was also calculated.ResultsFifteen patients participated in both rounds of the online Delphi study. At the completion of the study, two items were dropped and 13 were revised, resulting in a 35-item ED PREM. The scale-level content validity index score for the final 35-item instrument was 0.95.ConclusionsThe newly developed ED PREM demonstrates good content validity and aligns strongly with the concept of Emergency Department patient experience as described in the literature. The ED PREM will next be administered in a larger study to establish its' construct validity and reliability. There is an imperative for clear guidance on PREM content validation methodologies. Thus, this study may inform the efforts of other researchers undertaking PREM content validation.

Project description:BackgroundThe Global Research on the Impact of Dermatological Diseases (GRIDD) team is developing the new Patient-Reported Impact of Dermatological Diseases (PRIDD) measure of the impact of dermatological conditions on the patient's life, in partnership with patients. To develop PRIDD, we conducted a systematic review, followed by a qualitative interview study with 68 patients worldwide and subsequently a global Delphi survey of 1,154 patients to ensure PRIDD items were meaningful and important to patients.ObjectiveTo pilot test PRIDD with patients with dermatological conditions, focusing on its content validity (comprehensiveness, comprehensibility, and relevance), acceptability, and feasibility.MethodsWe conducted a theory-led qualitative study using the Three-Step Test-Interview method of cognitive interviewing. Three rounds of semi-structured interviews were conducted online. Adults (≥ 18 years) living with a dermatological condition and who spoke English sufficiently to take part in the interview were recruited through the International Alliance of Dermatology Patient Organizations' (GlobalSkin) global membership network. The topic guide met the gold-standard COSMIN (Consensus-based Standards for the Selection of Health Measurement Instruments) standards for cognitive interviewing. Analysis followed the thematic analytical model of cognitive interviewing.ResultsTwelve people (58% male) representing six dermatological conditions from four countries participated. Overall, patients found PRIDD to be comprehensible, comprehensive, relevant, acceptable, and feasible. Participants were able to discern the conceptual framework domains from the items. Feedback resulted in: the recall period being extended from 1 week to 1 month; removal of the 'not relevant' response option; and changes to the instructions and item ordering and wording to improve clarity and increase respondents' confidence in their ability to respond. These evidence-based adjustments resulted in a 26-item version of PRIDD.ConclusionThis study met the gold-standard COSMIN criteria for the pilot testing of health measurement instruments. The data triangulated our previous findings, in particular the conceptual framework of impact. Our findings illuminate how patients understand and respond to PRIDD and other patient-reported measurement instruments. The results of comprehensibility, comprehensiveness, relevance, acceptability, and feasibility of PRIDD provide evidence of content validity from the target population. The next step in the development and validation of PRIDD is psychometric testing.

Project description:BackgroundAdherence to lifesaving antiretroviral therapy (ART) for HIV infection remains a challenge for many patients. Routine screening for barriers to ART adherence could help make HIV care more patient-centered and prevent virologic rebound or failure. Our team is currently developing a new HIV-specific patient-reported outcome measure (PROM) of these barriers for use in Canada and France along with a digital app for its electronic administration. In our previous work, we developed the PROM's multidimensional conceptual framework and generated 100 English items, which have been translated to French.ObjectiveThis study aims to use a Web-based Delphi to help validate and select the content of this new HIV-specific PROM, based on the perspective of anglophone and francophone patients and providers in Canada and France. Here, we present the proposal for this Delphi.MethodsThis modified Delphi will involve a diverse panel of patients (n=32) and providers (n=52) recruited especially from the 9 sites of the PROM development study (site locations in Canada: Montreal, Toronto, Vancouver; in France: Paris, Nantes, Clermont-Ferrand, Saint-Martin, Cayenne). Overall, 2 rounds of Web-based questionnaires will be conducted. The threshold for consensus is set at 60% and will determine which items are carried forward to the second round. Per item, 3 aspects will be rated: importance as a barrier to ART adherence, relevance for HIV care, and clarity. In both rounds, space will be available for free text comments. Overall comprehensiveness will be assessed in the second round.ResultsThis study has undergone a methodological review by experts in patient-oriented research. It has received approval from a research ethics board of the McGill University Health Centre. It is financially supported, in part, by the Canadian Institutes of Health Research's Strategy for Patient-Oriented Research-Quebec Support Unit (M006). As of May 21, 2019, 15 people living with HIV and 25 providers completed the first round of the Delphi (24 from Canada and 16 from France).ConclusionsTo our knowledge, this is the first Delphi to seek consensus on the most relevant and clinically actionable barriers to ART adherence, collecting opinions on an extensive list of barriers. Drawing on a relatively large and diverse panel of HIV patients and providers, it essentially engages key stakeholders in decision making about the PROM's final content, helping to ensure its utility and adoption.International registered report identifier (irrid)PRR1-10.2196/12836.

Dataset Information

Mixed methods study to develop the content validity and the conceptual framework of the electronic patient-reported outcome measure for vascular conditions.

Publications

Mixed methods study to develop the content validity and the conceptual framework of the electronic patient-reported outcome measure for vascular conditions.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets