Dataset Information

International multiphase mixed methods study protocol to develop a cross-cultural patient-reported outcome and experience measure for hand conditions (HAND-Q).

ABSTRACT:

Introduction

patient-reported outcome measures (PROMs) are instruments used to measure outcomes and experiences of healthcare from the patient perspective. The specific methodology used to develop a PROM should be communicated to establish the quality of the instrument. This mixed methods protocol describes the development of a cross-cultural, internationally applicable PROM for hand conditions, the HAND-Q.

Methods and analysis

The multiphase approach used for this study has been previously used with the development of other PROMs by our team (eg, BODY-Q, BREAST-Q, CLEFT-Q, FACE-Q). In Phase I, we establish what important concepts matter to patients with hand conditions. A conceptual framework is developed from a systematic review of existing PROMs in the field and an extensive international qualitative study. Interpretive description is the qualitative approach used. Item generation is based on the qualitative data. The preliminary scales will be created for each theme identified in the conceptual framework. These scales will be refined by cognitive debriefing interviews with participants and expert input. Phase II involves a large international sample of patients with varied hand conditions completing the field-test version of the HAND-Q. The scales will be refined using the modern psychometric approach of Rasch Measurement Theory. Analysis will result in a shortened set of clinically meaningful and scientifically robust HAND-Q scales.

Ethics and dissemination

This study is coordinated at Flinders University (Adelaide, Australia) where it has ethics board approval for phase I and phase II. Findings will be published in peer-reviewed journals and presented at local, national and international conferences.

SUBMITTER: Sierakowski K

PROVIDER: S-EPMC6475356 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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International multiphase mixed methods study protocol to develop a cross-cultural patient-reported outcome and experience measure for hand conditions (HAND-Q).

Sierakowski Kyra K Dean Nicola R NR Pusic Andrea L AL Cano Stefan J SJ Griffin Philip A PA Bain Gregory I GI Klassen Anne A Lalonde Donald D

BMJ open 20190320 3

<h4>Introduction</h4>patient-reported outcome measures (PROMs) are instruments used to measure outcomes and experiences of healthcare from the patient perspective. The specific methodology used to develop a PROM should be communicated to establish the quality of the instrument. This mixed methods protocol describes the development of a cross-cultural, internationally applicable PROM for hand conditions, the HAND-Q.<h4>Methods and analysis</h4>The multiphase approach used for this study has been ...[more]

PMID: 30898824

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Project description:IntroductionOur recent systematic review has indicated the lack of a patient-reported outcome (PRO) instrument to measure health-related quality of life (HRQOL) of children and adolescents with lower limb deformities. We are developing a PRO instrument which will be applicable internationally across various countries. This manuscript describes our approach to the development of a new PRO instrument for measuring HRQOL for children and adolescents with lower limb deformities.Methods and analysisThree phases in the development of this PRO instrument are as described: (1) This phase involves the development of a conceptual framework of HRQOL and item pool that is used to inform a set of preliminary scales. We have developed a preliminary conceptual framework of HRQOL based on our systematic review. Qualitative interviews are being conducted at five sites in Canada, Ethiopia, India and the USA. An item pool will be generated from this qualitative phase. The preliminary items and scales will be sent out to children at the five participating centres. Cognitive debriefing interviews will gather detailed feedback on the items from the children. Expert opinion will be sought from clinicians from the participating centres. (2) During this phase, an international field-test study will be conducted to refine the scales and examine their psychometric properties. (3) During this phase, tests of reliability, validity and responsiveness will be conducted. Phase 1 will also involve translations and cultural adaptations. At the end of this study, we expect to produce an internationally applicable PRO instrument which is scientifically sound and clinically relevant to the lower limb deformity population.Ethics and disseminationThis study is approved by Research Ethics Boards for each of the participating sites.Results of this study will be published in peer-reviewed journals and presented at national and international conferences. An integrated knowledge translation approach is applied to engage patients, families and clinicians from the start of the study.

Project description:ObjectiveThe 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.DesignA 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.ParticipantsVascular 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.ResultsThe 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.ConclusionsThis 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.

Project description:BackgroundGeneric preference-based measures (PBM), though commonly used, may not be optimal for use in economic evaluations of breast cancer interventions. No breast cancer-specific PBM currently exists, and the generic PBMs fail to capture the unique concerns of women with breast cancer (e.g., body image, appearance, treatment-specific adverse effects). Hence, the objective of this study was to develop a breast cancer-specific PBM, the BREAST-Q Utility module.MethodsWomen diagnosed with breast cancer (stage 0-4, any treatment) were recruited from two tertiary hospitals in Canada and one in the US. The study followed an exploratory sequential mixed methods approach, whereby semi-structured interviews were conducted and at the end of the interview, participants were asked to list their top five health-related quality of life (HRQOL) concerns and to rate the importance of each item on the BREAST-Q. Interviews were audio-recorded, transcribed verbatim, and coded. Constant comparison was used to refine the codes and develop a conceptual framework. Qualitative and quantitative data were triangulated to develop the content of the Utility module that was refined through 2 rounds of cognitive debriefing interviews with women diagnosed with breast cancer and feedback from experts.ResultsInterviews were conducted with 57 women aged 55 ± 10 years. A conceptual framework was developed from 3948 unique codes specific to breasts, arms, abdomen, and cancer experience. Five top-level domains were HRQOL (i.e., physical, psychological, social, and sexual well-being) and appearance. Data from the interviews, top 5 HRQOL concerns, and BREAST-Q item ratings were used to inform dimensions for inclusion in the Utility module. Feedback from women with breast cancer (N = 9) and a multidisciplinary group of experts (N = 27) was used to refine the module. The field-test version of the HSCS consists of 10 unique dimensions. Each dimension is measured with 1 or 2 candidate items that have 4-5 response levels each.ConclusionThe field-test version of the BREAST-Q Utility module was derived from extensive patient and expert input. This comprehensive approach ensured that the content of the Utility module is relevant, comprehensive, and includes concerns that matter the most to women with breast cancer.

Project description:IntroductionA critical barrier to outcome assessment in gender-affirming healthcare is the lack of a specific patient-reported outcome measure (PROM). This phase I protocol describes an international collaboration between investigators in Canada, Denmark, the Netherlands and the USA who have coalesced to develop a new PROM (ie, the GENDER-Q) to evaluate outcomes of psychological, hormonal and surgical gender-affirming treatments.Methods and analysisThis phase I study uses an interpretive description approach. Participants aged 16 years and older seeking any form of gender-affirming treatments in centres located in Canada, Denmark, the Netherlands and the USA will be invited to take part in qualitative interviews. Participants will review BREAST-Q and FACE-Q scales hypothesised to contain content relevant to specific gender-affirming treatments. Interviews will elicit new concepts for additional scale development. Each interview will be digitally recorded, transcribed and coded. The main outcome of this phase I study will be the development of a conceptual framework and set of scales to measure outcomes important to evaluating gender-affirming treatments. To this end, analysis will be used to add/drop/revise items of existing scales to achieve content validity. For new concepts, coding will assign top-level domains and themes/subthemes to participant quotes. Codes will be used to develop an item pool to inform scale development. Draft scales will be shown to transgender and gender diverse persons and experts to obtain feedback that will be used to refine and finalise the scales. The field-test version of the GENDER-Q will be translated by following rigorous methods to prepare for the international field-test study.Ethics and disseminationThis study is coordinated at McMaster University (Canada). Ethics board approval was received from the Hamilton Integrated Ethics Board (Canada), the Medical Ethical Committee at VUmc (The Netherlands) and Advarra (USA). Findings will be published in peer-reviewed journals and presented at national and international conferences and meetings.

Project description:IntroductionThe global prevalence of diabetes in 2019 in adults was estimated to be 9.3%. This study developed in Ecuador, for the first time, instruments to assess patient-reported outcomes and experiences.MethodsThe Experiences of the Person with Diabetes (EPD) Questionnaire is a diabetes-specific instrument. A mixed-methods study was conducted. First, a qualitative item development phase that included four focus groups and six semi-structured interviews with patients was conducted in different rural and urban areas of Ecuador to obtain information on culture, beliefs, demographics, diet and social perspectives. A second quantitative phase for psychometric validation was carried out in primary care settings of rural and urban areas of Ecuador.ResultsForty-two and four hundred and eighty-nine participants were included in each phase, respectively. The item development phase resulted in a questionnaire of 44 items (23 for perceived outcomes and 21 for experiences). In the validation study, most participants were women (58%) and from urban areas (57%). Exploratory factor analysis revealed three dimensions for each instrument. Outcomes instrument dimensions were symptoms and burnout, worries and fears and social limitations. Experiences instrument dimensions were information, patient-centred care and care delivery. Cronbach's α values of the total score and dimensions were high, ranging between .81 and .93 in both instruments. Confirmatory factor analysis showed an acceptable fit of the data.ConclusionThe EPD Questionnaire is probably the first instrument developed to assess patient-reported experiences and perceived outcomes in a middle-income country that included patients to capture all dimensions relevant for the intended population. Its psychometric properties are robust and could provide valuable information for clinicians and policymakers in the region.Patient or public contributionThe development of these instruments has taken into consideration patients and the public since their conception. A qualitative approach gathered relevant information related to the cultural, social and economic burden of different populations in Ecuador. Before validation, a pilot test was carried out with users of the National Health Services to obtain their perspectives and insights of the developed instrument. Finally, during the data analysis, we have given special consideration to social variables such as rural and urban populations.

Project description:ObjectivesMeasuring patient experience of gastrointestinal (GI) procedures is a key component of evaluation of quality of care. Current measures of patient experience within GI endoscopy are largely clinician derived and measured; however, these do not fully represent the experiences of patients themselves. It is important to measure the entirety of experience and not just experience directly during the procedure. We aimed to develop a patient-reported experience measure (PREM) for GI procedures.DesignPhase 1: semi-structured interviews were conducted in patients who had recently undergone GI endoscopy or CT colonography (CTC) (included as a comparator). Thematic analysis identified the aspects of experience important to patients. Phase 2: a question bank was developed from phase 1 findings, and iteratively refined through rounds of cognitive interviews with patients who had undergone GI procedures, resulting in a pilot PREM. Phase 3: patients who had attended for GI endoscopy or CTC were invited to complete the PREM. Psychometric properties were investigated. Phase 4 involved item reduction and refinement.ResultsPhase 1: interviews with 35 patients identified six overarching themes: anxiety, expectations, information & communication, embarrassment & dignity, choice & control and comfort. Phase 2: cognitive interviews refined questionnaire items and response options. Phase 3: the PREM was distributed to 1650 patients with 799 completing (48%). Psychometric properties were found to be robust. Phase 4: final questionnaire refined including 54 questions assessing patient experience across five temporal procedural stages.ConclusionThis manuscript gives an overview of the development and validation of the Newcastle ENDOPREM™, which assesses all aspects of the GI procedure experience from the patient perspective. It may be used to measure patient experience in clinical care and, in research, to compare patients' experiences of different endoscopic interventions.

Dataset Information

International multiphase mixed methods study protocol to develop a cross-cultural patient-reported outcome and experience measure for hand conditions (HAND-Q).

Introduction

Methods and analysis

Ethics and dissemination

Publications

International multiphase mixed methods study protocol to develop a cross-cultural patient-reported outcome and experience measure for hand conditions (HAND-Q).

Similar Datasets

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