Development and content validation of a financial and functional outcomes tool for diabetes-related foot disease in patients undergoing major lower limb amputation: a prospective observational study from Pakistan

Objective To develop and content validate a questionnaire to assess the financial and functional impact of major lower limb amputation in patients with diabetes-related foot disease.Design Prospective observational study.Setting This study was conducted at a tertiary care centre in Pakistan.Particip...

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Main Authors: Sadaf Khan, Nadeem Ahmed Siddiqui, Muhammad Anees Khaliq, Muhammad Ammar Pirzada, Ziaur Rehman, Fareed Shaikh, Amna Riaz
Format: Article
Language:English
Published: BMJ Publishing Group 2024-03-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/14/3/e080853.full
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author Sadaf Khan
Nadeem Ahmed Siddiqui
Muhammad Anees Khaliq
Muhammad Ammar Pirzada
Ziaur Rehman
Fareed Shaikh
Amna Riaz
author_facet Sadaf Khan
Nadeem Ahmed Siddiqui
Muhammad Anees Khaliq
Muhammad Ammar Pirzada
Ziaur Rehman
Fareed Shaikh
Amna Riaz
author_sort Sadaf Khan
collection DOAJ
description Objective To develop and content validate a questionnaire to assess the financial and functional impact of major lower limb amputation in patients with diabetes-related foot disease.Design Prospective observational study.Setting This study was conducted at a tertiary care centre in Pakistan.Participants We conducted a thorough literature review and a group interview with 10 participants, resulting in domain identification and item generation. The group included seven patients with diabetes-related foot disease who underwent major lower limb amputation and three caregivers. Subsequently, a focused group discussion was held to assess overlap and duplication among the items, and two rounds of content validation were carried out by five content and five lay experts in both English and Urdu. Question items with a Content Validity Index (CVI) score of >0.79 were retained, items with a CVI score between 0.70 and 0.79 were revised and items with a CVI score of <0.70 were excluded.Results The initial literature review and group interview resulted in 61 items in the financial and functional domains. After the focused group discussion, the questionnaire was reduced to 37 items. Following two rounds of content validation, the English questionnaire achieved the Scale-Content Validity Index/Average (S-CVI/Ave) of 0.92 and 0.89 on relevance and clarity, respectively. Similarly, the Urdu questionnaire achieved the S-CVI-Ave of 0.92 and 0.95, respectively.Conclusion A 37-item multidimensional questionnaire was developed and rigorously content-validated to assess the financial and functional impact of major lower limb amputation in patients with diabetes-related foot disease. The questionnaire used in this study has shown robust content validity specifically for our population.
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spelling doaj-art-a2aa7302b28c4e5bb44f622594d5a3a02025-08-20T02:13:44ZengBMJ Publishing GroupBMJ Open2044-60552024-03-0114310.1136/bmjopen-2023-080853Development and content validation of a financial and functional outcomes tool for diabetes-related foot disease in patients undergoing major lower limb amputation: a prospective observational study from PakistanSadaf Khan0Nadeem Ahmed Siddiqui1Muhammad Anees Khaliq2Muhammad Ammar Pirzada3Ziaur Rehman4Fareed Shaikh5Amna Riaz6Surgery, The Aga Khan University, Karachi, Sindh, PakistanSurgery, The Aga Khan University, Karachi, Sindh, PakistanSurgery, The Aga Khan University, Karachi, Sindh, PakistanDow International Medical College, Karachi, Sindh, PakistanSurgery, The Aga Khan University, Karachi, Sindh, PakistanSurgery, The Aga Khan University, Karachi, Sindh, PakistanSurgery, The Aga Khan University, Karachi, Sindh, PakistanObjective To develop and content validate a questionnaire to assess the financial and functional impact of major lower limb amputation in patients with diabetes-related foot disease.Design Prospective observational study.Setting This study was conducted at a tertiary care centre in Pakistan.Participants We conducted a thorough literature review and a group interview with 10 participants, resulting in domain identification and item generation. The group included seven patients with diabetes-related foot disease who underwent major lower limb amputation and three caregivers. Subsequently, a focused group discussion was held to assess overlap and duplication among the items, and two rounds of content validation were carried out by five content and five lay experts in both English and Urdu. Question items with a Content Validity Index (CVI) score of >0.79 were retained, items with a CVI score between 0.70 and 0.79 were revised and items with a CVI score of <0.70 were excluded.Results The initial literature review and group interview resulted in 61 items in the financial and functional domains. After the focused group discussion, the questionnaire was reduced to 37 items. Following two rounds of content validation, the English questionnaire achieved the Scale-Content Validity Index/Average (S-CVI/Ave) of 0.92 and 0.89 on relevance and clarity, respectively. Similarly, the Urdu questionnaire achieved the S-CVI-Ave of 0.92 and 0.95, respectively.Conclusion A 37-item multidimensional questionnaire was developed and rigorously content-validated to assess the financial and functional impact of major lower limb amputation in patients with diabetes-related foot disease. The questionnaire used in this study has shown robust content validity specifically for our population.https://bmjopen.bmj.com/content/14/3/e080853.full
spellingShingle Sadaf Khan
Nadeem Ahmed Siddiqui
Muhammad Anees Khaliq
Muhammad Ammar Pirzada
Ziaur Rehman
Fareed Shaikh
Amna Riaz
Development and content validation of a financial and functional outcomes tool for diabetes-related foot disease in patients undergoing major lower limb amputation: a prospective observational study from Pakistan
BMJ Open
title Development and content validation of a financial and functional outcomes tool for diabetes-related foot disease in patients undergoing major lower limb amputation: a prospective observational study from Pakistan
title_full Development and content validation of a financial and functional outcomes tool for diabetes-related foot disease in patients undergoing major lower limb amputation: a prospective observational study from Pakistan
title_fullStr Development and content validation of a financial and functional outcomes tool for diabetes-related foot disease in patients undergoing major lower limb amputation: a prospective observational study from Pakistan
title_full_unstemmed Development and content validation of a financial and functional outcomes tool for diabetes-related foot disease in patients undergoing major lower limb amputation: a prospective observational study from Pakistan
title_short Development and content validation of a financial and functional outcomes tool for diabetes-related foot disease in patients undergoing major lower limb amputation: a prospective observational study from Pakistan
title_sort development and content validation of a financial and functional outcomes tool for diabetes related foot disease in patients undergoing major lower limb amputation a prospective observational study from pakistan
url https://bmjopen.bmj.com/content/14/3/e080853.full
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