Literature DB >> 23269541

Content validity of the PedsQL™ 3.2 Diabetes Module in newly diagnosed patients with Type 1 diabetes mellitus ages 8-45.

James W Varni1, Bradley H Curtis, Linda N Abetz, Kathryn E Lasch, Elisabeth C Piault, Andrea A Zeytoonjian.   

Abstract

OBJECTIVES: The content validity of the 28-item PedsQL™ 3.0 Diabetes Module has not been established in research on pediatric and adult patients with newly diagnosed Type 1 diabetes across a broad age range. This study aimed to document the content validity of three age-specific versions (8-12 years, 13-18 years, and 18-45 years) of the PedsQL™ Diabetes Module in a population of newly diagnosed patients with Type 1 diabetes.
METHODS: The study included in-depth interviews with 31 newly diagnosed patients with Type 1 diabetes between the ages of 8 and 45 years, as well as 14 parents and/or caregivers of child and teenage patients between the ages of 8 and 18 years of age; grounded theory data collection and analysis methods; and review by clinical and measurement experts.
RESULTS: Following the initial round of interviews, revisions reflecting patient feedback were made to the Child and Teen versions of the Diabetes Module, and an Adult version of the Diabetes Module was drafted. Cognitive interviews of the modified versions of the Diabetes Module were conducted with an additional sample of 11 patients. The results of these interviews support the content validity of the modified 33-item PedsQL™ 3.2 Diabetes Module for pediatric and adult patients, including interpretability, comprehensiveness, and relevance suitable for all patients with Type 1 Diabetes.
CONCLUSIONS: Qualitative methods support the content validity of the modified PedsQL™ 3.2 Diabetes Module in pediatric and adult patients. It is recommended that the PedsQL™ 3.2 Diabetes Module replaces version 3.0 and is suitable for measuring patient-reported outcomes in all patients with newly diagnosed, stable, or long-standing diabetes in clinical research and practice.

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Year:  2012        PMID: 23269541     DOI: 10.1007/s11136-012-0339-8

Source DB:  PubMed          Journal:  Qual Life Res        ISSN: 0962-9343            Impact factor:   4.147


  34 in total

1.  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.

Authors:  Donald L Patrick; Laurie B Burke; Chad J Gwaltney; Nancy Kline Leidy; Mona L Martin; Elizabeth Molsen; Lena Ring
Journal:  Value Health       Date:  2011-10-10       Impact factor: 5.725

2.  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 1--eliciting concepts for a new PRO instrument.

Authors:  Donald L Patrick; Laurie B Burke; Chad J Gwaltney; Nancy Kline Leidy; Mona L Martin; Elizabeth Molsen; Lena Ring
Journal:  Value Health       Date:  2011-10-13       Impact factor: 5.725

3.  The pediatric quality of life inventory: measuring pediatric health-related quality of life from the perspective of children and their parents.

Authors:  James W Varni; Christine A Limbers
Journal:  Pediatr Clin North Am       Date:  2009-08       Impact factor: 3.278

4.  Validation of a diabetes-specific quality-of-life scale for patients with type 1 diabetes.

Authors:  U Bott; I Mühlhauser; H Overmann; M Berger
Journal:  Diabetes Care       Date:  1998-05       Impact factor: 19.112

5.  Health-related quality of life (HRQoL) of children with type 1 diabetes mellitus (T1DM): self and parental perceptions.

Authors:  Efrosini Kalyva; Evlampia Malakonaki; Christine Eiser; Dimitrios Mamoulakis
Journal:  Pediatr Diabetes       Date:  2011-02       Impact factor: 4.866

6.  PRO development: rigorous qualitative research as the crucial foundation.

Authors:  Kathryn Eilene Lasch; Patrick Marquis; Marc Vigneux; Linda Abetz; Benoit Arnould; Martha Bayliss; Bruce Crawford; Kathleen Rosa
Journal:  Qual Life Res       Date:  2010-05-30       Impact factor: 4.147

7.  A randomized, controlled trial comparing twice-a-day insulin glargine mixed with rapid-acting insulin analogs versus standard neutral protamine Hagedorn (NPH) therapy in newly diagnosed type 1 diabetes.

Authors:  Krishnavathana Hassan; Luisa M Rodriguez; Susan E Johnson; Susanne Tadlock; Rubina A Heptulla
Journal:  Pediatrics       Date:  2008-02-25       Impact factor: 7.124

8.  Living with cystic fibrosis-related diabetes or type 1 diabetes mellitus: a comparative study exploring health-related quality of life and patients' reported experiences of hypoglycaemia.

Authors:  Stephanie Tierney; Kevin Webb; Andrew Jones; Mary Dodd; Diane McKenna; Rachel Rowe; Joanna Whitehouse; Christi Deaton
Journal:  Chronic Illn       Date:  2008-12

9.  Worldwide childhood type 1 diabetes incidence--what can we learn from epidemiology?

Authors:  G Soltesz; C C Patterson; G Dahlquist
Journal:  Pediatr Diabetes       Date:  2007-10       Impact factor: 4.866

Review 10.  Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PRO Task Force Report.

Authors:  Margaret Rothman; Laurie Burke; Pennifer Erickson; Nancy Kline Leidy; Donald L Patrick; Charles D Petrie
Journal:  Value Health       Date:  2009-09-25       Impact factor: 5.725

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  11 in total

1.  Mother, father, and adolescent self-control and adherence in adolescents with Type 1 diabetes.

Authors:  Amy Hughes Lansing; Rebecca Crochiere; Carrie Cueto; Deborah J Wiebe; Cynthia A Berg
Journal:  J Fam Psychol       Date:  2017-01-12

Review 2.  Psychosocial Patient-Reported Outcomes in Pediatric and Adolescent Diabetes: a Review and Case Example.

Authors:  Sarah D Corathers; Constance A Mara; Pavan K Chundi; Jessica C Kichler
Journal:  Curr Diab Rep       Date:  2017-07       Impact factor: 4.810

3.  PedsQL 3.2 Diabetes Module for Children, Adolescents, and Young Adults: Reliability and Validity in Type 1 Diabetes.

Authors:  James W Varni; Alan M Delamater; Korey K Hood; Jennifer K Raymond; Nancy T Chang; Kimberly A Driscoll; Jenise C Wong; Joyce P Yi-Frazier; Ellen K Grishman; Melissa A Faith; Sarah D Corathers; Jessica C Kichler; Jennifer L Miller; Elena M Doskey; Robert W Heffer; Don P Wilson
Journal:  Diabetes Care       Date:  2018-07-30       Impact factor: 19.112

4.  Development of the pediatric quality of life inventory neurofibromatosis type 1 module items for children, adolescents and young adults: qualitative methods.

Authors:  Kavitha Nutakki; James W Varni; Sheila Steinbrenner; Claire B Draucker; Nancy L Swigonski
Journal:  J Neurooncol       Date:  2017-01-11       Impact factor: 4.130

5.  Diabetes symptoms predictors of health-related quality of life in adolescents and young adults with type 1 or type 2 diabetes.

Authors:  James W Varni; Alan M Delamater; Korey K Hood; Jennifer K Raymond; Kimberly A Driscoll; Jenise C Wong; Saleh Adi; Joyce P Yi-Frazier; Ellen K Grishman; Melissa A Faith; Sarah D Corathers; Jessica C Kichler; Jennifer L Miller; Elena M Doskey; Vincent P Aguirre; Robert W Heffer; Don P Wilson
Journal:  Qual Life Res       Date:  2018-05-21       Impact factor: 4.147

6.  Factors Associated With Diabetes-Specific Health-Related Quality of Life in Youth With Type 1 Diabetes: The Global TEENs Study.

Authors:  Barbara J Anderson; Lori M Laffel; Catherine Domenger; Thomas Danne; Moshe Phillip; Carmen Mazza; Ragnar Hanas; Sheridan Waldron; Roy W Beck; Francoise Calvi-Gries; Chantal Mathieu
Journal:  Diabetes Care       Date:  2017-05-25       Impact factor: 19.112

7.  Young Adults With Type 1 Diabetes Preparing to Transition to Adult Care: Psychosocial Functioning and Associations With Self-Management and Health Outcomes.

Authors:  Ana M Gutierrez-Colina; Sarah Corathers; Sarah Beal; Holly Baugh; Katie Nause; Jessica C Kichler
Journal:  Diabetes Spectr       Date:  2020-08

8.  The Celiac Disease and Diabetes-Dietary Intervention and Evaluation Trial (CD-DIET) protocol: a randomised controlled study to evaluate treatment of asymptomatic coeliac disease in type 1 diabetes.

Authors:  Farid H Mahmud; Emilia N De Melo; Karima Noordin; Esther Assor; Kamaljeet Sahota; Jolie Davies-Shaw; Ernest Cutz; Gino Somers; Margaret Lawson; David R Mack; Patricia Gallego; Charlotte McDonald; Melanie D Beaton; Kevin Bax; Fred Saibil; Jeremy Gilbert; Susan Kirsch; Bruce A Perkins; Maria Cino; Eva Szentgyorgyi; Dror Koltin; Amish Parikh; Geetha Mukerji; Andrew Advani; Olivia Lou; Margaret A Marcon
Journal:  BMJ Open       Date:  2015-05-11       Impact factor: 2.692

9.  Safety and efficacy of the predictive low glucose management system in the prevention of hypoglycaemia: protocol for randomised controlled home trial to evaluate the Suspend before low function.

Authors:  M B Abraham; J A Nicholas; T T Ly; H C Roby; N Paramalingam; J Fairchild; B R King; G R Ambler; F Cameron; E A Davis; T W Jones
Journal:  BMJ Open       Date:  2016-04-15       Impact factor: 2.692

10.  Use of Relational Agents to Improve Family Communication in Type 1 Diabetes: Methods.

Authors:  Debbe Thompson; Karen W Cullen; Maria J Redondo; Barbara Anderson
Journal:  JMIR Res Protoc       Date:  2016-07-28
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