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Development of the PedsQL™ sickle cell disease module items: qualitative methods

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Abstract

Purpose

The objective of this qualitative study was to develop the items and support the content validity of the PedsQL™ Sickle Cell Disease Module for pediatric patients with sickle cell disease (SCD).

Methods

The iterative process included multiphase qualitative methodology. A literature review on SCD was conducted to generate domains of interest for the individual in-depth interviews. Ten healthcare experts with clinical experience in SCD participated in the development of the conceptual framework. A total of 13 pediatric patients with SCD ages 5–18 and 18 parents of patients ages 2–18 participated in the individual in-depth interviews. A total of 33 pediatric patients with SCD ages 5–18 and 39 parents of patients ages 2–18 participated in individually conducted cognitive interviews that included both think aloud and cognitive debriefing techniques to assess the interpretability and readability of the item stems.

Results

Six domains were derived from the qualitative methods involving patient/parent interviews and expert opinion, with content saturation achieved, resulting in 48 items. The six domains consisted of items measuring Pain Intensity/Location (9 items), Pain Interference (11 items), Worry (7 items), Emotions (3 items), Disease Symptoms/Treatment, (12 items), and Communication (6 items).

Conclusions

Qualitative methods involving pediatric patients and parents in the item development process support the content validity for the PedsQL™ SCD Module. The PedsQL™ SCD Module is now undergoing national multisite field testing for the psychometric validation phase of instrument development.

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Abbreviations

SCD:

Sickle cell disease

HRQOL:

Health-related quality of life

PedsQL™:

Pediatric Quality of Life Inventory™

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Acknowledgments

This work was supported by a grant from the National Institutes of Health (U54 HL090503, Project 3 and CTSI 1-UL1-RR031973).

Conflict of Interests

Dr. Varni holds the copyright and the trademark for the PedsQL™ and receives financial compensation from the Mapi Research Trust, which is a nonprofit research institute that charges distribution fees to for-profit companies that use the Pediatric Quality of Life Inventory™.

Author information

Authors and Affiliations

  1. Department of Pediatrics, Children’s Hospital of Wisconsin of the Children’s Research Institute/Medical College of Wisconsin, Hematology/Oncology/Bone Marrow Transplantation, 8701 Watertown Plank Road, Milwaukee, WI, 53226, USA

    Julie A. Panepinto & Sylvia Torres

  2. Department of Pediatrics, College of Medicine, Texas A&M University, College Station, TX, USA

    James W. Varni

  3. Department of Landscape Architecture and Urban Planning, College of Architecture, Texas A&M University, College Station, TX, USA

    James W. Varni

Authors
  1. Julie A. Panepinto
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  2. Sylvia Torres
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  3. James W. Varni
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Corresponding author

Correspondence to Julie A. Panepinto.

Appendices

Appendix A

Appendix B: PedsQL™ sickle cell disease module scales child self-report item content

The number of items might change as a function of the quantitative analyses.

About my pain and hurt

  1. 1.

    I hurt a lot

  2. 2.

    I hurt all over my body

  3. 3.

    I hurt in my arms

  4. 4.

    I hurt in my legs

  5. 5.

    I hurt in my stomach

  6. 6.

    I hurt in my chest

  7. 7.

    I hurt in my back

  8. 8.

    I have pain every day

  9. 9.

    I have pain so much that I need medicine

About my pain impact

  1. 1.

    It is hard for me to do things because I might get pain

  2. 2.

    I miss school when I have pain

  3. 3.

    It is hard for me to run when I have pain

  4. 4.

    I want to be alone when I have pain

  5. 5.

    It is hard to have fun when I have pain

  6. 6.

    I have trouble moving when I have pain

  7. 7.

    It is hard to stay standing when I have pa

  8. 8.

    It is hard for me to take care of myself when I have pain

  9. 9.

    It is hard for me to do what others can do because I might get pain

  10. 10.

    I wake up at night when I have pain

  11. 11.

    I get tired when I have pain

About me worrying

  1. 1.

    I worry that I will have pain

  2. 2.

    I worry that others will not know what to do if I have pain

  3. 3.

    I worry when I am away from home

  4. 4.

    I worry I might have to go to the emergency room

  5. 5.

    I worry I might have to stay overnight in the hospital

  6. 6.

    I worry I might have a stroke

  7. 7.

    I worry I might have a chest crisis

About my emotions

  1. 1.

    Needle sticks scare me

  2. 2.

    I feel mad I have sickle cell disease

  3. 3.

    I feel mad when I have pain

About my disease symptoms and treatment

  1. 1.

    I have headaches

  2. 2.

    I get yellow eyes when I am sick

  3. 3.

    It is hard for me to manage my pain

  4. 4.

    It is hard for me to control my pain

  5. 5.

    It is hard for me to remember to take my medicine

  6. 6.

    I do not like how I feel after I take my medicine

  7. 7.

    I do not like the way my medicine tastes

  8. 8.

    My medicine make me sleepy

  9. 9.

    I worry about whether my medicine is working

  10. 10.

    I worry about whether my treatments are working

  11. 11.

    My medicine does not make me feel better

  12. 12.

    Other kids make me feel different because of how I look

About communication

  1. 1.

    It is hard for me to tell others when I am in pain

  2. 2.

    It is hard for me to tell the doctors and nurses how I feel

  3. 3.

    It is hard for me to ask the doctors and nurses questions

  4. 4.

    It is hard for me when others do not understand about my sickle cell disease

  5. 5.

    It is hard for me when others do not understand how much pain I feel

  6. 6.

    It is hard for me to tell others I have sickle cell disease

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Panepinto, J.A., Torres, S. & Varni, J.W. Development of the PedsQL™ sickle cell disease module items: qualitative methods. Qual Life Res 21, 341–357 (2012). https://doi.org/10.1007/s11136-011-9941-4

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