Youth-Perceived Burden of Type 1 Diabetes: Problem Areas in Diabetes Survey Pediatric Version (PAID-Peds)
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1 583506DSTXXX / Journal of Diabetes Science and TechnologyMarkowitz et al research-article2015 Original Article Youth-Perceived Burden of Type 1 Diabetes: Problem Areas in Diabetes Survey Pediatric Version (PAID-Peds) Journal of Diabetes Science and Technology 2015, Vol. 9(5) Diabetes Technology Society Reprints and permissions: sagepub.com/journalspermissions.nav DOI: / dst.sagepub.com Jessica T. Markowitz, PhD 1,2, Lisa K. Volkening, MA 2, Deborah A. Butler, MSW 1,2, and Lori M. B. Laffel, MD, MPH 1,2 Abstract Background: Management of type 1 diabetes in childhood can be challenging and overwhelming. Despite availability of advanced treatments and new technologies, the burden has not decreased as current approaches to intensive therapy are not without need for patient involvement. This study aimed to design and validate a measure of youth-reported burden related to type 1 diabetes management. Method: A multidisciplinary pediatric diabetes team designed the survey, based on a previously validated parent measure of diabetes-related burden (PAID-PR); survey revisions and pilot testing followed. The 20-item PAID-Peds assesses burden over the past month. Youth with type 1 diabetes (N = 126, ages 8-17, intensively treated with insulin pump therapy or multiple daily injections) completed the new survey, along with other surveys; parents completed companion measures. Electronic medical records and blood glucose meter download provided other salient data. Results: The PAID-Peds displayed excellent internal consistency (α =.94) and acceptable test retest reliability (intraclass correlation.66, P <.0001). The PAID-Peds correlated significantly with both youth and parent reports of diabetes-specific family conflict, negative affect around blood glucose monitoring, depressive symptomatology, trait anxiety, and quality of life. It was not correlated with demographic or clinical characteristics of the youth. Conclusions: This new measure, the PAID-Peds, of youth-reported burden related to type 1 diabetes may have clinical and research utility, particularly in the current era of emerging diabetes technologies that require ongoing patient input. Keywords adolescence, burden, psychosocial, type 1 diabetes Managing pediatric diabetes can be challenging and overwhelming for youth with type 1 diabetes and their caregivers. 1,2 Despite advances in diabetes treatments and technologies, glycemic control remains suboptimal in the pediatric population. 3-5 Advanced treatments and technologies can also add burden, as none are automated in their implementation, 6,7 which can lead youth to stop wearing them. Such treatment burdens have the potential to impact quality of life, which is an important factor in clinical and research realms. Because diabetes management is multifaceted and time-consuming, it is important for clinicians and researchers to be able to assess diabetes-related burden in those impacted by the disease. The Problem Areas in Diabetes Survey (PAID) 8 was first created and validated in the 1990s to measure and assess diabetesrelated burden in adults with diabetes. This original PAID has excellent psychometrics 8 and is widely used. Recently, a shorter version (PAID-5) 9 was utilized in an international study of psychosocial factors associated with diabetes. 10 In addition, 2 different applications of the PAID have been created and validated for use in the pediatric population; the PAID Parent Revised survey (PAID-PR) 11 assesses diabetes-related burden in parents, and the PAID Teen survey (PAID-T) 12 assesses diabetes-related burden in teens with type 1 diabetes, ages We created a Pediatric PAID prior to the publication of the PAID-T, as a companion to the PAID-PR for use in younger pediatric 1 Joslin Diabetes Center, Pediatric, Adolescent, & Young Adult Section, Department of Psychiatry, Harvard Medical School, Boston, MA, USA 2 Joslin Diabetes Center, Section on Genetics & Epidemiology, Boston, MA, USA Corresponding Author: Jessica T. Markowitz, PhD, Joslin Diabetes Center, Pediatric, Adolescent, & Young Adult Section, Department of Psychiatry, Harvard Medical School, 1 Joslin Pl, Boston, MA 02215, USA. jessica.markowitz@joslin.harvard.edu
2 Markowitz et al 1081 patients as well as teens, spanning the pediatric ages of 8-17 years. This report describes the development of this measure, created to accompany the PAID-PR, and its psychometric properties. Methods Participants were ages 8-17 years with type 1 diabetes for 1 year; all received intensive insulin therapy (insulin pump or multiple daily injections 3 /day), as intensively based treatment programs are the recommended approach to type 1 diabetes management. 13 Participants completed surveys at baseline and after 1 week. All study procedures were approved by the local Institutional Review Board. Written informed consent/assent was obtained prior to any study procedures. Survey Design Items from the PAID-PR (n = 18) were reviewed by a multidisciplinary team for face validity and applicability to pediatric patients and salient items were modified for delivery to a pediatric sample. In addition, 2 new items were added to address youth s emotional response to diabetes ( I am annoyed when I have to stop what I am doing to check my blood sugar ; I feel embarrassed about having diabetes ). The preliminary PAID-Peds then underwent feasibility testing with patients who spanned the target age range to assess its face validity, applicability, and ease of administration. The 20-item Paid-Peds assesses burden over the past month. There are 5 response options scored on a 0-4 Likerttype scale (agree to disagree). Higher score indicates greater burden related to having diabetes. Sample questions include During the past month... I feel sad a lot when I think about having diabetes ; It bothers me to think so much about what I eat ; I feel left out when I can t eat things other kids are eating ; I am tired of having to remember to give insulin shots or to bolus. Construct validity was assessed by correlation with other validated measures that evaluate related constructs (see below), as well as with treatment data from the electronic health record (EHR). Glucose meter download provided data on blood glucose monitoring frequency. Youth completed the PAID-Peds again after 1 week to assess test retest reliability. Internal consistency was also assessed. Measures Parent PAID (PAID-PR). Parents completed the 20-item PAID- PR 11 to assess their perceived burden associated with caring for a child with diabetes over the past month. Items are answered on a 5-point Likert-type scale (0 = agree to 4 = disagree ) with higher scores indicating greater diabetesrelated burden. Diabetes Family Conflict Scale Revised (DFCS-R). Youth and parents completed the 19-item DFCS-R 14 to assess the level of diabetes-specific family conflict around diabetes management tasks over the past month. Items are answered on a 3-point Likert-type scale (1 = never argue, 2 = sometimes argue, 3 = always argue ). Higher scores indicate greater diabetes-specific family conflict. Blood Glucose Monitoring Communication Survey (BGMC). Youth and parents completed the 8-item BGMC 15 to assess their negative affect related to blood glucose monitoring over the past month. Items are answered on a 3-point Likert-type scale (1 = almost never, 2 = sometimes, 3 = almost always ). Higher scores indicate a greater degree of negative affect surrounding blood glucose monitoring. Center for Epidemiological Studies Depression Scale (CESD). Youth completed the 20-item CESD 16 to assess their symptoms of depression in the past week. Items are scored on a 4-point Likert-type scale (0 = not at all, 1 = a little, 2 = some, 3 = a lot ), with higher scores indicating greater symptoms of depression. A score of 15 for youth and 16 for parents denotes endorsement of depressive symptoms. 17,18 State Trait Anxiety Inventory for Children (STAIC). Youth completed the 40-item STAIC 19 to self-assess symptoms of anxiety in general (no time period) related to both state and trait. Items are scored on a 1-3 Likert-type scale with higher scores indicating more symptoms of anxiety (examples are I feel... very calm; calm, not calm ; I worry about making mistakes... hardly ever; sometimes, often ). In addition, parents completed a proxy version, the State-Trait Anxiety Inventory for Children Parent Report Trait Version, assessing their child s symptoms of trait anxiety. 20 Pediatric Quality of Life Inventory (PedsQL). Youth and parents completed the PedsQL, 21,22 generic (23 items) and diabetesspecific (28 items) modules, to assess youth health-related quality of life over the past month. Items are scored on a 4-point Likert-type scale (0 = never, 1 = almost never, 2 = sometimes, 3 = often, 4 = almost always ), with higher scores indicating greater quality of life. The parent surveys provide proxy assessments of youth quality of life. Statistical Analyses Statistical analyses were performed with SAS (v9.2, SAS Institute, Cary, NC). Tests included descriptive and univariate analyses, Pearson and Spearman correlations, chi-square, and Cronbach s alpha. A P value of <.05 defined significance. Results Participant Characteristics Participants were 126 youth with type 1 diabetes (51% female) and their parents (83% mothers). Youth were 12.8 ± 2.7 years old, had duration of type 1 diabetes of 6.0 ± 3.5 years, and had a mean A1c of 8.0 ± 0.9% (64 ± 9 mmol/mol).
3 1082 Journal of Diabetes Science and Technology 9(5) Table 1. Participant Characteristics. Mean ± SD or % Range Age (years) 12.8 ± 2.7 Sex (% female) 51% Age at diagnosis (years) 6.7 ± Type 1 diabetes duration (years) 6.0 ± A1c (%) [mmol/mol] 8.0 ± 0.9 [64 ± 9] [44-98] Insulin regimen (% pump treated) 83% BG monitoring frequency (times/day) 6.8 ± The majority (83%) were treated with insulin pump therapy; participants were checking their blood glucose levels 6.8 ± 2.4 times/day. See Table 1 for participant characteristics. Psychometrics of PAID-Peds Mean score on the PAID-Peds was 29.3 ± 23.8, with a median of 23.8 and a range of (see Figure 1 for the distribution of scores). The PAID-Peds was not correlated with any demographic or clinical characteristics such as youth age, family structure, household income, youth age at onset of type 1 diabetes, type 1 diabetes duration, A1c, or frequency of blood glucose monitoring (see Table 2). Youth and parent responses on all surveys were significantly correlated with one another (P.03), with the exception of the CESD (P =.05). This is not surprising, as the CESD assesses self-reported depressive symptoms in youth and in parents separately while the other surveys measure the same construct (ie, diabetes-specific family conflict) or provide youth and parent assessments of youth characteristics (eg, quality of life). Internal Consistency and Construct Validity of PAID-Peds The PAID-Peds displayed excellent internal consistency with a Cronbach s alpha of.94. Item-to-total correlations were all.50. The average time from test to retest was 7.7 ± 1.4 days, with a minimum of 6 days and a maximum of 13 days. Test retest reliability (n = 117) was acceptable, with an intraclass correlation of.66 (P <.0001). The PAID-Peds correlated significantly with a number of measures that evaluate constructs associated with diabetesrelated burden (see Table 3). Correlations between the PAID- Peds with child reports of diabetes-specific family conflict, negative affect around blood glucose monitoring, depressive symptomatology, trait anxiety, and quality of life (both generic and diabetes-specific) were all robust (r = , all P <.0001). On the other hand, the PAID-Peds was less strongly, although significantly (r = , all P <.01), correlated with parent reports of these survey domains with the exception of parent self-report of depressive symptomatology (r =.09, P =.3). As anticipated, the PAID-Peds was directly correlated with all domains described above except for quality of life, which was inversely correlated with the PAID-Peds. Diabetes Burden and Depressive Symptomatology We next examined the proportions of youth and parents scoring above the median on the PAID-Peds and PAID-PR, respectively, according to CESD scores below and above the CESD cutoffs for depressive symptomatology ( 15 for youth and 16 for parents). Of those youth scoring above the CESD cutoff (n = 28), 82% scored above the median on the PAID- Peds while only 39% of the youth below the CESD cut point scored above the median on the PAID-Peds (χ 2 = 16.40, df = 1, P <.0001). Those youth who endorsed depressive symptoms were 4 times more likely to endorse diabetes-related burden (defined as scoring above the median). For the parents, those who endorsed depressive symptoms were 2 times more likely to endorse diabetes-related burden (defined as scoring above the median). Of those parents scoring above the CESD cutoff (n = 19), 68% scored above the median on the PAID-PR while only 45% of the parents below the CESD cut point scored above the median on the PAID-PR (χ 2 = 3.59, df = 1, P =.058). Discussion The PAID-Peds provides a self-reported measure of burden related to living with type 1 diabetes for youth across the ages of Modern diabetes technologies such as pumps and sensors, coupled with intensive insulin therapy, likely add to the burdens of daily management of type 1 diabetes because none are automated in their implementation and ongoing use. Thus, the PAID-Peds is particularly relevant in this current age of diabetes management when we ask so much of patients. The PAID-Peds, a measure of youth perceived diabetesrelated burden, was positively correlated with parent perceived diabetes-related burden, as well as a number of other important constructs reported by youth and their parents. Perceived burden by youth was directly related to youth and parent reported diabetes-specific family conflict, negative
4 Markowitz et al 1083 Figure 1. Distribution of PAID-Peds scores. (a) Cumulative score. (b) Distribution of PAID-Peds scores. affect around blood glucose monitoring, youth depressive symptomatology, and youth and parent reported youth anxiety. Youth perceived diabetes burden was also indirectly related to youth and parent reported youth health related quality of life. The lack of the correlation between the PAID- Peds with demographic and clinical characteristics may have been influenced by the limited variability of the study sample. The original adult PAID, 8 which was validated in a population of adults with type 1 and type 2 diabetes, was found to be positively correlated with age, diabetes duration, general emotional distress, and A1c, and negatively correlated with diabetes self-care. It is notable that in the adult sample, the PAID was associated with demographic and clinical characteristics, but that we did not find this same association in our pediatric sample. This may be explained by factors that differ between pediatric and adult patients. First, our sample included only patients with type 1 diabetes, while the adult sample included both type 1 and type 2 diabetes. Second, the age and duration of diabetes were more widely distributed in the adult
5 1084 Journal of Diabetes Science and Technology 9(5) Table 2. Correlations/Associations of PAID-Peds With Demographic and Clinical Characteristics. Youth age Family structure (1 vs 2 adult household) Household income Youth age at type 1 diabetes diagnosis Type 1 diabetes duration A1c (%) (mmol/mol) Insulin regimen (pump vs injections) BG monitoring frequency Table 3. Construct Validity of PAID-Peds. Parent PAID Diabetes Family Conflict Scale Revised Youth report.43 <.0001 Parent report Blood Glucose Monitoring Communication Survey Youth report.61 <.0001 Parent report Center for Epidemiologic Studies Depression Scale Youth report.48 <.0001 Parent report State Trait Anxiety Inventory (STAI) (youth reported) State anxiety Trait anxiety.52 <.0001 STAI parent-proxy report trait version PedsQL Generic Core Scale Youth report.54 <.0001 Parent-proxy report.37 <.0001 PedsQL Diabetes Module Youth report.58 <.0001 Parent-proxy report sample, given that they were older. Third, there may be other factors unique to pediatric patients such as parental involvement in care. Youth perception of burden may be reduced among those whose parents remain involved in their care. Previous reports have suggested that in adults, there is substantial overlap between burden of diabetes care and symptoms of depression. 23,24 Given that depressive symptomatology occurs twice as commonly in youth with diabetes than in the general population, 25 we examined the co-occurrence of depressive symptomatology and burden related to type 1 diabetes in youth and their parents. We confirmed significant overlap between depressive symptoms and burden related to type 1 diabetes with those endorsing depressive symptoms being 2-4 times more likely to endorse higher levels of diabetes-related burden. In this evaluation, the PAID-Peds was purposefully assessed in a population of youth treated intensively to r r/t P P capture the impact of contemporary therapies. However, it is possible that perceived burden of type 1 diabetes by both youth and parents extends beyond the tools of intensive therapy to the routine demands of type 1 diabetes management related to the need to attend to food, exercise, illness, and stress in addition to insulin delivery and blood glucose monitoring 24 hours a day, without any break. Therefore, future assessments of the PAID-Peds should also include more diverse patient samples with respect to patient demographics and treatment characteristics. Limitations of this study include the fact that the majority of participants received insulin pump therapy and were intensively treated; in addition this measure only assesses diabetes-related burden for those with type 1 diabetes and was not designed to assess perceived burden in youth with type 2 diabetes. While these data may not generalize to a broader sample of patients, our selection of an intensively treated group was intentional, as patients treated with conventional therapy, for example, or those with uncontrolled diabetes may reflect greater psychosocial stressors and additional life challenges, independent of diabetes-specific burden, and their perceived diabetes burden could be impacted by these competing issues. Our evaluation of the PAID-Peds assessed burden related to diabetes management using contemporary therapies. In addition, the current study included only 1 center, had a limited sample size, and was cross-sectional. Conclusions The PAID-Peds may have clinical and research utility as a valid and reliable measure of youth perceived burden of type 1 diabetes. The PAID-Peds may also help assess perceived treatment burden as additional technological advances are implemented into routine care, including continuous glucose monitoring tools and various aspects of the artificial pancreas. Future research is needed to assess this measure in more diverse pediatric samples and in longitudinal studies to assess its sensitivity to change over time. Abbreviations A1c, hemoglobin A1c; BGMC, Blood Glucose Monitoring Communication Survey; CESD, Center for Epidemiological Studies Depression Scale; DFCS-R, Diabetes Family Conflict Scale Revised; EHR, electronic health record; PAID, Problem Areas in Diabetes Survey; PedsQL, Pediatric Quality of Life Inventory; STAIC, State Trait Anxiety Inventory for Children. Authors Note The measure is available from the authors at the Joslin Diabetes Center. Please contact them for licensing agreement information. Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
6 Markowitz et al 1085 Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported in part by National Institute of Diabetes and Digestive and Kidney Diseases Grants 5R01DK089349, 1K23DK092335, and P30DK036836, the Charles H. Hood Foundation, the Katherine Adler Astrove Youth Education Fund, the Maria Griffin Drury Pediatric Fund, and the Eleanor Chesterman Beatson Fund. References 1. American Diabetes Association. Clinical practice recommendations Diabetes Care. 2005;28(suppl 1):S1-S Chiang JL, Kirkman MS, Laffel LM, Peters AL. Type 1 diabetes through the life span: a position statement of the American Diabetes Association. Diabetes Care. 2014;37(7): Beck RW, Tamborlane WV, Bergenstal RM, Miller KM, Dubose SN, Hall CA. The T1D Exchange Clinic Registry. J Clin Endocrinol Metab. 2012;97(12): Wood JR, Miller KM, Maahs DM, et al. Most youth with type 1 diabetes in the T1D Exchange Clinic Registry do not meet American Diabetes Association or International Society for Pediatric and Adolescent Diabetes clinical guidelines. Diabetes Care. 2013;36(7): Petitti DB, Klingensmith GJ, Bell RA, et al. Glycemic control in youth with diabetes: the SEARCH for diabetes in Youth Study. J Pediatr. 2009;155(5): Markowitz JT, Harrington KR, Laffel LM. Technology to optimize pediatric diabetes management and outcomes. Curr Diab Rep. 2013;13(6): Markowitz JT, Pratt K, Aggarwal J, Volkening LK, Laffel LM. Psychosocial correlates of continuous glucose monitoring use in youth and adults with type 1 diabetes and parents of youth. Diabetes Technol Ther. 2012;14(6): Polonsky WH, Anderson BJ, Lohrer PA, et al. Assessment of diabetes-related distress. Diabetes Care. 1995;18(6): McGuire BE, Morrison TG, Hermanns N, et al. Short-form measures of diabetes-related emotional distress: the Problem Areas in Diabetes Scale (PAID)-5 and PAID-1. Diabetologia. 2010;53(1): Nicolucci A, Kovacs BK, Holt RI, et al. Diabetes Attitudes, Wishes and Needs second study (DAWN2): cross-national benchmarking of diabetes-related psychosocial outcomes for people with diabetes. Diabet Med. 2013;30(7): Markowitz JT, Volkening LK, Butler DA, Antisdel-Lomaglio J, Anderson BJ, Laffel LM. Re-examining a measure of diabetes-related burden in parents of young people with Type 1 diabetes: the Problem Areas in Diabetes Survey Parent Revised version (PAID-PR). Diabet Med. 2012;29(4): Weissberg-Benchell J, Antisdel-Lomaglio J. Diabetes-specific emotional distress among adolescents: feasibility, reliability, and validity of the Problem Areas in Diabetes Teen version. Pediatr Diabetes. 2011;12(4 pt 1): American Diabetes Association. Standards of medical care in diabetes Diabetes Care. 2014;37(suppl 1):S14-S Hood KK, Butler DA, Anderson BJ, Laffel LMB. Updated and revised Diabetes Family Conflict Scale. 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Gainesville: University of Florida; Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the Pediatric Quality of Life Inventory. Med Care. 1999;37(2): Varni JW, Burwinkle TM, Jacobs JR, Gottschalk M, Kaufman F, Jones KL. The PedsQL in type 1 and type 2 diabetes: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales and type 1 Diabetes Module. Diabetes Care. 2003;26(3): Hermanns N, Kulzer B, Krichbaum M, Kubiak T, Haak T. How to screen for depression and emotional problems in patients with diabetes: comparison of screening characteristics of depression questionnaires, measurement of diabetesspecific emotional problems and standard clinical assessment. Diabetologia. 2006;49(3): Hood KK, Beavers DP, Yi-Frazier J, et al. Psychosocial burden and glycemic control during the first 6 years of diabetes: results from the SEARCH for Diabetes in Youth Study. J Adolesc Health. 2014;55: Hood KK, Huestis S, Maher A, Butler D, Volkening L, Laffel LM. 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