A systematic review of patient-reported measures of burden of treatment in three chronic diseases

Figures & data

Figure 1 Flow diagram of study screening and selection.

Table 1 Identified patient-reported measures assessing burden of treatment (57)

Diabetes measures (47)
Treatment/regimen-related impact and burden measures (8)
Diabetic Foot Ulcer Scale
Multidimensional Diabetes Self-Management Checklist
Perceived Burden of Diabetes Treatment (single item)
Perceptions About Medications for Diabetes
Practicality/comfort of treatment (single item)
Survey of Treatment Burdens in Diabetes (individual item scoring)
Treatment-Related Impact Measure – diabetes
Treatment-Related Impact Measure – diabetes device
Barriers to self-care measures (8)
Barriers in Diabetes Questionnaire
Barriers to Adherence Questionnaire
Barriers to Diabetes Adherencechild
Diabetes Self-Care Barriers Assessment for Older Adults
Dietary Barriers
General Barriers to Diabetes Self-Management
Perceived Difficulties in Diabetes Self-Care (individual item scoring)
Personal Diabetes Questionnaire
Distress measures (7)
Diabetes Distress Scale (including 2-item, 3-item, and 4-item short versions)
Diabetes Fear of Injecting and Self-testing Questionnairechild
Perceptions of Insulin Shots and Fingersticks (individual item scoring)child
Problem Areas in Diabetes
Insulin treatment measures (6)
Insulin Delivery System Rating Questionnaire
Insulin Pen Questionnaire
Insulin Treatment Appraisal Scale
Insulin Treatment Questionnaire
Insulin Treatment Satisfaction Questionnaire
Patient Satisfaction with Insulin Therapy
Family conflict/strain measures (6)
Diabetes Family Adherence Measurechild
Diabetes Family Behavior Checklistchild
Diabetes Family Conflict Scalechild
Diabetes Family Support and Conflict Scale
Diabetes Responsibility and Conflict Scalechild
Multidimensional Diabetes Questionnaire
General diabetes quality-of-life measures (5)
Diabetes-39
Diabetes Health Profile
Diabetes-specific Quality of Life Scale
DISABKIDS Diabetes modulechild
Pediatric Quality of Life Inventory 3.0 Diabetes modulechild
Glucose monitoring measures (4)
Blood Glucose Monitoring System Rating Questionnaire
Continuous Glucose Monitoring Satisfaction Scalechild
Glucose Monitoring Surveychild
Measure of Invasiveness as a Reason for Skipping Self-Monitoring of Glucose
Treatment satisfaction measures (3)
Diabetes Medication Satisfaction Measure
Diabetes Medication Treatment Satisfaction Tool
Treatment Satisfaction Measure for People with Insulin-dependent Diabeteschild
Kidney disease measures (6)
Treatment/regimen-related impact and burden measures (2)
Renal Adherence Attitudes Questionnaire
Treatment Effects Questionnaire
Distress measures (2)
Continuous Ambulatory Peritoneal Dialysis Stressor Scale
Hemodialysis Stressor Scale
Barriers to self-care measures (1)
Health Beliefs about Fluid Adherence
Treatment satisfaction measures (1)
Satisfaction with Care Questionnaire
Heart failure measures (4)
Barriers to self-care measures (3)
Beliefs about Dietary Compliance Scale
Beliefs about Medication Compliance Scale
Dietary Sodium Restriction Questionnaire
Treatment/regimen-related impact and burden measures (1)
Perceived difficulty affording health care (single item)

Note:

child: suitable for administration to children and adolescents.

Table 2 Summary of scale characteristics and psychometric properties

Instrument	Relevant subscales, items (n)	Patient input	Reliability	Scale analyses	Convergent/discriminant validity	Known-group/concurrent validity	Sensitive to change
Diabetes measures
Barriers to Adherence Questionnaire^Citation56,Citation92	Diet (4), insulin injection (3), exercise (3), glucose testing (5), total (15)	√	X	NR	NR	√	NR
Barriers to Diabetes Adherence^Citation26	Stress/burnout (4), time pressure/planning (5), stigma (6)	√	√	√	NR	√	NR
Barriers in Diabetes Questionnaire^Citation49	Self-control and advice from providers (9), injecting, monitoring and overall self-regulation (10), self-regulation in specific situations (9), total (28)	X	√	√	NR	√	NR
Blood Glucose Monitoring System Rating Questionnaire^Citation58,Citation93	Convenience (NR), interference (NR), blood glucose burden (NR)	X	√	NR	NR	√	X
Continuous Glucose Monitoring Satisfaction Scale^Citation61,Citation62,Citation78	Hassles (20)	X	√	√	NR	√	NR
Diabetes-39^Citation67,Citation94	Diabetes control (12)	√	√	√	√	√	NR
Diabetes Distress Scale^Citation28,Citation73,Citation84,Citation95	Emotional burden (5), regimen-related distress (5)	√	√	√	√	√	√
DDS-2, DDS-3, and DDS-4^Citation27	Totals for scales (2-items, 3-items, and 4-items, respectively)	√	√	NR	√	√	NR
Diabetes Family Adherence Measure^Citation39	Coercion (7)	X	√	√	√	√	NR
Diabetes Family Behavior Checklist^Citation40,Citation96	Nonsupportive behaviors (7)	√	X	NR	√	√	√
Diabetes Family Conflict Scale-Revised^Citation41,Citation86,Citation97^–^Citation100	Direct management (9), indirect management (10), total (19)	√	√	√	√	√	√
Diabetes Family Support and Conflict Scale^Citation42	Family conflict (4)	√	√	√	NR	√	NR
Diabetes Fear of Injecting and Self-testing Questionnaire^Citation30,Citation79,Citation91	Self-injecting fear (15), self-testing fear (15), total (30)a	X	√	√	√	√	NR
Diabetes Health Profile^Citation37,Citation82,Citation101,Citation102	Barriers to activity (NR)	√	√	√	√	√	√
Diabetes Medication Satisfaction Measure^Citation46,Citation81,Citation90,Citation103	Burden (11), symptoms (5)	√	√	√	√	√	√
Diabetes Medication Treatment Satisfaction Tool^Citation47	Lifestyle (5), convenience (3), well-being (3)	√	√	√	NR	√	NR
Diabetes-specific Quality of Life Scale^Citation48,Citation75,Citation80	Diet restrictions (9), daily hassles (6)	√	√	√	√	√	√
Diabetes Responsibility and Conflict Scale^Citation43	Conflict (NR)	X	NR	NR	NR	X	NR
Diabetes Self-Care Barriers Assessment for Older Adults^Citation60,Citation104	Glucose monitoring barriers (4), diet regimen barriers (4), exercise barriers (4), total (12)	√	√	√	NR	√	NR
Diabetic Foot Ulcer Scale^Citation59,Citation105	Ulcer care (4), financial (2)	√	√	√	√	√	X
DISABKIDS Diabetes module^Citation24,Citation106	Impact/acceptance (6), treatment (4)	√	√	√	NR	√	NR
General Barriers to Diabetes Self-Management^Citation57,Citation107	Diet (7), exercise (7), glucose testing (7), medication taking (7), general barriers (4), total (31)	√	√	NR	NR	√	NR
Dietary Barriers^Citation57,Citation107	At home (7), food purchase (8), away from home (5), total (27)	√	√	NR	NR	√	NR
Glucose Monitoring Survey^Citation62	Glucose control (7), social complications (6), total (22) (note, 9 items do not load on either subscale)	X	√	√	√	√	NR
Insulin Delivery System Rating Questionnaire^Citation50,Citation58,Citation93	Convenience (NR), interference (NR), blood glucose burden (NR)b	√	√	NR	NR	√	√
Insulin Pen Questionnaire^Citation51	Convenience (7), facilitation of self-care (6), cost (1)	√	√	NR	NR	√	NR
Insulin Treatment Appraisal Scale^Citation31	Negative appraisal (16)	√	√	√	√	√	NR
Insulin Treatment Questionnaire^Citation45	Insulin therapy perception (12)	X	√	√	X	X	√
Insulin Treatment Satisfaction Questionnaire^Citation52,Citation108^–^Citation111	Inconvenience of regimen (5) lifestyle flexibility (3), delivery device satisfaction (6)c	√	√	√	√	√	X
Measure of Invasiveness as a Reason for Skipping Self-Monitoring of Glucose^Citation63	Total (7)	X	√	NR	√	√	NR
Multidimensional Diabetes Questionnaire^Citation44	Misguided support behaviors (4)	√	√	√	NR	√	NR
Multidimensional Diabetes Self-Management Checklist^Citation53	Burden of diet self-management (3), burden of injecting insulin (3), burden of glucose monitoring (3), burden of adjusting insulin dose (3)	X	√	NR	NR	√	NR
Patient Satisfaction with Insulin Therapy^Citation54,Citation74	Convenience/ease (10), social comfort (5), global satisfaction (15)	√	√	√	NR	√	√
Pediatric Quality of Life Inventory 3.0 Diabetes module^Citation25,Citation112,Citation113	Treatment barriers (4), treatment adherence (7)	√	X	NR	√	√	NR
Perceived Burden of Diabetes Treatment^Citation18	Single item on perceived burden of treatment	X	NR	NA	NR	√	NR
Perceived Difficulties in Diabetes Self-Care^Citation22	Individual items assessing difficulties in insulin treatment (2), glucose monitoring (1), diet (3), exercise (1), smoking (1), daily self-care (1), and self-care during certain occasions (4)	√	NR	NR	NR	√	NR
Perceptions About Medications for Diabetes^Citation29	Schedule flexibility (3), portability convenience (2), regimen inconvenience (5), difficulty remembering medications (2), gastrointestinal side effects (3), weight/edema side effects (3), emotional (10)	√	√	√	NR	√	NR
Perceptions of Insulin Shots and Fingersticks^Citation23	Injection pain (1), injection fear (1), fingerstick pain (1), fingerstick fear (1)	X	NR	NR	NR	√	X
Personal Diabetes Questionnaire^Citation38	Diet barriers (7), medication barriers (8), monitoring barriers (8), exercise barriers (7)	√	√	NR	NR	√	NR
Practicality/comfort of treatment^Citation19	Single item on practicality and comfort of treatment	X	NR	NA	NR	NR	NR
Problem Areas in Diabetes^Citation32,Citation77,Citation83,Citation114	Treatment-related (3) and food-related problems (3)	√	√	√	√	√	√
Survey of Treatment Burdens in Diabetes^Citation2,Citation21	Individual items assessing burden of: oral agents (1), insulin (4), oral + insulin therapy (1), self-monitoring of blood glucose (3), diet (2), pain (1), and interference with activities (1)	X	NR	NR	NR	√	NR
Treatment-Related Impact Measure – Diabetes^Citation6	Treatment burden (6), daily life (5), psychological health (8)	√	√	√	√	√	NR
TRIM-Diabetes Device^Citation6	Device function (5), bother (3), total (8)	√	√	√	√	√	NR
Treatment Satisfaction Measure for People with Insulin-dependent Diabetes^Citation64	Perceived compatibility with lifestyle (PCL) (3)	√	NR	√	NR	√	NR
Kidney disease measures
Health Beliefs About Fluid Adherence^Citation33	Barriers to fluid adherence (7)	X	√	NR	NR	√	NR
Hemodialysis Stressor Scale^Citation34,Citation35,Citation85,Citation115	Physiological, psychosocial, totald	X	√	√	NR	X	√
Continuous Ambulatory Peritoneal Dialysis Stressor Scale^Citation35		X	√	NR	NR	NR	NR
Renal Adherence Attitudes Questionnaire^Citation65	Attitude towards social restrictions (8), acceptance/lifestyle impact (11)	√	√	√	NR	NR	NR
Satisfaction with Care Questionnaire^Citation68	Financial/transportation (7)	√	√	NR	√	NR	NR
Treatment Effects Questionnaire^Citation16,Citation36,Citation76	Total (20)	X	√	NR	√	√	NR
Heart failure measures
Beliefs about Medicine Compliance Scale^Citation55,Citation116	Medication barriers (6)	√	√	√	NR	NR	NR
Beliefs about Diet Compliance Scale^Citation55,Citation116,Citation117	Diet barriers (5)	√	√	√	NR	X	NR
Dietary Sodium Restriction Questionnaire^Citation66,Citation118	Perceived behavioral control (7)e	√	√	√	NR	NR	NR
Perceived Difficulty Affording Health Care^Citation20,Citation72	Single item on economic burden of medical costs	X	NR	NA	NR	√	NR

Notes:

a Mollema et al³⁰ added 4 items to fear of injecting and 4 items to fear of testing subscales;

b modified from original scoring⁵⁰ which scored two subscales, ie, treatment satisfaction (15 items) and treatment interference with activities (11 items);

c Bode et al¹⁰⁸ used a modified scoring procedure for all subscales;

d number of items in the subscales and the overall scale fluctuate across studies. A third subscale (“dependency/restriction”) was identified by Murphy et al;¹¹⁵

e original scoring¹¹⁸ recorded only response frequencies of individual items.

Abbreviations: √, satisfactory; X, unsatisfactory or incomplete; NR, not reported; NA, not applicable.

Table 3 Content domains common across burden of treatment measures

Emotional impact/regimen-related distress	Scheduling flexibility
Family conflict/unsupportive behavior	Medication side effects
Treatment convenience	Diet/food-related problems
Self-care convenience	Overall treatment burden
Monitoring burden	Device function/bother
Lifestyle impact (includes social restrictions and work interference)	Economic burden

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