(2024) 22:347
Yang et al. BMC Medicine
https://doi.org/10.1186/s12916-024-03560-3

BMC Medicine

RESEARCH ARTICLE

Open Access

Patient‑reported outcome measures
for medication treatment satisfaction:a systematic review of measure development
and measurement properties
Mengting Yang1,2,3,4,5, Puwen Zhang1,2,3,4,5, Jillian Halladay6,7, Kun Zou1,2,3,4, Imti Choonara8, Xiaorui Ji9,
Shuya Zhang9, Weiyi Yan9, Liang Huang1,2,3,4, Xiaoxi Lu4,10, Huiqing Wang11, Yuxin Jiang12, Xinyu Liu12,
Linan Zeng1,2,3,4*, Lingli Zhang1,2,3,4,13* and Gordon H. Guyatt14,15

Abstract
Background Medication Treatment Satisfaction (M-TS) from the patients’ perspective is important for comprehensively evaluating the effect of medicines. The extent to which current patient-reported outcome measures (PROMs)
for M-TS are valid, reliable, responsive, and interpretable remains unclear. To assess the measurement propertiesof existing PROMs for M-TS and to highlight research gaps.
Methods Using PubMed, Embase (Ovid), Cochrane library (Ovid), IPA (Ovid), PsycINFO, Patient-Reported Outcome
and Quality of Life Questionnaires biomedical databases, and four Chinese databases, we performed a systematic
search for studies addressing the development and validation of PROMs for M-TS. Based on the Consensus-basedStandards for the selection of health Measurement Instruments (COSMIN) guideline, pairs of reviewers independently
assessed the measurement properties of the PROMs and rated the quality of evidence on the measurement properties of each PROM. (The Open Science Framework registration: https://​doi.​org/​10.​17605/​OSF.​IO/​8S5ZM).
Results This review identified 69 PROMs for M-TS in 114 studies (four generic, 32 disease-specific, and 33 drugspecific) of which 60 were intended for adults. All provided limited or no information regarding interpretability. Most
demonstrated appropriate construct validity including convergent validity (39/69) and discriminative or knowngroups validity (40/69) (high to moderate quality of evidence). Only a few provided evidence of sufficient content
validity (8/69), structural validity (13/69), and internal consistency (11/69). Of 38 PROMs reporting test–retest reliability,
results in 24 provided evidence of satisfactory test–retest reliability (18 with high to moderate, 6 with low to very low
quality of evidence). Few PROMs reported responsiveness (16/69). Two generic PROMs (Treatment Satisfaction Questionnaire for Medication initial Version 1.4, TSQM-1.4; Treatment Satisfaction with Medicines Questionnaire, SATMEDQ) and one drug-specific PROM (Insulin Treatment Satisfaction Questionnaire, ITSQ) demonstrated both satisfactory
validity and reliability.

*Correspondence:
Linan Zeng
LinanZeng@scu.edu.cn
Lingli Zhang
zhanglingli@scu.edu.cn
Full list of author information is available at the end of the article© The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0
International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as longas you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if
you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article orparts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicatedotherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not
permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To
view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/4.0/.

Yang et al. BMC Medicine(2024) 22:347

Page 2 of 36

Conclusions Most existing PROMs for M-TS require further exploration of measurement properties. Reporting guidelines are needed to enhance the reporting quality of the development and validation of PROMs for M-TS.
Keywords Patient-reported outcome measures, Systematic review, Medication treatment satisfaction, COSMIN,
Measurement properties

Background
Medication Treatment Satisfaction (M-TS) is a subjective
patient-reported outcome (PRO) that evaluates patients’
perception of medication-taking process and its associated outcomes [1]. Both the US Food and Drug Administration (FDA) [2] and the European Medicines Agency(EMA) [3] encourage involving patient-reported satisfaction with treatment in drug development and evaluation,with an emphasis placed upon patients’ judgment.
M-TS, if captured in a scientifically rigorous way [3,4], can predict adherence (e.g., by identifying areas
where patients are dissatisfied with their medication) [5],inform clinical decision-making (e.g., by allowing healthcare professionals to select therapies based on patient
feedback) [3, 6–8], and influence health care policy (e.g.,
by guiding reimbursement decision and quality improvement initiatives based on patient-centered outcomes)[3, 6–8]. Patient-reported outcome measures (PROMs)
with poor validity, reliability, or responsiveness in thetarget population may inadequately capture the changes
in M-TS [9, 10] resulting in inaccurate estimates of theeffect of drugs and misguided clinical decisions [9–11].
With the growing breadth of available PROMs for M-TS
[12–15], heterogeneity in outcome reporting has stifled
efforts to synthesize findings across trials [16, 17].
Identifying valid, reliable, responsive, and interpretable PROMs for M-TS therefore is crucial for clinical trials and clinical practice [7, 8, 10]. To date, no study has
systematically reviewed existing PROMs for M-TS andassessed their measurement properties. Our systematic
review aims to identify currently available PROMs for
M-TS, to evaluate the measurement properties of these
PROMs, to provide evidence for choosing PROM for
M-TS, and if any to highlight the research gap regarding
the development and validation of PROMs for M-TS.
Methods
We registered this systematic review on the Open Science Framework (https://​doi.​org/​10.​17605/​OSF.​IO/​
8S5ZM) and adhered to the Preferred Reporting Items
for Systematic Reviews and Meta-Analyses (PRISMA)
reporting guideline [18] and the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guideline for systematic reviewsof patient-reported outcome measures [19–21]. The

COSMIN guideline provides a standardized data abstraction form for characteristics and measurement properties of the included PROMs, and criteria for assessing themeasurement properties of PROMs. The reviewers used
the COSMIN Risk of Bias checklist to assess the risk ofbias of individual studies, and the modified Grading ofRecommendations Assessment, Development, and Evaluation (GRADE) to grade the quality of evidence.
The research team formation

We established a multidisciplinary research team, comprising two PROM methodologists, one epidemiology
methodologist, three clinicians, three pharmacists, andtwo pharmacy students, to ensure comprehensive analysis and diverse perspectives in this review.
Literature search and selection

Using PubMed, Embase (Ovid), Cochrane library (Ovid),International Pharmaceutical Abstracts (IPA, Ovid), PsycINFO, Patient-Reported Outcome and Quality of Life
Questionnaires biomedical databases (PROQOLID),
China National Knowledge Infrastructure (CNKI), Wanfang, Chinese Scientific Journal Database (VIP database),
and Chinese Biomedicine Literature Database (CBM)(from inception through 5 December, 2022) and ePROVIDE (https://​eprov​ide.​mapi-​trust.​org/), the reviewers
performed a systematic search for literature publishedin English and Chinese reporting the development (i.e.,development study including cognitive interview orother pilot study) and validation (i.e., validation study) of
PROMs for M-TS in adults and children with any medical condition (Additional file 1: table S1).
After removing duplicate records, pairs of reviewers (M.Y., X.J., W.Y., and S.Z.) independently screened
the titles and subsequent full-text articles, with conflicts
handled by a fifth reviewer (L.Z.). For including relevant literature, the reviewers reviewed the references ofincluded articles.
Data extraction

Using a pilot tested data abstraction form, after a calibration exercise, pairs of reviewers (M.Y., X.J., W.Y. and S.Z.)
independently extracted data including the characteristics of the individual studies (e.g., study design, country, sample size, study population), the characteristics of
the PROMs (e.g., target population, domains, responseYang et al. BMC Medicine(2024) 22:347

options, and copyright based on ePROVIDE), and themeasurement properties of the PROMs (i.e., content
validity, structural validity, construct validity, criterion
validity, cross-cultural validity or measurement invariance, internal consistency, test–retest reliability, measurement error, and responsiveness) and information
about interpretability of the PROMs [19, 22].
For the PROM development, we extracted the origin of
the construct to be measured reported in the study (e.g.,a theory, conceptual framework, or disease model used,or a clear rationale provided to define the construct).
Then, after group discussion within our research team,
we summarized the concepts, components, and influencing factors of treatment satisfaction into a table.
Assessment of measurement properties

Using the criteria for good measurement properties [19,20], two reviewers (M.Y. and P.Z.) based on individual
studies independently assessed the measurement properties of each PROM as sufficient ( +), insufficient ( −),or indeterminate (?) (Additional file 1: table S2 [19, 20,22]). For example, we rated the test–retest reliability of a
PROM as sufficient if the intraclass correlation coefficient(ICC) or weighted Kappa ≥ 0.70, as insufficient if < 0.70,
or as indeterminate if ICC or weighted Kappa were notreported. Based on all studies relevant to a particularPROM, the reviewers assessed the overall measurement
properties of that PROM as sufficient ( +), insufficient( −), inconsistent ( ±), or indeterminate (?) [19, 20]. A
third reviewer (L.Z.) resolved any disagreement.
Grading the quality of evidence

Using the COSMIN risk of bias checklist [19, 23], tworeviewers (M.Y. and P.Z.) independently assessed the riskof bias (RoB) of individual development and validation
study as very good, adequate, doubtful, inadequate quality. For example, we rated RoB of a PROM development
study as very good if PROM design (including construct
to be measured, origin of the construct, target population, context of use etc.) and cognitive interview study
or another pilot test regarding the relevance, comprehensibility, and comprehensiveness of the PROM wereclearly described; adequate if assumably appropriate but
not clearly described; and doubtful or inadequate if notclearly described. A third reviewer (L.Z.) resolved any
disagreement.
Using the modified GRADE approach in COSMIN
guideline, the reviewers graded the overall quality ofevidence on the measurement properties of a PROM
as high, moderate, low, or very low (Additional file 1:
table S3 [20–22, 24]) [19, 24]. When a specific measurement property was assessed as indeterminate (e.g.,
due to lack of reporting), the reviewers did not rate thePage 3 of 36

quality of evidence on that particular measurement
property [19, 20].

Results
Literature screening and characteristics of included studies

The search strategy yielded 2813 records, with 114 studies [25–138] included in this review (Fig. 1). Sixty-threestudies (55%) pertained to the development and validation of PROMs for M-TS, while the remaining 51 studies(45%) focused on the validation of PROMs (Additional
file 1: table S4 [25–138]). The United States accounted
for the majority of studies conducted (46, 40%), followedby Spain (16, 14%) and the UK (15, 13%). The mediansample sizes of studies that developed and validated thePROMs is 205 (with a range from 13 to 1336) and thatof studies that validated the PROMs is 197 (with a range
from 10 to 2511).
Characteristics of PROMs for M‑TS

The 114 studies [25–138] reported 69 PROMs for M-TS.
Sixty PROMs (87%) were intended for adults (Table 1).
Most of the PROMs are disease-specific (32, 46%) or
drug-specific (33, 48%), while four are generic (6%).
The disease-specific PROMs cover 12 categories of diseases under the International Classification of Diseases
11th (ICD-11) [139] with 29 specific diseases (mostly
often diabetes, asthma, and migraine). The drug-specific
PROMs targeted 12 categories of medicines under theAnatomical Therapeutic Chemical Classification System(ATC) [140] (mostly often anticoagulants, insulin, andiron chelation).
The majority of M-TS PROMs (61, 88%) were selfreported, four (6%) were either self-reported orproxy-reported (e.g., by parents or clinicians), and theremaining four (6%) were health practitioner administered (e.g., through interviews). Data collection modes
for self-reported PROMs include questionnaires (inpaper and pen or electronic versions), interviews (faceto-face or via phone script), and mobile applications.
All included 69 M-TS PROMs have questionnaire data
mode; only the TSQM-1.4, TSQM-II, and TSQM-9 (3,4%) have further developed phone scripts and mobile
applications [141]. In practical applications, patients can
independently complete self-reported M-TS PROMs
on paper or electronic devices, or with the assistance of
researchers, who will read the questions aloud and record
the patient’s answers (e.g., in-person or telephone interviews). Thirty-eight PROMs (55%) reported copyrightinformation, of which 28 belong to the pharmaceuticalindustry. Sixty-four PROMs (93%) provided free accessto full questionnaires. Ten PROMs (14%) proved easy to
be administrated and completed in the context of clinical
trials.

Yang et al. BMC Medicine(2024) 22:347

Page 4 of 36

Fig. 1 Preferred Reporting Items for Systematic Reviews and Meta-Analysis Diagram of Study Selection

The most commonly measured domains were convenience (40, 58%), side effects (39, 57%), and perceived
effectiveness of medication (29, 42%) (Table 1). The mostcommonly used response option was a 5-point Likert
scale (32, 46%). Less than half of the PROMs (32, 46%)
clarified the timing for measuring M-TS. Among thoseclarified, the most common recall period for measuring
M-TS was 2 to 4 weeks after the initiation of medication.
Measurement properties of PROMs for M‑TS with qualityof evidence

Among sixty-four PROMs reported the development
process (Table 2). All of these 64 PROMs described theconstruct measured and the target population. Tenreported the conceptual framework or theory for defining
the construct being measured that supported their generation of measurement items (Additional file 1: table S5 [1,30, 44, 66, 82, 95, 100, 117, 125, 126, 129, 142]). No common framework or theory was used. Figure 2 summarizes

the concepts, components, and influence factors of treatment satisfaction from the ten frameworks [30, 44, 66, 82,
95, 100, 117, 125, 126, 129] and two theories [1, 142].
Eight PROMs (12%) had sufficient overall content
validity (i.e., relevance: items were relevant for the construct of interest, the target population, and the context of use; comprehensiveness: all key concepts were
included; comprehensibility: the PROM was understoodby the target population) (5/8, moderate; 3/8, low qualityof evidence) (Table 2). The other PROMs failed to simultaneously meet the criteria of relevance, comprehensiveness, or comprehensibility or did not report the content
validity. Among 54 PROMs that reported structuralvalidity (all of which applied classical test theory), 13 hadsufficient structural validity (i.e., comparative fit index(CFI) or Tucker–Lewis index (TLI) or comparable measure > 0.95, or Root Mean Square Error of Approximation(RMSEA) < 0.06 or standardized root mean residuals(SRMR) < 0.08) (high to moderate quality of evidence).

5

DTSQ-IP [51](English version)

2009, UK

Endocrine, nutritional, or metabolic diseases

Disease-specific PROMs for M-TS a
Teens and adults

AdultsSATMED-Q [31,37–40](English, French,and Polish version)

4

2008, Spain

TSQM-9 [36](English version)

3

AdultsAdults2005, USA

TSQM-II [30–35](English, French,
Chinese, Japanese,and Persian version)

2

2009, USA

AdultsTarget population

2004, USA
TSQM-1.4 [25–29](English, Arabic,
Kurdish, and Spanish
version)Year and countryof development

1

Generic PROMs for M-TS

PROM
(language version)

Insulin-treateddiabetes

Generic

Generic

Generic

Generic

Target disease/drug

Table 1 Characteristics of PROMs for medication treatment satisfaction

Self-report

Self-report

Self-report

Self-report

Self-report

Administration

Past 2 weeks

Not specified

Past 2–3 weeks
or since last used
the medicine

Past 2–3 weeks
or since last used
the medicine

Past 2–3 weeks
or since last used
the medicine

Recall period

4-point Likert scale

17NR

6-point Likert scale

7-point or 5-point
Likert scale9

1. Effectiveness; 2.
Convenience; 3.
Global Satisfaction

19

7-point or 5-point
Likert scale

11

1. Effectiveness; 2.
Side effects; 3. Convenience; 4. Global
Satisfaction

1. Treatment
effectiveness; 2.
Convenience of use;
3. Impact on dailyliving/activity;
4. Medical care/
medical follow-up;
5. Undesirable side
effects; 6.Global
satisfaction

7-point or 5-point
Likert scale

Response options

14

Numberof items

1. Effectiveness; 2.
Side effects; 3. Convenience; 4. Global
Satisfaction

Domains

No information© Miguel A. Ruiz, 2008.
All Rights Reserved© 2023 IQVIA. All
rights reserved. Anyuse, distribution,or reproduction,in whole or in part,is expressly prohibitedwithout the prior
express written permission of IQVIA© 2023 IQVIA. All
rights reserved. Anyuse, distribution,or reproduction,in whole or in part,is expressly prohibitedwithout the prior
express written permission of IQVIA© 2023 IQVIA. All
rights reserved. Anyuse, distribution,or reproduction,in whole or in part,is expressly prohibitedwithout the prior
express written permission of IQVIA

Copyright

Yang et al. BMC Medicine(2024) 22:347
Page 5 of 36

ThyTSQ [56, 57](English version)

MS-TSQ [58](English version)

Acro-TSQ [59, 60](English version)

7

8

9

2019, USA2007, USA2004, UK

2020, USAYear and countryof development

10

SATQ [75–77](English, Spanish,
and Polish version)

2003, UK

Diseases of the respiratory system

DIDS [55](English version)

6

PROM(language version)

Table 1 (continued)

AdultsAdultsAdultsAdultsAdultsTarget population

AsthmaAcromegaly

Hot flashes, menopause

Hypothyroidism

Type 1 diabetes

Target disease/drug

Self-report

Self-report

Self-report

Self-report

Self-report and parent/proxy report

Administration

Not specified

Past 4 weeks

Past 4 weeks

Past few weeks

Not specified

Recall period

5-point Likert scale

NR

8

26

1. Effectivenessof treatment; 2. Easeof use; 3. Medication
burden; 4.Sideeffects and worries

1. Treatment
effectiveness; 2.
Symptom burden;
3. Treatment sideeffects; 4. Convenience of treatment; 5.
Overall satisfaction

1. Satisfaction
with the treatment’s
ability to control
specific symptoms associatedwith menopause; 2.
Side effects or treatment tolerability;
3. Global treatment
satisfaction

7-point Likert scale

6-point Likert scale7
1. Present satisfaction; 2. How well
working; 3. Convenient; 4. Understanding of condition; 5.
Encourage; 6. Controlling symptoms; 7.
Continue

26

10-point Likert scale

12

1. Device satisfaction; 2. Diabetes
impactResponse options

Numberof items

Domains

No information

No information

No information

No information

No information

Copyright

Yang et al. BMC Medicine(2024) 22:347
Page 6 of 36

PASAPQ [78](English version)

PPMQ [79](English version)

PPMQ-R [80, 81](English version)

MTSM [82, 83](English version)

PTSS [85, 86](English and Traditional Chinese
Cantonese version)

MSTCQ [87](English version)

12

13

14

15

16

Diseases of the nervous system

11

PROM
(language version)

Table 1 (continued)

AdultsAdults2004, USA, Italy,
France2006, USA

AdultsAdults2006, USA2003, USA, UK

AdultsNR

Target population

2002, Canada,
Finland, The Netherlands, New Zealand,
Spain

2005, USAYear and countryof development

Multiple sclerosis

Acute pain, chronic
pain

Migraine

Migraine

Migraine

Asthma, asthmachronic obstructive
pulmonary disease
overlap syndrome

Target disease/drug

Self-report

Self-report

Self-report

Self-report

Not specified

Not specified

Not specified

Past 24 h

Past 4 h

Not specified

Self-report

Self-report

Recall period

Administration

1. Satisfaction
with the injection
system; 2. Side
effects

5-point Likert scale

NR

39

30

NR

NR
1. Expectationsof treatment
outcomes; 2. Importance of attributes; 3.
Rating of treatment
outcome; 4.Satisfaction with treatment
1. Information; 2.
Medical care; 3.
Impact of current
pain medication;
4. Satisfaction
with pain medication which included
the two subscales
medication characteristics; 5. Side
effects

7-point or 5-point
Likert scale32
1. Efficacy; 2. Function; 3. Ease of use; 4.
Cost; 5. Side effects;
6. Global items

7-point Likert scale

14

7-point or 5-point
Likert scale

Response options

Numberof items

15

NR

1. Performance; 2.
Convenience; 3.
Overall satisfaction

Domains

The instrument is copyrighted by Joyce A.
Cramer

The PTSS is copyrighted by Pfizer

No information©2008 GlaxoSmithKline. All rights
reserved©2008 GlaxoSmithKline. All rights
reserved© Boehringer
Ingelheim holdthe copyright

Copyright

Yang et al. BMC Medicine(2024) 22:347
Page 7 of 36

CTSQ [90–94](English, Korean,
Dutch, and Malay
version)

TSQ-G [96](English version)

GTSQ [97](English version)

TSQ-C [98](English version)

18

19

20

Diseases of the digestive system

17

Neoplasms

PROM(language version)

Table 1 (continued)

2005, USA2005, USA2003, USA2005, USA, UK,
FranceYear and countryof development

NR

AdultsAdultsAdultsTarget population

Administration

Crohn’s disease

Gastroesophageal
reflux disease

Gastroesophageal
reflux disease

Self-report

Self-report

Self-report

Generic for Neoplasms Self-report

Target disease/drug

Not specified

Past 2 weeks

Past 2 weeks

Past 4 weeks

Recall period

21

Numberof items

1. Symptoms; 2.
Satisfaction; 3.
Expectations; 4. Physician Relationships;
5. Bother; 6. Cost

1. Specific symptom
relief; 2. Nighttime relief; 3.
Daytime relief; 4.
Quick and longlasting relief; 5. Easeand convenience; 6.
Health-related quality of life (HRQL); 7.
Overall satisfaction

5-point Likert scale

6-point Likert scale

32

NR

5-point Likert scale

Response options

25

1. Symptoms; 2. Sat- 28
isfaction; 3. Expectations; 4. Provider
relationships; 5. Cost;
6. Bother; 7. Flexibility with dosing

1. Expectationsof cancer therapy; 2.
Feelings about side
effects; 3. Oral cancer therapy adherence; 4. Convenience; 5. Satisfaction
with cancer therapy;
6.Stopping cancer
therapy; 7. Reasonsfor nonadherence

Domains

No information

No information© Astrazeneca. All
rights reserved© 2007, Cronos ClinicalConsulting Services,an IQVIA business

Copyright

Yang et al. BMC Medicine(2024) 22:347
Page 8 of 36

SPACE-Q [99, 100](English and French
version)

Adults2011, France

HIVTSQs [108](English version)

HIVTSQc [109](English version)

22

23

2006, UK

2001, USA, Canada

AdultsAdultsTarget population

Year and countryof development

Certain infectious or parasitic diseases

21

PROM
(language version)

Table 1 (continued)

Human immunodeficiency virus infection

Human immunodeficiency virus infection

Crohn’s disease

Target disease/drug

Self-report

Self-report

Self-report

Administration

Past 4 weeks

Past 4 weeks

Not specified

Recall period

Numberof items

NR

NR

1. Current treatment; 10
2. Control; 3. Side
effects; 4. Demands;
5. Convenience;
6. Flexibility; 7.
Understanding; 8.
Lifestyle; 9. Recommend to others; 10.
Continue

4-point or 5-point
Likert scale, dichotomous (Yes/No)

Response options

1. Current treatment; 10
2. Control; 3. Side
effects; 4. Demands;
5. Convenience;
6. Flexibility; 7.
Understanding; 8.
Lifestyle; 9. Recommend to others; 10.
Continue

1. Disease control; 2. 58
Symptoms transition
scale; 3. Anal symptoms transition scale;
4. Quality of lifetransition scale;
5. Tolerability; 6. Convenience; 7. Expectation confirmation
toward efficacy; 8.
Expectation confirmation toward side
effects; 9. Expectation confirmation
toward convenience;
10. Satisfaction
with treatment; 11.
Motivation

Domains© Professor C Bradley© Professor C Bradley© Abbott France, 2011.
All rights reserved

Copyright

Yang et al. BMC Medicine(2024) 22:347
Page 9 of 36

GHerpTSQ [111](English version)

HCVTSat [112](English version)

25

26

TSS-IOP [113](English version)

RetTSQs [114–116](English, German,
and Serbian version)27

28

Diseases of the visual system

ESTAR [110](Spanish version)

24

PROM
(language version)

Table 1 (continued)

AdultsAdults2004, UK, Germany

AdultsAdultsAdultsTarget population

2003, USA2013, USA2006, Canada

2007, Spain

Year and countryof development

Diabetic retinopathy

Primary open-angle
glaucoma or ocular
hypertension

Chronic hepatitis C
virus infection

Genital herpes

Human immunodeficiency virus infection

Target disease/drug

Self-report

Self-report

Self-report

Self-report

Self-report

Administration

Not specified

Not specified

Not specified

Not specified

Past 4 weeks

Recall period

NR

NR

12

12

7-point Likert scaleNR

6-point Likert scale

10

15

Response options

Numberof items

26
1. Household tasks;
2. Personal affairs; 3.
Shopping; 4. Feelings future; 5. Feelings past; 6. Working
life; 7. Close personal
relationship; 8.
Family life; 9. Social
life; 10. Do thingsfor others; 11. Get
out and about; 12.
Journeys; 13. Holidays; 14. Finances;
15. People react; 16.
Physical appearance; 17. Physicallydo; 18. Leisure; 19.
Hobbies/interests;
20. Self-confidence;
21. Motivation; 22.
Dependence; 23.
Mishaps/losses;
24. Time; 25. Careof diabetes; 26. Enjoy
nature1. Eye irritation; 2.
Convenience of use;
3. Ease of use; 4.
Hyperemia; 5. Medication effectiveness1. Treatment experience; 2. Side effects;
3. Social aspects

1. Satisfied; 2.
Controlled; 3. Side
effects; 4. Convenience; 5. Flexibility;
6. Understanding;
7. Demanding; 8.
Lifestyle; 9. Recommend to others; 10.
Continue; 11. Effectiveness; 12. Effects
on quality of life

1. Clinical satisfaction; 2. Satisfaction
with lifestyle

Domains© Professor C Bradley© 2003, Cronos ClinicalConsulting Services,an IQVIA businessNo information© Professor Clare
Bradley

No information

Copyright

Yang et al. BMC Medicine(2024) 22:347
Page 10 of 36

MacTSQ [120, 121]
(English and Greek
version)2018, UK

2010, Spain
Patient satisfaction
with glaucoma treatment [119](Spanish version)

Year and countryof development

DermaSat [123](Spanish version)

AdultsNR

AdultsAdultsTarget population

33

OPSAT-Q [124](English version)

2006, USA

Adults

Diseases of the musculoskeletal system or connective tissue

32

2010, Spain

1999, USA
Patient satisfaction
with treatmentof otitis externa [122](English version)

Diseases of the skin31

Diseases of the ear or mastoid process

30

29

PROM
(language version)

Table 1 (continued)

Osteoporosis
with bisphosphonate
treatments

Eczema (dermatitis)
affecting the hands

Otitis externa

Macular degeneration

GlaucomaTarget disease/drug

Self-report

Self-report

Self-report

Self-report

Self-report

Administration

Not specified

Not specified

Not specified

Not specified

Not specified

Recall period

1. Convenience;
2. Confidencewith daily activities;
3. Side effects; 4.
Overall satisfaction

16

17
1. Effectiveness; 2.
Convenience; 3.
Impact on healthrelated quality of life;
4. Medical follow-up;
5. Side effects; 6.
General opinion

4-point Likert scale

5-point Likert scale

7-point Likert scale

5-point Likert scale

5-point Likert scale

22

14

Response options

Numberof items

22
1. Information; 2.
Ease of administration; 3. Side effects;
4. Relief of symptoms; 5. Medical carein general; 6. Cost;
7. Functioning; 8.
Overall satisfaction

NR

1. Expectations and beliefs
about treatment; 2.
Ease of use; 3. Efficacy; 4. Undesired
effects; 5. Impact
on health-related
quality of life; 6.
Medical care; 7.
General satisfaction
with treatment

Domains© 2005 Roche Laboratories, Inc. All Rights
Reserved

No information

No information© Professor C Bradley

No information

Copyright

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Page 11 of 36

Year and countryof development

OAB-S [125](English version)

2008, USA2004, Germany
TSS [129, 130]
(English, French,and German version)

36

1999, USAEDITS [128](English version)

35

Conditions related to sexual health34

Diseases of the genitourinary system

PROM(language version)

Table 1 (continued)

AdultsAdultsAdultsTarget population

Erectile dysfunction

Erectile dysfunction

Prostatic hyperplasia,
overactive urinary
bladder

Target disease/drug

Self-report

Self-report

Self-report

Administration

Past 4 weeks

Past 4 weeks

Past 1 week

Recall period

Numberof items

5-point Likert scale

5-point Likert scaleNR
1. Satisfaction
with medication;
2. Ease with erection; 3. Satisfaction with erectile
function; 4. Pleasurefrom sexual activity; 5. Satisfaction
with orgasm; 6.
Sexual confidence(for patients) or Confidence in completion (for partners)

4- to 6-point Likert
scale

Response options

11

NR

41
1. Overactive bladder (OAB) control
expectations; 2.
Impact on dailyliving with OAB; 3.
OAB control; 4. OAB
medication tolerability; 5. Satisfaction
with OAB control; 6.
Fulfillment of OAB
medication expectations; 7. Interruption of day-to-day
life due to OAB; 8.
Overall satisfaction
with OAB medication; 9. Willingness
to continue OAB
medication; 10.
Improved life
with OAB medication

Domains© Bayer Schering
Pharma AG© 1999, Cronos ClinicalConsulting Services,an IQVIA business© 2005, Cronos ClinicalConsulting Services,an IQVIA business

Copyright

Yang et al. BMC Medicine(2024) 22:347
Page 12 of 36

Year and countryof development

DTTQ [45](English version)

2008, USASOADAS [46, 47](English and Chineseversion)

DM-SAT [48](English version)

40

41

42

2009, USA2007, UK

AdultsAdultsAdultsAdults2006, USA

DiabMedSat [44](English version)

39

AdultsAdultsTarget population

2004, USAITSQ [42, 43](English version)

38

2000, USAPSIT [41](English version)

37

A10 drugs used in diabetes

Drug-specific PROMs for M-TS b

PROM(language version)

Table 1 (continued)

Diabetes medication

Oral anti-diabetic
agentsDiabetes tablet

Diabetes medication

Insulin for diabetes
mellitus

Insulin for diabetes
mellitus

Target disease/drug

Self-report

Self-report

Self-report

Self-report

Self-report

Self-report

Administration

Past 4 weeks

Past 4 weeks

Past 2 weeks

Past 2 weeks

Past 4 weeks

Past 12 weeks

Recall period

1. Life style; 2.
Convenience; 3.
Glucose control; 4.
Well-beingNR

5-point Likert scale

10-point Likert scale

616

6-point Likert scale

1. Tablet-taking
as recommended; 2.
Tablet difficulty; 3.
Tablet side effects; 4.
Perceived hyperglycemia; 5. Perceived
hypoglycemia; 6.
Tablet continue

7

7-point Likert scale

22

5- to 7-point Likert
scale

5-point Likert scale

Response options

15

Numberof items

1. Burden; 2. Efficacy; 23
3. Symptoms

1. Inconvenienceof regimen; 2.
Lifestyle flexibility;
3. Glycemic control;
4. Hypoglycemic
control; 5. Insulindelivery device
satisfaction

1. Convenienceand ease of use; 2.
Social comfort

Domains© 2022 Merck & Co.,
Inc., Rahway, NJ, USA
and its affiliates. All
rights reserved© 2006 GlaxoSmithKline. All rights
reserved

No information© Novo Nordisk June
2004

© Novo Nordisk, 2004,
All rights reserved© 1996 Pfizer Inc. All
rights reserved

Copyright

Yang et al. BMC Medicine(2024) 22:347
Page 13 of 36

PAM-D [49](English version)

PRAM-TSQ [50](English version)

OHA-Q [52](Japanese version)DMSRQ [53](English version)

43

44

45

46

PROM
(language version)

Table 1 (continued)

2012, USA2012, Japan

2009, USA2009, USAYear and countryof development

AdultsAdultsAdultsAdultsTarget population

Diabetes medication

Oral hypoglycemic
agent for type 2
diabetes

Type 1 or type 2
diabetes using pramlintide as adjunctive
therapy with insulin

Diabetes medication

Target disease/drug

Not specified

Self-report

Not specified

Past 2 weeks

Self-report

Self-report

Past month

Recall period

Self-report

Administration

Numberof items

NR
1. Convenience; 2.
Negative events;
3. Interference; 4.
Self-monitoringof blood glucose
burden; 5. Efficacy;
6. Social burden; 7.
Psychological wellbeing; 8. Treatment
satisfaction; 9. Treatment preference54

6-point Likert scale

NR

14

NR

Response options

20
1. Treatment
convenience; 2.
Somatic symptom; 3.
Satisfaction

1. Specific benefits;
2. Absence of side
effects; 3. Global
benefits; 4. Treatment preference37
1. Scheduling flexibility; 2. Portability
convenience; 3. Regimen inconvenience;
4. Medication effectiveness (perceived
effectiveness); 5.
Difficulty remembering medications; 6.
Gastrointestinal side
effects; 7. Hypoglycemia-related side
effects; 8. Weight/
edema side effects;
9. Emotional side
effects

Domains© Mark Peyrot
and Richard R. Rubin© Dr. Hitoshi Ishii. All
rights reserved

No information

No information

Copyright

Yang et al. BMC Medicine(2024) 22:347
Page 14 of 36

DMSRQ-SF [54](English version)

PACT-Q [63, 66](English and Maltese
version)

ACTS [34, 68–73](English, Spanish,
Danish, Japanese,
Arabic, and Chineseversion)

49

50

51

SQ-ISHI [136](English version)

B02 antihemorrhagics

DASS [61–65](English, Brazilian–Portuguese, Maltese,
Arabic, and Chineseversion)48

B01 antithrombotic agents

47

PROM
(language version)

Table 1 (continued)

Adults2012, UK

Children, teens
and adults

Adults2009, USA, France,
Netherlands

2021, USA

AdultsAdultsTarget population

2004, USA2014, USAYear and countryof development
Self-report

Administration

Emicizumab
for hemophilia A

Anticlot treatment

Self-report

Self-report

Anticoagulation drugs Self-report

Anticoagulation drugs Self-report

Diabetes medication

Target disease/drug

Not specified

Past 4 weeks

Not specified

Not specified

Not specified

Recall period

1. Treatment’s easeof administration;
2. Convenience; 3.
Influence on daily
life; 4. Participant’s
confidence and satisfaction

11-point Likert scale

4-point Likert scale

17
1. Burdens; 2.
Benefits; 3. Global
satisfaction

15

5-point Likert scale
1. Convenience; 2.
Burden of disease
and treatment; 3.
Anticoagulant treatment satisfaction

20

NR

19

5-point Likert scale

Response options

Numberof items

25
1. Limitations
on physical exercise;
2. Diet restrictions; 3.
Hassles and burdens;
4. Positive impacts

1. Conveniencesatisfaction; 2.
Negative events;
3. Interference; 4.
Self-monitoringof blood glucose
burden; 5. Efficacy;
6. Social burden; 7.
Psychological wellbeing; 8. Treatment
satisfaction; 9. Treatment preference
if the respondent
previously used
another diabetes
medication regimen

Domains© 2016, Roche Products Limited. All Rights
Reserved© Bayer AG, 2006. All
Rights Reserved© 2007 Sanofi-Aventis,
France. All rights
reserved

No information

No information

Copyright

Yang et al. BMC Medicine(2024) 22:347
Page 15 of 36

ICT-sat [135](English version)

53

2012, Egypt

2009, USA, UK

Year and countryof development

SSQ [133](English version)

RASQ [95](English version)

56

PESaM [126, 127]
(English and Dutch
version)L04 immunosuppressants55

L01 antineoplastic agents54

2017, Netherlands

2016, USA2017, USA

H02 corticosteroids for systemic use

SICT [134](English version)

52

B03 antianemic preparations

PROM(language version)

Table 1 (continued)

AdultsAdultsAdultsChildren, teens
and adults

Children, teens
and adults

Target population

Pirfenidone (for idiopathic pulmonary
fibrosis) and eculizumab (for atypicalhemolytic uremic
syndrome)

Rituximab for nonHodgkin lymphoma

Steroid for systemic
lupus erythematosus

Iron chelation
therapy for patientswith β-thalassemia
major

Iron chelation therapy

Target disease/drug

Interview-basedInterview-based

Past 4 weeks

Most recent injection

Past 7 days

Past 4 weeks

Self-report and parent/proxy report

Self-report

Not specified

Recall period

Self-report and parent/proxy report

Administration

1. Effectiveness; 2.
Side effects; 3. Easeof use; 4. Overallsatisfaction

16

1. Treatment satisfac- 15
tion; 2. Convenience;
3. Physical impact;
4. Psychologicalimpact; 5. Impact
on activities of dailyliving1. Steroid dose/
duration; 2. Generalimpact of steroids; 3.
Benefits of steroids;
4. Work/productivity; 5. Side effects; 6.
Emotions; 7. Overallsatisfaction

44

5-point Likert scale

3-point or 5-point
Likert scale

11-point Likert scale

5-point Likert scale

1. Perceived
effectiveness; 2. Fear
and worries; 3. Burden; 4. Side effects

15

Response options

5-point Likert scale

Numberof items

28
1. Effectiveness; 2.
Safety/side effects;
3. Convenience;
4. Costs; 5. Overallsatisfaction; 6.
Impact on daily life;
7. Patient adherence;
8. Preferences

Domains

Instrument copyrighted by the MUMC
(Maastricht University
Medical Centre)© 2013, Roche Products Limited. All Rights
Reserved© 2017 GlaxoSmithKline. All rights
reserved

No information

No information

Copyright

Yang et al. BMC Medicine(2024) 22:347
Page 16 of 36

TASQ [137](English version)

SPM [84](Spanish version)

2004, Spain

2021, UK

Year and countryof development

SWAM Scale® [101](English version)

PASAP [103](French version)

MSQ [104, 105](English version)

60

61

62

2014, USA2005, France

2005, UK

2015, France
Patient satisfaction
with antiepileptic
drugs/epilepsy treatment [89](French version)

N05 psycholeptics

59

N03 antiepileptics

58

N02 analgesics

57

PROM
(language version)

Table 1 (continued)

AdultsAdultsTeens and adults

AdultsAdultsAdultsTarget population

Self-report

Atypical antipsychotics

Psychotropics

Self-report

Self-report

Not specified

Not specified

Not specified

Not specified

Not specified

Not specified

Interview-based

Self-report

Recall period

Administration

Antipsychotic medica- Self-reporttion

Antiepileptic drugs

Pain medication

Eculizumab for rareparoxysmal nocturnal
hemoglobinuria

Target disease/drug

Numberof items

NR

1. Efficacy; 2. Tolerability; 3. Convenience; 4. Therapeutic
relationship; 5.
Global satisfaction

1. Treatment acceptability; 2. Medication
insight

NR

1. Speed/durationof effect; 2. Adverse
events; 3. Functional
benefit; 4. Overallsatisfaction

6-point Likert scale

5-point Likert scale

910

5-point Likert scale

4-point Likert scale,
10-cmr VAS

5-point Likert scale

5-point Likert scale

Response options

23

4

10

1. Treatment satisfac- 12
tion; 2. Convenience;
3. Physical impact;
4. Psychologicalimpact; 5. Impact
on activities of dailyliving

Domains© Instrument copyrighted by the International Society for CNS
Drug Development(ISCDD)© Boehringer
Ingelheim holdthe copyright© 2001—2007, Diana
Rofail. All Rights
Reserved

No information

No information

No information

Copyright

Yang et al. BMC Medicine(2024) 22:347
Page 17 of 36

SAMS [102](German version)

2011, Germany

Year and countryof development

SASMAT-BUNHER[107](Spanish version)

65

Adults2014, Spain

66

PSAM [74](English version)

2000, Canada

AdultsAdultsChildren and teens

Target population

1999, Spain

R03 drugs for obstructive airway diseases

SASMAT-METHER[106](Spanish version)64

N07 other nervous system drugs

63

N06 psychoanaleptics

PROM(language version)

Table 1 (continued)
Administration

Asthma medication

Buprenorphine-naloxone sublingual tablets
treatment for heroin
addiction

Methadone treatment
for heroin-dependence

Past 2 weeks

Not specified

Self-report

Self-report

Not specified

Not specified

Recall period

Self-report

Medication for atten- Self-report and partion deficit hyperactiv- ent/proxy report
ity disorder

Target disease/drug

NR

1. Overall satisfaction; 2. Pharmacotherapy; 3. Initiation;
4. Anti-addictive
effect on main
substance; 5. Mental
state; 6. Physicalstate; 7. Personalfunctioning; 8.
Acceptability; 9.
Anti-addictive
effect on secondary
substances

1. Overall satisfaction; 2. Pharmacotherapy; 3. Initiation;
4. Anti-addictive
effect on main
substance; 5. Mental
state; 6. Physicalstate; 7. Personalfunctioning; 8.
Acceptability; 9.
Anti-addictive
effect on secondary
substances

NR

DomainsNR

5-point Likert scale

44

77

5-point Likert scale

6-point Likert scale

Response options

44

13

Numberof items

No information

No information

No information

No information

Copyright

Yang et al. BMC Medicine(2024) 22:347
Page 18 of 36

EDSQ [117, 118]
(English and French
version)ESPIA [131, 132]
(English and Spanish
version)2011, Spain

2007, FranceYear and countryof development

2022, IranAdultsTraditional medicines
treatment

Allergen immunotherapy

Eye-drop for glaucoma

Target disease/drug

Self-report

Self-report

Interview-based

Administration

Not specified

Not specified

Not specified

Recall period

The classification of PROMs is based on the International Classification of Diseases 11th (ICD-11) Revision (https://​icd.​who.​int/​en)

TSTMQ [138](Persian version)

AdultsAdultsTarget population

Numberof items

1. Satisfaction
with efficacy;
2. Satisfaction
with convenience; 3.
Overall satisfaction

14

1. Perceived efficacy; 16
2. Daily life activities/
activities and environment; 3. Cost–
benefit balance; 4.
General satisfaction

1. Patient character- 56
istics; 2. Treatment
characteristics; 3.
Patient-clinician
relationship; 4.
Patient experience
with the disease
and the treatment;
5. Interaction
between the patient
and the treatment; 6.
Patient knowledgeof the disease
and the treatment

Domains5-point Likert scale

5-point Likert scale

Likert scale

Response options

No information

No information© Alcon Research,
2006. All rights
reserved

Copyright

The classification of PROMs is based on the Anatomical Therapeutic Chemical Classification System (ATC) 2nd level—pharmacological or therapeutic subgroup (https://​www.​who.​int/​tools/​atc-​ddd-​toolk​it/​atc-​class​ifica​tion)

b

a

69

Not applicable to ATC classification

68

V01 allergens

67

S01 ophthalmologicals

PROM(language version)

Table 1 (continued)

Yang et al. BMC Medicine(2024) 22:347
Page 19 of 36

Doubtful

Doubtful

Sufficient

Low
High

Sufficient
Inconsistent

Low
Low

SufficientSufficient

Low
Low

Sufficient
Inconsistent

Moderate

Low

GRADE

Doubtful

Doubtful

CTSQ

Inadequate

Doubtful

Inadequate

Doubtful

Doubtful

Doubtful

Inadequate

Doubtful

Inadequate

Inadequate

Doubtful

Doubtful

Doubtful

Doubtful

Doubtful

Doubtful

Inadequate

Doubtful

Doubtful

Doubtful

Doubtful

Doubtful

Doubtful

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Sufficient

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Sufficient

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Sufficient

Low

Low

Low

Low

Low

Moderate

Low

Low

Moderate

Low

Low

Low

Low

Low

Low

Low

Low

Low

Low

Low

Low

Moderate

Sufficient

Inconsistent

Inconsistent

SufficientSufficientSufficientInsufficientInsufficientSufficientInsufficientInsufficientInsufficientSufficientInsufficientInsufficientSufficientSufficientInsufficientSufficientSufficientSufficientSufficient

Low

Very low

Very low

Low

Low

Low

Low

Low

Moderate

Low

Low

Low

Low

Low

Low

Low

Low

Low

Low

Low

Low

Low

Sufficient

Inconsistent

Inconsistent

SufficientSufficient

Inconsistent

Sufficient

Inconsistent

Sufficient

Inconsistent

SufficientSufficientSufficient

Inconsistent

SufficientInsufficientSufficientSufficientSufficientSufficient

Inconsistent

Sufficient

Low

Very low

Very low

Low

Moderate

Very low

Low

Low

Moderate

Low

Low

Low

Low

Low

Low

Very low

Low

Low

Low

Low

Low

Low

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Sufficient

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Sufficient

Low

Very low

Very low

Low

Moderate

Moderate

Low

Low

Moderate

Low

Low

Low

Low

Low

Low

Very low

Low

Low

Low

Low

Low

Moderate(2024) 22:347

Doubtful

Doubtful

Doubtful

ESTAR​

GHerpTSQ

Doubtful
Doubtful

Doubtful

Doubtful

HIVTSQs

HIVTSQc

Certain infectious or parasitic diseases

Inadequate

Doubtful

Doubtful

TSQ-C

SPACE-Q

Doubtful

Doubtful

Doubtful

Doubtful

TSQ-G

Inadequate

Inadequate

Doubtful

GTSQ

Diseases of the digestive system

Doubtful

Doubtful

Doubtful

Neoplasms

MSTCQ

Doubtful

Doubtful

Doubtful

MTSM

PTSS

Doubtful

Doubtful

Doubtful

PPMQ

Doubtful

Doubtful

PPMQ-R

Diseases of the nervous system

Doubtful

Doubtful

SATQ

PASAPQ

Diseases of the respiratory system
Inadequate

Doubtful
Doubtful

Doubtful

Doubtful

ThyTSQ

MS-TSQ

Acro-TSQ

Doubtful

Doubtful

Doubtful

DTSQ-IP

Doubtful

Doubtful

DIDS

Endocrine, nutritional, or metabolic diseases

Disease-specific PROMs for M-TS a

Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed

Sufficient

RatingDoubtful

Doubtful

GRADE

Overall

TSQM-9Doubtful

RatingComprehensibility

SATMED-Q

Doubtful

Doubtful

TSQM-1.4

GRADE

RatingRatingGRADE

Comprehensiveness

Relevance

Overall

DesignPilot study

Content validity

PROM development

TSQM-II

Generic PROMs for M-TS

PROM

Table 2 Development and content validity of PROMs for medication treatment satisfaction

Yang et al. BMC Medicine
Page 20 of 36

Adequate

Doubtful

Doubtful

Low

Inconsistent

Low

Doubtful

Doubtful
Doubtful

Inconsistent
Inconsistent

Low
Low

SufficientSufficient

Low
Low

SufficientSufficient

Low
Low

Inconsistent
Inconsistent

Low
Low

(2024) 22:347

Doubtful

Doubtful

InconsistentDMSRQ-SF

Low

Low
Low

Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed

Sufficient

Inconsistent
Inconsistent

Doubtful

Low

Low
Moderate

OHA-Q

SufficientSufficient
Inconsistent

DMSRQDoubtful

Moderate

Low

Doubtful

InsufficientSufficient

Low

Doubtful

Low
Low

Inconsistent

Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed

Inconsistent
Inconsistent

Low

PAM-D

Doubtful
Doubtful

Inconsistent

Low

Low

Moderate

Low

Low

Low

Moderate

Low

Low

Low

PRAM-TSQ

Doubtful

Very low

Sufficient

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Sufficient

Inconsistent

Inconsistent

Inconsistent

Low
Low

Doubtful

Sufficient

Low

Low

Moderate

Low

Low

Low

Low

Low

Low

Low

Inconsistent
Inconsistent

Low

Doubtful

Low

Sufficient

Inconsistent

Sufficient

Inconsistent

SufficientSufficientSufficientSufficientSufficientSufficient

Low
Moderate

Inconsistent

Doubtful

Inconsistent

Very low

Low

Low

Low

Low

Low

Moderate

Low

Low

Low

InsufficientSufficient

Moderate

SOADAS

Doubtful

SufficientInsufficientSufficient

Inconsistent

SufficientSufficientSufficientSufficientSufficientSufficient

Low
Low

Sufficient

DM-SAT

Doubtful

Low

Low

Moderate

High

Low

Low

Moderate

Low

Low

Low

SufficientSufficient

Low

GRADE

Doubtful

Sufficient

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Sufficient

Inconsistent

Inconsistent

Inconsistent

Low
Low

Sufficient

RatingNot assessed Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed Not assessed

Doubtful

Doubtful

Doubtful

Inadequate

Doubtful

Doubtful

Doubtful

Doubtful

Doubtful

Doubtful

Inconsistent
Inconsistent

High

GRADE

Overall

DiabMedSat

Doubtful

Doubtful

Doubtful

Inadequate

Doubtful

Doubtful

Doubtful
Doubtful

Inconsistent

RatingComprehensibility

DTTQ

Doubtful

Adequate

PSIT

ITSQ

A10 drugs used in diabetes

Drug-specific PROMs for M-TS b

Doubtful

Doubtful

EDITS

Doubtful

Doubtful

TSS

Conditions related to sexual health

OAB-S

Diseases of the genitourinary system

OPSAT-Q

Diseases of the musculoskeletal system or connective tissue

DermaSat

Diseases of the skin

Patient satisfaction with treatmentof otitis externa

Doubtful

Doubtful

Doubtful

Diseases of the ear or mastoid process

MacTSQ

Doubtful

DoubtfulPatient satisfaction with glaucoma
treatment

Doubtful
Doubtful

Doubtful

DoubtfulTSS-IOP

Doubtful

Doubtful

Doubtful

GRADE

RatingRatingGRADE

Comprehensiveness

Relevance

Pilot study

DesignOverallContent validity

PROM development

RetTSQs

Diseases of the visual system

HCVTSat

PROM

Table 2 (continued)

Yang et al. BMC Medicine
Page 21 of 36

SQ-ISHI

Inconsistentsufficient

Inconsistent

Doubtful

MSQ

SAMS

PSAM

Doubtful

Doubtful

Doubtful

Inadequate

Inadequate

Inadequate

Doubtful

Doubtful

Doubtful

Doubtful

Doubtful

Doubtful

Inadequate

Inadequate

Inadequate

Doubtful

Doubtful

Doubtful

Doubtful

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Sufficient

Inconsistent

Inconsistent

Inconsistent

Low

Moderate

Low

Low

Low

Low

Moderate

Moderate

Low

Low

Moderate

Moderate

low

Low

Low

Low

High

Moderate

Low

SufficientSufficientSufficientSufficientInsufficientInsufficientSufficientSufficientInsufficientInsufficientInsufficientSufficientsufficientSufficientSufficientSufficientSufficientSufficientSufficient

Low

Low

Low

Very low

Very low

Very low

Low

Low

Low

Low

Very lowLow

moderate

Low

Low

Low

Low

Low

Low

SufficientSufficient

Inconsistent

Inconsistent

Inconsistent

SufficientSufficient

Inconsistent

InsufficientSufficientSufficientsufficientSufficientSufficient

Inconsistent

SufficientSufficientSufficientSufficient

RatingModerate

Low

Very low

Very low

Very low

Moderate

Low

Low

Low

Moderate

Moderate

moderate

Moderate

Low

Low

Moderate

Low

Moderate

Low

GRADE

Comprehensibility

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Sufficient

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistentsufficient

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Sufficient

RatingOverall

Moderate

Low

Very low

Very low

Very low

Moderate

Moderate

Low

Low

Moderate

Moderate

moderate

Low

Low

Low

Moderate

Moderate

Moderate

Low

GRADE

(2024) 22:347

R03 drugs for obstructive airway diseases

Doubtful

Doubtful

SASMAT-METHERSASMAT-BUNHER

N07 other nervous system drugs

Doubtful

Doubtful

PASAP

N06 psychoanaleptics

Doubtful

Doubtful

SWAM Scale ®

N05 psycholeptics

Patient satisfaction with antiepilep- Doubtful
tic Drugs/epilepsy treatment

N03 antiepileptics

SPM

N02 analgesics

Doubtful

Doubtful

doubtful

Doubtful

Inconsistent

Inconsistent

Inconsistent

Inconsistent

Not assessed Not assessed Not assessed Inconsistent

Doubtful

doubtful

Adequate

Doubtful

Doubtful

Doubtful

Doubtful

Sufficient
Inconsistent

PESaM

doubtful

Doubtful

Doubtful

Doubtful

Doubtful

Doubtful
Doubtful

TASQ

L04 immunosuppressants

RASQ

L01 antineoplastic agentsSSQ

H02 corticosteroids for systemic use

Doubtful

Doubtful

SICT

ICT-sat

B03 antianemic preparations

Doubtful

Doubtful

B02 antihemorrhagics

ACTS

Doubtful

Doubtful
Doubtful

Doubtful

Doubtful

DASS

GRADE

RatingRatingGRADE

Comprehensiveness

Relevance

Overall

DesignPilot study

Content validity

PROM development

PACT-Q

B01 antithrombotic agents

PROM

Table 2 (continued)

Yang et al. BMC Medicine
Page 22 of 36

Doubtful

Doubtful

Doubtful

Doubtful

Doubtful

Doubtful

Inconsistent

Inconsistent

Inconsistent

Moderate

Moderate

Low

InsufficientInsufficientSufficient

The classification of PROMs is based on the International Classification of Diseases 11th (ICD-11) Revision (https://​icd.​who.​int/​en)Doubtful

Doubtful

Adequate

Low

Low

Low

GRADE

RatingRatingGRADE

Comprehensiveness

Relevance

Overall

DesignPilot study

Content validity

PROM development

Sufficient

Inconsistent

Sufficient

Rating

Low

Low

Low

GRADE

Comprehensibility

Inconsistent

Inconsistent

Inconsistent

RatingOverallLow

Moderate

Low

GRADE

The classification of PROMs is based on the Anatomical Therapeutic Chemical Classification System (ATC) 2nd level – pharmacological or therapeutic subgroup (https://​www.​who.​int/​tools/​atc-​ddd-​toolk​it/​atc-​class​ifica​
tion)

b

a

TSTMQ [138]Not applicable to ATC classification

ESPIA

V01 allergens

EDSQ

S01 ophthalmologicals

PROM

Table 2 (continued)

Yang et al. BMC Medicine(2024) 22:347
Page 23 of 36

Yang et al. BMC Medicine(2024) 22:347

Page 24 of 36

Fig. 2 The concept, component and influence factors of medication treatment satisfaction from current conceptual frameworks

The others did not report or meet the criteria for structural validity (Table 3 and Additional file 1: table S6[25–138]) [19, 20]. Among 56 PROMs that reported
construct validity, 39 had sufficient convergent validity(e.g., correlations with instruments measuring similar
constructs ≥ 0.50) (39/44, 89%; 38/39, high to moderate;
1/39, low quality of evidence) and 43 had sufficient discriminative or known-groups validity (e.g., correlations
with instruments measuring unrelated construct < 0.30)(42/45, 93%; 41/43, high to moderate; 2/42, low quality ofevidence).
Among 63 PROMs that reported internal consistency,
11 PROMs demonstrated sufficient (i.e., Cronbach’s
alpha(s) ≥ 0.70 and at least low evidence for sufficient
structural validity) (11/63, 17%, high quality of evidence).
Thirty-eight PROMs reported test–retest reliability, of
which 24 had sufficient test–retest reliability (i.e., ICC
and weighted Kappa ≥ 0.70) (24/38, 63%; 18/24, high tomoderate; 6/24, low to very low quality of evidence). The
others did not report or meet the criteria for test–retest
reliability.
Sixteen PROMs reported responsiveness, of which six
drug or disease-specific PROMs demonstrated sufficient(e.g., area under the ROC Curve (AUC) ≥ 0.7). No generic
PROMs had sufficient responsiveness.
Four PROMs for M-TS [60, 78, 80, 87] proposed theminimal important difference (MID) (Additional file 1:

table S7 [25–138]). Four PROMs demonstrated normally distributed scores in the study population while 11
PROMs showed negatively or positively skewed scores.
Thirty-two PROMs for M-TS reported floor or ceiling
effects.
PROMs for M‑TS with sufficient validity and reliability

One drug-specific PROM (Insulin Treatment Satisfaction Questionnaire, ITSQ) [42, 43] demonstrated sufficient construct validity, internal consistency, test–retest
reliability and responsiveness (high to moderate qualityof evidence), and content validity (low quality evidence).
Two generic PROMs (TSQM-1.4 [25–29] and SATMEDQ) [31, 37–40] demonstrated sufficient construct validity,
structural validity, and internal consistency (high qualityof evidence) and content validity (moderate to low quality of evidence), but lack of evidence on test–retest reliability or responsiveness.

Discussion
Summary of findings

This review systematically searched and evaluated current PROMs for M-TS. Over 85% of the PROMs targeted
adult patients. Most PROMs demonstrated sufficientconstruct validity including convergent validity (39/69,
57%) and discriminative or known-groups validity (40/69,
58%) (high to moderate quality of evidence) but failed

High

CTSQ

Sufficient

Not assessed

Indeterminate ΝΑ

ESTAR​

Not assessed
Sufficient

Moderate Not assessed

Indeterminate ΝΑInsufficient

HIVTSQs

Not assessed

Sufficient

Not assessed

Sufficient

High

High

High

High

High

High

High

Sufficient

Not assessed

SufficientSufficientSufficientSufficientSufficientSufficientSufficient

Not assessed

SufficientSufficientSufficientSufficientSufficient

High

High
High

Sufficient

High

High

Indeterminate ΝΑIndeterminate ΝΑIndeterminate ΝΑIndeterminate ΝΑIndeterminate ΝΑ

Sufficient

Indeterminate ΝΑIndeterminate NA

Indeterminate NA

Sufficient

Indeterminate NA

Indeterminate NA

Indeterminate NA

High

Indeterminate NA

Indeterminate NA

Indeterminate ΝΑModerate Indeterminate ΝΑ

High

High

High

High

High

High

High

High

High

High

High

High
High

Not assessed

Low

High

Very low

High

High

Low

Sufficient

Not assessed

Not assessed
Very low

Indeterminate ΝΑ

Not assessed

Not assessed

Indeterminate ΝΑIndeterminate ΝΑInsufficient

Not assessed

Not assessed

RatingHigh

Not assessed

Not assessed

Not assessed

Indeterminate ΝΑ

Not assessed

Not assessed

Not assessed

Not assessed

Not assessed

Indeterminate NA

Sufficient

Indeterminate NA

Indeterminate NA

Indeterminate NA

Not assessed

Indeterminate NA

Not assessed

Not assessed

Not assessed

Not assessed

Indeterminate NA

GRADEResponsiveness b

Moderate Not assessedHigh

Indeterminate NA

Not assessed

Sufficient

Not assessed

Not assessed

SufficientSufficient

Not assessed

Not assessed

Insufficient

Not assessed

SufficientSufficientSufficient

GRADE

Test–retest reliability

GRADE Rating

Indeterminate NA

SufficientSufficientSufficientSufficient

RatingModerate Not assessed

High

High

High

High

Low

High

GRADE

Internal consistency(2024) 22:347

HIVTSQc

Certain infectious or parasitic diseases

SPACE-Q

Indeterminate

Indeterminate ΝΑ

TSQ-C

Sufficient

Indeterminate ΝΑ

Not assessed

TSQ-G

Sufficient

Moderate SufficientSufficient

GTSQ

Diseases of the digestive system

SufficientSufficient

Indeterminate ΝΑNeoplasms

MSTCQ

Indeterminate NA

Indeterminate ΝΑIndeterminate ΝΑ

MTSM

High

PTSS

Sufficient

Indeterminate ΝΑ

High

High

SufficientHigh

SufficientSufficient

Moderate Sufficient

High

PPMQ

Sufficient

Not assessed

SufficientSufficientSufficient

RatingDiscriminative or
known‐groups validity

Moderate Insufficient

High

GRADE

PPMQ-R

Diseases of the nervous system

Indeterminate ΝΑIndeterminate ΝΑ

SATQ

Indeterminate NA

PASAPQ

Diseases of the respiratory system

Acro-TSQ

Not assessed
Not assessed

Indeterminate NA

Sufficient

ThyTSQ

MS-TSQHigh

Not assessed

Indeterminate ΝΑIndeterminate ΝΑDTSQ-IPNot assessed

SufficientSufficientSufficientSufficient

RatingConvergent validity

Construct ­validityb

DIDS

Endocrine, nutritional, or metabolic diseases

Disease-specific PROMs for M-TS dHigh

SufficientSufficient

TSQM-9SATMED-Q

High

High

SufficientSufficient

High

GRADE

TSQM-1.4

RatingStructural validity

TSQM-II

Generic PROMs for M-TS

PROM

Table 3 Measurement ­propertiesa of PROMs for medication treatment satisfaction

Yang et al. BMC Medicine
Page 25 of 36

Sufficient

Not assessed

OPSAT-Q

Not assessed
Not assessed

Indeterminate NA

Indeterminate ΝΑIndeterminate ΝΑIndeterminate ΝΑIndeterminate ΝΑDM-SAT

PAM-D

PRAM-TSQ

OHA-Q

Not assessed

Indeterminate ΝΑDTTQ

SOADAS

Sufficient

Not assessed

Not assessed

Rating

SufficientSufficientSufficientSufficientSufficient

Not assessed

Not assessed

SufficientSufficientSufficient

Not assessed

Not assessed

Not assessed

Not assessedHigh

SufficientInsufficientSufficient

Moderate Sufficient

High

High

High

High

High

High

High

High

High

High

Moderate Sufficient

GRADE

High

High

Indeterminate ΝΑIndeterminate ΝΑIndeterminate ΝΑInsufficient

Indeterminate ΝΑIndeterminate ΝΑ

Sufficient

Indeterminate ΝΑIndeterminate ΝΑIndeterminate ΝΑHigh

Indeterminate ΝΑIndeterminate NA

Indeterminate ΝΑ

Sufficient

High

High

High

Indeterminate ΝΑIndeterminate ΝΑIndeterminate ΝΑModerate Indeterminate ΝΑ

High

High

High

High

Moderate Indeterminate ΝΑHigh

Not assessed

Sufficient

Not assessed

Sufficient

Not assessed

Sufficient

Not assessed

Not assessed

SufficientInsufficient

Not assessed

SufficientSufficient

Not assessed

Not assessed

Not assessed

Sufficient

Not assessed

RatingNot assessed

Not assessed

Sufficient

Not assessed

Not assessed

Not assessed

Not assessed

Not assessed

Moderate Not assessed

Low

High

Not assessed

Moderate Sufficient

Low

Low

Moderate

High

Moderate Indeterminate ΝΑ

Not assessed

Not assessed

Not assessed

High

GRADE

Responsiveness b

Moderate Not assessedHigh

Indeterminate ΝΑ

Not assessed

Not assessed

Sufficient

Not assessed

Sufficient

Indeterminate ΝΑ

Not assessed

GRADE

Test–retest reliability

GRADE Rating

Indeterminate ΝΑRatingModerate Indeterminate ΝΑ

Low

High

GRADE

Discriminative or
known‐groups validity

Internal consistency(2024) 22:347

Not assessed

Not assessed

SufficientSufficientSufficient

DiabMedSat

High

Indeterminate NA

Sufficient

PSIT

Not assessed

Sufficient

Not assessed

SufficientSufficient

ITSQ

A10 drugs used in diabetes

Drug-specific PROMs for M-TS e

Not assessed

Not assessed

EDITS

Indeterminate ΝΑ

Not assessed

TSS

Conditions related to sexual health

OAB-S

Diseases of the genitourinary system

SufficientSufficientInsufficientSufficientSufficient

Not assessed

Not assessed

RatingConvergent validity

Construct ­validityb

Moderate Insufficient

Indeterminate ΝΑ

highDiseases of the musculoskeletal system or connective tissue

DermaSat

Diseases of the skin

Patient satisfaction with treatmentof otitis externa

Diseases of the ear or mastoid process

MacTSQ

Patient Satisfaction with Glaucoma Sufficient
Treatment

Indeterminate ΝΑIndeterminate ΝΑTSS-IOP

RetTSQs

Diseases of the visual system

High

Indeterminate ΝΑ

Sufficient

GRADE

GHerpTSQ

RatingStructural validity

HCVTSat

PROM

Table 3 (continued)

Yang et al. BMC Medicine
Page 26 of 36

Sufficient

SAMS

SASMAT-METHER

Indeterminate ΝΑIndeterminate ΝΑ
Sufficient

Not assessed
Low

Not assessed

Not assessed

Sufficient

Not assessed

Not assessed

Not assessed

Not assessed

Not assessed

Sufficient

Not assessed

Not assessed

SufficientSufficient

Not assessed

SufficientSufficientSufficientSufficientSufficient

Rating

High

High

High

High

High

High

High

High

High

GRADE

Discriminative or
known‐groups validity

High
High

High

Indeterminate ΝΑIndeterminate ΝΑ

Not assessed

Indeterminate ΝΑIndeterminate ΝΑ

Not assessed

Indeterminate ΝΑ

Not assessed

Sufficient

Indeterminate ΝΑ

Not assessed

SufficientSufficient

Not assessed

Indeterminate ΝΑIndeterminate ΝΑIndeterminate ΝΑIndeterminate ΝΑ

Sufficient

High

High

Not assessed

Not assessed

Not assessed

Not assessed

Not assessed

Not assessed

Not assessed

Not assessed

Sufficient

High

High

GRADE

Not assessed

Not assessed

Moderate Not assessed

Indeterminate ΝΑ

Not assessed

Not assessed

Moderate Sufficient

Indeterminate ΝΑ

Not assessed

Sufficient

Not assessed

Not assessed

Not assessed

Sufficient

Not assessed

Indeterminate ΝΑ

Not assessed

Not assessed

Indeterminate ΝΑ

Not assessed

Not assessed

Sufficient

Not assessed

Not assessed

RatingResponsiveness b

Moderate Not assessedHigh

Indeterminate NA

SufficientSufficient

GRADE

Test–retest reliability

GRADE Rating

Indeterminate ΝΑRatingInternal consistency(2024) 22:347

N07 other nervous system drugs

High

Sufficient

Not assessed

N06 psychoanaleptics

MSQ

Indeterminate ΝΑIndeterminate ΝΑHigh

Indeterminate ΝΑ

Not assessed

Not assessed

Not assessed

Not assessed

High

High

High

High

High

High

High

GRADE

PASAP

Not assessed

Indeterminate ΝΑHigh

Sufficient

Not assessed

SufficientSufficient

Not assessed

Sufficient

Not assessed

SufficientSufficientSufficient

RatingConvergent validity

Construct ­validityb

SWAM Scale®

N05 psycholeptics

Patient satisfaction with antiepileptic drugs/epilepsy treatment

N03 antiepileptics

SPM

N02 analgesics

Sufficient

Not assessed

PESaM

Not assessed

Not assessed

TASQ

L04 immunosuppressants

RASQ

L01 antineoplastic agentsSSQ

H02 corticosteroids for systemic use

HighIndeterminate ΝΑ

Sufficient

SICT

Not assessed

ICT-sat

B03 antianemic preparations

SQ-ISHIB02 antihemorrhagics

Indeterminate ΝΑ

ACTS

High

Indeterminate ΝΑInsufficient

DASS

PACT-Q

B01 antithrombotic agents

Indeterminate ΝΑ

Not assessed

GRADE

DMSRQ

RatingStructural validity

DMSRQ-SF

PROM

Table 3 (continued)

Yang et al. BMC Medicine
Page 27 of 36

PSAM

InsufficienthighIndeterminate ΝΑIndeterminate ΝΑ

Not assessed

Not assessed

Sufficient

Not assessed

SufficientSufficient

RatingNot assessed

RatingHigh
Not assessed

SufficientSufficient
High

Low

Indeterminate ΝΑIndeterminate ΝΑIndeterminate ΝΑVery low

SufficientSufficient

Not assessed

Not assessed

Not assessed

Not assessed

RatingGRADEResponsiveness b

Moderate Not assessed

Moderate Indeterminate ΝΑIndeterminate NA

Sufficient

GRADE

Test–retest reliability

GRADE Rating

Indeterminate ΝΑRatingInternal consistency

Moderate Indeterminate ΝΑ

GRADEDiscriminative or
known‐groups validity

Moderate Sufficient

High

GRADE

Convergent validity

Construct ­validityb

The classification of PROMs is based on the International Classification of Diseases 11th (ICD-11) Revision (https://​icd.​who.​int/​en)

The classification of PROMs is based on the Anatomical Therapeutic Chemical Classification System (ATC) 2nd level—pharmacological or therapeutic subgroup (https://​www.​who.​int/​tools/​atc-​ddd-​toolk​it/​atc-​class​ifica​tion)dc

If no hypothesis was set in the original study, the review team defined generic hypotheses as follows: (1) correlations with (changes in) instruments measuring similar constructs should be ≥ 0.50; (2) correlations with(changes in) instruments measuring related, but dissimilar constructs should be lower, i.e., 0.30–0.50; 3); (3) correlations with (changes in) instruments measuring unrelated constructs should be < 0.30; (4) correlations
with (changes in) instruments measuring similar constructs should differ by a minimum of 0.10 from correlations with (changes in) instruments measuring related but dissimilar constructs; (5) correlations with (changesin) instruments measuring related but dissimilar constructs should differ by a minimum of 0.10 from correlations with (changes in) instruments measuring unrelated constructs; and (6) meaningful changes between
relevant (sub)groups (e.g., patients with expected high versus low levels of the construct of interest) [17]bThe results of all available studies on a measurement property are quantitatively pooled or qualitatively summarized and compared against the criteria for good measurement properties. The overall ratings of eachmeasurement property will be accompanied by a grading for the quality of the evidence using the GRADE approach [17]aScore: Quality of measurement properties of PROMs: sufficient; insufficient; indeterminate; inconsistent. Quality of the evidence (GRADE): high; moderate; low; very low. Level of recommendations for the use of PROMs: A;
B; C

TSTMQ [138]Not applicable to ATC classification

ESPIA

V01 allergens

EDSQ

S01 ophthalmologicals

GRADE

Indeterminate ΝΑRatingStructural validity

R03 drugs for obstructive airway diseases

SASMAT-BUNHER

PROM

Table 3 (continued)

Yang et al. BMC Medicine(2024) 22:347
Page 28 of 36

Yang et al. BMC Medicine(2024) 22:347

to demonstrate sufficient content validity (61/69, 88%),
structural validity (56/69, 81%), internal consistency(58/69, 84%), or test–retest reliability (45/69, 65%). Few
PROMs reported responsiveness (16/69, 23%). Only four
PROMs provided an approach for interpreting the resultsof the PROMs (i.e., the MIDs).
Introduction of the three PROMs for M‑TS with sufficientvalidity and reliability

The ITSQ [42, 43] is a drug-specific PROMs for insulin
treatment satisfaction including domains of inconvenience of regimen (5 items), lifestyle flexibility (3 items),
glycemic control (3 items), hypoglycemic control (5items), and insulin delivery device satisfaction (6 items).
According to the Allie database (i.e., a database forsearching studies in PubMed and MEDLINE that involvea particular abbreviation and long form) [143], 12 trials
in adults have applied the ISTQ. Due to unclear recall
period and lack of evaluation on content validity, thequality of evidence on the content validity of ITSQ was
still low.
Both TSQM-1.4 [25–29] (with 14 items) and SATMED-Q [31, 37–40] (with 17 items) are generic PROMs
for adults with chronic diseases. The two PROMs sharedfour common domains including perceived effectiveness,side effects, convenience, and global satisfaction. The
SATMED-Q had two additional domains (i.e., impact ondaily living or activity, process of medical care or medical follow-up). The TSQM-1.4 was the most widely used
PROMs for M-TS (106 trials applied, 4 of which were inchildren and adolescents) while SATMED-Q was rarely
used in trials (ten trials in adults applied during the last
15 years) [143]. Both PROMs still lack high quality of evidence on content validity and responsiveness.
Limitations of current PROMs for M‑TS

Although conceptual framework is not mandatory fordeveloping measures, providing a theoretical foundation
facilitates defining key components and their relationships within the construct [6, 7]. Our study revealed thatover 70% PROMs did not define a conceptual framework
for treatment satisfaction. The existing frameworks draw
heavily from Shikiar’s pyramid theory [1] and Weaver’s
concept of treatment satisfaction [142]. These frameworks, however, have limitations on considering the difference between patients with chronic disease and thosewith acute disease toward treatment satisfaction (e.g.,chronic disease patients tend to emphasize long-term
outcomes and quality of life, while acute disease patientsprioritize immediate relief and symptom management)[144] and the difference between adults and children(e.g., children might prioritize medication side effects
and ease of administration, whereas adults focus more on

Page 29 of 36

the effectiveness) [145]. These differing priorities highlight the need for PROMs that are tailored to specific disease contexts to accurately capture patient satisfaction.
More than half of the PROMs (41/69, 59%) did not clearlyreport the process of cognitive interviews or other pilot
tests of the PROMs damaging the transparency and rigorof the development process [146–148].
Regarding content validity, because the context of use
was vague, we rated the relevance of most of the PROMs
as indeterminate (e.g., whether the PROMs is for clinical
trial or clinical practice, for discriminative, evaluative, orpredictive purpose was unclear); due to paucity of justification on the appropriateness of response option andrecall period, we rated the comprehensiveness as insufficient; due to lack of justification on the understandabilityof the PROMs in target population, we rated the comprehensibility as insufficient (Additional file 1: table S6[25–138]).
Our systematic search found six PROMs for M-TS
were developed specifically for children and adolescents.
These PROMs, however, lacked of evidence on sufficientvalidity, reliability, or responsiveness [51, 101, 102, 134–136]. Compared with adults children and adolescents
have limited vocabulary, comprehension, and self-awareness, which probably influence their ability to respondaccurately to adult-oriented measures [149]. The validity,
reliability, responsiveness, and feasibility of the PROMs
developed for adults should be evaluated before they areapplied in children and adolescents.
According to Allie [143], we found most PROMs were
infrequently used with 38% never applied by any trial
and 42% applied by less than 5 trials. Patient and Partner Treatment Satisfaction Scale in Erectile Dysfunction(TSS), the second most often used PROM (the first was
TSQM), had inconsistent content validity (moderatequality of evidence) (Table 2). The infrequent applicationof the PROMs for M-TS and wide use of PROMs withpoor measurement properties indicates that potential
stakeholders (e.g., clinicians or researchers) probably lackawareness and access to validated PROMs for M-TS.
The practical application of self-reporting in M-TS
PROMs faces several challenges, particularly for specificpopulations. Individuals with mental health issues may
struggle to report treatment satisfaction accurately due tocognitive impairments or emotional distress [150]. Thosewith limited digital skills may find electronic PROMs difficult, resulting in incomplete or biased data [151]. Similarly, individuals with reading difficulties or low literacy
may misinterpret questions, compromising response reliability [152]. These challenges underscore the need forinclusive PROM design, ensuring accessibility and comprehension for diverse patients. Alternative data collection methods, such as interviews or caregiver reports,

Yang et al. BMC Medicine(2024) 22:347

should be considered for those unable to self-reportreliably.
Strengths and limitations of this systematic review

We conducted a comprehensive search for current
PROMs for M-TS. This review included four Chinese
databases, which expanded the scope beyond Englishlanguage publications to provide a more comprehensive
understanding of M-TS across different cultural contexts
and enhance the diversity, comprehensiveness, robustness, and applicability of our systematic review [153].
Following the COSMIN guideline [19, 20] we assessed
the measurement properties of the PROMs, risk of biasof individual studies, and rated the quality of body of evidence on the development and validation of the PROMs.
This review has some limitations. First, we only
included studies published in English and Chinese andmight have missed PROMs for M-TS reported in otherlanguages. Second, poor reporting of individual studies impeded our ability to assess the measurement
properties and to rate the quality of evidence. To minimize the impact of ambiguous reporting, we searched
for and abstracted data from all available literature foreach included PROM. Third, some evaluation criteria
for measurement properties were subjective (e.g., forthe criteria for content validity: “are all key concepts
included?”). We attempted to reduce the difference
between reviewers by conducting calibration exercises,
duplicated assessments and group discussions whendiscrepancy occurred. Fourth, we did not recommend
PROMs based on the COSMIN guideline criteria (i.e.,
PROMs that have potential to be recommended as themost suitable PROM for those with evidence for sufficient content validity (any level) and sufficient internalconsistency (at least low level) [19, 20]) because we think
the evaluation of content validity was subjective. We,
however, based on the evaluation of measurement properties, highlighted three PROMs with sufficient validity(particularly construct validity) and reliability (particularly internal consistency).
Recommendations for future research and clinical practiceConfident use of current available PROMs for M-TS will
require validation study to assess their measurement
properties (especially content validity, test–retest reliability, and responsiveness), interpretability, and feasibility indifferent context and population. Further studies can pay
more attention to assess the measurement properties ofcurrent PROMs in children and adolescents or to develop
PROMs targeted at this population. Although COSMIN
provided a reporting guideline for validation study [154],
our review found that the guideline was not widely used.
A uniformed standard for reporting the development andPage 30 of 36

validation of PROMs is needed to improve the reporting quality of studies on the development and validationof PROMs for M-TS. Additionally, collaborative efforts
among researchers, clinicians, and policymakers are
essential to develop and implement robust M-TS PROMs
applicable to diverse patient groups. This will bridge thegap between current PROMs and patient needs, enhancing patient care and treatment outcomes.
The implementation of validated and reliable M-TS
PROMs in clinical practice can significantly enhancepatient care by providing healthcare providers with better
tools to assess and address patient satisfaction and treatment outcomes. By accurately capturing patient experiences and preferences, PROMs can help tailor treatments
to individual needs, leading to improved adherence andbetter health outcomes. Moreover, the use of PROMs canfacilitate shared decision-making, empowering patientsto be active participants in their own care. This patientcentered approach not only improves satisfaction but
also contributes to more effective and efficient healthcaredelivery. Ensuring that PROMs are culturally sensitive
and accessible to all patient groups, including those withmental health issues, limited digital skills, and reading
difficulties, is crucial for their widespread adoption andutility in diverse clinical settings.

Conclusions
Most current PROMs for M-TS demonstrated sufficientconstruct validity while only a few had sufficient content validity, structural validity, internal consistency, andtest–retest reliability. Few PROMs reported responsiveness. Confident use of current PROMs requires further
evaluation on the validity, reliability, responsiveness, andinterpretability of current PROMs. Reporting guidelines
are needed to enhance the reporting quality of the development and validation of PROMs for M-TS.
Abbreviations
M-TS	Medication Treatment Satisfaction
PROMs	Patient-reported outcome measures
COSMIN	Consensus-based Standards for the selection of health
Measurement Instruments
TSQM	Treatment Satisfaction Questionnaire for Medication
TSQM-1.4	Treatment Satisfaction Questionnaire for Medication initial Version
TSQM-II	Treatment Satisfaction Questionnaire for Medication Version II
TSQM-9	Treatment Satisfaction Questionnaire for Medication—9
items (an abbreviated 9-item TSQM)
SATMED-Q	Treatment Satisfaction with Medicines Questionnaire
ITSQ	Insulin Treatment Satisfaction QuestionnairePRO	Patient-reported outcome
FDA	US Food and Drug Administration
EMA	European Medicines Agency
PRISMA	Preferred Reporting Items for Systematic Reviews andMeta-Analyses
GRADE	Grading of Recommendations Assessment, Development,
and Evaluation
ICC	Intraclass correlation coefficientYang et al. BMC Medicine(2024) 22:347

RoB	Risk of bias
ICD-11	International Classification of Diseases 11thATC​	Anatomical Therapeutic Chemical Classification System
CFI	Comparative fit index
TLI	Tucker–Lewis index
RMSEA	Root mean square error of approximation
SRMR	Standardized root mean residuals
AUC​	Area under the ROC curveMID	Minimal important difference
TSS	Patient and Partner Treatment Satisfaction Scale in Erectile
Dysfunction
VAS	Visual analogue scale
NR	Information was not reported
PSIT	Patient Satisfaction with Insulin Therapy questionnaire
DiabMedSat	Diabetes Medication Satisfaction Questionnaire
DTTQ	Diabetes Tablet Treatment Questionnaire
SOADAS	Satisfaction with Oral Anti-Diabetic Agents Scale
DM-SAT	Diabetes Medication Satisfaction Questionnaire
PAM-D	Perceptions About Medications for Diabetes questionnaire
PRAM-TSQ	Treatment Satisfaction Associated With Pramlintide Use
Questionnaire
DTSQ-IP	Diabetes Treatment Satisfaction Questionnaire for in-patients
OHA-Q	Oral Hypoglycemic Agent Questionnaire
DMSRQ	Diabetes Medication System Rating Questionnaire
DMSRQ-SF	Diabetes Medication System Rating Questionnaire-Short
Form
DIDS	Diabetes Impact and Device Satisfaction Questionnaire
ThyTSQ	Underactive Thyroid Treatment Satisfaction Questionnaire
MS-TSQ	Menopause Symptoms Treatment Satisfaction Questionnaire
Acro-TSQ	Acromegaly Treatment Satisfaction Questionnaire
DASS	Duke Anticoagulation Satisfaction Scale
PACT-Q2	Perception of Anticoagulant Treatment Questionnaire 2
ACTS	Anticlot Treatment Scale
PSAM	Patient Satisfaction with Asthma Medication questionnaire
SATQ	Satisfaction with Asthma Treatment Questionnaire
PASAPQ	Patient Satisfaction and Preference Questionnaire
PPMQ	Patient Perception of Migraine Questionnaire
PPMQ-R	Patient Perception of Migraine Questionnaire-Revised
MTSM	Migraine Treatment Satisfaction Measure
SPM	Patient Satisfaction with Pain Medication Questionnaire
PTSS	Pain Treatment Satisfaction Scale
MSTCQ	Multiple Sclerosis Treatment Concerns Questionnaire
CTSQ	Cancer Therapy Satisfaction Questionnaire
RASQ	Rituximab Administration Satisfaction Questionnaire
TSQ-G	Treatment Satisfaction Questionnaire for Gastro-esophageal reflux disease
GTSQ	Gastroesophageal Reflux Disease Treatment Satisfaction
Questionnaire
TSQ-C	Treatment Satisfaction Questionnaire for Crohn’s Disease
SPACE-Q	Satisfaction of PAtients with Crohn’s disease Questionnaire
SWAM Scale ®	Satisfaction With Antipsychotic Medication scale ®
SAMS	Satisfaction with Medication Scale
PASAP	PAtient SAtisfaction with Psychotropics questionnaire
MSQ	Medication Satisfaction Questionnaire
SASMAT-METHER	Satisfaction with Medications for Addiction Treatmentmethadone for Heroin Addiction questionnaire
SASMAT-BUNHER	Satisfaction with Medications for Addiction TreatmentBuprenorphine-Naloxone for Heroin addiction questionnaire
HIVTSQs	Human Immunodeficiency Virus (HIV) Treatment Satisfaction Questionnaire—Status version
HIVTSQc	HIV Treatment Satisfaction Questionnaire—Change version
ESTAR​	Escala de Satisfacción con el Tratamiento Antirretroviral,
Antiretroviral Treatment Satisfaction scale
GHerpTSQ	Genital Herpes Treatment Satisfaction Questionnaire
HCVTSat	Chronic Hepatitis C Virus Treatment Satisfaction questionnaire
TSS-IOP	Treatment Satisfaction Survey for Intraocular Pressure
RetTSQs	Retinopathy Treatment Satisfaction Questionnaire (status)
EDSQ	Eye-Drop Satisfaction Questionnaire
MacTSQ	Macular Disease Treatment Satisfaction Questionnaire
DermaSat	
Satisfaction with dermatological treatment of handeczema questionnaire

Page 31 of 36

OPSAT-Q	Osteoporosis Patient Satisfaction Questionnaire
OAB-S	Overactive Bladder Satisfaction Questionnaire
PESaM	Patient Experiences and Satisfaction with Medications
Questionnaire
EDITS	Erectile Dysfunction Inventory of Treatment Satisfaction
Questionnaire
ESPIA	Satisfaction Scale for Patients Receiving Allergen Immunotherapy Questionnaire
SSQ	Systemic Lupus Erythematosus Steroid Questionnaire
SICT	Satisfaction with Iron Chelation Therapy Questionnaire
ICT-Sat	
Satisfaction with Iron Chelation Therapy for patientsquestionnaire
SQ-ISHI	Satisfaction Questionnaire with Intravenous or Subcutaneous Hemophilia Injection
TASQ	Therapy Administration Satisfaction Questionnaire
TASQ-SC	Therapy Administration Satisfaction
Questionnaire—subcutaneous
TASQ-IV	Therapy Administration Satisfaction
Questionnaire—intravenous
TSTMQ	Treatment Satisfaction with Traditional Medicines Questionnaire

Supplementary Information
The online version contains supplementary material available at https://​doi.​
org/​10.​1186/​s12916-​024-​03560-3.
Additional file 1: Tables S1-S7. Table S1 - Search Resources and Search
Strategies. Table S2 - Definitions of Measurement Properties and Criteria
for Assessing Measurement Properties. Table S3 - Grading of Quality of
Evidence. Table S4 - Characteristics of Individual Studies. Table S5 - Summary of the Current Theories and Conceptual Frameworks for Medication
Treatment Satisfaction. Table S6 - Measurement Properties Reported by
Individual Studies and Risk of Bias of Individual Studies. Table S7 - Interpretability evidence of the PROMs.
Additional file 2. The PRISMA 2020 checklist.
Acknowledgements
None.
Authors’ contributions
All authors read and approved the final manuscript. MTY: Concept and design,acquisition, analysis, or interpretation of data, drafting of the manuscript, andstatistical analysis. LNZ: Concept and design, acquisition, analysis, or interpretation of data, administrative, technical, or material support, critical revisionof the manuscript for important intellectual content, and supervision. ZLL:
Obtained funding, administrative, technical, or material support, and supervision. PWZ: Acquisition, analysis, or interpretation of data, critical revision of
the manuscript for important intellectual content, and statistical analysis. JH:
Concept and design, critical revision of the manuscript for important intellectual content, and administrative, technical, or material support. XRJ, SYZ, WYY,
XYJ, YXL: Acquisition, analysis, or interpretation of data. GG, IC, LH, KZ, XXL,
HQW: Critical revision of the manuscript for important intellectual content. All
authors had full access to all of the data in the study and takes responsibility
for the integrity of the data and the accuracy of the data analysis.
Funding
A grant from the medical cross key project of Sichuan University, China (toLingli Zhang) supported this work.
Availability of data and materials
All data in this systematic review are publicly available. All extracted data are
available in the online supplementary files.

Declarations
Ethics approval and consent to participate
Not applicable.

Yang et al. BMC Medicine(2024) 22:347

Consent for publication
Not applicable.
Competing interests
The authors declare that they have no competing interests.
Author details
1
Department of Pharmacy/Evidence‑Based Pharmacy Center, West China
Second University Hospital, Sichuan University, Chengdu, China. 2 Children’s
Medicine Key Laboratory of Sichuan Province, Chengdu, China. 3 NMPA Key
Laboratory for Technical Research On Drug Products In Vitro and In Vivo Correlation, Chengdu, China. 4 Key Laboratory of Birth Defects and Related Diseasesof Women and Children, Sichuan University, Ministry of Education, Chengdu,
China. 5 West China School of Medicine, Sichuan University, Chengdu, China.
6
The Matilda Centre for Research in Mental Health and Substance Use, University of Sydney, Camperdown, NSW, Australia. 7 Joseph’s Healthcare Hamilton(SJHH), Research Institute of St. Joe’s Hamilton Mental Health and Addictions
Research Program, McMaster University, Hamilton, ON, Canada. 8 Schoolof Medicine, University of Nottingham, Nottingham, UK. 9 West China Schoolof Pharmacy, Sichuan University, Chengdu, China. 10 Department of Paediatric
Haematology and Oncology, West China Second Hospital, Sichuan University,
Chengdu, China. 11 Medical Simulation Centre, West China Second University
Hospital, Sichuan University, Chengdu, Sichuan, China. 12 School of Mathematics, Sichuan University, Chengdu, China. 13 Chinese Evidence‑Based Medicine
Center, West China Hospital, Sichuan University, Chengdu, China. 14 Department of Health Research Methods, Evidence, and Impact, McMaster University,
Hamilton, ON, Canada. 15 Department of Medicine, McMaster University,
Hamilton, ON, Canada.
Received: 13 January 2024 Accepted: 13 August 2024

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