
==== Front
BMC Med
BMC Med
BMC Medicine
1741-7015
BioMed Central London

39218858
3560
10.1186/s12916-024-03560-3
Research Article
Patient-reported outcome measures for medication treatment satisfaction: a systematic review of measure development and measurement properties
Yang Mengting 12345
Zhang Puwen 12345
Halladay Jillian 67
Zou Kun 1234
Choonara Imti 8
Ji Xiaorui 9
Zhang Shuya 9
Yan Weiyi 9
Huang Liang 1234
Lu Xiaoxi 410
Wang Huiqing 11
Jiang Yuxin 12
Liu Xinyu 12
Zeng Linan LinanZeng@scu.edu.cn

1234
Zhang Lingli zhanglingli@scu.edu.cn

123413
Guyatt Gordon H. 1415
1 grid.461863.e 0000 0004 1757 9397 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 grid.13291.38 0000 0001 0807 1581 Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, China
5 https://ror.org/011ashp19 grid.13291.38 0000 0001 0807 1581 West China School of Medicine, Sichuan University, Chengdu, China
6 https://ror.org/0384j8v12 grid.1013.3 0000 0004 1936 834X The Matilda Centre for Research in Mental Health and Substance Use, University of Sydney, Camperdown, NSW Australia
7 grid.25073.33 0000 0004 1936 8227 Joseph’s Healthcare Hamilton (SJHH), Research Institute of St. Joe’s Hamilton Mental Health and Addictions Research Program, McMaster University, Hamilton, ON Canada
8 https://ror.org/01ee9ar58 grid.4563.4 0000 0004 1936 8868 School of Medicine, University of Nottingham, Nottingham, UK
9 https://ror.org/011ashp19 grid.13291.38 0000 0001 0807 1581 West China School of Pharmacy, Sichuan University, Chengdu, China
10 https://ror.org/011ashp19 grid.13291.38 0000 0001 0807 1581 Department of Paediatric Haematology and Oncology, West China Second Hospital, Sichuan University, Chengdu, China
11 grid.461863.e 0000 0004 1757 9397 Medical Simulation Centre, West China Second University Hospital, Sichuan University, Chengdu, Sichuan China
12 https://ror.org/011ashp19 grid.13291.38 0000 0001 0807 1581 School of Mathematics, Sichuan University, Chengdu, China
13 grid.412901.f 0000 0004 1770 1022 Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, China
14 https://ror.org/02fa3aq29 grid.25073.33 0000 0004 1936 8227 Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON Canada
15 https://ror.org/02fa3aq29 grid.25073.33 0000 0004 1936 8227 Department of Medicine, McMaster University, Hamilton, ON Canada
2 9 2024
2 9 2024
2024
22 34713 1 2024
13 8 2024
© The Author(s) 2024
2024
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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 properties of 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-based Standards 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 drug-specific) 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 known-groups 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, SATMED-Q) and one drug-specific PROM (Insulin Treatment Satisfaction Questionnaire, ITSQ) demonstrated both satisfactory validity and reliability.

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.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12916-024-03560-3.

Keywords

Patient-reported outcome measures
Systematic review
Medication treatment satisfaction
COSMIN
Measurement properties
the medical cross key project of Sichuan University, Chinaissue-copyright-statement© BioMed Central Ltd., part of Springer Nature 2024
==== Body
pmcBackground

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 health care 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 the target population may inadequately capture the changes in M-TS [9, 10] resulting in inaccurate estimates of the effect 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 and assessed 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 reviews of 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 the measurement properties of PROMs. The reviewers used the COSMIN Risk of Bias checklist to assess the risk of bias of individual studies, and the modified Grading of Recommendations 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, and two 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://eprovide.mapi-trust.org/), the reviewers performed a systematic search for literature published in English and Chinese reporting the development (i.e., development study including cognitive interview or other 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 of included 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 options, and copyright based on ePROVIDE), and the measurement 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 not reported. Based on all studies relevant to a particular PROM, 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], two reviewers (M.Y. and P.Z.) independently assessed the risk of 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 were clearly described; adequate if assumably appropriate but not clearly described; and doubtful or inadequate if not clearly described. A third reviewer (L.Z.) resolved any disagreement.

Using the modified GRADE approach in COSMIN guideline, the reviewers graded the overall quality of evidence 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 the 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-three studies (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%), followed by Spain (16, 14%) and the UK (15, 13%). The median sample sizes of studies that developed and validated the PROMs is 205 (with a range from 13 to 1336) and that of studies that validated the PROMs is 197 (with a range from 10 to 2511).Fig. 1 Preferred Reporting Items for Systematic Reviews and Meta-Analysis Diagram of Study Selection

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 the Anatomical Therapeutic Chemical Classification System (ATC) [140] (mostly often anticoagulants, insulin, and iron chelation). Table 1 Characteristics of PROMs for medication treatment satisfaction

	PROM
(language version)	Year and country of development	Target population	Target disease/drug	Administration	Recall period	Domains	Number of items	Response options	Copyright	
Generic PROMs for M-TS	
1	TSQM-1.4 [25–29]

(English, Arabic, Kurdish, and Spanish version)

	2004, USA	Adults	Generic	Self-report	Past 2–3 weeks or since last used the medicine	1. Effectiveness; 2. Side effects; 3. Convenience; 4. Global Satisfaction	14	7-point or 5-point Likert scale	© 2023 IQVIA. All rights reserved. Any use, distribution, or reproduction, in whole or in part, is expressly prohibited without the prior express written permission of IQVIA	
2	TSQM-II [30–35]

(English, French, Chinese, Japanese, and Persian version)

	2005, USA	Adults	Generic	Self-report	Past 2–3 weeks or since last used the medicine	1. Effectiveness; 2. Side effects; 3. Convenience; 4. Global Satisfaction	11	7-point or 5-point Likert scale	© 2023 IQVIA. All rights reserved. Any use, distribution, or reproduction, in whole or in part, is expressly prohibited without the prior express written permission of IQVIA	
3	TSQM-9 [36]

(English version)

	2009, USA	Adults	Generic	Self-report	Past 2–3 weeks or since last used the medicine	1. Effectiveness; 2. Convenience; 3. Global Satisfaction	9	7-point or 5-point Likert scale	© 2023 IQVIA. All rights reserved. Any use, distribution, or reproduction, in whole or in part, is expressly prohibited without the prior express written permission of IQVIA	
4	SATMED-Q [31, 37–40]

(English, French, and Polish version)

	2008, Spain	Adults	Generic	Self-report	Not specified	1. Treatment effectiveness; 2. Convenience of use; 3. Impact on daily living/activity; 4. Medical care/ medical follow-up; 5. Undesirable side effects; 6.Global satisfaction	17	4-point Likert scale	© Miguel A. Ruiz, 2008. All Rights Reserved	
Disease-specific PROMs for M-TS a	
Endocrine, nutritional, or metabolic diseases	
5	DTSQ-IP [51]

(English version)

	2009, UK	Teens and adults	Insulin-treated diabetes	Self-report	Past 2 weeks	NR	19	6-point Likert scale	No information	
6	DIDS [55]

(English version)

	2020, USA	Adults	Type 1 diabetes	Self-report and parent/proxy report	Not specified	1. Device satisfaction; 2. Diabetes impact	12	10-point Likert scale	No information	
7	ThyTSQ [56, 57]

(English version)

	2004, UK	Adults	Hypothyroidism	Self-report	Past few weeks	1. Present satisfaction; 2. How well working; 3. Convenient; 4. Understanding of condition; 5. Encourage; 6. Controlling symptoms; 7. Continue	7	6-point Likert scale	No information	
8	MS-TSQ [58]

(English version)

	2007, USA	Adults	Hot flashes, menopause	Self-report	Past 4 weeks	1. Satisfaction with the treatment's ability to control specific symptoms associated with menopause; 2. Side effects or treatment tolerability; 3. Global treatment satisfaction	8	5-point Likert scale	No information	
9	Acro-TSQ [59, 60]

(English version)

	2019, USA	Adults	Acromegaly	Self-report	Past 4 weeks	1. Treatment effectiveness; 2. Symptom burden; 3. Treatment side-effects; 4. Convenience of treatment; 5. Overall satisfaction	26	NR	No information	
Diseases of the respiratory system	
10	SATQ [75–77]

(English, Spanish, and Polish version)

	2003, UK	Adults	Asthma	Self-report	Not specified	1. Effectiveness of treatment; 2. Ease of use; 3. Medication burden; 4.Side-effects and worries	26	7-point Likert scale	No information	
11	PASAPQ [78]

(English version)

	2005, USA	NR	Asthma, asthma-chronic obstructive pulmonary disease overlap syndrome	Self-report	Not specified	1. Performance; 2. Convenience; 3. Overall satisfaction	14	7-point Likert scale	© Boehringer Ingelheim hold the copyright	
Diseases of the nervous system	
12	PPMQ [79]

(English version)

	2002, Canada, Finland, The Netherlands, New Zealand, Spain	Adults	Migraine	Self-report	Past 4 h	NR	15	7-point or 5-point Likert scale	©2008 GlaxoSmithKline. All rights reserved	
13	PPMQ-R [80, 81]

(English version)

	2006, USA	Adults	Migraine	Self-report	Past 24 h	1. Efficacy; 2. Function; 3. Ease of use; 4. Cost; 5. Side effects; 6. Global items	32	7-point or 5-point Likert scale	©2008 GlaxoSmithKline. All rights reserved	
14	MTSM [82, 83]

(English version)

	2003, USA, UK	Adults	Migraine	Self-report	Not specified	1. Expectations of treatment outcomes; 2. Importance of attributes; 3. Rating of treatment outcome; 4.Satisfaction with treatment	NR	NR	No information	
15	PTSS [85, 86]

(English and Traditional Chinese Cantonese version)

	2004, USA, Italy, France	Adults	Acute pain, chronic pain	Self-report	Not specified	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	39	5-point Likert scale	The PTSS is copyrighted by Pfizer	
16	MSTCQ [87]

(English version)

	2006, USA	Adults	Multiple sclerosis	Self-report	Not specified	1. Satisfaction with the injection system; 2. Side effects	30	NR	The instrument is copyrighted by Joyce A. Cramer	
Neoplasms	
17	CTSQ [90–94]

(English, Korean, Dutch, and Malay version)

	2005, USA, UK, France	Adults	Generic for Neoplasms	Self-report	Past 4 weeks	1. Expectations of cancer therapy; 2. Feelings about side effects; 3. Oral cancer therapy adherence; 4. Convenience; 5. Satisfaction with cancer therapy; 6.Stopping cancer therapy; 7. Reasons for nonadherence	21	5-point Likert scale	© 2007, Cronos Clinical Consulting Services, an IQVIA business	
Diseases of the digestive system	
18	TSQ-G [96]

(English version)

	2003, USA	Adults	Gastroesophageal reflux disease	Self-report	Past 2 weeks	1. Symptoms; 2. Satisfaction; 3. Expectations; 4. Provider relationships; 5. Cost; 6. Bother; 7. Flexibility with dosing	28	NR	© Astrazeneca. All rights reserved	
19	GTSQ [97]

(English version)

	2005, USA	Adults	Gastroesophageal reflux disease	Self-report	Past 2 weeks	1. Specific symptom relief; 2. Nighttime relief; 3. Daytime relief; 4. Quick and long-lasting relief; 5. Ease and convenience; 6. Health-related quality of life (HRQL); 7. Overall satisfaction	25	5-point Likert scale	No information	
20	TSQ-C [98]

(English version)

	2005, USA	NR	Crohn’s disease	Self-report	Not specified	1. Symptoms; 2. Satisfaction; 3. Expectations; 4. Physician Relationships; 5. Bother; 6. Cost	32	6-point Likert scale	No information	
21	SPACE-Q [99, 100]

(English and French version)

	2011, France	Adults	Crohn’s disease	Self-report	Not specified	1. Disease control; 2. Symptoms transition scale; 3. Anal symptoms transition scale; 4. Quality of life transition 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	58	4-point or 5-point Likert scale, dichotomous (Yes/No)	© Abbott France, 2011. All rights reserved	
Certain infectious or parasitic diseases	
22	HIVTSQs [108]

(English version)

	2001, USA, Canada	Adults	Human immunodeficiency virus infection	Self-report	Past 4 weeks	1. Current treatment; 2. Control; 3. Side effects; 4. Demands; 5. Convenience; 6. Flexibility; 7. Understanding; 8. Lifestyle; 9. Recommend to others; 10. Continue	10	NR	© Professor C Bradley	
23	HIVTSQc [109]

(English version)

	2006, UK	Adults	Human immunodeficiency virus infection	Self-report	Past 4 weeks	1. Current treatment; 2. Control; 3. Side effects; 4. Demands; 5. Convenience; 6. Flexibility; 7. Understanding; 8. Lifestyle; 9. Recommend to others; 10. Continue	10	NR	© Professor C Bradley	
24	ESTAR [110]

(Spanish version)

	2007, Spain	Adults	Human immunodeficiency virus infection	Self-report	Past 4 weeks	1. Clinical satisfaction; 2. Satisfaction with lifestyle	10	6-point Likert scale	No information	
25	GHerpTSQ [111]

(English version)

	2006, Canada	Adults	Genital herpes	Self-report	Not specified	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	12	NR	© Professor Clare Bradley	
26	HCVTSat [112]

(English version)

	2013, USA	Adults	Chronic hepatitis C virus infection	Self-report	Not specified	1. Treatment experience; 2. Side effects; 3. Social aspects	12	NR	No information	
Diseases of the visual system	
27	TSS-IOP [113]

(English version)

	2003, USA	Adults	Primary open-angle glaucoma or ocular hypertension	Self-report	Not specified	1. Eye irritation; 2. Convenience of use; 3. Ease of use; 4. Hyperemia; 5. Medication effectiveness	15	NR	© 2003, Cronos Clinical Consulting Services, an IQVIA business	
28	RetTSQs [114–116]

(English, German, and Serbian version)

	2004, UK, Germany	Adults	Diabetic retinopathy	Self-report	Not specified	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 things for others; 11. Get out and about; 12. Journeys; 13. Holidays; 14. Finances; 15. People react; 16. Physical appearance; 17. Physically do; 18. Leisure; 19. Hobbies/interests; 20. Self-confidence; 21. Motivation; 22. Dependence; 23. Mishaps/losses; 24. Time; 25. Care of diabetes; 26. Enjoy nature	26	7-point Likert scale	© Professor C Bradley	
29	Patient satisfaction with glaucoma treatment [119]

(Spanish version)

	2010, Spain	Adults	Glaucoma	Self-report	Not specified	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	22	5-point Likert scale	No information	
30	MacTSQ [120, 121]

(English and Greek version)

	2018, UK	Adults	Macular degeneration	Self-report	Not specified	NR	14	5-point Likert scale	© Professor C Bradley	
Diseases of the ear or mastoid process	
31	Patient satisfaction with treatment of otitis externa [122]

(English version)

	1999, USA	NR	Otitis externa	Self-report	Not specified	1. Information; 2. Ease of administration; 3. Side effects; 4. Relief of symptoms; 5. Medical care in general; 6. Cost; 7. Functioning; 8. Overall satisfaction	22	7-point Likert scale	No information	
Diseases of the skin	
32	DermaSat [123]

(Spanish version)

	2010, Spain	Adults	Eczema (dermatitis) affecting the hands	Self-report	Not specified	1. Effectiveness; 2. Convenience; 3. Impact on health-related quality of life; 4. Medical follow-up; 5. Side effects; 6. General opinion	17	5-point Likert scale	No information	
Diseases of the musculoskeletal system or connective tissue	
33	OPSAT-Q [124]

(English version)

	2006, USA	Adults	Osteoporosis with bisphosphonate treatments	Self-report	Not specified	1. Convenience; 2. Confidence with daily activities; 3. Side effects; 4. Overall satisfaction	16	4-point Likert scale	© 2005 Roche Laboratories, Inc. All Rights Reserved	
Diseases of the genitourinary system	
34	OAB-S [125]

(English version)

	2008, USA	Adults	Prostatic hyperplasia, overactive urinary bladder	Self-report	Past 1 week	1. Overactive bladder (OAB) control expectations; 2. Impact on daily living 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	41	4- to 6-point Likert scale	© 2005, Cronos Clinical Consulting Services, an IQVIA business	
Conditions related to sexual health	
35	EDITS [128]

(English version)

	1999, USA	Adults	Erectile dysfunction	Self-report	Past 4 weeks	NR	11	5-point Likert scale	© 1999, Cronos Clinical Consulting Services, an IQVIA business	
36	TSS [129, 130]

(English, French, and German version)

	2004, Germany	Adults	Erectile dysfunction	Self-report	Past 4 weeks	1. Satisfaction with medication; 2. Ease with erection; 3. Satisfaction with erectile function; 4. Pleasure from sexual activity; 5. Satisfaction with orgasm; 6. Sexual confidence (for patients) or Confidence in completion (for partners)	NR	5-point Likert scale	© Bayer Schering Pharma AG	
Drug-specific PROMs for M-TS b	
A10 drugs used in diabetes	
37	PSIT [41]

(English version)

	2000, USA	Adults	Insulin for diabetes mellitus	Self-report	Past 12 weeks	1. Convenience and ease of use; 2. Social comfort	15	5-point Likert scale	© 1996 Pfizer Inc. All rights reserved	
38	ITSQ [42, 43]

(English version)

	2004, USA	Adults	Insulin for diabetes mellitus	Self-report	Past 4 weeks	1. Inconvenience of regimen; 2. Lifestyle flexibility; 3. Glycemic control; 4. Hypoglycemic control; 5. Insulin delivery device satisfaction	22	7-point Likert scale	© Novo Nordisk, 2004, All rights reserved	
39	DiabMedSat [44]

(English version)

	2006, USA	Adults	Diabetes medication	Self-report	Past 2 weeks	1. Burden; 2. Efficacy; 3. Symptoms	23	5- to 7-point Likert scale	© Novo Nordisk June 2004	
40	DTTQ [45]

(English version)

	2007, UK	Adults	Diabetes tablet	Self-report	Past 2 weeks	1. Tablet-taking as recommended; 2. Tablet difficulty; 3. Tablet side effects; 4. Perceived hyperglycemia; 5. Perceived hypoglycemia; 6. Tablet continue	7	6-point Likert scale	No information	
41	SOADAS [46, 47]

(English and Chinese version)

	2008, USA	Adults	Oral anti-diabetic agents	Self-report	Past 4 weeks	NR	6	5-point Likert scale	© 2006 GlaxoSmithKline. All rights reserved	
42	DM-SAT [48]

(English version)

	2009, USA	Adults	Diabetes medication	Self-report	Past 4 weeks	1. Life style; 2. Convenience; 3. Glucose control; 4. Well-being	16	10-point Likert scale	© 2022 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved	
43	PAM-D [49]

(English version)

	2009, USA	Adults	Diabetes medication	Self-report	Past month	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	37	NR	No information	
44	PRAM-TSQ [50]

(English version)

	2009, USA	Adults	Type 1 or type 2 diabetes using pramlintide as adjunctive therapy with insulin	Self-report	Past 2 weeks	1. Specific benefits; 2. Absence of side effects; 3. Global benefits; 4. Treatment preference	14	6-point Likert scale	No information	
45	OHA-Q [52]

(Japanese version)

	2012, Japan	Adults	Oral hypoglycemic agent for type 2 diabetes	Self-report	Not specified	1. Treatment convenience; 2. Somatic symptom; 3. Satisfaction	20	NR	© Dr. Hitoshi Ishii. All rights reserved	
46	DMSRQ [53]

(English version)

	2012, USA	Adults	Diabetes medication	Self-report	Not specified	1. Convenience; 2. Negative events; 3. Interference; 4. Self-monitoring of blood glucose burden; 5. Efficacy; 6. Social burden; 7. Psychological well-being; 8. Treatment satisfaction; 9. Treatment preference	54	NR	© Mark Peyrot and Richard R. Rubin	
47	DMSRQ-SF [54]

(English version)

	2014, USA	Adults	Diabetes medication	Self-report	Not specified	1. Convenience satisfaction; 2. Negative events; 3. Interference; 4. Self-monitoring of blood glucose burden; 5. Efficacy; 6. Social burden; 7. Psychological well-being; 8. Treatment satisfaction; 9. Treatment preference if the respondent previously used another diabetes medication regimen	19	NR	No information	
B01 antithrombotic agents	
48	DASS [61–65]

(English, Brazilian–Portuguese, Maltese, Arabic, and Chinese version)

	2004, USA	Adults	Anticoagulation drugs	Self-report	Not specified	1. Limitations on physical exercise; 2. Diet restrictions; 3. Hassles and burdens; 4. Positive impacts	25	5-point Likert scale	No information	
49	PACT-Q [63, 66]

(English and Maltese version)

	2009, USA, France, Netherlands	Adults	Anticoagulation drugs	Self-report	Not specified	1. Convenience; 2. Burden of disease and treatment; 3. Anticoagulant treatment satisfaction	20	5-point Likert scale	© 2007 Sanofi-Aventis, France. All rights reserved	
50	ACTS [34, 68–73]

(English, Spanish, Danish, Japanese, Arabic, and Chinese version)

	2012, UK	Adults	Anticlot treatment	Self-report	Past 4 weeks	1. Burdens; 2. Benefits; 3. Global satisfaction	17	4-point Likert scale	© Bayer AG, 2006. All Rights Reserved	
B02 antihemorrhagics	
51	SQ-ISHI [136]

(English version)

	2021, USA	Children, teens and adults	Emicizumab for hemophilia A	Self-report	Not specified	1. Treatment’s ease of administration; 2. Convenience; 3. Influence on daily life; 4. Participant’s confidence and satisfaction	15	11-point Likert scale	© 2016, Roche Products Limited. All Rights Reserved	
B03 antianemic preparations	
52	SICT [134]

(English version)

	2009, USA, UK	Children, teens and adults	Iron chelation therapy	Self-report and parent/proxy report	Not specified	1. Effectiveness; 2. Safety/side effects; 3. Convenience; 4. Costs; 5. Overall satisfaction; 6. Impact on daily life; 7. Patient adherence; 8. Preferences	28	5-point Likert scale	No information	
53	ICT-sat [135]

(English version)

	2012, Egypt	Children, teens and adults	Iron chelation therapy for patients with β-thalassemia major	Self-report and parent/proxy report	Past 4 weeks	1. Perceived effectiveness; 2. Fear and worries; 3. Burden; 4. Side effects	15	5-point Likert scale	No information	
H02 corticosteroids for systemic use	
54	SSQ [133]

(English version)

	2017, USA	Adults	Steroid for systemic lupus erythematosus	Self-report	Past 7 days	1. Steroid dose/duration; 2. General impact of steroids; 3. Benefits of steroids; 4. Work/productivity; 5. Side effects; 6. Emotions; 7. Overall satisfaction	44	11-point Likert scale	© 2017 GlaxoSmithKline. All rights reserved	
L01 antineoplastic agents	
55	RASQ [95]

(English version)

	2016, USA	Adults	Rituximab for non-Hodgkin lymphoma	Interview-based	Most recent injection	1. Treatment satisfaction; 2. Convenience; 3. Physical impact; 4. Psychological impact; 5. Impact on activities of daily living	15	3-point or 5-point Likert scale	© 2013, Roche Products Limited. All Rights Reserved	
L04 immunosuppressants	
56	PESaM [126, 127]

(English and Dutch version)

	2017, Netherlands	Adults	Pirfenidone (for idiopathic pulmonary fibrosis) and eculizumab (for atypical hemolytic uremic syndrome)	Interview-based	Past 4 weeks	1. Effectiveness; 2. Side effects; 3. Ease of use; 4. Overall satisfaction	16	5-point Likert scale	Instrument copyrighted by the MUMC (Maastricht University Medical Centre)	
57	TASQ [137]

(English version)

	2021, UK	Adults	Eculizumab for rare paroxysmal nocturnal hemoglobinuria	Interview-based	Not specified	1. Treatment satisfaction; 2. Convenience; 3. Physical impact; 4. Psychological impact; 5. Impact on activities of daily living	12	5-point Likert scale	No information	
N02 analgesics	
58	SPM [84]

(Spanish version)

	2004, Spain	Adults	Pain medication	Self-report	Not specified	1. Speed/duration of effect; 2. Adverse events; 3. Functional benefit; 4. Overall satisfaction	10	5-point Likert scale	No information	
N03 antiepileptics	
59	Patient satisfaction with antiepileptic drugs/epilepsy treatment [89]

(French version)

	2015, France	Adults	Antiepileptic drugs	Self-report	Not specified	NR	4	4-point Likert scale, 10-cmr VAS	No information	
N05 psycholeptics	
60	SWAM Scale® [101]

(English version)

	2005, UK	Teens and adults	Antipsychotic medication	Self-report	Not specified	1. Treatment acceptability; 2. Medication insight	23	5-point Likert scale	© 2001—2007, Diana Rofail. All Rights Reserved	
61	PASAP [103]

(French version)

	2005, France	Adults	Psychotropics	Self-report	Not specified	1. Efficacy; 2. Tolerability; 3. Convenience; 4. Therapeutic relationship; 5. Global satisfaction	9	5-point Likert scale	© Boehringer Ingelheim hold the copyright	
62	MSQ [104, 105]

(English version)

	2014, USA	Adults	Atypical antipsychotics	Self-report	Not specified	NR	10	6-point Likert scale	© Instrument copyrighted by the International Society for CNS Drug Development (ISCDD)	
N06 psychoanaleptics	
63	SAMS [102]

(German version)

	2011, Germany	Children and teens	Medication for attention deficit hyperactivity disorder	Self-report and parent/proxy report	Not specified	NR	13	6-point Likert scale	No information	
N07 other nervous system drugs	
64	SASMAT-METHER [106]

(Spanish version)

	1999, Spain	Adults	Methadone treatment for heroin-dependence	Self-report	Not specified	1. Overall satisfaction; 2. Pharmacotherapy; 3. Initiation; 4. Anti-addictive effect on main substance; 5. Mental state; 6. Physical state; 7. Personal functioning; 8. Acceptability; 9. Anti-addictive effect on secondary substances	44	5-point Likert scale	No information	
65	SASMAT-BUNHER [107]

(Spanish version)

	2014, Spain	Adults	Buprenorphine-naloxone sublingual tablets treatment for heroin addiction	Self-report	Not specified	1. Overall satisfaction; 2. Pharmacotherapy; 3. Initiation; 4. Anti-addictive effect on main substance; 5. Mental state; 6. Physical state; 7. Personal functioning; 8. Acceptability; 9. Anti-addictive effect on secondary substances	44	5-point Likert scale	No information	
R03 drugs for obstructive airway diseases	
66	PSAM [74]

(English version)

	2000, Canada	Adults	Asthma medication	Self-report	Past 2 weeks	NR	77	NR	No information	
S01 ophthalmologicals	
67	EDSQ [117, 118]

(English and French version)

	2007, France	Adults	Eye-drop for glaucoma	Interview-based	Not specified	1. Patient characteristics; 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 knowledge of the disease and the treatment	56	Likert scale	© Alcon Research, 2006. All rights reserved	
V01 allergens	
68	ESPIA [131, 132]

(English and Spanish version)

	2011, Spain	Adults	Allergen immunotherapy	Self-report	Not specified	1. Perceived efficacy; 2. Daily life activities/activities and environment; 3. Cost–benefit balance; 4. General satisfaction	16	5-point Likert scale	No information	
Not applicable to ATC classification	
69	TSTMQ [138]

(Persian version)

	2022, Iran	Adults	Traditional medicines treatment	Self-report	Not specified	1. Satisfaction with efficacy; 2. Satisfaction with convenience; 3. Overall satisfaction	14	5-point Likert scale	No information	
aThe classification of PROMs is based on the International Classification of Diseases 11th (ICD-11) Revision (https://icd.who.int/en)

bThe 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-toolkit/atc-classification)

The majority of M-TS PROMs (61, 88%) were self-reported, four (6%) were either self-reported or proxy-reported (e.g., by parents or clinicians), and the remaining four (6%) were health practitioner administered (e.g., through interviews). Data collection modes for self-reported PROMs include questionnaires (in paper and pen or electronic versions), interviews (face-to-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 copyright information, of which 28 belong to the pharmaceutical industry. Sixty-four PROMs (93%) provided free access to full questionnaires. Ten PROMs (14%) proved easy to be administrated and completed in the context of clinical trials.

The most commonly measured domains were convenience (40, 58%), side effects (39, 57%), and perceived effectiveness of medication (29, 42%) (Table 1). The most commonly 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 those clarified, 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 quality of evidence

Among sixty-four PROMs reported the development process (Table 2). All of these 64 PROMs described the construct measured and the target population. Ten reported 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]. Table 2 Development and content validity of PROMs for medication treatment satisfaction

PROM	PROM development	Content validity	
Design	Pilot study	Overall	Relevance	Comprehensiveness	Comprehensibility	Overall	
Rating	GRADE	Rating	GRADE	Rating	GRADE	Rating	GRADE	
Generic PROMs for M-TS	
TSQM-1.4	Doubtful	Doubtful	Doubtful	Sufficient	Low	Sufficient	Low	Sufficient	Low	Sufficient	Low	
TSQM-II	Doubtful	Doubtful	Doubtful	Sufficient	High	Inconsistent	Low	Sufficient	Low	Inconsistent	Moderate	
TSQM-9	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	
SATMED-Q	Doubtful	Doubtful	Doubtful	Sufficient	Moderate	Sufficient	Low	Sufficient	Low	Sufficient	Moderate	
Disease-specific PROMs for M-TS a	
Endocrine, nutritional, or metabolic diseases	
DTSQ-IP	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Low	Inconsistent	Low	Inconsistent	Low	
DIDS	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Low	Sufficient	Low	Inconsistent	Low	
ThyTSQ	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Low	Sufficient	Low	Inconsistent	Low	
MS-TSQ	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Insufficient	Low	Sufficient	Low	Inconsistent	Low	
Acro-TSQ	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Low	Sufficient	Low	Inconsistent	Low	
Diseases of the respiratory system	
SATQ	Doubtful	Inadequate	Inadequate	Inconsistent	Low	Sufficient	Low	Insufficient	Very low	Inconsistent	Very low	
PASAPQ	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Insufficient	Low	Sufficient	Low	Inconsistent	Low	
Diseases of the nervous system	
PPMQ	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Insufficient	Low	Inconsistent	Low	Inconsistent	Low	
PPMQ-R	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Low	Sufficient	Low	Inconsistent	Low	
MTSM	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Insufficient	Low	Sufficient	Low	Inconsistent	Low	
PTSS	Doubtful	Doubtful	Doubtful	Sufficient	Low	Insufficient	Low	Sufficient	Low	Inconsistent	Low	
MSTCQ	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Insufficient	Low	Inconsistent	Low	Inconsistent	Low	
Neoplasms	
CTSQ	Doubtful	Inadequate	Inadequate	Inconsistent	Moderate	Sufficient	Moderate	Sufficient	Moderate	Inconsistent	Moderate	
Diseases of the digestive system	
TSQ-G	Doubtful	Inadequate	Inadequate	Inconsistent	Low	Insufficient	Low	Inconsistent	Low	Inconsistent	Low	
GTSQ	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Insufficient	Low	Sufficient	Low	Inconsistent	Low	
TSQ-C	Doubtful	Inadequate	Inadequate	Inconsistent	Moderate	Sufficient	Low	Inconsistent	Very low	Inconsistent	Moderate	
SPACE-Q	Doubtful	Doubtful	Doubtful	Sufficient	Low	Sufficient	Low	Sufficient	Moderate	Sufficient	Moderate	
Certain infectious or parasitic diseases	
HIVTSQs	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Low	Sufficient	Low	Inconsistent	Low	
HIVTSQc	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Inconsistent	Very low	Inconsistent	Very low	Inconsistent	Very low	
ESTAR	Doubtful	Inadequate	Inadequate	Inconsistent	Low	Inconsistent	Very low	Inconsistent	Very low	Inconsistent	Very low	
GHerpTSQ	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Low	Sufficient	Low	Inconsistent	Low	
HCVTSat	Doubtful	Doubtful	Doubtful	Inconsistent	High	Sufficient	Low	Sufficient	Moderate	Inconsistent	Low	
Diseases of the visual system	
TSS-IOP	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Low	Insufficient	Low	Inconsistent	Low	
RetTSQs	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Low	Sufficient	Moderate	Inconsistent	Low	
Patient satisfaction with glaucoma treatment	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Low	Sufficient	Low	Inconsistent	Low	
MacTSQ	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Low	Sufficient	Low	Inconsistent	Low	
Diseases of the ear or mastoid process	
Patient satisfaction with treatment of otitis externa	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Low	Sufficient	Low	Inconsistent	Low	
Diseases of the skin	
DermaSat	Adequate	Doubtful	Doubtful	Sufficient	Moderate	Sufficient	Moderate	Sufficient	Low	Sufficient	Moderate	
Diseases of the musculoskeletal system or connective tissue	
OPSAT-Q	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Low	Sufficient	Low	Inconsistent	Low	
Diseases of the genitourinary system	
OAB-S	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Low	Sufficient	Low	Inconsistent	Low	
Conditions related to sexual health	
EDITS	Doubtful	Inadequate	Inadequate	Inconsistent	High	Inconsistent	Low	Inconsistent	Low	Inconsistent	Low	
TSS	Doubtful	Doubtful	Doubtful	Inconsistent	Moderate	Sufficient	Low	Sufficient	Moderate	Inconsistent	Moderate	
Drug-specific PROMs for M-TS b	
A10 drugs used in diabetes	
PSIT	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Insufficient	Low	Inconsistent	Low	Inconsistent	Low	
ITSQ	Adequate	Doubtful	Doubtful	Sufficient	Low	Sufficient	Very low	Sufficient	Low	Sufficient	Low	
DiabMedSat	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Very low	Inconsistent	Low	Inconsistent	Low	
DTTQ	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	
SOADAS	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Insufficient	Low	Sufficient	Low	Inconsistent	Low	
DM-SAT	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Moderate	Inconsistent	Moderate	Inconsistent	Low	
PAM-D	Doubtful	Doubtful	Doubtful	Sufficient	Low	Sufficient	Low	Inconsistent	Low	Inconsistent	Low	
PRAM-TSQ	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	
OHA-Q	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	Not assessed	
DMSRQ	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Low	Sufficient	Low	Inconsistent	Low	
DMSRQ-SF	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Low	Sufficient	Low	Inconsistent	Low	
B01 antithrombotic agents	
DASS	Doubtful	Doubtful	Doubtful	Sufficient	Low	Sufficient	Low	Sufficient	Low	Sufficient	Low	
PACT-Q	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Low	Sufficient	Moderate	Inconsistent	Moderate	
ACTS	Doubtful	Doubtful	Doubtful	Inconsistent	Moderate	Sufficient	Low	Sufficient	Low	Inconsistent	Moderate	
B02 antihemorrhagics	
SQ-ISHI	Doubtful	Doubtful	Doubtful	Inconsistent	High	Sufficient	Low	Sufficient	Moderate	Inconsistent	Moderate	
B03 antianemic preparations	
SICT	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Low	Inconsistent	Low	Inconsistent	Low	
ICT-sat	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Low	Sufficient	Low	Inconsistent	Low	
H02 corticosteroids for systemic use	
SSQ	Doubtful	Adequate	Doubtful	Inconsistent	Low	Sufficient	Low	Sufficient	Moderate	Inconsistent	Low	
L01 antineoplastic agents	
RASQ	doubtful	doubtful	doubtful	sufficient	low	sufficient	moderate	sufficient	moderate	sufficient	moderate	
L04 immunosuppressants	
PESaM	Doubtful	Doubtful	Doubtful	Inconsistent	Moderate	Sufficient	Low	Sufficient	Moderate	Inconsistent	Moderate	
TASQ	Not assessed	Not assessed	Not assessed	Inconsistent	Moderate	Insufficient	Very low	Sufficient	Moderate	Inconsistent	Moderate	
N02 analgesics	
SPM	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Insufficient	Low	Insufficient	Low	Inconsistent	Low	
N03 antiepileptics	
Patient satisfaction with antiepileptic Drugs/epilepsy treatment	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Insufficient	Low	Inconsistent	Low	Inconsistent	Low	
N05 psycholeptics	
SWAM Scale®	Doubtful	Doubtful	Doubtful	Inconsistent	Moderate	Sufficient	Low	Sufficient	Low	Inconsistent	Moderate	
PASAP	Doubtful	Doubtful	Doubtful	Sufficient	Moderate	Sufficient	Low	Sufficient	Moderate	Sufficient	Moderate	
MSQ	Doubtful	Inadequate	Inadequate	Inconsistent	Low	Insufficient	Very low	Inconsistent	Very low	Inconsistent	Very low	
N06 psychoanaleptics	
SAMS	Doubtful	Inadequate	Inadequate	Inconsistent	Low	Insufficient	Very low	Inconsistent	Very low	Inconsistent	Very low	
N07 other nervous system drugs	
SASMAT-METHER	Doubtful	Inadequate	Inadequate	Inconsistent	Low	Sufficient	Very low	Inconsistent	Very low	Inconsistent	Very low	
SASMAT-BUNHER	Doubtful	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Low	Sufficient	Low	Inconsistent	Low	
R03 drugs for obstructive airway diseases	
PSAM	Doubtful	Doubtful	Doubtful	Inconsistent	Moderate	Sufficient	Low	Sufficient	Moderate	Inconsistent	Moderate	
S01 ophthalmologicals	
EDSQ	Adequate	Doubtful	Doubtful	Inconsistent	Low	Sufficient	Low	Sufficient	Low	Inconsistent	Low	
V01 allergens	
ESPIA	Doubtful	Doubtful	Doubtful	Inconsistent	Moderate	Insufficient	Low	Inconsistent	Low	Inconsistent	Moderate	
Not applicable to ATC classification	
TSTMQ [138]	Doubtful	Doubtful	Doubtful	Inconsistent	Moderate	Insufficient	Low	Sufficient	Low	Inconsistent	Low	
aThe classification of PROMs is based on the International Classification of Diseases 11th (ICD-11) Revision (https://icd.who.int/en)

bThe 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-toolkit/atc-classification)

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

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 understood by the target population) (5/8, moderate; 3/8, low quality of 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 structural validity (all of which applied classical test theory), 13 had sufficient 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). 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 of evidence). Table 3 Measurement propertiesa of PROMs for medication treatment satisfaction

PROM	Structural validity	Construct validityb	Internal consistency	Test–retest reliability	Responsiveness b	
Convergent validity	Discriminative or known‐groups validity	
Rating	GRADE	Rating	GRADE	Rating	GRADE	Rating	GRADE	Rating	GRADE	Rating	GRADE	
Generic PROMs for M-TS	
TSQM-1.4	Sufficient	High	Sufficient	High	Sufficient	High	Sufficient	High	Not assessed		Not assessed		
TSQM-II	Sufficient	High	Sufficient	Moderate	Insufficient	Low	Sufficient	High	Sufficient	High	Not assessed		
TSQM-9	Sufficient	High	Sufficient	High	Sufficient	High	Sufficient	High	Sufficient	Moderate	Not assessed		
SATMED-Q	Sufficient	High	Sufficient	High	Sufficient	High	Sufficient	High	Sufficient	High	Indeterminate	NA	
Disease-specific PROMs for M-TS d	
Endocrine, nutritional, or metabolic diseases	
DTSQ-IP	Indeterminate	ΝΑ	Not assessed		Not assessed		Indeterminate	NA	Not assessed		Not assessed		
DIDS	Indeterminate	ΝΑ	Not assessed		Sufficient	High	Indeterminate	NA	Insufficient	High	Not assessed		
ThyTSQ	Indeterminate	NA	Not assessed		Not assessed		Indeterminate	NA	Not assessed		Not assessed		
MS-TSQ	Sufficient	High	Not assessed		Sufficient	High	Sufficient	High	Not assessed		Not assessed		
Acro-TSQ	Indeterminate	NA	Sufficient	Moderate	Sufficient	Moderate	Not assessed		Sufficient	Very low	Indeterminate	NA	
Diseases of the respiratory system	
SATQ	Indeterminate	ΝΑ	Sufficient	High	Sufficient	High	Indeterminate	NA	Sufficient	High	Not assessed		
PASAPQ	Indeterminate	ΝΑ	Not assessed		Sufficient	High	Indeterminate	NA	Not assessed		Indeterminate	NA	
Diseases of the nervous system	
PPMQ	Indeterminate	ΝΑ	Sufficient	High	Sufficient	High	Indeterminate	NA	Not assessed		Indeterminate	NA	
PPMQ-R	Sufficient	High	Sufficient	High	Sufficient	High	Sufficient	High	Sufficient	Low	Indeterminate	NA	
MTSM	Indeterminate	ΝΑ	Sufficient	High	Sufficient	High	Indeterminate	NA	Not assessed		Sufficient	High	
PTSS	Indeterminate	ΝΑ	Indeterminate	NA	Sufficient	High	Indeterminate	NA	Indeterminate	NA	Indeterminate	NA	
MSTCQ	Indeterminate	ΝΑ	Sufficient	High	Not assessed		Indeterminate	ΝΑ	Insufficient	Low	Not assessed		
Neoplasms	
CTSQ	Sufficient	Moderate	Sufficient	High	Sufficient	High	Sufficient	High	Indeterminate	ΝΑ	Not assessed		
Diseases of the digestive system	
TSQ-G	Indeterminate	ΝΑ	Sufficient	High	Sufficient	High	Indeterminate	ΝΑ	Indeterminate	ΝΑ	Not assessed		
GTSQ	Not assessed		Sufficient	High	Sufficient	High	Indeterminate	ΝΑ	Not assessed		Not assessed		
TSQ-C	Indeterminate	ΝΑ	Indeterminate		Sufficient	High	Indeterminate	ΝΑ	Not assessed		Not assessed		
SPACE-Q	Not assessed		Sufficient	High	Sufficient	High	Indeterminate	ΝΑ	Indeterminate	ΝΑ	Indeterminate	ΝΑ	
Certain infectious or parasitic diseases	
HIVTSQs	Indeterminate	ΝΑ	Not assessed		Sufficient	High	Indeterminate	ΝΑ	Not assessed		Not assessed		
HIVTSQc	Insufficient	Moderate	Not assessed		Sufficient	Moderate	Indeterminate	ΝΑ	Not assessed		Not assessed		
ESTAR	Indeterminate	ΝΑ	Sufficient	High	Not assessed		Indeterminate	ΝΑ	Sufficient	Very low	Not assessed		
GHerpTSQ	Indeterminate	ΝΑ	Not assessed		Not assessed		Indeterminate	ΝΑ	Not assessed		Not assessed		
HCVTSat	Sufficient	High	Not assessed		Not assessed		Sufficient	High	Not assessed		Sufficient	High	
Diseases of the visual system	
TSS-IOP	Indeterminate	ΝΑ	Sufficient	Moderate	Sufficient	High	Indeterminate	ΝΑ	Indeterminate	ΝΑ	Not assessed		
RetTSQs	Indeterminate	ΝΑ	Sufficient	High	Not assessed		Indeterminate	ΝΑ	Sufficient	High	Not assessed		
Patient Satisfaction with Glaucoma Treatment	Sufficient	high	Insufficient	High	Not assessed		Insufficient	High	Not assessed		Not assessed		
MacTSQ	Indeterminate	ΝΑ	Sufficient	High	Not assessed		Indeterminate	ΝΑ	Sufficient	Moderate	Not assessed		
Diseases of the ear or mastoid process	
Patient satisfaction with treatment of otitis externa	Not assessed		Sufficient	High	Not assessed		Indeterminate	ΝΑ	Not assessed		Not assessed		
Diseases of the skin	
DermaSat	Sufficient	Moderate	Insufficient	High	Sufficient	Low	Indeterminate	ΝΑ	Not assessed		Not assessed		
Diseases of the musculoskeletal system or connective tissue	
OPSAT-Q	Not assessed		Sufficient	High	Sufficient	Moderate	Indeterminate	ΝΑ	Indeterminate	ΝΑ	Not assessed		
Diseases of the genitourinary system	
OAB-S	Indeterminate	ΝΑ	Sufficient	High	Sufficient	High	Indeterminate	ΝΑ	Sufficient	Moderate	Indeterminate	ΝΑ	
Conditions related to sexual health	
EDITS	Not assessed		Not assessed		Not assessed		Indeterminate	ΝΑ	Sufficient	Low	Not assessed		
TSS	Not assessed		Sufficient	High	Not assessed		Indeterminate	ΝΑ	Not assessed	Sufficient	High	
Drug-specific PROMs for M-TS e	
A10 drugs used in diabetes	
PSIT	Indeterminate	NA	Not assessed		Sufficient	Moderate	Indeterminate	ΝΑ	Insufficient	Low	Not assessed		
ITSQ	Sufficient	High	Sufficient	High	Sufficient	High	Sufficient	High	Sufficient	Moderate	Sufficient	Moderate	
DiabMedSat	Indeterminate	NA	Not assessed		Sufficient	High	Indeterminate	ΝΑ	Not assessed		Not assessed		
DTTQ	Not assessed		Not assessed		Sufficient	High	Indeterminate	NA	Not assessed		Not assessed		
SOADAS	Indeterminate	ΝΑ	Sufficient	High	Sufficient	High	Indeterminate	ΝΑ	Sufficient	High	Not assessed		
DM-SAT	Indeterminate	ΝΑ	Sufficient	Moderate	Sufficient	Moderate	Indeterminate	ΝΑ	Not assessed		Not assessed		
PAM-D	Indeterminate	ΝΑ	Not assessed		Sufficient	High	Indeterminate	ΝΑ	Sufficient	Low	Not assessed		
PRAM-TSQ	Indeterminate	ΝΑ	Not assessed		Insufficient	High	Indeterminate	ΝΑ	Not assessed		Not assessed		
OHA-Q	Indeterminate	ΝΑ	Sufficient	High	Sufficient	High	Indeterminate	ΝΑ	Sufficient	Moderate	Not assessed		
DMSRQ	Indeterminate	ΝΑ	Sufficient	High	Sufficient	High	Indeterminate	ΝΑ	Sufficient	High	Not assessed		
DMSRQ-SF	Not assessed		Sufficient	High	Sufficient	High	Indeterminate	ΝΑ	Sufficient	High	Not assessed		
B01 antithrombotic agents	
DASS	Indeterminate	ΝΑ	Sufficient	High	Sufficient	High	Indeterminate	ΝΑ	Sufficient	Moderate	Not assessed		
PACT-Q	Insufficient	High	Not assessed		Sufficient	High	Indeterminate	ΝΑ	Indeterminate	NA	Not assessed		
ACTS	Indeterminate	ΝΑ	Sufficient	High	Sufficient	High	Indeterminate	ΝΑ	Sufficient	High	Sufficient	High	
B02 antihemorrhagics	
SQ-ISHI	Not assessed		Not assessed		Not assessed		Not assessed		Not assessed		Not assessed		
B03 antianemic preparations	
SICT	Indeterminate	ΝΑ	Sufficient	High	Sufficient	High	Sufficient	High	Not assessed		Not assessed		
ICT-sat	Sufficient	High	Sufficient	High	Sufficient	High	Sufficient	High	Indeterminate	ΝΑ	Not assessed		
H02 corticosteroids for systemic use	
SSQ	Not assessed		Not assessed		Not assessed		Not assessed		Not assessed		Not assessed		
L01 antineoplastic agents	
RASQ	Not assessed		Sufficient	High	Not assessed		Indeterminate	ΝΑ	Not assessed		Not assessed		
L04 immunosuppressants	
PESaM	Sufficient	High	Sufficient	High	Sufficient	High	Sufficient	High	Indeterminate	ΝΑ	Not assessed		
TASQ	Not assessed		Not assessed		Not assessed		Not assessed		Not assessed		Not assessed		
N02 analgesics	
SPM	Indeterminate	ΝΑ	Not assessed		Not assessed		Indeterminate	ΝΑ	Sufficient	Moderate	Sufficient	High	
N03 antiepileptics	
Patient satisfaction with antiepileptic drugs/epilepsy treatment	Not assessed		Not assessed		Not assessed		Not assessed		Not assessed		Not assessed		
N05 psycholeptics	
SWAM Scale®	Indeterminate	ΝΑ	Not assessed		Not assessed		Indeterminate	ΝΑ	Not assessed		Not assessed		
PASAP	Indeterminate	ΝΑ	Indeterminate	ΝΑ	Not assessed		Indeterminate	ΝΑ	Not assessed		Indeterminate	ΝΑ	
MSQ	Not assessed		Sufficient	High	Sufficient	High	Not assessed		Sufficient	Moderate	Not assessed		
N06 psychoanaleptics	
SAMS	Indeterminate	ΝΑ	Not assessed		Not assessed		Indeterminate	ΝΑ	Not assessed		Not assessed		
N07 other nervous system drugs	
SASMAT-METHER	Indeterminate	ΝΑ	Sufficient	Low	Not assessed		Indeterminate	ΝΑ	Indeterminate	ΝΑ	Not assessed		
SASMAT-BUNHER	Indeterminate	ΝΑ	Sufficient	High	Not assessed		Indeterminate	ΝΑ	Sufficient	Very low	Not assessed		
R03 drugs for obstructive airway diseases	
PSAM	Not assessed		Sufficient	Moderate	Sufficient	Moderate	Indeterminate	ΝΑ	Indeterminate	NA	Not assessed		
S01 ophthalmologicals	
EDSQ	Indeterminate	ΝΑ	Not assessed		Sufficient	Low	Indeterminate	ΝΑ	Not assessed		Not assessed		
V01 allergens	
ESPIA	Indeterminate	ΝΑ	Sufficient	High	Sufficient	High	Indeterminate	ΝΑ	Sufficient	Moderate	Indeterminate	ΝΑ	
Not applicable to ATC classification	
TSTMQ [138]	Insufficient	high	Not assessed		Not assessed		Indeterminate	ΝΑ	Sufficient	Moderate	Not assessed		
Score: 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

aThe 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 each measurement property will be accompanied by a grading for the quality of the evidence using the GRADE approach [17]

bIf 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 (changes in) 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]

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

dThe 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-toolkit/atc-classification)

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 to moderate; 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 the minimal 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 quality of evidence), and content validity (low quality evidence). Two generic PROMs (TSQM-1.4 [25–29] and SATMED-Q) [31, 37–40] demonstrated sufficient construct validity, structural validity, and internal consistency (high quality of 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 sufficient construct validity including convergent validity (39/69, 57%) and discriminative or known-groups validity (40/69, 58%) (high to moderate quality of evidence) but failed 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 results of the PROMs (i.e., the MIDs).

Introduction of the three PROMs for M-TS with sufficient validity 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 (5 items), and insulin delivery device satisfaction (6 items). According to the Allie database (i.e., a database for searching studies in PubMed and MEDLINE that involve a 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, the quality 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 shared four common domains including perceived effectiveness, side effects, convenience, and global satisfaction. The SATMED-Q had two additional domains (i.e., impact on daily 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 in children 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 for developing measures, providing a theoretical foundation facilitates defining key components and their relationships within the construct [6, 7]. Our study revealed that over 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 those with acute disease toward treatment satisfaction (e.g., chronic disease patients tend to emphasize long-term outcomes and quality of life, while acute disease patients prioritize 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 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 clearly report the process of cognitive interviews or other pilot tests of the PROMs damaging the transparency and rigor of 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, or predictive purpose was unclear); due to paucity of justification on the appropriateness of response option and recall period, we rated the comprehensiveness as insufficient; due to lack of justification on the understandability of 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 sufficient validity, 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 respond accurately to adult-oriented measures [149]. The validity, reliability, responsiveness, and feasibility of the PROMs developed for adults should be evaluated before they are applied 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 (moderate quality of evidence) (Table 2). The infrequent application of the PROMs for M-TS and wide use of PROMs with poor measurement properties indicates that potential stakeholders (e.g., clinicians or researchers) probably lack awareness and access to validated PROMs for M-TS.

The practical application of self-reporting in M-TS PROMs faces several challenges, particularly for specific populations. Individuals with mental health issues may struggle to report treatment satisfaction accurately due to cognitive impairments or emotional distress [150]. Those with 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 for inclusive PROM design, ensuring accessibility and comprehension for diverse patients. Alternative data collection methods, such as interviews or caregiver reports, should be considered for those unable to self-report reliably.

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 English-language 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 bias of 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 and might have missed PROMs for M-TS reported in other languages. 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 for each included PROM. Third, some evaluation criteria for measurement properties were subjective (e.g., for the 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 when discrepancy occurred. Fourth, we did not recommend PROMs based on the COSMIN guideline criteria (i.e., PROMs that have potential to be recommended as the most suitable PROM for those with evidence for sufficient content validity (any level) and sufficient internal consistency (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 practice

Confident 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 in different context and population. Further studies can pay more attention to assess the measurement properties of current 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 and validation of PROMs is needed to improve the reporting quality of studies on the development and validation of 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 the gap 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 enhance patient 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 and better health outcomes. Moreover, the use of PROMs can facilitate shared decision-making, empowering patients to be active participants in their own care. This patient-centered approach not only improves satisfaction but also contributes to more effective and efficient healthcare delivery. Ensuring that PROMs are culturally sensitive and accessible to all patient groups, including those with mental health issues, limited digital skills, and reading difficulties, is crucial for their widespread adoption and utility in diverse clinical settings.

Conclusions

Most current PROMs for M-TS demonstrated sufficient construct validity while only a few had sufficient content validity, structural validity, internal consistency, and test–retest reliability. Few PROMs reported responsiveness. Confident use of current PROMs requires further evaluation on the validity, reliability, responsiveness, and interpretability of current PROMs. Reporting guidelines are needed to enhance the reporting quality of the development and validation of PROMs for M-TS.

Supplementary Information

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.

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 Questionnaire

PRO Patient-reported outcome

FDA US Food and Drug Administration

EMA European Medicines Agency

PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analyses

GRADE Grading of Recommendations Assessment, Development, and Evaluation

ICC Intraclass correlation coefficient

RoB Risk of bias

ICD-11 International Classification of Diseases 11th

ATC 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 curve

MID 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 Treatment-methadone for Heroin Addiction questionnaire

SASMAT-BUNHER Satisfaction with Medications for Addiction Treatment-Buprenorphine-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 hand eczema questionnaire

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 patients questionnaire

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

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, and statistical analysis. LNZ: Concept and design, acquisition, analysis, or interpretation of data, administrative, technical, or material support, critical revision of 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 (to Lingli 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.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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