Drug therapy is a common method to cure diseases and relieve symptoms. The value of patient-reported outcome (PRO) in evaluating the effect of drug therapy has been increasingly paid attention. The PRO scale is a standardized questionnaire, which can scientifically evaluate the experiences and subjective effects of drug use from a patient-centered perspective, and help patients and clinicians make more reasonable medication decisions. By reviewing and sorting out relevant global literature, this paper found that the content of the PRO scales relevant to drug therapy focused on five fields: "medication satisfaction" "medication adherence" "drug treatment burden" "medication-related quality of life" and "adverse drug reactions". This paper described the basic information, measurement characteristics and application of common scales in recent years respectively, and summarized and analyzed the problems and enlightenment of scale development, aiming to provide theoretical reference for the selection, application and development of PRO scales.
1.姚慧娟, 李平, 刘昕竹, 等. 临床药师开展内科住院患者入院药物重整的药学服务实践[J]. 中国药房, 2017, 28(32): 4580-4584. [Yao HJ, Li P, Liu XZ, et al. Pharmaceutical care practice for admission medication reconciliation in the internal medicine inpatient by clinical pharmacists[J]. China Pharmacy, 2017, 28(32): 4580-4584.] DOI: 10.6039/j.issn.1001-0408.2017.32.31.
2.许静, 陈杰, 罗子玲. “药学服务联合体”服务模式实践分析与探索[J]. 中国医院管理, 2019, 39(1): 65-67. [Xu J, Chen J, Luo ZL, et al. Practice analysis and exploration of the working mode of pharmaceutical services alliance[J]. Chinese Hospital Management, 2019, 39(1): 65-67.] DOI: CNKI:SUN:YYGL.0.2019-01-034.
3.席晓宇, 姚东宁, 黄元楷, 等. 我国三级医院临床药学服务现状及问题研究(二): 临床药师团队建设现状分析[J]. 中国药学杂志, 2018, 53(6):472-476. [Xi XY, Yao DN, Hang YK, et al. National survey on clinical pharmacy services of tertiary hospitals in China: Part 2. staffing of clinical pharmacist team[J]. Chinese Pharmaceutical Journal, 2018, 53(6): 472-476.] DOI: 10.11669/cpj. 2018.06.014.
4.Churruca K, Pomare C, Ellis LA, et al. Patient-reported outcome measures (PROMs): a review of generic and condition-specific measures and a discussion of trends and issues[J]. Health Expect, 2021, 24(4): 1015-1024. DOI: 10.1111/hex.13254.
5.Basch E, Dueck AC. Patient-reported outcome measurement in drug discovery: a tool to improve accuracy and completeness of efficacy and safety data[J]. Expert Opin Drug Discov, 2016, 11(8): 753-758. DOI: 10. 1080/17460441.2016.1193148.
6.隆莉芝, 袁玲. 患者报告结局的应用近况及思考[J]. 中国全科医学, 2020, 23(32): 4120-4127. [Long LZ, Yuan L. The application and consideration of patient-reported outcomes[J]. Chinese General Practice, 2020, 23(32): 4120-4127.] DOI: 10.12114/j.issn.1007-9572. 2020.00.015.
7.Black N. Patient reported outcome measures could help transform healthcare[J]. BMJ, 2013, 346: f167. DOI: 10. 1136/bmj.f167.
8.Atkinson MJ, Sinha A, Hass SL, et al. Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease[J]. Health Qual Life Outcomes, 2004, 2: 12. DOI: 10.1186/1477-7525-2-12.
9.Chen H, Rosenzweig EB, Gotzkowsky SK, et al. Treatment satisfaction is associated with improved quality of life in patients treated with inhaled treprostinil for pulmonary arterial hypertension[J]. Health Qual Life Outcomes, 2013, 11: 31. DOI: 10.1186/1477-7525-11-31.
10.Trujols J, Iraurgi I, Siñol N, et al. Satisfaction with methadone as a medication: psychometric properties of the Spanish version of the treatment satisfaction questionnaire for medication[J]. J Clin Psychopharmacol, 2012, 32(1): 69-74. DOI: 10.1097/JCP.0b013e3182401e09.
11.尚雅彬, 刘红霞, 于立新, 等. 药物治疗满意度量表的跨文化调试及其在肾移植受者中应用的信度效度检验[J]. 中国护理管理, 2018, 18(5): 612-616. [Shang YB, Liu HX, Yu LX, et al. Transcultural adaptation of the treatment satisfaction questionnaire for medication[J]. Chinese Nursing Management, 2018, 18(5): 612-616.] DOI: 10.3969/j.issn.1672-1756.2018.05.008.
12.Atkinson MJ, Kumar R, Cappelleri JC, et al. Hierarchical construct validity of the treatment satisfaction questionnaire for medication (TSQM version Ⅱ) among outpatient pharmacy consumers[J]. Value Health, 2005, 8(1): S9-S24. DOI: 10.1111/j.1524-4733.2005.00066.x.
13.沈志莹, 丁四清, 钟竹青, 等. 药物治疗满意度量表第二版中文版测评高血压患者的效度和信度[J]. 中国心理卫生杂志, 2021, 35(4): 277-283. [Shen ZY, Ding SQ, Zhong ZQ, et al. Validity and reliability of the Chinese version of the treatment satisfaction questionnaire for medication-second edition in patients with hypertension[J]. Chinese Mental Health Journal, 2021, 35(4): 277-283.] DOI: 10.3969/j.issn.1000-6729.2021.04.003.
14.Ruiz MA, Pardo A, Rejas J, et al. Development and validation of the "Treatment Satisfaction with Medicines Questionnaire" (SATMED-Q)[J]. Value Health, 2008, 11(5): 913-926. DOI: 10.1111/j.1524-4733.2008.00323.x.
15.López-Torres López J, Rabanales-Sotos J, López-Torres Hidalgo MR, et al. Reliability and validity of the treatment satisfaction with medicines questionnaire (SATMED-Q) in persons with arterial hypertension[J]. Int J Environ Res Public Health, 2021, 18(6): 3212. DOI: 10.3390/ijerph18063212.
16.Świątoniowska-Lonc N, Kołtuniuk A, Jankowska-Polańska B. Psychometric properties of the treatment satisfaction with medicines questionnaire (SATMED-Q) in patients with diabetes, arterial hypertension and heart failure[J]. Int J Environ Res Public Health, 2022, 19(3): 1088. DOI: 10.3390/ijerph19031088.
17.Kwan YH, Weng SD, Loh DHF, et al. Measurement properties of existing patient-reported outcome measures on medication adherence: systematic review[J]. J Med Internet Res, 2020, 22(10): e19179. DOI: 10.2196/19179.
18.Naqvi AA, Hassali MA, Rizvi M, et al. Development and validation of a novel general medication adherence scale (GMAS) for chronic illness patients in Pakistan[J]. Front Pharmacol, 2018, 9: 1124. DOI: 10.3389/fphar. 2018.01124.
19.Naqvi AA, Hassali MA, Jahangir A, et al. Translation and validation of the English version of the general medication adherence scale (GMAS) in patients with chronic illnesses[J]. J Drug Assess, 2019, 8(1): 36-42. DOI: 10. 1080/21556660.2019.1579729.
20.Nguyen TH, Truong HV, Vi MT, et al. Vietnamese version of the general medication adherence scale (GMAS): translation, adaptation, and validation[J]. Healthcare (Basel), 2021, 9(11): 1471. DOI: 10.3390/healthcare9111471.
21.Kwan YH, Weng SD, Loh DHF, et al. Measurement properties of existing patient-reported outcome measures on medication adherence: systematic review[J]. J Med Internet Res, 2020, 22(10): e19179. DOI: 10.2196/19179.
22.Shrestha R, Sapkota B, Khatiwada AP, et al. Translation, cultural adaptation and validation of general medication adherence scale (GMAS) into the Nepalese language[J]. Patient Prefer Adherence, 2021, 15: 1873-1885. DOI: 10. 2147/PPA.S320866.
23.Wang Y, Wang X, Wang X,et al. Translation and validation of the Chinese version of the general medication adherence scale (GMAS) in patients with chronic illness[J]. Curr Med Res Opin, 2021, 37(5): 829-837. DOI: 10. 1080/03007995.2021.1901680.
24.Garfield S, Eliasson L, Clifford S, et al. Developing the diagnostic adherence to medication scale (the DAMS) for use in clinical practice[J]. BMC Health Serv Res, 2012, 12:350. DOI: 10.1186/1472-6963-12-350.
25.Cameron KA, Ross EL, Clayman ML, et al. Measuring patients' self-efficacy in understanding and using prescription medication[J]. Patient Educ Couns, 2010, 80(3): 372-376. DOI: 10.1016/j.pec.2010.06.029.
26.Al Abboud SA, Ahmad S, Bidin MB, et al. Validation of malaysian versions of perceived diabetes self-management scale (PDSMS) medication understanding and use self-efficacy scale (MUSE) and 8-morisky medication adherence scale (MMAS-8) using partial credit rasch model[J]. J Clin Diagn Res, 2016, 10(11): LC01-LC05. DOI: 10.7860/JCDR/2016/15079.8845.
27.Maleki S, Glewis S, Fua T, et al. A randomised controlled trial of clinical pharmacy intervention versus standard care to improve medication adherence in outpatients with head and neck cancer receiving radiotherapy[J]. Support Care Cancer, 2022, 30(5): 4243-4253. DOI: 10.1007/s00520-021-06779-5.
28.Tran VT, Montori VM, Eton DT, et al. Development and description of measurement properties of an instrument to assess treatment burden among patients with multiple chronic conditions[J]. BMC Med, 2012, 10: 68. DOI: 10. 1186/1741-7015-10-68.
29.Tran VT, Harrington M, Montori VM, et al. Adaptation and validation of the treatment burden questionnaire (TBQ) in English using an internet platform[J]. BMC Med, 2014, 12: 109. DOI: 10.1186/1741-7015-12-109.
30.Chin WY, Wong CKH, Ng CCW, et al. Cultural adaptation and psychometric properties of the Chinese burden of treatment questionnaire (C-TBQ) in primary care patients with multi-morbidity[J]. Fam Pract, 2019, 36(5): 657-665. DOI: 10.1093/fampra/cmz008.
31.Duncan P, Murphy M, Man MS, et al. Development and validation of the multimorbidity treatment burden questionnaire (MTBQ)[J]. BMJ Open, 2018, 8(4): e019413. DOI: 10.1136/bmjopen-2017-019413.
32.Friis K, Lasgaard M, Pedersen MH, et al. Health literacy, multimorbidity, and patient-perceived treatment burden in individuals with cardiovascular disease. A Danish population-based study[J]. Patient Educ Couns, 2019, 102(10): 1932-1938. DOI: 10.1016/j.pec.2019.05.013.
33.Schulze J, Breckner A, Duncan P, et al. Adaptation and validation of a german version of the multimorbidity treatment burden questionnaire[J]. Health Qual Life Outcomes, 2022, 20(1): 90. DOI: 10.1186/s12955-022-01993-z.
34.Guénette L, Turcotte V, Bélanger L,et al. Multimorbidity treatment burden questionnaire (MTBQ): translation, cultural adaptation, and validation in French-Canadian[J]. Can J Aging, 2022, 10: 1-9. DOI: 10.1017/S0714980822000058.
35.Dou L, Huang J, Duncan P, et al. Translation, cultural adaptation and validation of the Chinese multimorbidity treatment burden questionnaire (C-MTBQ): a study of older hospital patients[J]. Health Qual Life Outcomes, 2020, 18(1): 194. DOI: 10.1186/s12955-020-01395-z.
36.Krska J, Morecroft CW, Rowe PH, et al. Measuring the impact of long-term medicines use from the patient perspective[J]. Int J Clin Pharm, 2014, 36(4): 675-678. DOI: 10.1007/s11096-014-9970-5.
37.Krska J, Katusiime B, Corlett SA. Validation of an instrument to measure patients' experiences of medicine use: the living with medicines questionnaire[J]. Patient Prefer Adherence, 2017, 11: 671-679. DOI: 10.2147/PPA.S126647.
38.Katusiime B, Corlett SA, Krska J. Development and validation of a revised instrument to measure burden of long-term medicines use: the living with medicines questionnaire version 3[J]. Patient Relat Outcome Meas, 2018, 9: 155-168. DOI: 10.2147/PROM.S151143.
39.James KA, Cadel L, Hitzig SL, et al Patient-reported outcome measures for medication-related quality of life: a scoping review[J]. Res Social Adm Pharm, 2022, 18(9): 3501-3523. DOI: 10.1016/j.sapharm.2022.03.003.
40.Tseng HM, Lee CH, Chen YJ, et al. Developing a measure of medication-related quality of life for people with polypharmacy[J]. Qual Life Res, 2016, 25(5): 1295-1302. DOI: 10.1007/s11136-015-1177-2.
41.Tegegn HG, Erku DA, Sebsibe G, et al. Medication-related quality of life among Ethiopian elderly patients with polypharmacy: a cross-sectional study in an Ethiopia university hospital[J]. PLoS One, 2019, 14(3): e0214191. DOI: 10.1371/journal.pone.0214191.
42.Mohammed MA, Moles RJ, Hilmer SN, et al. Development and validation of an instrument for measuring the burden of medicine on functioning and well-being: the medication-related burden quality of life (MRB-QoL) tool[J]. BMJ Open, 2018, 8(1): e018880. DOI: 10.1136/bmjopen-2017-018880.
43.Sakthong P, Suksanga P, Sakulbumrungsil R, et al. Development of patient-reported outcomes measure of pharmaceutical therapy for quality of life (PROMPT-QoL): a novel instrument for medication management[J]. Res Social Adm Pharm, 2015, 11(3): 315-338. DOI: 10.1016/j.sapharm.2014.10.002.
44.Lim R, Ellett LK, Roughead EE, et al. Patient-reported questionnaires to identify adverse drug reactions: a systematic review[J]. Int J Environ Res Public Health, 2021, 18(22): 11877. DOI: 10.3390/ijerph182211877.
45.Schoenmakers TW, Teichert M, Wensing M, et al. Evaluation of potentially drug-related patient-reported common symptoms assessed during clinical medication reviews: a cross-sectional observational study[J]. Drug Saf, 2017, 40(5): 419-430. DOI: 10.1007/s40264-017-0504-7.
46.de Vries ST, Mol PG, de Zeeuw D, et al. Development and initial validation of a patient-reported adverse drug event questionnaire[J]. Drug Saf, 2013, 36(9): 765-777. DOI: 10.1007/s40264-013-0036-8.
47.Cella D, Hays RD. A patient reported outcome ontology: conceptual issues and challenges addressed by the patient-reported outcomes measurement information system® (PROMIS®)[J]. Patient Relat Outcome Meas, 2022, 13: 189-197. DOI: 10.2147/PROM.S371882.
48.刁莎, 杨梦婷, 曾力楠, 等. 医学评估量表用户手册撰写框架的定性系统评价[J]. 医学新知, 2022, 32(1): 10-22. [Diao S, Yang MT, Zeng LN, et al. The framework of user's manuals for assessment scales in the medical fields: a qualitative systematic review[J]. New Medicine, 2022, 32(1): 10-22.] DOI: 10.12173/j.issn.1004-5511. 202111007.
49.Reeve BB, Wyrwich KW, Wu AW, et al. ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research[J]. Qual Life Res, 2013, 22(8): 1889-1905. DOI: 10.1007/s11136-012-0344-y.
50.Czerwonka N, Desai SS, Arciero E, et al. Contemporary review: an overview of the utility of patient-reported outcome measurement information system (PROMIS) in foot and ankle surgery[J]. Foot Ankle Int, 2023, 44(6): 554-564. DOI: 10.1177/10711007231165752.
51.刘衍波. 电子化和传统纸质病人报告的临床结局数据质量的比较[D]. 上海: 复旦大学, 2013. DOI: 10.7666/d.Y2704331.