Translation of the Patient-reported Outcomes Measure of Pharmaceutical Therapy for Quality of Life and Its Validation in Elderly Patients with Polypharmacy

doi:10.12114/j.issn.1007-9572.2023.0281

Abstract

Abstract:

Background

There is a high prevalence of polypharmacy among elderly patients with severe situation. There is an urgent need for more comprehensive and objective tools to assess the benefits and risks of medication use in patients to ensure maximum length of life and quality of life for patients.

Objective

To translate the Patient-reported Outcomes Measure of Pharmaceutical Therapy for Quality of Life (PROMPT-QoL) Scale into Chinese and evaluate its reliability and validity among elderly patients with polypharmacy.

Methods

With the authorization of the original author, Brislin's translation model of forward-back translation, cultural adaptation, and cognitive interviews were used to develop a test draft of the Chinese version of the PROMPT-QoL. Elderly patients with polypharmacy who visited outpatient clinics, received health checkups and took medicine at community health centers of Gongyuan street, Beishan street and Henan street, Yanji Hospital and Yanbian University Hospital from June to August in 2022 were selected as the survey respondents. Item analysis was conducted using the item-dimension correlation analysis and the critical ratio (CR). The content validity of the scale was evaluated using the item-level content validity index (I-CVI), universal agreement scale-level CVI (S-CVI/UA) and average scale-level CVI (S-CVI/AVE). Structural validity was evaluated using exploratory factor analysis (EFA) and confirmatory factor analysis (CFA). Internal consistency tests (Cronbach's alpha coefficient) and the split-half coefficient were used to assess reliability.

Results

A total of 590 patients were investigated and 564 valid data were recovered, with a recovery rate of 95.8%. Among them, 234 data were applied to the item analysis and EFA in the first stage, and 330 data were applied to the CFA in the second stage. The correlation coefficients between the scores of each item and the scores of each dimension ranged from 0.504~0.915 (P<0.01), and the CR value of each item was >3.0 (P<0.05). The I-CVI ranged from 0.89 to 1.00, the S-CVI/UA was 0.91>0.80, and the S-CVI/Ave was 0.99>0.90. A total of 8 common factors were extracted from EFA, which were basically consistent with the results of the source questionnaire, among which item G34 had a loading of <0.40 on the common factor to which it belonged, so this item was deleted. CFA was performed on the remaining 41 items as follows: χ²/df=2.160, goodness of fit index (GFI) =0.791, normed fit index (NFI) =0.848, incremental fit index (IFI) =0.912, comparative fit idex (CFI) =0.911, Tucker-Lewis index (TLI) =0.902, root mean square error of approximation (RMSEA) =0.059. In the reliability test, Cronbach's α coefficient for the scale was 0.839, Cronbach's α coefficient for each dimension ranged from 0.823 to 0.955, and the split-half coefficient of each dimension ranged from 0.815 to 0.957.

Conclusion

The Chinese version of the PROMPT-QoL scale has good reliability and validity, and can be applied to evaluate the pharmaceutical therapy-related quality of life of elderly patients with polypharmacy in China.

Key words: Polypharmacy, Patient reported outcome measures, Pharmaceutical therapy-related quality of life, Patient-reported Outcomes Measure of Pharmaceutical Therapy for Quality of Life Scale, Aged, Validation, Reliability

摘要：

背景

老年多重用药人群数量庞大，用药形势严峻，为保证用药患者生命长度与质量最大化，亟需使用特异性测评工具更加全面、客观地评估患者用药后的益处及风险。

目的

汉化基于患者报告结局用药相关生活质量量表（PROMPT-QoL），并评价该量表在老年多重用药患者中的信度和效度。

方法

征得原作者的授权，采用Brislin的双人直译-回译法、文化调适、认知性访谈，形成中文版PROMPT-QoL施测稿。于2022年6—8月便利选取延吉市公园街道、北山街道及河南街道社区卫生服务中心、延吉市医院及延边大学附属医院门诊就诊、健康体检、取药的老年多重用药患者作为调查对象。采用条目-维度相关分析法和决断值法进行项目分析；采用条目水平的内容效度指数（I-CVI）、全体一致量表水平的内容效度指数（S-CVI/UA）和平均S-CVI（S-CVI/Ave）评价量表的内容效度；采用探索性因子分析（EFA）和验证性因子分析（CFA）检验结构效度；采用内部一致性（Cronbach's α系数）和折半信度检验量表的信度。

结果

共调查590例患者，回收有效资料564份，有效回收率为95.8%。其中234份资料应用于第一阶段的项目分析和EFA，330份资料应用于第二阶段的CFA。各条目得分与各维度得分的相关系数为0.504~0.915（P<0.01），各条目决断值（CR值）均>3.0（P<0.05）；I-CVI为0.89~1.00，S-CVI/UA为0.91>0.80，S-CVI/Ave为0.99>0.90；EFA共提取8个公因子，与源问卷结构基本相符，其中条目G34在所属公因子上的载荷量<0.40，故删除条目G34；对剩余41个条目进行CFA，χ²/df=2.160，拟合优度指数（GFI）=0.791，规范拟合指数（NFI）=0.848，增值拟合指数（IFI）=0.912，比较拟合指数（CFI）=0.911，非标准拟合指数（TLI）=0.902，近似误差均方根（RMSEA）=0.059；总量表Cronbach's α系数为0.839，各维度Cronbach's α系数为0.823~0.955（P<0.01）；各维度的折半信度为0.815~0.957（P<0.01）。

结论

经汉化和文化调适后的中文版PROMPT-QoL信效度良好，可应用于我国老年多重用药患者的用药相关生活质量水平的评估。

关键词: 多重用药, 患者报告结局评价, 用药相关生活质量, 患者报告结局用药相关生活质量量表, 老年人, 信度, 效度

XU Huijing,WU Shanyu,JIANG Jiawei, et al. Translation of the Patient-reported Outcomes Measure of Pharmaceutical Therapy for Quality of Life and Its Validation in Elderly Patients with Polypharmacy[J]. Chinese General Practice, 2024, 27(05): 612-621. DOI: 10.12114/j.issn.1007-9572.2023.0281.
许惠靖,吴善玉,蒋佳玮等. 基于患者报告结局用药相关生活质量量表的汉化及其在老年多重用药患者中的信效度研究[J]. 中国全科医学, 2024, 27(05): 612-621. DOI: 10.12114/j.issn.1007-9572.2023.0281.

Figures/Tables 9

References 24

[1]	中国发展研究基金会. 创新铸就健康基业：公共卫生领域的创新研究[M]. 北京：中国发展出版社，2019.
[2]	GBD Viewpoint Collaborators. Five insights from the global burden of disease study 2019[J]. Lancet，2020,396(10258): 1135-1159. DOI：10.1016/S0140-6736(20)31404-5.
[3]	王可，唐静，杨昆，等. 中国14省27家医院住院老年慢病患者多重用药现状横断面研究[J]. 药物流行病学杂志，2022,31(1): 38-44. DOI：10.19960/j.cnki.issn1005-0698.2022.01.006.
[4]	徐倩. 老年住院患者共病与多重用药的分析[D]. 昆明：昆明医科大学，2017.
[5]	王永利，栾文艳，郭亚雯，等. 居家老年多病共存患者多重用药体验的质性研究[J]. 中国全科医学，2020,23(17): 2197-2202. DOI：10.3969/j.issn.1008-9993.2014.22.001.
[6]	MOHAMMED M A, MOLES R J, CHEN T F. Impact of pharmaceutical care interventions on health-related quality-of-life outcomes：a systematic review and meta-analysis[J]. Ann Pharmacother，2016,50(10): 862-881. DOI：10.1177/1060028016656016.
[7]	许清安，常履华，万崇华，等. 基于健康调查量表的脑卒中患者报告结局与临床客观指标的相关性研究[J]. 中国全科医学，2018,21(6): 643-647. DOI：10.3969/j.issn.1007-9572.2017.00.193.
[8]	JONES J B, SNYDER C F, WU A W. Issues in the design of Internet-based systems for collecting patient-reported outcomes[J]. Qual Life Res，2007,16(8): 1407-1417. DOI：10.1007/s11136-007-9235-z.
[9]	SAKTHONG P. Relationships between pharmaceutical therapy-related quality of life and health utility scores in Thai patients with chronic diseases[J]. Value Health Reg Issues，2020,21: 222-225. DOI：10.1016/j.vhri.2019.12.003.
[10]	ABDELA O A, ABAY E, BEKA S，et al. Medication-related needs and humanistic impact of patient-centered pharmaceutical care at university of Gondar comprehensive specialized hospital，north-west Ethiopia[J]. Integr Pharm Res Pract，2020,9: 229-242. DOI：10.2147/IPRP.S268248.
[11]	SAKTHONG P, SURIYAPAKORN B. Medication-related quality of life in Thai epilepsy patients[J]. J Epilepsy Res，2019,9(2): 139-146. DOI：10.14581/jer.19016.
[12]	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.
[13]	SAKTHONG P, CHINTHAMMIT C, SUKARNJANASET P，et al. Psychometric properties of the patient-reported outcomes measure of pharmaceutical therapy for quality of life （PROMPT-QOL）[J]. Value Health Reg Issues，2017,12: 41-49. DOI：10.1016/j.vhri.2017.02.003.
[14]	JONES P S, LEE J W, PHILLIPS L R，et al. An adaptation of Brislin's translation model for cross-cultural research[J]. Nurs Res，2001,50(5): 300-304. DOI：10.1097/00006199-200109000-00008.
[15]	SOUSA V D, ROJJANASRIRAT W. Translation，adaptation and validation of instruments or scales for use in cross-cultural health care research：a clear and user-friendly guideline[J]. J Eval Clin Pract，2011,17(2): 268-274. DOI：10.1111/j.1365-2753.2010.01434.x.
[16]	BOOMSMA A. The robustness of LISREL against small sample sizes in factor analysis models[M]//JÖRESKOG K G，WOLD H. Systems under indirect observation：causality，structure，prediction （Part I）. Amsterdam：North-Holland，1982.
[17]	CHARLSON M E, POMPEI P, ALES K L，et al. A new method of classifying prognostic comorbidity in longitudinal studies：development and validation[J]. J Chronic Dis，1987,40(5): 373-383. DOI：10.1016/0021-9681(87)90171-8.
[18]	蒋红莲，闫伟，路云. 老年共病指数的应用与推广问题研究[J]. 中国慢性病预防与控制，2020,28(7): 548-551. DOI：10.16386/j.cjpccd.issn.1004-6194.2020.07.017.
[19]	郑日昌. 心理测量学[M]. 北京：人民教育出版社，1999.
[20]	吴明隆. 问卷统计分析实务：SPSS操作与应用[M]. 重庆：重庆大学出版社，2010.
[21]	王永利，张振香，林蓓蕾，等. 用药生活问卷的汉化及其在社区老年多重用药患者中的信效度分析[J]. 中国全科医学，2020,23(15): 1864-1872. DOI：10.12114/j.issn.1007-9572.2020.00.234.
[22]	李嘉音. 预立医疗照护计划参与问卷汉化及在社区老年慢病患者中的应用研究[D]. 郑州：郑州大学，2021.
[23]	李跃平，黄子杰. 验证性因子分析在量表结构效度考核中作用[J]. 中国公共卫生，2007,23(10): 1198-1199. DOI：10.3321/j.issn:1001-0580.2007.10.024.
[24]	吴明隆. 结构方程模型：AMOS的操作与应用[M]. 重庆：重庆大学出版社，2009.

项目	例数	构成比（%）	项目	例数	构成比（%）
性别			确诊疾病患病年限（年）
男	245	43.4	<5	131	23.3
女	319	56.6	5~10	285	50.5
年龄（岁）			>10	148	26.2
60~69	230	40.8	自感疾病控制情况
70~79	279	49.4	差	38	6.7
80~89	55	9.8	一般	290	51.5
民族			好	236	41.8
汉族	391	69.3	每月药费支出（元）
朝鲜族及其他	173	30.7	<100	14	2.5
文化程度			100~200	8	15.1
小学及以下	222	39.4	>200~500	243	43.0
初中	200	35.4	>500	222	39.4
高中及中专	102	18.1	每日用药种类（种）
大专及以上	40	7.1	5~10	358	63.5
婚姻状况			11~15	106	18.8
已婚	431	76.4	>15	100	17.7
未婚/离异/丧偶	133	23.6	用药年限（年）
居住情况			<1	20	3.5
独居	83	14.7	1~4	135	23.9
与配偶同住	309	54.8	5~9	245	43.4
其他	172	30.5	10~20	118	20.9
家庭人均月收入（元）			>20	46	8.3
<3 000	303	53.7	是否经历过用药不良反应
3 000~5 000	208	36.9	否	125	22.2
>5 000	53	9.4	是	439	77.8
医疗付费方式			用药一般态度
城镇职工医保	110	19.5	药物治疗	253	44.8
城乡居民医保	328	58.2	补充和替代疗法	24	4.3
其他	126	22.3	药物治疗联合替代疗法	287	50.9
CCI分级
中度	206	36.5
重度	358	63.5

项目	例数	构成比（%）	项目	例数	构成比（%）
性别			确诊疾病患病年限（年）
男	245	43.4	<5	131	23.3
女	319	56.6	5~10	285	50.5
年龄（岁）			>10	148	26.2
60~69	230	40.8	自感疾病控制情况
70~79	279	49.4	差	38	6.7
80~89	55	9.8	一般	290	51.5
民族			好	236	41.8
汉族	391	69.3	每月药费支出（元）
朝鲜族及其他	173	30.7	<100	14	2.5
文化程度			100~200	8	15.1
小学及以下	222	39.4	>200~500	243	43.0
初中	200	35.4	>500	222	39.4
高中及中专	102	18.1	每日用药种类（种）
大专及以上	40	7.1	5~10	358	63.5
婚姻状况			11~15	106	18.8
已婚	431	76.4	>15	100	17.7
未婚/离异/丧偶	133	23.6	用药年限（年）
居住情况			<1	20	3.5
独居	83	14.7	1~4	135	23.9
与配偶同住	309	54.8	5~9	245	43.4
其他	172	30.5	10~20	118	20.9
家庭人均月收入（元）			>20	46	8.3
<3 000	303	53.7	是否经历过用药不良反应
3 000~5 000	208	36.9	否	125	22.2
>5 000	53	9.4	是	439	77.8
医疗付费方式			用药一般态度
城镇职工医保	110	19.5	药物治疗	253	44.8
城乡居民医保	328	58.2	补充和替代疗法	24	4.3
其他	126	22.3	药物治疗联合替代疗法	287	50.9
CCI分级
中度	206	36.5
重度	358	63.5

条目	r值	条目	r值	条目	r值
B2	0.721^a	D16	0.710^a	E30	0.665^a
B3	0.751^a	D17	0.777^a	F31	0.807^a
B4	0.692^a	D18	0.697^a	F32	0.789^a
B5	0.528^a	D19	0.738^a	F33	0.826^a
B6	0.792^a	D20	0.612^a	G34	0.504^a
B7	0.722^a	D21	0.789^a	G35	0.843^a
B8	0.772^a	E22	0.661^a	G36	0.915^a
B9	0.799^a	E23	0.571^a	G37	0.890^a
B10	0.752^a	E24	0.621^a	H38	0.766^a
C11	0.822^a	E25	0.693^a	H39	0.851^a
C12	0.805^a	E26	0.712^a	H40	0.870^a
C13	0.869^a	E27	0.737^a	I41	0.905^a
D14	0.751^a	E28	0.683^a	I42	0.897^a
D15	0.740^a	E29	0.751^a	I43	0.802^a

条目	r值	条目	r值	条目	r值
B2	0.721^a	D16	0.710^a	E30	0.665^a
B3	0.751^a	D17	0.777^a	F31	0.807^a
B4	0.692^a	D18	0.697^a	F32	0.789^a
B5	0.528^a	D19	0.738^a	F33	0.826^a
B6	0.792^a	D20	0.612^a	G34	0.504^a
B7	0.722^a	D21	0.789^a	G35	0.843^a
B8	0.772^a	E22	0.661^a	G36	0.915^a
B9	0.799^a	E23	0.571^a	G37	0.890^a
B10	0.752^a	E24	0.621^a	H38	0.766^a
C11	0.822^a	E25	0.693^a	H39	0.851^a
C12	0.805^a	E26	0.712^a	H40	0.870^a
C13	0.869^a	E27	0.737^a	I41	0.905^a
D14	0.751^a	E28	0.683^a	I42	0.897^a
D15	0.740^a	E29	0.751^a	I43	0.802^a

条目	高分组（n=63）	低分组（n=63）	CR值	df	P值
B2	3.39±1.18	2.76±0.95	3.231	107.178	0.002
B3	3.11±1.15	2.29±1.08	4.075	121.000	<0.001
B4	3.74±1.01	3.12±0.69	3.885	96.833	<0.001
B5	4.25±0.89	3.55±1.06	3.939	121.000	<0.001
B6	3.42±1.07	2.62±1.03	4.212	121.000	<0.001
B7	2.95±1.29	1.95±0.97	4.773	102.868	<0.001
B8	3.00±1.38	2.35±0.87	3.084	91.783	0.003
B9	3.19±1.30	2.41±0.96	3.750	101.675	<0.001
B10	3.47±1.10	2.74±0.85	4.073	104.219	<0.001
C11	4.35±0.55	3.88±0.71	4.061	121.000	<0.001
C12	4.32±0.54	3.73±0.78	4.935	116.007	<0.001
C13	4.46±0.66	3.53±0.85	6.828	119.722	<0.001
D14	4.46±0.68	3.29±0.94	7.949	117.686	<0.001
D15	4.32±0.66	3.17±0.89	8.046	121.000	<0.001
D16	4.39±0.65	3.41±1.01	6.478	112.284	<0.001
D17	4.84±0.46	4.09±0.97	5.606	95.016	<0.001
D18	4.58±0.50	3.56±0.95	7.604	101.272	<0.001
D19	4.86±0.40	4.09±0.99	5.799	88.125	<0.001
D20	4.82±0.50	4.30±0.74	4.602	114.864	<0.001
D21	4.67±0.58	3.41±0.99	8.729	106.904	<0.001
E22	3.23±1.10	2.24±0.95	5.338	121.000	<0.001
E23	3.58±1.12	2.92±1.24	3.050	121.000	0.003
E24	3.25±1.09	2.35±1.20	4.321	121.000	<0.001
E25	3.26±1.20	2.35±1.21	4.194	121.000	<0.001
E26	3.86±0.95	2.94±0.74	5.907	105.117	<0.001
E27	3.79±1.05	2.68±0.96	6.106	121.000	<0.001
E28	3.86±1.14	3.26±0.97	3.170	121.000	0.002
E29	3.63±1.08	2.70±1.11	4.718	121.000	<0.001
E30	3.84±1.15	2.95±1.28	4.020	121.000	<0.001
F31	4.14±0.72	3.58±0.77	4.196	121.000	<0.001
F32	4.04±0.73	3.55±0.75	3.658	121.000	<0.001
F33	3.96±0.73	3.45±0.83	3.602	121.000	<0.001
G34	4.23±1.07	3.50±1.04	3.819	121.000	<0.001
G35	3.88±0.95	2.41±0.91	8.754	121.000	<0.001
G36	4.04±1.02	2.39±1.05	8.767	121.000	<0.001
G37	4.12±1.00	2.30±1.16	9.223	121.000	<0.001
H38	4.58±0.57	4.11±0.77	3.839	121.000	<0.001
H39	4.35±0.58	3.85±0.79	3.963	121.000	<0.001
H40	4.33±0.69	3.65±0.85	4.833	121.000	<0.001
I41	4.12±0.91	3.36±0.82	4.884	121.000	<0.001
I42	4.19±0.90	3.36±0.76	5.566	121.000	<0.001
I43	4.28±0.88	3.62±0.74	4.513	121.000	<0.001