阿片类药物所致便秘的负担:患者与医疗服务提供者报告之间的差异
The Burden of Opioid-Induced Constipation: Discordance Between Patient and Health Care Provider Reports.
作者信息
LoCasale Robert J, Datto Catherine, Wilson Hilary, Yeomans Karen, Coyne Karin S
机构信息
1 Group Director of Quality, Design & Analytics, Global Medicines Development, Payer & Real World Evidence, AstraZeneca Pharmaceuticals, Gaithersburg, Maryland.
2 U.S. Medical Affairs Medical Lead, AstraZeneca Pharmaceuticals, Wilmington, Delaware.
出版信息
J Manag Care Spec Pharm. 2016 Mar;22(3):236-45. doi: 10.18553/jmcp.2016.22.3.236.
BACKGROUND
Opioid-induced constipation (OIC), a common side effect of opioid treatment for chronic pain, affects patient health-related quality of life (HRQL) and may prompt some patients to lower the dose or alter adherence to their opioid medication, compromising pain relief. Although health care providers (HCPs) are aware of the potential for OIC, patients may not inform their HCPs of their OIC symptoms, and HCPs may not initiate conversation regarding OIC if their patients' pain is controlled. Patients often try to address OIC symptoms on their own by using natural approaches or over-the-counter options. When OIC is discussed in an office visit, HCPs typically recommend conventional laxatives to relieve symptoms, but the efficacy of this approach is unproven and often suboptimal. In many areas of medicine, HCP perceptions of the impact of adverse effects of treatment on a patient's HRQL do not align with the patient's experience.
OBJECTIVES
To (a) describe HCP-reported understanding of his or her patients' experiences with OIC and (b) evaluate the level of agreement or discordance in perception between patients and their HCPs of OIC's impact on clinical outcomes.
METHODS
This was a prospective, longitudinal, observational cohort study conducted in the United States, Canada, Germany, and the United Kingdom (NCT01928953) in patients aged 18 to 85 years who had been receiving daily opioid therapy for ≥ 4 weeks for chronic noncancer pain with presence of OIC in the past 2 weeks. Data were collected from retrospective chart reviews, HCP questionnaires, and web-based patient surveys. Eligible patients enrolled online and completed the Patient Assessment of Constipation-Symptoms, the Work Productivity and Activity Impairment Questionnaire-Specific Health Problem, the EuroQOL 5 Dimensions, and the Global Assessment of Treatment Benefit, Satisfaction, and Willingness to Continue standardized questionnaires. The patient-reported component included 1 baseline survey and 8 follow-up surveys over 24 weeks. HCPs completed a web-based survey at baseline and at week 24 to assess their perceptions of OIC burden, treatment patterns, laxative use, and overall treatment satisfaction. The correspondence of patient- and HCP-reported data was evaluated for all similar outcomes from these 2 databases.
RESULTS
Patients (N = 489) reported a mean (SD) number of bowel movements (BMs) per week and spontaneous BMs per week of 3.7 (2.9) and 1.4 (2.3), respectively, at baseline. Most (87%) reported chronic pain of ≥ 2 years duration; 65% had used opioids for ≥ 2 years; and the mean pain score at baseline was 6.3, consistent with a moderate-to-severe pain population. Most (97%) patients at baseline reported any gastrointestinal-related symptom of at least moderate intensity, with 82% reporting the same intensity of any symptom at week 24. Of the 405 patients who had seen their HCPs in the past month, 63% reported that they had spoken to their HCPs about constipation, and 62% reported that their HCPs had asked them if they had constipation in the past month. The proportion of agreement between HCPs and their patients on the presence of constipation at baseline was 61%. Similar average pain ratings between HCPs and patients (5.9 vs. 6.0) at week 24 suggested clear communication regarding the level of pain experienced by the patient; however, OIC symptoms, laxative use and effectiveness, and impact of OIC on pain management and HRQL were not fully appreciated by HCPs.
CONCLUSIONS
The importance and severity of OIC are perceived differently by patients and their HCPs, a discordance that complicates pain management and demonstrates a need for greater communication. These disparate perceptions indicate a need for clinical education and coordination of care by HCPs to improve understanding and proactively manage OIC in patients with chronic noncancer pain.
背景
阿片类药物引起的便秘(OIC)是慢性疼痛阿片类药物治疗的常见副作用,会影响患者的健康相关生活质量(HRQL),并可能促使一些患者降低剂量或改变阿片类药物的依从性,从而影响疼痛缓解效果。尽管医疗保健提供者(HCP)意识到OIC的可能性,但患者可能不会将其OIC症状告知HCP,并且如果患者的疼痛得到控制,HCP可能不会主动提及OIC相关话题。患者通常会自行尝试通过自然方法或非处方选择来解决OIC症状。在门诊就诊时讨论OIC时,HCP通常会推荐传统泻药来缓解症状,但这种方法的疗效未经证实且往往效果不佳。在医学的许多领域,HCP对治疗不良反应对患者HRQL影响的认知与患者的体验不一致。
目的
(a)描述HCP报告的对其患者OIC经历的理解,以及(b)评估患者及其HCP对OIC对临床结果影响的认知之间的一致程度或不一致程度。
方法
这是一项在美国、加拿大、德国和英国进行的前瞻性、纵向、观察性队列研究(NCT01928953),研究对象为年龄在18至85岁之间、因慢性非癌性疼痛接受每日阿片类药物治疗≥4周且在过去2周内存在OIC的患者。数据通过回顾性病历审查、HCP问卷和基于网络的患者调查收集。符合条件的患者通过在线注册并完成便秘症状患者评估、工作效率和活动障碍问卷 - 特定健康问题、欧洲五维健康量表以及治疗益处、满意度和继续治疗意愿全球评估等标准化问卷。患者报告部分包括1次基线调查和24周内的8次随访调查。HCP在基线和第24周完成基于网络的调查,以评估他们对OIC负担、治疗模式、泻药使用和总体治疗满意度的认知。对这两个数据库中所有相似结果的患者报告数据和HCP报告数据的一致性进行了评估。
结果
患者(N = 489)在基线时报告每周平均(标准差)排便次数和每周自发排便次数分别为3.7(2.9)次和1.4(2.3)次。大多数(87%)报告慢性疼痛持续时间≥2年;65%使用阿片类药物≥2年;基线时平均疼痛评分为6.3,与中重度疼痛人群一致。大多数(97%)基线患者报告至少有中度强度的任何胃肠道相关症状,82%在第24周报告相同强度的任何症状。在过去一个月见过HCP的405名患者中,63%报告他们与HCP谈论过便秘,62%报告他们的HCP在过去一个月询问过他们是否便秘。HCP与患者在基线时对便秘存在情况的一致比例为61%。在第24周,HCP和患者之间相似的平均疼痛评分(5.9对6.0)表明就患者经历的疼痛程度进行了清晰的沟通;然而,HCP并未充分认识到OIC症状、泻药使用及其有效性,以及OIC对疼痛管理和HRQL的影响。
结论
患者及其HCP对OIC的重要性和严重程度的认知存在差异,这种不一致使疼痛管理复杂化,并表明需要加强沟通。这些不同的认知表明HCP需要进行临床教育和协调护理,以提高对慢性非癌性疼痛患者OIC的理解并积极进行管理。