Pascoe Katie, Lobosco Steve, Bell David, Hoskin Ben, Chang David J, Pobiner Bonnie, Ramachandran Sulabha
Value Evidence & Outcomes, GlaxoSmithKline, Middlesex, United Kingdom.
Adelphi Real World, Cheshire, United Kingdom.
Clin Ther. 2017 Sep;39(9):1811-1826. doi: 10.1016/j.clinthera.2017.07.039. Epub 2017 Aug 10.
This two-part study comprised two descriptive, cross-sectional surveys to evaluate treatment satisfaction among patients with systemic lupus erythematosus (SLE) and their physicians from US clinical practices. The Lupus Plus Project (LPP; part one) involved belimumab-containing regimens; the Disease Specific Program (DSP; part two) included all treatments and was designed to build on the body of evidence from part one.
The LPP recruited patients receiving belimumab, and comprised 2 paper questionnaires: a patient self-completion questionnaire (PSC) and a patient record form (PRF) completed by the physician. The DSP enrolled patients with SLE receiving any treatment and comprised four parts: a PSC, a PRF completed by the physician after patient consultation, face-to-face physician interviews, and a workload form completed by the physicians to indicate their total SLE patient workload. The key objective of this study was to assess physician and patient satisfaction with current treatment.
From the PSCs, data regarding patient-reported satisfaction with current treatment were available for 263 patients who were receiving belimumab combination therapy (LPP) and 250 patients who were receiving non-belimumab treatment (DSP). The majority of patients (belimumab, 86.3% [227/263]; non-belimumab, 78.4% [196/250]) responded positively (at least "somewhat satisfied") when asked about current treatment satisfaction, as did physicians (belimumab, 82.9% [311/375]; non-belimumab, 74.3% [326/439]). In multivariate analysis, factors most strongly associated with patient-reported satisfaction for patients receiving belimumab were patient-reported improvements in leisure activities since taking belimumab (odds ratio [OR] = 4.66), physician-reported improvements in fatigue (OR = 3.72), patient-reported improvements in general symptoms (OR = 3.02), and pain/achiness (OR = 2.71). Physician satisfaction was associated with clinical outcome such as improvements in pain/achiness (OR = 6.16), fatigue (OR = 3.76), and patient-reported satisfaction with treatment frequency (OR = 3.91). In patients receiving other SLE treatments, dosing frequency of current treatment (OR = 3.64) and a reduction in fatigue severity (OR = 3.61) were most strongly associated with patient-reported satisfaction; physician satisfaction was most strongly associated with a reduction in fatigue (OR = 6.22) and current remission status (OR = 6.05).
When considering SLE treatment satisfaction patients tend to consider impact on daily functioning, whereas physicians take into account a wider range of clinical outcomes; however, both strongly consider improvements in fatigue. These surveys provide insights into treatment satisfaction among prescribers and patients with SLE. GSK-ClinicalStudyRegister.com identifiers: GSK study 202146 [HO 15-15509] and 205086 [HO 15-16709].
这项分为两部分的研究包括两项描述性横断面调查,以评估美国临床实践中系统性红斑狼疮(SLE)患者及其医生对治疗的满意度。狼疮强化项目(LPP;第一部分)涉及含贝利尤单抗的治疗方案;疾病特异性项目(DSP;第二部分)包括所有治疗方法,旨在基于第一部分的证据体系开展研究。
LPP招募接受贝利尤单抗治疗的患者,包括2份纸质问卷:一份患者自填问卷(PSC)和一份由医生填写的患者记录表(PRF)。DSP纳入接受任何治疗的SLE患者,包括四个部分:一份PSC、一份医生在与患者会诊后填写的PRF、面对面的医生访谈以及一份由医生填写以表明其SLE患者总工作量的工作量表。本研究的主要目的是评估医生和患者对当前治疗的满意度。
从PSC中,获得了263例接受贝利尤单抗联合治疗的患者(LPP)和250例接受非贝利尤单抗治疗的患者(DSP)关于患者报告的对当前治疗满意度的数据。当被问及对当前治疗的满意度时,大多数患者(贝利尤单抗组,86.3%[227/263];非贝利尤单抗组,78.4%[196/250])给出了肯定回答(至少“有点满意”),医生也是如此(贝利尤单抗组,82.9%[311/375];非贝利尤单抗组,74.3%[326/439])。在多变量分析中,接受贝利尤单抗治疗的患者中,与患者报告的满意度最密切相关的因素是患者报告自服用贝利尤单抗以来休闲活动有所改善(比值比[OR]=4.66)、医生报告的疲劳有所改善(OR=3.72)、患者报告的一般症状有所改善(OR=3.02)以及疼痛/酸痛(OR=2.71)。医生的满意度与临床结果相关,如疼痛/酸痛的改善(OR=6.16)、疲劳的改善(OR=3.76)以及患者报告的对治疗频率的满意度(OR=3.91)。在接受其他SLE治疗的患者中,当前治疗的给药频率(OR=3.64)和疲劳严重程度的降低(OR=3.61)与患者报告的满意度最密切相关;医生的满意度与疲劳的减轻(OR=6.22)和当前的缓解状态(OR=6.05)最密切相关。
在考虑SLE治疗满意度时,患者倾向于考虑对日常功能的影响,而医生会考虑更广泛的临床结果;然而,两者都非常重视疲劳的改善。这些调查为SLE处方医生和患者的治疗满意度提供了见解。葛兰素史克临床研究注册网站标识符:葛兰素史克研究202146[HO 15 - 15509]和205086[HO 15 - 16709]。