Majani Giuseppina, Giardini Anna, Scotti Aurelio
Psychology Unit, Fondazione S, Maugeri, Clinica del Lavoro e della Riabilitazione, IRCCS, Istituto Scientifico di Montescano (PV), Italy.
Health Qual Life Outcomes. 2005 Mar 16;3:14. doi: 10.1186/1477-7525-3-14.
Clinical trials on osteoarthritis (OA) flare-ups treatment usually focus only on objective measures of health status, albeit recent literature suggestions on the importance of patients' subjectivity. Aim of the study was to evaluate the effects of OA and of its different types of medical treatment(s) on Health Related Quality of Life (HRQoL) in terms of both subjective satisfaction and functional status.
An observational study on prospective data collected from the Evaluation of Quality of life in OA (EQuO) clinical trial (April 1999-November 2000) was conducted; outpatients from 70 participating centers (Orthopedy or Rheumatology Departments in Italy) with a diagnosis of OA of the hip or knee were consecutively enrolled. Patients were observed at OA flare-ups (baseline) and at follow up 4 weeks after treatment. Patients' objective and subjective HRQoL were assessed by means of the SF-36 and the Satisfaction Profile (SAT-P, which focuses on subjective satisfaction); Present Pain at baseline and Pain Relief at follow up were also evaluated.
Among the 1323 patients, 1138 (86%) were prescribed one drug/treatment of osteoarthritis, 169 (13%) 2 drugs/treatments, and 16 (1%) 3 drugs/treatments; most of treatments involved the prescription of NSAIDs; non-coxib, COX2 selective NSAIDs were prescribed in about 50% of patients. Follow-up visits were performed after 29.0 days on average (+/- 7.69 SD). For all SF-36 domains, all SAT-P items and factors, the differences between baseline and follow up scores resulted statistically significant (p < 0.001), enlighting an improvement both in health status and in subjective HRQoL.
Besides the classic health status measures, the assessment of patients' subjective satisfaction provides important clues on treatments efficacy of OA within the patient-centered medicine model. In clinical practice this could lead to a better doctor-patient communication and to higher levels of treatment adherence.
骨关节炎(OA)发作治疗的临床试验通常仅关注健康状况的客观指标,尽管近期文献表明患者主观感受的重要性。本研究的目的是从主观满意度和功能状态两方面评估OA及其不同类型的药物治疗对健康相关生活质量(HRQoL)的影响。
对从骨关节炎生活质量评估(EQuO)临床试验(1999年4月至2000年11月)收集的前瞻性数据进行观察性研究;连续纳入来自70个参与中心(意大利的骨科或风湿病科)诊断为髋或膝OA的门诊患者。在OA发作时(基线)和治疗后4周进行随访观察。通过SF-36和满意度概况(SAT-P,侧重于主观满意度)评估患者的客观和主观HRQoL;还评估了基线时的当前疼痛和随访时的疼痛缓解情况。
在1323例患者中,1138例(86%)被开具了一种骨关节炎药物/治疗,169例(13%)开具了两种药物/治疗,16例(1%)开具了三种药物/治疗;大多数治疗涉及非甾体抗炎药(NSAIDs)的处方;约50%的患者开具了非环氧化酶(COX)选择性NSAIDs。平均在29.0天(±7.69标准差)后进行随访。对于所有SF-36领域、所有SAT-P项目和因素,基线和随访分数之间的差异具有统计学意义(p<0.001),表明健康状况和主观HRQoL均有所改善。
除了经典的健康状况测量指标外,患者主观满意度的评估为以患者为中心的医学模式下OA治疗效果提供了重要线索。在临床实践中,这可能会改善医患沟通并提高治疗依从性。