Bianchi M L, Duca P, Vai S, Guglielmi G, Viti R, Battista C, Scillitani A, Muscarella S, Luisetto G, Camozzi V, Nuti R, Caffarelli C, Gonnelli S, Albanese C, De Tullio V, Isaia G, D'Amelio P, Broggi F, Croci M
Bone Metabolism Unit, Istituto Auxologico Italiano IRCCS, Via L. Ariosto 13, 20145, Milano, Italy,
Osteoporos Int. 2015 May;26(5):1629-38. doi: 10.1007/s00198-015-3038-9. Epub 2015 Jan 27.
Osteoporosis treatment has low adherence and persistence. This study evaluated if greater patient involvement could improve them. At 12 months, only 114 out of 344 participants were "fully adherent and persistent" (all drug doses taken throughout the study). Only frequency of drug administration had a significant influence on adherence.
Osteoporosis affects millions of individuals worldwide. There are now several effective drugs, but adherence to and persistence with treatment are low. This 12-month multicenter, prospective, randomized study evaluated the efficacy of two different methods aimed at improving adherence and persistence through greater patient involvement, compared with standard clinical practice.
Three hundred thirty-four post-menopausal women, receiving an oral prescription for osteoporosis for the first time, were recruited and randomized into three groups: group 1 (controls, managed according to standard clinical practice) and groups 2 and 3 (managed with greater patient and caregiver involvement and special reinforcements: group 2, instructed to use several different "reminders"; group 3, same "reminders" as group 2, plus regular phone calls from and meetings at the referring Center). All enrolled women had two visits (baseline and 12 months).
Of 334 enrolled women, 247 (74%) started the prescribed therapy. Of those who started, 219 (88.7%) persisted in therapy for at least 10 months. At final evaluation, only 114 women were considered as "fully adherent and persistent" (all doses taken throughout the 12 months). There were no significant differences regarding "full adherence" among the three randomized groups. The frequency of drug administration had a significant influence: weekly administration had a >5-fold higher adherence and monthly administration an 8-fold higher adherence (p < 0.0001) than daily administration.
The special effort of devising and providing additional reminders did not prove effective. Additional interventions during the follow-up, including costly interventions such as phone calls and educational meetings, did not provide significant advantages.
骨质疏松症治疗的依从性和持续性较低。本研究评估了增加患者参与度是否能改善这些情况。在12个月时，344名参与者中只有114人“完全依从且持续用药”（在整个研究过程中服用了所有药物剂量）。只有给药频率对依从性有显著影响。
骨质疏松症影响着全球数百万人。现在有几种有效的药物，但治疗的依从性和持续性较低。这项为期12个月的多中心、前瞻性、随机研究评估了两种不同方法的疗效，这两种方法旨在通过增加患者参与度来提高依从性和持续性，并与标准临床实践进行比较。
招募了334名首次接受骨质疏松症口服处方的绝经后妇女，并将她们随机分为三组：第1组（对照组，按照标准临床实践管理）以及第2组和第3组（在患者和护理人员更多参与及特殊强化措施下管理：第2组，被指示使用几种不同的“提醒方式”；第3组，与第2组使用相同的“提醒方式”，外加转诊中心定期的电话随访和会议）。所有登记入组的女性都进行了两次就诊（基线期和12个月时）。
在334名登记入组的女性中，247人（74%）开始了规定治疗。在开始治疗的人中，219人（88.7%）持续治疗至少10个月。在最终评估时，只有114名女性被认为“完全依从且持续用药”（在整个12个月期间服用了所有剂量）。三个随机分组之间在“完全依从”方面没有显著差异。给药频率有显著影响：每周给药的依从性比每日给药高5倍以上，每月给药的依从性比每日给药高8倍（p < 0.0001）。
设计并提供额外提醒的特别努力并未证明有效。随访期间的额外干预措施（包括电话随访和教育会议等成本较高的干预措施）并未带来显著优势。
