1. Most Effective Adherence-Enhancing Interventions for Osteoporosis Medications Mickaël Hiligsmann 1-2, Maribel Salas 3,4, Dyfrig A. Hughes 5, Elizabeth Manias 6, Femida H. Gwadry-Sridhar 7, Pat Linck 5, Warren Cowell 8 1 Maastricht University, Netherlands. 2 University of Liège, Belgium. 3 AstraZeneca, USA. 4 CCEB, University of Pennsylvania, USA 5 Bangor University, United Kingdom. 6 University of Melbourne, Australia. 7 University of Western Ontario, Canada, 8 Bayer, United Kingdom Introduction Adherence to osteoporosis medications is suboptimal with persistence rates of between 25% and 35% at one year. This results in higher fracture rates with significant medical costs and hospitalizations. Over the past years, interventions have been proposed to improve medication adherence. The objective of this study was to critically appraise the literature and determine the most effective adherence-enhancing interventions for osteoporosis medications. We conducted a literature search using Medline, EMBASE, Cochrane library and CINAHL using the following key words: osteoporosis, low bone density, low bone mineral density, low bone mass, low bone turnover, low bone mass density and bisphosphonates, calcium, colecalciferol, estrogens, hormone replacement therapy, raloxifene, vitamin D and patient compliance, adherence, concordance, persistence, and interventions, clinical trials, RCT. The search period was January 1 st, 1999 to July 31 st, 2010. We included studies on adult users of osteoporosis medications that evaluated an adherence-enhancing intervention (e.g. patient education, intensified patient care), and which reported quantitative results of adherence. Each article was reviewed independently by two investigators and disagreements were resolved by consensus. Downs’ checklist was modified to assess the quality of studies. Since the studies were too heterogeneous, we focused on a narrative systematic review. The most effective adherence interventions with osteoporosis medications were in patients monitored by nursing staff and received education. There is a need to conduct additional research with interventions and to consider the impact of specific pharmacological treatments on medication adherence. This work was conducted by the Medication Adherence and Persistence SIG from the International Society of Pharmacoeconomics and Outcomes Research Identified abstracts = 27 Studies that fulfilled inclusion criteria = 8 Education = 6 Monitoring/supervision = 2 Excluded Reviews = 5 Protocols = 1 Lack of intervention = 7 No quantitative data on adherence = 6 Flow diagram of Studies Results of Included Studies ReferenceOutcomesControl Intervention for Study P value Blalock et al, 2002 Adherence/Calcium (Ca) intake Ca –not changes ↑ Ca intake 500mg/d <0.05 Clowes et al, 2004Adherence42%65%0.04 Robbins et al, 2004Adherence81%87%<0.05 Delmas et al, 2007Persistence77%80%0.016 Cook et al, 2007Adherence40%69%<0.001 Shu et al, 2009MPR73%74%0.18 Nielsen et al, 2010Adherence80%92%0.006 Ojeda-Bruno et al, 2011Adherence/Persistence16%71% / 76%-- ISPOR 16th Annual International Meeting, May 24, 2011, Baltimore, MD, USA 27 publications were identified including 8 studies which randomized more than 4,500 patients fulfilled the inclusion criteria. Articles on reviews (5), protocols (1), lack of intervention (7) or no quantitative data on adherence (6) were excluded. The most frequent intervention was education (6) followed by monitoring/supervision (2). Four studies used randomization, which was led by nurses (3), pharmacists (1), physicians (1) and Table 1. Characteristics of Included Studies ReferenceType of interventionStudy designSample size Follow- up time Randomization Use of Comparator Study Group Control Group Blalock et al. 2002Tailored educational programNoYes714012 m Clowes et al. 2004MonitoringYes 73241 y Robbins et al. 2004Educational information by nursesNo 10901 y Delmas et al. 2007Monitoring and feedback on resultsYes 230211131 y Cook et al. 2007Telehealth programNo 40206 m Shu et al. 2009Physician’s directed educationYes 186787510 m Nielsen et al. 2010Group-based educational programYes 3001502 y Ojeda-Bruno et al. 2011Patient education by nurse/ physicianNo 38004 y Table 2. Results of Included Studies multidisciplinary teams (2). Follow-up ranged from 3 to 48 months. The average intervention effect ranged from 12% (education) to 24% (patients monitored by nursing staff). The average quality score was 65.7%. Materials and Methods Results Conclusion Acknowledgements