METABOLIC DISORDERS
Encounter Decision Aid vs. Clinical Decision Support or Usual Care to Support Patient-Centered Treatment Decisions in Osteoporosis: The Osteoporosis Choice Randomized Trial II
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2015;3(22):10 PLoS One. 2015 May 26;10(5):e0128063.79 women aged 50 or older and 50 clinicians were enrolled into this study to compare the treatment decision making process and subsequent patient adherence to bisphosphonates using the Osteoporosis Choice (OC) decision aid and usual care with or without the fracture risk assessment tool (FRAX) for osteopenia or osteoporosis. The results indicated that several decision making process outcomes significantly favoured the Osteoporosis Choice group. However, due to a lack of funding patient enrollment was reduced from initial targets and the trial was not adequately sized to detect differences in treatment adherence between groups. As such, it is recommended that subsequent studies with larger sample sizes that place a larger focus on adherence outcomes are conducted.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
3/4
Randomização
3/4
Medidas de resultado
4/4
Inclusão/Exclusão
4/4
Descrição do tratamento
4/4
Estatística
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
Bisphosphonates are a common intervention prescribed to reduce the risk of fragility fractures in patients with osteoporosis; however, the treatment is often hindered by a lack of patient adherence. Previous research has indicated increased patient adherence when the prescription of bisphosphonates aligns with personal preference, demonstrating the need to include patients in the decision making process. The Osteoporosis Choice decision aid, which incorporates the World Health Organization’s FRAX calculator and available information surrounding the efficacy of bisphosphonates in reducing the risk of fractures, has been developed to increases patient involvement in the decision making process. This study aims to compare the Osteoporosis Choice decision with usual care, with or without the FRAX calculator on various outcomes involving the treatment decision making process and patient adherence to a bisphosphonate intervention.
主な研究課題は何ですか？
How does the Osteoporosis Choice decision aid compare to usual care, with and without the FRAX calculator, in improving patient involvement in the decision making process and adherence to a bisphosphonate intervention when assessed over a period of 6 months?
重要な知見は？
- Patients in the OC group displayed significantly greater knowledge in terms of what was covered in the decision aid (p=0.01) as well as risks without medication (p=0.01), and with medication (P<0.0001).
- Decisional conflict was low in both groups and not significantly different between the groups (p=0.18).
- Although not significant, more patients in the OC group (n=13) were prescribed bisphosphonates in comparison to the FRAX/UC group (n=12) (R=1.5 (95% CI 0.8, 2.9; p=0.20). Subsequently, more patients in the OC group (n=10) filled their prescription in comparison to the FRAX/UC group (n=4). This finding was also not significant (RR=2.1 (95% CI 0.9, 4.6); p=0.07).
- Patient involvement in the decision making process was significantly greater (p=0.001) in the OC group (OPTION score=57%; 95% CI 50, 64) compared to the FRAX/UC group (OPTION score=43%; 95% CI 37, 48).
- Fidelity concerning extent to which clinicians used the decision aid as intended during the encounter was significantly higher (P=<0.0001) in the OC group (67%; 95% CI 63, 78) in comparison to the FRAX/UC group (17%; 95% CI 12, 23).
- Patient satisfaction was comparable in both groups as 86% of those in the OC group and 77% of those in the FRAX/UC group said they would recommend the decision making process they received to others (p=0.52).
- A significantly higher number of clinicians in the OC group found the decision aid helpful in comparison to the FRAX/UC group (UC=70%; FRAX/UC=35%; p=0.01).
- 74% of clinicians in the OC group would recommend other clinicians using this decision making procedure for decisions about osteoporosis therapy in comparison to 30% in the FRAX/UC group. This difference was significant (p<0.001).
最も覚えておくべきことは？
In patients with osteopenia or osteoporosis and in clinicians who provided services to this population, patient knowledge and involvement in the decision making process, along with clinician fidelity in covering all necessary items and willingness to recommend their method to others significantly favoured the Osteoporosis Choice decision aid group over usual care. Decisional conflict and patient satisfaction outcomes were comparable between the groups. Moreover, the number of patients prescribed bisphosphonates and adherence to prescription was not significantly different between groups, however, a limitation of this study was that it was not sufficiently powered to detect differences in these outcomes.
それが私の患者ケアにどのように影響するか？
In comparison to usual care, with our without incorporation of the FRAX calculation, use of the Osteoporosis Choice decision aid significantly improved the decision making process and was satisfying to both clinicians and patients. It should be noted that the study was not sufficiently powered to determine whether this improved decision making efficacy translated into increased adherence. Further studies with larger sample sizes are recommended to more definitively report on this outcome.
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