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RCT
ACE Report #7823

Osteoporosis Choice decision aid improves treatment experience of clinicians and patients


Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A

Encounter Decision Aid vs. Clinical Decision Support or Usual Care to Support Patient-Centered Treatment Decisions in Osteoporosis: The Osteoporosis Choice Randomized Trial II

PLoS One. 2015 May 26;10(5):e0128063.

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Synopsis

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.

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
The Foundation for Informed Medical Decision Making
Conflicts:
None disclosed

Risk of Bias

5.5/10

Reporting Criteria

18/20

Fragility Index

N/A

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)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

3/4

Randomization

3/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

4/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.

Why was this study needed now?

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.

What was the principal research question?

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?

Study Characteristics -
Population:
79 English speaking women aged 50 and over who were diagnosed with either osteopenia or osteoporosis were eligible for the study. Patients were not taking any prescription medicines, including bisphosphonates. 50 clinicians who provided care for patients with osteopenia or osteoporosis were also enrolled.
Intervention:
Osteoporosis Choice (OC) Group: The clinician and patient used the Osteoporosis Choice decision aid during the clinical encounter. The decision aid included an individualized 10 year risk of suffering a bone fracture (estimated using FRAX calculator) with and without the use of bisphosphonates, as well as the risks associated with bisphosphonates. Patients and clinicians reviewed the decision aid together, discussed whether bisphosphonates should be initiated as a treatment, and collectively made the final decision. (n=32; 22 completed follow up)
Comparison:
FRAX Group: The clinician was provided with a copy of their patient’s individualized 10 year risk of suffering a fracture for use during the clinical encounter. (n=33; 22 completed follow up) Usual Care (UC) Group: Clinicians discussed treatment with bisphosphonates and the risk of fractures as per usual and did not use any aids in the process. (n=14; 8 completed follow up) **Note: No differences found between FRAX and UC group, nor did combining these two groups significantly impact findings. Therefore for all results, the FRAX and Usual Care groups combined into one group (FRAX/UC) (n=47; 30 completed follow up)
Outcomes:
Primary outcomes of concern included patients’ knowledge (13-point questionnaire used in a previous study), decisional conflict (Decision Conflict Scale), decision to start medication (recorded immediately after appointment), adherence to medication (pharmacy records and 6 month self-reported data), both primary (those who filled their initial prescription) and secondary (the percentage of days covered (PDC)), involvement in decision making by the clinician, fidelity to intended intervention, acceptability, satisfaction, and quality of life (EURO QOL5d health thermometer). The secondary outcome was decision quality for clinicians.
Methods:
RCT: Multicenter
Time:
All surveys were completed immediately after the appointment. A telephone follow up was completed at 6 months. Pharmacy records were obtained from 3 months prior to 9 months post enrolment.

What were the important findings?

  • 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).

What should I remember most?

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.

How will this affect the care of my patients?

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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