BackgroundPatients with type 2 diabetes (T2DM) often have poor glycemic control on first-line pharmacologic therapy and require treatment intensification. Intensification decisions can be difficult because of many available options and their many benefits and risks. The American Diabetes Association recommends patient-centered, evidence-based tools supporting shared decision-making between patients and clinicians. We developed a patient decision aid (PDA) targeting decisions about treatment intensification for T2DM. Our objective was to determine the effectiveness of this PDA for patients with T2DM on metformin who require treatment intensification.MethodsThis study was a pragmatic randomized controlled trial conducted in 27 US primary care and endocrinology clinics. Subjects were English-speaking adults with T2DM receiving metformin with persistent hyperglycemia who were recommended to consider medication intensification. Subjects were randomized to receive either the PDA or usual care (UC). Main outcome measures were change in knowledge, decisional self-efficacy, and decisional conflict.ResultsOf 225 subjects enrolled, 114 were randomized to the PDA and 111 to UC. Mean [SD] age was 52 [1] years, time since T2DM diagnosis was 6 [+/−6] years, 45.3 % were male, and most (55.5 %) were non-Caucasian. Compared to UC, PDA users had significantly larger knowledge gains (35.0 % [22.3] vs 9.9 % [22.2]; P < 0.0001) and larger improvements in self-efficacy (3.7 [16.7] vs−3.9 [19.2]; P < 0.0001) and decisional conflict (−22.2 [20.6] vs−7.5 [16.6]; P < 0.0001).ConclusionsThe PDA resulted in substantial and significant improvements in knowledge, decisional conflict and decisional self-efficacy. Decisional conflict scores after PDA use were within the range that correlates with effective decision-making. This PDA has the potential to facilitate shared-decision-making for patients with T2DM.Trial registration NCT02110979 Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-016-1262-4) contains supplementary material, which is available to authorized users.

After ACS, patients who undergo CABG within 5 days of receiving clopidogrel are at increased risk for reoperation, major bleeding, and increased length of stay. These risks must be balanced by the clinical benefits of clopidogrel use demonstrated in randomized clinical trials.

The National Breakthrough Pain Study is a large observational study that assessed breakthrough pain (BTP) in a population of commercially insured community-dwelling patients with opioid-treated chronic pain. Eligible patients were identified from an administrative claims database, and consenting patients were asked to complete a structured telephone interview and several validated questionnaires. Questionnaires assessed pain interference with function (Brief Pain Inventory-Short Form), health status (Short Form 12 [SF-12] Health Survey), disability (Sheehan Disability Scale), work performance (World Health Organization Health and Work Performance Questionnaire), and mood (Generalized Anxiety Disorder-7 Screener [GAD-7] and Patient Health Questionnaire-2 [PHQ-2]). Of 2198 patients interviewed, 1278 patients had persistent pain controlled with opioid therapy; 1023 (80%) of these patients reported BTP. Patients had a median of 2.0 episodes of BTP per day (range, 1-50) and a median duration of BTP of 45 minutes (range, 1-720). Compared with patients without BTP, patients with BTP had more pain-related interference in function (Brief Pain Inventory, mean ± SD: 34.2 ± 15.6 vs 25.0 ± 15.7 [P < 0.001]), worse physical health (SF-12 physical component score: 29.9 ± 9.6 vs 35.1 ± 10.4 [P < 0.001]) and mental health (SF-12 mental component score: 47.4 ± 11.3 vs 49.3 ± 10.4 [P < 0.001]), more disability (Sheehan Disability Scale global impairment score: 15.1 ± 9.1 vs 10.6 ± 8.5; World Health Organization Health and Work Performance Questionnaire absolute absenteeism: 12.4 ± 59.9 vs 7.7 ± 44.9 hours [both P < 0.001]), and worse mood (GAD-7 score: 7.4 ± 5.9 vs 5.9 ± 5.4; PHQ-2 anhedonia score: 1.2 ± 1.1 vs 0.9 ± 1.0 [both P < 0.001]). In this population of community-dwelling patients with opioid-treated chronic pain, BTP was highly prevalent and associated with negative outcomes. This burden of illness suggests the need for specific treatment plans.

Results indicate that BTcP among community-dwelling patients with cancer continues to be a health burden and reveals opportunities to improve its management.

IntroductionFailure to intensify treatment for type 2 diabetes mellitus (T2DM) when indicated, or clinical inertia, is a major obstacle to achieving optimal glucose control. This study investigates the impact of a values-focused patient decision aid (PDA) for T2DM antihyperglycemic agent intensification on patient values related to domains important in decision-making and preferred treatments.MethodsPatients with poorly controlled T2DM who were taking a metformin-containing regimen were recruited through physicians to access a PDA presenting evidence-based information on T2DM and antihyperglycemic agent class options. Participants’ preferences for treatment, decision-making, and the relative importance they placed on various values related to treatment options (e.g., dosing, weight gain, side effects) were assessed before and after interacting with the PDA. Changes from baseline were calculated (post-PDA minus pre-PDA difference) and assessed in univariate generalized linear models exploring associations with patients’ personal values.ResultsAnalyses included 114 diverse patients from 27 clinics across the US. The importance of avoiding injections, concern about hypoglycemia, and taking medications only once a day significantly decreased after interacting with the PDA [− 1.1 (p = 0.002), − 1.3 (p < 0.001), − 1.1 (p = 0.004), respectively], while the importance of taking medications that avoided weight gain increased [0.8 (p = 0.004)]. Prior to viewing the PDA, most patients (58.8%) had not begun thinking about the decision of adding a medication, and few (12.3%) indicated that they had already made a decision. Post-PDA, 46.5% could state a medication preference.ConclusionThe values-focused PDA for T2DM medication intensification prepared patients to make a shared decision with their clinician and changed patients’ values regarding what was important in making that decision. Helping patients understand their options and underlying values can promote shared decision-making and may reduce clinical inertia delaying treatment intensification.FundingJanssen Scientific Affairs, LLC.