BackgroundTo reduce the duration and overall costs of cardiovascular trials, use of the combined endpoints in trial design has become commonplace. Though this methodology may serve the needs of investigators and trial sponsors, the preferences of patients or potential trial subjects in the trial design process has not been studied.ObjectiveTo determine the preferences of patients in the design of cardiovascular trials.DesignParticipants were surveyed in a pilot study regarding preferences among various single endpoints commonly used in cardiovascular trials, preference for single vs. composite endpoints, and the likelihood of compliance with a heart medication if patients similar to them participated in the trial design process.ParticipantsOne hundred adult English-speaking patients, 38% male, from a primary care ambulatory practice located in an urban setting.Key resultsAmong single endpoints, participants rated heart attack as significantly more important than death from other causes (4.53 vs. 3.69, p=0.004) on a scale of 1–6. Death from heart disease was rated as significantly more important than chest pain (4.73 vs. 2.47, p<0.001), angioplasty/PCI/CABG (4.73 vs. 2.43, p<0.001), and stroke (4.73 vs. 2.43, p<0.001). Participants also expressed a slight preference for combined endpoints over single endpoint (43% vs. 57%), incorporation of the opinions of the study patient population into the design of trials (48% vs. 41% for researchers), and a greater likelihood of medication compliance if patient preferences were considered during trial design (67% indicated a significant to major effect).ConclusionsPatients are able to make judgments and express preferences regarding trial design. They prefer that the opinions of the study population rather than the general population be incorporated into the design of the study. This novel approach to study design would not only incorporate patient preferences into medical decision making, but it also has the potential to improve compliance with cardiovascular medications.

A 36-year-old Hispanic woman with a history of systemic lupus erythaematosus (SLE) in remission presented with progressive dyspnoea, bilateral leg swelling and increasing fatigue with rapid weight gain over the past few months. Her physical examination showed mildly tender thyromegaly and pericardial rub. Investigations showed new onset marked hypothyroidism as well as an active lupus serology with echocardiogram confirming severe pericardial effusion and a tamponade phenomenon. Urgent pericardiocentesis relieved her acute symptoms, and prompt treatment with thyroxine replacement and immunosuppression for lupus disease was initiated. Pericardial fluid analysis remained negative for any malignancy and/or infection/s. The patient had a gradual and consistent improvement with this treatment. She was discharged and appeared to be clinically stable at subsequent follow-up visits. However, the case remained a diagnostic dilemma over whether the tamponade was being driven by hypothyroidism versus lupus, leaving us with an opportunity to explore further.

A 33-year-old mother of 2 healthy children presented with bilateral recurrent breast infections despite successful treatment of each episode of an infection. With a negative rheumatologic medical history as well as a negative review of systems, she continued to have these infections frequently. Hence, a breast biopsy was performed after the treatment with a course of antimicrobials, which revealed changes suggestive of granulomatous mastitis. She was started on methotrexate (MTX) with a good response. But, due to persistent nodularity, corticosteroids were added to the regimen with MTX dose escalation. Patient remained disease free thereafter without any adverse effects.

Acute renal failure from rhabdomyolysis is a well-established clinical entity; however, rhabdomyolysis exclusively caused by the ingestion of methadone requiring hemodialysis is very uncommon. With a similar mechanism to opiates, methadone can cause rhabdomyolysis and further consequences. Given the increasing use of methadone as a therapy for opiate dependence, clinicians prescribing this medication should be aware of this life-threatening complication.