Institute Identifies Evidence Gaps for Treating Bipolar Disorder in Young People and Managing a Precursor of Breast Cancer in Women

Investigators prioritized research agendas to fill the evidence gaps surrounding treatments for bipolar disorder in young people and management of ductal carcinoma in situ in women. (Image: RTimages /

Investigators prioritized research agendas to fill the evidence gaps surrounding treatments for bipolar disorder in young people and management of ductal carcinoma in situ in women. (Image: RTimages /

Treatment decisions for bipolar disorder in young people and ductal carcinoma in situ (DCIS) in women pose difficulties for physicians and patients because these diagnoses are often imprecise and the usual therapies may cause serious adverse effects. With such treatment uncertainty surrounding both conditions, investigators have created priority lists for research that would fill the evidence gaps. The research agendas appear today in the Annals of Internal Medicine.

The investigators, from the Duke University Evidence Synthesis Group, Durham, North Carolina, worked with various stakeholders, including clinical experts and patients, to identify the evidence needed to improve treatment of bipolar disorder and DCIS. The project was funded by the Patient-Centered Outcomes Research Institute, which hopes to use the findings to set prioritized research agendas. The institute was established by Congress in 2010 with a mission to fund research providing evidence-based information to enable patients, their caregivers, and clinicians to make better health care decisions.

Regarding bipolar disorder in young people, the Duke researchers noted that up to 2.7% of individuals aged 12 to 21 years have the condition, but that it can be difficult to distinguish from other disorders, such as attention-deficit/hyperactivity disorder and behavioral disorders. They also said the use of antipsychotic drugs to treat the disorder has increased significantly in the past 20 years, but the use of these drugs in adolescents and young adults remains controversial because of the paucity of population-specific data on which to base practice recommendations.

Out of 23 potential evidence gaps regarding use of antipsychotics for bipolar disorder, the researchers and stakeholders identified 10 as high priority. In descending order of priority, they are

• effectiveness of monotherapy with antipsychotics vs combination therapy with “mood-stabilizing” medications;
• effect of antipsychotics on social, academic, and occupational functioning;
• defining key patient- and family-centered outcomes;
• effectiveness of psychiatric medications other than those from the mood-stabilizing class given as adjuncts to antipsychotics;
• effectiveness of mood-stabilizing medications vs antipsychotics;
• effectiveness of antipsychotics alone vs in combination with nonpharmacologic interventions;
• adverse effects of short- and long-term antipsychotic exposure;
• effect of demographic differences on the effectiveness of antipsychotics;
• effect of socioeconomic factors on the effectiveness of antipsychotics; and
• effect of antipsychotics on core disease features immediately and in the long-term.

As for DCIS, the researchers said screening mammography has led to a dramatic increase in the diagnosis of DCIS (now 32.5 cases per 100 000 women), but much uncertainty remains about the optimal clinical response because of the lack of reliable ways to distinguish DCIS that would never become symptomatic from DCIS that is likely to progress to life-threatening invasive cancer.

Out of 30 potential research topics addressing management strategies for DCIS, the stakeholders identified 10 future research needs. They are
• developing risk-stratification models;
• comparing a management strategy of no immediate treatment (that is, observation or active surveillance) vs immediate treatment;
• understanding the influence of clinical or biological characteristics on DCIS management strategies;
• assessing the effect of different approaches to communicating the diagnosis of DCIS to patients;
• testing decision-making tools;
• assessing preoperative imaging;
• examining the effect of management strategies on comorbid conditions,
• optimizing radiation therapy;
• identifying key patient-centered outcomes; and
• assessing the effect of management strategies on incident invasive cancer.

Categories: Breast Cancer, Evidence-Based Medicine, Psychiatry