Reporting outcomes in clinical trials for bipolar disorder: A commentary and suggestions for change

Bipolar Disorders Program, IDIBAPS, CIBER-SAM, Clinical Institute of Neuroscience, Hospital Clinic, University of Barcelona, Barcelona, Spain.
Bipolar Disorders (Impact Factor: 4.97). 07/2008; 10(5):566-79. DOI: 10.1111/j.1399-5618.2008.00611.x
Source: PubMed


Newer outcome measures and statistical reporting that better translate efficacy data to evidence-based psychiatric care are needed when evaluating clinical trials for bipolar disorder. Using efficacy studies as illustrations, the authors review and recommend changes in the reporting of traditional clinical outcomes both in the acute and maintenance phases of bipolar disorder.
Definitions of response, remission, relapse, recovery, and recurrence are reviewed and recommendations for change are made. These suggestions include reporting the numbers needed to treat or harm (NNT or NNH), and a ratio of the two, likelihood of help or harm (LHH), as an important element of the effect size (ES). Moreover, models of prediction that conduct sensitivity or specificity analyses and utilize decision trees to help predict positive and negative outcomes of interest (for instance, excessive weight gain, or time to remission) using positive or negative predictive values (PPV or NPV) are reviewed for potential value to clinicians. Finally, functional and cognitive assessments are recommended for maintenance studies of bipolar disorder.
The examples provided in this manuscript underscore that reporting the NNT or NNH, or alternative effect sizes, or using PPV or NPV may be of particular value to clinicians. Such reports are likely to help translate efficacy-driven clinical data to information that will more readily guide clinicians on the benefits and risks of specific interventions in bipolar disorder.
The authors opine that reporting these newer outcomes, such as NNT or NNH, area under the receiver operating curve (AUC), or PPV or NPV will help translate the results of clinical trials into a language that is more readily understood by clinicians. Moreover, assessing and evaluating functional and cognitive outcomes will not only inform clinicians about potential differences among therapeutic options, but likely will make it easier to communicate such differences to persons with bipolar illness or to their families. Finally, we hope such scientific and research efforts will translate to optimism for recovery-based outcomes in persons with bipolar disorder.

1 Follower
13 Reads
  • Source
    • "Most of these studies tried to control for the impact of subclinical symptoms that have been considered as a negative influence for the functional recovery of bipolar patients. One of the main problems is that remission and euthymia criteria are often not clearly defined, so differences between studies were found [41]. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Neurocognitive impairment constitutes a core feature of bipolar illness. The main domains affected are verbal memory, attention, and executive functions. Deficits in these areas as well as difficulties to get functional remission seem to be increased associated with illness progression. Several studies have found a strong relationship between neurocognitive impairment and low functioning in bipolar disorder, as previously reported in other illnesses such as schizophrenia. Cognitive remediation strategies, adapted from work conducted with traumatic brain injury patients and applied to patients with schizophrenia, also need to be adapted to individuals with bipolar disorders. Early intervention using functional remediation, involves neurocognitive techniques and training, but also psychoeducation on cognition-related issues and problem-solving within an ecological framework.
    Full-text · Article · Jun 2011 · Clinical Practice and Epidemiology in Mental Health
  • Source
    • "The course of BD is characterized by a multifinality of outcomes, which can include recovery, remission, relapse, recurrence, ongoing symptoms, or psychosocial impairments (Frank et al., 1991; Martinez-Arán et al., 2008 "
    [Show abstract] [Hide abstract]
    ABSTRACT: This article reviews the role of social factors, notably life events and family relationships, in the course of bipolar illness in adults and youth. We also discuss psychological variables that help explain the vulnerability of bipolar patients to social environments, including personality factors (e.g., neuroticism), reward sensitivity, and difficulty with the accurate perception of facial emotions. Bipolar patients are highly sensitive to reward, and excessive goal pursuit after goal-attainment events may be one pathway to mania. Negative life events predict depressive symptoms, as do levels of familial expressed emotion. Psychosocial interventions can speed recoveries from episodes and delay recurrences over one- to two-year intervals. Future research should examine the nature of vulnerability/stress interactions at different phases of development, and the role of psychosocial interventions in altering these processes.
    Full-text · Article · May 2009 · Clinical Psychology Science and Practice
  • [Show abstract] [Hide abstract]
    ABSTRACT: The technique of interpolated arrays is applied to ESPRIT-type direction-finding methods. The resulting method uses sensor arrays with arbitrary configuration, thus eliminating the basic restrictive requirement of ESPRIT for two (or more) identical arrays. The approach allows for resolving D narrowband signals if the number of sensors is at least D +1, while the original ESPRIT method requires at least 2 D sensors. Moreover, it is shown that while ESPRIT performs poorly for signals propagating in parallel (or close to parallel) with the array-displacement vector, this technique does not exhibit such weakness. While using two subarrays ESPRIT cannot resolve azimuth and elevation, even when the sensors are not collinear. The interpolated ESPRIT procedure resolves azimuth and elevation using only a single array. These advantages are obtained with a reasonable increase in computation load, thus preserving the basic and most outstanding advantage of ESPRIT
    No preview · Conference Paper · May 1991
Show more