Change in employment status over 52 weeks in patients with schizophrenia: an observational study

Abstract

Background:

The aim of this post-hoc analysis was to describe change in employment status over time in patients with schizophrenia.

Methods:

Data were from three 52-week open-label extensions of the double-blind pivotal trials of paliperidone extended-release (ER) (trial numbers NCT00650793, NCT00210769 and NCT00668837). Employment status prior to trial entry was recorded at baseline of the open-label phase and change was measured at 4-week intervals. Patients were included if they were in the open-label, intent-to-treat analysis set (i.e., received at least one dose of the study medication and had a baseline and at least one post-baseline efficacy measurement) and had valid dates in the productivity data. Employment categories included full-time, part-time, casual, sheltered work, unemployed but seeking work, unemployed and not seeking work, retired, not employed outside the home and student. Change in employment status from baseline to post-baseline (last visit) was assessed using McNemar’s test.

Results:

Of the 1077 patients enrolled in the open-label extensions, 1012 (94.0%) met inclusion criteria. The average age was 37.7 years (SD 10.9) and 59.1% were male. At baseline, the largest percentage of patients was unemployed and not seeking work (56.8%), followed by retired (14.9%) and unemployed but seeking work (11.7%). Five different definitions of employment were created. Employment rates increased according to all five definitions (p < 0.0001), ranging from a 43% increase according to the definition most similar to that used by the US Bureau of Labor Statistics to an increase of 114% when only part-time and full-time employment were considered.

Conclusion:

In this uncontrolled population of patients with schizophrenia who were treated with paliperidone ER, the percentage of patients who were employed increased over time. By using multiple measures of employment, researchers can identify the nature of the employment status change.

Key words::

• Schizophrenia
• Employment
• Functional status
• Productivity
• Paliperidone

Transparency

Declaration of funding

Supported by funding from Ortho-McNeil Janssen Scientific Affairs, LLC.

Declaration of financial/other relationships

R. Dirani, L. Mao, and C. Canuso are employees of Ortho-McNeil Janssen Scientific Affairs, LLC. C. Kozma was contracted by Ortho-McNeil Janssen Scientific Affairs, LLC, to perform the statistical analysis.

C. Kozma contributed to design of the analysis, execution of the statistical analysis, interpretation of the data, and final approval of the manuscript. R. Dirani contributed to the design of the analysis, interpretation of the data, decision to publish, writing/editing of the text, and final approval of the manuscript. L. Mao contributed to design of the analysis, execution of the statistical analysis, interpretation of the data, and final approval of the manuscript. C. Canuso contributed to the design of the analysis, interpretation of the data, decision to publish, writing/editing of the text, and final approval of the manuscript.

Acknowledgments

The authors wish to acknowledge the technical and editorial support provided by Dr. Matthew Grzywacz, PhD and Helix Medical Communications (funding supported by Ortho-McNeil Janssen Scientific Affairs, LLC).

The results in this manuscript were previously presented as an abstract at the following meeting: Dirani R, Kozma C, Mao L, Amatniek J, and Canuso C. Relationship Between Function and Employment Status in Patients With Schizophrenia, Poster presentation at the College of Psychiatric and Neurologic Pharmacists Annual Meeting, April 13–16, 2008, Scottsdale, Arizona, USA.