The utility of novel outcome measures in a naturalistic evaluation of schizophrenia treatment

Abstract

Background

A number of naturalistic studies have investigated paliperidone palmitate (PP) using proxy measures of effectiveness. An unexplored option is to examine the utility of the mental health clustering tool (MHCT), which is used in UK clinical practice to measure patient well-being and is linked to allocation of resources. This study evaluated the effectiveness of PP using the MHCT, the Health of the Nation Outcome Scales (HoNOS), and, for comparison, more conventional outcome measures.

Methods

This was a naturalistic, 1-year evaluation of PP (n=50) in schizophrenia as well as a comparator antipsychotic drugs group. Changes in the MHCT cluster-score cost ranking and four HoNOS-derived factors were analyzed using a mixed-model statistical analysis to explore the utility of these measures.

Results

At 1 year, 30 patients (60%) continued PP treatment. The mean “cluster-score cost ranking” (−1.5) and Severe Disturbance factor scores (−1.1) were significantly lower (p-value [adjusted] =0.0003, p-value [adjusted] =0.002, respectively) after 1 year of antipsychotic treatment but no differences were found between PP and the comparator antipsychotic drugs group. Patients prescribed PP were 1.8 times (95% CI 1.1−3.1) more likely to be discharged from hospital than those in the comparator antipsychotic drugs group.

Conclusion

PP’s continuation rate after 1 year made the study similar to the existing evaluations, and it was possible to prospectively evaluate antipsychotic effectiveness using the novel measures although these did not discriminate between PP and the comparator group. The investigation illustrates that in principle these novel measures are meaningful in naturalistic study designs.

Keywords:

• paliperidone palmitate
• antipsychotics
• schizophrenia
• patient satisfaction
• outcome measures

Supplementary materials

Table S1 Key to MHCT Care clusters 10–17 (“psychosis” super cluster)

Table S2 Key to individual HoNOS items

Table S3 Cluster-score cost ranking according to financial outlay

References

• Mental Health Clustering Booklet. (V5.0) (2016/17)NHS England Publications Available from https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/499475/Annex_B4_Mental_health_clustering_booklet.pdfAccessed January 19, 2018
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• International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10)-WHO Version for 2016 Available from: http://apps.who.int/classifications/icd10/browse/2016/en#/VAccessed January 19, 2018
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• Health of the Nation Outcome Scales (HoNOS) Available from: https://www.rcpsych.ac.uk/pdf/HoNOS-secure%20Glossary%20v2b%20Feb%2007.pdfAccessed January 19, 2018
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• NHSPayment by Results Guidance for 2013–142013 Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/232162/Mental_Health_PbR_Guidance_for_2013-14.pdfAccessed May 10, 2017
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Acknowledgments

The authors would like to acknowledge and thank Janssen Cilag Ltd. Without their investigator-initiated grant, the study could not have been resourced.

Disclosure

Parastou Donyai was the named principal investigator who was awarded the investigator-initiated grant from Janssen Cilag Ltd, which supported this work. In addition, Kate Masters reports that her husband is employed by Johnson & Johnson, which Janssen Cilag Ltd is a subsidiary of, and has shares in the company. The authors report no other conflicts of interest in relation to this work.