Skip to main content

Advertisement

SpringerLink
Log in

Adaptation and validation of the “tolerability and quality of life” (TOOL) questionnaire in Chinese bipolar patients

  • Published:
Quality of Life Research Aims and scope Submit manuscript

Abstract

Background

It is well known that the antipsychotic drugs impact the health-related quality of life (HRQoL) of the bipolar patients. The side effects had been assessed only from the doctors’ perspective and neglected the patients’ subjective feeling. The aim of the study is to validate the specific instrument “tolerability and quality of life” (TOOL) into Chinese to describe and grade the impact of antipsychotic drugs on HRQoL from patients’ view.

Methods

A psychometric study was conducted with euthymic bipolar disorder patients (N = 105) under antipsychotic treatment. The psychometric properties of the TOOL, including internal consistency, retest reliability, concurrent validity, content validity, discriminative validity, item analysis, confirmatory factor analysis and feasibility, were analyzed.

Results

The internal consistency and intraclass correlation coefficient (ICC) were adequate (Cronbach’s alpha = 0.80 and ICC = 0.81). A confirmatory factor analysis (CFA) validated the one-factor model. Significant Spearman’s rank correlations between the TOOL and both Bref QoL.BD (Brief version of Quality of Life in Bipolar Disorder) (r = −0.33, P < 0.01) and UKU (Udvalg for Kliniske Undersogelser side effects scale) (r = 0.13, P < 0.05) were found.

Limitations

Small sample size and no specific self-report instrument in Chinese to evaluate the criterion validity.

Conclusions

TOOL appears to be a reliable and valid measure to assess the impact of adverse events of antipsychotic drugs on HRQoL from the patients’ perspective.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Buckley, P. F. (2008). Update on the etiology and treatment of schizophrenia and bipolar disorder. CNS Spectrums, 13(Suppl 1), 3–10.

    Google Scholar 

  2. Edwards, S. J., & Smith, C. J. (2009). Tolerability of atypical antipsychotics in the treatment of adults with schizophrenia or bipolar disorder: A mixed treatment comparison of randomized controlled trials. Clinical Therapeutics, 31, 1345–1359.

    Article  CAS  PubMed  Google Scholar 

  3. Elmslie, J. L., Silverstone, J. J., Mann, J. I., Williams, S. M., & Romans, S. E. (2000). Prevalence of overweight and obesity in bipolar patients. Journal of Clinical Psychiatry, 61(3), 179–184.

    Article  CAS  PubMed  Google Scholar 

  4. Fagiolini, A., Chengappa, K. N., Soreca, I., & Chang, J. (2008). Bipolar disorder and the metabolic syndrome: Causal factors, psychiatric outcomes and economic burden. CNS Drugs, 22(8), 655–669.

    Article  CAS  PubMed  Google Scholar 

  5. Kolotkin, R. L., Corey, L., & Crosby, R. D. (2008). Impact of obesity on HRQoL in schizophrenia and bipolar disorder. Obesity, 16, 749–754.

    Article  PubMed  Google Scholar 

  6. Berk, M., & Berk, L. (2003). Mood stabilizers and treatment adherence in bipolar disorder: Addressing adverse events. Annals of Clinical Psychiatry, 15(3), 217–224.

    Article  PubMed  Google Scholar 

  7. Chue, P., & Kovacs, C. S. (2003). Safety and tolerability of atypical antipsychotics in patients with bipolar disorder: Prevalence, monitoring and management. Bipolar Disorders, 5(Suppl 2), 62–79.

    Article  CAS  PubMed  Google Scholar 

  8. Johnson, F. R., Ozdemir, S., Manjunath, R., Hauber, A. B., Burch, S. P., & Thompson, T. R. (2007). Factors that affect adherence to bipolar disorder treatments: A stated-preference approach. Medical Care, 45(6), 545–552.

    Article  PubMed  Google Scholar 

  9. Sachs, G. S. (2003). Unmet clinical needs in bipolar disorder. Journal of Clinical Psychopharmacology, 23(Suppl 1), S2–S8.

    PubMed  Google Scholar 

  10. Lingam, R., & Scott, J. (2002). Treatment non-adherence in affective disorders. Acta Psychiatrica Scand., 105(3), 164–172.

    Article  Google Scholar 

  11. Endicott, J., Paulsson, B., Gustafsson, U., Schioler, H., & Hassan, M. (2008). Quetiapine monotherapy in the treatment of depressive episodes of bipolar I and II disorder: Improvements in quality of life and quality of sleep. Journal of Affective Disorders, 111(2–3), 306–319.

    Article  CAS  PubMed  Google Scholar 

  12. Yen, C. F., Cheng, C. P., Huang, C. F., Yen, J. Y., Ko, C. H., & Chen, C. S. (2008). Quality of life and its association with insight, adverse effects of medication and use of atypical antipsychotics in patients with bipolar disorder and schizophrenia in remission. Bipolar Disorders, 10(5), 617–624.

    Article  PubMed  Google Scholar 

  13. Awad, A. G., Hogan, T. P., Voruganti, L. N., & Heslegrave, R. J. (1995). Patients’ subjective experiences on antipsychotic medications: Implications for outcome and quality of life. International Clinical Psychopharmacology, 10, 123–132.

    PubMed  Google Scholar 

  14. Ritsner, M., Modai, I., Endicott, J., Rivkin, O., Nechamkin, Y., Barak, P., et al. (2000). Differences in quality of life domains and psychopathologic and psychosocial factors in psychiatric patients. Journal of Clinical Psychiatry, 61(11), 880–889.

    Article  CAS  PubMed  Google Scholar 

  15. Reine, G., Lancon, C., Di, T. S., Sapin, C., & Auquier, P. (2003). Depression and subjective quality of life in chronic phase schizophrenic patients. Acta Psychiatrica Scandinavica, 108(4), 297–303.

    Article  CAS  PubMed  Google Scholar 

  16. Taksh, U. (2006). A critical review of rating scales in the assessment of movement disorders in schizophrenia. Current Drug Targets, 7(9), 1225–1229.

    Article  CAS  PubMed  Google Scholar 

  17. Lingjaerde, O., Ahlfors, U. G., Bech, P., Dencker, S. J., & Elgen, K. (1987). The UKU side effect rating scale. A new comprehensive rating scale for psychotropic drugs and a cross-sectional study of side effects in neuroleptic-treated patients. Acta Psychiatrica Scandinavica, 334, 1–100.

    Article  CAS  PubMed  Google Scholar 

  18. Thornicroft, G., & Tansella, M. (2005). Growing recognition of the importance of service user involvement in mental health service planning and evaluation. Epidemiologia e Psichiatria Sociale, 14(1), 1–3.

    Article  PubMed  Google Scholar 

  19. Montejo, A. L. (2008). Prolactin awareness: An essential consideration for physical health in schizophrenia. European Neuropsychopharmacology, 18(Suppl 2), S108–S114.

    Article  CAS  PubMed  Google Scholar 

  20. Montejo, A. L., Correas-Lauffer, J., Mauriño, J., Villa, G., Rebollo, P., Díez, T., & Cordero, L. (2011). Estimation of a multiattribute utility function for the Spanish version of the TOOL questionnaire. Value in Health, 14(4), 564–570.

    Article  PubMed  Google Scholar 

  21. Lindstrom, E., Jonsson, L., & Berntsson, A. (2009). A patient perspective on side effects of antipsychotic therapy: The TOOL instrument. Value in Health, 12(7), A361.

    Article  Google Scholar 

  22. Jonsson, L., Lang, A., & Lindstrom, E. (2009). TOOL: Multi-attribute utility function reflecting patient experience of side effects to antipsychotic therapy. Value in Health, 12(7), A361.

    Article  Google Scholar 

  23. Montejo, A. L., Lauffer, J. C., Cuervo, J., Rebollo, P., Cordero, L., Diez, T., & Maurino, J. (2011). Validation of a specific measure to assess health related quality of life in patients with schizophrenia and bipolar disorder: The ‘Tolerability and quality of life’ (TOOL) questionnaire. Annals of General Psychiatry, 10(1), 6.

    Article  PubMed  PubMed Central  Google Scholar 

  24. Maurino, J., Cordero, L., Montejo, A. L., Correas-Lauffer, J., Cuervo, J., Rebollo, P., et al. (2009). The Spanish version of the TOOL questionnaire: Validation of a specific measure to evaluate health related quality of life in patients with schizophrenia and bipolar disorder. Value in Health, 12(7), A362.

    Article  Google Scholar 

  25. Maurino, J., Cordero, L., Montejo, A., Rebollo, P., & Cuervo, J. (2008). The Spanish version of the TOOL questionnaire: A useful measure for evaluating the HRQoL and utilities from schizophrenic and bipolar patients. Value in Health, 11(6), A593.

    Article  Google Scholar 

  26. Gandek, B., & Ware, J. E. (1998). Methods for validating and norming translations of health status questionnaires: The IQOLA project approach. Journal of Clinical Epidemiology, 51(11), 953–959.

    Article  CAS  PubMed  Google Scholar 

  27. Hamilton, M. (1960). A rating scale for depression. Journal of Neurology, Neurosurgery and Psychiatry, 23, 56–62.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  28. Bech. (1979). The Bech-Rafaelsen Mania Scale and Hamilton Depression Scale. Acta Psychiatrica Scandinavica, 59, 420–429.

    Article  CAS  PubMed  Google Scholar 

  29. Zhang, Z. J. (2001). Hamilton Depression Scale. Chinese Journal of Behavioral Medical Science, 10, 134–135.

    Google Scholar 

  30. Cui, S. (1985). Bech-Rafaelsen Mania Rating Scale for the assessment of manic patients. Chinese Journal of Nervous and Mental Diseases, 18, 267–269.

    CAS  Google Scholar 

  31. Michalak, E. E., Murray, G., & CREST.BD. (2010). Development of the QoL.BD: A disorder specific scale to assess quality of life in bipolar disorder. Bipolar Disorders, 12(7), 727–740.

    Article  PubMed  Google Scholar 

  32. Xiao, L., Gao, Y. L., Zhang, L. L., Chen, P. Y., Sun, X. J., & Tang, S. Y. (2016). Validity and reliability of the Brief version of Quality of Life in Bipolar Disorder (Bref QoL.BD) among Chinese bipolar patients. Journal of Affective Disorders, 193, 66–72.

    Article  PubMed  Google Scholar 

  33. Polit, D. F., & Beck, C. T. (2006). The content validity index: Are you sure you know what’s being reported? critique and recommendations. Research in Nursing & Health, 29(5), 489–497. (Chinese journal).

    Article  Google Scholar 

  34. Shi, J. C., Mo, X. K., & Sun, Z. Q. (2012). Content validity index in scale development. Journal of Central South University, 37(2), 152–155. (Chinese journal).

    Google Scholar 

  35. Joreskog, K. G., & Sorbom, D. (1996). LISREL 8: User’s reference guide. Chicago: Scientific Software International.

    Google Scholar 

  36. Kelloway, E. K. (1998). Using LISREL for structural equation modeling: A researcher’s guide. Thousand Oaks, CA: SAGE.

    Google Scholar 

  37. Kline, R. B. (1998). Principals and practice of structural equation modeling. New York, NY: Guilford.

    Google Scholar 

  38. Guan, M. (2016). Factor structure of the Chinese version of the geriatric anxiety inventory. Annals of General Psychiatry, 15, 4.

    Article  PubMed  PubMed Central  Google Scholar 

  39. Bollen, K. A. (1989). Structural equation with latent variables. New York, NY: Wiley.

    Book  Google Scholar 

  40. Bonnin, C. M., Sanchez-Moreno, J., Martinez-Aran, A., Sole, B., Reinares, M., Rosa, A. R., et al. (2012). Subthreshold symptoms in bipolar disorder: Impact on neurocognition, quality of life and disability. Journal of Affective Disorders, 136(3), 650–659.

    Article  CAS  PubMed  Google Scholar 

  41. Cochran, W. G. (1952). The χ2 test of goodness of fit. The Annals of Mathematical Statistics, 23(3), 315–345.

    Article  Google Scholar 

  42. Michalak, E. E., Yatham, L. N., & Lam, R. W. (2005). Quality of life in bipolar disorder: A review of the literature. Health and Quality of Life Outcomes, 3, 72.

    Article  PubMed  PubMed Central  Google Scholar 

  43. Morselli, P. L., Elgie, R., & Cesana, B. M. (2004). GAMIAN-Europe/BEAM survey II: Cross-national analysis of unemployment, family history, treatment satisfaction and impact of the bipolar disorder on life style. Bipolar Disorders, 6(6), 487–497.

    Article  CAS  PubMed  Google Scholar 

  44. Endicott, J., Rajagopalan, K., Minkwitz, M., & Macfadden, W. (2007). BOLDER Study Group. A randomized, double-blind, placebo-controlled study of quetiapine in the treatment of bipolar I and II depression: Improvements in quality of life. International Clinical Psychopharmacology, 22, 29–37.

    Article  PubMed  Google Scholar 

  45. Vornik, L. A., & Hirschfeld, R. M. (2005). Bipolar disorder: Quality of life and the impact of atypical antipsychotics. The American Journal of Managed Care, 11(Suppl. 9), 275–280.

    Google Scholar 

  46. Perkins, D. O., Gu, H., Weiden, P. J., McEvoy, J. P., Hamer, R. M., & Lieberman, J. A. (2008). Predictors of treatment discontinuation and medication non-adherence in patients recovering from a first episode of schizophrenia, schizophreniform disorder, or schizoaffective disorder: A randomized, double-blind, flexible-dose, multicenter study. Journal of Clinical Psychiatry, 69(1), 106–113.

    Article  CAS  PubMed  Google Scholar 

  47. Briggs, A., Wild, D., Lees, M., Reaney, M., Dursun, S., Parry, D., & Mukherjee, J. (2008). Impact of schizophrenia and schizophrenia treatment-related adverse events on quality of life: Direct utility elicitation. Health and Quality of Life Outcomes, 6, 105.

    Article  PubMed  PubMed Central  Google Scholar 

  48. Hayhurst, H., Palmer, S., Abbott, R., Johnson, T., & Scott, J. (2006). Measuring health-related quality of life in bipolar disorder: Relationship of the EuroQol (EQ-5D) to condition-specific measures. Quality of Life Research, 15(7), 1271–1280.

    Article  PubMed  Google Scholar 

Download references

Acknowledgments

We thank all the participants and their caregivers that consented to participate in the study. And we appreciate the approval and support of the psychiatric wards of the Second Xiangya Hospital.

Funding

This study was funded by the Central South University Education, Grants 2014zzts329.

Author information

Authors and Affiliations

  1. School of Nursing, Southern Medical University, 1023 Sha Tai South Road, Bai Yun District, Guangzhou, 510515, Guangdong Province, China

    Lin Xiao, Yulin Gao, Lili Zhang, Peiyun Chen & Xiaojia Sun

  2. Nursing School of Central South University, 172 Tong Zi Po Street, Yue Lu District, Changsha, 410013, Hunan Province, China

    Siyuan Tang

Authors
  1. Lin Xiao
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Yulin Gao
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Lili Zhang
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Peiyun Chen
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Xiaojia Sun
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Siyuan Tang
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding authors

Correspondence to Lili Zhang or Siyuan Tang.

Ethics declarations

Conflict of interest

The authors declare no competing interests regarding the publication of this paper.

Ethical approval

The Ethics Committee of the Second Xiangya Hospital of Central South University approved this study in March 2014.

Appendix

Appendix

English version of TOOL questionnaire (Montejo et al. [20])

Likert scale: 1 = minimum to 4 = maximum impact

1. Mood

2. Function capabilities

① I do not feel anxious or depressed

① I have no difficulties with my usual activities

② I feel a little anxious or depressed

② I have some difficulties with my usual activities

③ I feel rather much anxious or depressed

③ I have rather much difficulties with my usual activities

④ I feel very anxious or depressed

④ I have great difficulties with my usual activities

3. Fatigue or weakness

4. Body weight

① I do not feel tired or weak

① I am not overweight

② I feel a little tired or weak

② I am a little overweight

③ I feel rather much tired or weak

③ I am rather much overweight

④ I feel very tired or weak

④ I am very overweight

5. Stiffness or tremor

6. Physical restlessness

① I have no problems with stiffness or tremor

① I feel no bodily restlessness

② I have some problems with stiffness or tremor

② I feel some bodily restlessness

③ I have rather much problems with stiffness or tremor

③ I feel rather much bodily restlessness

④ I have great problems with stiffness or tremor

④ I feel very much bodily restlessness

7. Sexual function

8. Dizziness or nausea

① I have normal sexual lust and ability

① I have no problems with dizziness or nausea

② I have somewhat reduced sexual lust and ability

② I have some problems with dizziness or nausea

③ I have very reduced sexual lust and ability

③ I have rather much problems with dizziness or nausea

④ I have no sexual lust and ability

④ I have great problems with dizziness or nausea

Chinese version of TOOL questionnaire

李克特等级评分,4级评分

1. 心境状态

2. 功能状态

① 我没有感觉到焦虑或抑郁

① 我应对日常活动没有困难

② 我感觉到有一点焦虑或抑郁

② 我应对日常活动有一点困难

③ 我感觉到比较多的焦虑或抑郁

③ 我应对日常活动有比较多的困难

④ 我感觉到非常焦虑或抑郁

④ 我应对日常活动有非常多的困难

3. 疲乏感或虚弱感

4. 体重

① 我没有感觉疲劳或虚弱

① 我没有超重

② 我感觉有一点疲劳或虚弱

② 我有一点超重

③ 我感觉比较疲劳或虚弱

③ 我超重比较多

④ 我感觉非常疲劳或虚弱

④ 我超重非常多

5. 僵硬或震颤

6. 身体坐立不安

① 我没有感到僵硬或震颤

① 我没有感到身体坐立不安

② 我感到有一点僵硬或震颤

② 我感到身体有一点坐立不安

③ 我感到比较僵硬或震颤

③ 我感到身体比较坐立不安

④ 我感到非常僵硬或震颤

④ 我感到身体非常坐立不安

7. 性功能

8. 眩晕或恶心

① 我的性欲望及性能力正常

① 我没有感到眩晕或恶心

② 我的性欲望及性能力有一点下降

② 我感觉有一点眩晕或恶心

③ 我的性欲望及性能力下降比较多

③ 我感觉比较眩晕或恶心

④ 我的性欲望及性能力消失

④ 我感觉非常眩晕或恶心

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Xiao, L., Gao, Y., Zhang, L. et al. Adaptation and validation of the “tolerability and quality of life” (TOOL) questionnaire in Chinese bipolar patients. Qual Life Res 25, 2825–2832 (2016). https://doi.org/10.1007/s11136-016-1319-1

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11136-016-1319-1

Keywords

Search

Navigation