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S YS T E M AT I C R E V I E W P R O T O C O L Experiences of medication adherence among people with schizophrenia: a systematic review protocol of qualitative evidence Nisakorn Pothimas 1 Patraporn Tungpunkom 2 Thidarat Kanungpiarn 1 1 Faculty of Nursing, Chiang Mai University, Thailand, 2Faculty of Nursing, Chiang Mai University, The Thailand Centre for Evidence-based Nursing, Midwifery and Health Science (TCEBNMHS): a Collaborating Centre of the Joanna Briggs Institute Review question/objective: The objective of this qualitative review is to synthesize the lived experiences of medication adherence among people with schizophrenia. The specific review question is: what are the experiences of taking prescribed medication among people with schizophrenia? Keywords Experience; medication adherence; qualitative; schizophrenia; antipsychotic medication Background chizophrenia is a chronic and serious mental illness that affects more than 21 million people worldwide.1 The incidence rate of schizophrenia is 15.2 per 100,000 persons. This mental illness affects both men and women. The study by McGrath and colleagues2 presented the rate ratio for males versus females as 1.4:1. The difference in age at the onset between men and women was not statistically significant. The mean age was 25 years for women and 23 years for men.3 The median lifetime prevalence for persons were 4.0 per 1000.2,4 Moreover, the finding from a systematic review by Saha et al.4 indicated that the prevalence of schizophrenia in migrant groups from eight countries including Australia, Germany, India, Israel, Taiwan, the Netherlands, United Kingdom and the United States was higher than that in natives of these countries. The median rate ratio for migrant versus native born was 1.84. Furthermore, the prevalence of this illness was related to economic status. The countries that had high per capita income showed lower prevalence than the low-income countries. The illness of schizophrenia is divided into three phases, namely, the prodromal phase, the active phase and the residual phase.5 First, the prodromal phase is a phase that can occur over several S Correspondence: Patraporn Tungpunkom, [email protected] There is no conflict of interest in this project. DOI: 10.11124/JBISRIR-2016-2538 JBI Database of Systematic Reviews and Implementation Reports months or years.6 Signs and symptoms, such as social withdrawal, deterioration of role functioning and grooming, unusual behavior,5 interest in activities that are para-normal and supernatural (e.g. black magic, demons, ghosts)6 and problems with language and communication,7 develop slowly during this period. Second, the active phase occurs after the prodromal period. This phase is characterized by psychotic symptoms, such as delusions, hallucinations and disturbances in behavior and feelings.8 Finally, in the residual phase, people with schizophrenia may present the psychotic symptoms that are similar to those in the prodromal phase.7 During their lifetime, people with schizophrenia could return to the active phase. Each time they return to this phase, the residual symptoms increase, whereas the ability to function normally may decline.8 There are three broad categories of symptoms: positive symptoms, negative symptoms and cognitive symptoms. Positive symptoms are psychotic behaviors that do not occur in healthy individuals and reflect a loss of contact with reality. Positive symptoms vary in intensity from minor to severe and include behaviors such as hallucinations, delusions and movement disorder.7,8 Negative symptoms are disruptions in normal emotions and behaviors and are often harder to detect.8 Negative symptoms include blunted affect or affective flattening, lack of pleasure or interest, lack of energy, loss of normal functions, lack of spontaneity and flow of conversation.9 Cognitive symptoms are relatively difficult to recognize as part of the disorder such as poor ability ß 2016 THE JOANNA BRIGGS INSTITUTE ©2016 Joanna Briggs Institute. Unauthorized reproduction of this article is prohibited. 51 SYSTEMATIC REVIEW PROTOCOL to understand information, trouble focusing or paying attention, and problems associated with the ability to use information immediately after learning it.8 The treatment for schizophrenia is aimed at controlling symptoms and preventing psychotic relapses. To this end, the crucial treatments are antipsychotic medications and psychosocial treatments.10 Psychosocial treatments could enhance coping strategies and emotional support such as cognitive behavior therapy, personal therapy, acceptance and commitment therapy and supportive therapy.11 Antipsychotic medications are considered a firstline treatment to decrease psychotic symptoms such as hallucinations and delusions in the acute phase. Moreover, it is a major treatment to prevent exacerbation of psychotic symptoms for long periods.12 They are generally divided into two categories including first-generation antipsychotics (typical agents) and second-generation antipsychotics (atypical agents).13 First-generation antipsychotics or typical agents are divided into three groups depending on the medication potency. The first group is high-potency neuroleptics that are fluphenazine, haloperidol, thiothixene and trifluoperazine. The second group is moderate-potency neuroleptics consisting of molindone and loxapine. The last one is low-potency neuroleptics, that is, chlorpromazine and thioridazine.7 These agents are used to control psychotic symptoms by blocking the dopamine reaction at the receptor site.7 High levels of dopamine activate nerves in the brainstem, leading to faster transmission of nerve impulses. This makes the patients present psychotic symptoms such as hallucinations, bizarre thoughts and behavior. Therefore, blocking this neurotransmitter can inhibit progression of uncommon thoughts and behavior.9 However, second-generation antipsychotics or atypical agents are the serotonin-dopamine antagonists consisting of risperidone, olanzapine, quetiapine and ziprasidone.7,9 They are used to treat positive and negative symptoms9 by blocking specific serotonin and dopamine at receptor sites.7 These agents induce less adverse effects than the neuroleptic agents.9 The adverse effects are generally associated with antipsychotic medications consisting of sedative, orthostatic hypotension, anticholinergic effects (e.g. constipation, urinary retention, dry mouth, blurred vision and cognitive impairment), extrapyramidal symptoms (e.g. pseudoparkinsonism, akathisia, JBI Database of Systematic Reviews and Implementation Reports N Pothimas et al. acute dystonia and tardive dyskinesia), hyperprolactinemia, sexual dysfunction, agranulocytosis, cardiac arrthymias, seizures and metabolic syndrome.14 A literature review found that individuals with schizophrenia have significant problems with adherence to antipsychotic medications. The results of the study by Quach et al.15 of 547 schizophrenia patients with a first psychotic episode found poor medication adherence in approximately 39 and 35% at one and two years follow-up, respectively, whereas the rates of good adherence were 51 and 44% at one and two years follow-up, respectively. Similarly, the study by Adelufosi et al.16 showed that medication adherence and medication non-adherence of 313 respondents were 59.7 and 40.3%, respectively. The findings are in line with the study by Dassa et al.17 who presented the medication adherence and non-adherence rates of 291 patients as 69.42% and approximately 30%, respectively. Furthermore, the study by Amr et al.18 demonstrated that 26% of 92 schizophrenia patients adhered to antipsychotic agents, whereas the other 74% was medication non-adherent. Moreover, Ngui et al.19 revealed that 12.57% of patients consistently showed good adherence and nearly 35% showed inconsistent adherence, whereas about 52% showed consistently poor adherence. From the literature reviewed, the factors associated with medication adherence can be divided into three groups, namely, clinical factors, personal factors and social support factors. The clinical factor that includes the severity of psychotic symptoms affects the patient’s medication adherence. It was found that patients who have low severity of psychotic symptoms tend to adhere to medications.20 The severity of psychotic symptoms, especially positive symptoms, is more likely to decrease medication adherence, for example patients who feel persecuted or are afraid that they will be poisoned would be reluctant to take medication.21 Therefore, persons with schizophrenia with less severe psychotic symptoms will show more adherence to the treatment regimen. This is because their insight into and awareness of their illness, that is, the personal factor 20, play a major role in influencing adherence behavior.21 In addition, positive attitudes toward medication which stem from a belief that antipsychotic medications can help improve their symptoms22 and help them cope with life,23 represent another factor that contributes to persons with schizophrenia adhering to medication. Social ß 2016 THE JOANNA BRIGGS INSTITUTE ©2016 Joanna Briggs Institute. Unauthorized reproduction of this article is prohibited. 52 SYSTEMATIC REVIEW PROTOCOL support factors such as support from family and friends could also assist in people with schizophrenia adhering to medication.24 Like adherent factors, medication non-adherence factors can be divided into three groups. The severity of psychotic symptoms, especially positive symptoms, is mostly found in the clinical factor, leading to medication non-adherence.20,25–28 The personal factors such as lack of insight into illness,20,25,27–29 substance use disorders,27,28 unemployment,27 poor functioning25,27 and negative attitudes to antipsychotic medications affect non-adherence.30 Schizophrenia patients feel that antipsychotic medications threaten their self-esteem and stigmatize them. When they stop taking medicine, it helps them think that they are not crazy.24 According to the social support factors, patients who live alone tend to have poor adherence or discontinuation of long-term treatment.29 Non-adherence to antipsychotic medications is an important problem as it leads to psychotic relapse, readmission and attempted suicide among people with schizophrenia.31 Moreover, medication nonadherence has significant cost implications with costs associated with relapse being significantly high. Ascher-Svanum and colleagues32 found that the direct costs in US dollars of relapse during the first year were about three times higher ($33,187 $47,616) in those who relapsed versus those who did not relapse ($11,771 $10,611). Similarly, Hong et al.33 found that the costs of relapse were about two times (£14,055 £7417) higher in those with relapses as compared with those without relapses.33 Similarly, Almond et al.34 found that the costs of relapse were over four times higher than the costs for non-relapse patients.34 Therefore, it is useful to understand the experiences and perspectives of people with schizophrenia who can maintain long-term treatment. However, there is no systematic review about the experiences of medication adherence among people with schizophrenia in the Cochrane Library or Joanna Briggs Institute (JBI) Database of Systematic Reviews and Implementation Reports. Therefore, the objective of this review is to synthesize those primary studies that explored lived experiences of medication adherence among people with schizophrenia. The results can shed some light on both positive and negative factors associated with medication adherence, especially subjective experiences from the insider’s point of view. It can lead to JBI Database of Systematic Reviews and Implementation Reports N Pothimas et al. recommendations for practice based on the patients’ perspectives. It also can serve as a basis to further develop effective programs for enhancing antipsychotic medication adherence in schizophrenia patients. Inclusion criteria Types of participants This review will consider studies that include patients aged 18 years and over who have been diagnosed with schizophrenia spectrum disorders (schizophrenia, schizophreniform, undifferentiated schizophrenia and schizoaffective disorder). The diagnostic criteria are based on any editions of the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders or the International Statistical Classification of Diseased and Related Health Problems-10. Studies related to patients with organic brain disorder or mental retardation, alcohol or drug abuse will be excluded. Phenomena of interest This review will consider primary studies that explored the experiences of medication adherence among people with schizophrenia. Context This review considers studies that have been conducted on people with schizophrenia who were hospitalized or living in the community. Types of studies The review will consider any qualitative studies that focus on the experiences of medication adherence of people with schizophrenia, using research methodologies including, but not limited to, phenomenology, grounded theory and ethnography. Search strategy Prior to reviewing the experiences of medication adherence among people with schizophrenia, this topic will be searched in the Cochrane Library and JBI Database of Systematic Reviews and Implementation Reports to ensure that there are no prior systematic reviews. An extensive search strategy will be conducted to find both published and unpublished studies in English and Thai from 1999 to 2015, because the first reported study exploring the experiences related to taking antipsychotic ß 2016 THE JOANNA BRIGGS INSTITUTE ©2016 Joanna Briggs Institute. Unauthorized reproduction of this article is prohibited. 53 SYSTEMATIC REVIEW PROTOCOL medication of people with schizophrenia was first investigated in the year of 1999. A three-step search strategy will be conducted for this review as follows: An initial limited search of MEDLINE and CINAHL will be undertaken followed by an analysis of the text words contained in the title, abstracts and subject descriptors/MeSH terms in relevant articles to identify additional keywords. All identified keywords and their synonyms will be used for the comprehensive search of electronic databases. The databases to be searched will include CINAHL, PubMed, Science Direct, Scopus, PsycINFO and ProQuest Dissertation and Theses. Reference lists and bibliographies of retrieved articles will be searched for further relevant articles. To avoid publication bias, handsearching will be undertaken in journals that are not listed on databases but are known to contain literature on this topic of investigation to ensure all relevant materials are captured. The database of Thailand in the National Research Council of Thailand will be used to find the relevant articles that are published in English. Assessment of methodological quality First, the qualitative articles retrieved will be assessed by two independent reviewers for methodological validity by using the standardized critical appraisal instrument from the Joanna Briggs Institute Qualitative Assessment and Review Instrument (JBI-QARI) (Appendix I). Disagreement between the reviewers will be resolved through discussion, or with a third reviewer. Data extraction The data will be extracted by using the standardized data extraction tool from JBI-QARI (Appendix II). The data extracted will include specific details about the methodology method, phenomena of interest, setting, geographical location, cultural content, participants, data analysis and authors’ conclusions. Data synthesis Qualitative research findings will be pooled using JBI-QARI. This will involve the aggregation or synthesis of findings to generate a set of statements that represent that aggregation, through assembling the findings rated according to their quality and JBI Database of Systematic Reviews and Implementation Reports N Pothimas et al. categorizing these findings on the basis of similarity in meaning. These categories will then be subjected to a meta-synthesis to produce a single comprehensive set of synthesized findings that can be used as a basis for evidence-based practice. Wherever textual pooling is not possible, the findings will be presented in narrative form. Acknowledgments The reviewers would like to acknowledge the Thailand Centre for Evidence Based Nursing, Midwifery and Health Science for providing workshop training for conducting reviews. References 1. World Health Organization. Schizophrenia. 2014 [Internet]. [cited 2015 June 16th]. Available from: http://www.who.int/ mental_health/management/schizophrenia/en/. 2. McGrath J, Saha S, Chant D, Welham J. Schizophrenia: a concise overview of incidence, prevalence, and mortality. Epidemiol Rev 2008;30:67–76. 3. Morgan VA, Castle DJ, Jablensky AV. Do women express and experience psychosis differently from men? Epidemiological evidence from the Australian National Study of Low Prevalence (Psychotic) Disorders. Aust N Z J Psychiatry 2008;42(1):74–82. 4. Saha S, Chant D, Welham J, McGrath J. A systematic review of the prevalence of schizophrenia. PLoS Med 2005;2(5): 413–33. 5. American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 4th ed. Washington, DC: American Psychiatric Association; 2000. 6. Grover S, Davuluri T, Chakrabarti S. Religion, spirituality, and schizophrenia: a review. Indian J Psychol Med 2014;36(2): 119–24. 7. O’Brien PG, Kennedy WZ, Ballard KA. Psychiatric mental health nursing: an introduction to therapy and practice Boston: Jones and Bartlett publishers; 2008. 8. Centre for Addiction and Mental Health. What is schizophrenia. 2012 [internet]. [Retrieved 2015 June 14th]. Available from: http://www.camh.ca/en/hospital/health_information/ a_z_mental_health_and_addiction_information/schizophre nia/schizophrenia_information_guide/Pages/schizophrenia_ whatis.aspx. 9. Shives LR. Basic concepts of psychiatric-mental health nursing. 6th ed. Philadelphia: Lippincott Williams & Wilkins; 2005. 10. Lotrakul M. Schizophrenia. 2011 [internet]. [Retrieved 2015 May 28th]. Available from: http://www.ramamental.com/ medicalstudent/generalpsyc/schizophrenia_article/. 11. Dickerson FB, Lehman AF. Evidence-based psychotherapy for schizophrenia 2011 update. J Nerv Ment Dis 2011;199(8): 520–6. ß 2016 THE JOANNA BRIGGS INSTITUTE ©2016 Joanna Briggs Institute. Unauthorized reproduction of this article is prohibited. 54 SYSTEMATIC REVIEW PROTOCOL 12. The National Health Service. Schizophrenia treatment. 2014 [internet]. [Retrieved 2015 June 14th]. Available from: http:// www.nhs.uk/Conditions/Schizophrenia/Pages/Treatment. aspx. 13. Centre for Addiction and Mental Health. Understanding psychiatric medications: antipsychotics. 2012 [internet]. [Retrieved 2015 June 14th]. Available from: http:// www.camh.ca/en/education/about/camh_publications/ Pages/understanding_psych_meds.aspx. 14. Muench J, Hamer A. Adverse effects of antipsychotic medications. Am Fam Physician 2010;81(5):617–22. 15. Quach PL, Mors O, Christensen TØ, Krarup G, Jørgensen P, Bertelsen M, et al. Predictors of poor adherence to medication among patients with first-episode schizophreniaspectrum disorder. Early Interv Psychiatry 2009;3(1):66–74. 16. Adelufosi AO, Adebowale TO, Abayode O, Mosanya JT. Medication adherence and quality of life among Nigeria outpatients with schizophrenia. Gen Hosp Psychiatry 2012;34(1):2–79. 17. Dassa D, Boyer L, Benoit M, Bourcet S, Raymondet P, Bottai T. Factors associated with medication non-adherence in patients suffering from schizophrenia: a cross-sectional study in a universal coverage health-care system. Aust N Z J Psychiatry 2010;44(10):921–8. 18. Amr M, El-Mogy A, El-Masry R. Adherence in Egyptian patients with schizophrenia: the role of insight, medication beliefs and spirituality. Arab J Psychiatr 2013;24(1): 60–8. 19. Ngui AN, Vasiliadis HM, Tempier R. Factors associated with adherence over time to antipsychotic drug treatment. Clin Epidemiol Glob Health 2015;3(1):3–9. 20. Kao YC, Liu YP. Compliance and schizophrenia: the predictive potential of insight into illness, symptoms, and side effects. Compr Psychiatry 2010;51(6):557–65. 21. Meguid M, Essawy HI, Sabry WM, Khalifa DA, Bastawy MA, Ali RR. Understanding medications non adherence in a sample of Egyptian patients with schizophrenia in relation to illness severity and insight. J Psychiatry 2015;18(5):1–7. 22. Perkins DO. Predictors of noncompliance in patients with schizophrenia. J Clin Psychiatry 2002;63(12):1121–212. 23. Yamada K, Watanabe K, Nemoto N, Fujita H, Chikaraishi C, Yamauchi K, et al. Prediction of medication noncompliance in outpatients with schizophrenia: 2-year follow-up study. Psychiatry Res 2006;141(1):61–9. JBI Database of Systematic Reviews and Implementation Reports N Pothimas et al. 24. Tranulis C, Goff D, Henderson DC, Freudenreich OF. Becoming adherent to ntipsychotics: a qualitative study of treatment-experienced schizophrenia patients. Psychiatr Serv 2011;62(8):888–92. 25. Brain C, Allerby K, Sameby B, Quinlan P, Joas E, Karilampi U, et al. Drug attitude and other predict of medication adherence in schizophrenia: 12 months of electronic monitoring (MEMS1) in the Swedish COAST-study. Eur Neuropharmacol 2013;23(12):1754–62. 26. Liu-Seifert H, Osuntokun OO, Feldman PD. Factors associated with adherence to treatment with olanzapine and other atypical antipsychotic medications in patients with schizophrenia. Compr Psychiatry 2012;53(1):107–15. 27. Nosé M, Brabui C, Tansella M. How often do patients with psychosis fail to adhere to treatment programmes? A systematic review. Psychol Med 2003;33(7):1149–60. 28. Kamali M, Kelly BD, Clarke M, Browne S, Gervin M, Kinsella A, et al. A prospective evaluation of adherence to medication in first episode schizophrenia. Eur Psychiatry 2006;21(1): 29–33. 29. Tsang HWH, Fung KMT, Corrigan PW. Psychosocial and socio-demographic correlates of medication compliance among people with schizophrenia. J Behav Ther Exp Psy 2009;40(1):3–14. 30. Gaebel W, Riesbeck M, von Wilmsdorff M, Burns T, Derks EM, Kahn RS, et al. Drug attitude as predictor for effectiveness in first-episode schizophrenia: results of an open randomized trial (EUFEST). Eur Neuropharmacol 2010;20(5):310–6. 31. Novick D, Haro JM, Suarez D, Perez V, Dittmann RW, Haddad PM. Predictors and clinical consequences of non-adherence with antipsychotic medication in the outpatient treatment of schizophrenia. Psychiatry Res 2010;176(2–3):109–13. 32. Ascher-Svanum H, Zhu B, Faries DE, Salkever D, Slade EP, Peng X, et al. The cost of relapse and the predictors of relapse in the treatment of schizophrenia. BMC Psychiatry 2010;10(2):1–7. 33. Hong J, Windmeijer F, Novick D, Haro JM, Brown J. The cost of relapse in patients with schizophrenia in the European SOHO (Schizophrenia Outpatient Health Outcomes) study. Prog Neuropsychopharmacolo Biol Psychiatry 2009;33(5): 835–41. 34. Almond S, Knapp M, Francois C, Toumi M, brugha T. Relapse in schizophrenia: costs, clinical outcomes and quality of life. Br J Psychiatry 2004;184(4):346–51. ß 2016 THE JOANNA BRIGGS INSTITUTE ©2016 Joanna Briggs Institute. Unauthorized reproduction of this article is prohibited. 55 SYSTEMATIC REVIEW PROTOCOL N Pothimas et al. Appendix I: Appraisal instrument QARI appraisal instrument JBI Database of Systematic Reviews and Implementation Reports ß 2016 THE JOANNA BRIGGS INSTITUTE ©2016 Joanna Briggs Institute. Unauthorized reproduction of this article is prohibited. 56 SYSTEMATIC REVIEW PROTOCOL N Pothimas et al. Appendix II: Data extraction instrument QARI data extraction instrument JBI Database of Systematic Reviews and Implementation Reports ß 2016 THE JOANNA BRIGGS INSTITUTE ©2016 Joanna Briggs Institute. Unauthorized reproduction of this article is prohibited. 57