How study designs influence comparative effectiveness outcomes: The case of oral versus long-acting injectable antipsychotic treatments for schizophrenia

Schizophrenia Research

Volumn 156, Issue 2-3, 2014, Pages 228-232

  Alphs, Larry ^a   Schooler, Nina ^b   Lauriello, John ^c  

^a JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^b SUNY DOWNSTATE MEDICAL CENTER   (United States)

^c University of Missouri   (United States)

Author keywords

Effectiveness; Explanatory; Long acting; Pragmatic

Indexed keywords

NEUROLEPTIC AGENT; DELAYED RELEASE FORMULATION;

ARTICLE; CLINICAL PRACTICE; COMPARATIVE STUDY; DRUG ADMINISTRATION ROUTE; DRUG EFFICACY; DRUG RESEARCH; DRUG RESPONSE; DRUG SAFETY; EXPLANATORY VARIABLE; HUMAN; INTERVENTION STUDY; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PATIENT SELECTION; PRIORITY JOURNAL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); SCHIZOPHRENIA; STUDY DESIGN; COMPARATIVE EFFECTIVENESS; DELAYED RELEASE FORMULATION; INJECTION; METHODOLOGY; ORAL DRUG ADMINISTRATION; RANDOMIZED CONTROLLED TRIAL;

ADMINISTRATION, ORAL; ANTIPSYCHOTIC AGENTS; COMPARATIVE EFFECTIVENESS RESEARCH; DELAYED-ACTION PREPARATIONS; HUMANS; INJECTIONS; PRAGMATIC CLINICAL TRIALS AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; SCHIZOPHRENIA;

EID: 84901839292     PISSN: 09209964     EISSN: 15732509     Source Type: Journal    
DOI: 10.1016/j.schres.2014.04.024     Document Type: Article

References (29)

1. American Psychological Association Preparing Manuscripts for Publication in Psychology Journals: A Guide for New Authors [Technical Guide] 2010, American Psychological Association, Washington, DC.
2. Austin P.C. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivar. Behav. Res. 2011, 46:399-424.
3. Bai Y.M., Chen T.T., Wu B., Hung C.H., Lin W.K., Hu T.M., Lin C.Y., Chou P. A comparative efficacy and safety study of long-acting risperidone injection and risperidone oral tablets among hospitalized patients: 12-week randomized, single-blind study. Pharmacopsychiatry 2006, 39:135-141.
4. Barrio P., Batalla A., Castellvi P., Hidalgo D., Garcia M., Ortiz A., Grande I., Pons A., Parellada E. Effectiveness of long-acting injectable risperidone versus oral antipsychotics in the treatment of recent-onset schizophrenia: a case-control study. Int. Clin. Psychopharmacol. 2013, 28:164-170.
5. Bossie C.A., Alphs L. Comparative trials of long-acting injectable vs. daily oral antipsychotic treatment in schizophrenia: do pragmatic vs. explanatory study designs matter?. Presented at the 52nd Annual Meeting of the American College of Neuropsychopharmacology (ACNP), December 8-12, 2013, Hollywood, Florida 2013, 2013.
6. Chue P., Eerdekens M., Augustyns I., Lachaux B., Molcan P., Eriksson L., Pretorius H., David A.S. Comparative efficacy and safety of long-acting risperidone and risperidone oral tablets. Eur. Neuropsychopharmacol. 2005, 15:111-117.
7. Emsley R., Oosthuizen P., Koen L., Niehaus D.J., Medori R., Rabinowitz J. Oral versus injectable antipsychotic treatment in early psychosis: post hoc comparison of two studies. Clin. Ther. 2008, 30:2378-2386.
8. Fleischhacker W.W., Gopal S., Lane R., Gassmann-Mayer C., Lim P., Hough D., Remmerie B., Eerdekens M. A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia. Int. J. Neuropsychopharmacol. 2012, 15:107-118.
9. Fusar-Poli P., Kempton M.J., Rosenheck R.A. Efficacy and safety of second-generation long-acting injections in schizophrenia: a meta-analysis of randomized-controlled trials. Int. Clin. Psychopharmacol. 2013, 28:57-66.
10. Gaebel W., Schreiner A., Bergmans P., de Arce R., Rouillon F., Cordes J., Eriksson L., Smeraldi E. Relapse prevention in schizophrenia and schizoaffective disorder with risperidone long-acting injectable vs quetiapine: results of a long-term, open-label, randomized clinical trial. Neuropsychopharmacology 2010, 35:2367-2377.
11. Grimaldi-Bensouda L., Rouillon F., Astruc B., Rossignol M., Benichou J., Falissard B., Limosin F., Beaufils B., Vaiva G., Verdoux H., Moride Y., Fabre A., Thibaut F., Abenhaim L. Does long-acting injectable risperidone make a difference to the real-life treatment of schizophrenia? Results of the cohort for the general study in schizophrenia. Schizophr. Res. 2012, 134:187-194.
12. Gutiérrez-Casares J.R., Cañas F., Rodríguez-Morales A., Hidalgo-Borrajo R., Alonso-Escolano D. Adherence to treatment and therapeutic strategies in schizophrenic patients: the ADHERE study. CNS Spectr. 2010, 15:327-337.
13. Jørgensen R., Munk-Jørgensen P., Lysaker P.H., Buck K.D., Hansson L., Zoffmann V. Overcoming recruitment barriers revealed high readiness to participate and low dropout rate among people with schizophrenia in a randomized controlled trial testing the effect of a Guided Self-Determination intervention. BMC Psychiatry 2014, 14:28.
14. Kirson N.Y., Weiden P.J., Yermakov S., Huang W., Samuelson T., Offord S.J., Greenberg P.E., Wong B.J. Efficacy and effectiveness of depot versus oral antipsychotics in schizophrenia: synthesizing results across different research designs. J. Clin. Psychiatry 2013, 74568-575.
15. Kishimoto T., Robenzadeh A., Leucht C., Leucht S., Watanabe K., Mimura M., Borenstein M., Kane J.M., Correll C.U. Long-acting injectable vs oral antipsychotics for relapse prevention in schizophrenia: a meta-analysis of randomized trials. Schizophr. Bull. 2014, 40:192-213.
16. Kishimoto T., Niatt M., Borenstein M., Kane J.M., Correll C.U. Long-acting injectable versus oral antipsychotics in schizophrenia: a systematic review and meta-analysis of mirror-image studies. J. Clin. Psychiatry 2013, 74:957-965.
17. Leucht C., Heres S., Kane J.M., Kissling W., Davis J.M., Leucht S. Oral versus depot antipsychotic drugs for schizophrenia: a critical systematic review and meta-analysis of randomised long-term trials. Schizophr. Res. 2011, 127:83-92.
18. Macfadden W., Ma Y.W., Thomas H.J., Bossie C.A., Alphs L. A prospective study comparing the long-term effectiveness of injectable risperidone long-acting therapy and oral aripiprazole in patients with schizophrenia. Psychiatry 2010, 7:23-31.
19. Rosenbaum P.R., Rubin D.B. The central role of the propensity score in observational studies for causal effects. Biometrika 1983, 70:41-55.
20. Rosenheck R.A., Krystal J.H., Lew R., Barnett P.G., Thwin S.S., Fiore L., Valley D., Huang G.D., Neal C., Vertrees J.E., Liang M.H. Challenges in the design and conduct of controlled clinical effectiveness trials in schizophrenia. Clin. Trials 2011, 8:196-204. the CSP 555 Research Group.
21. Schooler N.R., Buckley P.F., Mintz J., Goff D.C., Kopelowicz A., Lauriello J., Manschreck T.C., Mendelowitz A.J., Miller D.D., Wilson D., Bustillo J.R., Severe J.B., Kane J.M. PROACTIVE: initial results of an RCT comparing long-acting injectable risperidone to 2nd generation oral antipsychotics. Neuropsychopharmacology 2011, S104-S105.
22. Subotnik K., Nuechterlein K., Bartzokis G., Weiden P. Long-acting injectable antipsychotic medication after a first episode of schizophrenia. Early Interv. Psychiatry 2012, 6(Suppl. 1):1-19.
23. Thorpe K.E., Zwarenstein M., Oxman A.D., Treweek S., Furberg C.D., Altman D.G., Tunis S., Bergel E., Harvey I., Magid D.J., Chalkidou K. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. CMAJ 2009, 180:E47-E57.
24. Tosh G., Soares-Weiser K., Adams C.E. Pragmatic vs explanatory trials: the pragmascope tool to help measure differences in protocols of mental health randomized controlled trials. Dialogues Clin. Neurosci. 2011, 13:209-215.
25. Turkoz I., Fu D.J., Bossie C.A., Sheehan J.J., Alphs L. Relationship between the clinical global impression of severity for schizoaffective disorder scale and established mood scales for mania and depression. J. Affect. Disord. 2013, 150:17-22.
26. Valenstein M., Copeland L.A., Blow F.C., McCarthy J.F., Zeber J.E., Gillon L., Bingham C.R., Stavenger T. Pharmacy data identify poorly adherent patients with schizophrenia at increased risk for admission. Med. Care 2002, 40:630-639.
27. Weiden P.J., Schooler N.R., Weedon J.C., Elmouchtari A., Sunakawa A., Goldfinger S.M. A randomized controlled trial of long-acting injectable risperidone vs continuation on oral atypical antipsychotics for first-episode schizophrenia patients: initial adherence outcome. J. Clin. Psychiatry 2009, 70:1397-1406.
28. Weiden P.J., Schooler N.R., Weedon J.C., Elmouchtari A., Sunakawa-McMillan A. Maintenance treatment with long-acting injectable risperidone in first-episode schizophrenia: a randomized effectiveness study. J. Clin. Psychiatry 2012, 73:1224-1233.
29. Zhornitsky S., Stip E. Oral versus long-acting injectable antipsychotics in the treatment of schizophrenia and special populations at risk for treatment nonadherence: a systematic review. Schizophr. Res. Treat. 2012, 40:70-71.