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Long-acting injectable versus daily oral antipsychotic treatment trials in schizophrenia: pragmatic versus explanatory study designs.

Bossie CA, Alphs LD, Correll CU - Int Clin Psychopharmacol (2015)

Bottom Line: Each study's design was rated using the six-domain ASPECT-R (A Study Pragmatic : Explanatory Characterization Tool-Rating).Nonparametric Wilcoxon rank-sum tests compared ratings of studies supporting (n=7) and not supporting (n=4) a LAI advantage.ASPECT-R total and domain scores were significantly higher (more pragmatic) in studies finding a LAI versus oral AP treatment advantage than those that did not.

View Article: PubMed Central - PubMed

Affiliation: aJanssen Scientific Affairs, LLC, Titusville, New Jersey bDepartment of Psychiatry, The Zucker Hillside Hospital, Glen Oaks cHofstra-North Shore LIJ School of Medicine, Hempstead, New York, USA.

ABSTRACT
Trial design characteristics related to the explanatory : pragmatic spectrum may contribute toward the inconsistent results reported in studies comparing long-acting injectable (LAI) versus daily oral antipsychotic (AP) treatments in schizophrenia. A novel approach examined the hypothesis that a more pragmatic design is important to show the advantages of LAI versus oral APs. A literature search identified comparative studies assessing the clinical efficacy/effectiveness of LAI versus oral APs in more than 100 schizophrenia patients, with 6-month or more duration/follow-up, and published between January 1993 and December 2013 (n=11). Each study's design was rated using the six-domain ASPECT-R (A Study Pragmatic : Explanatory Characterization Tool-Rating). Nonparametric Wilcoxon rank-sum tests compared ratings of studies supporting (n=7) and not supporting (n=4) a LAI advantage. ASPECT-R total and domain scores were significantly higher (more pragmatic) in studies finding a LAI versus oral AP treatment advantage than those that did not. The rank order of this significance among domains was as follows: 'participant compliance assessment' (P=0.005), 'medical practice setting/practitioner expertise' (P=0.006), 'intervention flexibility' (P=0.007), 'follow-up intensity/duration' (P=0.009), 'primary trial outcomes' (P=0.012), and 'participant eligibility' (P=0.015). Findings support that more pragmatic, less explanatory design features are important to show advantages for LAI treatment. Explanatory studies may introduce features that obscure advantages related to adherence.

No MeSH data available.


Related in: MedlinePlus

ASPECT-R ratings for the four studies that concluded no advantage for a long-acting injectable versus oral daily antipsychotic treatment in patients with schizophrenia. ASPECT-R, A Study Pragmatic : Explanatory Characterization Tool-Rating.
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Figure 3: ASPECT-R ratings for the four studies that concluded no advantage for a long-acting injectable versus oral daily antipsychotic treatment in patients with schizophrenia. ASPECT-R, A Study Pragmatic : Explanatory Characterization Tool-Rating.

Mentions: ASPECT-R ratings of the seven studies concluding a benefit of LAI versus daily oral APs are shown in Fig. 2. Ratings of the four studies concluding no LAI versus daily oral AP difference are shown in Fig. 3. Total ASPECT-R scores (maximum possible score=36) ranged from 18 to 36 in the former group of studies and from 9 to 13 in the latter group (Table 2).


Long-acting injectable versus daily oral antipsychotic treatment trials in schizophrenia: pragmatic versus explanatory study designs.

Bossie CA, Alphs LD, Correll CU - Int Clin Psychopharmacol (2015)

ASPECT-R ratings for the four studies that concluded no advantage for a long-acting injectable versus oral daily antipsychotic treatment in patients with schizophrenia. ASPECT-R, A Study Pragmatic : Explanatory Characterization Tool-Rating.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4525810&req=5

Figure 3: ASPECT-R ratings for the four studies that concluded no advantage for a long-acting injectable versus oral daily antipsychotic treatment in patients with schizophrenia. ASPECT-R, A Study Pragmatic : Explanatory Characterization Tool-Rating.
Mentions: ASPECT-R ratings of the seven studies concluding a benefit of LAI versus daily oral APs are shown in Fig. 2. Ratings of the four studies concluding no LAI versus daily oral AP difference are shown in Fig. 3. Total ASPECT-R scores (maximum possible score=36) ranged from 18 to 36 in the former group of studies and from 9 to 13 in the latter group (Table 2).

Bottom Line: Each study's design was rated using the six-domain ASPECT-R (A Study Pragmatic : Explanatory Characterization Tool-Rating).Nonparametric Wilcoxon rank-sum tests compared ratings of studies supporting (n=7) and not supporting (n=4) a LAI advantage.ASPECT-R total and domain scores were significantly higher (more pragmatic) in studies finding a LAI versus oral AP treatment advantage than those that did not.

View Article: PubMed Central - PubMed

Affiliation: aJanssen Scientific Affairs, LLC, Titusville, New Jersey bDepartment of Psychiatry, The Zucker Hillside Hospital, Glen Oaks cHofstra-North Shore LIJ School of Medicine, Hempstead, New York, USA.

ABSTRACT
Trial design characteristics related to the explanatory : pragmatic spectrum may contribute toward the inconsistent results reported in studies comparing long-acting injectable (LAI) versus daily oral antipsychotic (AP) treatments in schizophrenia. A novel approach examined the hypothesis that a more pragmatic design is important to show the advantages of LAI versus oral APs. A literature search identified comparative studies assessing the clinical efficacy/effectiveness of LAI versus oral APs in more than 100 schizophrenia patients, with 6-month or more duration/follow-up, and published between January 1993 and December 2013 (n=11). Each study's design was rated using the six-domain ASPECT-R (A Study Pragmatic : Explanatory Characterization Tool-Rating). Nonparametric Wilcoxon rank-sum tests compared ratings of studies supporting (n=7) and not supporting (n=4) a LAI advantage. ASPECT-R total and domain scores were significantly higher (more pragmatic) in studies finding a LAI versus oral AP treatment advantage than those that did not. The rank order of this significance among domains was as follows: 'participant compliance assessment' (P=0.005), 'medical practice setting/practitioner expertise' (P=0.006), 'intervention flexibility' (P=0.007), 'follow-up intensity/duration' (P=0.009), 'primary trial outcomes' (P=0.012), and 'participant eligibility' (P=0.015). Findings support that more pragmatic, less explanatory design features are important to show advantages for LAI treatment. Explanatory studies may introduce features that obscure advantages related to adherence.

No MeSH data available.


Related in: MedlinePlus