Adherence, health care utilization, and costs between long-acting injectable and oral antipsychotic medications in South Carolina Medicaid beneficiaries with schizophrenia.

BACKGROUND: Schizophrenia and schizoaffective disorder require long-term antipsychotic treatment with antipsychotic medications, but poor medication adherence can lead to increased health care utilization and costs. Long-acting injectable antipsychotics (LAIs) offer potential therapeutic advantages in that they require less frequent dosing and improved medication adherence. South Carolina has the highest adoption of LAIs among US states, making it an ideal population for comparing the effectiveness of LAIs vs oral antipsychotics (OAPs) in treating schizophrenia or schizoaffective disorder. OBJECTIVE: To evaluate the effect of LAIs compared with OAPs on medication adherence, health care resource utilization, and costs among South Carolina Medicaid beneficiaries with schizophrenia or schizoaffective disorder. METHODS: South Carolina Medicaid beneficiaries with at least 1 claim for an LAI or OAP between January 1, 2015, and December 31, 2018, aged 18 to 65, with at least 2 claims with diagnoses of schizophrenia or schizoaffective disorder were included. Propensity scores (PSs) were calculated using logistic regression adjusting for confounders and predictors of the outcome. We estimated the "average treatment effect on the treated" by employing PS-weighted t-tests and chi-square tests. RESULTS: A total of 3,531 patients met the inclusion criteria, with 1,537 (44.5%) treated with LAIs and 1,994 (56.5%) treated with OAPs. In PS-weighted analyses, the LAI cohort had a greater proportion of days covered than the OAP cohort with a 365-day fixed denominator (69% vs 64%; P < 0.0001), higher medication possession ratio with a variable denominator while on therapy (85% vs 80%; P < 0.0001), and higher persistence (82% vs 64%; P < 0.0001). The average number of inpatient visits and emergency department visits did not significantly differ between cohorts (0.28 hospitalizations, P = 0.90; 3.68 vs 2.96 emergency department visits, P = 0.19). The number of outpatient visits, including visits for medication administration, were greater in the LAI cohort (23.1 [SD 24.2]) vs OAP (16.9 [SD 21.2]; P < 0.0001); however, including the costs for medication administration visits, outpatient costs (per member) were approximately $2,500 lower in the LAI cohort (P < 0.0001). The number of pharmacy visits was greater in the OAP cohort (LAI 21.0 [SD 17.0] vs OAP 23.0 [SD 15.0]; P = 0.006). All-cause total costs were greater in the LAI cohort ($26,025 [SD $29,909]) vs the OAP cohort ($17,291 [SD $25,261]; P < 0.0001) and were driven by the difference in pharmaceutical costs (LAI $15,273 [SD $16,183] vs OAP $4,696 [SD $10,371]; P < 0.0001). CONCLUSIONS: Among South Carolina Medicaid beneficiaries, treatment with LAIs for schizophrenia or schizoaffective disorder was associated with greater medication adherence rates. Patients using LAIs had higher drug costs and total costs, but lower outpatient and total nondrug costs compared with those using OAPs.

The effects of clinical decision support systems on insulin use: A systematic review.

BACKGROUND: A clinical decision support system (CDSS) is a computerized system using case-based reasoning to assist clinicians in assessing disease status, in selecting appropriate therapy or in making other clinical decisions. Previous randomized controlled trials (RCTs or trials) have shown that CDSSs have the potential to improve the insulin use, but the evidence was conflicting and uncertain. The purpose of our study was to determine whether a CDSS improves the use of insulin. METHOD: PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched from their inception to October 2018. The quality assessment was based on the risk of bias criteria of the Cochrane Handbook. RESULTS: Twenty-four RCTs, involving 7653 participants, were included. Thirteen of those trials (54.2%) used a computerized algorithm or a computer-assisted insulin protocol for insulin dose and therapy adjustment, of which 30.8% (four of 13) found significant changes. Of 10 trials that measured mean blood glucose levels and the 11 trials reported HbA1c, the computerized insulin dose adjustment resulted in lower mean blood glucose levels in 70.0% (seven of 10) and 36.4% (four of 11) of RCTs, respectively. Additionally, a significant reduction of hyperglycaemia events was reported in three of six RCTs. The evidence in a majority of the 24 RCTs was of moderate quality. CONCLUSIONS: CDSSs have the potential to improve the insulin use and blood glucose control in a clinical setting. The methodologies in these studies were of mixed quality. Better designed and longer-term studies are required to ensure a larger and more reliable evidence base on the effects of CDSS intervention on insulin use.

Evaluation of clinical decision support systems for diabetes care: An overview of current evidence.

BACKGROUND: Systematic reviews (SRs) have shown that clinical decision support systems (CDSSs) have the potential to improve diabetes care. However, methods of measuring and presenting outcomes are varied, and conclusions have been inconsistent. In addition, the reporting and methodological quality in this field is unknown, which could affect the integrity and accuracy of research. Therefore, it is difficult to confirm whether CDSSs are effective in improving diabetes care. OBJECTIVE: To comprehensively evaluate the effects of CDSS on diabetes care and to examine the methodological and reporting qualities. METHODS: We searched PubMed, EMBASE, and Cochrane Library from their inception to February 2017. Systematic reviews investigating the effects of CDSS on diabetes care were included. Outcomes were determined in advance and assessed separately for process of care and patient outcomes. Methodological and reporting qualities were assessed by AMSTAR and PRISMA, respectively. RESULTS: Seventeen SRs, consisting of 222 unique randomized controlled trials and 102 nonrandomized controlled trials, were included. Evidence that CDDS significantly impacted patient outcomes was found in 32 of 102 unique studies of the 15 SRs that examined this effect (31%). A significant impact of CDSS on process of care was found in 117 out of 143 unique studies of the 11 SRs that examined this effect (82%). Ratings for overall scores of AMSTAR resulted in a mean score of 6.5 with a range of scores from 3.5 to 10.0. Reporting quality related to methodological domains was particularly incomplete. CONCLUSIONS: Clinical decision support systems improved the quality of diabetes care by inconsistently improving process of care or patient outcomes. There is evidence that CDSS for providing alerts, reminders, or feedback to participants were most likely to impact diabetes care. Poor reporting of methodological domains, together with qualitative or narrative methods to combine findings, may limit the confidence in research evidence.

The Effects of Clinical Decision Support Systems on Medication Safety: An Overview.

BACKGROUND: The clinical decision support system(CDSS) has potential to improving medication safety. However, the effects of the intervention were conflicting and uncertain. Meanwhile, the reporting and methodological quality of this field were unknown. OBJECTIVE: The aim of this overview is to evaluate the effects of CDSS on medication safety and to examine the methodological and reporting quality. METHODS: PubMed, Embase and Cochrane Library were searched to August 2015. Systematic reviews (SRs) investigating the effects of CDSS on medication safety were included. Outcomes were determined in advance and assessed separately for process of care and patient outcomes. The methodological quality was assessed by Assessment of Multiple Systematic Reviews (AMSTAR) and the reporting quality was examined by Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). RESULTS: Twenty systematic reviews, consisting of 237 unique randomized controlled trials(RCTs) and 176 non-RCTs were included. Evidence that CDSS significantly impacted process of care was found in 108 out of 143 unique studies of the 16 SRs examining this effect (75%). Only 18 out of 90 unique studies of the 13 SRs reported significantly evidence that CDSS positively impacted patient outcomes (20%). Ratings for the overall scores of AMSTAR resulted in a mean score of 8.3 with a range of scores from 7.5 to 10.5. The reporting quality was varied. Some contents were particularly strong. However, some contents were poor. CONCLUSIONS: CDSS reduces medication error by obviously improving process of care and inconsistently improving patient outcomes. Larger samples and longer-term studies are required to ensure more reliable evidence base on the effects of CDSS on patient outcomes. The methodological and reporting quality were varied and some realms need to be improved.

Alpha-glucosidase inhibitors and hepatotoxicity in type 2 diabetes: a systematic review and meta-analysis.

Alpha-glucosidase inhibitors (AGIs) was reported to be associated with several rare adverse hepatic events, but with inconsistent results. We aimed to investigate the risk of hepatotoxicity associated with the use of AGIs in patients with type 2 diabetes mellitus (T2DM), and performed a systematic review and meta-analysis. Fourteen studies (n = 2881) were eligible, all of which were RCTs. Meta-analysis of data regarding elevation of more than 3-fold the upper limit of normal (ULN) of AST and ALT showed statistically significant differences between AGIs treatment versus control (OR 6.86, 95% CI 2.50 to 18.80; OR 6.48, 95% CI 2.40 to 17.49). Subgroup analyses of elevation of more than 1.8-fold ULN of AST and ALT by dose of AGIs showed differential effects on AST and ALT (AST: OR 0.38 vs 7.31, interaction P = 0.003; ALT: OR 0.32 vs 4.55, interaction p = 0.02). Meta-analysis showed that AGIs might increase the risk of hepatotoxicity, and higher dose appeared to be associated with higher risk of hepatotoxicity. However, the evidence is limited with surrogate measures (i.e. ALT and AST), and no clinically important adverse events were observed.

Glucagon-like peptide-1 receptor agonists and heart failure in type 2 diabetes: systematic review and meta-analysis of randomized and observational studies.

BACKGROUND: The effect of glucagon-like peptide-1(GLP-1) receptor agonists on heart failure remains uncertain. We therefore conducted a systematic review to assess the possible impact of GLP-1 agonists on heart failure or hospitalization for heart failure in patients with type 2 diabetes. METHODS: We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL) and ClinicalTrials.gov to identify randomized controlled trials (RCTs) and observational studies that addressed the effect of GLP-1 receptor agonists in adults with type 2 diabetes, and explicitly reported heart failure or hospitalization for heart failure. Two paired reviewers screened reports, collected data, and assessed the risk of bias. We pooled data from RCTs and observational studies separately, and used the GRADE approach to rate the quality of evidence. RESULTS: We identified 25 studies that were eligible for our review; 21 RCTs (n = 18,270) and 4 observational studies (n = 111,029). Low quality evidence from 20 RCTs suggested, if anything, a lower incidence of heart failure between GLP-1 agonists versus control (17/7,441 vs. 19/4,317; odds ratio (OR) 0.62, 95 % confidence interval (CI) 0.31 to 1.22; risk difference (RD) 19 fewer, 95 % CI 34 fewer to 11 more per 1000 over 5 years). Three cohort studies comparing GLP-1 agonists to alternative agents provided very low quality evidence that GLP-1 agonists do not increase the incidence of heart failure. One RCT provided moderate quality evidence that GLP-1 agonists were not associated with hospitalization for heart failure (lixisenatide vs placebo: 122/3,034 vs. 127/3,034; adjusted hazard ratio 0.96, 95 % CI 0.75 to 1.23; RD 4 fewer, 95 % CI 25 fewer to 23 more per 1000 over 5 years) and a case-control study provided very low quality evidence also suggesting no association (GLP-1 agonists vs. other anti-hyperglycemic drugs: 1118 cases and 17,626 controls, adjusted OR 0.67, 95 % CI 0.32 to 1.42). CONCLUSIONS: The current evidence suggests that GLP-1 agonists do not increase the risk of heart failure or hospitalization for heart failure among patients with type 2 diabetes.

Dipeptidyl peptidase-4 inhibitors and risk of heart failure in type 2 diabetes: systematic review and meta-analysis of randomised and observational studies.

OBJECTIVES: To examine the association between dipeptidyl peptidase-4 (DPP-4) inhibitors and the risk of heart failure or hospital admission for heart failure in patients with type 2 diabetes. DESIGN: Systematic review and meta-analysis of randomised and observational studies. DATA SOURCES: Medline, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov searched up to 25 June 2015, and communication with experts. ELIGIBILITY CRITERIA: Randomised controlled trials, non-randomised controlled trials, cohort studies, and case-control studies that compared DPP-4 inhibitors against placebo, lifestyle modification, or active antidiabetic drugs in adults with type 2 diabetes, and explicitly reported the outcome of heart failure or hospital admission for heart failure. DATA COLLECTION AND ANALYSIS: Teams of paired reviewers independently screened for eligible studies, assessed risk of bias, and extracted data using standardised, pilot tested forms. Data from trials and observational studies were pooled separately; quality of evidence was assessed by the GRADE approach. RESULTS: Eligible studies included 43 trials (n=68,775) and 12 observational studies (nine cohort studies, three nested case-control studies; n=1,777,358). Pooling of 38 trials reporting heart failure provided low quality evidence for a possible similar risk of heart failure between DPP-4 inhibitor use versus control (42/15,701 v 33/12,591; odds ratio 0.97 (95% confidence interval 0.61 to 1.56); risk difference 2 fewer (19 fewer to 28 more) events per 1000 patients with type 2 diabetes over five years). The observational studies provided effect estimates generally consistent with trial findings, but with very low quality evidence. Pooling of the five trials reporting admission for heart failure provided moderate quality evidence for an increased risk in patients treated with DPP-4 inhibitors versus control (622/18,554 v 552/18,474; 1.13 (1.00 to 1.26); 8 more (0 more to 16 more)). The pooling of adjusted estimates from observational studies similarly suggested (with very low quality evidence) a possible increased risk of admission for heart failure (adjusted odds ratio 1.41, 95% confidence interval 0.95 to 2.09) in patients treated with DPP-4 inhibitors (exclusively sitagliptin) versus no use. CONCLUSIONS: The relative effect of DPP-4 inhibitors on the risk of heart failure in patients with type 2 diabetes is uncertain, given the relatively short follow-up and low quality of evidence. Both randomised controlled trials and observational studies, however, suggest that these drugs may increase the risk of hospital admission for heart failure in those patients with existing cardiovascular diseases or multiple risk factors for vascular diseases, compared with no use.

An Evaluation of the Effects of Human Factors and Ergonomics on Health Care and Patient Safety Practices: A Systematic Review.

BACKGROUND: From the viewpoint of human factors and ergonomics (HFE), errors often occur because of the mismatch between the system, technique and characteristics of the human body. HFE is a scientific discipline concerned with understanding interactions between human behavior, system design and safety. OBJECTIVE: To evaluate the effectiveness of HFE interventions in improving health care workers' outcomes and patient safety and to assess the quality of the available evidence. METHODS: We searched databases, including MEDLINE, EMBASE, BIOSIS Previews and the CBM (Chinese BioMedical Literature Database), for articles published from 1996 to Mar.2015. The quality assessment tool was based on the risk of bias criteria developed by the Cochrane Effective Practice and Organization of Care (EPOC) Group. The interventions of the included studies were categorized into four relevant domains, as defined by the International Ergonomics Association. RESULTS: For this descriptive study, we identified 8, 949 studies based on our initial search. Finally, 28 studies with 3,227 participants were included. Among the 28 included studies, 20 studies were controlled studies, two of which were randomized controlled trials. The other eight studies were before/after surveys, without controls. Most of the studies were of moderate or low quality. Five broad categories of outcomes were identified in this study: 1) medical errors or patient safety, 2) health care workers' quality of working life (e.g. reduced fatigue, discomfort, workload, pain and injury), 3) user performance (e.g., efficiency or accuracy), 4) health care workers' attitudes towards the interventions(e.g., satisfaction and preference), and 5) economic evaluations. CONCLUSION: The results showed that the interventions positively affected the outcomes of health care workers. Few studies considered the financial merits of these interventions. Most of the included studies were of moderate quality. This review highlights the need for scientific and standardized guidelines regarding how HFE should be implemented in health care.