Time Savings and Surgery Task Load Reduction in Open Intraperitoneal Onlay Mesh Fixation Procedure.

BACKGROUND: This study assessed the reduction in surgeon stress associated with savings in procedure time for mechanical fixation of an intraperitoneal onlay mesh (IPOM) compared to a traditional suture fixation in open ventral hernia repair. STUDY DESIGN: Nine general surgeons performed 36 open IPOM fixation procedures in porcine model. Each surgeon conducted two mechanical (using ETHICON SECURESTRAP ™ Open) and two suture fixation procedures. Fixation time was measured using a stopwatch, and related surgeon stress was assessed using the validated SURG-TLX questionnaire. T-tests were used to compare between-group differences, and a two-sided 95% confidence interval for the difference in stress levels was established using nonparametric methodology. RESULTS: The mechanical fixation group demonstrated an 89.1% mean reduction in fixation time, as compared to the suture group (p < 0.00001). Surgeon stress scores measured using SURG-TLX were 55.5% lower in the mechanical compared to the suture fixation group (p < 0.001). Scores in five of the six sources of stress were significantly lower for mechanical fixation. CONCLUSIONS: Mechanical fixation with ETHICON SECURESTRAP ™ Open demonstrated a significant reduction in fixation time and surgeon stress, which may translate into improved operating efficiency, improved performance, improved surgeon quality of life, and reduced overall costs of the procedure.

Burden of schizophrenia on selected comorbidity costs.

Patients suffering from schizophrenia tend to have high rates of medical comorbidities and mortality.This study evaluated the healthcare costs of patients with schizophrenia and specific comorbidities relative to patients without schizophrenia with the same comorbidities, using Medicaid insurance claims databases from five states (from 2001-2010). The most common comorbidities were hypertension (48.8%), substance abuse (39.1%) and diabetes (28.4%). Patients with schizophrenia incurred greater all-cause monthly healthcare costs (cost difference [95% CI]: US$978 [933; 1024]) and comorbidity-related costs (cost difference [95% CI]: US$288 [269; 307]). Schizophrenia was also associated with significantly higher comorbidity-related costs in each comorbidity subgroup (among the three most common comorbidities: 99% higher in hypertension, 293% in substance abuse, and 105% in diabetes). The results suggest that patients with schizophrenia and comorbidities common in patients with schizophrenia had higher all-cause and comorbidity-related healthcare costs compared with patients without schizophrenia with the same comorbidities.

Bayesian data analysis in observational comparative effectiveness research: rationale and examples.

Many comparative effectiveness research and patient-centered outcomes research studies will need to be observational for one or both of two reasons: first, randomized trials are expensive and time-consuming; and second, only observational studies can answer some research questions. It is generally recognized that there is a need to increase the scientific validity and efficiency of observational studies. Bayesian methods for the design and analysis of observational studies are scientifically valid and offer many advantages over frequentist methods, including, importantly, the ability to conduct comparative effectiveness research/patient-centered outcomes research more efficiently. Bayesian data analysis is being introduced into outcomes studies that we are conducting. Our purpose here is to describe our view of some of the advantages of Bayesian methods for observational studies and to illustrate both realized and potential advantages by describing studies we are conducting in which various Bayesian methods have been or could be implemented.

Antipsychotic adherence patterns and health care utilization and costs among patients discharged after a schizophrenia-related hospitalization.

BACKGROUND: This study aimed to assess antipsychotic adherence patterns and all-cause and schizophrenia-related health care utilization and costs sequentially during critical clinical periods (i.e., before and after schizophrenia-related hospitalization) among Medicaid-enrolled patients experiencing a schizophrenia-related hospitalization. METHODS: All patients aged ≥ 18 years with a schizophrenia-related inpatient admission were identified from the MarketScan Medicaid database (2004-2008). Adherence (proportion of days covered [PDC]) to antipsychotics and schizophrenia-related and all-cause health care utilization and costs were assessed during preadmission (182- to 121-day, 120- to 61-day, and 60- to 0-day periods; overall, 6 months) and postdischarge periods (0- to 60-day, 61- to 120-day, 121- to 180-day, 181- to 240-day, 241- to 300-day, and 301- to 365-day periods; overall, 12 months). Health care utilization and costs (2010 US dollars) were compared between each adjacent 60-day follow-up period after discharge using univariate and multivariable regression analyses. No adjustment was made for multiplicity. RESULTS: Of the 2,541 patients with schizophrenia (mean age: 41.2 years; 57% male; 59% black) who were identified, approximately 89% were "discharged to home self-care." Compared with the 60- to 0-day period before the index inpatient admission, greater mean adherence as measured by PDC was observed during the 0- to 60-day period immediately following discharge (0.46 vs. 0.78, respectively). The mean PDC during the overall 6-month preadmission period was lower than during the 6-month postdischarge period (0.53 vs. 0.69; P < 0.001). Compared with the 0- to 60-day postdischarge period, schizophrenia-related health care costs were significantly lower during the 61- to 120-day postdischarge period (mean: $2,708 vs. $2,102; P < 0.001); the primary cost drivers were rehospitalization (mean: $978 vs. $660; P < 0.001) and pharmacy (mean: $959 vs. $743; P < 0.001). Following the initial 60-day period, both all-cause and schizophrenia-related costs declined and remained stable for the remaining postdischarge periods (days 121-365). CONCLUSIONS: Although long-term (e.g., 365-day) adherence measures are important, estimating adherence over shorter intervals may clarify the course of vulnerability to risk and enable clinicians to better design adherence/risk-related interventions. The greatest risk of rehospitalization and thus greater resource utilization were observed during the initial 60-day postdischarge period. Physicians should consider tailoring management and treatment strategies to help mitigate the economic and humanistic burden for patients with schizophrenia during this period.

Association between adherence to and persistence with atypical antipsychotics and psychiatric relapse among US Medicaid-enrolled patients with schizophrenia.

OBJECTIVE: Assess association between adherence and persistence with second-generation oral antipsychotics (SGOAs), psychiatric-related relapse and healthcare utilization among patients with schizophrenia experiencing two or more psychiatric-related relapses. METHODS: A retrospective analysis of the US Medicaid Multi-State Database for 2004-2008. Patients with schizophrenia (aged 18-64) with two or more psychiatric-related relapses within 1 year after SGOA initiation were selected. Associations between a dichotomous measure of adherence and persistence with SGOAs and psychiatric-related relapse and healthcare utilization were assessed using unadjusted and covariate-adjusted regression models. No adjustment was made for multiplicity. KEY FINDINGS: Study cohort consisted of 3714 patients with mean age of 42.6 years. Overall, 45% of patients were adherent and 50% persistent with SGOAs. Unadjusted and covariate-adjusted analysis results suggested the 12-month psychiatric-related relapse rate was lower among adherent/persistent patients versus non-adherent patients (unadjusted mean: 3.85 versus 4.13; P < 0.001; covariate-adjusted incident rate ratio (IRR): 0.90; 95% confidence interval (CI): 0.86-0.94) and non-persistent patients (unadjusted mean: 3.81 versus 4.21; P < 0.001; covariate-adjusted IRR: 0.88; 95%CI: 0.84-0.92). Compared with non-persistent patients, persistent patients had significantly lower rates of all-cause inpatient admissions (IRR: 0.87; 95%CI: 0.82-0.93) and emergency department visits (IRR: 0.78; 95%CI: 0.73-0.85). CONCLUSIONS: Although SGOAs have proven efficacy in lowering the rate of psychiatric-related relapses, lower adherence and persistence rates may be an inhibiting factor in achieving optimal benefits from SGOAs. Future research is needed to assess whether newer antipsychotics with less-frequent dosing may improve adherence among patients with schizophrenia.

Perceptions and prescribing considerations among US psychiatrists regarding drug-drug interactions associated with oral atypical antipsychotics.

OBJECTIVE: Contemporary literature has demonstrated the potential for drug-drug interactions (DDIs) with oral atypical antipsychotic (OAA) agents. However, less is known about psychiatrists' perceptions about DDIs when prescribing OAAs. This study addresses this gap by surveying US psychiatrists about their perceptions of DDI when prescribing a new OAA. METHODS: An online survey of 131 US psychiatrists was conducted to assess if considerations of DDIs were taken into account when prescribing a new OAA within their practice and prescribing patterns. For each survey question, results are presented as the proportion of psychiatrists in each rating category. Data were collected on physicians' awareness and concern about DDIs when prescribing OAAs, perception of frequency and severity of OAA-related DDIs, and methods of monitoring and preventing OAA-related DDIs. RESULTS: Of the psychiatrists surveyed, 9.2% considered themselves well-informed (rating of 10/10) about OAA-related DDIs. In the 3-month period preceding the survey date, psychiatrists reported that on average 7.5 (SD 12.4) of their patients experienced a potentially OAA-related DDI event which represented an average of 2.5% (SD 4.8%) of their total number of patients. In all, 19.8% of the psychiatrists reported they were currently tracking the level of confirmed OAA-related DDI events in their practices; these psychiatrists reported a mean 21.1% incidence rate of confirmed DDI events experienced by patients starting a new OAA therapy in their practice. The psychiatrists ranked the risks of cardiovascular events and of neurological impairment as the two most frequent and severe potential DDI events to consider when prescribing a new OAA, in combination with selective serotonin reuptake inhibitors, mood stabilizers, and antihypertensive agents, the drugs most frequently associated with the most severe OAA-related DDIs. CONCLUSIONS: Psychiatrists, on recall of recent cases, perceive DDI events to be frequent in patients starting a new OAA therapy. While there appears to be some awareness of DDI-related issues among psychiatrists, this survey of psychiatrists perceptions suggests the need for systematic tracking of OAA-related DDI events and additional psychiatrist training on optimal OAA choice to prevent DDIs.

Psychometric evaluation of the Medication Satisfaction Questionnaire (MSQ) to assess satisfaction with antipsychotic medication among schizophrenia patients.

The Medication Satisfaction Questionnaire (MSQ) is a single-item questionnaire which evaluates satisfaction with antipsychotic medication in schizophrenia patients. This study evaluated the reliability and validity for its use in research and clinical settings. Data pooled across treatment groups (control vs. Paliperidone ER) from a randomized 6-week study were used to conduct four psychometric assessments of the MSQ: (1) test-retest reliability, (2) convergent validity, (3) known-groups validity, and (4) minimally important difference (MID). This analysis included 191 randomized subjects. Test-retest reliability was evaluated for patients with no change in satisfaction from weeks 2 to 4 and weeks 4 to 6 (ICC=0.80; 0.83, respectively). Convergent validity was demonstrated through large correlations with Treatment Satisfaction Questionnaire for Medication (TSQM) global score (r=0.72-0.77), and through small correlations with variables measuring clinical symptoms and functioning (e.g., Positive and Negative Syndrome Scale (PANSS) total score [r=-0.30 to -0.17], CGI-S [r=-0.35 to -0.27], SF-36 Physical Functioning Score [r=0.18] and side effects and extrapiramidal measures (including UKU, ESRS-A, SAS). Mean MSQ scores were significantly different between those who completed and discontinued the study, and between different satisfaction groups based on TSQM, demonstrating good known-groups validity. MID estimates for the MSQ ranged from 0.47 (standard error of measurement) to 0.58 (anchor-based method). Results suggest that the MSQ has acceptable reliability and validity, making this single-item questionnaire appropriate and easy to use in clinical research and potentially in clinical practice. A 1-point change on the MSQ may be considered clinically meaningful.

Workplace productivity, employment issues, and resource utilization in patients with bipolar I disorder.

OBJECTIVE: To collect workplace productivity and healthcare utilization data from subjects with bipolar I disorder and compare the results with those from normative subjects. METHODS: A cross sectional survey was administered to patients and recruiting physicians. Data collected included employment status, Endicott Workplace Productivity Scale (EWPS) results, healthcare resource utilization, and quality-of-life. RESULTS: In comparison with normative subjects, bipolar I subjects reported lower levels of work productivity (measured by the EWPS). Bipolar I subjects also reported more frequent outpatient visits and more prescribed pharmaceuticals. Bipolar I subjects were more likely to miss work, have worked reduced hours due to medical or mental health issues, receive disability payments, been involved in a crime, be uninsured or covered by Medicare, or have been fired or laid off. The study groups were age- and gender-matched to reduce the impact of selection bias associated with a non-randomized study design. Other potential limitations affecting the results of the study include recall bias and possibly an impact of different data collection methods (e.g. Internet versus telephone). CONCLUSIONS: Bipolar I disorder is associated with a negative effect on work productivity and resource utilization and is an appropriate disease management target for employers and healthcare decision makers.

Cost and effectiveness of venlafaxine extended-release and selective serotonin reuptake inhibitors in the acute phase of outpatient treatment for major depressive disorder.

OBJECTIVE: The purpose of this retrospective analysis was to estimate the cost and effectiveness of venlafaxine extended-release (VXR) compared with selective serotonin reuptake inhibitors in the outpatient treatment of major depressive disorder. METHODS: Pooled data from 8, 8-week, randomized, double-blind studies comparing treatment of major depressive disorder with venlafaxine/venlafaxine XR (n = 851), selective serotonin reuptake inhibitors (fluoxetine, paroxetine, fluvoxamine; n = 748), or placebo (4 studies; n = 446) were retrospectively analyzed to determine the economic implications of symptom remission from the perspective of a US third party payer and that of an employer. A decision modeling approach was used to determine cost and effectiveness ratios. RESULTS: Patients on VXR were associated with 22.8 depression-free days versus 18.6 depression-free days with the studied selective serotonin reuptake inhibitors, based on the decision model. Productive and quality-adjusted days were also expected to increase for VXR patients (22.06 vs. 19.34 and 4.56 to 9.36 vs. 3.72 to 7.63), as was the percentage of patients achieving full activity (25.9% vs. 19.6%). The expected cost per patient achieving remission of symptoms was US 1303.94 dollars and US 1514.96 dollars, and the cost per depression-free days was US 25.66 dollars and US 28.25 dollars, for the VXR and selective serotonin reuptake inhibitors groups, respectively. CONCLUSIONS: Treatment with VXR is not only expected to increase the rate of remission of symptoms but is also associated with achievement of full activity, higher number of depression-free days, productive days, and quality-adjusted days. VXR is a cost-effective treatment option for major depressive disorder.

Use of losartan in diabetic patients in the primary care setting: review of the results in LIFE and RENAAL.

OBJECTIVE: To review outcomes of diabetic patients treated with losartan in two recent randomized, double-blind, clinical trials and compare outcomes to similar studies in diabetics. METHODS: The Reduction in ENdpoints with the Angiotensin II Antagonist Losartan (RENAAL) study recruited 1513 patients with type 2 diabetes and nephropathy. The Losartan Intervention For Endpoint reduction (LIFE) study recruited 9193 hypertensive patients with left ventricular hypertrophy (LVH) including 1195 with diabetes mellitus. The maximum losartan dose in both studies was 100 mg daily. All study patients could receive additional antihypertensive medications, excluding angiotensin converting enzyme inhibitors (ACEIs) and other angiotensin receptor blockers (ARBs), if blood pressures (BP) < 140/90 mmHg were not achieved. In RENAAL, the control group received placebo whereas in LIFE, controls received atenolol. BP reductions were comparable in the treatment and control groups of both studies. In RENAAL, the primary outcome was the composite of doubling of serum creatinine, end-stage renal disease, or death. In LIFE, the primary composite outcome was cardiovascular death and non-fatal myocardial infarction or stroke. RESULTS: In RENAAL, losartan reduced the primary composite end-point 16% (p = 0.02) and the incidence of end-stage renal disease (ESRD) 28% (p = 0.002). In LIFE, the primary composite endpoint among diabetics was reduced 24% (p = 0.03), cardiovascular mortality was reduced 37% (p = 0.03) and total mortality was reduced 39% (p = 0.002). DISCUSSION: In diabetic patients with nephropathy, losartan reduces progression to endstage renal disease. In hypertensive diabetic patients with LVH, losartan reduces cardiovascular morbidity and mortality and total mortality. Angiotensin receptor blockade with losartan appears to confer benefits beyond BP reduction in diabetic patients at high-risk for cardiovascular and renal events.

Retrospective cohort study of venlafaxine, fluoxetine or sertraline in long-term care.

OBJECTIVE: To describe the effects of venlafaxine, fluoxetine and sertraline treatment on mood and behaviour patterns, physical functioning, and tolerability issues in a long-term care environment. DESIGN, SETTING AND PARTICIPANTS: Retrospective cohort analysis of 257 elderly residents of three long-term care facilities in the US who used venlafaxine, fluoxetine or sertraline during a 3-month period. MAIN OUTCOME MEASURES: Indicators of depression, anxiety and sad mood, physical functioning, antidepressant-related adverse events, and the global impression of efficacy. RESULTS: The average age of the participants was 80.6 years. At the 3-month follow-up, more than 85% of the residents recorded no change in indicators of depression, anxiety and sad mood or physical functioning, and there were no statistically significant differences among the three antidepressant drug groups. A marginal improvement in the social interaction indicator was observed among residents who received venlafaxine (11%) compared with those receiving fluox-etine (3%) or sertraline (2%). Antidepressant-related adverse events were infrequent and similar in incidence across the three drug groups. CONCLUSIONS: Indicators of mood and functioning of most residents were stable over the 3-month period and similar among the venlafaxine, fluoxetine and sertraline groups, and no significant differences in the safety profiles of the three drugs were recorded.