PP029 Hospitalizations And Costs In Bipolar Disorder Patients Initiating Long-acting Injectable Antipsychotics

INTRODUCTION:Existing studies have not investigated the effectiveness of one long-acting injectable antipsychotic (LAI) versus another in preventing hospitalizations among patients with bipolar disorder (BD). This study was conducted to compare all-cause inpatient healthcare utilization and associated costs among BD patients who initiated LAIs.METHODS:This retrospective cohort analysis used the Truven Health Analytics MarketScan® Commercial and Medicaid claims database. Bipolar patients >18 years with at least one claim for one of the following LAIs were identified between 1 January 2013 and 30 June 2014 (identification period): aripiprazole, haloperidol, paliperidone, and risperidone. The first day of initiating an LAI was considered the index date. Logistic regression and generalized linear regression models were conducted to estimate risk of inpatient hospitalization and associated costs during the 1-year follow up.RESULTS:A total of 1,540 BD patients initiated an LAI: 14.5 percent aripiprazole, 16.3 percent risperidone, 21.0 percent haloperidol, and 48.1 percent paliperidone. With the aripiprazole cohort as the reference group, the odds of having any inpatient hospitalizations were significantly higher in haloperidol [Odds Ratio, OR (95 percent Confidence Interval, CI): 1.49 (1.01 - 2.19)] and risperidone [1.78 (1.19 - 2.66)] cohorts. The paliperidone cohort also had a higher risk of having a hospitalization than aripiprazole, but the difference was not statistically significant (p>.05). Among LAI initiators having any inpatient hospitalizations, the adjusted mean all-cause inpatient costs were lowest in the aripiprazole cohort (USD26,002), followed by risperidone (USD27,937), haloperidol (USD30,411), and paliperidone (USD33,240). However, the cost difference was not statistically significant.CONCLUSIONS:Our study findings highlight the value of aripiprazole in reducing all-cause inpatient hospitalizations and associated costs among patients with BD during the 1-year follow-up. It is worthwhile to note that bipolar diagnoses were identified from healthcare claims coded for reimbursement purposes, thus misclassification was possible. Future studies are warranted to understand the impact of LAI use in a longer period of time.

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VP51 Hospitalizations And Costs In Schizophrenia Patients Initiating Long-acting Injectable Antipsychotics

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462317003324 ◽

2017 ◽

Vol 33 (S1) ◽

pp. 171-171

Author(s):

Mallik Greene ◽

Tingjian Yan ◽

Eunice Chang ◽

Ann Hartry ◽

Michael Broder

Keyword(s):

Index Date ◽

Reference Group ◽

Cohort Analysis ◽

Paliperidone Palmitate ◽

Linear Regression Models ◽

Inpatient Hospitalization ◽

Retrospective Cohort Analysis ◽

Inpatient Hospitalizations ◽

Medicaid Population ◽

Long Acting

INTRODUCTION:Existing evidence on clinical and economic effectiveness of one long-acting injectable antipsychotic (LAI) versus another in successful management of schizophrenia is scarce. The study was conducted to compare all-cause inpatient healthcare utilization and associated costs among Medicaid patients with schizophrenia who initiated LAIs.METHODS:This retrospective cohort analysis used the Truven Health Analytics MarketScan® Medicaid claims database. Schizophrenia patients >18 years with at least one claim for one of the following LAI were identified between 1 January 2013 and 30 June 2014 (identification period): aripiprazole, fluphenazine, haloperidol, paliperidone palmitate, and risperidone. The first day of initiating an LAI was considered the index date. Patients were followed for 1 year from index date. Logistic and general linear regression models were used to estimate risk of inpatient hospitalization and associated costs during follow up.RESULTS:Of the identified Medicaid patients with schizophrenia, 1,672 (36.7 percent) initiated an LAI: 44.0 percent received paliperidone, 26.4 percent haloperidol, 13.8 percent risperidone, 9.2 percent aripiprazole, and 6.6 percent fluphenazine. With the aripiprazole cohort as the reference group, the odds of having any inpatient hospitalizations were significantly higher in haloperidol [Odds Ratio, OR (95 percent Confidence Interval, CI): 1.51 (1.05 - 2.16)] and risperidone [OR (95 percent CI): 1.58 (1.07 - 2.33)] cohorts. Fluphenazine and paliperidone palmitate cohorts also had higher risk of having any inpatient hospitalizations compared with aripiprazole, but the differences were not statistically significant (p>.05). Among LAI initiators with any inpatient hospitalizations, the adjusted mean inpatient costs were lowest in the aripiprazole cohort (USD25,616), followed by haloperidol (USD30,811), paliperidone (USD30,833), risperidone (USD31,584), and fluphenazine (USD37,338), although differences were not statistically significant.CONCLUSIONS:Our study findings highlight the value of aripiprazole in reducing inpatient hospitalizations and associated costs among patients with schizophrenia. However, our study is limited as our results are reflective of a multi-state Medicaid population. Future studies are warranted to confirm the results in non-Medicaid patient populations.

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Is the use of two versus one long-acting bronchodilator by patients with COPD associated with a higher risk of acute coronary syndrome in real-world clinical practice?

BMJ Open Respiratory Research ◽

10.1136/bmjresp-2020-000840 ◽

2021 ◽

Vol 8 (1) ◽

pp. e000840

Author(s):

Lianne Parkin ◽

Sheila Williams ◽

David Barson ◽

Katrina Sharples ◽

Simon Horsburgh ◽

...

Keyword(s):

Acute Coronary Syndrome ◽

Clinical Practice ◽

Real World ◽

Chronic Obstructive ◽

Treatment Intensification ◽

Cardiovascular Comorbidity ◽

Coronary Syndrome ◽

Long Acting ◽

The Impact

BackgroundCardiovascular comorbidity is common among patients with chronic obstructive pulmonary disease (COPD) and there is concern that long-acting bronchodilators (long-acting muscarinic antagonists (LAMAs) and long-acting beta2 agonists (LABAs)) may further increase the risk of acute coronary events. Information about the impact of treatment intensification on acute coronary syndrome (ACS) risk in real-world settings is limited. We undertook a nationwide nested case–control study to estimate the risk of ACS in users of both a LAMA and a LABA relative to users of a LAMA.MethodsWe used routinely collected national health and pharmaceutical dispensing data to establish a cohort of patients aged >45 years who initiated long-acting bronchodilator therapy for COPD between 1 February 2006 and 30 December 2013. Fatal and non-fatal ACS events during follow-up were identified using hospital discharge and mortality records. For each case we used risk set sampling to randomly select up to 10 controls, matched by date of birth, sex, date of cohort entry (first LAMA and/or LABA dispensing), and COPD severity.ResultsFrom the cohort (n=83 417), we identified 5399 ACS cases during 281 292 person-years of follow-up. Compared with current use of LAMA therapy, current use of LAMA and LABA dual therapy was associated with a higher risk of ACS (OR 1.28 (95% CI 1.13 to 1.44)). The OR in an analysis restricted to fatal cases was 1.46 (95% CI 1.12 to 1.91).ConclusionIn real-world clinical practice, use of two versus one long-acting bronchodilator by people with COPD is associated with a higher risk of ACS.

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A Prospective Comparison of Bipolar I and II Subjects With and Without Comorbid Alcohol Dependence From the COGA Dataset

Frontiers in Psychiatry ◽

10.3389/fpsyt.2020.522228 ◽

2020 ◽

Vol 11 ◽

Author(s):

Ulrich W. Preuss ◽

M. N. Hesselbrock ◽

V. M. Hesselbrock

Keyword(s):

Bipolar Disorder ◽

Alcohol Use ◽

Alcohol Dependence ◽

Collaborative Study ◽

Structured Interviews ◽

Prospective Comparison ◽

Bipolar Ii ◽

Bipolar Patients ◽

Alcohol Dependent

Objective: Comorbidity of alcohol use disorders in bipolar subjects is high as indicated by epidemiological and clinical studies. Though a more severe course of bipolar disorder in subjects with comorbid alcohol dependence has been reported, fewer studies considered the longitudinal course of alcohol dependence in bipolar subjects and the prospective course of comorbid bipolar II subjects. Beside baseline analysis, longitudinal data of the COGA (Collaborative Study on Genetics in Alcoholism) were used to evaluate the course of bipolar I and II disordered subjects with and without comorbid alcohol dependence over more than 5 years of follow-up.Methods: Characteristics of bipolar disorder, alcohol dependence and comorbid psychiatric disorders were assessed using semi-structured interviews (SSAGA) at baseline and at a 5-year follow-up. Two hundred twenty-eight bipolar I and II patients were subdivided into groups with and without comorbid alcohol dependence.Results: Of the 152 bipolar I and 76 bipolar II patients, 172 (75, 4%) had a comorbid diagnosis of alcohol dependence. Bipolar I patients with alcohol dependence, in particular women, had a more severe course of bipolar disorder, worse social functioning and more suicidal behavior than all other groups of subjects during the 5-year follow-up. In contrast, alcohol dependence improved significantly in both comorbid bipolar I and II individuals during this time.Conclusions: A 5-year prospective evaluation of bipolar patients with and without alcohol dependence confirmed previous investigations suggesting a more severe course of bipolar disorder in comorbid bipolar I individuals, whereas bipolar II individuals were less severely impaired by comorbid alcohol use disorder. While severity of alcohol dependence improved during this time in comorbid alcohol-dependent bipolar I patients, the unfavorable outcome for these individuals might be due to the higher comorbidity with personality and other substance use disorders which, together with alcohol dependence, eventually lead to poorer symptomatic and functional clinical outcomes.

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Impulsivity predicts illness severity in long-term course of bipolar disorder: A prospective approach

Australian & New Zealand Journal of Psychiatry ◽

10.1177/0004867418783062 ◽

2018 ◽

Vol 52 (9) ◽

pp. 876-886 ◽

Cited By ~ 2

Author(s):

Jonas Rote ◽

Alice-Mai-Ly Dingelstadt ◽

Annette Aigner ◽

Michael Bauer ◽

Jana Fiebig ◽

...

Keyword(s):

Bipolar Disorder ◽

Linear Regression Analysis ◽

Age At Onset ◽

Illness Severity ◽

Observation Time ◽

Barratt Impulsiveness Scale ◽

Trait Impulsivity ◽

Morbidity Index ◽

Bipolar Patients ◽

The Impact

Background: Bipolar disorder is a common, severe and chronic mental illness. Despite this, predictors of illness severity remain poorly understood. Impulsivity is reported to be associated with bipolar disorder and aggravating comorbidities. This study therefore sought to examine the predictive value of impulsivity for determining illness severity in euthymic bipolar disorder patients. Methods: Baseline trait impulsivity of 120 bipolar euthymic patients (81 bipolar disorder I [68%], 80 female [67%]) and 51 healthy controls was assessed using Barratt Impulsiveness Scale 11. The impact of impulsivity on illness severity (measured with morbidity index) was prospectively tested in 97 patients with sufficient follow-up data (average observation time: 54.4 weeks), using linear regression analysis. Results: Barratt Impulsiveness Scale 11 total (β = 0.01; p < 0.01) and in particular Barratt Impulsiveness Scale 11 attentional subscale scores (β = 0.04; p < 0.001) predicted illness severity in bipolar disorder, while controlling for other clinical variables. Only age at onset persisted as an additional, but less influential predictor. Barratt Impulsiveness Scale 11 total scores and Barratt Impulsiveness Scale 11 attentional subscale scores were significantly higher in euthymic patients compared to controls. This was not observed for the motor or non-planning subscale scores. Limitations: The average year-long observation time might not be long enough to account for the chronic course of bipolar disorder. Conclusion: Trait impulsivity and particularly attentional impulsivity in euthymic bipolar patients can be strong predictors of illness severity in bipolar disorder. Future studies should explore impulsivity as a risk assessment for morbidity and as a therapeutic target in bipolar disorder patients.

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Abstract MP25: Obesity, Heart Failure Risk & Cardiorespiratory Fitness

Circulation ◽

10.1161/circ.137.suppl_1.mp25 ◽

2018 ◽

Vol 137 (suppl_1) ◽

Author(s):

Peter F Kokkinos ◽

Puneet Narayan ◽

Charles Faselis ◽

Jonathan Myers ◽

Carl Lavie ◽

...

Keyword(s):

Heart Failure ◽

Exercise Capacity ◽

Cardiorespiratory Fitness ◽

Reference Group ◽

Normal Weight ◽

Entire Cohort ◽

Metabolic Equivalents ◽

Increased Risk ◽

The Impact

Introduction: Obesity, defined as body mass index (BMI) ≥30 kg/m 2 , is associated with increased incidence of heart failure (HF). Increased cardiorespiratory fitness (CRF), as indicated by increased exercise capacity, is associated with lower risk of cardiovascular disease and HF. However, the CRF-BMI-HF interaction has not been fully explored. Hypothesis: We assessed the hypothesis that the risk of HF associated with increased BMI is moderated by increased CRF. Methods: We identified 19,881 Veterans (mean age: 58.0±11.3 years) who completed an exercise tolerance test (ETT) to assess either CRF status or suspected ischemia at two VA Medical Centers (Washington DC and Palo Alto, CA). None had documented HF at baseline or evidence of ischemia during the ETT. We established four BMI categories: <25 kg/m 2 ; 25-29.9 kg/m 2 ; 30-34.9 kg/m 2 ; and ≥35 kg/m 2 . In addition, we established four CRF categories based on age-stratified quartiles of peak metabolic equivalents (METs) achieved (mean ± SD): Least-Fit (4.5±1.2 METs; n=4,743); Low-Fit (6.6±1.3; n=5,103); Moderate-Fit (8.0±1.3 METs; n=5,084); and High-Fit (11.1±2.4 METs; n=4,951). Multivariable Cox models were used to estimate hazard ratios (HR) and 95% confidence intervals [CI] for incidence of HF across BMI categories for the entire cohort, using BMI 25-29.9 kg/m 2 (lowest HF rate) as the reference group. We then stratified the cohort by the four BMI categories and assessed HF risk across CRF categories within each stratum, using the Least-fit category as the reference group. The models were adjusted for age, race, gender, cardiac risk factors, sleep apnea, alcohol dependence, medications. Results: During follow-up (median=11.8 years), 2,193 developed HF (10.5 per 1,000 person-years of follow-up). The HF risk for normal weight individuals (18.5-24.9 kg/m2) was 10% higher (p=0.93). For obese individuals, the HF risk was 22% higher in those with BMI 30-34.9 kg/m 2 (HR=1.22; 95% CI: 1.09-1.35) and 50% higher (HR=1.50, 95% CI: 1.32-1.72) for those with BMI ≥35 kg/m 2 . When CRF (peak METs achieved) was introduced in the model, the risk for those with BMI 30-34.9 was reduced from 22% to 16% (HR=1.16; 95% CI: 1.04-1.29) and from 50% to 29% (HR=1.29; 95% CI: 1.13-1.48) among those with ≥35 kg/m 2 . For every 1-MET increase in exercise capacity, HF risk was 15% lower (HR=0.85; 95% CI: 0.83-0.87). We then assessed the impact of CRF on the risk of HF within each of the four BMI categories. The HF risk declined progressively (range: 25% to 69%; p<0.01) with increasing fitness within all BMI categories. Conclusions: The obesity-associated increased risk of HF was attenuated by increased CRF. The HF risk was progressively decreased with increased CRF within all BMI categories.

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Impact of obesity on male urethral sling outcomes

Therapeutic Advances in Urology ◽

10.1177/1756287220927997 ◽

2020 ◽

Vol 12 ◽

pp. 175628722092799

Author(s):

M. Francesca Monn ◽

Hannah V. Jarvis ◽

Thomas A. Gardner ◽

Matthew J. Mellon

Keyword(s):

Operative Time ◽

Cohort Analysis ◽

Obese Patients ◽

Retrospective Cohort Analysis ◽

Surgical Complexity ◽

History Of ◽

Sling Placement ◽

The Impact ◽

Male Urethral Sling

Background: The impact of obesity on AdVance male urethral sling outcomes has been poorly evaluated. Anecdotally, male urethral sling placement can be more challenging due to body habitus in obese patients. The objective of this study was to evaluate the impact of obesity on surgical complexity using operative time as a surrogate and secondarily to evaluate the impact on postoperative pad use. Methods: A retrospective cohort analysis was performed using all men who underwent AdVance male urethral sling placement at a single institution between 2013 and 2019. Descriptive statistics comparing obese and non-obese patients were performed. Results: A total of 62 patients were identified with median (IQR) follow up of 14 (4–33) months. Of these, 40 were non-obese and 22 (35.5%) were obese. When excluding patients who underwent concurrent surgery, the mean operative times for the non-obese versus obese cohorts were 61.8 min versus 73.7 min ( p = 0.020). No Clavien 3–5 grade complications were noted. At follow up, 47.5% of the non-obese cohort and 63.6% of the obese cohort reported using one or more pads daily ( p = 0.290). Four of the five patients with a history of radiation were among the patients wearing pads following male urethral sling placement. Conclusion: Obese men undergoing AdVance male urethral sling placement required increased operative time, potentially related to operative complexity, and a higher proportion of obese compared with non-obese patients required postoperative pads for continued urinary incontinence. Further research is required to better delineate the full impact of obesity on male urethral sling outcomes.

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Uric acid and left ventricular hypertrophy: another relationship in hemodialysis patients

Clinical Kidney Journal ◽

10.1093/ckj/sfz172 ◽

2019 ◽

Author(s):

Gjulsen Selim ◽

Olivera Stojceva-Taneva ◽

Liljana Tozija ◽

Beti Zafirova-Ivanovska ◽

Goce Spasovski ◽

...

Keyword(s):

Uric Acid ◽

General Population ◽

Left Ventricular Hypertrophy ◽

Ventricular Hypertrophy ◽

Reference Group ◽

Left Ventricular ◽

Reactive Protein ◽

Cv Disease ◽

The Impact

Abstract Background The impact of serum uric acid (UA) on morbidity and mortality in hemodialysis (HD) patients is quite controversial in relation to the general population. The aim of this study was to evaluate the association of serum UA with both mortality and left ventricular hypertrophy (LVH) in HD patients. Methods This longitudinal study enrolled 225 prevalent HD patients who were classified into three groups according to their follow-up-averaged UA (FA-UA) levels: low FA-UA (FA-UA <400 µmol/L), intermediate/reference FA-UA (FA-UA between 400 and 450 µmol/L) and high FA-UA (FA-UA >450 µmol/L). Echocardiography was performed on a nondialysis day and the presence of LVH was defined based on a left ventricular mass index (LVMI) >131 and >100 g/m2 for men and women, respectively. The patients were followed during a 60-month period. Results The mean FA-UA level was 425 ± 59 µmol/L (range 294–620). There was a consistent association of higher FA-UA with better nutritional status (higher body mass index, normalized protein catabolic rate, creatinine, albumin and phosphorus), higher hemoglobin, but lower C-reactive protein and LVMI. During the 5-year follow-up, 81 patients died (36%) and the main causes of death were cardiovascular (CV) related (70%). When compared with the reference group, the hazard ratio for all-cause mortality was 1.75 [95% confidence interval (CI) 1.02–2.98; P = 0.041] in the low FA-UA group, but there was no significant association with the high FA-UA group. In contrast, FA-UA did not show an association with CV mortality neither with the lower nor with the high FA-UA group. The unadjusted odds ratio (OR) of LVH risk in the low FA-UA compared with the reference FA-UA group was 3.11 (95% CI 1.38–7.05; P = 0.006), and after adjustment for age, gender, diabetes and CV disease, ORs for LVH persisted significantly only in the low FA-UA group [OR 2.82 (95% CI 1.16–6.88,); P = 0.002]. Conclusions Low serum UA is a mortality risk factor and is associated with LVH in HD patients. These results are in contrast with the association of UA in the general population and should be the subject of further research.

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The Impact of Pre-Operative Mental Health and Depression on Outcomes after Total Ankle Arthroplasty

Foot & Ankle Orthopaedics ◽

10.1177/2473011420s00180 ◽

2020 ◽

Vol 5 (4) ◽

pp. 2473011420S0018

Author(s):

Daniel J. Cunningham ◽

John Steele ◽

Samuel B. Adams

Keyword(s):

Mental Health ◽

Patient Reported Outcomes ◽

Total Ankle Arthroplasty ◽

Linear Regression Models ◽

Ankle Arthroplasty ◽

Change Scores ◽

Short Musculoskeletal Function Assessment ◽

Patient Reported ◽

The Impact

Category: Ankle Introduction/Purpose: Poor pre-operative mental health and depression have been shown to negatively impact patient- reported outcomes (PROMs) after a broad array of orthopaedic procedures involving the spine, hip, knee, shoulder, and hand. However, the relationship of mental health and patient-reported outcomes in foot and ankle surgery is less clear. The purpose of this study is to characterize the impact of pre-operative mental health and depression on patient-reported outcomes after total ankle arthroplasty. The study hypothesis is that depression and decreased SF36 MCS will be significantly associated with diminished improvement in PROMs after total ankle arthroplasty. Methods: All patients undergoing primary TAA between January 2007 and December 2016 who were enrolled into a prospective, observational study and who had at least 1 to 2-year minimum study follow-up were included. Patients were separated into 4 groups based on the presence or absence of SF36 MCS<35 and diagnosis of depression. Pre-operative to post- operative change scores in the SF36 physical and mental component summary scores (PCS and MCS), Short Musculoskeletal Function Assessment (SMFA) function and bother components, and visual analog scale (VAS) pain were calculated in 1 to 2-year follow-up. Multivariable, main effects linear regression models were constructed to evaluate the impact of SF36 and depression status on pre-operative to 1 to 2-year follow-up change scores with adjustment for age, sex, race, body mass index, current smoking, American Society of Anesthesiologist’s score, smoking, and Charlson-Deyo comorbidity score. Results: As in Table 1, adjusted analyses demonstrated that patients with MCS<35 and depression had significantly lower improvements in all change scores including SF36 MCS (-5.1 points) and PCS (-7.6 points), SMFA bother (6 points) and function scores (5.7 points), and VAS pain (7.5 points) compared with patients that had SF36>=35 and no depression. Patients with MCS<35 and no depression had significantly greater improvement in SF36 MCS (5.3 points) compared with patients that had MCS>=35 and no depression. Patients with MCS>=35 and depression had significantly lower improvement in SF36 MCS (-3.2 points) compared with patients that had MCS>=35 and no depression. Adjusted analyses of minimum 5-year outcomes demonstrated significantly increased improvement in MCS and SMFA function for patients with pre-operative MCS<35 and no depression. Conclusion: Presence of depression and decreased SF36 MCS are risk factors for diminished improvement in PROMs. Patients with depression and decreased MCS should be counseled about their risk of diminished improvement in outcomes compared to peers. As PROM’s become part of physician evaluations, it is becoming increasingly important to identify factors for diminished improvement outside of the physician’s control. [Table: see text]

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Impact of Comorbid Alcohol Use Disorder on Health-Related Quality of Life Among Patients With Depressive Symptoms

Frontiers in Psychiatry ◽

10.3389/fpsyt.2021.688136 ◽

2021 ◽

Vol 12 ◽

Author(s):

Kaisa E. Luoto ◽

Lars H. Lindholm ◽

Antti Koivukangas ◽

Antero Lassila ◽

Harri Sintonen ◽

...

Keyword(s):

Psychiatric Care ◽

Behavioral Activation ◽

Reference Group ◽

Treatment Intervention ◽

Related Quality ◽

Health Related ◽

The Impact ◽

Depressive Patients

Background and Aim: In psychiatric clinical practice, comorbidity of depression and alcohol use disorder (AUD) is common. Both disorders have a negative impact on health-related quality of life (HRQoL) in general population. However, research on the impact of comorbid AUD on HRQoL among clinically depressed patients is limited. The purpose of this study was to explore the impact of a psychosocial treatment intervention on HRQoL for depressive patients in specialized psychiatric care with a special focus on the impact of AUD on HRQoL.Material and Methods: Subjects were 242 patients of the Ostrobothnia Depression Study (ClinicalTrials.gov Identifier NCT02520271). Patients referred to specialized psychiatric care who scored at least 17 points on the Beck Depression Inventory at baseline and who had no psychotic disorders were included in the ODS. The treatment intervention in ODS comprised behavioral activation for all but began with motivational interviewing for those with AUD. HRQoL was assessed regularly during 24-month follow-up by the 15D instrument. In the present study, HRQoL of ODS patients with or without AUD was compared and the factors explaining 15D score analyzed with a linear mixed model. In order to specify the impact of clinical depression on HRQoL during the early phase of treatment intervention, a general population sample of the Finnish Health 2011 Survey was used as an additional reference group.Results: HRQoL improved among all ODS study sample patients regardless of comorbid AUD during the first year of follow-up. During 12–24 months of follow-up the difference between groups was seen as HRQoL continued to improve only among the non-AUD patients. A combination of male gender, anxiety disorder, and AUD was associated with the poorest HRQoL in this sample. In combined sample analyses with the reference group, clinical depression had an impact on HRQoL in short-term follow-up regardless of the treatment intervention.Conclusions: This study suggests that, in terms of improvement in HRQoL, the heterogenous group of depressive patients in specialized psychiatric care can be successfully treated with behavioral activation in combination with motivational interviewing for those with AUD.Clinical Trial Registration:ClinicalTrials.gov Identifier: NCT02520271. Ostrobothnia Depression Study (ODS). A Naturalistic Follow-up Study on Depression and Related Substance Use Disorders. (2015). Available online at: https://clinicaltrials.gov/ct2/show/NCT02520271.

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Examining the Effectiveness of Telemonitoring with Routinely Acquired Blood Pressure Data in Primary Care: Challenges in the Statistical Analysis

10.21203/rs.3.rs-71464/v1 ◽

2020 ◽

Author(s):

Richard Parker ◽

Paul Padfield ◽

Janet Hanley ◽

Hilary Pinnock ◽

John Kennedy ◽

...

Keyword(s):

Blood Pressure ◽

Primary Care ◽

Statistical Analysis ◽

Cohort Analysis ◽

Random Coefficient ◽

White Coat ◽

White Coat Effect ◽

The Impact ◽

Analytical Approaches

Abstract BackgroundScale-up BP was a quasi-experimental implementation study, following a successful randomised controlled trial of the roll-out of telemonitoring in primary care across Lothian, Scotland. Our primary objective was to assess the effect of telemonitoring on blood pressure (BP) control using routinely collected data. Telemonitored systolic and diastolic BP were compared with surgery BP measurements from patients not using telemonitoring (comparator patients). The statistical analysis and interpretation of findings was challenging due to the broad range of biases potentially influencing the results, including differences in the frequency of readings, ‘white coat effect’, end digit preference, and missing data.MethodsThree different statistical methods were employed in order to minimise the impact of these biases on the comparison between telemonitoring and comparator groups. These methods were “standardisation with stratification”, “standardisation with matching”, and “random coefficient modelling”. The first two methods standardised the groups so that all participants provided exactly two measurements at baseline and 6-12 months follow-up before using stratification or matched cohort analysis to compare the groups. The third analysis used linear mixed modelling based on all available data. ResultsThe standardisation with stratification analysis showed a significantly lower systolic BP in telemonitoring patients at 6-12 months follow-up (-3.42, 95% CI -1.72 to -5.11, p<0.001). For the standardisation with matching analysis, systolic BP was also significantly lower (-5.96, 95% CI -3.55 to -8.36, p<0.001), even after assuming that -5 of the difference was due to ‘white coat effect’. For the random coefficient modelling, the improvement in systolic BP was estimated to be -4.68 (95% CI -3.12 to -6.24, p<0.001) after one year. ConclusionsThe three analyses provide additional evidence for the effectiveness of telemonitoring in controlling BP in routine primary care. However, adjusting for the complex array of biases was difficult. Researchers should appreciate the potential for bias in implementation studies and seek to acquire a detailed understanding of the study context in order to design appropriate analytical approaches.

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