Additional Healthcare Utilization Research Articles

The Burden of Health Care Utilization, Cost, and Mortality Associated with Select Surgical Site Infections

ObjectiveThis study assessed the additional healthcare utilization, cost, and mortality resulting from three surgical site infections (SSIs): mediastinitis/SSI after coronary artery bypass graft, SSI after bariatric surgery for obesity, and SSI after certain orthopedic procedures. MethodsThis retrospective observational cohort study used commercial and Medicare Advantage claims from 2016 to 2021. Patients with one of three SSIs were compared to a 1:1 propensity score-matched group of patients with the same surgeries but without SSI on outcomes up to one year post-discharge. ResultsThe total sample size was 4,620. Compared to their matched cohorts, the three SSI cohorts had longer mean index inpatient length of stay (LOS; adjusted days difference ranged from 1.73 to 6.27 days; all p < 0.001) and higher 30-day readmission rates (adjusted odds ratio ranged from 2.8 to 25.1; all p ≤ 0.001). The SSI cohort for orthopedic procedures had higher 12-month mortality (hazard ratio of 1.6; p = 0.01), though other cohorts did not have significant differences. Total medical costs were higher in all three SSI versus matched comparison cohorts for the index episode and six months and one year post-discharge. Average adjusted one-year total medical cost differences ranged from $40,606 to $68,101 per person, depending on the cohort (p < 0.001), with out-of-pocket cost differences ranging from $330 to $860 (p < 0.05). ConclusionPatients with SSIs experienced higher LOS, readmission rates, total medical costs, and higher mortality for some populations compared to their matched comparison cohorts during the first year post-discharge. Identifying strategies to reduce SSIs is important both for patient outcomes and affordability of care.

Outpatient Total Joint Arthroplasty in the “Unhealthy”: Staying Safe Using Institutional Protocols

BackgroundRecent expansion in the indications for outpatient total joint arthroplasty has led to debates over patient selection. The purpose of this study was to compare early clinical outcomes and complications of same-day discharge (SDD) hip and knee arthroplasties from a high-volume institution based on the American Society of Anesthesiologists (ASA) physical status classification. MethodsProspectively collected data were reviewed for all SDD primary joint arthroplasties between January 2013 and August 2023. There were 8 surgeons who performed 7,258 cases at hospital outpatient (n = 4,288) or ambulatory surgery centers (n = 2,970). This included 3,239 total hip arthroplasties, 1,503 total knee arthroplasties, and 2,516 unicompartmental knee arthroplasties. The ASA 1 group comprised 506 subjects, compared to 5,005 for ASA 2 and 1,736 for ASA 3. The primary outcomes included emergency department (ED) visits, readmissions, complications, and revisions within 24 hours and 90 days of surgery. The ASA 3 group was older (ASA 1 = 55 versus ASA 2 = 63 versus ASA 3 = 66 years; P < .01) and had a higher body mass index (ASA 1 = 25.4 versus ASA 2 = 28.5 versus ASA 3 = 32.7; P < .01). ResultsThere were no differences between ASA groups in joint-related ED visits, readmissions, and complications within 24 h and 90 days of surgery (P > .05). Subjects in the ASA 3 group experienced greater 90-day revisions compared to the other groups (ASA 1 = 1 of 506, 0.2% versus ASA 2 = 15 of 5,005, 0.3% versus ASA 3 = 15 of 1,736, 0.9%; P = .01). Regarding systemic events, ASA 1 subjects experienced significantly greater 24-hour complications (8 of 506, 1.6%) and ED visits (5 of 506, 1.0%), and the ASA 3 subjects had a higher incidence of 90-day readmissions (19 of 1,736, 1.1%) compared to the other groups (P < .05). Within 24 hours of discharge, urinary retention and syncope were the most frequent complications that required additional health care utilization. ConclusionsMedically optimized patients categorized as ASA 3 can safely undergo SDD hip and knee arthroplasty without increased risk of 24-hour or 90-day complications. Patient preference for outpatient care, reliable social support, and independent functional status are imperative for a successful outpatient program.

The cost of keeping patients waiting: retrospective treatment-control study of additional healthcare utilisation for UK patients awaiting elective treatment.

Long waiting times for elective hospital treatments are common in many countries. This study seeks to address a deficit in the literature concerning the effect of long waits on the wider consumption of healthcare resources. We carried out a retrospective treatment-control study in a healthcare system in South West England from 15 June 2021 to 15 December 2021. We compared weekly contacts with health services of patients waiting over 18 weeks for treatment ('Treatments') and people not on a waiting list ('Controls'). Controls were matched to Treatments based on age, sex, deprivation and multimorbidity. Treatments were stratified by the clinical specialty of the awaited hospital treatment, with healthcare usage assessed over various healthcare settings. Wilcoxon signed-rank tests assessed whether there was an increase in healthcare utilisation and bootstrap resampling was used to estimate the magnitude of any differences. A total of 44,616 patients were waiting over 18 weeks (the constitutional target in England) for treatment during the study period. There was an increase (p < 0.0004) in healthcare utilisation for all specialties. Patients in the Cardiothoracic Surgery specialty had the largest increase, with 17.9 [interquartile-range: 4.3, 33.8] additional contacts with secondary care and 17.3 [-1.1, 34.1] additional prescriptions per year. People waiting for treatment consume higher levels of healthcare than comparable individuals not on a waiting list. These findings are relevant for clinicians and managers in better understanding patient need and reducing harm. Results also highlight the possible 'false economy' in failing to promptly resolve long elective waits.

EE265 Excess Out-of-Pocket Expenditures and Burden of Prescription Opioid Use Among Older Cancer Survivors with Non-Cancer Chronic Pain Conditions (NCPC)

Opioids are needed for managing cancer-related pain. However, cancer survivors may experience substantial out-of-pocket spending because opioid use may trigger additional healthcare utilization to manage the opioids’ side and adverse effects. This study aims to estimate the excess out-of-pocket expenditures and out-of-pocket burden of prescription opioid use among older adults with any NCPC and cancer.

Faster Time to Treatment of Seizure Clusters With Diazepam Nasal Spray Is Associated With Faster Cessation of Clusters and a Similar Rate of Second Dose Usage (P9-1.009)

Faster Time to Treatment of Seizure Clusters With Diazepam Nasal Spray Is Associated With Faster Cessation of Clusters and a Similar Rate of Second Dose Usage (P9-1.009)

The efficient moral hazard effect of health insurance: Evidence from the consolidation of urban and rural resident health insurance in China

Ex post moral hazard, the additional healthcare utilization induced by health insurance, can be decomposed into an efficient portion generated by the income effect and an inefficient portion caused by the substitution effect, which has been discussed theoretically, but few studies have provided evidence of the efficient moral hazard. In 2016, the Chinese government launched the consolidation of urban and rural resident health insurance at the national level. After the consolidation, insurance benefits for nearly 800 million rural residents got improved. This paper uses a nationally-representative sample of 30,972 individuals from the China Health and Retirement Longitudinal Study (2011–2018) and adopts a 2-step empirical approach with the difference-in-differences method and the fuzzy regression discontinuity design to estimate the efficient moral hazard in the consolidation among rural residents. We find that the price shock contained in the consolidation increases inpatient care utilization, and the corresponding price elasticity is between −0.68 and −0.62. Further analysis shows that the efficient moral hazard resulting in welfare gains accounts for 43.33%–66.36% of the additional healthcare utilization. These findings highlight the necessity of evaluating the efficient moral hazard when analyzing the cost-benefit of health insurance reform.

Long-Awaited AAP Hyperbilirubinemia Guidelines Have Arrived.

Long-Awaited AAP Hyperbilirubinemia Guidelines Have Arrived.

Can Use of Default Dispensing Quantities in Electronic Medical Record Lower Opioid Prescribing?

Leftover opioids can contribute to misuse and abuse. Recommended dosing quantities in the electronic medical record can guide prescribing patterns. We hypothesized that decreasing the default from 30 doses to 12 doses would decrease the overall number of opioids prescribed without increasing second opioid prescriptions or additional health utilization. We performed a single-center retrospective study of children with forearm and elbow fractures who presented to the emergency department for evaluation and subsequent orthopedic follow-up between January 15, and September 19, 2017. The default dispensing quantity was decreased on June 1, 2016 from 30 doses to 12 doses. Patients were categorized to preintervention and postintervention groups. We compared the number of opioids prescribed, second opioid prescriptions, emergency department visits, and pain-related telephone calls and orthopedic visits with χ2 and logistic regression analyses. There were 1107 patients included. Rates of opioid prescribing were similar preintervention and postintervention (61% vs 56%, P = 0.13). After the change to the default quantity, the median number of doses decreased from 18 to 12 doses, with opioid prescriptions of 30 or more doses dropping from 35% to 11%. No significant association was found between preintervention versus postintervention, opioid prescription at discharge, and having 1 or more pain-related or unexpected follow-up visits. Lowering the default dispensing quantity of opioids in the electronic medical record decreases the number of opioids prescribed without increasing second prescriptions or additional health care utilization. These findings suggest that a further reduction in the number of opioids prescribed for upper-extremity fractures may be possible.

Management trends of clavicular fractures at a level 1 trauma center: a retrospective chart review

Background: Controversy remains regarding optimal treatment of clavicular fractures, despite evidence touting lower nonunion rates for operative interventions. Given increasing evidence supporting operative treatment, the goal of this study was to observe trends in operative versus nonoperative treatment over a 15-year period. Methods: One thousand and eighty nine patients with any clavicular fracture (AO Foundation/Orthopaedic Trauma Association 15A to 15AC) between 2004 and 2018 were identified. Patient records were queried for demographic information, injuries to the head or chest, and treatment modality (operative vs. nonoperative). Independent sample t-tests, Fisher exact, or chi-square tests were used for analysis, with P less than 0.05 representing significance. Results: Of the 1089 qualified patients, the average age was 47.5 yr and 70.7% were men. Two hundred forty-two patients (20.2%) were managed operatively. Two hundred seventy-one patients (24.8%) had isolated injuries. Operative clavicle management increased from 6.4% of patients in 2004 and 2005 to 31.5% in 2018 (P&lt;0.001). During this time, both patient age and chest-injury rates increased (both P&lt;0.01). Patients with head injuries had a fixation rate of 4.8%, compared with 45.5% in patients with chest injuries. Those fixation rates differed from the rate for isolated clavicular fractures (30.9%) and those polytraumatized patients who had both chest and head injuries (18.8%) (P=0.026). Conclusions: Our data indicated that from 2004 to 2018, there was a five-fold increase in the rate of operative management of clavicular fractures. This rise in fixation rates may substantially influence the rate of complications, secondary surgeries, and cost of additional healthcare utilization. It is important to counsel patients individually to limit unnecessary surgery. Level of Evidence: Level IV.

Childhood health and education outcomes following early term induction for large-for-gestational age: A population-based record linkage study.

There is debate about optimal management of pregnancies with a large-for-gestational age baby. A recent randomized controlled trial reported that early term induction of labor reduced cesarean section rates and infant morbidity. However, long term childhood outcomes have not been assessed. The aim of this study was to assess maternal, neonatal and child health and education outcomes for large-for-gestational age babies induced at 37-38weeks' gestation. Population-based record linkage study of term (37+weeks), cephalic-presenting singleton pregnancies with a large-for-gestational age baby in New South Wales, Australia, 2002-2006. Linked birth, hospital, mortality and education data were used with at least 9years follow up from birth. Exposure was induction of labor at 37-38weeks, compared to expectant management (spontaneous birth at ≥37weeks and planned births at ≥39weeks). Relative risks and 95% confidence intervals were estimated using Modified Poisson regression with robust variance. Among 10174 eligible pregnancies, 412 (4.0%) had an induction at 37-38weeks. Women in the induction group were less likely to have a cesarean section (RR: 0.65, 95% CI: 0.51-0.82). Infants had higher rates of: low Apgar scores, birth trauma, neonatal jaundice and phototherapy use, and admission to special care nursery or neonatal intensive care than their expectantly managed counterparts. As children, they had higher rates of hospital admission (RR: 1.16, 95% CI: 1.04-1.30) and special needs (RR: 1.98, 95% CI: 1.12-3.50). However, by age 8 there was no difference in overall literacy and numeracy achievement. Although women who had an early term labor induction with large-for-gestational age were less likely to have a cesarean section, the increased risk of neonatal morbidities and additional healthcare utilization suggests the need for caution in early induction of large-for-gestational age babies before 39weeks' gestation.

PHS91 - Do Medical Homes Affect Healthcare Utilization Rates? A Longitudinal Evaluation on Medical Home Implementation in Italy

This study compares healthcare utilization rates between patient populations served by general practitioners (GPs) affiliated with newly established medical homes (MHs) and those not affiliated with MHs. This longitudinal study of administrative healthcare data from the Local Health Authority of Parma, Emilia-Romagna, Italy included residents ≥14 years residing in Parma ≥1 year prior to entry in the study. During the study period (1/1/2010-12/31/2016), 16 MHs were established at various times, with the first one opening in December 2011. The exposure of interest for any patient at any time was assignment to a GP affiliated with an MH. Utilization measures evaluated were Emergency Department (ED) visits and hospital admissions, including ambulatory care sensitive conditions (ACSCs). The association between MH healthcare and each outcome was evaluated through a series of Cox proportional hazards models with a time-dependent MH status. To adjust for the strong influence on healthcare utilization rates of patients treated by a GP with a disposition to join an MH, the models were adjusted for GP type (i.e., GP who joined an MH during the study period vs. GP who had not). 412,394 patients contributed exposure time to non-MH healthcare and 124,801 contributed to a MH healthcare (median follow-up time 4.5 years and 3.9 years, respectively). Most patients (65.4%) were followed for the entire 6-year period. Compared to patients not exposed to MH healthcare, those exposed had a lower risk (HR; 95% CI) of ED visits (0.96; 0.95-0.97) and ordinary hospital admissions (0.98; 0.96-0.99). No difference was observed among admissions for ACSCs. These findings suggest MH healthcare is associated with improvements in healthcare utilization rates. Additional healthcare utilization outcomes should be evaluated and further longitudinal analyses, including adjustments for other potential confounders, should be conducted as more MHs are implemented and additional years’ data become available.

The direct and indirect costs of Dravet Syndrome

ObjectiveThe objective of this study was to estimate the annual direct and indirect costs associated with Dravet Syndrome (DS). MethodsA survey was electronically administered to the caregivers of patients with DS treated at Children's Hospital Colorado. Survey domains included healthcare utilization of the patient with DS and DS caregiver work productivity and activity impairment. Patient healthcare utilization was measured using modified questions from the National Health Interview Survey; caregiver work productivity and activity impairment were measured using modified questions from the Work Productivity and Activity Impairment questionnaire. Direct costs were calculated by multiplying the caregiver-reported healthcare utilization rates by the mean unit cost for each healthcare utilization category. Indirect costs included lost productivity, income loss, and lost leisure time. The indirect costs were a function of caregiver-reported hours spent caregiving and an hourly unit cost. ResultsThe survey was emailed to 60 DS caregivers, of which 34 (57% response rate) responded. Direct costs on average were $27,276 (95% interval: $15,757, $41,904) per patient with DS. Hospitalizations ($11,565 a year) and in-home medical care visits ($9894 a year) were substantial cost drivers. Additionally, caregivers reported extensive time spent providing care to an individual with DS. This caregiver time resulted in average annual indirect costs of $81,582 (95% interval: $57,253, $110,151), resulting in an average total annual financial burden of $106,378 (95% interval: $78,894, $137,906). ConclusionDravet Syndrome results in substantial healthcare utilization, financial burden, and time commitment. Establishing evidence on the financial burden of DS is essential to understanding the overall impact of DS, identifying potential areas for support needs, and assessing the impact of novel treatments as they become available. Based on the study findings, in-home visits, hospitalizations, and lost productivity and leisure time of caregivers are key domains for DS economic evaluations. Future research should extend these estimates to include the potential additional healthcare utilization of the DS caregiver.

Exploring associations between psychiatric disorder, psychological distress, and health care utilization in cancer patients.

The mental burden of cancer might elicit additional health care utilization. However, it is unclear how psychiatric disorder and psychological distress relate to health care utilization. Therefore, this study explores associations between psychiatric disorder, psychological distress, and health care utilization. It was hypothesized that presence of psychiatric disorder and psychological distress was associated with increased health care utilization and costs. The current study consisted of secondary analyses of baseline data of a larger randomized controlled trial. Two hundred forty-five mixed-cancer patients with at least mild symptoms of psychological distress (Hospital Anxiety and Depression Scale-T≥11) were mainly recruited via online media, participating centers and patient associations. Patients were assessed with Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID-I) for depressive, anxiety, and/or adjustment disorder. Psychological distress was measured by the Hospital Anxiety and Depression Scale. Retrospective self-reported health care utilization in the past 3months was collected. Associations between predictors and health care utilization in terms of incidence rate ratios (IRR) and costs per category (mental, primary, somatic, and complementary) were assessed by negative binomial, logistic, and gamma regression. Eighty-nine (36.3%) patients suffered from psychiatric disorder, which was associated with mental health care utilization (IRR=1.63) and costs (OR=3.11). We observed a nonsignificant trend of somatic health care utilization in patients with psychiatric disorder. Psychological distress was associated with mental health care utilization (IRR=1.09) and costs (OR=1.09). Psychological distress was also associated with complementary health care utilization (IRR=1.03). Psychiatric disorder and psychological distress were associated with mental health care use and costs. Psychological distress was associated with complementary health care use. Adequate assessment and referral to mental health care might prevent unnecessary health care utilization.

Evaluation of the FilmArray Gastrointestinal Panel on Health Care Utilization in Immunocompetent Adults Presenting to the Emergency Department with Non-Clostridium difficile Acute Gastrointestinal Infection

BackgroundMultiplex polymerase chain reaction (PCR) rapid diagnostic technologies, such as the FilmArray Gastrointestinal (GI) Panel, have the potential to quickly determine the microbiologic etiology of acute gastrointestinal illnesses and prevent additional healthcare utilization through further diagnostic tests. However, the utility of this diagnostic on clinical management in patients with these illnesses remains unclear. This study compares health care utilization for patients where GI panel testing was performed in the emergency department (ED) vs. patients where conventional stool diagnostic methods were utilized.MethodsThis retrospective cohort study included adults presenting to hospital EDs and diagnosed with an intestinal infectious disease. Exclusion criteria included: immunocompromised state, C. difficile positive by PCR, and chronic diarrheal illness. Rate of hospital admission, total healthcare length of stay, use of diagnostic imaging, identification of pathogen, 30-day readmission for diarrhea, and mortality were compared between patients receiving a GI panel diagnostic test and those not receiving the test.ResultsA total of 100 patients were included in each group. Rates of hospital admission were numerically higher in the GI panel group (23% vs. 14%, P = 0.10). Time spent in the ED was longer in the GI panel group (4.3 vs. 3.4 hours, P <0.001) however total time in hospital was shorter (2.2 vs. 4.0 days, P = 0.04). A pathogen was identified in 91% of GI panel patients vs. 5% of patients not receiving the test (P <0.001). Abdominal computerized tomography scans were more frequently obtained in the GI panel group (42% vs. 29%, P = 0.05). The rate of 30-day emergency department presentation or readmission for diarrhea was similar between groups, and 30-day mortality was zero in each group.ConclusionPatients with a positive GI panel were more likely to have a pathogen identified, undergo diagnostic imaging, and be admitted from the ED, although their length of stay was significantly shorter. Further study is needed to determine the appropriateness of healthcare utilization and cost-benefits with use of the GI panel in the emergency department as well as impact on antimicrobial utilization.Disclosures All authors: No reported disclosures.

Hospital-Based Health Care After Traumatic Brain Injury

ObjectiveTo investigate trends of hospital-based health care utilization after admission to a level I trauma center after acute traumatic brain injury (TBI). DesignRetrospective review. SettingLarge urban trauma hospital and a hospital council data registry consisting of 88 member institutions (>150 hospitals) covering 15,000 square miles. ParticipantsAll patients (N=5291) admitted to a level I trauma center between January 1, 2006, and June 30, 2014, who experienced an acute TBI based on International Classification of Diseases, Ninth Revision coding. InterventionsNot applicable. Main Outcome MeasuresIncluded the incidence and type of select hospital-based services received. Analyses were also categorized based on demographic and injury-related information. ResultsOf the 5291 patients with newly acquired TBI who were admitted, 512 died, leaving 4779 patients for inclusion in the final analysis. Additional health care utilization from January 1, 2006, and June 30, 2014, was recorded for 3158 patients (66%), totaling 12,307 encounters, with a median of 3 encounters (interquartile range, 1–5) and a maximum of 102 encounters. Most nonadmission urgent or procedural visits (96%) and inpatient encounters (93%) occurred in the first year. Of all the additional encounters, 9769 visits were nonadmission urgent or procedural visits (79%) with a median charge of $1955. The most common type of encounter was elective (46%), followed by medical emergency (29%). Of the remaining 2538 inpatient encounters (21%), the mean length of stay was 6 days with a median charge of $28,450. Medical emergency (39%) and elective admissions (33%) again were the most common encounter type. ConclusionsThis analysis encompasses health care utilization across the range of TBI severity and numerous hospital systems, allowing for a more comprehensive and objective identification of reasons for readmission. This represents an initial step to developing a preventive intervention to manage secondary complications postinjury.

A Closer Look at Rural-Urban Health Disparities: Associations Between Obesity and Rurality Vary by Geospatial and Sociodemographic Factors.

Obesity affects over one-third of older adults in the United States. Both aging and obesity contribute to an increased risk for chronic disease, early mortality, and additional health care utilization. Obesity rates are higher in rural areas than in urban areas, although findings are mixed. The objectives of this study are to assess potential nonlinearity in the association between rurality and obesity, and to evaluate the potential for socioeconomic status and geographic area to moderate the associations between rurality and obesity. Using a representative sample of adults aged 65 and above from the Behavioral Risk Factor Surveillance System, obesity (BMI ≥ 30 kg/m2 ) was modeled against the primary exposure of rural-urban status, as measured by the Index of Relative Rurality. Binary logistic regression models were used to estimate the odds of obesity by rurality both as a continuous variable and by decile of rurality. Models were then stratified by per-capita income and state to assess potential moderation by these factors. The prevalence of obesity in older adults was highest in intermediate rurality areas (OR in rurality decile #5 1.134, 95% CI: 1.086-1.184) and lowest in the most rural and most urban areas. Obesity was highest in low- and middle-income areas, regardless of rural-urban status. In high-income areas, obesity among older adults was highest in areas of intermediate rurality and lowest in the most rural areas (OR 0.726, 95% CI: 0.606-0.870) and more urban areas, showing a J-shaped association. There were substantial differences in the associations between rurality and obesity in older adults among states. Associations between rurality and obesity varied by degree of rurality, socioeconomic status, and geography. Therefore, traditional "one-size-fits-all" approaches to reducing rural-urban health disparities in older adults may be more effective if tailored to the area-specific rural-urban gradients in health.

Long‐term urinary catheter users self‐care practices and problems

To characterise a sample of 202 adult community-living long-term indwelling urinary catheter users, to describe self-care practices and catheter problems, and to explore relationships among demographics, catheter practices and problems. Long-term urinary catheter users have not been well studied, and persons using the device indefinitely for persistent urinary retention are likely to have different patterns of catheter practices and problems. The study was a cross-sectional descriptive and exploratory analysis. Home interviews were conducted with catheter users who provided information by self-reported recall over the previous two months. Data were analysed by descriptive statistics and tests of association between demographics, catheter practices and catheter problems. The sample was widely diverse in age (19-96years), race and medical diagnosis. Urethral catheters were used slightly more often (56%) than suprapubic (44%), for a mean of six years (SD 7years). Many persons were highly disabled, with 60% having difficulty in bathing, dressing, toileting and getting out of the bed; 19% also required assistance in eating. A high percentage of catheter problems were reported with: 43% experiencing leakage (bypassing of urine), 31% having had a urinary tract infection, 24% blockage of the catheter, 23% catheter-associated pain and 12% accidental dislodgment of the catheter. Treatments of catheter-related problems contributed to additional health care utilisation, including extra nurse or clinic visits, trips to the emergency department or hospitalisation. Symptoms of catheter-associated urinary tract infections were most often related to changes in the colour or character of urine or generalised symptoms. Catheter-related problems contribute to excess morbidity and health care utilisation and costs. More research is needed in how to minimise catheter-associated problems in long-term catheter users. Information from this study could help inform the development of interventions in this population.

All-cause health care utilization and costs associated with newly diagnosed multiple sclerosis in the United States.

Multiple sclerosis (MS) is a costly and crippling neurologic disease. Approximately 250,000 to 400,000 persons in the United States are currently diagnosed with MS. Most individuals experience their first symptoms between the ages of 20 and 40 years; therefore, this disease may have substantial impact over many years of life on health, quality of life, productivity, and employment. Whereas a number of studies have utilized a cross-sectional design to evaluate the costs associated with MS, no study has used a large administrative claims database to analyze the direct costs associated with newly diagnosed MS. To estimate the additional health care utilization and costs in otherwise healthy patients with newly diagnosed MS. This was a retrospective cohort analysis of the Medstat MarketScan Commercial Claims and Encounters database, which is composed of medical and pharmacy claims for approximately 8 million beneficiaries from 45 U.S. commercial health plans. Cases extracted from the database included adults aged 18 to 64 years with either (a) at least 2 medical claims with a diagnosis of MS (ICD-9-CM code 340) in any diagnosis field on the claim or (b) 1 prescription (medical or pharmacy) claim for injectable MS drug therapy (interferon beta-1a, interferon beta- 1b, glatiramer acetate) for dates of service between January 1, 2004, and December 31, 2006. Natalizumab was not used to identify MS cases, but was used to exclude potential comparison group subjects. The index date for patients with MS was the first qualifying diagnosis or pharmacy claim. Each MS patient was matched to 5 "healthy comparison" cases without MS diagnoses or treatment using the following variables: region, insurance type, gender, relation to employee, age, and enrollment period. Cases with any condition listed in the Charlson Comorbidity Index were excluded from both the MS and "healthy comparison" cohorts. Each "healthy comparison" case was assigned the index date of the matching MS patient. Continuous enrollment 12 months pre- and post-index was required for both the MS and "healthy comparison" groups. Costs broken down by type of utilization were adjusted to 2010 dollars using the appropriate medical component of the Consumer Price Index. Use of services and costs were compared using chi-square, t-tests, parametric and nonparametric tests. 1,411 MS cases (65.6% female) were matched to 7,055 "healthy comparison" cases (65.6% female). In the analyses of all-cause health care services during the 12-month post-index period, MS patients were significantly more likely to use all categories of health services examined. Compared with the "healthy comparison" group, new MS patients were 3.5 times as likely to be hospitalized (15.2% vs. 4.3% for MS vs. comparison, respectively), twice as likely to have at least 1 emergency room (ER) visit (25.5% vs. 12.2%) and 2.4 times as likely to have at least 1 visit for physical, occupational, or speech therapy (23.7% vs. 9.9%; P < 0.001 for all comparisons). MS patients also had higher mean 12-month costs related to each category of service (inpatient services $4,110 vs. $836; radiology services $1,693 vs. $259; ER $432 vs. $189; office visits $849 vs. $310; therapies $295 vs. $81, respectively; all P values < 0.001). Total mean 12-month all-cause health care costs were significantly higher for MS patients than for the "healthy comparison" group ($18,829 vs. $4,038, respectively, P < 0.001). Claims attributed to MS by diagnosis code in any field on the claim or use of an MS injectable drug accounted for a mean cost of $8,839 (46.9%), and MS injectable drugs accounted for $4,573 (24.3%) of total all-cause health care costs. Newly diagnosed MS patients have significantly higher rates of hospitalizations, radiology services, and ER and outpatient visits compared with non-MS "healthy comparison" patients. MS presents a considerable burden to the U.S. health care system within the first year of diagnosis.

A randomized clinical trial of the effectiveness of mechanical traction for sub-groups of patients with low back pain: study methods and rationale

BackgroundPatients with signs of nerve root irritation represent a sub-group of those with low back pain who are at increased risk of persistent symptoms and progression to costly and invasive management strategies including surgery. A period of non-surgical management is recommended for most patients, but there is little evidence to guide non-surgical decision-making. We conducted a preliminary study examining the effectiveness of a treatment protocol of mechanical traction with extension-oriented activities for patients with low back pain and signs of nerve root irritation. The results suggested this approach may be effective, particularly in a more specific sub-group of patients. The aim of this study will be to examine the effectiveness of treatment that includes traction for patients with low back pain and signs of nerve root irritation, and within the pre-defined sub-group.Methods/DesignThe study will recruit 120 patients with low back pain and signs of nerve root irritation. Patients will be randomized to receive an extension-oriented treatment approach, with or without the addition of mechanical traction. Randomization will be stratified based on the presence of the pre-defined sub-grouping criteria. All patients will receive 12 physical therapy treatment sessions over 6 weeks. Follow-up assessments will occur after 6 weeks, 6 months, and 1 year. The primary outcome will be disability measured with a modified Oswestry questionnaire. Secondary outcomes will include self-reports of low back and leg pain intensity, quality of life, global rating of improvement, additional healthcare utilization, and work absence. Statistical analysis will be based on intention to treat principles and will use linear mixed model analysis to compare treatment groups, and examine the interaction between treatment and sub-grouping status.DiscussionThis trial will provide a methodologically rigorous evaluation of the effectiveness of using traction for patients with low back pain and signs of nerve root irritation, and will examine the validity of a pre-defined sub-grouping hypothesis. The results will provide evidence to inform non-surgical decision-making for these patients.Trial RegistrationThis trial has been registered with http://ClinicalTrials.gov: NCT00942227

Testing minimal clinically important difference: consensus or conundrum?

Background Context Various methodologies have been used in attempting to elucidate a standard method for calculating minimal clinically important difference (MCID). A consensus-based decision (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials [IMMPACT] group) suggested a 30% reduction from baseline as a means to define the MCID of self-report back pain measures. Additionally, important psychometric issues need to be addressed regarding use of an independent measure of the same construct as an external criterion, instead of simply using another self-report measure, when using an anchor-based approach to MCID. Purpose The purpose was to test the validity of recently published guidelines regarding MCID using self-report back pain measures and objective socioeconomic outcomes. Study Design/Setting This is a prospective study assessing change scores on commonly used spinal pain assessment measures in patients with chronic disabling occupational spinal disorders (CDOSDs) treated in a regional referral rehabilitation center performing interdisciplinary functional restoration. Patient Sample The study consisted of consecutive cohort of patients (N=1,180) with CDOSDs completing a functional restoration program. Outcomes Measures Self-report measures including the Oswestry Disability Index (ODI) and the physical component summary (PCS) and mental component summary (MCS) of the Short Form-36 (SF-36) obtained before and after treatment, were compared with objective socioeconomically relevant outcomes obtained 1 year after treatment (ie, work status and additional health-care utilization), that were the external criteria for evaluating MCID. Methods Pre- to posttreatment improvement was calculated separately for each measure, and subjects were divided into two groups based on the change in scores relative to baseline: 30% or greater versus less than 30% improvement. One-year posttreatment objective socioeconomic outcomes were used as independent external criteria relevant to the CDOSD population. This population is often studied as the most costly and problematic cohort in spine care. Results The ODI and SF-36 MCS were not associated with any of the objective 1-year outcomes used as external criteria. Reduced post-rehabilitation health-care utilization (based on the percentage of patients pursuing health care from a new provider) was weakly associated with 30% or greater improvement on the SF-36 PCS, relative to patients whose scores changed by less than 30% relative to baseline (17.0% vs. 21.1%). The same was true for the ODI and return-to-work. Conclusions When objective and independent criteria are used (socioeconomic outcomes) in a CDOSD cohort, the 30% improvement in the ODI and SF-36 may not be a valid MCID index. This replicates similar conclusions made by an independent research group using a distribution-based approach to MCID. The validity of the MCID concept rests on future research using objective external criteria. Moreover, there remains a question whether the term “important” in MCID can be unequivocally and operationally defined as a reliable construct.