Pen needle use patterns in an insured population with diabetes: US retrospective claims analysis.

BACKGROUND: People with diabetes who inject insulin with pen devices may reuse the pen needles (PNs), a practice that can cause PN tip deformity, breakage, and contamination, and that is associated with lipohypertrophy and injection-related pain. OBJECTIVE: This retrospective study aimed to estimate the extent of PN reuse among people with diabetes in two insured populations in the United States. METHODS: Using claims data for Commercial Fully Insured (CFI) and Medicare Advantage (MA) populations from 1-Oct-2018 to 31-Dec-2022, we identified adults with type 1 or type 2 diabetes (T1D/T2D) who had ≥1 claim for PNs and ≥2 claims for insulin from 1-Jan-2019 to 31-Dec-2021, with continuous medical/pharmacy eligibility for 3 months before first claim and 1 year after (follow-up). Those receiving hospice or palliative care or using mail-order prescriptions were excluded. We compared actual annual fill rate of PNs with expected fill rate (assuming single use) according to prescribed insulin regimen. Whether the annual actual-to-expected ratio for PN numbers equaled 1 was evaluated using sign tests with 2-sided p-values. RESULTS: Median annual actual-to-expected ratios ranged from 0.41 (T1D basal+prandial cohort) to 0.82 (T2D basal cohort; all p<0.001) in the CFI population (N=10,854), and from 0.55 (TID basal+prandial) to 1.10 (T2D basal and basal+prandial; p=0.382 to <0.001) in the MA population (N=32,495); medians were 0.34 and 0.55 for four expected T2D basal+prandial injections/day in CFI and MA populations, respectively (p<0.001). Annual actual-to-expected ratios were <1 for 62% and 47% of CFI and MA populations, respectively. An estimated 2-27% and 0-17%, respectively, depending on insulin regimen, had inadequate supplies of PNs suggesting that PNs could have been used ≥5 times. CONCLUSIONS: These findings highlight the need for educating people with diabetes about reasons for avoiding PN reuse and the key role that pharmacists can play in providing this information and adequate supplies of PNs.

The surgical treatment of subaxial acute cervical spine facet dislocations in adults: a systematic review and meta-analysis.

Adult cervical spine traumatic facet joint dislocations occur when excessive traumatic forces displace the vertebrae's facets, leading to loss of joint congruence. Reduction requires either cranial traction or open surgical procedures. This study aims to appraise the effects of different surgical techniques in the treatment of subaxial cervical spine acute traumatic facet blocks in adults. This study was based on a systematic literature review and meta-analysis, registered in Prospero (CRD42021279249). The PICO question was composed of adults with acute cervical spine traumatic facet dislocations submitted to anterior or posterior surgical approaches, associated or not with cranial traction for reduction. Each surgical technique was compared to the other. The primary clinical outcomes included neurological improvement or worsening and surgical success/failure rates. The anterior approach without cranial traction was efficient in reducing facet displacements. Skull traction was an efficient and immediate method to achieve spine dislocation reductions. Differences were not present among techniques regarding neurological improvement. There were no surgical failures in patients operated on via the posterior approach. The need to decompress and stabilize the cervical spine can be achieved by anterior or posterior surgical approaches, and there is no clear answer as to which initial approach is superior to the other.

Impact of Direct to Consumer Store-and-Forward Teledermatology on Access to Care, Satisfaction, Utilization, and Costs in a Commercial Health Plan Population.

PURPOSE: Store-and-forward teledermatology can improve access to dermatology by enabling asynchronous consults. This study assesses it on access, satisfaction, utilization, and costs in a commercial health plan setting. METHODOLOGY: In this prospective observational study with matched control, 47,411 individuals were provided access to teledermatology services staffed by board-certified, licensed dermatologists for 6 months. Two hundred forty-three individuals used the service. One hundred fifty-two participants successfully matched to similar users of in-person services for comparison. Average number of dermatology-related visits and dermatology-related costs in 30, 60, and 90 days postvisit, most frequent diagnoses, time to consult, patient satisfaction, and number of procedures were measured. RESULTS: Average time to consult for the teledermatology group was 16.31 h. Patient satisfaction was 4.38/5. Total dermatology utilization in the postvisit period for the teledermatology and the control groups respectively was 9 and 21 visits at 30 days (p = 0.074), 15 and 46 visits at 60 days (p = 0.005), and 26 and 74 at 90 days (p = 0.001). The dermatology-related spend for the teledermatology and control groups, respectively, was $59 and $113 on the day of the initial consult (p < 0.01), $70 and $202 for 30 days (p = 0.03), $78 and $ 221 for 60 days (p = 0.02), and $86 and $307 for 90 days (p = 0.08) following initial visit. Total number of procedures conducted in the control group at the index visit was 26. In the postvisit period, the total number of procedures in the study and control groups, respectively, were 5 and 15 at 30 days (p = 0.053), 10 and 26 at 60 days (p = 0.088), and 14 and 32 at 90 days (p = 0.082). CONCLUSIONS: Teledermatology services are accessible within hours and associated with high patient satisfaction. There is no evident increased utilization or costs postvisit.

Full coverage for preventive medications after myocardial infarction.

BACKGROUND: Adherence to medications that are prescribed after myocardial infarction is poor. Eliminating out-of-pocket costs may increase adherence and improve outcomes. METHODS: We enrolled patients discharged after myocardial infarction and randomly assigned their insurance-plan sponsors to full prescription coverage (1494 plan sponsors with 2845 patients) or usual prescription coverage (1486 plan sponsors with 3010 patients) for all statins, beta-blockers, angiotensin-converting-enzyme inhibitors, or angiotensin-receptor blockers. The primary outcome was the first major vascular event or revascularization. Secondary outcomes were rates of medication adherence, total major vascular events or revascularization, the first major vascular event, and health expenditures. RESULTS: Rates of adherence ranged from 35.9 to 49.0% in the usual-coverage group and were 4 to 6 percentage points higher in the full-coverage group (P<0.001 for all comparisons). There was no significant between-group difference in the primary outcome (17.6 per 100 person-years in the full-coverage group vs. 18.8 in the usual-coverage group; hazard ratio, 0.93; 95% confidence interval [CI], 0.82 to 1.04; P=0.21). The rates of total major vascular events or revascularization were significantly reduced in the full-coverage group (21.5 vs. 23.3; hazard ratio, 0.89; 95% CI, 0.90 to 0.99; P=0.03), as was the rate of the first major vascular event (11.0 vs. 12.8; hazard ratio, 0.86; 95% CI, 0.74 to 0.99; P=0.03). The elimination of copayments did not increase total spending ($66,008 for the full-coverage group and $71,778 for the usual-coverage group; relative spending, 0.89; 95% CI, 0.50 to 1.56; P=0.68). Patient costs were reduced for drugs and other services (relative spending, 0.74; 95% CI, 0.68 to 0.80; P<0.001). CONCLUSIONS: The elimination of copayments for drugs prescribed after myocardial infarction did not significantly reduce rates of the trial's primary outcome. Enhanced prescription coverage improved medication adherence and rates of first major vascular events and decreased patient spending without increasing overall health costs. (Funded by Aetna and the Commonwealth Fund; MI FREEE ClinicalTrials.gov number, NCT00566774.).

Multimorbidity in Atherosclerotic Cardiovascular Disease and Its Associations With Adverse Cardiovascular Events and Healthcare Costs: A Real-World Evidence Study.

Background: Atherosclerotic cardiovascular disease (ASCVD) remains the leading cause of mortality and disability in the United States and worldwide. Objective: To assess the multimorbidity burden and its associations with adverse cardiovascular events (ACE) and healthcare costs among patients with ASCVD. Methods: This is a retrospective observational cohort study using Aetna claims database. Patients with ASCVD were identified during the study period (1/1/2018-10/31/2021). The earliest ASCVD diagnosis date was identified as the index date. Qualified patients were ≥18 years of age and had ≥12 months of health plan enrollment before and after the index date. Comorbid conditions were assessed using all data available within 12 months prior to and including the index date. Association rule mining was applied to identify comorbid condition combinations. ACEs and healthcare costs were assessed using all data within 12 months after the index date. Multivariable generalized linear models were performed to examine the associations between multimorbidity and ACEs and healthcare costs. Results: Of 223 923 patients with ASCVD (mean [SD] age, 73.6 [10.7] years; 42.2% female), 98.5% had ≥2, and 80.2% had ≥5 comorbid conditions. The most common comorbid condition dyad was hypertension-hyperlipidemia (78.7%). The most common triad was hypertension-hyperlipidemia-pain disorders (61.1%). The most common quartet was hypertension-hyperlipidemia-pain disorders-diabetes (30.2%). The most common quintet was hypertension-hyperlipidemia-pain disorders-diabetes-obesity (16%). The most common sextet was hypertension-hyperlipidemia-pain disorders-diabetes-obesity-osteoarthritis (7.6%). The mean [SD] number of comorbid conditions was 7.1 [3.2]. The multimorbidity burden tended to increase in older age groups and was comparatively higher in females and in those with higher social vulnerability. The increased number of comorbid conditions was significantly associated with increased ACEs and increased healthcare costs. Discussion: Extremely prevalent multimorbidity should be considered in the context of clinical decision-making to optimize secondary prevention of ASCVD. Conclusions: Multimorbidity was extremely prevalent among patients with ASCVD. Multimorbidity patterns varied considerably across ASCVD patients and by age, gender, and social vulnerability status. Multimorbidity was strongly associated with ACEs and healthcare costs.

Comparative Effectiveness of Transcutaneous Afferent Patterned Stimulation Therapy for Essential Tremor: A Randomized Pragmatic Clinical Trial.

Background: Transcutaneous afferent patterned stimulation (TAPS) is a wrist-worn, non-invasive therapy delivering calibrated stimulation to the median and radial nerves. Previous randomized controlled studies have demonstrated the efficacy and safety of TAPS therapy in some patients with essential tremor (ET), but evidence supporting therapeutic benefits of TAPS versus standard of care (SOC) is lacking. This randomized prospective study evaluated the clinical benefit of adding TAPS treatment to SOC versus SOC alone. Methods: This randomized pragmatic trial recruited patients from a large health plan's Commercially Insured and Medicare Advantage population. All 310 patients received a TAPS device and were randomized 1:1 to either one month adding TAPS therapy to usual care (TX arm) or usual care with tremor assessment only (SOC arm). The pre-specified endpoints were changes in tremor power measured by motion sensors on the device (primary) and improvement in Bain & Findley Activities of Daily Living (BF-ADL) upper limb scores (secondary) between TX and SOC in all patients who completed the one-month study. Results: 276 patients completed the one-month study (N = 133 TX, N = 143 SOC). The study met the primary and secondary endpoints, with significantly reduced tremor power in TX compared with SOC (0.017 (0.003) versus 0.08 (0.014) (m/s2)2; geometric mean (SE); p < 0.0001) and greater improvement in the BF-ADL score in TX than SOC (1.6 (0.43) vs 0.2 (0.37) points; mean (SE); p < 0.05). No serious device-related adverse events were reported. Discussion: This trial demonstrates that adding TAPS treatment to SOC significantly improves tremor power and BF-ADLs in patients with ET compared to SOC alone over one month of home use. Highlights: This study found that adding TAPS treatment to SOC significantly improves tremor power and BF-ADL scores in patients with ET compared to SOC alone over one month of home use. This real-world evidence study suggests that non-invasive TAPS therapy is a safe and valuable treatment option for patients with ET.

The incidence of gastrointestinal perforations among rheumatoid arthritis patients.

OBJECTIVE: Gastrointestinal (GI) perforation has emerged as a novel safety concern in relation to medications used to treat rheumatoid arthritis (RA). This study was undertaken to characterize the incidence and risk factors for GI perforation in RA patients. METHODS: Using administrative databases of a large US health plan, we identified RA patients treated with biologic agents, methotrexate (MTX), oral glucocorticoids, and nonsteroidal antiinflammatory drugs (NSAIDs). Additional risk factors we evaluated included diverticulitis. Hospitalization with GI perforation was identified using a validated algorithm. Incidence rates and risk factors were evaluated using Cox proportional hazards models. RESULTS: Among 40,841 RA patients, 37 hospitalizations with GI perforation were identified. The rate of GI perforation among patients currently being treated with biologic agents who were also receiving oral glucocorticoids was higher (1.12 per 1,000 person-years [95% confidence interval (95% CI) 0.50-2.49]) than for patients being treated with biologic agents who were not also receiving glucocorticoids (0.47 per 1,000 person-years [95% CI 0.22-0.98]) or for patients being treated with MTX who were also receiving glucocorticoids (0.87 per 1,000 person-years [95% CI 0.36-2.10]). Neither biologic agents nor MTX was significantly associated with GI perforation, in contrast to current treatment with glucocorticoids and NSAIDs together (hazard ratio 4.7 [95% CI 1.9-12.0]) or glucocorticoids alone (hazard ratio 2.8 [95% CI 1.3-6.1]). Diverticulitis also was a strong risk factor (hazard ratio 9.1 [95% CI 3.1-26.4]). Seventy percent of patients with GI perforation received glucocorticoids, had antecedent diverticulitis, or both. CONCLUSION: GI perforation is an uncommon but serious adverse event among RA patients. Because a majority of patients with GI perforation were being treated with glucocorticoids or had previously experienced diverticulitis, these individuals should be considered at higher risk.

Multiple Comorbidities, Psychiatric Disorders, Healthcare Resource Utilization and Costs Among Adults with Essential Tremor: A Retrospective Observational Study in a Large US Commercially Insured and Medicare Advantage Population.

Background: Essential tremor (ET), the most common movement disorder, often impairs patients' ability to perform activities of daily living, mental health, and quality of life. Objectives: To assess comorbidities, psychiatric disorders, healthcare resource utilization (HCRU), and costs among patients with ET compared with patients without ET. Methods: This retrospective observational study was conducted using a large US administrative claims database. Patients with ET were identified during the study period (1/1/2017-12/31/2019). The earliest claim date with ET diagnosis was identified as the index date. An index date was assigned randomly for each non-ET patient. Patients had to be at least 22 years old and be enrolled in the health plan for at least 6 months before and at least 12 months after the index date. Patients with and those without ET were matched 1:1 on age, gender, payer type, and first 3 digits of their ZIP code. Comorbidities were assessed using data within 6 months prior to the index date. Psychiatric disorders, HCRU, and costs were examined using data within 12 months after the index date. Results: The mean (SD) age of ET patients (n = 5286) was 70.8 (11.8) years, 49.1% were female, and 82.9% were Medicare Advantage members. In the 12 months following the index date, 26.0% of patients had no insurance claims for ET-related pharmacotherapy or invasive therapies. Patients with ET had a higher number of comorbidities than non-ET patients (5.3 [3.2] vs 4.0 [3.3]); a higher prevalence of psychiatric disorders (depression: 25.6% vs 15.3%; adjusted odds ratio (AOR) [95% CI], 1.56 [1.41-1.73]; anxiety: 27.7% vs 15.5%, AOR: 1.78 [1.61-1.96]); and higher total healthcare costs: $17 560 [$39 972] vs $13 237 [$27 098], adjusted cost ratio [95% CI]: 1.11 [1.06-1.16]; all P<.0001. Discussion: Highly prevalent multiple comorbidities and psychiatric disorders should be considered in the context of clinical decision-making to optimize ET management. Conclusions: This study represents the largest observational study to report ET disease and economic burdens in a real-world setting. The data demonstrate increased comorbidity, mental health, and healthcare cost burdens among ET patients compared with matched non-ET patients. These findings underscore the need for innovative care for this complex population.

Efficacy and Complications of Subcutaneous versus Conventional Cardioverter Defibrillators: A Systematic Review and Meta-analysis.

BACKGROUND/OBJECTIVES: Implantable cardioverter defibrillators are used to prevent sudden cardiac death. The subcutaneous implantable cardioverter-defibrillator was newly developed to overcome the limitations of the conventional implantable cardioverter defibrillator-transvenous device. The subcutaneous implantable cardioverter defibrillator is indicated for young patients with heart disease, congenital heart defects, and poor venous access, who have an indication for implantable cardioverter defibrillator without the need for anti-bradycardic stimulation. We aimed to compare the efficacy and complications of subcutaneous with transvenous implantable cardioverter- defibrillator devices. METHODOLOGY: A systematic review was conducted using different databases. The inclusion criteria were observational and clinical randomized trials with no language limits and no publication date limit that compared subcutaneous with transvenous implantable cardioverter-defibrillators. The selected patients were aged > 18 years with complex ventricular arrhythmia. RESULTS: Five studies involving 2111 patients who underwent implantable cardioverter defibrillator implantation were included. The most frequent complication in the subcutaneous device group was infection, followed by hematoma formation and electrode migration. For the transvenous device, the most frequent complications were electrode migration and infection. Regarding efficacy, the total rates of appropriate shocks were 9.04% and 20.47% in the subcutaneous and transvenous device groups, respectively, whereas inappropriate shocks to the subcutaneous and transvenous device groups were 11,3% and 10,7%, respectively. CONCLUSION: When compared to the transvenous device, the subcutaneous device had lower complication rates owing to lead migration and less inappropriate shocks due to supraventricular tachycardia; nevertheless, infection rates and improper shocks due to T wave oversensing were comparable for both devices CRD42021251569.

The comparative risk of serious infections among rheumatoid arthritis patients starting or switching biological agents.

BACKGROUND: It is unclear whether anti-tumour necrosis factor alpha and biological agents with different mechanisms of action have similar safety. This study evaluated the incidence of hospitalised infections among rheumatoid arthritis (RA) patients starting or switching various biological agents. METHODS: Using a database from a large US healthcare organisation from January 2005 to August 2009, the authors identified enrollees with RA and their treatment episodes entailing the new use of a biological agent, stratified by no biological use in the previous year ('biological-free') or switching from a different biological agent ('switchers'). Outcomes were hospitalised infections identified using previously validated algorithms. Proportional hazards models estimated the hazard ratio of hospitalised infections, comparing each biological agent with infliximab. RESULTS: Among 7847 biological treatment episodes, 63% were for biological-free patients and 37% for switchers. There were 364 hospitalised infections. Rates of hospitalised infection among biological-free patients and switchers were 4.6 and 7.0 per 100 person-years, respectively (p<0.0001). After multivariable adjustment controlling for biological-free/switcher status and other infection-related factors and compared with infliximab, users of abatacept (HR 0.68, 95% CI 0.48 to 0.96), adalimumab (HR 0.52, 0.39 to 0.71), etanercept (HR 0.64, 0.49 to 0.84) and rituximab (HR 0.81, 0.55 to 1.20) had lower rates of hospitalised infection. Patient risk factors contributed more to the risk of infection than did the risk associated with specific biological therapies. CONCLUSION: The rate of hospitalised infections among RA patients was highest for infliximab. Most of the variability in patients' risk of infection was driven by factors other than biological agent exposure.

Health-Related Quality of Life in Elderly Patients with Pacemakers.

INTRODUCTION: Cardiac pacemaker (PM) therapy is of paramount importance. PM use increases with age, with an estimated increased use of 70% to 80% in patients over 65 years. This study evaluated the perception of the health-related quality of life (HRQoL) of elderly patients with PM, comparing them with patients without PM, by applying two quality of life questionnaires: EuroQoL 5-dimensions (EQ-5D) and 36-Item Short Form Health Survey (SF-36). METHODS: This study included elderly patients divided into a group with PM and another without PM. Information on HRQoL was obtained using the EQ-5D and SF-36 questionnaires. RESULTS: The study involved 104 elderly patients with PM and 150 without PM. The distribution of responses to the EQ-5D was similar between groups. Statistical differences within the gender variable in the group of elderly people with PM were significant for the mobility, habitual activities, and anxiety/depression domains and for the average EQoL utility score and visual analogue scale (EQ-VAS). Elderly patients with PM presented significant differences between New York Heart Association classes 1 and 2 for the mobility domain and EQ-VAS, while those evaluated through SF-36 presented higher averages in vitality, general health status, and pain. However, a different analysis was observed in the physical aspect domain. CONCLUSION: The SF-36 demonstrated that elderly patients with PM had an HRQoL similar to or greater than those without PM. However, the results of the EQ-5D did not show significant differences regarding the implantation of PM and HRQoL between the two groups of elderly individuals in the study.

Effectiveness of multipoint cardiac resynchronizing therapy in heart failure: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Cardiac resynchronization therapy is an important validated technique for patients with dyssynchrony and heart failure. However, the response rate to conventional resynchronization is approximately 50%; therefore, new techniques and schedules have emerged. This study aimed to evaluate the different clinical and echocardiographic variables of conventional versus multipoint cardiac resynchronization therapy. RESEARCH DESIGN AND METHOD: A systematic review was conducted of randomized clinical trials in the PubMed, Cochrane, and Embase databases on cardiac resynchronization intervention with multipoint stimulation clinical and echocardiographic outcomes evaluated before and 3 months after the intervention. RESULTS: Three studies (N = 139) were ultimately selected, and 100% of patients had a New York Heart Association functional class of II-IV, QRS > 120 ms, and a left ventricular ejection fraction < 35%. Significantly greater improvement was observed in the functional class of patients who underwent multipoint versus conventional therapy. The final systolic volume and ejection fraction improved in the multipoint group, but the difference was not statistically significant. CONCLUSIONS: The literature lacks sufficient randomized controlled studies to enable conclusions regarding cardiac resynchronization therapy responses using different strategies. Moreover, the improvement in functional class in the multipoint pacing group involved few patients and had slight statistical relevance.

Single-Position Surgery versus Lateral-Then-Prone-Position Circumferential Lumbar Interbody Fusion: A Systematic Literature Review.

OBJECTIVE: We sought to compare the outcomes of single-position (SP) circumferential lumbar interbody fusion in lateral decubitus versus dual-position (DP) fusion. METHODS: A systematic literature review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines in PubMed, Web of Science, and Scopus databases to identify comparative studies reporting the outcomes of SP lumbar interbody fusion versus DP. For risk of bias assessment, the ROBINS-I (risk of bias in nonrandomized studies of interventions) tool was used. RESULTS: Four comparative studies were included from an initial search of 3780 papers. All 4 studies were retrospective cohort studies comparing outcomes of SP versus DP LLIF. A total of 349 patients were operated using SP versus 254 using DP. All studies involved reported operating time, estimated blood loss, length of stay, change in segmental lordosis, and complications. From a general perspective, baseline variables were similar in both groups in all the studies and all reported a significant decrease in operative time and length of stays with SP. CONCLUSIONS: Literature comparing SP versus lateral-then-prone lumbar fusion shows a tendency toward shorter operating time and hospital stays in SP lumbar fusion while maintaining similar perioperative outcomes.

Vertebral body chondrosarcoma with metastasis to the scalp.

We present a case of a 30-year-old man who had a 3-year history of low back pain. MRI demonstrated an infiltrative mass, affecting the vertebral body and pedicles of L4, with some extension to the vertebral canal. There was also tumor invasion in the inferior vena cava and in the left iliopsoas muscle. The anatomopathological examination of the resected L4 vertebral body was of a malignant neoplasia compatible with mesenchymal chondrosarcoma (high histological grade). About 2 months after surgery, he developed a progressive bladder incontinence, bilateral leg weakness and severe back pain. A new MRI was obtained, confirming progression of the disease. An occipital scalp lesion was detected and biopsy confirmed cutaneous metastasis. Primary malignant bone tumors are rare but should be ruled out in young patients with persistent low back pain. We present a case of a confirmed mesenchymal chondrosarcoma affecting lumbar spine, with MRI and pathological illustrations. Early diagnosis may improve the chances of local disease control and even cure.

New Genotypes of Coxiella burnetii Circulating in Brazil and Argentina.

Coxiella burnetii, the zoonotic agent of Q fever, has a worldwide distribution. Despite the vast information about the circulating genotypes in Europe and North America, there is a lack of data regarding C. burnetii strains in South America. Here, we show the presence of novel multispacer sequence typing (MST) genotypes of C. burnetii in two clusters detected in Brazil and Argentina that seem to be distant in parenthood. Argentinian strains isolated from a tick belongs to a new phylogenetic branch of C. burnetii, and the Brazilians strains may be related to MST 20 and 61. Multilocus variable number tandem repeats analysis (MLVA) typing provided a deeper resolution that may be related to host clusters of bovines, caprine, ovine, and ticks. Our results corroborate with the reports of geotypes of C. burnetii. Thus, we highlight the need for more genotyping studies to understand the genetic diversity of C. burnetii in South America and to confirm the hypothesis of host-related genotypes. We also emphasize the importance of virulence studies for a better understanding of Q fever in the region, which may help in surveillance and disease prevention programs.

Rationale and design of the Post-MI FREEE trial: a randomized evaluation of first-dollar drug coverage for post-myocardial infarction secondary preventive therapies.

BACKGROUND: Medication nonadherence is a major public health problem, especially for patients with coronary artery disease. The cost of prescription drugs is a central reason for nonadherence, even for patients with drug insurance. Removing patient out-of-pocket drug costs may increase adherence, improve clinical outcomes, and even reduce overall health costs for high-risk patients. The existing data are inadequate to assess whether this strategy is effective. TRIAL DESIGN: The Post-Myocardial Infarction Free Rx and Economic Evaluation (Post-MI FREEE) trial aims to evaluate the effect of providing full prescription drug coverage (ie, no copays, coinsurance, or deductibles) for statins, beta-blockers, angiotensin-converting enzyme inhibitors, and angiotensin II receptor blockers to patients after being recently discharged from the hospital. Potentially eligible patients will be those individuals who receive their health and pharmacy benefits through Aetna, Inc. Patients enrolled in a Health Savings Account plan, who are > or =65 years of age, whose plan sponsor (ie, the employer, union, government, or association that sponsors the particular benefits package) has opted out of participating in the study, and who do not receive both medical services and pharmacy coverage through Aetna will be excluded. The plan sponsor of each eligible patient will be block randomized to either full drug coverage or current levels of pharmacy benefit, and all subsequently eligible patients of that same plan sponsor will be assigned to the same benefits group. The primary outcome of the trial is a composite clinical outcome of readmission for acute MI, unstable angina, stroke, congestive heart failure, revascularization, or inhospital cardiovascular death. Secondary outcomes include medication adherence and health care costs. All patients will be followed up for a minimum of 1 year. CONCLUSION: The Post-MI FREEE trial will be the first randomized study to evaluate the impact of reducing cost-sharing for essential cardiac medications in high-risk patients on clinical and economic outcomes.

Health-Related Quality of Life in Elderly Patients with Pacemakers

Abstract Introduction: Cardiac pacemaker (PM) therapy is of paramount importance. PM use increases with age, with an estimated increased use of 70% to 80% in patients over 65 years. This study evaluated the perception of the health-related quality of life (HRQoL) of elderly patients with PM, comparing them with patients without PM, by applying two quality of life questionnaires: EuroQoL 5-dimensions (EQ-5D) and 36-Item Short Form Health Survey (SF-36). Methods: This study included elderly patients divided into a group with PM and another without PM. Information on HRQoL was obtained using the EQ-5D and SF-36 questionnaires. Results: The study involved 104 elderly patients with PM and 150 without PM. The distribution of responses to the EQ-5D was similar between groups. Statistical differences within the gender variable in the group of elderly people with PM were significant for the mobility, habitual activities, and anxiety/depression domains and for the average EQoL utility score and visual analogue scale (EQ-VAS). Elderly patients with PM presented significant differences between New York Heart Association classes 1 and 2 for the mobility domain and EQ-VAS, while those evaluated through SF-36 presented higher averages in vitality, general health status, and pain. However, a different analysis was observed in the physical aspect domain. Conclusion: The SF-36 demonstrated that elderly patients with PM had an HRQoL similar to or greater than those without PM. However, the results of the EQ-5D did not show significant differences regarding the implantation of PM and HRQoL between the two groups of elderly individuals in the study.

Effectiveness of tegaserod therapy on GI-related resource utilization in a managed care population.

This study sought to determine the real-world effectiveness of tegaserod therapy on gastrointestinal (GI)-related resource utilization in a managed care population with a retrospective, longitudinal pre-/post-parallel cohort study of tegaserod users and a matched reference cohort of tegaserod nonusers through medical and pharmacy claims data from a large, geographically diverse, managed care organization. Continuously enrolled benefit-eligible patients newly initiated on tegaserod therapy (index prescription) were identified between August 1, 2002, and June 30, 2003, and were categorized (using International Statistical Classification of Diseases, 9th Revision, Clinical Modification codes) as having irritable bowel syndrome (IBS) or another GI-related disorder (e.g., gastroesophageal reflux disease). GI-related resource utilization (office visits, hospitalizations, emergency department visits, endoscopic and nonendoscopic procedures, and GI drug prescriptions) was determined for the 6-month period before and after the index prescription date for tegaserod users and nonusers. The study population consisted of 3365 tegaserod users and 3364 matched nonusers. Within-cohort differences before and after therapy were tested using the Wilcoxon signed rank test. The mean age of 3365 tegaserod users and 3364 matched nonusers was 47 years (+/-15 years); 92% were women, 47% had an index diagnosis of IBS, and 53% had an index diagnosis of another GI-related disorder. Within-cohort GI resource utilization comparisons before and after therapy initiation showed significant decreases (P < .01) in all utilization categories, except GI drug prescriptions, for tegaserod users; these decreases were not consistently observed for matched nonusers. Tegaserod use appeared to be associated with consistent decreases in GI-related resource utilization after 6 months of therapy; similarly consistent reductions were not observed in tegaserod nonusers. These early findings suggest that tegaserod may provide important clinical and economic benefits.

Spinal Cord Injuries ­ When Is the Initial Tomography Insufficient?

Introduction Spinal cord injury (SCI) is common in polytrauma patients. The standard exam for the initial evaluation is computed tomography (CT), due to its higher sensitivity and specificity when compared with plain radiographs. However, CT is insufficient for themanagement of some cases, especially to evaluate ligamentous and spinal cord injuries. The objective of the present study is to describe clinical scenarios in which the CT scan was insufficient to guide the treatment of SCIs. Methods We present the cases of four polytrauma patients with normal CT scans at admission and with unstable or surgically-treated lesions. Discussion The cases reported evidence the need for ongoing neurological surveillance with serial physical examination and magnetic resonance imaging (MRI) in cases of neurological injury not explained by CT or occult instability. Conclusion Computed tomography is not always sufficient to determine the management of SCIs. A comprehensive evaluation of the clinical data, CT findings and, occasionally, MRI findings is crucial in order to choose the best conduct.

Terminology and Legislation referring to Percutaneous Facet Procedures to Treat Low Back Pain in Brazil ­ Current Status

Incongruities in the terminology and in the Brazilian legislation about percutaneous facet procedures (PFPs) for the treatment of chronic lower back pain are frequently the subject of litigations between health professionals and supplementary healthcare providers. The Brazilian Hierarchical Classification of Medical Procedures (CBHPM, in the Portuguese acronym) describes four types of PFPs, while the Brazilian Unified Supplementary Health Terminology (TUSS, in the Portuguese acronym) describes five distinct lumbar PFPs, which correlate with the ones described on the List of Procedures and Events in Health, created by the Brazilian National Agency of Supplementary Health (ANS, in the Portuguese acronym). In the present paper, we review the terminology of the procedures, proposing the unification of the terminology and the abolition of redundancies in the tables. Finally, we developed a single terminology proposal for the PFPs based on their complexity and objectives to be used for the treatment of lower back pain.