Identification of a HIV-1 circulating BF1 recombinant form (CRF75_BF1) of Brazilian origin that also circulates in Southwestern Europe.

Introduction: The high recombinogenic potential of HIV-1 has resulted in the generation of countless unique recombinant forms (URFs) and around 120 reported circulating recombinant forms (CRFs). Here we identify through analyses of near full-length genomes (NFLG) a new HIV-1 CRF derived from subtypes B and F1. Methods: HIV-1 protease-reverse transcriptase (Pr-RT) sequences were obtained by RT-PCR amplification from plasma RNA. Near full-length genome sequences were obtained after amplification by RT-PCR in 5 overlapping fragments. Phylogenetic sequence analyses were performed via maximum likelihood. Mosaic structures were analyzed by bootscanning and phylogenetic analyses of genome segments. Temporal and geographical estimations of clade emergence were performed with a Bayesian coalescent method. Results: Through phylogenetic analyses of HIV-1 Pr-RT sequences obtained by us from samples collected in Spain and downloaded from databases, we identified a BF1 recombinant cluster segregating from previously reported CRFs comprising 52 viruses, most from Brazil (n = 26), Spain (n = 11), and Italy (n = 9). The analyses of NFLG genomes of 4 viruses of the cluster, 2 from Spain and 2 from Italy, allowed to identify a new CRF, designated CRF75_BF1, which exhibits a complex mosaic structure with 20 breakpoints. All 4 patients harboring CRF75_BF1 viruses studied by us had CD4+ T-cell lymphocyte counts below 220/mm3 less than one year after diagnosis, a proportion significantly higher (p = 0.0074) than the 29% found in other patients studied in Spain by us during the same period. The origin of the clade comprising CRF75_BF1 and related viruses was estimated around 1984 in Brazil, with subsequent introduction of CRF75_BF1 in Italy around 1992, and migration from Italy to Spain around 1999. Conclusion: A new HIV-1 CRF, designated CRF75_BF1, has been identified. CRF75_BF1 is the 6th CRF of South American origin initially identified in Western Europe, reflecting the increasing relationship of South American and European HIV-1 epidemics. The finding of low CD4+ T-cell lymphocyte counts early after diagnosis in patients harboring CRF75_BF1 viruses warrants further investigation on the virulence of this variant.

Factors associated with HIV-1 resistance to integrase strand transfer inhibitors in Spain: Implications for dolutegravir-containing regimens.

Integrase strand transfer inhibitor (INSTI)-containing regimens in HIV-1-infected patients have experienced a global increase. Recently, WHO has emphasized the need to fast-track the transition to dolutegravir (DTG)-based antiretroviral (ARV) treatments. However, continued surveillance of INSTI resistance is recommended. In this study, clinical, epidemiological, and virological features associated with INSTI resistance diagnosed in Spain were analyzed. Samples collected between 2008 and 2021 from HIV-1-infected patients were analyzed in integrase, protease, and reverse transcriptase using Sanger population sequencing. ARV drug resistance was evaluated with the Stanford University HIVdb program. Among 2,696 patients, 174 (6.5%) had INSTI resistance, all of them to first-generation INSTIs, and 71 (2.6%) had also resistance to second-generation INSTIs. Of these, only 5 individuals were exposed to DTG as the only INSTI, in whom resistance development was associated with poor treatment adherence and/or resistance to other ARV classes. Of newly HIV-1-diagnosed individuals, 0.92% harbored INSTI-resistant viruses, with low prevalences maintained along time, and only one had low-level resistance to DTG. Persons who inject drugs, age over 39 years, resistance to other ARV classes, and longer time from diagnosis were associated with INSTI resistance (p < 0.001). Non-subtype B INSTI-resistant viruses lacked the Q148H + G140S resistance pathway and showed lower INSTI resistance levels than subtype B viruses. In conclusion, INSTI resistance is uncommon and associated with long-term infections, older age and additional resistance to other ARV drug classes, and is rare in newly diagnosed HIV-1 infections. Our results also support the preferential use of DTG-containing regimens in first-line treatments, although surveillance of INSTI resistance is encouraged.

Identification of CRF66_BF, a New HIV-1 Circulating Recombinant Form of South American Origin.

Circulating recombinant forms (CRFs) are important components of the HIV-1 pandemic. Among 110 reported in the literature, 17 are BF1 intersubtype recombinant, most of which are of South American origin. Among these, all 5 identified in the Southern Cone and neighboring countries, except Brazil, derive from a common recombinant ancestor related to CRF12_BF, which circulates widely in Argentina, as deduced from coincident breakpoints and clustering in phylogenetic trees. In a HIV-1 molecular epidemiological study in Spain, we identified a phylogenetic cluster of 20 samples from 3 separate regions which were of F1 subsubtype, related to the Brazilian strain, in protease-reverse transcriptase (Pr-RT) and of subtype B in integrase. Remarkably, 14 individuals from this cluster (designated BF9) were Paraguayans and only 4 were native Spaniards. HIV-1 transmission was predominantly heterosexual, except for a subcluster of 6 individuals, 5 of which were men who have sex with men. Ten additional database sequences, from Argentina (n = 4), Spain (n = 3), Paraguay (n = 1), Brazil (n = 1), and Italy (n = 1), branched within the BF9 cluster. To determine whether it represents a new CRF, near full-length genome (NFLG) sequences were obtained for 6 viruses from 3 Spanish regions. Bootscan analyses showed a coincident BF1 recombinant structure, with 5 breakpoints, located in p17 gag , integrase, gp120, gp41-rev overlap, and nef, which was identical to that of two BF1 recombinant viruses from Paraguay previously sequenced in NFLGs. Interestingly, none of the breakpoints coincided with those of CRF12_BF. In a maximum likelihood phylogenetic tree, all 8 NFLG sequences grouped in a strongly supported clade segregating from previously identified CRFs and from the CRF12_BF "family" clade. These results allow us to identify a new HIV-1 CRF, designated CRF66_BF. Through a Bayesian coalescent analysis, the most recent common ancestor of CRF66_BF was estimated around 1984 in South America, either in Paraguay or Argentina. Among Pr-RT sequences obtained by us from HIV-1-infected Paraguayans living in Spain, 14 (20.9%) of 67 were of CRF66_BF, suggesting that CRF66_BF may be one of the major HIV-1 genetic forms circulating in Paraguay. CRF66_BF is the first reported non-Brazilian South American HIV-1 CRF_BF unrelated to CRF12_BF.

Identification of CRF89_BF, a new member of an HIV-1 circulating BF intersubtype recombinant form family widely spread in South America.

Circulating recombinant forms (CRFs) contribute substantially to the HIV-1 pandemic. Among 105 CRFs described in the literature, 16 are BF intersubtype recombinants, most of South American origin, of which CRF12_BF is the most widely spread. A BF recombinant cluster identified in Bolivia was suggested to represent a new CRF_BF. Here we find that it belongs to a larger cluster incorporating 39 viruses collected in 7 countries from 3 continents, 22 of them in Spain, most from Bolivian or Peruvian individuals, and 12 in South America (Bolivia, Argentina, and Peru). This BF cluster comprises three major subclusters, two associated with Bolivian and one with Peruvian individuals. Near full-length genome sequence analyses of nine viruses, collected in Spain, Bolivia, and Peru, revealed coincident BF mosaic structures, with 13 breakpoints, 6 and 7 of which coincided with CRF12_BF and CRF17_BF, respectively. In a phylogenetic tree, they grouped in a clade closely related to these CRFs, and more distantly to CRF38_BF and CRF44_BF, all circulating in South America. These results allowed to identify a new HIV-1 CRF, designated CRF89_BF. Through phylodynamic analyses, CRF89_BF emergence was estimated in Bolivia around 1986. CRF89_BF is the fifth CRF member of the HIV-1 recombinant family related to CRF12_BF.

Effects of a Behavioral Health and Chronic Illness Care Intervention on Patient Outcomes in Primary Care Practices in the Dakotas.

From 2012 to 2015, Sanford Health, a large health care system, integrated behavioral health services and chronic condition care management in some of its primary care practices in the Dakotas and rural Minnesota. Using difference-in-differences analyses for fee-for-service Medicare beneficiaries attributed to 22 participating practices and 91 matched comparison practices, we found that the program increased the receipt of four recommended diabetes care processes by 8.6% (p=.048) and, by slowing the increase in emergency department (ED) visits, reduced them by 4.9% (p=.07) relative to the comparison group. However, the findings are mixed: the program did not affect hospital admissions, readmissions, or Medicare spending. In addition, the program increased admissions for ambulatory care-sensitive conditions by 13.6% (p=.07) relative to the comparison group. Sanford's program provides a concrete example of how to incorporate behavioral health services in primary care in underserved areas with some positive results on quality-of-care processes and ED utilization.

Effects of a community-based care management model for super-utilizers.

OBJECTIVES: Medicare, Medicaid, and commercial plans have all explored ways to improve outcomes for patients with high costs and complex medical and social needs. The purpose of this study was to test the effectiveness of a high-intensity care management program that the Rutgers University Center for State Health Policy (CSHP) implemented as an adaptation of a promising model developed by the Camden Coalition of Healthcare Providers. STUDY DESIGN: We estimated the impact of the program on 6 utilization and spending outcomes for a subgroup of beneficiaries enrolled in Medicare fee-for-service (n = 149) and a matched comparison group (n = 1130). METHODS: We used Medicare claims for all analyses. We used propensity score matching to construct a comparison group of beneficiaries with baseline characteristics similar to those of program participants. We employed regression models to test the relationship between program enrollment and outcomes over a 12-month period while controlling for baseline characteristics. RESULTS: A test of joint significance across all outcomes showed that the CSHP program reduced service use and spending in aggregate (P = .012), although estimates for most of the individual measures were not statistically significant. Participants had 37% fewer unplanned readmissions (P = .086) than did comparison beneficiaries. Although we did not find statistically significant results for the other 5 outcomes, the CIs for these outcomes spanned substantively large effects. CONCLUSIONS: Although these findings are mixed, they suggest that adaptations of the Camden model hold promise for reducing short-term service use and spending for Medicare super-utilizers.

Rural hospital transitional care program reduces Medicare spending.

OBJECTIVES: To evaluate impacts of a telephonic transitional care program on service use and spending for Medicare fee-for-service beneficiaries at a rural hospital. STUDY DESIGN: Observational cohort study. METHODS: Patients discharged from Atlantic General Hospital (AGH) with an AGH primary care provider were assigned a nurse care coordinator for 30 days. The nurse reviewed the patient's conditions, assessed needs for transition support, conducted weekly telephone calls (beginning 24-72 hours after discharge) to monitor adherence to treatment plans, and scheduled follow-up appointments. Using claims data, we evaluated impacts on service use and spending using a difference-in-differences design with a matched comparison group. RESULTS: The intervention reduced Medicare spending in the 6-month period after discharge by 30.8%, or $1333 per beneficiary per month (90% CI, -$2078 to -$589), which was partly driven by a 39.4% reduction in spending for inpatient claims (difference, -$729; 90% CI, -$1234 to -$225). There were no statistically significant changes in the 14-day ambulatory care follow-up rate, 30-day unplanned readmission rate, number of inpatient admissions, or number of emergency department visits, although this may be due to modest statistical power to detect effects. CONCLUSIONS: The estimated $5.4 million in savings from this intervention more than offset the costs of the $1.1 million funding for the award. Although other studies have found that care transitions programs can improve outcomes, this study was unique in the size of the impacts relative to the low-touch intervention and the location in a small rural healthcare system.

Evaluation of Functional Status Associated With Overweight in Adults With Cerebral Palsy.

PURPOSE: The aim of this study was to describe the motor disability level of ambulatory adults with overweight and cerebral palsy (CP) and to investigate the functional factors associated with weight gain in this population. DESIGN: Cross-sectional study. METHODS: Thirty adults with CP were classified according to their body mass index (BMI). Mobility, physical disability, functional independence, gait and balance, gross motor function, and maximum walking speed were assessed to evaluate their physical status. The influence of demographic and functional factors on BMI was analyzed using bivariate and multivariate regression analyses. FINDINGS: Multiple regression analyses showed that age (p = .012) and lower cardiorespiratory function/lower walking distance (p = .048) were significantly associated with higher BMI. Other functional outcomes were not associated with BMI. CONCLUSIONS: Greater age and reduced walking distance related to cardiorespiratory function seem to be the main factors associated with BMI. CLINICAL RELEVANCE: Cardiorespiratory rehabilitation is recommended in conjunction with nutritional nursing interventions.

The Impact of a Health Information Technology-Focused Patient-centered Medical Neighborhood Program Among Medicare Beneficiaries in Primary Care Practices: The Effect on Patient Outcomes and Spending.

BACKGROUND: The Center for Medicare & Medicaid Innovation (CMMI) tests new models of paying for or delivering health care services and expands models that improve health outcomes while lowering medical spending. CMMI gave TransforMED, a national learning and dissemination contractor, a 3-year Health Care Innovation Award (HCIA) to integrate health information technology systems into physician practices. This paper estimates impacts of TransforMED's HCIA-funded program on patient outcomes and Medicare parts A and B spending. RESEARCH DESIGN: We compared outcomes for Medicare fee-for-service (FFS) beneficiaries served by 87 treatment practices to outcomes for Medicare FFS beneficiaries served by 286 matched comparison practices, adjusting for differences in outcomes between the 2 groups during a 1-year baseline period. We estimated impacts in 3 evaluation outcome domains: quality-of-care processes, service use, and spending. RESULTS: We estimated the program led to a 7.1% reduction in inpatient admissions and a 5.7% decrease in the outpatient emergency department visits. However, there was no evidence of statistically significant effects in outcomes in either the quality-of-care processes or spending domains. CONCLUSIONS: These results indicate that TransforMED's program reduced service use for Medicare FFS beneficiaries, but also show that the program did not have statistically significant favorable impacts in the quality-of-care processes or spending domains. These results suggest that providing practices with population health management and cost-reporting software-along with technical assistance for how to use them-can complement practices' own patient-centered medical home transformation efforts and add meaningfully to their impacts on service use.

Association Between Extending CareFirst's Medical Home Program to Medicare Patients and Quality of Care, Utilization, and Spending.

Importance: CareFirst, the largest commercial insurer in the mid-Atlantic Region of the United States, runs a medical home program focusing on financial incentives for primary care practices and care coordination for high-risk patients. From 2013 to 2015, CareFirst extended the program to Medicare fee-for-service (FFS) beneficiaries in participating practices. If the model extension improved quality while reducing spending, the Centers for Medicare and Medicaid Services could expand the program to Medicare beneficiaries broadly. Objective: To test whether extending CareFirst's program to Medicare FFS patients improves care processes and reduces hospitalizations, emergency department visits, and spending. Design, Setting, and Participants: This difference-in-differences analysis compared outcomes for roughly 35 000 Medicare FFS patients attributed to 52 intervention practices (grouped by CareFirst into 14 "medical panels") to outcomes for 69 000 Medicare patients attributed to 42 matched comparison panels during a 1-year baseline period and 2.5-year intervention at Maryland primary care practices. Main Outcomes and Measures: Hospitalizations (all-cause and ambulatory-care sensitive), emergency department visits, Medicare Part A and B spending, and 3 quality-of-care process measures: ambulatory care within 14 days of a hospital stay, cholesterol testing for those with ischemic vascular disease, and a composite measure for those with diabetes. Interventions: CareFirst hired nurses who worked with patients' usual primary care practitioners to coordinate care for 3656 high-risk Medicare patients. CareFirst paid panels rewards for meeting cost and quality targets for their Medicare patients and advised panels on how to meet these targets based on analyses of claims data. Results: On average, each of the 14 intervention panels had 9.3 primary care practitioners and was attributed 2202 Medicare FFS patients in the baseline period. The panels' attributed Medicare patients were, on average, 73.8 years old, 59.2% female, and 85.1% white. The extension of CareFirst's program to Medicare patients was not statistically associated with improvements in any outcomes, either for the full Medicare population or for a high-risk subgroup in which impacts were expected to be largest. For the full population, the difference-in-differences estimates were 1.4 hospitalizations per 1000 patients per quarter (P = .54; 90% CI, -2.1 to 5.0), -2.5 outpatient ED visits per 1000 patients per quarter (P = .26; 90% CI, -6.2 to 1.1), and -$1 per patient per month in Medicare Part A and B spending (P = .98; 90% CI, -$40 to $39). For hospitalizations and Medicare spending, the 90% CIs did not span CareFirst's expected impacts. Hospitalizations for the intervention group declined by 10% from baseline year to the final 18 months of the intervention, but this was matched by similar declines in the comparison group. Conclusion and Relevance: The extension of CareFirst's program to Medicare did not measurably improve quality-of-care processes or reduce service use or spending for Medicare patients. Further program refinement and testing would be needed to support scaling the program more broadly to Medicare patients.

Experimental impacts of a teacher professional development program in Chile on preschool classroom quality and child outcomes.

We assessed impacts on classroom quality and on 5 child language and behavioral outcomes of a 2-year teacher professional-development program for publicly funded prekindergarten and kindergarten in Chile. This cluster-randomized trial included 64 schools (child N = 1,876). The program incorporated workshops and in-classroom coaching. We found moderate to large positive impacts on observed emotional and instructional support as well as classroom organization in prekindergarten classrooms after 1 year of the program. After 2 years of the program, moderate positive impacts were observed on emotional support and classroom organization. No significant program impacts on child outcomes were detected at posttest (1 marginal effect, an increase in a composite of self-regulation and low problem behaviors, was observed). Professional development for preschool teachers in Chile can improve classroom quality. More intensive curricular approaches are needed for these improvements to translate into effects on children.

Evaluation of pain associated with chronic venous insufficiency in Spanish postmenopausal women.

OBJECTIVE: Menopause status has been associated with an increase in venous diseases and lower limb-related symptoms. The purpose of our study was to evaluate pain associated with chronic venous insufficiency and its risk factors in postmenopausal women. METHODS: A controlled cross-sectional study was performed in 139 postmenopausal women with chronic venous insufficiency and 40 control women. Pain was assessed with a visual analogue scale, the McGill Pain Questionnaire, and the Pain Matcher (Cefar Medical AB, Lund, Sweden). The influence of several demographic and clinical risk factors was analyzed using bivariate and multivariate regression analyses. RESULTS: Women in the chronic venous insufficiency group had significantly higher pain intensity and significantly lower pain threshold (P = 0.001) than the control group. The level of pain was independently and significantly associated with venous refill time and osteoarthritis index scores. It was not associated with other risk factors or with disease severity according to the clinical, etiological, anatomical, and pathophysiological classification. CONCLUSIONS: Venous pain is a consistent symptom in postmenopausal women with chronic venous insufficiency, in whom nociceptive thresholds are generally decreased. Reduced physical activity, venous reflux, and osteoarthritis seem to influence pain level in chronic venous insufficiency.

Effect of a mixed kinesio taping-compression technique on quality of life and clinical and gait parameters in postmenopausal women with chronic venous insufficiency: double-blinded, randomized controlled trial.

OBJECTIVE: To investigate the short-term effect of a mixed Kinesio taping (KT) model on range of ankle motion (ROAM), gait, pain, perimeter of lower limbs, and quality of life in postmenopausal women with chronic venous insufficiency (CVI). DESIGN: Double-blinded, randomized controlled trial. SETTING: Clinical setting. PARTICIPANTS: Consecutive postmenopausal women (N=130; mean age ± SD, 65.44±14.7y) with mild CVI. No participant withdrew because of adverse effects. INTERVENTION: Participants were randomly assigned to either (1) an experimental group to receive a mixed KT-compression treatment following KT recommendations for gastrocnemius muscle enhancement and functional correction of the ankle, and adding 2 tapes to simulate traditional compression bandages (no KT guidelines); or (2) a placebo control group for sham KT. Both interventions were performed 3 times a week during a 4-week period. MAIN OUTCOME MEASURES: ROAM, gait, pain, perimeter of right and left lower limb, and quality of life were assessed at baseline and 48 hours posttreatment. RESULTS: Quality of life was better in the intervention group by a mean of 8.76 points (95% confidence interval [CI], 4.96-12.55). The experimental group also showed significant pre-/posttreatment improvements in both lower limbs in gait dorsiflexion ROAM (95% CI, 1.02-2.49), cadence (95% CI, 3.45-1.47), stride length (95% CI, 21.48-10.83), step length (95% CI, 1.68-6.61), stance phase (95% CI, 61-107), and foot (95% CI, .56-.92) and malleolus (95% CI, 1.15-1.63) circumference. None of these variables were significantly modified in the placebo group. Both groups reported a significant reduction in pain. CONCLUSIONS: Ankle dorsiflexion during gait, walking parameters, peripheral edema, venous pain, and quality of life remain improved in patients with CVI at 1 month after mixed KT-compression therapy. KT may have a placebo effect on pain perception.

A randomized controlled trial of a mixed Kinesio taping-compression technique on venous symptoms, pain, peripheral venous flow, clinical severity and overall health status in postmenopausal women with chronic venous insufficiency.

OBJECTIVES: To investigate the effect of a mixed Kinesio taping treatment in women with chronic venous insufficiency. DESIGN: A double-blinded randomized clinical trial. SETTING: Clinical setting. PARTICIPANTS: One hundred and twenty postmenopausal women with mild-moderate chronic venous insufficiency were randomly assigned to an experimental group receiving standardized Kinesio taping treatment for gastrocnemius muscle enhancement and ankle functional correction, or to a placebo control group for simulated Kinesio taping. MAIN OUTCOMES VARIABLES: Venous symptoms, pain, photoplethysmographic measurements, bioelectrical impedance, temperature, severity and overall health were recorded at baseline and after four weeks of treatment. RESULTS: The 2 × 2 mixed model ANCOVA with repeated measurements showed statistically significant group * time interaction for heaviness (F = 22.99, p = 0.002), claudication (F = 8.57, p = 0.004), swelling (F = 22.58, p = 0.001), muscle cramps (F = 7.14, p = 0.008), venous refill time (right: F = 9.45, p = 0.023; left: F = 14.86, p = 0.001), venous pump function (right: F = 35.55, p = 0.004; left: F = 17.39 p = 0.001), extracellular water (right: F = 35.55, p = 0.004; left: F = 23.84, p = 0.001), severity (F = 18.47, p = 0.001), physical function (F = 9.15, p = 0.003) and body pain (F = 3.36, p = 0.043). Both groups reported significant reduction in pain. CONCLUSION: Mixed Kinesio taping-compression therapy improves symptoms, peripheral venous flow and severity and slightly increases overall health status in females with mild chronic venous insufficiency. Kinesio taping may have a placebo effect on pain.

Effects of kinesio taping on venous symptoms, bioelectrical activity of the gastrocnemius muscle, range of ankle motion, and quality of life in postmenopausal women with chronic venous insufficiency: a randomized controlled trial.

OBJECTIVE: To assess the efficacy of Kinesio taping (KT) on venous symptoms, quality of life, severity, pain, edema, range of ankle motion (ROAM), and peripheral muscle myoelectrical activity in lower limbs of postmenopausal women with mild chronic venous insufficiency (CVI). DESIGN: Double-blinded randomized controlled trial with concealed allocation. SETTING: Clinical setting. PARTICIPANTS: Consecutive postmenopausal women (N=123; age range, 62-67y) with early-stage CVI. None of the participants withdrew because of adverse effects. INTERVENTION: Participants were randomly assigned to an experimental group for standardized KT application for external gastrocnemius (EG) and internal gastrocnemius (IG) muscle enhancement and ankle function correction or a placebo control group for sham KT application. Both interventions were performed 3 times a week during a 4-week period. MAIN OUTCOME MEASURES: Venous symptoms, CVI severity, pain, leg volume, gastrocnemius electromyographic data, ROAM, and quality of life were recorded at baseline and after treatment. RESULTS: The experimental group evidenced significant improvements in pain distribution, venous claudication, swelling, heaviness, muscle cramps, pruritus, and CVI severity score (P≤.042). Both groups reported significant reductions in pain (experimental group: 95% confidence interval [CI], 1.6 to 2.1; control group: 95% CI, -0.2 to 0.3). There were no significant changes in either group in quality of life, leg volume, or ROAM. The experimental group showed significant improvements in root mean square signals (right leg: EG 95% CI, 2.99-5.84; IG 95% CI, 1.02-3.42; left leg: EG 95% CI, 3.00-6.25; IG 95% CI, 3.29-5.3) and peak maximum contraction (right leg: EG 95% CI, 4.8-22.7; IG 95% CI, 2.67-24.62; left leg: EG 95% CI, 2.37-20.44; IG 95% CI, 2.55-25.53), which were not changed in controls. CONCLUSIONS: KT may reduce venous symptoms, pain, and their severity and enhance gastrocnemius muscle activity, but its effects on quality of life, edema, and ROAM remain uncertain. KT may have a placebo effect on venous pain.

A program of 3 physical therapy modalities improves peripheral arterial disease in diabetes type 2 patients: a randomized controlled trial.

BACKGROUND AND OBJECTIVE: Type 2 diabetes is one of the main causes of peripheral vascular disease. The beneficial effects of exercise on glucose homeostasis include a marked stimulation of blood glucose utilization during and after its performance. The objective of this study was to determine the effects of a program of 3 physical therapy modalities on blood circulation in patients with type 2 diabetes with peripheral arterial disease. SUBJECTS AND METHOD: A randomized controlled trial was undertaken. Sixty-eight patients with type 2 diabetes with Leriche-Fontaine stage I or IIa peripheral arterial disease were randomly assigned to an exercise or placebo group. For 20 weeks, the exercise group underwent treatment comprising 3 exercises at proximal, medium, and distal segments of the lower limbs, and the placebo group received sham treatment with disconnected ultrasound equipment. Peripheral arterial disease was determined by evaluating the ankle/brachial index (ABI), Doppler flow velocity, blood parameters, cardiovascular risk score, and heart rate during exercise test. RESULTS: After 20 weeks of treatment, significant differences between groups were found in the following: right (P < .039) and left (P < .023) ABI; Doppler flow velocity (cm/s) in the right (P < .010) and left (P < .026) posterior tibial artery and in the right (P < .012) and left (P < .022) dorsalis pedis artery; and fibrinogen (P < .045), hemoglobin (P < .021), cholesterol (P < .012), high-density lipoprotein cholesterol (P < .031), and HbA1c (P < .034) values. There was no significant difference in low-density lipoprotein cholesterol values (P < .110) between the groups. CONCLUSION: A program of these physical therapy modalities improves ABI, Doppler flow velocity, and blood parameters in patients with type 2 diabetes.

Using multifactorial experiments for comparative effectiveness research in physician practices with electronic health record.

Two key challenges related to conducting comparative effectiveness research are the lack of available data and the lack of rigorous techniques for efficiently and quickly testing the effectiveness of the many possible ways of implementing components of care. The confluence of two things offers the promise of overcoming these challenges: (1) the increased adoption of electronic health records (EHRs), which can provide easier access to clinical information, and (2) burgeoning appreciation for an under-used but powerful statistical research and evaluation method for multifactor interventions known as multifactor experimental design. The use of multifactorial experiments paired with EHR data has great potential to help providers conduct rapid-cycle comparative effectiveness research and examine alternative ways of implementing care. Its power is its ability to enable scientifically rigorous testing of many facets of care provision simultaneously in real-world settings where change is ongoing. In this paper, we identify the opportunities for using efficient multifactorial designs and EHR data to evaluate quality-improvement efforts in physician practices. We illustrate the power of multifactorial designs through several examples relevant to physician practices with EHRs, such as evaluating clinical decision support features and studying components of a patient-centered medical home.

Effect of music as nursing intervention for people diagnosed with fibromyalgia.

Primary fibromyalgia, a poorly understood chronic pain syndrome, is a disorder of uncertain etiology. The ultimate goal of fibromyalgia treatment is to develop a multimodal therapy. In recent years, the use of music as an intervention for the pain management and other symptoms has increased. The purpose of this study was to investigate the effects of music on pain and depression for people diagnosed with fibromyalgia using Rogers' theory of the unitary human being as the theoretical framework. An experimental 4-week longitudinal trial design was undertaken. Sixty patients diagnosed with fibromyalgia were randomly assigned to either a music intervention group or a control group. Music interventions consisted of listening to music once a day for 4 consecutive weeks using two types of CDs. Pain was measured with the McGill Pain Questionnaire Long Form and depression with the Beck inventory; a 100-mm visual analog scale was used to measure pain and depression. The treatment group reported a significant reduction in pain and depression at week 4 compared with the control group. Members of the control group reported no differences in pain. The findings of this pilot study suggest the importance of music therapy as a nursing intervention and justify further investigation into music as a self-management intervention to reduce pain and depression.

Can myofascial techniques modify immunological parameters?

OBJECTIVES: The objective was to determine the effect of myofascial techniques on the modulation of immunological variables. DESIGN: Thirty-nine healthy male volunteers were randomly assigned to an experimental or control group. INTERVENTIONS: The experimental group underwent three manual therapy modalities: suboccipital muscle release, so-called fourth intracranial ventricle compression, and deep cervical fascia release. The control group remained in a resting position for the same time period under the same environmental conditions. OUTCOME MEASURES: Changes in counts of CD3, CD4, CD8, CD19, and natural killer (NK) cells (as immunological markers) between baseline and 20 minutes post-intervention. RESULTS: Repeated-measures ANOVA revealed a significant time × groups interaction (F(1,35)=9.33; p=0.004) for CD19. There were no significant time × group interaction effects on CD3, CD4, CD8, or NK cell counts. Intrasubject analyses showed a higher CD19 count in the experimental group post-intervention versus baseline (t=-4.02; p=0.001), with no changes in the control group (t=0.526; p=0.608). CONCLUSION: A major immunological modulation, with an increased B lymphocyte count, was observed at 20 minutes after the application of craniocervical myofascial induction techniques.