Browsing by Subject "Disease Management"
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Item Open Access Baseline Antihypertensive Drug Count and Patient Response to Hypertension Medication Management.(Journal of clinical hypertension (Greenwich, Conn.), 2016-04) Crowley, Matthew J; Olsen, Maren K; Woolson, Sandra L; King, Heather A; Oddone, Eugene Z; Bosworth, Hayden BTelemedicine-based medication management improves hypertension control, but has been evaluated primarily in patients with low antihypertensive drug counts. Its impact on patients taking three or more antihypertensive agents is not well-established. To address this evidence gap, the authors conducted an exploratory analysis of an 18-month, 591-patient trial of telemedicine-based hypertension medication management. Using general linear models, the effect of medication management on blood pressure for patients taking two or fewer antihypertensive agents at study baseline vs those taking three or more was compared. While patients taking two or fewer antihypertensive agents had a significant reduction in systolic blood pressure with medication management, those taking three or more had no such response. The between-subgroup effect difference was statistically significant at 6 months (-6.4 mm Hg [95% confidence interval, -12.2 to -0.6]) and near significant at 18 months (-6.0 mm Hg [95% confidence interval, -12.2 to 0.2]). These findings suggest that baseline antihypertensive drug count may impact how patients respond to hypertension medication management and emphasize the need to study management strategies specifically in patients taking three or more antihypertensive medications.Item Open Access Clinic variation in recruitment metrics, patient characteristics and treatment use in a randomized clinical trial of osteoarthritis management.(BMC musculoskeletal disorders, 2014-12) Allen, Kelli D; Bosworth, Hayden B; Chatterjee, Ranee; Coffman, Cynthia J; Corsino, Leonor; Jeffreys, Amy S; Oddone, Eugene Z; Stanwyck, Catherine; Yancy, William S; Dolor, Rowena JBackground
The Patient and PRovider Interventions for Managing Osteoarthritis (OA) in Primary Care (PRIMO) study is one of the first health services trials targeting OA in a multi-site, primary care network. This multi-site approach is important for assessing generalizability of the interventions. These analyses describe heterogeneity in clinic and patient characteristics, as well as recruitment metrics, across PRIMO study clinics.Methods
Baseline data were obtained from the PRIMO study, which enrolled n = 537 patients from ten Duke Primary Care practices. The following items were examined across clinics with descriptive statistics: (1) Practice Characteristics, including primary care specialty, numbers and specialties of providers, numbers of patients age 55+, urban/rural location and county poverty level; (2) Recruitment Metrics, including rates of eligibility, refusal and randomization; (3) Participants' Characteristics, including demographic and clinical data (general and OA-related); and (4) Participants' Self-Reported OA Treatment Use, including pharmacological and non-pharmacological therapies. Intraclass correlation coefficients (ICCs) were computed for participant characteristics and OA treatment use to describe between-clinic variation.Results
Study clinics varied considerably across all measures, with notable differences in numbers of patients age 55+ (1,507-5,400), urban/rural location (ranging from "rural" to "small city"), and proportion of county households below poverty level (12%-26%). Among all medical records reviewed, 19% of patients were initially eligible (10%-31% across clinics), and among these, 17% were randomized into the study (13%-21% across clinics). There was considerable between-clinic variation, as measured by the ICC (>0.01), for the following patient characteristics and OA treatment use variables: age (means: 60.4-66.1 years), gender (66%-88% female), race (16%-61% non-white), low income status (5%-27%), presence of hip OA (26%-68%), presence both knee and hip OA (23%-61%), physical therapy for knee OA (24%-61%) and hip OA (0%-71%), and use of knee brace with metal supports (0%-18%).Conclusions
Although PRIMO study sites were part of one primary care practice network in one health care system, clinic and patient characteristics varied considerably, as did OA treatment use. This heterogeneity illustrates the importance of including multiple, diverse sites in trials for knee and hip OA, to enhance the generalizability and evaluate potential for real-world implementation.Trial registration
Clinical trial registration number
NCT 01435109.Item Open Access Clinical Insights Into the Biology and Treatment of Pancreatic Cancer.(J Oncol Pract, 2016-01) Mettu, Niharika B; Abbruzzese, James LPancreatic cancer is a devastating disease with a universally poor prognosis. In 2015, it is estimated that there will be 48,960 new cases of pancreatic cancer and that 40,560 people will die of the disease. The 5-year survival rate is 7.2% for all patients with pancreatic cancer; however, survival depends greatly on the stage at diagnosis. Unfortunately, 53% of patients already have metastatic disease at diagnosis, which corresponds to a 5-year survival rate of 2.4%. Even for the 9% of patients with localized disease confined to the pancreas, the 5-year survival is still modest at only 27.1%. These grim statistics highlight the need for ways to identify cohorts of individuals at highest risk, methods to screen those at highest risk to identify preinvasive pathologic precursors, and development of effective systemic therapies. Recent clinical and translational progress has emphasized the relationship with diabetes, the role of the stroma, and the interplay of each of these with inflammation in the pathobiology of pancreatic cancer. In this article, we will discuss these relationships and how they might translate into novel management strategies for the treatment of this disease.Item Open Access Consideration of Out-of-Office Blood Pressure Monitoring in Hypertension Management.(Journal of clinical hypertension (Greenwich, Conn.), 2016-05) Goldstein, Karen M; Zullig, Leah L; Bosworth, Hayden B; Oddone, Eugene ZItem Open Access Economic evaluation of telephone self-management interventions for blood pressure control.(American heart journal, 2012-06) Wang, Virginia; Smith, Valerie A; Bosworth, Hayden B; Oddone, Eugene Z; Olsen, Maren K; McCant, Felicia; Powers, Benjamin J; Van Houtven, Courtney HaroldBackground
Half of patients with hypertension have poor blood pressure (BP) control. Recent models for treating hypertension have integrated disease monitoring and telephone-based interventions delivered in patients' homes. This study evaluated the costs of the Hypertension Intervention Nurse Telemedicine Study (HINTS), aimed to improve BP control in veterans.Methods
Eligible veterans were randomized to either usual care or 1 of 3 telephone-based intervention groups using home BP telemonitoring: (1) behavioral management, (2) medication management, or (3) combined. Intervention costs were derived from information collected during the trial. Direct medical costs (inpatient, outpatient, and outpatient pharmacy, including hypertension-specific pharmacy) at 18 months by group were calculated using Veterans Affairs (VA) Decision Support System data. Bootstrapped CIs were computed to compare intervention and medical costs between intervention groups and usual care.Results
Patients receiving behavior or medication management showed significant gains in BP control at 12 months; there were no differences in BP control at 18 months. In subgroup analysis, patients with poor baseline BP control receiving combined intervention significantly improved BP at 12 and 18 months. In overall and subgroup samples, average intervention costs were similar in the 3 study arms, and at 18 months, there were no statistically significant differences in direct VA medical costs or total VA costs between treatment arms and usual care.Conclusions
To optimize investment in telephone-based home interventions such as the HINTS, it is important to identify groups of patients who are most likely to benefit from more intensive home BP management.Item Open Access Evidence and Recommendations on the Use of Telemedicine for the Management of Arterial Hypertension: An International Expert Position Paper.(Hypertension (Dallas, Tex. : 1979), 2020-11) Omboni, Stefano; McManus, Richard J; Bosworth, Hayden B; Chappell, Lucy C; Green, Beverly B; Kario, Kazuomi; Logan, Alexander G; Magid, David J; Mckinstry, Brian; Margolis, Karen L; Parati, Gianfranco; Wakefield, Bonnie JTelemedicine allows the remote exchange of medical data between patients and healthcare professionals. It is used to increase patients' access to care and provide effective healthcare services at a distance. During the recent coronavirus disease 2019 (COVID-19) pandemic, telemedicine has thrived and emerged worldwide as an indispensable resource to improve the management of isolated patients due to lockdown or shielding, including those with hypertension. The best proposed healthcare model for telemedicine in hypertension management should include remote monitoring and transmission of vital signs (notably blood pressure) and medication adherence plus education on lifestyle and risk factors, with video consultation as an option. The use of mixed automated feedback services with supervision of a multidisciplinary clinical team (physician, nurse, or pharmacist) is the ideal approach. The indications include screening for suspected hypertension, management of older adults, medically underserved people, high-risk hypertensive patients, patients with multiple diseases, and those isolated due to pandemics or national emergencies.Item Open Access Factors associated with persistent poorly controlled diabetes mellitus: clues to improving management in patients with resistant poor control.(Chronic illness, 2014-12) Crowley, Matthew J; Holleman, Rob; Klamerus, Mandi L; Bosworth, Hayden B; Edelman, David; Heisler, MicheleObjectives
Patients with persistent poorly controlled diabetes mellitus (PPDM), defined as an uninterrupted hemoglobin A1c >8.0% for ≥1 year despite standard care, are at high risk for complications. Additional research to define patient factors associated with PPDM could suggest barriers to improvement in this group and inform the development of targeted strategies to address these patients' resistant diabetes.Methods
We analyzed patients with type 2 diabetes from a multi-site randomized trial. We characterized patients with PPDM relative to other patients using detailed survey data and multivariable modeling.Results
Of 963 patients, 118 (12%) had PPDM, 265 (28%) were intermittently poorly controlled, and 580 (60%) were well-controlled. Patients with PPDM had younger age, earlier diabetes diagnosis, insulin use, higher antihypertensive burden, higher low-density lipoprotein cholesterol, and lower statin use relative to well-controlled patients. Among patients with objective adherence data (Veterans Affairs patients), a larger oral diabetes medication refill gap was associated with PPDM.Discussion
Strategies are needed to target-specific barriers to improvement among patients whose diabetes is resistant to standard diabetes care. Our data suggest that strategies for targeting PPDM should accommodate younger patients' lifestyles, include medication management for insulin titration and comorbid disease conditions, and address barriers to self-management adherence.Item Open Access Global guideline for the diagnosis and management of rare mould infections: an initiative of the European Confederation of Medical Mycology in cooperation with the International Society for Human and Animal Mycology and the American Society for Microbiology.(The Lancet. Infectious diseases, 2021-08) Hoenigl, Martin; Salmanton-García, Jon; Walsh, Thomas J; Nucci, Marcio; Neoh, Chin Fen; Jenks, Jeffrey D; Lackner, Michaela; Sprute, Rosanne; Al-Hatmi, Abdullah MS; Bassetti, Matteo; Carlesse, Fabianne; Freiberger, Tomas; Koehler, Philipp; Lehrnbecher, Thomas; Kumar, Anil; Prattes, Juergen; Richardson, Malcolm; Revankar, Sanjay; Slavin, Monica A; Stemler, Jannik; Spiess, Birgit; Taj-Aldeen, Saad J; Warris, Adilia; Woo, Patrick CY; Young, Jo-Anne H; Albus, Kerstin; Arenz, Dorothee; Arsic-Arsenijevic, Valentina; Bouchara, Jean-Philippe; Chinniah, Terrence Rohan; Chowdhary, Anuradha; de Hoog, G Sybren; Dimopoulos, George; Duarte, Rafael F; Hamal, Petr; Meis, Jacques F; Mfinanga, Sayoki; Queiroz-Telles, Flavio; Patterson, Thomas F; Rahav, Galia; Rogers, Thomas R; Rotstein, Coleman; Wahyuningsih, Retno; Seidel, Danila; Cornely, Oliver AWith increasing numbers of patients needing intensive care or who are immunosuppressed, infections caused by moulds other than Aspergillus spp or Mucorales are increasing. Although antifungal prophylaxis has shown effectiveness in preventing many invasive fungal infections, selective pressure has caused an increase of breakthrough infections caused by Fusarium, Lomentospora, and Scedosporium species, as well as by dematiaceous moulds, Rasamsonia, Schizophyllum, Scopulariopsis, Paecilomyces, Penicillium, Talaromyces and Purpureocillium species. Guidance on the complex multidisciplinary management of infections caused by these pathogens has the potential to improve prognosis. Management routes depend on the availability of diagnostic and therapeutic options. The present recommendations are part of the One World-One Guideline initiative to incorporate regional differences in the epidemiology and management of rare mould infections. Experts from 24 countries contributed their knowledge and analysed published evidence on the diagnosis and treatment of rare mould infections. This consensus document intends to provide practical guidance in clinical decision making by engaging physicians and scientists involved in various aspects of clinical management. Moreover, we identify areas of uncertainty and constraints in optimising this management.Item Open Access Impact of Movement Disorders on Management of Spinal Deformity in the Elderly.(Neurosurgery, 2015-10) Ha, Yoon; Oh, Jae Keun; Smith, Justin S; Ailon, Tamir; Fehlings, Michael G; Shaffrey, Christopher I; Ames, Christopher PSpinal deformities are frequent and disabling complications of movement disorders such as Parkinson disease and multiple system atrophy. The most distinct spinal deformities include camptocormia, antecollis, Pisa syndrome, and scoliosis. Spinal surgery has become lower risk and more efficacious for complex spinal deformities, and thus more appealing to patients, particularly those for whom conservative treatment is inappropriate or ineffective. Recent innovations and advances in spinal surgery have revolutionized the management of spinal deformities in elderly patients. However, spinal deformity surgeries in patients with Parkinson disease remain challenging. High rates of mechanical complications can necessitate revision surgery. The success of spinal surgery in patients with Parkinson disease depends on an interdisciplinary approach, including both surgeons and movement disorder specialists, to select appropriate surgical patients and manage postoperative movement in order to decrease mechanical failures. Achieving appropriate correction of sagittal alignment with strong biomechanical instrumentation and bone fusion is the key determinant of satisfactory results.Item Open Access International comparisons of the management of patients with non-ST segment elevation acute myocardial infarction in the United Kingdom, Sweden, and the United States: The MINAP/NICOR, SWEDEHEART/RIKS-HIA, and ACTION Registry-GWTG/NCDR registries.(Int J Cardiol, 2014-08-01) McNamara, RL; Chung, SC; Jernberg, T; Holmes, D; Roe, M; Timmis, A; James, S; Deanfield, J; Fonarow, GC; Peterson, ED; Jeppsson, A; Hemingway, HOBJECTIVES: To compare management of patients with acute non-ST segment elevation myocardial infarction (NSTEMI) in three developed countries with national ongoing registries. BACKGROUND: Results from clinical trials suggest significant variation in care across the world. However, international comparisons in "real world" registries are limited. METHODS: We compared the use of in-hospital procedures and discharge medications for patients admitted with NSTEMI from 2007 to 2010 using the unselective MINAP/NICOR [England and Wales (UK); n=137,009], the unselective SWEDEHEART/RIKS-HIA (Sweden; n=45,069), and the selective ACTION Registry-GWTG/NCDR [United States (US); n=147,438] clinical registries. RESULTS: Patients enrolled among the three registries were generally similar except those in the US who were younger but had higher rates of smoking, diabetes, hypertension, prior heart failure, and prior MI than in Sweden or in UK. Angiography and percutaneous coronary intervention (PCI) were performed more often in the US (76% and 44%) and Sweden (65% and 42%) relative to the UK (32% and 22%). Discharge betablockers were also prescribed more often in the US (89%) and Sweden (89%) than in the UK (76%). In contrast, discharge statins, angiotensin converting enzyme inhibitors/angiotensin receptor blockers (ACEI/ARB), and dual antiplatelet agents (among those not receiving PCI) were higher in the UK (92%, 79%, and 71%) than in the US (85%, 65%, 41%) and Sweden (81%, 69%, and 49%). CONCLUSIONS: The care for patients with NSTEMI differed substantially among the three countries. These differences in care among countries provide an opportunity for future comparative effectiveness research as well as identify opportunities for global quality improvement.Item Open Access Isolated Noncompaction of the Left Ventricle in Adults.(J Am Coll Cardiol, 2015-08-04) Hussein, Ayman; Karimianpour, Ahmadreza; Collier, Patrick; Krasuski, Richard AIsolated left ventricular noncompaction (ILVNC) is a cardiomyopathy that was first described in 1926 as a "spongy myocardium." The disorder results from intrauterine arrest of compaction of the loose interwoven meshwork of the fetal myocardial primordium and subsequent persistence of deep trabecular recesses in the myocardial wall. The classical clinical presentation is a triad of heart failure, arrhythmias, and embolic events from mural thrombi. ILVNC has been associated with several autosomal dominant, X-linked, and mitochondrial genetic mutations that are also shared among other cardiomyopathies. Over the past decade, ILVNC has been subject to intensive research, as it increases the risk for sudden cardiac death. This review focuses on the current understanding of ILVNC in adult populations and attempts to provide organized insight into the disease process, screening, diagnosis, management, role of device therapy, and prognosis.Item Open Access Leave no one behind: response to new evidence and guidelines for the management of cryptococcal meningitis in low-income and middle-income countries.(The Lancet. Infectious Diseases, 2019-04) Loyse, Angela; Burry, Jessica; Cohn, Jennifer; Ford, Nathan; Chiller, Tom; Ribeiro, Isabela; Koulla-Shiro, Sinata; Mghamba, Janneth; Ramadhani, Angela; Nyirenda, Rose; Aliyu, Sani H; Wilson, Douglas; Le, Thuy; Oladele, Rita; Lesikari, Sokoine; Muzoora, Conrad; Kalata, Newton; Temfack, Elvis; Mapoure, Yacouba; Sini, Victor; Chanda, Duncan; Shimwela, Meshack; Lakhi, Shabir; Ngoma, Jonathon; Gondwe-Chunda, Lilian; Perfect, Chase; Shroufi, Amir; Andrieux-Meyer, Isabelle; Chan, Adrienne; Schutz, Charlotte; Hosseinipour, Mina; Van der Horst, Charles; Klausner, Jeffrey D; Boulware, David R; Heyderman, Robert; Lalloo, David; Day, Jeremy; Jarvis, Joseph N; Rodrigues, Marcio; Jaffar, Shabbar; Denning, David; Migone, Chantal; Doherty, Megan; Lortholary, Olivier; Dromer, Françoise; Stack, Muirgen; Molloy, Síle F; Bicanic, Tihana; van Oosterhout, Joep; Mwaba, Peter; Kanyama, Cecilia; Kouanfack, Charles; Mfinanga, Sayoki; Govender, Nelesh; Harrison, Thomas SIn 2018, WHO issued guidelines for the diagnosis, prevention, and management of HIV-related cryptococcal disease. Two strategies are recommended to reduce the high mortality associated with HIV-related cryptococcal meningitis in low-income and middle-income countries (LMICs): optimised combination therapies for confirmed meningitis cases and cryptococcal antigen screening programmes for ambulatory people living with HIV who access care. WHO's preferred therapy for the treatment of HIV-related cryptococcal meningitis in LMICs is 1 week of amphotericin B plus flucytosine, and the alternative therapy is 2 weeks of fluconazole plus flucytosine. In the ACTA trial, 1-week (short course) amphotericin B plus flucytosine resulted in a 10-week mortality of 24% (95% CI -16 to 32) and 2 weeks of fluconazole and flucytosine resulted in a 10-week mortality of 35% (95% CI -29 to 41). However, with widely used fluconazole monotherapy, mortality because of HIV-related cryptococcal meningitis is approximately 70% in many African LMIC settings. Therefore, the potential to transform the management of HIV-related cryptococcal meningitis in resource-limited settings is substantial. Sustainable access to essential medicines, including flucytosine and amphotericin B, in LMICs is paramount and the focus of this Personal View.Item Open Access MnSOD is implicated in accelerated wound healing upon Negative Pressure Wound Therapy (NPWT): A case in point for MnSOD mimetics as adjuvants for wound management.(Redox biology, 2019-01) Bellot, Gregory Lucien; Dong, Xiaoke; Lahiri, Amitabha; Sebastin, Sandeep Jacob; Batinic-Haberle, Ines; Pervaiz, Shazib; Puhaindran, Mark EdwardNegative Pressure Wound Therapy (NPWT), a widely used modality in the management of surgical and trauma wounds, offers clear benefits over conventional wound healing strategies. Despite the wide-ranging effects ascribed to NPWT, the precise molecular mechanisms underlying the accelerated healing supported by NPWT remains poorly understood. Notably, cellular redox status-a product of the balance between cellular reactive oxygen species (ROS) production and anti-oxidant defense systems-plays an important role in wound healing and dysregulation of redox homeostasis has a profound effect on wound healing. Here we investigated potential links between the use of NPWT and the regulation of antioxidant mechanisms. Using patient samples and a rodent model of acute injury, we observed a significant accumulation of MnSOD protein as well as higher enzymatic activity in tissues upon NPWT. As a proof of concept and to outline the important role of SOD activity in wound healing, we replaced NPWT by the topical application of a MnSOD mimetic, Mn(III) meso-tetrakis(N-ethylpyridinium-2-yl)porphyrin (MnTE-2-PyP5+, MnE, BMX-010, AEOl10113) in the rodent model. We observed that MnE is a potent wound healing enhancer as it appears to facilitate the formation of new tissue within the wound bed and consequently advances wound closure by two days, compared to the non-treated animals. Taken together, these results show for the first time a link between NPWT and regulation of antioxidant mechanism through the maintenance of MnSOD activity. Additionally this discovery outlined the potential role of MnSOD mimetics as topical agents enhancing wound healing.Item Open Access Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics.(Contemporary clinical trials, 2016-09) Jackson, George L; Weinberger, Morris; Kirshner, Miriam A; Stechuchak, Karen M; Melnyk, Stephanie D; Bosworth, Hayden B; Coffman, Cynthia J; Neelon, Brian; Van Houtven, Courtney; Gentry, Pamela W; Morris, Isis J; Rose, Cynthia M; Taylor, Jennifer P; May, Carrie L; Han, Byungjoo; Wainwright, Christi; Alkon, Aviel; Powell, Lesa; Edelman, DavidDespite the availability of efficacious treatments, only half of patients with hypertension achieve adequate blood pressure (BP) control. This paper describes the protocol and baseline subject characteristics of a 2-arm, 18-month randomized clinical trial of titrated disease management (TDM) for patients with pharmaceutically-treated hypertension for whom systolic blood pressure (SBP) is not controlled (≥140mmHg for non-diabetic or ≥130mmHg for diabetic patients). The trial is being conducted among patients of four clinic locations associated with a Veterans Affairs Medical Center. An intervention arm has a TDM strategy in which patients' hypertension control at baseline, 6, and 12months determines the resource intensity of disease management. Intensity levels include: a low-intensity strategy utilizing a licensed practical nurse to provide bi-monthly, non-tailored behavioral support calls to patients whose SBP comes under control; medium-intensity strategy utilizing a registered nurse to provide monthly tailored behavioral support telephone calls plus home BP monitoring; and high-intensity strategy utilizing a pharmacist to provide monthly tailored behavioral support telephone calls, home BP monitoring, and pharmacist-directed medication management. Control arm patients receive the low-intensity strategy regardless of BP control. The primary outcome is SBP. There are 385 randomized (192 intervention; 193 control) veterans that are predominately older (mean age 63.5years) men (92.5%). 61.8% are African American, and the mean baseline SBP for all subjects is 143.6mmHg. This trial will determine if a disease management program that is titrated by matching the intensity of resources to patients' BP control leads to superior outcomes compared to a low-intensity management strategy.Item Open Access Operative Management of Adult Spinal Deformity Results in Significant Increases in QALYs Gained Compared to Nonoperative Management: Analysis of 479 Patients With Minimum 2-Year Follow-Up.(Spine, 2018-03) Scheer, Justin K; Hostin, Richard; Robinson, Chessie; Schwab, Frank; Lafage, Virginie; Burton, Douglas C; Hart, Robert A; Kelly, Michael P; Keefe, Malla; Polly, David; Bess, Shay; Shaffrey, Christopher I; Smith, Justin S; Ames, Christopher P; International Spine Study GroupStudy design
Retrospective review of prospective multicenter adult spinal deformity (ASD) database.Objective
To compare the quality-adjusted life years (QALYs) between operative and nonoperative treatments for ASD patients.Summary of background data
Operative management of ASD repeatedly demonstrates improvements in HRQOL over nonoperative treatment. However, little is reported regarding QALY improvements after surgical correction of ASD.Methods
Inclusion criteria: ≥18 years, ASD. Health utility values were calculated from SF6D scores and used to calculate QALYs at minimum 2 years from the baseline utility value as well as at 1, 2, and 3 years for the available patients. A 1:1 propensity score matching using six baseline variables was conducted to account for the nonrandom distribution of operative and nonoperative treatments.Results
Four hundred seventy-nine patients were included (OP:258, 70.7%, NONOP:221, 47.1%). One hundred fifty-one (OP:90, NONOP:61) had complete 1, 2, and 3 year data available for QALY trending. Unmatched results are not listed in the abstract. Mean baseline utility scores were statistically similar between the matched groups (OP: 0.609 ± 0.093, NONOP: 0.600 ± 0.091, P = 0.6401) and at 2 year min postop mean OP QALY was greater than NONOP (1.377 ± 0.345 vs. 1.256 ± 0.286, respectively, P < 0.01). For the subanalysis cohort, mean OP QALYs at 1, 2, and 3 years postoperative were all significantly greater than NONOP, P < 0.03 for all (1 yr: 0.651 ± 0.089 vs. 0.61 ± 0.079, 2 yr: 1.29 ± 0.157 vs. 1.189 ± 0.141, and 3 yr: 1.903 ± 0.235 vs. 1.749 ± 0.198, respectively). Matched OP had a larger QALYs gained (from baseline) at 2 year minimum postoperative (0.112 ± 0.243 vs. 0.008 ± 0.195, P < 0.01). For subanalysis of patients with complete 1 to 3 years data, OP had a significantly larger QALYs gained at 1, 2, and 3 years compared with NONOP: 1 year (0.073 ± 0.121 vs. 0.029 ± 0.082, P = 0.0447), 2 years (0.167 ± 0.232 vs. 0.036 ± 0.173, P = 0.0030), and 3years (0.238 ± 0.379 vs. 0.059 ± 0.258, P < 0.01).Conclusion
The operative treatment of adult spinal deformity results in significantly greater mean QALYs and QALYs gained at minimum 2 years postop as well as at the 1-, 2-, and 3-year time points compared with nonoperative management.Level of evidence
3.Item Open Access Point-of-care diagnostics for invasive aspergillosis: nearing the finish line.(Expert review of molecular diagnostics, 2020-10) Jenks, Jeffrey D; Hoenigl, MartinIntroduction
The spectrum of disease caused by Aspergillus spp. is dependent on the immune system of the host, with invasive aspergillosis (IA) its most severe manifestation. Early and reliable diagnosis of Aspergillus disease is important to decrease associated morbidity and mortality from IA.Areas covered
The following review searched Pub Med for literature published since 2007 and will give an update on the current point-of-care diagnostic strategies for the diagnosis of IA, discuss needed areas of improvement for these tests, and future directions.Expert opinion
Several new diagnostic tests for IA - including point-of-care tests - are now available to complement conventional galactomannan (GM) testing. In particular, the Aspergillus-specific Lateral Flow Device (LFD) test and the sōna Aspergillus GM Lateral Flow Assay (LFA) are promising for the diagnosis of IA in patients with hematologic malignancy, although further evaluation in the non-hematology setting is needed. In addition, a true point-of-care test, particularly for easily obtained specimens like serum or urine that can be done at the bedside or in the Clinic in a matter of minutes is needed, such as the lateral flow dipstick test, which is under current evaluation. Lastly, improved diagnostic algorithms to diagnose IA in non-neutropenic patients is needed.Item Open Access Primary Care Networks and Starfield's 4Cs: A Case for Enhanced Chronic Disease Management.(International journal of environmental research and public health, 2021-03-12) Foo, Chuan De; Surendran, Shilpa; Jimenez, Geronimo; Ansah, John Pastor; Matchar, David Bruce; Koh, Gerald Choon HuatThe primary care network (PCN) was implemented as a healthcare delivery model which organises private general practitioners (GPs) into groups and furnished with a certain level of resources for chronic disease management. A secondary qualitative analysis was conducted with data from an earlier study exploring facilitators and barriers GPs enrolled in PCN's face in chronic disease management. The objective of this study is to map features of PCN to Starfield's "4Cs" framework. The "4Cs" of primary care-comprehensiveness, first contact access, coordination and continuity-offer high-quality design options for chronic disease management. Interview transcripts of GPs (n = 30) from the original study were purposefully selected. Provision of ancillary services, manpower, a chronic disease registry and extended operating hours of GP practices demonstrated PCN's empowering features that fulfil the "4Cs". On the contrary, operational challenges such as the lack of an integrated electronic medical record and disproportionate GP payment structures limit PCNs from maximising the "4Cs". However, the enabling features mentioned above outweighs the shortfalls in all important aspects of delivering optimal chronic disease care. Therefore, even though PCN is in its early stage of development, it has shown to be well poised to steer GPs towards enhanced chronic disease management.Item Open Access Racial Differences in the Effect of a Telephone-Delivered Hypertension Disease Management Program.(Journal of general internal medicine, 2012-08) Jackson, GL; Oddone, EZ; Olsen, MK; Powers, BJ; Grubber, JM; McCant, F; Bosworth, HBBACKGROUND: African Americans are significantly more likely than whites to have uncontrolled hypertension, contributing to significant disparities in cardiovascular disease and events. OBJECTIVE: The goal of this study was to examine whether there were differences in change in blood pressure (BP) for African American and non-Hispanic white patients in response to a medication management and tailored nurse-delivered telephone behavioral program. PARTICIPANTS: Five hundred and seventy-three patients (284 African American and 289 non-Hispanic white) primary care patients who participated in the Hypertension Intervention Nurse Telemedicine Study (HINTS) clinical trial. INTERVENTIONS: Study arms included: 1) nurse-administered, physician-directed medication management intervention, utilizing a validated clinical decision support system; 2) nurse-administered, behavioral management intervention; 3) combined behavioral management and medication management intervention; and 4) usual care. All interventions were activated based on poorly controlled home BP values. MAIN MEASURES: Post-hoc analysis of change in systolic and diastolic blood pressure. General linear models (PROC MIXED in SAS, version 9.2) were used to estimate predicted means at 6-month, 12-month, and 18-month time points, by intervention arm and race subgroups (separate models for systolic and diastolic blood pressure). KEY RESULTS: Improvement in mean systolic blood pressure post-baseline was greater for African American patients in the combined intervention, compared to African American patients in usual care, at 12 months (6.6 mmHg; 95 % CI: -12.5, -0.7; p = 0.03) and at 18 months (9.7 mmHg; -16.0, -3.4; p = 0.003). At 18 months, mean diastolic BP was 4.8 mmHg lower (95 % CI: -8.5, -1.0; p = 0.01) among African American patients in the combined intervention arm, compared to African American patients in usual care. There were no analogous differences for non-Hispanic white patients. CONCLUSIONS: The combination of home BP monitoring, remote medication management, and telephone tailored behavioral self-management appears to be particularly effective for improving BP among African Americans. The effect was not seen among non-Hispanic white patients.Item Open Access Racial Differences in the Effectiveness of a Multifactorial Telehealth Intervention to Slow Diabetic Kidney Disease.(Medical care, 2020-11) Kobe, Elizabeth A; Diamantidis, Clarissa J; Bosworth, Hayden B; Davenport, Clemontina A; Oakes, Megan; Alexopoulos, Anastasia-Stefania; Pendergast, Jane; Patel, Uptal D; Crowley, Matthew JBackground
African Americans are significantly more likely than non-African Americans to have diabetes, chronic kidney disease, and uncontrolled hypertension, increasing their risk for kidney function decline.Objective
The objective of this study was to compare how African Americans and non-African Americans with diabetes responded to a multifactorial telehealth intervention designed to slow kidney function decline.Research design
Secondary analysis of a randomized trial. Primary care patients (N=281, 56% African American) were allocated to either: (1) a multifactorial, pharmacist-delivered phone-based telehealth intervention focused on behavioral and medication management of diabetic kidney disease; or (2) an education control.Measures
The primary study outcome was change in estimated glomerular filtration rate (eGFR). Linear mixed models were used to explore the moderating effect of race on the relationship between study arm and eGFR decline over time; the mean annual rate of eGFR decline was estimated by race and study arm.Results
Findings demonstrated a differential intervention effect on kidney function over time by race (Pinteraction=0.005). Among African Americans, the intervention arm had significantly greater preservation of eGFR over time than the control arm (difference in the annual rate of eGFR decline=1.5 mL/min/1.73 m; 95% confidence interval: 0.04, 3.02). For non-African Americans, the intervention arm had a faster decline in eGFR over time than the control arm (difference in the annual rate of eGFR decline=-1.7 mL/min/1.73 m; 95% confidence interval: -3.3, -0.02).Conclusion
A multifactorial, pharmacist-delivered telehealth intervention for diabetic kidney disease may be more effective for slowing eGFR decline among African Americans than non-African Americans.Item Open Access Sensitization and Desensitization in Vascularized Composite Allotransplantation.(Frontiers in immunology, 2021-01) Moris, Dimitrios; Cendales, Linda CVascularized composite allotransplantation (VCA) is a field under research and has emerged as an alternative option for the repair of severe disfiguring defects that result from severe tissue loss in a selected group of patients. Lifelong immunosuppressive therapy, immunosuppression associated complications, and the effects of the host immune response in the graft are major concerns in this type of quality-of-life transplant. The initial management of extensive soft tissue injury can lead to the development of anti-HLA antibodies through injury-related factors, transfusion and cadaveric grafting. The role of antibody-mediated rejection, donor-specific antibody (DSA) formation and graft rejection in the context of VCA still remain poorly understood. The most common antigenic target of preexisting alloantibodies are MHC mismatches, though recognition of ABO incompatible antigens, minor histocompatibility complexes and endothelial cells has also been shown to contribute to rejection. Mechanistically, alloantibody-mediated tissue damage occurs primarily through complement fixation as well as through antibody-dependent cellular toxicity. If DSA exist, activation of complement and coagulation cascades can result in vascular thrombosis and infarction and thus rejection and graft loss. Both preexisting DSA but especially de-novo DSA are currently considered as main contributors to late allograft injury and graft failure. Desensitization protocols are currently being developed for VCA, mainly including removal of alloantibodies whereas treatment of established antibody-mediated rejection is achieved through high dose intravenous immunoglobulins. The long-term efficacy of such therapies in sensitized VCA recipients is currently unknown. The current evidence base for sensitizing events and outcomes in reconstructive transplantation is limited. However, current data show that VCA transplantation has been performed in the setting of HLA-sensitization.