Browsing by Subject "Evidence-Based Medicine"
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Item Open Access A few of our favorite unconfirmed ideas.(Crit Care, 2015) Marini, John J; Gattinoni, Luciano; Ince, Can; Kozek-Langenecker, Sibylle; Mehta, Ravindra L; Pichard, Claude; Westphal, Martin; Wischmeyer, Paul; Vincent, Jean-LouisMedical practice is rooted in our dependence on the best available evidence from incremental scientific experimentation and rigorous clinical trials. Progress toward determining the true worth of ongoing practice or suggested innovations can be glacially slow when we insist on following the stepwise scientific pathway, and a prevailing but imperfect paradigm often proves difficult to challenge. Yet most experienced clinicians and clinical scientists harbor strong thoughts about how care could or should be improved, even if the existing evidence base is thin or lacking. One of our Future of Critical Care Medicine conference sessions encouraged sharing of novel ideas, each presented with what the speaker considers a defensible rationale. Our intent was to stimulate insightful thinking and free interchange, and perhaps to point in new directions toward lines of innovative theory and improved care of the critically ill. In what follows, a brief background outlines the rationale for each novel and deliberately provocative unconfirmed idea endorsed by the presenter.Item Open Access A novel classification system for spinal instability in neoplastic disease: an evidence-based approach and expert consensus from the Spine Oncology Study Group.(Spine, 2010-10) Fisher, Charles G; DiPaola, Christian P; Ryken, Timothy C; Bilsky, Mark H; Shaffrey, Christopher I; Berven, Sigurd H; Harrop, James S; Fehlings, Michael G; Boriani, Stefano; Chou, Dean; Schmidt, Meic H; Polly, David W; Biagini, Roberto; Burch, Shane; Dekutoski, Mark B; Ganju, Aruna; Gerszten, Peter C; Gokaslan, Ziya L; Groff, Michael W; Liebsch, Norbert J; Mendel, Ehud; Okuno, Scott H; Patel, Shreyaskumar; Rhines, Laurence D; Rose, Peter S; Sciubba, Daniel M; Sundaresan, Narayan; Tomita, Katsuro; Varga, Peter P; Vialle, Luiz R; Vrionis, Frank D; Yamada, Yoshiya; Fourney, Daryl RStudy design
Systematic review and modified Delphi technique.Objective
To use an evidence-based medicine process using the best available literature and expert opinion consensus to develop a comprehensive classification system to diagnose neoplastic spinal instability.Summary of background data
Spinal instability is poorly defined in the literature and presently there is a lack of guidelines available to aid in defining the degree of spinal instability in the setting of neoplastic spinal disease. The concept of spinal instability remains important in the clinical decision-making process for patients with spine tumors.Methods
We have integrated the evidence provided by systematic reviews through a modified Delphi technique to generate a consensus of best evidence and expert opinion to develop a classification system to define neoplastic spinal instability.Results
A comprehensive classification system based on patient symptoms and radiographic criteria of the spine was developed to aid in predicting spine stability of neoplastic lesions. The classification system includes global spinal location of the tumor, type and presence of pain, bone lesion quality, spinal alignment, extent of vertebral body collapse, and posterolateral spinal element involvement. Qualitative scores were assigned based on relative importance of particular factors gleaned from the literature and refined by expert consensus.Conclusion
The Spine Instability Neoplastic Score is a comprehensive classification system with content validity that can guide clinicians in identifying when patients with neoplastic disease of the spine may benefit from surgical consultation. It can also aid surgeons in assessing the key components of spinal instability due to neoplasia and may become a prognostic tool for surgical decision-making when put in context with other key elements such as neurologic symptoms, extent of disease, prognosis, patient health factors, oncologic subtype, and radiosensitivity of the tumor.Item Open Access A strategy to advance the evidence base in palliative medicine: formation of a palliative care research cooperative group.(J Palliat Med, 2010-12) Abernethy, Amy P; Aziz, Noreen M; Basch, Ethan; Bull, Janet; Cleeland, Charles S; Currow, David C; Fairclough, Diane; Hanson, Laura; Hauser, Joshua; Ko, Danielle; Lloyd, Linda; Morrison, R Sean; Otis-Green, Shirley; Pantilat, Steve; Portenoy, Russell K; Ritchie, Christine; Rocker, Graeme; Wheeler, Jane L; Zafar, S Yousuf; Kutner, Jean SBACKGROUND: Palliative medicine has made rapid progress in establishing its scientific and clinical legitimacy, yet the evidence base to support clinical practice remains deficient in both the quantity and quality of published studies. Historically, the conduct of research in palliative care populations has been impeded by multiple barriers including health care system fragmentation, small number and size of potential sites for recruitment, vulnerability of the population, perceptions of inappropriateness, ethical concerns, and gate-keeping. METHODS: A group of experienced investigators with backgrounds in palliative care research convened to consider developing a research cooperative group as a mechanism for generating high-quality evidence on prioritized, clinically relevant topics in palliative care. RESULTS: The resulting Palliative Care Research Cooperative (PCRC) agreed on a set of core principles: active, interdisciplinary membership; commitment to shared research purposes; heterogeneity of participating sites; development of research capacity in participating sites; standardization of methodologies, such as consenting and data collection/management; agile response to research requests from government, industry, and investigators; focus on translation; education and training of future palliative care researchers; actionable results that can inform clinical practice and policy. Consensus was achieved on a first collaborative study, a randomized clinical trial of statin discontinuation versus continuation in patients with a prognosis of less than 6 months who are taking statins for primary or secondary prevention. This article describes the formation of the PCRC, highlighting processes and decisions taken to optimize the cooperative group's success.Item Open Access An Update on Surgical versus Expectant Management of Ovarian Endometriomas in Infertile Women.(BioMed research international, 2015-01) Keyhan, Sanaz; Hughes, Claude; Price, Thomas; Muasher, SuheilOvarian endometriomas are a common manifestation of endometriosis that can represent a more severe stage of the disease. There is much debate over the treatment of these cysts in infertile women, particularly before use of assisted reproductive technologies. Evidence exists that supports surgical excision of ovarian endometriomas, as well as evidence that cautions against surgical intervention. Certain factors need to be examined closely before proceeding with surgery or continuing with expectant management. These include the patient's symptoms, age, ovarian reserve, size and laterality of the cyst, prior surgical treatment, and level of suspicion for malignancy. The most recent evidence appears to suggest that certain patient profiles may benefit from proceeding directly to in vitro fertilization (IVF). These include symptomatic infertile patients, especially those that are older, those that have diminished ovarian reserve, those that have bilateral endometriomas, or those that have had prior surgical treatment. Although endometriomas can be detrimental to the ovarian reserve, surgical therapy may further lower a woman's ovarian reserve. Nevertheless, the presence of an endometrioma does not appear to adversely affect IVF outcomes, and surgical excision of endometriomas does not appear to improve IVF outcomes. Regardless of treatment plan, infertile patients with endometriomas must be counseled appropriately before choosing either treatment path.Item Open Access Assessing applicability when comparing medical interventions: AHRQ and the Effective Health Care Program.(Journal of clinical epidemiology, 2011-11) Atkins, David; Chang, Stephanie M; Gartlehner, Gerald; Buckley, David I; Whitlock, Evelyn P; Berliner, Elise; Matchar, DavidObjective
To describe a systematic approach for identifying, reporting, and synthesizing information to allow consistent and transparent consideration of the applicability of the evidence in a systematic review according to the Population, Intervention, Comparator, Outcome, Setting domains.Study design and setting
Comparative effectiveness reviews need to consider whether available evidence is applicable to specific clinical or policy questions to be useful to decision makers. Authors reviewed the literature and developed guidance for the Effective Health Care program.Results
Because applicability depends on the specific questions and needs of the users, it is difficult to devise a valid uniform scale for rating the overall applicability of individual studies or body of evidence. We recommend consulting stakeholders to identify the factors most relevant to applicability for their decisions. Applicability should be considered separately for benefits and harms. Observational studies can help determine whether trial populations and interventions are representative of "real world" practice. Reviewers should describe differences between available evidence and the ideally applicable evidence for the question being asked and offer a qualitative judgment about the importance and potential effect of those differences.Conclusion
Careful consideration of applicability may improve the usefulness of systematic reviews in informing practice and policy.Item Open Access Caveat emptor: the combined effects of multiplicity and selective reporting.(Trials, 2018-09-17) Li, Tianjing; Mayo-Wilson, Evan; Fusco, Nicole; Hong, Hwanhee; Dickersin, KayClinical trials and systematic reviews of clinical trials inform healthcare decisions. There is growing concern, however, about results from clinical trials that cannot be reproduced. Reasons for nonreproducibility include that outcomes are defined in multiple ways, results can be obtained using multiple methods of analysis, and trial findings are reported in multiple sources ("multiplicity"). Multiplicity combined with selective reporting can influence dissemination of trial findings and decision-making. In particular, users of evidence might be misled by exposure to selected sources and overly optimistic representations of intervention effects. In this commentary, drawing from our experience in the Multiple Data Sources in Systematic Reviews (MUDS) study and evidence from previous research, we offer practical recommendations to enhance the reproducibility of clinical trials and systematic reviews.Item Open Access Changing CHANGE: adaptations of an evidence-based telehealth cardiovascular disease risk reduction intervention.(Translational behavioral medicine, 2018-03) Zullig, Leah L; McCant, Felicia; Silberberg, Mina; Johnson, Fred; Granger, Bradi B; Bosworth, Hayden BRelatively few successful medication adherence interventions are translated into real-world clinical settings. The Prevention of Cardiovascular Outcomes in African Americans with Diabetes (CHANGE) intervention was originally conceived as a randomized controlled trial to improve cardiovascular disease-related medication adherence and health outcomes. The purpose of the study was to describe the translation of the CHANGE trial into two community-based clinical programs. CHANGE 2 was available to Medicaid patients with diabetes and hypertension whose primary care homes were part of a care management network in the Northern Piedmont region of North Carolina. CHANGE 3 was available to low-income patients receiving care in three geographical areas with multiple chronic conditions at low or moderate risk for developing cardiovascular disease. Adaptations were made to ensure fit with available organizational resources and the patient population's health needs. Data available for evaluation are presented. For CHANGE 2, we evaluated improvement in A1c control using paired t test. For both studies, we describe feasibility measured by percentage of patients who completed the curriculum. CHANGE 2 involved 125 participants. CHANGE 3 had 127 participants. In CHANGE 2, 69 participants had A1c measurements at baseline and 12-month follow-up; A1c improved from 8.4 to 7.8 (p = .008). In CHANGE 3, interventionists completed 47% (n = 45) of calls to enroll participants at the 4-month encounter, and among those eligible for a 12-month call (n = 52), 21% of 12-month calls were completed with participants. In CHANGE 2, 40% of participants (n = 50) completed all 12 encounters. Thoughtful adaptation is critical to translate clinical trials into community-based clinic settings. Successful implementation of adapted evidence-based interventions may be feasible and can positively affect patients' disease control.Item Open Access Chapter 11: challenges in and principles for conducting systematic reviews of genetic tests used as predictive indicators.(Journal of general internal medicine, 2012-06) Jonas, Daniel E; Wilt, Timothy J; Taylor, Brent C; Wilkins, Tania M; Matchar, David BIn this paper, we discuss common challenges in and principles for conducting systematic reviews of genetic tests. The types of genetic tests discussed are those used to 1). determine risk or susceptibility in asymptomatic individuals; 2). reveal prognostic information to guide clinical management in those with a condition; or 3). predict response to treatments or environmental factors. This paper is not intended to provide comprehensive guidance on evaluating all genetic tests. Rather, it focuses on issues that have been of particular concern to analysts and stakeholders and on areas that are of particular relevance for the evaluation of studies of genetic tests. The key points include: The general principles that apply in evaluating genetic tests are similar to those for other prognostic or predictive tests, but there are differences in how the principles need to be applied or the degree to which certain issues are relevant. A clear definition of the clinical scenario and an analytic framework is important when evaluating any test, including genetic tests. Organizing frameworks and analytic frameworks are useful constructs for approaching the evaluation of genetic tests. In constructing an analytic framework for evaluating a genetic test, analysts should consider preanalytic, analytic, and postanalytic factors; such factors are useful when assessing analytic validity. Predictive genetic tests are generally characterized by a delayed time between testing and clinically important events. Finding published information on the analytic validity of some genetic tests may be difficult. Web sites (FDA or diagnostic companies) and gray literature may be important sources. In situations where clinical factors associated with risk are well characterized, comparative effectiveness reviews should assess the added value of using genetic testing along with known factors compared with using the known factors alone. For genome-wide association studies, reviewers should determine whether the association has been validated in multiple studies to minimize both potential confounding and publication bias. In addition, reviewers should note whether appropriate adjustments for multiple comparisons were used.Item Open Access Chapter 1: Introduction to the Methods Guide for Medical Test Reviews.(Journal of general internal medicine, 2012-06) Matchar, David BEvaluation of medical tests presents challenges distinct from those involved in the evaluation of therapies; in particular, the very great importance of context and the dearth of comprehensive RCTs aimed at comparing the clinical outcomes of different tests and test strategies. Available guidance provides some suggestions: 1) Use of the PICOTS typology for clarifying the context relevant to the review, and 2) use of an organizing framework for classifying the types of medical test evaluation studies and their relationship to potential key questions. However, there is a diversity of recommendations for reviewers of medical tests and a proliferation of concepts, terms, and methods. As a contribution to the field, this Methods Guide for Medical Test Reviews seeks to provide practical guidance for achieving the goals of clarity, consistency, tractability, and usefulness.Item Open Access Chapter 5: assessing risk of bias as a domain of quality in medical test studies.(Journal of general internal medicine, 2012-06) Santaguida, P Lina; Riley, Crystal M; Matchar, David BAssessing methodological quality is a necessary activity for any systematic review, including those evaluating the evidence for studies of medical test performance. Judging the overall quality of an individual study involves examining the size of the study, the direction and degree of findings, the relevance of the study, and the risk of bias in the form of systematic error, internal validity, and other study limitations. In this chapter of the Methods Guide for Medical Test Reviews, we focus on the evaluation of risk of bias in the form of systematic error in an individual study as a distinctly important component of quality in studies of medical test performance, specifically in the context of estimating test performance (sensitivity and specificity). We make the following recommendations to systematic reviewers: 1) When assessing study limitations that are relevant to the test under evaluation, reviewers should select validated criteria that examine the risk of systematic error, 2) categorizing the risk of bias for individual studies as "low," "medium," or "high" is a useful way to proceed, and 3) methods for determining an overall categorization for the study limitations should be established a priori and documented clearly.Item Open Access Chapter 6: assessing applicability of medical test studies in systematic reviews.(Journal of general internal medicine, 2012-06) Hartmann, KE; Matchar, DB; Chang, SUse of medical tests should be guided by research evidence about the accuracy and utility of those tests in clinical care settings. Systematic reviews of the literature about medical tests must address applicability to real-world decision-making. Challenges for reviews include: (1) lack of clarity in key questions about the intended applicability of the review, (2) numerous studies in many populations and settings, (3) publications that provide too little information to assess applicability, (4) secular trends in prevalence and the spectrum of the condition for which the test is done, and (5) changes in the technology of the test itself. We describe principles for crafting reviews that meet these challenges and capture the key elements from the literature necessary to understand applicability.Item Open Access Chapter 7: grading a body of evidence on diagnostic tests.(Journal of general internal medicine, 2012-06) Singh, Sonal; Chang, Stephanie M; Matchar, David B; Bass, Eric BIntroduction
Grading the strength of a body of diagnostic test evidence involves challenges over and above those related to grading the evidence from health care intervention studies. This chapter identifies challenges and outlines principles for grading the body of evidence related to diagnostic test performance.Challenges
Diagnostic test evidence is challenging to grade because standard tools for grading evidence were designed for questions about treatment rather than diagnostic testing; and the clinical usefulness of a diagnostic test depends on multiple links in a chain of evidence connecting the performance of a test to changes in clinical outcomes.Principles
Reviewers grading the strength of a body of evidence on diagnostic tests should consider the principle domains of risk of bias, directness, consistency, and precision, as well as publication bias, dose response association, plausible unmeasured confounders that would decrease an effect, and strength of association, similar to what is done to grade evidence on treatment interventions. Given that most evidence regarding the clinical value of diagnostic tests is indirect, an analytic framework must be developed to clarify the key questions, and strength of evidence for each link in that framework should be graded separately. However if reviewers choose to combine domains into a single grade of evidence, they should explain their rationale for a particular summary grade and the relevant domains that were weighed in assigning the summary grade.Item Open Access Clinician's guide to the updated ABCs of cardiovascular disease prevention.(Journal of the American Heart Association, 2014-09) Kohli, Payal; Whelton, Seamus P; Hsu, Steven; Yancy, Clyde W; Stone, Neil J; Chrispin, Jonathan; Gilotra, Nisha A; Houston, Brian; Ashen, M Dominique; Martin, Seth S; Joshi, Parag H; McEvoy, John W; Gluckman, Ty J; Michos, Erin D; Blaha, Michael J; Blumenthal, Roger STo facilitate the guideline-based implementation of treatment recommendations in the ambulatory setting and to encourage participation in the multiple preventive health efforts that exist, we have organized several recent guideline updates into a simple ABCDEF approach. We would remind clinicians that evidence-based medicine is meant to inform recommendations but that synthesis of patient-specific data and use of appropriate clinical judgment in each individual situation is ultimately preferred.Item Open Access Commentary: Appropriate Use Criteria for Lumbar Degenerative Scoliosis: Developing Evidence-based Guidance for Complex Treatment Decisions.(Neurosurgery, 2017-03) Glassman, Steven D; Berven, Sigurd H; Shaffrey, Christopher I; Mummaneni, Praveen V; Polly, David WLumbar degenerative scoliosis is a relatively common problem, and is being treated more frequently due to the confluence of an aging population and an increased capacity and willingness to manage difficult problems in older patients. Lumbar degenerative scoliosis is a complex pathology as it often involves the intersection of degenerative spinal stenosis and spinal deformity. While previous studies provide an indication that these patients may benefit from surgical treatment, the substantial variability in treatment underscores the opportunity for improvement. Optimizing treatment for lumbar degenerative scoliosis is critical as surgical intervention, while potentially providing substantial clinical benefit also entails measurable risk and significant expense. In light of these issues, evidence-based guidance generated through Appropriate Use Criteria (AUC) development offers the potential to improve both the quality and cost effectiveness of care.The lumbar degenerative scoliosis AUC represents a significant step toward evidence-based treatment in spinal surgery. This is the first time that spine societies and industry partners have collaborated to support evidence development. The willingness of all involved to support a completely independent process underlines a commitment to trust the evidence. Subsequent studies may validate and/or refine the AUC recommendations, but the most important result is that the standard for evidence quality has been raised.Item Open Access Critical Review of Current Approaches for Echocardiographic Reproducibility and Reliability Assessment in Clinical Research.(Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography, 2016-12) Crowley, Anna Lisa; Yow, Eric; Barnhart, Huiman X; Daubert, Melissa A; Bigelow, Robert; Sullivan, Daniel C; Pencina, Michael; Douglas, Pamela SBackground
There is no broadly accepted standard method for assessing the quality of echocardiographic measurements in clinical research reports, despite the recognized importance of this information in assessing the quality of study results.Methods
Twenty unique clinical studies were identified reporting echocardiographic data quality for determinations of left ventricular (LV) volumes (n = 13), ejection fraction (n = 12), mass (n = 9), outflow tract diameter (n = 3), and mitral Doppler peak early velocity (n = 4). To better understand the range of possible estimates of data quality and to compare their utility, reported reproducibility measures were tabulated, and de novo estimates were then calculated for missing measures, including intraclass correlation coefficient (ICC), 95% limits of agreement, coefficient of variation (CV), coverage probability, and total deviation index, for each variable for each study.Results
The studies varied in approaches to reproducibility testing, sample size, and metrics assessed and values reported. Reported metrics included mean difference and its SD (n = 7 studies), ICC (n = 5), CV (n = 4), and Bland-Altman limits of agreement (n = 4). Once de novo estimates of all missing indices were determined, reasonable reproducibility targets for each were identified as those achieved by the majority of studies. These included, for LV end-diastolic volume, ICC > 0.95, CV < 7%, and coverage probability > 0.93 within 30 mL; for LV ejection fraction, ICC > 0.85, CV < 8%, and coverage probability > 0.85 within 10%; and for LV mass, ICC > 0.85, CV < 10%, and coverage probability > 0.60 within 20 g.Conclusions
Assessment of data quality in echocardiographic clinical research is infrequent, and methods vary substantially. A first step to standardizing echocardiographic quality reporting is to standardize assessments and reporting metrics. Potential benefits include clearer communication of data quality and the identification of achievable targets to benchmark quality improvement initiatives.Item Open Access Developing Treatment Guidelines During a Pandemic Health Crisis: Lessons Learned From COVID-19.(Annals of internal medicine, 2021-08) Kuriakose, Safia; Singh, Kanal; Pau, Alice K; Daar, Eric; Gandhi, Rajesh; Tebas, Pablo; Evans, Laura; Gulick, Roy M; Lane, H Clifford; Masur, Henry; NIH COVID-19 Treatment Guidelines Panel; Aberg, Judith A; Adimora, Adaora A; Baker, Jason; Kreuziger, Lisa Baumann; Bedimo, Roger; Belperio, Pamela S; Cantrill, Stephen V; Coopersmith, Craig M; Davis, Susan L; Dzierba, Amy L; Gallagher, John J; Glidden, David V; Grund, Birgit; Hardy, Erica J; Hinkson, Carl; Hughes, Brenna L; Johnson, Steven; Keller, Marla J; Kim, Arthur Y; Lennox, Jeffrey L; Levy, Mitchell M; Li, Jonathan Z; Martin, Greg S; Naggie, Susanna; Pavia, Andrew T; Seam, Nitin; Simpson, Steven Q; Swindells, Susan; Tien, Phyllis; Waghmare, Alpana A; Wilson, Kevin C; Yazdany, Jinoos; Zachariah, Philip; Campbell, Danielle M; Harrison, Carly; Burgess, Timothy; Francis, Joseph; Sheikh, Virginia; Uyeki, Timothy M; Walker, Robert; Brooks, John T; Ortiz, Laura Bosque; Davey, Richard T; Doepel, Laurie K; Eisinger, Robert W; Han, Alison; Higgs, Elizabeth S; Nason, Martha C; Crew, Page; Lerner, Andrea M; Lund, Claire; Worthington, ChristopherThe development of the National Institutes of Health (NIH) COVID-19 Treatment Guidelines began in March 2020 in response to a request from the White House Coronavirus Task Force. Within 4 days of the request, the NIH COVID-19 Treatment Guidelines Panel was established and the first meeting took place (virtually-as did subsequent meetings). The Panel comprises 57 individuals representing 6 governmental agencies, 11 professional societies, and 33 medical centers, plus 2 community members, who have worked together to create and frequently update the guidelines on the basis of evidence from the most recent clinical studies available. The initial version of the guidelines was completed within 2 weeks and posted online on 21 April 2020. Initially, sparse evidence was available to guide COVID-19 treatment recommendations. However, treatment data rapidly accrued based on results from clinical studies that used various study designs and evaluated different therapeutic agents and approaches. Data have continued to evolve at a rapid pace, leading to 24 revisions and updates of the guidelines in the first year. This process has provided important lessons for responding to an unprecedented public health emergency: Providers and stakeholders are eager to access credible, current treatment guidelines; governmental agencies, professional societies, and health care leaders can work together effectively and expeditiously; panelists from various disciplines, including biostatistics, are important for quickly developing well-informed recommendations; well-powered randomized clinical trials continue to provide the most compelling evidence to guide treatment recommendations; treatment recommendations need to be developed in a confidential setting free from external pressures; development of a user-friendly, web-based format for communicating with health care providers requires substantial administrative support; and frequent updates are necessary as clinical evidence rapidly emerges.Item Open Access Effect of a Multifaceted Quality Improvement Intervention on Hospital Personnel Adherence to Performance Measures in Patients With Acute Ischemic Stroke in China: A Randomized Clinical Trial.(JAMA, 2018-07) Wang, Yilong; Li, Zixiao; Zhao, Xingquan; Wang, Chunjuan; Wang, Xianwei; Wang, David; Liang, Li; Liu, Liping; Wang, Chunxue; Li, Hao; Shen, Haipeng; Bettger, Janet; Pan, Yuesong; Jiang, Yong; Yang, Xiaomeng; Zhang, Changqing; Han, Xiujie; Meng, Xia; Yang, Xin; Kang, Hong; Yuan, Weiqiang; Fonarow, Gregg C; Peterson, Eric D; Schwamm, Lee H; Xian, Ying; Wang, Yongjun; GOLDEN BRIDGE—AIS InvestigatorsIn China and other parts of the world, hospital personnel adherence to evidence-based stroke care is limited.To determine whether a multifaceted quality improvement intervention can improve hospital personnel adherence to evidence-based performance measures in patients with acute ischemic stroke (AIS) in China.A multicenter, cluster-randomized clinical trial among 40 public hospitals in China that enrolled 4800 patients hospitalized with AIS from August 10, 2014, through June 20, 2015, with 12-month follow-up through July 30, 2016.Twenty hospitals received a multifaceted quality improvement intervention (intervention group; 2400 patients), including a clinical pathway, care protocols, quality coordinator oversight, and performance measure monitoring and feedback. Twenty hospitals participated in the stroke registry with usual care (control group; 2400 patients).The primary outcome was hospital personnel adherence to 9 AIS performance measures, with co-primary outcomes of a composite of percentage of performance measures adhered to, and as all-or-none. Secondary outcomes included in-hospital mortality and long-term outcomes (a new vascular event, disability [modified Rankin Scale score, 3-5], and all-cause mortality) at 3, 6, and 12 months.Among 4800 patients with AIS enrolled from 40 hospitals and randomized (mean age, 65 years; women, 1757 [36.6%]), 3980 patients (82.9%) completed the 12-month follow-up of the trial. Patients in intervention group were more likely to receive performance measures than those in the control groups (composite measure, 88.2% vs 84.8%, respectively; absolute difference, 3.54% [95% CI, 0.68% to 6.40%], P = .02). The all-or-none measure did not significantly differ between the intervention and control groups (53.8% vs 47.8%, respectively; absolute difference, 6.69% [95% CI, -0.41% to 13.79%], P = .06). New clinical vascular events were significantly reduced in the intervention group compared with the control group at 3 months (3.9% vs 5.3%, respectively; difference, -2.03% [95% CI, -3.51% to -0.55%]; P = .007), 6 months (6.3% vs 7.8%, respectively; difference, -2.18% [95% CI, -4.0% to -0.35%]; P = .02) and 12 months (9.1% vs 11.8%, respectively; difference, -3.13% [95% CI, -5.28% to -0.97%]; P = .005).Among 40 hospitals in China, a multifaceted quality improvement intervention compared with usual care resulted in a statistically significant but small improvement in hospital personnel adherence to evidence-based performance measures in patients with acute ischemic stroke when assessed as a composite measure, but not as an all-or-none measure. Further research is needed to understand the generalizability of these findings.ClinicalTrials.gov Identifier: NCT02212912.Item Open Access Effective Implementation of Enhanced Recovery Pathway Programs: The Key to Disseminating Evidence into Practice.(Jt Comm J Qual Patient Saf, 2015-10) Hopkins, Thomas J; Miller, Timothy EItem Open Access Effectiveness of spinal fusion versus structured rehabilitation in chronic low back pain patients with and without isthmic spondylolisthesis: a systematic review.(Spine, 2011-10) Wood, Kirkham B; Fritzell, Peter; Dettori, Joseph R; Hashimoto, Robin; Lund, Teija; Shaffrey, ChrisStudy design
Systematic review.Objective
To determine if the presence of isthmic spondylolisthesis modifies the effect of treatment (fusion vs. multidimensional supervised rehabilitation) in patients with chronic low back pain (CLBP).Summary of background data
Results of spinal surgery for CLBP are variable. It is unclear whether patients with CLBP and isthmic spondylolisthesis have more success with surgery versus a multidimensional supervised rehabilitation program when compared with those with CLBP but without spondylolisthesis.Methods
A systematic search was conducted in MEDLINE and the Cochrane Collaboration Library for articles published through January 2011. Randomized controlled trials (RCTs) were included that compared spine fusion versus multidimensional supervised rehabilitation in patients with and without isthmic spondylolisthesis. Standardized mean differences (SMDs) and risk differences were calculated for common outcomes, and then compared to determine potential heterogeneity of treatment effect. The final strength of the body of literature was expressed as "high," "moderate," or "low" confidence that the evidence reflects the true effect.Results
No studies were found that directly compared the two subgroups. Three RCTs compared fusion with supervised nonoperative care in patients with CLBP without isthmic spondylolisthesis; one RCT evaluated these treatments in patients with isthmic spondylolisthesis. There were study differences in patient characteristics, type of fusion, the nature of the rehabilitation, outcomes assessed, and length of follow-up. The SMDs for pain in favor of fusion were modest at 2 years for those without isthmic spondylolisthesis, but large in favor of fusion for those with isthmic spondylolisthesis compared with rehabilitation. Similarly, the SMDs for function in patients without isthmic spondylolisthesis compared with rehabilitation was small at 2 years, but appreciably higher in favor of fusion in patients with isthmic spondylolisthesis.Conclusion
The overall strength of evidence evaluating whether the presence of isthmic spondylolisthesis modifies the effect of fusion compared with rehabilitation patients with CLBP is "low." Fusion should be considered for patients with low back pain and isthmic spondylolisthesis who have failed nonoperative treatment.Clinical recommendations
We recommend considering fusion for patients with isthmic spondylolisthesis and lower back pain who have failed nonoperative treatment.Recommendation
Weak.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.