RESUMO
AIM: The "2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease" provides recommendations to guide clinicians in the treatment of patients with lower extremity peripheral artery disease across its multiple clinical presentation subsets (ie, asymptomatic, chronic symptomatic, chronic limb-threatening ischemia, and acute limb ischemia). METHODS: A comprehensive literature search was conducted from October 2020 to June 2022, encompassing studies, reviews, and other evidence conducted on human subjects that was published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through May 2023 during the peer review process, were also considered by the writing committee and added to the evidence tables where appropriate. STRUCTURE: Recommendations from the "2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with peripheral artery disease have been developed.
Assuntos
American Heart Association , Extremidade Inferior , Doença Arterial Periférica , Humanos , Doença Arterial Periférica/terapia , Doença Arterial Periférica/diagnóstico , Extremidade Inferior/irrigação sanguínea , Estados Unidos , Cardiologia/normasRESUMO
Little is known about the acute changes in cutaneous microvascular function that occur in response to exercise, the accumulation of which may provide the basis for beneficial chronic cutaneous vascular adaptations. Therefore, we examined the effects of acute exercise on cutaneous thermal hyperaemia. Twelve healthy, recreationally active participants (11 male, 1 female) performed 30-minute cycling at 50 % (low-intensity exercise, LOW) or 75 % (high-intensity exercise, HIGH) maximum heart rate. Laser Doppler flowmetry (LDF) and rapid local skin heating were used to quantify cutaneous thermal hyperaemia before (PRE), immediately following (IMM) and 1-h (1HR) after exercise. Baseline, axon reflex peak, axon reflex nadir, plateau, maximum skin blood flow responses to rapid local heating (42 °C for 30-min followed by 44 °C for 15-min) at each stage were assessed and indexed as cutaneous vascular conductance [CVC = flux / mean arterial blood pressure (MAP), PU·mm Hg-1], and expressed as a percentage of maximum (%CVCmax). Exercise increased heart rate (HR), MAP and skin blood flow (all P < 0.001), and to a greater extent during HIGH (all P < 0.001). The axon reflex peak and nadir were increased immediately and 1-h after exercise (all comparisons P < 0.01 vs. PRE), which did not differ between intensities (peak: P = 0.34, axon reflex nadir: P = 0.91). The endothelium-dependent plateau response was slightly elevated after exercise (P = 0.06), with no effect of intensity (P = 0.58) nor any interaction effect (P = 0.55). CONCLUSION: Exercise increases cutaneous microvascular axonal responses to local heating for up to 1-h, suggesting an augmented sensory afferent function post-exercise. Acute exercise may only modestly affect endothelial function in cutaneous microcirculation.
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Hiperemia , Humanos , Masculino , Feminino , Vasodilatação , Pele/irrigação sanguínea , Administração Cutânea , Exercício Físico , Fluxo Sanguíneo Regional , Fluxometria por Laser-DopplerRESUMO
BACKGROUND: The development of rigorous, high-quality clinical guidelines increases the need for resources and skilled personnel within guideline-producing organizations. While collaboration between organizations provides a unique opportunity to pool resources and save time and effort, the collaboration presents its own unique challenges. OBJECTIVE: To assess the perceived needs and current challenges of guideline producers worldwide related to guideline development and collaboration efforts. DESIGN: Survey questions were developed by the Guidelines International Network and the US GRADE Network, pilot-tested among attendees of a guideline development workshop, and disseminated electronically using convenience and snowball sampling methods. PARTICIPANTS: A total of 171 respondents representing 30 countries and more than 112 unique organizations were included in this analysis. MAIN MEASURES: The survey included free-response, multiple-choice, and seven-point Likert-scale questions. Questions assessed respondents' perceived value of guidelines, resource availability and needs, guideline development processes, and collaboration efforts of their organization. KEY RESULTS: Time required to develop high-quality systematic reviews and guidelines was the most relevant need (median=7; IQR=5.5-7). In-house resources to conduct literature searches (median=4; IQR=3-6) and the resources to develop rigorous guidelines rapidly (median=4; IQR=2-5) were perceived as the least available resources. Difficulties reconciling differences in guideline methodology (median=6; IQR=4-7) and the time required to establish collaborative agreements (median=6; IQR=5-6) were the most relevant barriers to collaboration between organizations. Results also indicated a general need for improvement in conflict of interest (COI) disclosure policies. CONCLUSION: The survey identified organizational challenges in supporting rigorous guideline development, including the time, resources, and personnel required. Connecting guideline developers to existing databases of high-quality systematic reviews and the use of freely available online platforms may facilitate guideline development. Guideline-producing organizations may also consider allocating resources to hiring or training personnel with expertise in systematic review methodologies or utilizing resources more effectively by establishing collaborations with other organizations.
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Conflito de Interesses , Medicina Baseada em Evidências , Revelação , Medicina Baseada em Evidências/métodos , Humanos , Avaliação das Necessidades , Inquéritos e QuestionáriosRESUMO
OBJECTIVE: To update the 1995 American Academy of Neurology (AAN) practice parameter on persistent vegetative state and the 2002 case definition on minimally conscious state (MCS) and provide care recommendations for patients with prolonged disorders of consciousness (DoC). METHODS: Recommendations were based on systematic review evidence, related evidence, care principles, and inferences using a modified Delphi consensus process according to the AAN 2011 process manual, as amended. RECOMMENDATIONS: Clinicians should identify and treat confounding conditions, optimize arousal, and perform serial standardized assessments to improve diagnostic accuracy in adults and children with prolonged DoC (Level B). Clinicians should counsel families that for adults, MCS (vs vegetative state [VS]/ unresponsive wakefulness syndrome [UWS]) and traumatic (vs nontraumatic) etiology are associated with more favorable outcomes (Level B). When prognosis is poor, long-term care must be discussed (Level A), acknowledging that prognosis is not universally poor (Level B). Structural MRI, SPECT, and the Coma Recovery Scale-Revised can assist prognostication in adults (Level B); no tests are shown to improve prognostic accuracy in children. Pain always should be assessed and treated (Level B) and evidence supporting treatment approaches discussed (Level B). Clinicians should prescribe amantadine (100-200 mg bid) for adults with traumatic VS/UWS or MCS (4-16 weeks post injury) to hasten functional recovery and reduce disability early in recovery (Level B). Family counseling concerning children should acknowledge that natural history of recovery, prognosis, and treatment are not established (Level B). Recent evidence indicates that the term chronic VS/UWS should replace permanent VS, with duration specified (Level B). Additional recommendations are included.
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Transtornos da Consciência , Assistência de Longa Duração/normas , Neurologia/normas , Medicina Física e Reabilitação/normas , Adulto , Criança , Feminino , Humanos , Vida Independente , Masculino , Estado Vegetativo Persistente , Pesquisa de ReabilitaçãoRESUMO
OBJECTIVE: To update the 1995 American Academy of Neurology (AAN) practice parameter on persistent vegetative state and the 2002 case definition for the minimally conscious state (MCS) by reviewing the literature on the diagnosis, natural history, prognosis, and treatment of disorders of consciousness lasting at least 28 days. METHODS: Articles were classified per the AAN evidence-based classification system. Evidence synthesis occurred through a modified Grading of Recommendations Assessment, Development and Evaluation process. Recommendations were based on evidence, related evidence, care principles, and inferences according to the AAN 2011 process manual, as amended. RESULTS: No diagnostic assessment procedure had moderate or strong evidence for use. It is possible that a positive EMG response to command, EEG reactivity to sensory stimuli, laser-evoked potentials, and the Perturbational Complexity Index can distinguish MCS from vegetative state/unresponsive wakefulness syndrome (VS/UWS). The natural history of recovery from prolonged VS/UWS is better in traumatic than nontraumatic cases. MCS is generally associated with a better prognosis than VS (conclusions of low to moderate confidence in adult populations), and traumatic injury is generally associated with a better prognosis than nontraumatic injury (conclusions of low to moderate confidence in adult and pediatric populations). Findings concerning other prognostic features are stratified by etiology of injury (traumatic vs nontraumatic) and diagnosis (VS/UWS vs MCS) with low to moderate degrees of confidence. Therapeutic evidence is sparse. Amantadine probably hastens functional recovery in patients with MCS or VS/UWS secondary to severe traumatic brain injury over 4 weeks of treatment. Recommendations are presented separately.
Assuntos
Transtornos da Consciência , Neurologia/normas , Estado Vegetativo Persistente , Medicina Física e Reabilitação/normas , Guias de Prática Clínica como Assunto , Adulto , Criança , Feminino , Humanos , Vida Independente , Masculino , Prognóstico , Pesquisa de ReabilitaçãoRESUMO
BACKGROUND: Clinical guidelines support decision-making at the point-of-care but the onus is often on individual users such as physicians to implement them. Research shows that the inclusion of implementation tools in or with guidelines (GItools) is associated with guideline use. However, there is little research on which GItools best support implementation by individual physicians. The purpose of this study was to investigate naturalistic access and use of GItools produced by the American Academy of Neurology (AAN) to inform future tool development. METHODS: Website accesses over six months were summarized for eight AAN guidelines and associated GItools published between July 2012 and August 2013. Academy members were surveyed about use of tools accompanying the sport concussion guideline. Data were analyzed using summary statistics and the Chi-square test. RESULTS: The clinician summary was accessed more frequently (29.0%, p < 0.001) compared with the slide presentation (26.8%), patient summary (23.2%) or case study (20.9%), although this varied by guideline topic. For the sport concussion guideline, which was accompanied by a greater variety of GItools, the mobile phone quick reference check application was most frequently accessed, followed by the clinician summary, patient summary, and slide presentation. For the sports concussion guideline survey, most respondents (response rate 21.8%, 168/797) were aware of the guideline (88.1%) and had read the guideline (78.6%). For GItool use, respondents indicated reading the reference card (51.2%), clinician summary (45.2%), patient summary (28.0%), mobile phone application (26.2%), and coach/athletic trainer summary (20.2%). Patterns of sports concussion GItool use were similar between respondents who said they had and had not yet implemented the guideline. CONCLUSIONS: Developers faced with resource limitations may wish to prioritize the development of printable or mobile application clinician summaries, which were accessed significantly more than other types of GItools. Further research is needed to understand how to optimize the design of such GItools.
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Sistemas de Apoio a Decisões Clínicas/estatística & dados numéricos , Aplicações da Informática Médica , Médicos/estatística & dados numéricos , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/estatística & dados numéricos , Humanos , Neurologia/normas , Sociedades Médicas/normasRESUMO
BACKGROUND: Uncompensated vestibular hypofunction results in postural instability, visual blurring with head movement, and subjective complaints of dizziness and/or imbalance. We sought to answer the question, "Is vestibular exercise effective at enhancing recovery of function in people with peripheral (unilateral or bilateral) vestibular hypofunction?" METHODS: A systematic review of the literature was performed in 5 databases published after 1985 and 5 additional sources for relevant publications were searched. Article types included meta-analyses, systematic reviews, randomized controlled trials, cohort studies, case control series, and case series for human subjects, published in English. One hundred thirty-five articles were identified as relevant to this clinical practice guideline. RESULTS/DISCUSSION: Based on strong evidence and a preponderance of benefit over harm, clinicians should offer vestibular rehabilitation to persons with unilateral and bilateral vestibular hypofunction with impairments and functional limitations related to the vestibular deficit. Based on strong evidence and a preponderance of harm over benefit, clinicians should not include voluntary saccadic or smooth-pursuit eye movements in isolation (ie, without head movement) as specific exercises for gaze stability. Based on moderate evidence, clinicians may offer specific exercise techniques to target identified impairments or functional limitations. Based on moderate evidence and in consideration of patient preference, clinicians may provide supervised vestibular rehabilitation. Based on expert opinion extrapolated from the evidence, clinicians may prescribe a minimum of 3 times per day for the performance of gaze stability exercises as 1 component of a home exercise program. Based on expert opinion extrapolated from the evidence (range of supervised visits: 2-38 weeks, mean = 10 weeks), clinicians may consider providing adequate supervised vestibular rehabilitation sessions for the patient to understand the goals of the program and how to manage and progress themselves independently. As a general guide, persons without significant comorbidities that affect mobility and with acute or subacute unilateral vestibular hypofunction may need once a week supervised sessions for 2 to 3 weeks; persons with chronic unilateral vestibular hypofunction may need once a week sessions for 4 to 6 weeks; and persons with bilateral vestibular hypofunction may need once a week sessions for 8 to 12 weeks. In addition to supervised sessions, patients are provided a daily home exercise program. DISCLAIMER: These recommendations are intended as a guide for physical therapists and clinicians to optimize rehabilitation outcomes for persons with peripheral vestibular hypofunction undergoing vestibular rehabilitation.Video Abstract available for more insights from the author (see Video, Supplemental Digital Content 1, http://links.lww.com/JNPT/A124).
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Tontura/reabilitação , Prática Clínica Baseada em Evidências , Doenças Vestibulares/reabilitação , Humanos , Modalidades de Fisioterapia , Equilíbrio Postural , Resultado do Tratamento , Doenças Vestibulares/fisiopatologiaRESUMO
BACKGROUND: Evidence-based clinical practice guidelines (CPGs) are statements that provide recommendations to optimize patient care for a specific clinical problem or question. Merely reading a guideline rarely leads to implementation of recommendations. The American Academy of Neurology (AAN) has a formal process of guideline development and dissemination. The last few years have seen a burgeoning of social media such as Facebook, Twitter, and LinkedIn, and newer methods of dissemination such as podcasts and webinars. The role of these media in guideline dissemination has not been studied. Systematic evaluation of dissemination methods and comparison of the effectiveness of newer methods with traditional methods is not available. It is also not known whether specific dissemination methods may be more effectively targeted to specific audiences. OBJECTIVE: Our aim was to (1) develop an innovative dissemination strategy by adding social media-based dissemination methods to traditional methods for the AAN clinical practice guidelines "Complementary and alternative medicine in multiple sclerosis" ("CAM in MS") and (2) evaluate whether the addition of social media outreach improves awareness of the CPG and knowledge of CPG recommendations, and affects implementation of those recommendations. METHODS: Outcomes were measured by four surveys in each of the two target populations: patients and physicians/clinicians ("physicians"). The primary outcome was the difference in participants' intent to discuss use of complementary and alternative medicine (CAM) with their physicians or patients, respectively, after novel dissemination, as compared with that after traditional dissemination. Secondary outcomes were changes in awareness of the CPG, knowledge of CPG content, and behavior regarding CAM use in multiple sclerosis (MS). RESULTS: Response rates were 25.08% (622/2480) for physicians and 43.5% (348/800) for patients. Awareness of the CPG increased after traditional dissemination (absolute difference, 95% confidence interval: physicians 36%, 95% CI 25-46, and patients 10%, 95% CI 1-11) but did not increase further after novel dissemination (physicians 0%, 95% CI -11 to 11, and patients -4%, 95% CI -6 to 14). Intent to discuss CAM also increased after traditional dissemination but did not change after novel dissemination (traditional: physicians 12%, 95% CI 2-22, and patients 19%, 95% CI 3-33; novel: physicians 11%, 95% CI -1 to -21, and patients -8%, 95% CI -22 to 8). Knowledge of CPG recommendations and behavior regarding CAM use in MS did not change after either traditional dissemination or novel dissemination. CONCLUSIONS: Social media-based dissemination methods did not confer additional benefit over print-, email-, and Internet-based methods in increasing CPG awareness and changing intent in physicians or patients. Research on audience selection, message formatting, and message delivery is required to utilize Web 2.0 technologies optimally for dissemination.
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Terapias Complementares/estatística & dados numéricos , Disseminação de Informação/métodos , Esclerose Múltipla/terapia , Guias de Prática Clínica como Assunto , Mídias Sociais , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-IdadeRESUMO
AIM: The "2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease" provides recommendations to guide clinicians in the treatment of patients with lower extremity peripheral artery disease across its multiple clinical presentation subsets (ie, asymptomatic, chronic symptomatic, chronic limb-threatening ischemia, and acute limb ischemia). METHODS: A comprehensive literature search was conducted from October 2020 to June 2022, encompassing studies, reviews, and other evidence conducted on human subjects that was published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through May 2023 during the peer review process, were also considered by the writing committee and added to the evidence tables where appropriate. STRUCTURE: Recommendations from the "2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with peripheral artery disease have been developed.
Assuntos
American Heart Association , Extremidade Inferior , Doença Arterial Periférica , Humanos , Doença Arterial Periférica/terapia , Doença Arterial Periférica/diagnóstico , Extremidade Inferior/irrigação sanguínea , Estados Unidos , Cardiologia/normas , Sociedades Médicas/normasRESUMO
BACKGROUND: A number of jurisdictions have instituted legislation requiring an independent person to be present during police interviews with vulnerable people. In Victoria, Australia, a group of volunteers known as independent third persons help to fulfil this role with people who present with cognitive impairment arising from their mental illness or disability. This study sought to explore the perspectives of the Independent Third Person volunteers on police identification of and responses to people with intellectual disability (ID). METHODS: All registered Independent Third Person volunteers across the State of Victoria in Australia were identified and sent a postal survey on their experiences and confidence in performing their role, their perceptions of police competency, and the challenges they faced working at this interface. RESULTS: Of the 207 Independent Third Persons identified, 94 (45%) completed and returned the survey. Participants reported that despite being overly reliant on previous police contacts and cues relating to communication difficulties, they viewed police as generally competent in their ability to identify people with ID. They also considered themselves confident in performing their own roles at this interface, albeit more so at the perfunctory aspects of the role and less so with the emotional aspects of supporting the person being interviewed. CONCLUSIONS: Police are seen as competent at identifying those with cognitive deficits and seeking appropriate supports for the person with ID in the interview context. More specialised training for police members is recommended in communicating with people with IDs. Volunteers working at this interface require additional support and training in helping to meet the emotional needs of those being interviewed.
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Deficiência Intelectual , Transtornos Mentais , Defesa do Paciente/legislação & jurisprudência , Polícia/legislação & jurisprudência , Idoso , Coleta de Dados , Feminino , Direitos Humanos/legislação & jurisprudência , Humanos , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Polícia/educação , VitóriaRESUMO
OBJECTIVE: To examine the relationship between committing homicide, the presence of schizophrenia, substance misuse and past criminality. METHOD: The study employed a data linkage design, using contacts recorded on two statewide databases, one of which recorded public mental health services contacts and the second of which recorded contacts with the police. The estimated rates of schizophrenia disorders, substance abuse and criminal convictions found among a population of 435 homicide offenders were contrasted with estimated rates in two composite comparison samples. RESULTS: Of the 435 offenders, 38 (8.7%) had been diagnosed with a schizophrenia disorder, which was RR 13.11 (95% CI 9.14-18.80) times more likely than a comparison sample. Rates of known substance abuse between homicide offenders with and without schizophrenia and community-dwelling residents with schizophrenia did not differ significantly. However, these rates were higher than those found in the general community. A similar pattern emerged for comparisons regarding offending histories between these same groups. CONCLUSION: The association between homicidal violence and having a schizophrenia disorder cannot be explained away simply on the basis of either comorbid substance abuse or prior criminal offending.
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Homicídio , Polícia/estatística & dados numéricos , Esquizofrenia , Transtornos Relacionados ao Uso de Substâncias , Violência/psicologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Austrália/epidemiologia , Psiquiatria Comunitária/métodos , Comorbidade , Criminosos/psicologia , Coleta de Dados , Feminino , Psiquiatria Legal/métodos , Homicídio/psicologia , Homicídio/estatística & dados numéricos , Humanos , Masculino , Notificação de Abuso , Pessoa de Meia-Idade , Medição de Risco , Esquizofrenia/complicações , Esquizofrenia/epidemiologia , Transtornos Relacionados ao Uso de Substâncias/complicações , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Violência/estatística & dados numéricos , Adulto JovemRESUMO
PURPOSE: One of the recently published concepts that combine the soft-tissue imaging capabilities of MRI with external beam radiotherapy involves the rigid coupling of a linac with a rotating biplanar low-field MR imaging system. While such a system would prevent possible image distortion resulting from relative motion between the magnet and the linac, the rotation of the magnet around the patient can itself introduce possibilities for image distortion that need to be addressed. While there are straightforward techniques in the literature for correcting distortions from gradient nonlinearities and nonuniform magnetic fields during image reconstruction, the correction of distortions related to tissue magnetic susceptibility is more complex. This work investigates the extent of this latter distortion type under the regime of a rotating magnetic field. METHODS: CT images covering patient anatomy in the head, lung, and male pelvic regions were obtained and segmented into components of air, bone, and soft tissue. Each of these three components was assigned bulk magnetic susceptibility values in accordance with those found in the literature. A finite-difference algorithm was then implemented to solve for magnetic field distortion maps should the anatomies be placed in the uniform polarizing field of an MR system. The algorithm was repeated multiple times as the polarizing field was rotated axially about the virtual patient in 15 degrees increments. In this way, a map of maximum distortion, and the range of distortion as the magnetic field is rotated about each anatomical region could be determined. The consequence of these susceptibility distortions in terms of geometric signal shift was calculated for 0.2 T, as well as another low-field system (0.5 T), and a higher field 1.5 T system for comparison, using the assumption of a frequency encoding gradient strength of 5 mT/m. RESULTS: At 0.2 T, the susceptibility-related distortion was limited to less than 0.5 mm given an encoding gradient strength of 5 mT/m or higher. To maintain this same level of geometric accuracy, the 0.5 T system would require a moderately higher minimum gradient strength of 11 mT/m, and at a typical MR field strength of 1.5 T this minimum gradient strength would increase to 33 mT/m. The influence of magnetic susceptibility on mean frequency shift as the field orientation was rotated was also investigated and found to account for less than half a millimeter at 1.5 T, and negligible for low-field systems. CONCLUSIONS: A study of three sites (head, lung, and prostate) that are vulnerable to magnetic susceptibility-related distortions were studied, and showed that in the context of a rotating polarizing magnet, low-field systems can maintain geometric accuracy of 0.5 mm with at most moderate limitations on sequence parameters. This conclusion will likely apply only to endogenous tissues, as implanted materials such as titanium can create field distortions much in excess of what may normally be induced in the body. Items containing such materials (hip prostheses, for example) will require individual scrutiny.
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Imageamento por Ressonância Magnética/instrumentação , Radioterapia/instrumentação , Algoritmos , Simulação por Computador , Desenho de Equipamento , Cabeça/patologia , Humanos , Processamento de Imagem Assistida por Computador , Pulmão/patologia , Imageamento por Ressonância Magnética/métodos , Magnetismo , Masculino , Próstata/patologia , Radioterapia/métodos , Reprodutibilidade dos Testes , Titânio/química , Tomografia Computadorizada por Raios X/métodosRESUMO
INTRODUCTION: The high failure rate of clinical trials in traumatic brain injury (TBI) may be attributable, in part, to the use of untested or insensitive measurement instruments. Of more than 1,000 clinical outcome assessment measures (COAs) for TBI, few have been systematically vetted to determine their performance within specific "contexts of use (COU)." As described in guidance issued by the U.S. Food and Drug Administration (FDA), the COU specifies the population of interest and the purpose for which the COA will be employed. COAs are commonly used for screening, diagnostic categorization, outcome prediction, and establishing treatment effectiveness. COA selection typically relies on expert consensus; there is no established methodology to match the appropriateness of a particular COA to a specific COU. We developed and pilot-tested the Evidence-Based Clinical Outcome assessment Platform (EB-COP) to systematically and transparently evaluate the suitability of TBI COAs for specific purposes. METHODS AND FINDINGS: Following a review of existing literature and published guidelines on psychometric standards for COAs, we developed a 6-step, semi-automated, evidence-based assessment platform to grade COA performance for six specific purposes: diagnosis, symptom detection, prognosis, natural history, subgroup stratification and treatment effectiveness. Mandatory quality indicators (QIs) were identified for each purpose using a modified Delphi consensus-building process. The EB-COP framework was incorporated into a Qualtrics software platform and pilot-tested on the Glasgow Outcome Scale-Extended (GOSE), the most widely-used COA in TBI clinical studies. CONCLUSION: The EB-COP provides a systematic methodology for conducting more precise, evidence-based assessment of COAs by evaluating performance within specific COUs. The EB-COP platform was shown to be feasible when applied to a TBI COA frequently used to detect treatment effects and can be modified to address other populations and COUs. Additional testing and validation of the EB-COP are warranted.
Assuntos
Lesões Encefálicas Traumáticas/diagnóstico , Lesões Encefálicas Traumáticas/terapia , Ensaios Clínicos como Assunto , Medicina Baseada em Evidências , Avaliação de Resultados em Cuidados de Saúde , Humanos , Prognóstico , Psicometria , SoftwareRESUMO
Postimplant evaluation of prostate brachytherapy using magnetic resonance imaging (MRI) at 1.5 T has met with some difficulties due to the uncertainty associated with seed localization despite the excellent anatomical delineation this imaging modality can achieve. Seeds in vascularized regions or outside the prostate, where signal heterogeneity or drop off can obscure their position, can be difficult to identify. The increase in SNR available at 3.0 T offers the potential to improve these issues with visualization. However, before moving directly to in vivo studies, it is important to investigate the effects of artifact size on the ability to localize multiple seeds in close proximity. These artifacts are of extra concern at higher field because of the increased induced field distortions surrounding the seeds. A single prostate brachytherapy seed (IMC6711, OncoSeed) and arrays of seed pairs were suspended in a porcine gel medium and imaged on 1.5 and 3 T MRI scanners for comparison. Two basic acquisition techniques utilized in a wide array of clinical sequences [spin-echo based and gradient-echo (GE) based] were investigated for the types of artifacts they produce, and their dependence on field. Analysis of the resulting voids was performed to determine the relative size of seeds as seen on the images, as well as the ability to distinguish seeds at close proximity. The seed voids at 3 T were only slightly larger than those obtained at 1.5 T (0.5 mm longer and wider) when using a spin-echo type sequence. For this work, the authors used a proton density fast spin-echo (FSE) sequence. These results are promising for the use of 3 T imaging for postimplant evaluation since the SNR will increase by roughly a factor of 2 with only a limited corresponding increase in artifact size. The minimum separation of the seeds to be completely distinguished using void analysis increased from between 1.5 and 3 mm to between 3 and 4.5 mm when going from 1.5 to 3 T FSE imaging. The minimum separation of the seeds for GE at the demonstration TE of 11 ms was found to be between 3 and 4.5 mm for 1.5 T and between 4.5 and 6 mm for 3 T. These GE artifact dimensions will scale down with TE and, as this happens, approach the dimensions of the FSE artifacts given above.
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Braquiterapia/métodos , Imageamento por Ressonância Magnética/métodos , Neoplasias da Próstata/patologia , Neoplasias da Próstata/radioterapia , Animais , Artefatos , Humanos , Masculino , Imagens de Fantasmas , SuínosRESUMO
OBJECTIVE: To update the 2001 American Academy of Neurology (AAN) guideline on mild cognitive impairment (MCI). METHODS: The guideline panel systematically reviewed MCI prevalence, prognosis, and treatment articles according to AAN evidence classification criteria, and based recommendations on evidence and modified Delphi consensus. RESULTS: MCI prevalence was 6.7% for ages 60-64, 8.4% for 65-69, 10.1% for 70-74, 14.8% for 75-79, and 25.2% for 80-84. Cumulative dementia incidence was 14.9% in individuals with MCI older than age 65 years followed for 2 years. No high-quality evidence exists to support pharmacologic treatments for MCI. In patients with MCI, exercise training (6 months) is likely to improve cognitive measures and cognitive training may improve cognitive measures. MAJOR RECOMMENDATIONS: Clinicians should assess for MCI with validated tools in appropriate scenarios (Level B). Clinicians should evaluate patients with MCI for modifiable risk factors, assess for functional impairment, and assess for and treat behavioral/neuropsychiatric symptoms (Level B). Clinicians should monitor cognitive status of patients with MCI over time (Level B). Cognitively impairing medications should be discontinued where possible and behavioral symptoms treated (Level B). Clinicians may choose not to offer cholinesterase inhibitors (Level B); if offering, they must first discuss lack of evidence (Level A). Clinicians should recommend regular exercise (Level B). Clinicians may recommend cognitive training (Level C). Clinicians should discuss diagnosis, prognosis, long-term planning, and the lack of effective medicine options (Level B), and may discuss biomarker research with patients with MCI and families (Level C).
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Disfunção Cognitiva/diagnóstico , Disfunção Cognitiva/terapia , Disfunção Cognitiva/epidemiologia , Técnica Delphi , HumanosRESUMO
OBJECTIVE: To update the 1995 American Academy of Neurology (AAN) practice parameter on persistent vegetative state and the 2002 case definition for the minimally conscious state (MCS) by reviewing the literature on the diagnosis, natural history, prognosis, and treatment of disorders of consciousness lasting at least 28 days. METHODS: Articles were classified per the AAN evidence-based classification system. Evidence synthesis occurred through a modified Grading of Recommendations Assessment, Development and Evaluation process. Recommendations were based on evidence, related evidence, care principles, and inferences according to the AAN 2011 process manual, as amended. RESULTS: No diagnostic assessment procedure had moderate or strong evidence for use. It is possible that a positive EMG response to command, EEG reactivity to sensory stimuli, laser-evoked potentials, and the Perturbational Complexity Index can distinguish MCS from vegetative state/unresponsive wakefulness syndrome (VS/UWS). The natural history of recovery from prolonged VS/UWS is better in traumatic than nontraumatic cases. MCS is generally associated with a better prognosis than VS (conclusions of low to moderate confidence in adult populations), and traumatic injury is generally associated with a better prognosis than nontraumatic injury (conclusions of low to moderate confidence in adult and pediatric populations). Findings concerning other prognostic features are stratified by etiology of injury (traumatic vs nontraumatic) and diagnosis (VS/UWS vs MCS) with low to moderate degrees of confidence. Therapeutic evidence is sparse. Amantadine probably hastens functional recovery in patients with MCS or VS/UWS secondary to severe traumatic brain injury over 4 weeks of treatment. Recommendations are presented separately.
Assuntos
Transtornos da Consciência/reabilitação , Neurologia , Medicina Física e Reabilitação/normas , Guias de Prática Clínica como Assunto , Pesquisa de Reabilitação , Humanos , Vida Independente , Neurologia/métodos , Neurologia/organização & administração , Neurologia/normas , Pesquisa de Reabilitação/métodos , Pesquisa de Reabilitação/organização & administração , Pesquisa de Reabilitação/normas , Estados UnidosRESUMO
OBJECTIVE: To update the 1995 American Academy of Neurology (AAN) practice parameter on persistent vegetative state and the 2002 case definition on minimally conscious state (MCS) and provide care recommendations for patients with prolonged disorders of consciousness (DoC). METHODS: Recommendations were based on systematic review evidence, related evidence, care principles, and inferences using a modified Delphi consensus process according to the AAN 2011 process manual, as amended. RECOMMENDATIONS: Clinicians should identify and treat confounding conditions, optimize arousal, and perform serial standardized assessments to improve diagnostic accuracy in adults and children with prolonged DoC (Level B). Clinicians should counsel families that for adults, MCS (vs vegetative state [VS]/unresponsive wakefulness syndrome [UWS]) and traumatic (vs nontraumatic) etiology are associated with more favorable outcomes (Level B). When prognosis is poor, long-term care must be discussed (Level A), acknowledging that prognosis is not universally poor (Level B). Structural MRI, SPECT, and the Coma Recovery Scale-Revised can assist prognostication in adults (Level B); no tests are shown to improve prognostic accuracy in children. Pain always should be assessed and treated (Level B) and evidence supporting treatment approaches discussed (Level B). Clinicians should prescribe amantadine (100-200 mg bid) for adults with traumatic VS/UWS or MCS (4-16 weeks post injury) to hasten functional recovery and reduce disability early in recovery (Level B). Family counseling concerning children should acknowledge that natural history of recovery, prognosis, and treatment are not established (Level B). Recent evidence indicates that the term chronic VS/UWS should replace permanent VS, with duration specified (Level B). Additional recommendations are included.
Assuntos
Transtornos da Consciência/reabilitação , Medicina Física e Reabilitação/normas , Guias de Prática Clínica como Assunto/normas , Pesquisa de Reabilitação , Humanos , Neurologia/métodos , Neurologia/organização & administração , Pesquisa de Reabilitação/métodos , Pesquisa de Reabilitação/organização & administração , Estados UnidosRESUMO
OBJECTIVE: To develop recommendations for disease-modifying therapy (DMT) for multiple sclerosis (MS). METHODS: A multidisciplinary panel developed DMT recommendations, integrating findings from a systematic review; followed an Institute of Medicine-compliant process to ensure transparency and patient engagement; and developed modified Delphi consensus-based recommendations concerning starting, switching, and stopping DMTs pertinent to people with relapsing-remitting MS, secondary progressive MS, primary progressive MS, and clinically isolated syndromes of demyelination. Recommendations were supported by structured rationales, integrating evidence from one or more sources: systematic review, related evidence (evidence not from the systematic review), principles of care, and inference from evidence. RESULTS: Thirty recommendations were developed: 17 on starting DMTs, including recommendations on who should start them; 10 on switching DMTs if breakthrough disease develops; and 3 on stopping DMTs. Recommendations encompassed patient engagement strategies and individualization of treatment, including adherence monitoring and disease comorbidity assessment. The panel also discussed DMT risks, including counseling about progressive multifocal leukoencephalopathy risk in people with MS using natalizumab, fingolimod, rituximab, ocrelizumab, and dimethyl fumarate; and made suggestions for future research to evaluate relative merits of early treatment with higher potency DMTs vs standard stepped-care protocols, DMT comparative effectiveness, optimal switching strategies, long-term effects of DMT use, definitions of highly active MS, and effects of treatment on patient-specified priority outcomes. This guideline reflects the complexity of decision-making for starting, switching, or stopping MS DMTs. The field of MS treatment is rapidly changing; the Academy of Neurology development process includes planning for future updates.
Assuntos
Antirreumáticos/uso terapêutico , Esclerose Múltipla/terapia , Neurologia/organização & administração , Neurologia/normas , Guias de Prática Clínica como Assunto/normas , Adulto , Humanos , Estados UnidosRESUMO
OBJECTIVE: To review evidence on starting, switching, and stopping disease-modifying therapies (DMTs) for multiple sclerosis (MS) in clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and progressive MS forms. METHODS: Relevant, peer-reviewed research articles, systematic reviews, and abstracts were identified (MEDLINE, CENTRAL, EMBASE searched from inception to November 2016). Studies were rated using the therapeutic classification scheme. Prior published Cochrane reviews were also used. RESULTS: Twenty Cochrane reviews and an additional 73 full-text articles were selected for data extraction through an updated systematic review (completed November 2016). For people with RRMS, many DMTs are superior to placebo (annualized relapses rates [ARRs], new disease activity [new MRI T2 lesion burden], and in-study disease progression) (see summary and full text publications). For people with RRMS who experienced a relapse on interferon-ß (IFN-ß) or glatiramer acetate, alemtuzumab is more effective than IFN-ß-1a 44 µg subcutaneous 3 times per week in reducing the ARR. For people with primary progressive MS, ocrelizumab is probably more effective than placebo (in-study disease progression). DMTs for MS have varying adverse effects. In people with CIS, glatiramer acetate and IFN-ß-1a subcutaneous 3 times per week are more effective than placebo in decreasing risk of conversion to MS. Cladribine, immunoglobulins, IFN-ß-1a 30 µg intramuscular weekly, IFN-ß-1b subcutaneous alternate day, and teriflunomide are probably more effective than placebo in decreasing risk of conversion to MS. Suggestions for future research include studies considering comparative effectiveness, usefulness of high-efficacy treatment vs stepped-care protocols, and research into predictive biomarkers.