Annette M Totten

Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition.

The scope and purpose of this work is 2-fold: to synthesize the available evidence and to translate it into recommendations. This document provides recommendations only when there is evidence to support them. As such, they do not constitute a complete protocol for clinical use. Our intention is that these recommendations be used by others to develop treatment protocols, which necessarily need to incorporate consensus and clinical judgment in areas where current evidence is lacking or insufficient. We think it is important to have evidence-based recommendations to clarify what aspects of practice currently can and cannot be supported by evidence, to encourage use of evidence-based treatments that exist, and to encourage creativity in treatment and research in areas where evidence does not exist. The communities of neurosurgery and neuro-intensive care have been early pioneers and supporters of evidence-based medicine and plan to continue in this endeavor. The complete guideline document, which summarizes and evaluates the literature for each topic, and supplemental appendices (A-I) are available online at https://www.braintrauma.org/coma/guidelines.

Pressure Ulcer Treatment Strategies: A Systematic Comparative Effectiveness Review

BACKGROUND Pressure ulcers affect as many as 3 million Americans and are major sources of morbidity, mortality, and health care costs. PURPOSE To summarize evidence comparing the effectiveness and safety of treatment strategies for adults with pressure ulcers. DATA SOURCES MEDLINE, EMBASE, CINAHL, Evidence-Based Medicine Reviews, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, and Health Technology Assessment Database for English- or foreign-language studies; reference lists; gray literature; and individual product packets from manufacturers (January 1985 to October 2012). STUDY SELECTION Randomized trials and comparative observational studies of treatments for pressure ulcers in adults and noncomparative intervention series (n > 50) for surgical interventions and evaluation of harms. DATA EXTRACTION Data were extracted and evaluated for accuracy of the extraction, quality of included studies, and strength of evidence. DATA SYNTHESIS 174 studies met inclusion criteria and 92 evaluated complete wound healing. In comparison with standard care, placebo, or sham interventions, moderate-strength evidence showed that air-fluidized beds (5 studies [n = 908]; high consistency), protein-containing nutritional supplements (12 studies [n = 562]; high consistency), radiant heat dressings (4 studies [n = 160]; moderate consistency), and electrical stimulation (9 studies [n = 397]; moderate consistency) improved healing of pressure ulcers. Low-strength evidence showed that alternating-pressure surfaces, hydrocolloid dressings, platelet-derived growth factor, and light therapy improved healing of pressure ulcers. The evidence about harms was limited. LIMITATION Applicability of results is limited by study quality, heterogeneity in methods and outcomes, and inadequate duration to assess complete wound healing. CONCLUSION Moderate-strength evidence shows that healing of pressure ulcers in adults is improved with the use of air-fluidized beds, protein supplementation, radiant heat dressings, and electrical stimulation.

Outcomes From Health Information Exchange: Systematic Review and Future Research Needs

Background Health information exchange (HIE), the electronic sharing of clinical information across the boundaries of health care organizations, has been promoted to improve the efficiency, cost-effectiveness, quality, and safety of health care delivery. Objective To systematically review the available research on HIE outcomes and analyze future research needs. Methods Data sources included citations from selected databases from January 1990 to February 2015. We included English-language studies of HIE in clinical or public health settings in any country. Data were extracted using dual review with adjudication of disagreements. Results We identified 34 studies on outcomes of HIE. No studies reported on clinical outcomes (eg, mortality and morbidity) or identified harms. Low-quality evidence generally finds that HIE reduces duplicative laboratory and radiology testing, emergency department costs, hospital admissions (less so for readmissions), and improves public health reporting, ambulatory quality of care, and disability claims processing. Most clinicians attributed positive changes in care coordination, communication, and knowledge about patients to HIE. Conclusions Although the evidence supports benefits of HIE in reducing the use of specific resources and improving the quality of care, the full impact of HIE on clinical outcomes and potential harms are inadequately studied. Future studies must address comprehensive questions, use more rigorous designs, and employ a standard for describing types of HIE. Trial Registration PROSPERO Registry No CRD42014013285; http://www.crd.york.ac.uk/PROSPERO/ display_record.asp?ID=CRD42014013285 (Archived by WebCite at http://www.webcitation.org/6dZhqDM8t).

Barriers and facilitators to exchanging health information: a systematic review.

OBJECTIVES We conducted a systematic review of studies assessing facilitators and barriers to use of health information exchange (HIE). METHODS We searched MEDLINE, PsycINFO, CINAHL, and the Cochrane Library databases between January 1990 and February 2015 using terms related to HIE. English-language studies that identified barriers and facilitators of actual HIE were included. Data on study design, risk of bias, setting, geographic location, characteristics of the HIE, perceived barriers and facilitators to use were extracted and confirmed. RESULTS Ten cross-sectional, seven multiple-site case studies, and two before-after studies that included data from several sources (surveys, interviews, focus groups, and observations of users) evaluated perceived barriers and facilitators to HIE use. The most commonly cited barriers to HIE use were incomplete information, inefficient workflow, and reports that the exchanged information that did not meet the needs of users. The review identified several facilitators to use. DISCUSSION Incomplete patient information was consistently mentioned in the studies conducted in the US but not mentioned in the few studies conducted outside of the US that take a collective approach toward healthcare. Individual patients and practices in the US may exercise the right to participate (or not) in HIE which effects the completeness of patient information available to be exchanged. Workflow structure and user roles are key but understudied. CONCLUSIONS We identified several facilitators in the studies that showed promise in promoting electronic health data exchange: obtaining more complete patient information; thoughtful workflow that folds in HIE; and inclusion of users early in implementation.

Assessing Content Validity of the Patient Generated Index Using Cognitive Interviews

The effects of cancer and its treatment on quality of life contribute to patient and clinician decisions. Health-related quality of life (HRQL) is a subjective concept, leading to variation in its definition. This presents challenges when measuring HRQL and evaluating interventions. The designers of the Patient Generated Index (PGI) addressed these challenges by having individuals identify areas of their lives affected by illness and treatment, then report on these self-defined areas. We used cognitive interviews to collect information about patient understanding of the PGI, the response processes used to complete the PGI, and how well the PGI reflected participant HRQL. Interview data support the content validity of the PGI in comprehensively defining and adequately sampling participant HRQL as an individualized construct. Findings also support our recommendation to revise PGI formatting to reduce response errors. We make recommendations to reduce the cognitive demands the PGI places on respondents.

Predictive Utility of the Total Glasgow Coma Scale Versus the Motor Component of the Glasgow Coma Scale for Identification of Patients With Serious Traumatic Injuries

Study objective The motor component of the Glasgow Coma Scale (mGCS) has been proposed as an easier‐to‐use alternative to the total GCS (tGCS) for field assessment of trauma patients by emergency medical services. We perform a systematic review and meta‐analysis to compare the predictive utility of the tGCS versus the mGCS or Simplified Motor Scale in field triage of trauma for identifying patients with adverse outcomes (inhospital mortality or severe brain injury) or who underwent procedures (neurosurgical intervention or emergency intubation) indicating need for high‐level trauma care. Methods Ovid MEDLINE, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, Health and Psychosocial Instruments, and the Cochrane databases were searched through June 2016 for English‐language cohort studies. We included studies that compared the area under the receiver operating characteristic curve (AUROC) of the tGCS versus the mGCS or Simplified Motor Scale assessed in the field or shortly after arrival in the emergency department for predicting the outcomes described above. Meta‐analyses were performed with a random‐effects model, and subgroup and sensitivity analyses were conducted. Results We included 18 head‐to‐head studies of predictive utility (n=1,703,388). For inhospital mortality, the tGCS was associated with slightly greater discrimination than the mGCS (pooled mean difference in [AUROC] 0.015; 95% confidence interval [CI] 0.009 to 0.022; I2=85%; 12 studies) or the Simplified Motor Scale (pooled mean difference in AUROC 0.030; 95% CI 0.024 to 0.036; I2=0%; 5 studies). The tGCS was also associated with greater discrimination than the mGCS or Simplified Motor Scale for nonmortality outcomes (differences in AUROC from 0.03 to 0.05). Findings were robust in subgroup and sensitivity analyses. Conclusion The tGCS is associated with slightly greater discrimination than the mGCS or Simplified Motor Scale for identifying severe trauma. The small differences in discrimination are likely to be clinically unimportant and could be offset by factors such as convenience and ease of use.

AHRQ series on complex intervention systematic reviews—paper 3: adapting frameworks to develop protocols

BACKGROUND Once a proposed topic has been identified for a systematic review and has undergone a question formulation stage, a protocol must be developed that specifies the scope and research questions in detail and outlines the methodology for conducting the systematic review. RATIONALE Framework modifications are often needed to accommodate increased complexity. We describe and give examples of adaptations and alternatives to traditional analytic frameworks. DISCUSSION This article identifies and describes elements of frameworks and how they can be adapted to inform the protocol and conduct of systematic reviews of complex interventions. Modifications may be needed to adapt the population, intervention, comparators, and outcomes normally used in protocol development to successfully describe complex interventions; in some instances, alternative frameworks may be better suited. Possible approaches to analytic frameworks for complex interventions that illustrate causal and associative linkages are outlined, including time elements, which systematic reviews of complex interventions may need to address. The need for and specifics of the accommodations vary with details of a specific systematic review. This in turn helps determine whether traditional frameworks are sufficient, can be refined, or if alternate frameworks must be adopted.

Fit for purpose: perspectives on rapid reviews from end-user interviews

BackgroundThere is increasing demand for rapid reviews and timely evidence synthesis. The goal of this project was to understand end-user perspectives on the utility and limitations of rapid products including evidence inventories, rapid responses, and rapid reviews.MethodsInterviews were conducted with key informants representing: guideline developers (n = 3), health care providers/health system organizations (n = 3), research funders (n = 1), and payers/health insurers (n = 1). We elicited perspectives on important characteristics of systematic reviews, acceptable methods to streamline reviews, and uses of rapid products. We analyzed content of the interview transcripts and identified themes and subthemes.ResultsKey informants identified the following as critical features of evidence reviews: (1) originating from a reliable source (i.e., conducted by experienced reviewers from an established research organization), (2) addressing clinically relevant questions, and (3) trusted relationship between the user and producer. Key informants expressed strong preference for the following review methods and characteristics: use of evidence tables, quality rating of studies, assessments of total evidence quality/strength, and use of summary tables for results and conclusions. Most acceptable trade-offs to increase efficiencies were limiting the literature search (e.g., limiting search dates or language) and performing single screening of citations and full texts for relevance. Key informants perceived rapid products (particularly evidence inventories and rapid responses) as useful interim products to inform downstream investigation (e.g., whether to proceed with a full review or guideline, direction for future research). Most key informants indicated that evidence analysis/synthesis and quality/strength of evidence assessments were important for decision-making. They reported that rapid reviews in particular were useful for guideline development on narrow topics, policy decisions when a quick turn-around is needed, decision-making for practicing clinicians in nuanced clinical settings, and decisions about coverage by payers/health insurers. Rapid reviews may be more relevant within specific clinical settings or health systems; whereas, broad/national guidelines often need a traditional systematic review.ConclusionsKey informants interviewed in our study indicated that evidence inventories, rapid responses, and rapid reviews have utility in specific decisions and contexts. They indicated that the credibility of the review producer, relevance of key questions, and close working relationship between the end-user and producer are critical for any rapid product. Our findings are limited by the sample size which may have been too small to reach saturation for the themes described.

Health Information Exchange Use (1990-2015): A Systematic Review

Background: In June 2014, the Office of the National Coordinator for Health Information Technology published a 10-year roadmap for the United States to achieve interoperability of electronic health records (EHR) by 2024. A key component of this strategy is the promotion of nationwide health information exchange (HIE). The 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act provided significant investments to achieve HIE. Objective: We conducted a systematic literature review to describe the use of HIE through 2015. Methods: We searched MEDLINE, PsycINFO, CINAHL, and Cochrane databases (1990 – 2015); reference lists; and tables of contents of journals not indexed in the databases searched. We extracted data describing study design, setting, geographic location, characteristics of HIE implementation, analysis, follow-up, and results. Study quality was dual-rated using pre-specified criteria and discrepancies resolved through consensus. Results: We identified 58 studies describing either level of use or primary uses of HIE. These were a mix of surveys, retrospective database analyses, descriptions of audit logs, and focus groups. Settings ranged from community-wide to multinational. Results suggest that HIE use has risen substantially over time, with 82% of non-federal hospitals exchanging information (2015), 38% of physician practices (2013), and 17-23% of long-term care facilities (2013). Statewide efforts, originally funded by HITECH, varied widely, with a small number of states providing the bulk of the data. Characteristics of greater use include the presence of an EHR, larger practice size, and larger market share of the health-system. Conclusions: Use of HIE in the United States is growing but is still limited. Opportunities remain for expansion. Characteristics of successful implementations may provide a path forward.

In Reply: Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition

To the Editor: We thank Drs Picetti, Iaccarino, and Servadei for their thoughtful comments1 in relation to the recently published Guidelines for theManagement of Severe Traumatic Brain Injury, Fourth Edition.2 We share their distress and disappointment with the gaps that exist in current evidence for important topics. It is our great hope that the fourth edition guidelines will inspire investigators to complete high-quality studies that will fill these gaps. We also fully agree with the Parma group1 that published guidelines should not be viewed as “formally correct.” The Guidelines should serve as a starting point for individualized patient care protocols, integrating broad information specific to patient characteristics. The science of guidelines and making evidence-based recommendations has evolved substantially since the first edition of the Brain Trauma Foundation’s Guidelines for the Management of Severe Traumatic Brain Injury3—the first published guidelines produced by any surgical specialty. Indeed, much has changed even since the publication of the previous, third edition in 2007.4 The Institute of Medicine’s “Clinical Practice Guidelines We Can Trust” (2011)5 has played a particularly important role in setting the modern standard for high-quality guidelines documents. Our authorship group was challenged by the fact that the evidence supporting widely adopted recommendations in our previous guidelines—such as indications for intracranial pressure (ICP) monitoring—no longer meets current evidence standards prompting the pragmatic but carefully considered approach of restating select old recommendations. The Brain Trauma Foundation prides itself on producing rigorous and transparent evidence-based guidelines of the highest standard. The authors underwent a period of discussion and introspection in preparation for the fourth edition. As the fourth edition2 will serve as the foundation for the “Living Guidelines,” it was essential that the nature of this foundation be very carefully considered. We recognize that the consensus statements recently produced by the Neurocritical Care Society and by the American College of Surgeons supplement evidence with expert opinion. The Brain Trauma Foundation decided not to take this approach. We are mindful that expert opinion can be wrong: noteworthy examples include prophylactic hyperventilation and administration of corticosteroids, which used to be commonplace in the care of the severely brain injured. Evidence has ultimately shown these practices to be harmful. Moreover, the methodology inherent to building consensus-based recommendations or treatment protocols is distinct from those used in a rigorous evidence-based review. With these issues in mind and in the context of current guidelines standards, we made the difficult and important decision to keep our recommendations focused on a strict interpretation of available evidence. In doing so, we believe we have filled a different niche than that occupied by recently published consensus statements. The Brain Trauma Foundation recognizes the tremendous demand for an updated consensus-based treatment protocol which can serve as a template for local protocols reflecting local preferences and resources. The treatment algorithm that the Brain Trauma Foundation developed and published in conjunction with the first3 and second6 edition of the guidelines were very frequently requested reprints. We have been developing an updated protocol7 that conceptualizes the treatment of elevated ICP or brain hypoxia in 3 tiers based on efficacy and risk. This conceptual approach is the basis for what has been adopted by recent high-profile studies including PRoTECT III and TRACKTBI. We are making plans to further develop this protocol incorporating the recommendations of the fourth edition guidelines. We believe that collaboration with other societies and stakeholders will be important to prevent multiple independent efforts, which would result in a further fragmentation of recommendations and conflicting protocols. Although there is much evidence supporting improved outcomes from ICP-directed therapies, evidence does not currently support selective ICP monitoring in severe TBI patient subgroups. We agree with the Parma group that published consensus statements are helpful. We are mindful, though, of the 1982 paper by Narayan et al.8 Though this paper does not meet current evidence standards, it made the important finding that patients in coma with 2 or more of hypotension, posturing, or age over 40 are at risk for ICP elevation despite a normal head computed tomography. This paper has been influential and led some to mandate the exclusion of ICP elevation prior to making a diagnosis of diffuse axonal injury.We recognize that the question of which patients should undergo ICP monitoring remains an appropriately debated aspect of TBI patient care, and we hope that in the future new high-quality data will inform this issue. The ICP treatment threshold has evolved over time in accordance with the available evidence and evidence standards. The main evidence for the current 22 mm Hg threshold comes from the work of Sorrentino et al.9 Though the optimal ICP threshold is still not known with absolute certainty, it is the view of the fourth edition authors that this paper provides the best estimate to date. It is important, of course, that the threshold be reported with as much precision as possible, even though this reflects a small change from the previous edition. We acknowledge that there is some early evidence that different individuals may have different optimal ICP thresholds9; however, this evidence is insufficient for recommendations as yet. In summary, the fourth edition of the Guidelines for the Management of Severe TBI evaluated and weighed available evidence according to current methodological standards, which are now utilized across medical disciplines. The authors were very