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Frascati international research criteria for HIV-associated neurocognitive disorders (HAND) are controversial; some investigators have argued that Frascati criteria are too liberal, resulting in a high false positive rate. Meyer et al. recommended more conservative revisions to HAND criteria, including exploring other commonly used methodologies for neurocognitive impairment (NCI) in HIV including the global deficit score (GDS). This study compares NCI classifications by Frascati, Meyer, and GDS methods, in relation to neuroimaging markers of brain integrity in HIV.
Two hundred forty-one people living with HIV (PLWH) without current substance use disorder or severe (confounding) comorbid conditions underwent comprehensive neurocognitive testing and brain structural magnetic resonance imaging and magnetic resonance spectroscopy. Participants were classified using Frascati criteria versus Meyer criteria: concordant unimpaired [Frascati(Un)/Meyer(Un)], concordant impaired [Frascati(Imp)/Meyer(Imp)], or discordant [Frascati(Imp)/Meyer(Un)] which were impaired via Frascati criteria but unimpaired via Meyer criteria. To investigate the GDS versus Meyer criteria, the same groupings were utilized using GDS criteria instead of Frascati criteria.
When examining Frascati versus Meyer criteria, discordant Frascati(Imp)/Meyer(Un) individuals had less cortical gray matter, greater sulcal cerebrospinal fluid volume, and greater evidence of neuroinflammation (i.e., choline) than concordant Frascati(Un)/Meyer(Un) individuals. GDS versus Meyer comparisons indicated that discordant GDS(Imp)/Meyer(Un) individuals had less cortical gray matter and lower levels of energy metabolism (i.e., creatine) than concordant GDS(Un)/Meyer(Un) individuals. In both sets of analyses, the discordant group did not differ from the concordant impaired group on any neuroimaging measure.
The Meyer criteria failed to capture a substantial portion of PLWH with brain abnormalities. These findings support continued use of Frascati or GDS criteria to detect HIV-associated CNS dysfunction.
Few independent studies have examined the psychometric properties of the NIH Toolbox Cognition Battery (NIHTB-CB) in older adults, despite growing interest in its use for clinical purposes. In this paper we report the test–retest reliability and construct validity of the NIHTB-CB, as well as its agreement or concordance with traditional neuropsychological tests of the same construct to determine whether tests could be used interchangeably.
Sixty-one cognitively healthy adults ages 60–80 completed “gold standard” (GS) neuropsychological tests, NIHTB-CB, and brain MRI. Test–retest reliability, convergent/discriminant validity, and agreement statistics were calculated using Pearson’s correlations, concordance correlation coefficients (CCC), and root mean square deviations.
Test–retest reliability was acceptable (CCC = .73 Fluid; CCC = .85 Crystallized). The NIHTB-CB Fluid Composite correlated significantly with cerebral volumes (r’s = |.35−.41|), and both composites correlated highly with their respective GS composites (r’s = .58−.84), although this was more variable for individual tests. Absolute agreement was generally lower (CCC = .55 Fluid; CCC = .70 Crystallized) due to lower precision in fluid scores and systematic overestimation of crystallized composite scores on the NIHTB-CB.
These results support the reliability and validity of the NIHTB-CB in healthy older adults and suggest that the fluid composite tests are at least as sensitive as standard neuropsychological tests to medial temporal atrophy and ventricular expansion. However, the NIHTB-CB may generate different estimates of performance and should not be treated as interchangeable with established neuropsychological tests.
A national need is to prepare for and respond to accidental or intentional disasters categorized as chemical, biological, radiological, nuclear, or explosive (CBRNE). These incidents require specific subject-matter expertise, yet have commonalities. We identify 7 core elements comprising CBRNE science that require integration for effective preparedness planning and public health and medical response and recovery. These core elements are (1) basic and clinical sciences, (2) modeling and systems management, (3) planning, (4) response and incident management, (5) recovery and resilience, (6) lessons learned, and (7) continuous improvement. A key feature is the ability of relevant subject matter experts to integrate information into response operations. We propose the CBRNE medical operations science support expert as a professional who (1) understands that CBRNE incidents require an integrated systems approach, (2) understands the key functions and contributions of CBRNE science practitioners, (3) helps direct strategic and tactical CBRNE planning and responses through first-hand experience, and (4) provides advice to senior decision-makers managing response activities. Recognition of both CBRNE science as a distinct competency and the establishment of the CBRNE medical operations science support expert informs the public of the enormous progress made, broadcasts opportunities for new talent, and enhances the sophistication and analytic expertise of senior managers planning for and responding to CBRNE incidents.
Consumption of certain berries appears to slow postprandial glucose absorption, attributable to polyphenols, which may benefit exercise and cognition, reduce appetite and/or oxidative stress. This randomised, crossover, placebo-controlled study determined whether polyphenol-rich fruits added to carbohydrate-based foods produce a dose-dependent moderation of postprandial glycaemic, glucoregulatory hormone, appetite and ex vivo oxidative stress responses. Twenty participants (eighteen males/two females; 24 (sd 5) years; BMI: 27 (sd 3) kg/m2) consumed one of five cereal bars (approximately 88 % carbohydrate) containing no fruit ingredients (reference), freeze-dried black raspberries (10 or 20 % total weight; LOW-Rasp and HIGH-Rasp, respectively) and cranberry extract (0·5 or 1 % total weight; LOW-Cran and HIGH-Cran), on trials separated by ≥5 d. Postprandial peak/nadir from baseline (Δmax) and incremental postprandial AUC over 60 and 180 min for glucose and other biochemistries were measured to examine the dose-dependent effects. Glucose AUC0–180 min trended towards being higher (43 %) after HIGH-Rasp v. LOW-Rasp (P=0·06), with no glucose differences between the raspberry and reference bars. Relative to reference, HIGH-Rasp resulted in a 17 % lower Δmax insulin, 3 % lower C-peptide (AUC0–60 min and 3 % lower glucose-dependent insulinotropic polypeptide (AUC0–180 min) P<0·05. No treatment effects were observed for the cranberry bars regarding glucose and glucoregulatory hormones, nor were there any treatment effects for either berry type regarding ex vivo oxidation, appetite-mediating hormones or appetite. Fortification with freeze-dried black raspberries (approximately 25 g, containing 1·2 g of polyphenols) seems to slightly improve the glucoregulatory hormone and glycaemic responses to a high-carbohydrate food item in young adults but did not affect appetite or oxidative stress responses at doses or with methods studied herein.
Objectives: Studies of neurocognitively elite older adults, termed SuperAgers, have identified clinical predictors and neurobiological indicators of resilience against age-related neurocognitive decline. Despite rising rates of older persons living with HIV (PLWH), SuperAging (SA) in PLWH remains undefined. We aimed to establish neuropsychological criteria for SA in PLWH and examined clinically relevant correlates of SA. Methods: 734 PLWH and 123 HIV-uninfected participants between 50 and 64 years of age underwent neuropsychological and neuromedical evaluations. SA was defined as demographically corrected (i.e., sex, race/ethnicity, education) global neurocognitive performance within normal range for 25-year-olds. Remaining participants were labeled cognitively normal (CN) or impaired (CI) based on actual age. Chi-square and analysis of variance tests examined HIV group differences on neurocognitive status and demographics. Within PLWH, neurocognitive status differences were tested on HIV disease characteristics, medical comorbidities, and everyday functioning. Multinomial logistic regression explored independent predictors of neurocognitive status. Results: Neurocognitive status rates and demographic characteristics differed between PLWH (SA=17%; CN=38%; CI=45%) and HIV-uninfected participants (SA=35%; CN=55%; CI=11%). In PLWH, neurocognitive groups were comparable on demographic and HIV disease characteristics. Younger age, higher verbal IQ, absence of diabetes, fewer depressive symptoms, and lifetime cannabis use disorder increased likelihood of SA. SA reported increased independence in everyday functioning, employment, and health-related quality of life than non-SA. Conclusions: Despite combined neurological risk of aging and HIV, youthful neurocognitive performance is possible for older PLWH. SA relates to improved real-world functioning and may be better explained by cognitive reserve and maintenance of cardiometabolic and mental health than HIV disease severity. Future research investigating biomarker and lifestyle (e.g., physical activity) correlates of SA may help identify modifiable neuroprotective factors against HIV-related neurobiological aging. (JINS, 2019, 25, 507–519)
This article retrospectively examines the evolution of rapid assessments (RAs) produced by the Health Technology Assessment (HTA) Program at the Institute of Health Economics over its 25-year relationship with a single requester, the Alberta Health Ministry (AHM).
The number, types, and methodological attributes of RAs produced over the past 25 years were reviewed. The reasons for developmental changes in RA processes and products over time were charted to document the push–pull tension between AHM needs and the HTA Program's drive to meet those needs while responding to changing methodological benchmarks.
The review demonstrated the dynamic relationship required for HTA researchers to meet requester needs while adhering to good HTA practice. The longstanding symbiotic relationship between the HTA Program and the AHM initially led to increased diversity in RA types, followed by controlled extinction of the less fit (useful) “transition species.” Adaptations in RA methodology were mainly driven by changes in best practice standards, requester needs, the healthcare environment, and staff expertise and technology.
RAs are a useful component of HTA programs. To remain relevant and useful, RAs need to evolve according to need within the constraints of HTA best practice.
Developing clinical practice guidelines (CPGs) is a collaborative, multi-stakeholder enterprise. Over the last 13 years, health technology assessment (HTA) researchers from the Institute of Health Economics (IHE) partnered in a unique manner with provincial clinicians and stakeholders to develop and update CPGs using an innovative adaptation method. The complexities, intricacies, and attributes for success are presented, with emphasis on the role played by HTA resources.
A governance structure (Advisory Committee, Steering Committee, Guideline Development Group) was designed to provide adequate oversight and quick, effective decision making, facilitate progress of the activities, and provide a mechanism for involving a wide variety of participants in the guideline development processes—stakeholders who represent policy, multidisciplinary care practice, knowledge translation, and research.
The HTA researchers served various functions and played multiple translation roles in the guideline development process: acting as a hub for connecting researchers with government to address relevant policy questions; liaising with committees to translate clinical queries into searchable questions for information specialists; preparing background documents and compiling discussion materials to expedite review by committees; connecting committees with external stakeholders such as the provincial CPG program; and bringing lay advisors into the final review process. Elements for success included effective communication, development and use of consistent methods, reliance on the highest quality of research evidence, willingness to contribute and share expertise, awareness of other initiatives and projects, transparency and openness, efficiency, flexibility, respect, enthusiasm, commitment, and patience.
The development of CPGs requires the establishment of sophisticated multi-stakeholder collaboration and time. HTA agencies are well positioned to be an effective translation hub connecting the various stakeholders by virtue of their inherent ability to communicate in the language of policy makers, clinicians, and patients, so that all participants understand enough to add their voice to the process.
Clinical practice guidelines (CPGs) are a key vehicle for converting evidence into action. CPGs can be produced by various methods: de novo, adaptation, adoption, or a combination of these. Deciding whether and how to develop a guideline can be challenging. Health technology assessment (HTA) researchers from the Institute of Health Economics developed a multi-step decisional algorithm highlighting the decision nodes in the initial phase of guideline development where HTA products and expertise can be valuable in demystifying these decisions.
A literature search was conducted for articles comparing methods of developing CPGs, with particular focus on finding a priori criteria for deciding when to use one method versus another.
The published literature is sparse and there are no specific criteria available for deciding when to use one method of development versus another. The proposed multi-step algorithm identifies similar steps in the production of all types of CPGs: the set-up phase; establishing the need for a new CPG in consultation with a guideline development group and local stakeholders; developing research question(s); conducting searches for suitable existing guidelines; and finalizing the guideline. HTA can help set the health question(s) and identify and screen existing CPGs. When CPGs are not available, HTA methods are implemented to update the evidence in a blend of de novo and adaptation processes by reviewing umbrella reviews, systematic reviews, and primary studies. Quality appraisal of existing guidelines and syntheses of evidence in a rapid review fashion help determine whether there are enough studies to support the guideline scope.
Deciding which method of guideline development to employ requires ample methodological expertise, an intimate knowledge of the clinical practice environment, and access to detailed contextual information. The proposed multi-step algorithm shows how to successfully leverage HTA resources to support CPG production and move research evidence into practice.
The Health Technology Assessment (HTA) Program at the Institute of Health Economics (IHE) has conducted rapid assessments (RAs) for 25 years. The presentation draws on this experience to chart the evolution of RAs over a 25-year relationship between a policy maker and an arms-length HTA agency to quantify the effects of this partnership on the RAs produced.
The number, types, and methodological attributes of RAs produced over a 25-year partnership with a single requestor were reviewed. The reasons for developmental changes in RA products over time were charted to document the push-pull tension between requestor needs and HTA best practice. The elements contributing to the relevance and impact, or not, of the RAs were also identified.
Results demonstrated the dynamic relationship required for HTA researchers to meet best practice and requestor needs. As literature search spans lengthened and data analyses became more complex, limitations were imposed on RAs to fulfill the requirements of timeliness, utility, and best practice. Adaptations were driven by requestor, researcher, and the external policy environment. Facilitators of RA utility for HTA requestors include: asking focused, well-articulated questions; specifying the request's purpose; providing detailed information about local context and other relevant issues; and understanding the risk of bias associated with RAs. Considerations for HTA doers include: assembling a team using a triage process; involving requestors throughout RA development; negotiating deliverables and timelines using a HTA product matrix; transparently reporting methods; narratively describing methodological issues; and internally reviewing the draft RAs.
RAs are a useful component of HTA programs. To keep these products relevant and useful, HTA agencies must allow RAs to evolve according to need, but with grounding in good practice. Negotiating the line between rigor and relevance is a key skill for HTA agencies. Having the right team is helpful.
Immune globulin (IG) is a publicly funded blood product with high utilization rates and rapidly rising costs. Inappropriate use of IG, particularly in dose and treatment duration, is observed in about 10 percent of cases, and the national guidelines for IG treatment are outdated. To develop a utilization management policy for IG, the Alberta, Manitoba and Saskatchewan Ministries of Health collaborated with health technology assessment (HTA) researchers and clinicians to develop evidence-based guideline recommendations for IG treatment to inform an authorization policy for IG utilization in the provinces.
A multidisciplinary committee comprising HTA researchers and 22 physicians from seven medical specialties adapted recommendations from 43 “seed” guidelines into one locally contextualized IG guideline. HTA methods and rapid review products were used extensively to update gaps in the evidence base. The guideline recommendation document was used to develop a provincial IG utilization management policy. The challenges of achieving a methodologically rigorous guideline development process will be discussed.
The guideline contained over 60 recommendations for IG use in different medical specialties. The health ministries used the guideline recommendations to develop an IG authorization policy. The clinician-sanctioned review criteria were used to construct a conditional reimbursement system for generating outcome data from controlled off-label IG use for conditions where evidence gaps existed, and were built into policies for benchmarking compliance.
Three provinces successfully collaborated to develop an IG utilization management policy. The unique approach involved a credible and transparent process that incorporated key review elements for compliance benchmarking and reimbursement, promoted clinician buy-in, and created a cadre of clinical champions willing to assist in policy development and implementation. The proactive, rather than retroactive, incorporation of clinician-sanctioned benchmarking and review criteria into policy will help bridge the know-do gap and foster a stronger, more direct link between health policy and evidence.
Clinical practice guidelines (CPGs) are an ideal implementation mechanism for promoting effective clinical practice, but without due consideration of costs they may do more harm than good and become a source of inefficiency. The Alberta Guideline Adaptation Program sought current best practice for incorporating economic information into CPGs to better leverage health technology assessment (HTA) and health economic expertise in its guideline development program.
A comprehensive, systematic review of published and grey literature was undertaken to: (i) catalogue theoretical frameworks and practical methods for incorporating economic information into CPGs and forecasting the post-implementation economic impact of CPGs; (ii) summarize current methods for evaluating the economic impact of CPGs; and, (iii) identify barriers and facilitators to incorporating economic information into CPGs.
Rigorous economic analyses were infrequently incorporated in CPG development. While a selection of guidance documents and CPG manuals published between 2001 and 2017 by leading CPG developers emphasized the health economist's role and the importance of incorporating economic evidence into CPGs, few provided adequate guidance on the best way to do this. There is no agreement on how best to monitor the economic impact of CPGs. Analysis of a sample of over 100 studies published between 2005 and 2013 identified the three main methods currently used to assess the post-implementation economic impact of CPGs: pre-test/post-test cost analyses, mapping studies, and modelled cost-effectiveness studies. The key elements of each study type were summarized and compared.
The review highlighted the under-recognized know-do gap among developers with respect to using health economics information and expertise in CPG development. It identified the advantages and potential limitations of applying health economics to CPG development, as well as areas where developers can better utilize HTA researchers and health economists to improve the quality of guidelines and better document the resource implications and feasibility of the interventions they recommend.
Understanding Curriculum is a critical introduction to contemporary curriculum theory and practice. Substantially revised, the second edition includes more detailed consideration of the ideological underpinnings of curriculum development, features new chapters on assessment and reporting, and updated vignettes and extracts. These features, combined with all the elements of the previous edition, encourages readers to reflect on how curriculum theory can inform and enhance classroom practice.