The development of multiplex PCR assays for the rapid identification of multiple Saccostrea species, and their practical applications in restoration and aquaculture.

BACKGROUND: The ecology and biology of oysters (Ostreidae) across the tropics is poorly understood. Morphological plasticity and shared characteristics among oysters have resulted in the misidentification of species, creating challenges for understanding basic species-specific biological information that is required for restoration and aquaculture. Genetic barcoding has proven essential for accurate species identification and understanding species geographic ranges. To reduce the costs of molecular species identification we developed multiplex assays using the cytochrome c oxidase subunit I (COI or cox1) barcoding gene for the rapid identification of five species of oysters within the genus Saccostrea that are commonly found in Queensland, Australia: Saccostrea glomerata, Saccostrea lineage B, Saccostrea lineage F, Saccostrea lineage G, and Saccostrea spathulata (lineage J). RESULTS: Multiplex assays were successful in species-specific amplification of targeted species. The practical application of these primers was tested on wild spat collected from a pilot restoration project in Moreton Bay, Queensland, with identified species (S. glomerata, lineage B and lineage G) validated by Sanger sequencing. DNA sampling by extraction of oyster pallial fluid was also tested on adult oysters collected from the Noosa estuary in Queensland to assess whether oysters were able to be identified non-destructively. DNA concentrations as low as 1 ng/ µL still amplified in most cases, allowing for identification, and mortality at 6 weeks post pallial fluid collection was low (3 out of 104 sampled oysters). CONCLUSION: These multiplex assays will be essential tools for species identification in future studies, and we successfully demonstrate their practical application in both restoration and aquaculture contexts in Queensland. The multiplex assays developed in this study outline easily replicable methods for the development of additional species-specific primer sets for the rapid identification of other species of Saccostrea found across the Indo-Pacific, which will be instrumental in unravelling the taxonomic ambiguities within this genus in tropical regions.

Moving from intervention management to disease management: a qualitative study exploring a systems approach to health technology assessment in Canada.

OBJECTIVES: Health technology assessment (HTA) traditionally informs decision making for single health technologies, which could lead to ill-informed decisions, suboptimal care, and system inefficiencies. We explored opportunities for conceptualizing the decision space in HTA as a disease management question versus an intervention management question. METHODS: Semistructured interviews were conducted between April 2022 and October 2022 with purposefully selected individuals from national and provincial HTA agencies and related organizations in Canada. We conducted manual line by line coding of data informed by our interview guide and sensitizing concepts from the literature. One author coded the data, and findings were independently verified by a second author who coded a subset of transcripts. RESULTS: Twenty-four invitations were distributed, and eighteen individuals agreed to participate. A disease management approach to HTA was differentiated from traditional approaches as being disease-based, multi-interventional, and dynamic. There was general support for an explicit care pathway approach to HTA by informing discussions around patient choice and suboptimal care, creating a space where decision makers can collaborate on shared objectives, and in setting up a platform for open dialogue about managing high-cost and high-severity diseases. There are opportunities for a care pathway approach to be implemented that build on the strengths of the existing HTA system in Canada. CONCLUSIONS: A disease management approach may enhance the impact of HTA by supporting dynamic decision making that could better inform a proactive, resilient, and sustainable healthcare system in Canada.

The effectiveness and value of AMX0035 and oral edaravone for amyotrophic lateral sclerosis: A summary from the Institute for Clinical and Economic Review's Midwest Comparative Effectiveness Public Advisory Council.

DISCLOSURES: Funding for this summary was contributed by Blue Cross Blue Shield of MA, California Healthcare Foundation, The Patrick and Catherine Weldon Donaghue Medical Research Foundation, Arnold Ventures, and Kaiser Foundation Health Plan Inc., to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from Aetna, America's Health Insurance Plans, AbbVie, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Boehringer Ingelheim, Cambia Health Services, CVS, Editas, Evolve Pharmacy Solutions, Express Scripts, Genentech/ Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, Health First, Health Partners, Humana, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Pfizer. Premera, Prime Therapeutics, Regeneron, Sanofi, Spark Therapeutics, Sun Life Financial, uniQure, and United Healthcare. Mr Nikitin, Ms McKenna, Ms Richardson, and Drs Rind and Pearson are employed by ICER. Through their affiliated institutions, Drs Makam, Carlson, and Suh received funding from ICER for the work described in this summary.

Systems thinking in health technology assessment: a scoping review.

OBJECTIVE: Our objective was to assess how, and to what extent, a systems-level perspective is considered in decision-making processes for health interventions by illustrating how studies define the boundaries of the system in their analyses and by defining the decision-making context in which a systems-level perspective is undertaken. METHOD: We conducted a scoping review following the Joanna Briggs Institute methodology. MEDLINE, EMBASE, Cochrane Library, and EconLit were searched and key search concepts included decision making, system, and integration. Studies were classified according to an interpretation of the "system" of analysis used in each study based on a four-level model of the health system (patient, care team, organization, and/or policy environment) and using categories (based on intervention type and system impacts considered) to describe the decision-making context. RESULTS: A total of 2,664 articles were identified and 29 were included for analysis. Most studies (16/29; 55%) considered multiple levels of the health system (i.e., patient, care team, organization, environment) in their analysis and assessed multiple classes of interventions versus a single class of intervention (e.g., pharmaceuticals, screening programs). Approximately half (15/29; 52%) of the studies assessed the influence of policy options on the system as a whole, and the other half assessed the impact of interventions on other phases of the disease pathway or life trajectory (14/29; 48%). CONCLUSIONS: We found that systems thinking is not common in areas where health technology assessments (HTAs) are typically conducted. Against this background, our study demonstrates the need for future conceptualizations and interpretations of systems thinking in HTA.

Assessing adolescent immunization options for pertussis in Canada: A cost-utility analysis.

BACKGROUND: Adolescent tetanus, diphtheria and pertussis (Tdap) immunization helps prevent pertussis infection. Timing of Tdap receipt represents an important facet of successful adolescent pertussis immunization. Potential strategies for timing of vaccine administration are each associated with different benefits - including disease prevention - and costs. The objective of this study was to assess the cost-utility of adolescent pertussis immunization strategies in Canada. METHODS: A cost-utility analysis was conducted using a pertussis disease history-simulating Markov model, with adolescents (beginning at age 10 years) as the cohort of interest. The model assessed three Tdap vaccination strategies: (1) immunization of 10 year olds, (2) removal of adolescent vaccination, and (3) immunization of 14 year olds (status quo). The analysis was conducted from a healthcare payer perspective and used a lifetime time horizon. Primary outcomes included life years, quality-adjusted life years (QALYs), health system costs, and an incremental cost-effectiveness ratio (ICER). Costs and outcomes were discounted at 1.5 percent annually. Deterministic and probabilistic sensitivity analyses were performed to assess parameter uncertainty. RESULTS: The current recommended adolescent immunization strategy (at age 14) resulted in an average of 40.4432 expected QALYs and $26.28 per individual. This strategy was dominated by immunization at 10 years and no immunization. Compared to no immunization, immunizing adolescents at age 10 had an ICER of $74,899 per QALY. Results were most sensitive to the incidence of pertussis and the utility of moderate or severe pertussis. At a cost-effectiveness threshold of $50,000/QALY, removal of adolescent vaccination represented the most cost-effective strategy in 78% of simulations. CONCLUSION: Analysis assumes a policy context where immunization of pregnant women is recommended. Findings suggest that alternate adolescent Tdap vaccine strategies - either immunization of 10 year olds, or removal of the adolescent vaccine - are more cost-effective than the current practice of immunizing 14 year olds.

Mapping the evidence on health equity considerations in economic evaluations of health interventions: a scoping review protocol.

BACKGROUND: Equity in health has become an important policy agenda around the world, prompting health economists to advance methods to enable the inclusion of equity in economic evaluations. Among the methods that have been proposed to explicitly include equity are the weighting analysis, equity impact analysis, and equity trade-off analysis. This is a new development and a comprehensive overview of trends and concepts of health equity in economic evaluations is lacking. Thus, our objective is to map the current state of the literature with respect to how health equity is considered in economic evaluations of health interventions reported in the academic and gray literature. METHODS: We will conduct a scoping review to identify and map evidence on how health equity is considered in economic evaluations of health interventions. We will search relevant electronic, gray literature and key journals. We developed a search strategy using text words and Medical Subject Headings terms related to health equity and economic evaluations of health interventions. Articles retrieved will be uploaded to reference manager software for screening and data extraction. Two reviewers will independently screen the articles based on their titles and abstracts for inclusion, and then will independently screen a full text to ascertain final inclusion. A simple numerical count will be used to quantify the data and a content analysis will be conducted to present the narrative; that is, a thematic summary of the data collected. DISCUSSION: The results of this scoping review will provide a comprehensive overview of the current evidence on how health equity is considered in economic evaluations of health interventions and its research gaps. It will also provide key information to decision-makers and policy-makers to understand ways to include health equity into the prioritization of health interventions when aiming for a more equitable distribution of health resources. SYSTEMATIC REVIEW REGISTRATION: This protocol was registered with Open Science Framework (OSF) Registry on August 14, 2019 (https://osf.io/9my2z/registrations).

Assessing the impact of a home-based stroke rehabilitation programme: a cost-effectiveness study.

Background: Stroke is often a severe and debilitating event that requires ongoing rehabilitation. The Community Stroke Rehabilitation Teams (CSRTs) offer home-based stroke rehabilitation to individuals for whom further therapy is unavailable or inaccessible. The objective of this study was to evaluate the cost-effectiveness of the CSRT programme compared with a "Usual Care" cohort. Methods: We collected data on CSRT clients from January 2012 to February 2013. Comparator data were derived from a study of stroke survivors with limited access to specialised stroke rehabilitation. Literature-derived values were used to inform a long-term projection. Using Markov modelling, we projected the model for 35 years in six-month cycles. One-way, two-way, and probabilistic sensitivity analyses were performed. Results were discounted at 3% per year. Results: Results demonstrated that the CSRT programme has a net monetary benefit (NMB) of $43,655 over Usual Care, and is both less costly and more effective (incremental cost = -$17,255; incremental effect = 1.65 Quality Adjusted Life Years [QALYs]). Results of the probabilistic sensitivity analysis revealed that incremental cost-effectiveness of the CSRT programme is superior in 100% of iterations when compared to Usual Care. Conclusions: The study shows that CSRT model of care is cost-effective, and should be considered when evaluating potential stroke rehabilitation delivery methods. Implications for Rehabilitation Ongoing rehabilitation following stroke is imperative for optimal recovery. Home-based specialised stroke rehabilitation may be an option for individuals for whom ongoing rehabilitation is unavailable or inaccessible. The results of this study demonstrated that home-based rehabilitation is a cost-effective means of providing ongoing rehabilitation to individuals who have experienced a stroke.

Building a Knowledge to Action Program in Stroke Rehabilitation.

The knowledge to action (KTA) process proposed by Graham et al (2006) is a framework to facilitate the development and application of research evidence into clinical practice. The KTA process consists of the knowledge creation cycle and the action cycle. The Evidence Based Review of Stroke Rehabilitation is a foundational part of the knowledge creation cycle and has helped guide the development of best practice recommendations in stroke. The Rehabilitation Knowledge to Action Project is an audit-feedback process for the clinical implementation of best practice guidelines, which follows the action cycle. The objective of this review was to: (1) contextualize the Evidence Based Review of Stroke Rehabilitation and Rehabilitation Knowledge to Action Project within the KTA model and (2) show how this process led to improved evidence-based practice in stroke rehabilitation. Through this process, a single centre was able to change clinical practice and promote a culture that supports the use of evidence-based practices in stroke rehabilitation.

The stroke impact scale: performance as a quality of life measure in a community-based stroke rehabilitation setting.

PURPOSE: The objective of this study was to assess the psychometric properties of the Stroke Impact Scale (SIS). METHODS: Data was derived from a study assessing a community-based stroke rehabilitation program. Patients were administered the SIS and Euroqol-5D (EQ-5D-5L) on admission to the study, and at six month and 12 month follow-up. The psychometric performance of each domain of the SIS was assessed at each time point. RESULTS: A total of 164 patients completed outcome measures at baseline, 108 patients at six months and 37 patients at 12 months. Correlation of the SIS domains with the EQ-5D-5L suggested that the dimensions of health contributing to a patient's perception of health-related quality of life changes over time. CONCLUSION: The SIS performed well in a sample of patients undergoing stroke rehabilitation in the community. Our findings suggest that the multidimensionality of the SIS may allow health professionals to track patient progress and tailor rehabilitation interventions to target the dimensions of health that are most important to a patient's overall health and perceived quality of life over time. Implications for Rehabilitation There is an increased need for valid and reliable measures to evaluate the outcomes of patients recovering from stroke in the community. The Stroke Impact Scale (SIS) measures multiple domains of health and is well-suited for use in patients recovering from stroke in the community. There is a high level of internal consistency in the eight SIS domains with no evidence of floor effects; ceiling effects were noted for several domains. Correlation of the SIS with the Euroqol-5D suggested that the dimensions of health contributing to a patient's perception of health related quality of life changes over time.

Community Stroke Rehabilitation: How Do Rural Residents Fare Compared With Their Urban Counterparts?

BACKGROUND: Rural living has been demonstrated to have an effect on a person's overall health status, and rural residing individuals often have decreased access to health and specialized rehabilitation services. AIM: The aim of this study was to determine if there are differences in recovery from stroke between urban and rural-dwelling stroke survivors accessing an in-home, community-based, interdisciplinary, stroke rehabilitation program. METHODS: Data from a cohort of 1222 stroke survivors receiving care from the Community Stroke Rehabilitation Teams between January 2009 and June 2013 was analyzed. This program delivers stroke rehabilitation care directly in a person's home and community. Functional and psychosocial outcomes were evaluated at baseline, discharge, and six -month follow-up. A series of multiple linear regression analyses was performed to determine if rural versus urban status was a significant predictor of discharge and 6-month health outcomes. RESULTS: The mean age of the rural cohort was 68.8 (±13.1) years (53.6% male), and the urban cohort was 68.4 (±13.0) years (44.8% male). A total of 278 (35.4%) individuals were classified as living in a rural area using the Rurality Index for Ontario. In multivariate linear regression analysis, no significant differences on the Functional Independence Measure, the Stroke Impact Scale, the Hospital Anxiety and Depression Scale, or the Reintegration to Normal Living Index were found between urban and rural cohorts. CONCLUSIONS: When provided with access to a home-based, specialized stroke rehabilitation program, rural dwelling stroke survivors make and maintain functional gains comparable to their urban-living counterparts.

An Overview of Acquired Brain Injury Rehabilitation Randomized Controlled Trials.

OBJECTIVE: To summarize randomized controlled trials published in the acquired brain injury rehabilitation literature. SETTING: N/A. PARTICIPANTS: N/A. DESIGN: Systematic literature review. MAIN MEASURES: A total of 143 published randomized controlled trials in acquired brain injury rehabilitation literature from January 1980 to October 2012. Measures were area of research, number of studies, sample size, methodological quality, and country of origin. RESULTS: There were no significant differences in median sample sizes (P = .212; 95% confidence interval [CI], 0.199-0.215) or PEDro scores (P = .492; 95% CI, .491-.510) between 4 research areas in acquired brain injury: sensory-motor, cognitive-communication, medical complications, and psychosocial. Between 1980 and 2012, there was no significant difference in median sample sizes (P = .202; 95% CI, 0.198-0.214). Median PEDro scores did not significantly improve between 1983-1987 (median = 4, interquartile range = 4.5) and 2008-2012 (median = 6, interquartile range = 2; P = .100; 95% CI, 0.093-0.105). CONCLUSIONS: This study demonstrates the need for more randomized controlled trials, increased sample sizes, and improved methodological quality to better guide clinical practice for acquired brain injury rehabilitation.

Toning it down: selecting outcome measures for spasticity management using a modified Delphi approach.

OBJECTIVE: To identify a set of clinically useful outcome measures for assessment of adults receiving treatment for spasticity. DESIGN: A modified Delphi process was conducted. In round 1, key areas of spasticity assessment and associated outcome measures were identified. In round 2, participants were presented with reviews of eligible outcome measures and were asked to select the tool they believed to be the "best" in each area. Consensus was achieved if there was at least 70% agreement among participants. In round 3, participants rated measures based on feasibility, ability to capture change, and usefulness of information gained for areas where consensus was not achieved in round 2. SETTING: The Modified Delphi process was conducted online using survey software. PARTICIPANTS: Clinicians (N=32) from centers across Canada participated in this study. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Not applicable. RESULTS: Of 51 tools identified initially, 8 were selected. Tools related to body structure and function included the visual analog scale, manual muscle testing, Penn Spasm Frequency Scale, and goniometry. Activity level measures included the Berg Balance Scale, Goal Attainment Scaling (GAS), and the FIM. The Modified Caregiver Strain Index was selected for the assessment of caregiver burden, while GAS was selected for participation level outcomes. CONCLUSIONS: A standardized set of outcome measures will assist with better documentation and standardization of assessment practices of clinicians who manage spasticity.

A systematic review of studies reporting multivariable models to predict functional outcomes after post-stroke inpatient rehabilitation.

PURPOSE: This systematic review summarizes the utility of variables available at acute discharge after stroke for predicting functional independence at discharge from inpatient rehabilitation. METHODS: A systematic review of four electronic databases (Medline, EMBASE, PsycINFO and CINAHL) was conducted to identify studies reporting multivariable models predicting post-rehabilitation Barthel Index (BI) or Functional Independence Measure (FIM®) scores. In studies meeting inclusion criteria, the frequency with which candidate predictors were found statistically significant was calculated and summarized. RESULTS: A total of 3260 articles were screened, of which 27 were included and 63 multivariable models of discharge BI or FIM® were reported. In all, 126 candidate predictors of BI or FIM® were explored. Variables found to be significant most frequently included admission functional level (BI or FIM®), National Institute of Health Stroke Scale (NIHSS), dysphasia, impulsivity, neglect, previous stroke, and age. CONCLUSIONS: Only a selected group of variables have repeatedly proven to be significant predictors of functional ability after post-stroke inpatient rehabilitation. [Box: see text].

The next revolution in stroke care.

Stroke is the second leading cause of death and disability worldwide. Initiatives to decrease the burden of stroke have largely focused on prevention and acute care strategies. Despite considerable resources and attention, the focus on prevention and acute care has not been successful in changing the clinical trajectory for the majority of stroke patients. While efforts to prevent strokes will continue to have an impact, the total burden of stroke will increase due to the aging population and decreased mortality rates. There is strong evidence for the effectiveness of rehabilitation in better managing stroke and its related disabilities. The time has come to shift the attention in stroke care and research from prevention and cure to a greater focus and investment in the rehabilitation and quality of life of stroke survivors. The rebalancing of stroke care and research initiatives requires a reinvestment in rehabilitation and community reintegration of stroke survivors.

The Effect of tPA on Inpatient Rehabilitation after Stroke: A Cost Comparison.

BACKGROUND: Tissue plasminogen activator has been found to significantly improve patient outcomes post stroke. Previous economic evaluations have adjusted for fewer admissions to inpatient rehabilitation but not for decreased length of stay in rehabilitation. Our objective was to estimate the potential cost savings associated with a decreased length of stay in inpatient rehabilitation for patients who receive tissue plasminogen activator compared to those who do not, in a Canadian context. METHODS: Decreased length of stay in inpatient rehabilitation for patients who received tissue plasminogen activator compared to controls was reported previously in a population of 1962 patients admitted to hospital with an ischemic stroke in Ontario between July 1, 2003 and March 31, 2008. Average per diem cost savings associated with the use of tissue plasminogen activator were calculated using a literature based cost estimate. Sensitivity analysis varying the length of stay in inpatient rehabilitation was performed. RESULTS: The estimated mean per diem cost of inpatient rehabilitation derived from the literature was $626. Based on previously reported estimates for reduced length of stay, receipt of tissue plasminogen activator was estimated to result in savings of $939 per patient during inpatient rehabilitation. Sensitivity analysis suggested that these cost savings could range from $501 to $1377 per patient on average. CONCLUSIONS: Future economic evaluations of tissue plasminogen activator should consider adjusting for shortened length of stay in inpatient rehabilitation for patients who receive tissue plasminogen activator.