Key Message

No relevant literature was identified regarding the clinical effectiveness of Trendelenburg patient positioning during a hypotensive episode for adults undergoing hemodialysis versus neutral supine patient positioning. Additionally, no evidence-based guidelines were identified regarding Trendelenburg patient positioning during a hypotensive episode for adults undergoing hemodialysis.

Key Message

One systematic review was identified with a scope broad enough to include potentially relevant primary studies, however this systematic review did not include any primary studies with relevance to the research questions for this report. Additionally, no evidence-based guidelines were identified. Therefore, no conclusion can be provided regarding intravenous multivitamin or micronutrient supplementation for patients with malabsorption issues, patients post-surgery, and patients with burns, trauma, intoxication, or other serious infectious diseases either in a hospital or in an outpatient setting.

Key Message

Nineteen studies were retrieved surrounding the clinical effectiveness of transcatheter aortic valve implantation for patients with degenerated mitral or tricuspid valve bioprostheses, comprising one systematic review of single arm studies, two non-randomized studies with comparator groups, and 16 single-arm studies with no comparator groups.

Two retrospective cohort studies in patients with degenerated mitral valve bioprostheses reported no difference for in-hospital mortality, or mortality at one and two years, for transcatheter mitral valve-in-valve procedures compared to surgical replacement. One study also concluded that there was a trend towards improved clinical outcomes, such as reduced rates of stroke and bleeding, for transcatheter procedures compared to surgical replacement; however, these differences were not statistically significant. There were serious limitations in both studies related to selection bias, bias due to confounding, and small sample size (121 patients in one study and 61 patients in the other study).

One systematic review and 12 single arm studies evaluated transcatheter valve-in-valve procedures for degenerated mitral valve bioprostheses in patients at high risk for surgery. Four single arm studies evaluated transcatheter valve-in-valve procedures for degenerated tricuspid valves in patients at high risk for surgery. Authors of these studies concluded, based on low rates of mortality, complications, and adverse effects, that transcatheter procedures were feasible, effective, and safe. New York Heart Association functional class improved after the procedure compared to baseline, suggesting that transcatheter valve-in-valve procedures for degenerated mitral or tricuspid valves lead to improved patient function and symptoms compared to baseline. These single arm studies were mostly small (11 out of 12 mitral valve studies had sample sizes ≤ 60 and three out of four tricuspid valve studies had sample sizes ≤ 7) and lacked comparison groups, making it impossible to judge the benefits and harms of transcatheter approaches relative to surgery or medical management. Authors of these studies acknowledged the need for larger, long-term studies.

No relevant economic evaluations were identified and thus the cost-effectiveness of transcatheter aortic valve implantation for degenerated mitral or tricuspid valves is unclear.

Despite identifying nineteen eligible studies for this report, the limitations and methodological concerns with current body of evidence suggest that further research is necessary to establish the clinical effectiveness and cost-effectiveness of transcatheter aortic valve implantation for degenerated mitral or tricuspid bioprostheses compared to open-heart surgical procedures and medical management. While it may be challenging or impossible to conduct randomized studies (given high or prohibitive risk for re-do surgery) or mitigate selection bias in this context, future studies of transcatheter aortic valve implantation for degenerated mitral or tricuspid valves should feature larger sample sizes, comparator groups, and appropriate techniques to minimize selection bias and bias due to confounding, particularly confounding by indication, in order to generate higher-quality evidence.

Key Message

Two evidence-based guidelines were identified regarding interventions for the prevention of Sudden Infant Death Syndrome (SIDS) and Sudden Unexplained Death in Infancy. The American Academy of Pediatrics (AAP) guideline recommends always placing infants in the supine position (on the back) to sleep, on a firm and separate surface without any soft or loose objects in the parental room (room sharing) for the first year of life. The AAP further recommend: breastfeeding, infant immunization in accordance with existing guidelines, avoidance of prenatal and post-natal exposure to smoke, supervised and awake tummy time, and that care be taken to avoid overheating. The AAP suggests that pacifiers can be used. Home cardiorespiratory monitoring devices are not recommended to reduce the risk of SIDS, and there was no evidence to recommend swaddling as a risk reduction strategy for SIDS. The AAP guideline also recommends continuing safe sleeping campaigns, continued research and accurate media messaging.The second guideline, developed by the National Institute for Health and Care Excellence (NICE), focused mainly on post-natal care of women and babies, and advises healthcare providers to discuss the association between co-sleeping or bedsharing and risk of SIDS with parents.

Key Message

Five observational descriptive studies were included in this report. Four of the included observational studies had relatively small sample sizes ranging from six patients to 19 patients. One of the observational studies had a larger sample size (total of 172 patients enrolled), but only provided an analysis at month 14 for 57 patients. Overall, these studies indicated improvements were reflected in the Hammersmith Functional Motor Scale Expanded score, to a lesser extent on the Revised Upper Limb Module score, and mixed scores of improvements, stabilization, and decline in the 6-Minute Walk Test across the studies. Safety was reported in two of the included studies with three events registered as severe. 

Limitations of the available evidence revolve around the study design and missing data. The study design (observational and uncontrolled) prevents any sort of statistical inference to be made from the generally small samples within the studies. In addition, several biases are likely to have had an effect in favour of nusinersen, including: selection bias, expectation bias, and attrition bias.

The review cannot answer the question of the clinical effectiveness of nusinersen in adolescent and adult patients with SMA because of the significant limitations of the included studies. The included evidence serves as exploratory information for the formulation of a scientific hypothesis to be tested within a controlled clinical trial study design.​

Key Message

This rapid qualitative evidence synthesis included 13 primary studies on the views and understanding of patients and providers on PGx testing.Overall, PGx testing was seen by patients and providers as being beneficial. Although sometimes more information in and of itself was desired, most patients and providers described PGx testing as helping narrow down their choices to the best medication to avoid adverse reactions.However, patients and providers alike expressed worries around how PGx testing would limit patient centered care by limiting patients’ choices of medications. For patients, particularly those with mental health conditions, they worried about not having their personal experiences with medications heard by providers. Having to select less effective or more expensive medications to avoid potential adverse reactions flagged by PGx test results was also raised as a substantial concern.Issues around the ordering of PGx testing revealed that providers’ opinions varied about whether to order tests at medication initiation or after. Providers described comfort and familiarity with PGx tests as affecting their decisions to order testing. The potential for genetic discrimination by insurers and employers raised concerns about privacy and confidentiality. Limited access to PGx test results was considered a key strategy for mitigating this risk.PGx test results can shape patient care over their life course. The potential for secondary findings from PGx testing made patients worry about how these results would affect them in the present and the future. The potential for the results of PGx tests to impact current and future family members also troubled patients and providers. There was limited information on the use of and views on PGx by disease or by type of testing. Findings point to the need for faster results from PGx testing in life-limiting or rapidly progressing conditions. In areas such as mental health, PGx testing was used less routinely, and generally applied where patients experience adverse reactions or limited effectiveness. Providers and patients expected PGx test results to be one of several types of information in decision making.

Key Message

Two systematic reviews and one randomized controlled trial were identified regarding hypodermoclysis in patients who are frail or who are in long term care. Hypodermoclysis appeared to have fewer adverse effects or complications when compared with intravenous fluids but did not have a significantly better clinical improvement of dehydration. The studies were of low quality, with poor reporting of methods and small sample sizes. No economic evaluations were identified regarding hypodermoclysis in frail patients or patients in long term care, and no evidence-based guidelines were identified.

Key Message

One systematic review with meta-analysis, three primary non-randomized studies, and one evidence-based guideline regarding the safety or use of immediately sequential bilateral cataract surgery (ISBCS) for the treatment of bilateral cataracts were included in this report. The identified literature revealed varied, but largely neutral, conclusions regarding the safety of ISBCS for the treatment of bilateral cataracts. Specifically, the systematic review with meta-analysis suggested that there were no significant differences in postoperative quality of life scores including Visual Function 7- and 14-item questionnaire, EuroQOL Five Dimensions questionnaire, and Health Utility Index Mark 3 score between those who underwent ISBCS versus delayed sequential bilateral cataract surgery (DSBCS). However, patients who underwent ISBCS exhibited significantly greater improvements in postoperative Catquest scores compared to those who underwent DSBCS. Findings from a primary non-randomized study suggested that there were no significant differences in the rates of intraoperative complications including posterior capsular rupture and vitrectomy, while another non-randomized study observed numerically similar rates of posterior capsular rupture after adjustments for case complexity between ISBCS and DSBCS patients. One primary non-randomized study detected no significant differences in rates of postoperative endophthalmitis between ISBCS and DSBCS patients. However, patients who underwent ISBCS exhibited significantly lower rates of macular edema compared to those who underwent DSBCS. Based on variable quality evidence, the NICE guideline recommends that patients need to be informed of the risks versus benefits of ISBCS (recommendation strength not assigned). In addition, ISBCS should be considered for patients with a low complication risk, or for those needing general anesthesia but anesthesia may increase their complication risk (evidence of benefit is less certain). Overall, the body of evidence used to inform this report was limited in quantity and was largely low to moderate in quality. Additionally, the high degree of heterogeneity of studies in the systematic review and lack of randomization in the primary clinical studies should be taken into consideration when interpreting these results. Finally, since the sample populations consisted of patients living in the US, United Kingdom, Spain, New Zealand, Australia, Japan, Finland, Sweden, or Switzerland, these findings may not be generalizable to the Canadian setting.