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Published on July 23, 2015
The lack of evidence for PET or PET/CT surveillance of patients with treated lymphoma, colorectal cancer, and head and neck cancer
12 Studies • 2 Key Questions • 12 Extraction Forms
(Last updated on March 01, 2021)
Objectives: Systematic review of diagnostic accuracy and clinical impact of PET and PET-CT used for surveillance in several cancer types
Published on July 23, 2015
Fructose Consumption and Non-alcoholic Fatty Liver Disease (NAFLD)
23 Studies • 5 Key Questions • 23 Extraction Forms
(Last updated on March 01, 2021)
Objectives: Background: There are growing concerns about the effects of dietary fructose on health outcomes because the intakes appear to have parallel trends in non-alcoholic fatty liver disease (NAFLD) and obesity prevalence in the United States. Purpose: To examine the effect of different levels and sources of dietary fructose on the incidence or prevalence of NAFLD and on indices of liver health in humans. Data Sources: English-language studies identified from MEDLINE, Cochrane Central Register of Controlled Trials, CAB Abstracts, and Global Health databases up to September 2012. Study Selection: Human studies of any design in children and adults with low to no alcohol intake and reporting at least one predetermined measure of liver health. Data Extraction: Study data was extracted by one investigator and corroborated by a second investigator. Differences were resolved by consensus. Data Synthesis: Twenty-two studies met the inclusion criteria, 3 reported NAFLD outcomes and 19 reported indices of liver health. Of these, all but 1 study were rated at medium or high risk of bias. The overall strength of evidence for an association between fructose intake and incidence of NAFLD was rated insufficient because of the biases and confounding in the study results. The 19 studies reporting indices of liver health were synthesized separately by each outcome: liver fat outcomes (7 studies), liver enzymes (11 studies), hepatic de novo lipogenesis rates (2 studies), and plasma bilirubin concentrations (2 studies). The overall strength of evidence was rated insufficient for all outcomes, except for some plasma liver enzymes. Our random-effects meta-analysis of 3 short-term RCTs (6 to 7 days) showed a significant increase in alanine aminotransferase (ALT) concentrations (+4.32 IU/L, 95% CI 0.20, 8.43, P=0.04) when a free fructose enriched excess energy diet was compared to a habitual weight maintenance diet. Limitations: Most studies were rated at medium or high risk of bias, were small in sample size, included healthy adult men only, and were highly heterogeneous in study design and intervention, and thus limiting comparability. Conclusions: Due to scarce, poor-quality, and heterogeneous data, we concluded that evidence is insufficient to draw conclusions regarding the effect of fructose consumption on NAFLD, while there is low level of evidence for a relationship between high free fructose intake in excess of energy needs and elevated liver enzyme concentrations. Large prospective cohort studies using standard NAFLD diagnosis are needed to examine the complex relationships between dietary factors and the risk of NAFLD.
Published on September 25, 2015
Sling surgery for stress urinary incontinence in women: SGS 2013
104 Studies • 2 Key Questions • 104 Extraction Forms
(Last updated on March 01, 2021)
Objectives: The SR compares use of different slings versus other surgical interventions to treat stress urinary incontinence in women.
Published on September 06, 2017
Diet and PA for Prevention of Diabetes-Full Data Extraction
50 Studies • 1 Key Questions • 50 Extraction Forms
(Last updated on March 01, 2021)
Published on July 23, 2015
Benefits and Harms of Routine Preoperative Testing: Comparative Effectiveness Review 2013
220 Studies • 4 Key Questions • 220 Extraction Forms
(Last updated on March 01, 2021)
Objectives: Objectives: Preoperative testing is used to guide the action plan for patients undergoing surgical and other procedures that require anesthesia and to predict potential postoperative complications. There is uncertainty whether routine or per-protocol testing in the absence of a specific indication prevents complications and improves outcomes, or whether it causes unnecessary delays, costs, and harms due to false-positive results. Data sources: We searched MEDLINE® and Ovid Healthstar® (from inception to July 22, 2013), as well as Cochrane Central Trials Registry and Cochrane Database of Systematic Reviews. Review methods: We included comparative and cohort studies of both adults and children undergoing surgical and other procedures requiring either anesthesia or sedation (excluding local anesthesia). We included all preoperative tests that were likely to be conducted routinely (in all patients) or on a per-protocol basis (in selected patients). For comparative studies, the comparator of interest was either no testing or ad hoc testing done at the discretion of the clinician. We also looked for studies that compared routine and per-protocol testing. The outcomes of interest were mortality, perioperative events, complications, patient satisfaction, resource utilization, and harms related to testing. Results: Fifty-seven studies (14 comparative and 43 cohort) met inclusion criteria for the review. Well-conducted randomized controlled trials (RCTs) of cataract surgeries suggested that routine testing with electrocardiography, complete blood count, and/or a basic metabolic panel did not affect procedure cancellations (2 RCTs, relative risks [RRs] of 1.00 or 0.97), and there was no clinically important difference for total complications (3 RCTs, RR = 0.99; 95% confidence interval, 0.86 to 1.14). Two RCTs and six nonrandomized comparative studies of general elective surgeries in adults varied greatly in the surgeries and patients included, along with the routine or per-protocol tests used. They also mostly had high risk of bias due to lack of adjustment for patient and clinician factors, making their results unreliable. Therefore, they yielded insufficient evidence regarding the effect of routine or per-protocol testing on complications and other outcomes. There was also insufficient evidence for patients undergoing other procedures. No studies reported on quality of life, patient satisfaction, or harms related to testing. Conclusions: There is high strength of evidence that, for patients scheduled for cataract surgery, routine preoperative testing has no effect on total perioperative complications or procedure cancellation. There is insufficient evidence for all other procedures and insufficient evidence comparing routine and per-protocol testing. There is no evidence regarding quality of life or satisfaction, resource utilization, or harms of testing and no evidence regarding other factors that may affect the balance of benefits and harms. The findings of the cataract surgery studies are not reliably applicable to other patients undergoing other higher risk procedures. Except arguably for cataract surgery, numerous future adequately powered RCTs or well-conducted and analyzed observational comparative studies are needed to evaluate the benefits and harms of routine preoperative testing in specific groups of patients with different risk factors for surgical and anesthetic complications undergoing specific types of procedures and types of anesthesia.
Published on March 04, 2016
Diet and Physical Activity for Prevention of Diabetes: Evidence Map
239 Studies • 1 Key Questions • 239 Extraction Forms
(Last updated on March 01, 2021)
Objectives: Evidence mapping for topic development of diet and physical activity promotion programs systematic review. Most data are derived from abstracts, not full text articles.
Published on July 23, 2015
Therapeutic Management, Delivery, and Postpartum Risk Assessment and Screening in Gestational Diabetes [Entered Retrospectively]
43 Studies • 8 Key Questions • 43 Extraction Forms
(Last updated on March 03, 2021)
Objectives: Objectives: We focused on four questions: (1) What are the risks and benefits of an oral diabetes agent (i.e., glyburide), as compared to all types of insulin, for gestational diabetes? (2) What is the evidence that elective labor induction, cesarean delivery, or timing of induction is associated with benefits or harm to the mother and neonate? (3) What risk factors are associated with the development of type 2 diabetes after gestational diabetes? (4) What are the performance characteristics of diagnostic tests for type 2 diabetes in women with gestational diabetes? Data Sources: We searched electronic databases for studies published through January 2007. Additional articles were identified by searching the table of contents of 13 journals for relevant citations from August 2006 to January 2007 and reviewing the references in eligible articles and selected review articles. Review Methods: Paired investigators reviewed abstracts and full articles. We included studies that were written in English, reported on human subjects, contained original data, and evaluated women with appropriately diagnosed gestational diabetes. Paired reviewers performed serial abstraction of data from each eligible study. Study quality was assessed independently by each reviewer. Main Results: The search identified 45 relevant articles. The evidence indicated that (1) maternal glucose levels do not differ substantially in those treated with insulin versus insulin analogues or oral agents; (2) average infant birth weight may be lower in mothers treated with insulin than with glyburide; (3) induction at 38 weeks may reduce the macrosomia rate, with no increase in cesarean delivery rates; (4) anthropometric measures, fasting blood glucose (FBG), and 2-hour glucose value are the strongest risk factors associated with development of type 2 diabetes; (5) FBG had high specificity, but variable sensitivity, when compared to the 75-gm oral glucose tolerance test (OGTT) in the diagnosis of type 2 diabetes after delivery. Conclusions: The evidence suggests that benefits and a low likelihood of harm are associated with the treatment of gestational diabetes with an oral diabetes agent or insulin. The effect of induction or elective cesarean on outcomes is unclear. The evidence is consistent that anthropometry identifies women at risk of developing subsequent type 2 diabetes; however, no evidence suggested the FBG out-performs the 75-gm OGTT in diagnosing type 2 diabetes after delivery.
Published on October 21, 2016
Sugars and Health - Evidence Map
213 Studies • 2 Key Questions • 213 Extraction Forms
(Last updated on March 03, 2021)
Objectives: This evidence map on sugars and health outcomes was developed using an iterative process. Evidence Map data are being used to support a stakeholders ‘ decision-making on refining research questions and topic prioritization. The goal of this Future Research Needs project is to characterize the available evidence regarding the intake of sugars and health outcomes and identify priority areas where additional research needs remain.
Published on May 23, 2019
Decision Aids for Cancer Screening and Treatment
74 Studies • 2 Key Questions • 74 Extraction Forms
(Last updated on March 03, 2021)
Objectives: Background: Many health decisions about screening and treatment for cancers involve uncertainty or tradeoffs between the expected benefits and harms. Patient decision aids have been developed to help health care consumers and their providers identify the available alternatives and choose the one that aligns with their values. It is unclear whether the effectiveness of decision aids for decisions related to cancers differs by people’s average risk of cancer or by the content and format of the decision aid.; Objectives: We sought to appraise and synthesize the evidence assessing the effectiveness of decision aids targeting health care consumers who face decisions about cancer screening or prevention, or early cancer treatment (Key Question 1), particularly with regard to decision aid or patient characteristics that might function as effect modifiers. We also reviewed interventions targeting providers for promotion of shared decision making using decision aids (Key Question 2).; Data sources: We searched MEDLINE®, Embase®, the Cochrane Central Register of Controlled Trials (CENTRAL), PsycINFO®, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL®) from inception to the end of June 2014.; Review methods: For Key Question 1, we included randomized controlled trials comparing decision aid interventions among themselves or with a control. We included trials of previously developed decision aids that were delivered at the point of the actual decision. We predefined three population groups of interest based on risk or presence of cancer (average cancer risk, high cancer risk, early cancer). The assessed outcomes pertained to measurements of decisional quality and cognition (e.g., knowledge scores), attributes of the decision-making process (e.g., Decisional Conflict Scale), emotion and quality of life (e.g., decisional regret), and process and system-level attributes. We assessed for effect modification by population group, by the delivery format or content of the decision aid or other attributes, or by methodological characteristics of the studies. For Key Question 2, we included studies of any intervention to promote patient decision aid use, regardless of study design and outcomes assessed.; Results: Of the 16,669 screened citations, 87 publications were eligible, corresponding to 83 (68 trials; 25,337 participants) and 5 reports for Key Questions 1 and 2, respectively. Regarding the evolution of the decision aid format and content over time, more recent trials increasingly studied decision aids that were more practical to deliver (e.g., over the Internet or without human mediation) and more often clarified preferences explicitly. Overall, participants using decision aids had higher knowledge scores compared with those not using decision aids (standardized mean difference, 0.23; 95% credible interval [CrI], 0.09 to 0.35; 42 comparison strata with 12,484 participants). Compared with not using decision aids, using decision aids resulted in slightly lower decisional conflict scores (weighted mean difference of -5.3 units [CrI, -8.9 to - 1.8] on the 0-100 Decisional Conflict Scale; 28 comparison strata; 7,923 participants). There was no difference in State-Trait Anxiety Inventory scores (weighted mean difference = 0.1; 95% CrI, -1.0 to 0.7 on a 20-80 scale; 16 comparison strata; 2,958 participants). Qualitative synthesis suggested that patients using decision aids are more likely to make informed decisions and have accurate risk perceptions; further, they may make choices that best agree with their values and may be less likely to remain undecided. Because there was insufficient, sparse, or no information about effects of decision aids on patient-provider communication, patient satisfaction with decision-making process, resource use, consultation length, costs, or litigation rates, a quantitative synthesis was not done. There was no evidence for effect modification by population group, by the delivery format or content of the decision aid or other attributes, or by methodological characteristics of the studies. Data on Key Question 2 were very limited.; Conclusions: Cancer-related decision aids have evolved over time, and there is considerable diversity in both format and available evidence. We found strong evidence that cancer-related decision aids increase knowledge without adverse impact on decisional conflict or anxiety. We found moderate- or low-strength evidence that patients using decision aids are more likely to make informed decisions, have accurate risk perceptions, make choices that best agree with their values, and not remain undecided. This review adds to the literature that the effectiveness of cancer-related decision aids does not appear to be modified by specific attributes of decision aid delivery format, content, or other characteristics of their development and implementation. Very limited information was available on other outcomes or on the effectiveness of interventions that target providers to promote shared decision making by means of decision aids.
Published on July 14, 2015
SGS: Local Estrogen For Genitourinary Complaints in Post-Menopausal Women
56 Studies • 1 Key Questions • 56 Extraction Forms
(Last updated on March 03, 2021)
Objectives: To comprehensively review and critically assess the literature on vaginal estrogen and its alternatives for women with genitourinary syndrome of menopause and to provide clinical practice guidelines.
Published on July 23, 2015
Therapies for Children with Autism Spectrum Disorders [Entered Retrospectively]
170 Studies • 2 Key Questions • 170 Extraction Forms
(Last updated on March 03, 2021)
Objectives: The Vanderbilt Evidence-based Practice Center systematically reviewed evidence on therapies for children ages 2 to 12 with autism spectrum disorders (ASDs). We focused on treatment outcomes, modifiers of treatment effectiveness, evidence for generalization of outcomes to other contexts, and evidence to support treatment decisions in children ages 0-2 at risk for an ASD diagnosis.
Published on December 08, 2015
Off-Label Use of Atypical Antipsychotics: An Update [Entered Retrospectively]
129 Studies • 4 Key Questions • 129 Extraction Forms
(Last updated on March 03, 2021)
Objectives: Objectives: Antipsychotic medications are approved by the U.S. Food and Drug Administration (FDA) for treatment of schizophrenia, bipolar disorder, and for some drugs, depression. We performed a systematic review on the efficacy and safety of atypical antipsychotic drugs for use in conditions lacking FDA approval. Data Sources: We searched PubMed, Embase, PsycINFO, CINAHL (Cumulative Index to Nursing and Allied Health Literature), Cochrane DARE (Database of Abstracts of Reviews of Effects), and Cochrane CENTRAL (Cochrane Central Register of Controlled Trials) from inception to May 2011. We included only English-language studies. Review Methods: Controlled trials comparing an atypical antipsychotic (risperidone, olanzapine, quetiapine, aripiprazole, ziprasidone, asenapine, iloperidone, paliperidone) to either placebo, another atypical antipsychotic drug, or other pharmacotherapy, for the off-label conditions of anxiety disorder, attention deficit hyperactivity disorder, dementia and severe geriatric agitation, major depressive disorder, eating disorders, insomnia, obsessive compulsive disorder (OCD), post traumatic stress disorder (PTSD), personality disorders, substance abuse, and Tourette’s syndrome were included. Observational studies with sample sizes greater than 1,000 were included to assess rare adverse events. Two investigators conducted independent article review, data abstraction, and study quality assessment. Results: One hundred seventy trials contributed data to the efficacy review. Among the placebocontrolled trials of elderly patients with dementia reporting a total/global outcome score that includes symptoms such as psychosis, mood alterations, and aggression, small but statistically significant effect sizes ranging from 0.12 and 0.20 were observed for aripiprazole, olanzapine, and risperidone. For generalized anxiety disorder, pooled analysis of three large trials showed that quetiapine was associated with a 26 percent greater likelihood of "responding," defined as at least 50 percent improvement on the Hamilton Anxiety Scale, compared with placebo. For obsessive-compulsive disorder, risperidone was associated with a 3.9-fold greater likelihood of "responding," defined as a 25 to 35 percent improvement on the Yale Brown Obsessive Compulsive Scale (YBOCS) compared with placebo. We identified 6 trials on eating disorders, 12 on personality disorder, an existing metaanalysis and 10 trials of risperidone or olanzapine for PTSD, 36 trials for depression of which 7 assessed drugs without an FDA-approved indication, and 33 trials of aripiprazole, olanzapine, quetiapine, or risperidone for treating substance abuse disorders. We identified one small trial (N=13) of atypical antipsychotics for insomnia which was inconclusive. For eating disorder patients specifically, evidence shows that atypicals are do not cause significant weight gain. The level of evidence is mixed regarding personality disorders and moderate for an association of risperidone with improving post-traumatic stress disorder. Evidence does not support efficacy of atypical antipsychotics for substance abuse. In elderly patients, adverse events included an increased risk of death (number needed to harm [NNH]=87), stroke (for risperidone, NNH=53), extrapyramidal symptoms (for olanzapine (NNH=10) and risperidone (NNH=20), and urinary symptoms (NNH= from 16 to 36). In nonelderly adults, adverse events included weight gain (particularly with olanzapine), fatigue, sedation, akithisia (for aripiprazole) and extrapyramidal symptoms. Direct comparisons of different atypical antipsychotics for off-label conditions are rare. Conclusions: Benefits and harms vary among atypical antipsychotics for off-label usage. For symptoms associated with dementia in elderly patients, small but statistically significant benefits were observed for aripiprazole, olanzapine, and risperidone. Quetiapine was associated with benefits in the treatment of generalized anxiety disorder, and risperidone was associated with benefits in the treatment of OCD; however, adverse events were common.
Published on July 23, 2015
Treatment of Common Hip Fractures [Entered Retrospectively]
85 Studies • 8 Key Questions • 85 Extraction Forms
(Last updated on March 03, 2021)
Objectives: Objectives: To conduct a systematic review and synthesize the evidence for the effects of surgical treatments for subcapital and intertrochanteric/subtrochanteric hip fractures on patient-focused outcomes for elderly patients. Data Sources: MEDLINE®, Cochrane databases, Scirus, and, and expert consultants. We also manually searched reference lists from relevant systematic reviews. Review Methods: High quality quasi-experimental design studies were used to examine relationships between patient characteristics, type of fracture, and patient outcomes. Randomized controlled trials were used to examine relationships between type of surgical treatment and patient outcomes. Patient mortality was examined with Forest plots. Narrative analysis was used for pain, quality of life (QoL), and functional outcomes due to inconsistently measured and reported outcomes. Results: Mortality does not appear to differ by device class, or by devices within a class. Nor, on the whole, do pain, functioning, and QoL. Some internal fixation devices may confer earlier return to functioning over others for some patients, but such gains are very short lived. Very limited results suggest that subcapital hip fracture patients with total hip replacements have improved patient outcomes over internal fixation, but it is unclear whether these results would continue to hold if the analyses included the full complement of relevant covariates. Age, gender, prefracture functioning, and cognitive impairment appear to be related to mortality and functional outcomes. Fracture type does not appear to be independently related to patient outcomes. Again, however, the observational literature does not include the full complement of potential covariates and it is uncertain if these results would hold. Conclusions: Several factors limit our ability to definitively answer the key questions posed in this study using the existing literature. Limited perspectives lead to incomplete sets of independent variables included in analyses. Specific populations are poorly defined and separated for comparative study. Fractures with widely varying biomechanical problems are often lumped together. Outcome variables are inconsistently measured and reported, making it very difficult to aggregate or even compare results. If future high quality trials continue to support the evidence that differences in devices are short term at best, within the first few weeks to few months of recovery, policy implications involve establishing the value of a shorter recovery relative to the cost of the new device. As the literature generally focuses on community dwelling elderly patients, more attention needs to be directed toward understanding implications of surgical treatment choices for the nursing home population.
Published on September 25, 2015
Adverse Events in Women with Silicone Gel Breast Implants: A Systematic Review
57 Studies • 1 Key Questions • 57 Extraction Forms
(Last updated on March 03, 2021)
Objectives: Breast implants are medical devices used to reconstruct the breast following mastectomy, to augment breast size, or to correct a congenital abnormality.1 Breast implants consist of a silicone outer shell and a filler (most commonly silicone gel or saline). In the US about half of implants are silicone gel-filled implants. Recently, the Food and Drug Administration (FDA) has recommended the creation of a surveillance registry to monitor for potential adverse events associated with silicone gel breast implants. However, a clinical registry that can provide meaningful data on the long-term safety requires a large number of patients and rigorous patient follow-up, both of which have been difficult for breast implant companies to achieve. The American Society of Plastic Surgeons (ASPS®) and the Plastic Surgery Foundation (PSF) has solicited this systematic review (SR) to summarize the state of the literature on safety outcomes in women with silicone gel breast implants for the purpose of informing the development of the registry.
Published on December 02, 2015
Recommendations for decision and simulation modeling
69 Studies • 1 Key Questions • 69 Extraction Forms
(Last updated on March 03, 2021)
Objectives: Purpose: We aimed to update and expand previous syntheses of evidence- and consensus-based guidance on decision and simulation modeling using a systematic review-driven stakeholder-led process.
Published on July 23, 2015
First- and Second- Generation Antipsychotics for Children and Young Adults [Entered Retrospectively]
81 Studies • 4 Key Questions • 81 Extraction Forms
(Last updated on March 03, 2021)
Objectives: Methods: Two reviewers conducted study selection and quality assessment independently and resolved discrepancies by consensus. One reviewer extracted data, and a second reviewer verified the data. We conducted a descriptive analysis for all studies and performed metaanalyses when appropriate. Results: Eighty-one studies (64 trials and 17 cohort studies) examined the following conditions: pervasive developmental disorders (12 studies); attention deficit hyperactivity disorder (ADHD) or disruptive behavior disorders (8 studies); bipolar disorder (11 studies); schizophrenia and related psychosis (31 studies); Tourette syndrome (7 studies); behavioral issues (4 studies); and multiple conditions (9 studies). One study reported data on both bipolar disorder and schizophrenia. The majority of the trials had a high risk of bias. The methodological quality of the cohort studies was moderate. Results are presented by outcome below: Symptoms: The strength of evidence for all head-to-head comparisons of FGAs and SGAs was low or insufficient to draw conclusions. SGAs were favored over placebo for behavior symptoms (ADHD and disruptive behavior disorders), the Clinical Global Impressions scale (ADHD and disruptive behavior disorders, bipolar disorder, and schizophrenia), positive and negative symptoms (schizophrenia), and tics (Tourette syndrome) (moderate strength of evidence). Other short- and long-term outcomes: All head-to-head comparisons had low or insufficient strength of evidence. There was no significant difference between SGAs and placebo for suicide related behaviors (moderate strength of evidence). The evidence was rated as insufficient to draw conclusions for health-related quality of life, involvement with the legal system, and other patient-, parent-, or care provider-reported outcomes for all conditions. Adverse events: All outcomes comparing FGAs with SGAs had low or insufficient strength of evidence. Outcomes comparing FGAs versus FGAs and FGAs versus placebo had insufficient evidence. Risperidone was favored over olanzapine for dyslipidemia; olanzapine was favored over risperidone for prolactin-related events; and both quetiapine and risperidone were favored over olanzapine for weight gain (moderate strength of evidence). For nearly all outcomes and comparisons, placebo resulted in significantly fewer adverse events than SGAs. Subpopulations: Thirty-six studies examined the association between various patient subpopulations and outcomes. Most concluded that the results did not differ by subpopulations, or findings were discordant across studies. Conclusion: Evidence comparing FGAs with SGAs, various FGAs, and FGAs with placebo was very limited. Some SGAs appear to have a better side-effect profile than other SGAs. Compared with placebo, SGAs have better symptom improvement but more adverse events. Future high quality research examining head-to-head antipsychotic comparisons is needed.
Published on September 16, 2015
Behavioral programs for diabetes mellitus
166 Studies • 6 Key Questions • 166 Extraction Forms
(Last updated on March 03, 2021)
Objectives: A systematic review focusing on the effectiveness of behavioral programs for type 1 diabetes (T1DM), and identifying factors contributing to program effectiveness for type 2 diabetes (T2DM).
Published on February 18, 2016
Catheter Ablation for Treatment of Atrial Fibrillation [Prospectively Entered]
50 Studies • 7 Key Questions • 50 Extraction Forms
(Last updated on March 03, 2021)
Objectives: Because catheter ablation is increasingly being used to treat AF patients in the Medicare population, and there is uncertainty regarding the efficacy and harms of this procedure in this population in particular, a systematic review to re-evaluate the current state of evidence, identify and evaluate inconsistencies in the evidence, and identify important research gaps is warranted to help inform clinical practice and policy.