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Therapies for Clinically Localized Prostate Cancer [Entered Retrospectively]


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Statistics: 67 Studies, 1 Key Question, 1 Extraction Form,
Date Published: Aug 10, 2020 12:58PM
Description: Structured Abstract Objective. To identify new information that updates findings from previous AHRQ and AUA funded reviews evaluating therapies for clinically localized prostate cancer (CLPC). Sources. Bibliographic databases (2013-January 2020); ClinicalTrials.gov; systematic reviews Methods. Controlled studies of CLPC (T1-T3a) treatments with duration ≥5 years for mortality and metastases and ≥1 year for quality of life and harms. Interventions included watchful waiting (WW), active surveillance or monitoring (AS, AM), androgen deprivation (AD), focal and whole gland therapies or combinations. We evaluated how patient and tumor characteristics modify treatment outcomes and how provider/hospital characteristics modify effectiveness of radical prostatectomy (RP) compared to other therapies. One investigator rated risk of bias (ROB), extracted data, and assessed certainty of evidence; a second checked accuracy. We analyzed English-language studies with low or medium ROB. We incorporated findings from RCTs identified in the 2014 AHRQ and 2016 AUA funded reviews if new RCTs provided information on the same intervention comparison. We derived thresholds defining “small”, “moderate” and “large” effect, summarize key findings from prior reviews and the impact of new research. Results. We identified 67 eligible references; 17 unique RCTs. Among clinically, rather than PSA detected CLPC, WW may increase overall and prostate-cancer mortality, and metastases versus RP at 20+ years. Urinary and erectile dysfunction were lower with WW versus RP. WW‘s effect on mortality may have varied by tumor risk and age but not by race, health status, comorbidities or PSA. AM probably results in little to no difference in overall or prostate-cancer mortality in PSA detected CLPC versus RP or EBR plus AD through 10 years regardless of tumor risk. Metastases were infrequent but slightly higher with AM. Harms were greater with RP than AM and mixed between EBR plus AD versus AM. 3D-Conformal EBR and AD plus low-dose-rate brachytherapy (BT) provided a small reduction in all-cause mortality versus 3D-CRT and AD but little to no difference on metastases. EBR plus AD versus EBR alone may have resulted in a small reduction in overall and prostate-cancer mortality and metastases in higher risk disease but may increase sexual harms. EBR plus initiating neoadjuvant AD versus EBR plus initiating concurrent AD may result in little to no difference in mortality at 12 years and genitourinary toxicity at 3 years. Conventionally fractionated EBR versus ultra-hypofractionated EBR may result in little to no difference in mortality and metastasis at 5 years and urinary and bowel toxicity at 2 years. Limited evidence suggested that AS results in fewer harms than photodynamic therapy and laparoscopic RP resulted in more harms than robotic-assisted RP. There was little to no information on long-term comparative effectiveness of other treatments. No studies evaluated WW or AS in screen detected CLPC or MRI for risk assessment or were conducted since effective pharmacologic therapies for advanced disease. No studies assessed provider or hospital factors of RP comparative effectiveness. Conclusions. RP reduces mortality versus WW in clinically detected CLPC but causes more harms. Effectiveness may be limited to younger men, those with intermediate risk disease and requires many years to occur. AM results in little to no mortality difference versus RP or EBR plus AD. EBR plus AD reduces mortality versus EBR alone in higher risk CLPC but may worsen sexual function. Adding low-dose-rate BT to 3D-Conformal EBR and AD may reduce mortality in higher risk CLPC. Little information exists on other treatments or the effects of patient, tumor and provider factors. Large, long-term RCTs in PSA-detected and MRI staged CLPC are needed.
Contributor(s): Philipp Dahm, M.D., M.H.S.C. Michelle Brasure, Ph.D., M.S.P.H., M.L.I.S. Elizabeth Ester, M.D. Eric J. Linskens, B.S. Roderick MacDonald, M.S. Victoria A. Nelson, M.Sc. Charles Ryan, M.D. Jayati Saha, Ph.D. Shahnaz Sultan, M.D., M.H.S.C. Kristen E. Ullman, M.P.H. Timothy J. Wilt, M.D., M.P.H.
DOI: DOI pending.
Funding Source: AHRQ Contract HHSA290201500008I
Methodology Description: None Provided

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SRDR Project Indexing


Public Project Complete

Statistics: 171 Studies, 1 Key Question, 1 Extraction Form,
Date Published: Aug 10, 2020 12:55PM
Description: This is a Methods Research project that catalogs the various projects with publicly available data on the SRDR Webpage.
Contributor(s): Ian Saldanha, Bryant Smith
Funding Source: Agency for Healthcare Research and Quality
Methodology Description: None Provided

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The effect of IDH inhibitors in AML patients.


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Statistics: 4 Studies, 2 Key Questions, 1 Extraction Form,
Date Published: Jul 28, 2020 04:27PM
Description: 12% of patients with AML harbor mutation at Isocitrate dehydrogenase enzyme (IDH).Mutations at these enzymes result in high level of R2 hydroxyglutarate which competes with 2-alpha-hydroxygluterate resulted in DNA and histone hypermethylation. DNA and histone hypermethylation inhibits cell differentiation and promotes leukemic transformation. Ivosidenib and Enasidenib are IDH inhibitors that promotes cell differentiation and showed promising activity in phase1 and 2 trials in relapse/refractory AML patients and in elderly patients who are not candidate for traditional induction regimens. In this systematic review and meta-analysis, we intend to integrate the results of phase1 and 2 trials that looked at the efficacy and the side effects of IDH inhibitor. Therefore,we will have a clearer picture regarding the efficacy and side effect of these medications.
Contributor(s): Yanal Alnimer, MD Munther Mansour, MD Ayman Qasrawi, MD
DOI: DOI pending.
Funding Source: N/A
Methodology Description: We will use the ("Metaprop") package in R in order to integrate the results pertaining to the Objective response, Complete remission, and other response outcomes in addition to grade 3 and 4 Treatment Emergent Adverse Events (TEAE) in these trials.

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Masks for Prevention of COVID-19 in Community and Healthcare Settings: A Living Rapid Review


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Statistics: 40 Studies, 2 Key Questions, 1 Extraction Form,
Date Published: Jul 27, 2020 01:39PM
Description: To address the comparative effectiveness of various types of face masks in healthcare workers and in the community and to address the effectiveness and safety of mask reuse. Surveillance Report, July 20, 2020 Version 2, June 24, 2020 Version 1, June 18, 2020
Contributor(s): Roger Chou, M.D., FACP; Tracy Dana, M.L.S.; Rebecca Jungbauer, Dr.P.H.; Chandler Weeks, M.P.H.; Marian S. McDonagh, Pharm.D.
DOI: DOI pending.
Funding Source: Agency for Healthcare Research and Quality. Prepared by the Pacific Northwest Evidence-based Practice Center, Oregon Health & Science University. AHRQ Publication No. 20-EHC016.
Methodology Description: We initially searched PubMed MEDLINE and Elsevier Embase (from 2003 through April 14, 2020) and conducted ongoing search updates to identify new studies (surveillance). The WHO Database of Publications on Coronavirus Disease, and the medRxiv preprint server were also searched initially. Reference lists of systematic reviews and included studies were reviewed for additional studies.

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Interventions for Drug Use – Supplemental Report: A Systematic Review for the U.S. Preventive Services Task Force [Entered Retrospectively]


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Statistics: 91 Studies, 6 Key Questions, 1 Extraction Form,
Date Published: Jun 23, 2020 02:30PM
Description: Background: A U.S. Preventive Services Task Force (USPSTF) report found no consistent evidence that counseling interventions are effective at reducing drug use or improving other health outcomes in populations whose drug use was identified through primary care-based screening with questions about drug use or drug-related risks (i.e., “screen-detected populations”). Evidence from studies of persons seeking or referred for treatment for substance use or with clinical signs or symptoms of substance use (i.e., “treatment-seeking populations”) might also be useful for informing assessments regarding screening in primary care settings. Purpose: This report updates a 2008 USPSTF report on screening for illicit drug use and supplements an updated USPSTF report on screening for any drug use, focusing on the benefits and harms of pharmacotherapy and psychosocial interventions for persons whose drug use was identified when seeking substance use treatment, when presenting with signs or symptoms of drug use, when screened for drug use in primary care or other settings with questions about drug use or drug-related risks, or other means. Data Sources: The Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Ovid MEDLINE, Embase, and PsycINFO from inception to September 2018; surveillance for new literature was conducted through November 22, 2019. Study Selection: We included trials of Food and Drug Administration (FDA)-approved pharmacotherapies for opioid use disorder (methadone, buprenorphine, and naltrexone) and trials of psychosocial interventions for persons engaging in opioid, stimulant, cannabis, and mixed drug or polysubstance use. We also included trials of preemptive prescribing of naloxone in primary care settings as a rescue medication for opioid-related overdose. Trials compared included interventions against placebo, a minimal intervention, waitlist control, or usual care, and evaluated outcomes at >3 months for drug use or other risky behaviors; health, social, and legal consequences of drug use; or harms of treatment. Data Extraction: One investigator abstracted data and a second investigator checked data abstraction for accuracy. Two investigators independently assessed study quality using methods developed by the USPSTF. Data Synthesis (Results): We included a total of 71 trials, with 19 trials of pharmacotherapies and 52 trials of psychosocial interventions. All trials of pharmacotherapies and 25 trials of psychosocial interventions were conducted in treatment-seeking populations. Psychosocial interventions commonly incorporated cognitive-behavioral or motivational interventions and ranged from brief interventions consisting of one or two sessions of no more than one hour to multiple treatment sessions over weeks or months. In most pharmacotherapy trials, drug use counseling was provided to all patients. No study evaluated benefits or harms of preemptive naloxone prescribed in primary care settings versus placebo or no naloxone as a rescue medication for opioid-related overdose. In treatment-seeking populations with opioid use disorder, naltrexone (12 trials; relative risk [RR] 0.73, 95% confidence interval [CI] 0.62 to 0.85; number needed to treat [NNT] 5.3) and opioid agonist therapy with methadone or buprenorphine (4 trials; RR 0.75, 95% CI 0.59 to 0.82; NNT 2.9) were associated with decreased risk of drug use relapse compared with placebo or no pharmacotherapy. Naltrexone and methadone/buprenorphine therapy were also associated with increased likelihood of retention in substance use treatment (9 trials; RR 1.71, 95% CI 1.13 to 2.49; NNT 6.7 and 7 trials; RR 2.58, 95% CI 1.78 to 4.59; NNT 2.6; respectively). Evidence on harms of pharmacotherapies was limited, but indicated no increased risk of serious adverse events. Psychosocial interventions were associated with increased likelihood of abstinence from drug use versus control conditions at 3 to 4 months (15 trials, RR 1.60, 95% CI 1.24 to 2.13; NNT 11) and at 6 to 12 months (14 trials; RR 1.25, 95% CI 1.11 to 1.52; NNT 17), based on trials primarily conducted in treatment-seeking populations. Psychosocial interventions were also associated with a greater decrease versus control conditions in the number of drug use days (19 trials; mean difference -0.49 day in the last 7 days, 95% CI -0.85 to -0.13) and a small but statistically significant greater decrease in drug use severity (16 trials; standard mean difference -0.18, 95% CI -0.32 to -0.05) at 3- to 4-month followup. There was no difference between psychosocial interventions versus controls on drug use days or severity at longer (6 to 12 month) followup. Effects of psychosocial interventions were generally stronger in trials of treatment-seeking than screen-detected populations, trials that evaluated cannabis use than other types of drug use, and trials of more intensive than brief interventions. Few trials evaluated effects of psychosocial interventions for opioid or stimulant use, and estimates were imprecise. Limitations: Limitations included restriction to English-language articles, statistical heterogeneity in pooled analyses, and little evidence on drug-related health, social, or legal outcomes; most trials had methodological limitations. Evidence was lacking on effectiveness of treatments for opioid use disorder related to prescription drug use or stimulant use and evidence was limited for adolescents or pregnant persons. Conclusions: Pharmacotherapy and psychosocial interventions are effective at improving drug use outcomes, but evidence of effectiveness remains primarily derived from trials conducted in treatment-seeking populations. Although the applicability of data from such trials to persons whose drug use is identified through primary care-based screening is uncertain, intervention trials that enrolled patients based on screening identified a spectrum of drug use, ranging from mild drug use to more severe, untreated disease. The applicability of current evidence on drug use interventions to screening might be greater for the subset of patients screened in primary care settings with severe, untreated drug use who could utilize pharmacotherapies or more intensive psychosocial interventions.
Contributor(s): Roger Chou, MD Tracy Dana, MLS Ian Blazina, MPH Sara Grusing, BA Rongwei Fu, PhD Christina Bougatsos, MPH
DOI: DOI pending.
Funding Source: This report is based on research conducted by the Pacific Northwest Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. HHSA-290-2015-00007-I, Task Order No. 4)
Methodology Description: Study Selection: We included trials of Food and Drug Administration (FDA)-approved pharmacotherapies for opioid use disorder (methadone, buprenorphine, and naltrexone) and trials of psychosocial interventions for persons engaging in opioid, stimulant, cannabis, and mixed drug or polysubstance use. We also included trials of preemptive prescribing of naloxone in primary care settings as a rescue medication for opioid-related overdose. Trials compared included interventions against placebo, a minimal intervention, waitlist control, or usual care, and evaluated outcomes at >3 months for drug use or other risky behaviors; health, social, and legal consequences of drug use; or harms of treatment. Data Extraction: One investigator abstracted data and a second investigator checked data abstraction for accuracy. Two investigators independently assessed study quality using methods developed by the USPSTF. Data Synthesis (Results): We included a total of 71 trials, with 19 trials of pharmacotherapies and 52 trials of psychosocial interventions. All trials of pharmacotherapies and 25 trials of psychosocial interventions were conducted in treatment-seeking populations. Psychosocial interventions commonly incorporated cognitive-behavioral or motivational interventions and ranged from brief interventions consisting of one or two sessions of no more than one hour to multiple treatment sessions over weeks or months. In most pharmacotherapy trials, drug use counseling was provided to all patients. No study evaluated benefits or harms of preemptive naloxone prescribed in primary care settings versus placebo or no naloxone as a rescue medication for opioid-related overdose. In treatment-seeking populations with opioid use disorder, naltrexone (12 trials; relative risk [RR] 0.73, 95% confidence interval [CI] 0.62 to 0.85; number needed to treat [NNT] 5.3) and opioid agonist therapy with methadone or buprenorphine (4 trials; RR 0.75, 95% CI 0.59 to 0.82; NNT 2.9) were associated with decreased risk of drug use relapse compared with placebo or no pharmacotherapy. Naltrexone and methadone/buprenorphine therapy were also associated with increased likelihood of retention in substance use treatment (9 trials; RR 1.71, 95% CI 1.13 to 2.49; NNT 6.7 and 7 trials; RR 2.58, 95% CI 1.78 to 4.59; NNT 2.6; respectively). Evidence on harms of pharmacotherapies was limited, but indicated no increased risk of serious adverse events. Psychosocial interventions were associated with increased likelihood of abstinence from drug use versus control conditions at 3 to 4 months (15 trials, RR 1.60, 95% CI 1.24 to 2.13; NNT 11) and at 6 to 12 months (14 trials; RR 1.25, 95% CI 1.11 to 1.52; NNT 17), based on trials primarily conducted in treatment-seeking populations. Psychosocial interventions were also associated with a greater decrease versus control conditions in the number of drug use days (19 trials; mean difference -0.49 day in the last 7 days, 95% CI -0.85 to -0.13) and a small but statistically significant greater decrease in drug use severity (16 trials; standard mean difference -0.18, 95% CI -0.32 to -0.05) at 3- to 4-month followup. There was no difference between psychosocial interventions versus controls on drug use days or severity at longer (6 to 12 month) followup. Effects of psychosocial interventions were generally stronger in trials of treatment-seeking than screen-detected populations, trials that evaluated cannabis use than other types of drug use, and trials of more intensive than brief interventions. Few trials evaluated effects of psychosocial interventions for opioid or stimulant use, and estimates were imprecise.

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