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Completed Systematic Reviews




Integrating Palliative Care in Ambulatory Care of Non-Cancer Serious Chronic Illness


Public Project Complete

Statistics: 40 Studies, 15 Key Questions, 1 Extraction Form,
Date Published: Oct 22, 2020 03:42PM
Description: Objectives. To evaluate availability, effectiveness, and implementation of interventions for integrating palliative care into ambulatory care for U.S.-based adults with serious life-threatening chronic illness or conditions other than cancer and their caregivers We evaluated interventions addressing identification of patients, patient and caregiver education, shared decision-making tools, clinician education, and models of care. Data sources. We searched key U.S. national websites (March 2020) and PubMed®, CINAHL, and the Cochrane Central Register of Controlled Trials (through May 2020). We also engaged Key Informants. Review methods. We completed a mixed-methods review; we sought, synthesized, and integrated Web resources; quantitative, qualitative and mixed-methods studies; and input from patient/caregiver and clinician/stakeholder Key Informants. Two reviewers screened websites and search results, abstracted data, assessed risk of bias or study quality, and graded strength of evidence (SOE) for key outcomes: health-related quality of life, patient overall symptom burden, patient depressive symptom scores, patient and caregiver satisfaction, and advance directive documentation. We performed meta-analyses when appropriate. Results. We included 46 Web resources, 20 quantitative effectiveness studies, and 16 qualitative implementation studies across primary care and specialty populations. Various prediction models, tools, and triggers to identify patients are available, but none were evaluated for effectiveness or implementation. Numerous patient and caregiver education tools are available, but none were evaluated for effectiveness or implementation. All of the shared decision-making tools addressed advance care planning; these tools may increase patient satisfaction and advance directive documentation compared with usual care (SOE: Low). Patients and caregivers prefer advance care planning discussions grounded in patient and caregiver experiences with individualized timing. Although numerous education and training resources for non-palliative care clinicians are available, we were unable to draw conclusions about implementation, and none have been evaluated for effectiveness. Models for integrating palliative care were not more effective than usual care for improving health-related quality of life or patient depressive symptom scores (SOE: Moderate) and may have little to no effect on increasing patient satisfaction or decreasing overall symptom burden (SOE: Low), but models for integrating palliative care were effective for increasing advance directive documentation (SOE: Moderate). Multimodal interventions may have little to no effect on increasing advance directive documentation (SOE: Low) and other graded outcomes were not assessed. For utilization, models for integrating palliative care were not more effective than usual care for decreasing hospitalizations; we were unable to draw conclusions about most other aspects of utilization or cost and resource use. We were unable to draw conclusions about caregiver satisfaction or specific characteristics of models for integrating palliative care. Patient preferences for appropriate timing of palliative care varied; costs, additional visits, and travel were seen as barriers to implementation. Conclusions. For integrating palliative care into ambulatory care for serious illness and conditions other than cancer, advance care planning shared decision-making tools and palliative care models were the most widely evaluated interventions and may be effective for improving only a few outcomes. More research is needed particularly on identification of patients for these interventions; education for patients, caregivers, and clinicians; shared decision-making tools beyond advance care planning and advance directive completion; and specific components, characteristics, and implementation factors in models for integrating palliative care.
Contributor(s): Sydney M. Dy, M.D., M.S., F.A.A.H.P.M. Julie M. Waldfogel, Pharm.D. Danetta H. Sloan, Ph.D., M.S.W. Valerie Cotter, Dr.NP., M.S.N. Susan Hannum, Ph.D. JaAlah-Ai Heughan, M.S. Linda Chyr, M.P.H. Lyndsay DeGroot, R.N., B.S.N. Renee Wilson, M.S. Allen Zhang, B.A. Darshan Mahabare, B.A. David S. Wu, M.D., F.A.A.H.P.M. Karen A. Robinson, Ph.D.
DOI: DOI pending.
Funding Source: Agency for Healthcare Research and Quality
Methodology Description: Review Approach This mixed methods review includes a grey literature search and systematic reviews of the published quantitative and qualitative, mixed-methods, and process evaluation literature, as well as an integration of results across these sources and review methods. We followed the methods outlined in the Agency for Healthcare Research and Quality’s (AHRQ’s) Methods Guide for Effectiveness and Comparative Effectiveness Reviews (refer to the Methods Appendix for additional details). We have reported the results of the systematic review in accordance with the Preferred Items for Reporting in Systematic Reviews and Meta-Analyses (PRISMA).8 Integrative review methods are based on the 2017 Cochrane guidance, Qualitative and Implementation Methods Group Guidance Paper 5: Methods for integrating qualitative and implementation evidence within intervention effectiveness reviews,9 and the Joanna Briggs Institute methods for mixed methods systematic reviews.10 AHRQ developed the topic of this systematic review. We recruited Key Informants (KIs) to refine the topic and key questions and provide input on the integration of results. We recruited a Technical Expert Panel (TEP) to provide input on all details of the protocol, including outcomes. The KIs and TEP represented palliative care, primary care, and other ambulatory specialties, and included physicians, nurses, and social workers; we also included patient advocate KIs. With the feedback from the TEP, KIs, AHRQ, and our partners, the National Institute for Nursing Research, and the Health Resources and Services Administration, we finalized the protocol and posted it on the AHRQ Effective Health Care Program’s website (www.effectivehealthcare.ahrq.gov). Study Selection We searched PubMed, CINAHL, and the Cochrane Central Register of Controlled Trials in May 2020. Two team members independently applied eligibility criteria (Table 1 and Table 2) to citations identified by these searches. In March 2020, we searched key U.S. national websites identified as relevant to the Key Questions and refined with input from AHRQ and Technical Experts, including websites from palliative care organizations, primary care and specialty healthcare professional organizations, government organizations, foundations with a major focus in palliative care, and patient organizations (see Methods Appendix A-2 for full list of websites searched). Two reviewers simultaneously screened available website content for eligibility based on the Population, Intervention, Comparisons, Outcomes, Type of study, Setting (PICOTS); specific relevance to integrating palliative care into ambulatory care in the United States; and our criterion that materials must have been developed or updated within the last 5 years. Full details on the search strategy and eligibility criteria are in the Methods Appendix (Appendix A-4). Paired investigators abstracted data sequentially. For quantitative studies, reviewers assessed risk of bias independently. We used the Cochrane Risk of Bias Tool, Version 2, for assessing the risk of bias of randomized controlled trials (RCTs).12 For non-randomized studies, we used the Cochrane Risk of Bias Assessment Tool for Non-Randomized Studies of Interventions (ROBINS-I) tool.13 For qualitative and mixed-methods studies, reviewers independently assessed study quality using the Joanna Briggs Institute Checklist14, 15 (see Methods Appendix A-12 for more details). In addition to seeking feedback from the Key Informants on the key questions, we engaged two separate groups of Key Informants to provide input on the integrative review process: one group of patients and caregivers; and one group of stakeholders, including practicing clinicians, relevant professional and consumer organizations, purchasers of healthcare, representatives of Learning Health Systems, and others with experience making healthcare decisions. We compiled key issues elicited from the Key Informants and used those to inform our analysis of the qualitative, mixed-methods, and process evaluation literature and the overall integration. At the end of the project, we also conducted sessions with the Key Informants to refine the analysis and integration results.

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Maternal, Fetal, and Child Outcomes of Mental Health Treatments in Women: A Systematic Review of Perinatal Pharmacological Interventions


Public Project Complete

Statistics: 168 Studies, 4 Key Questions, 1 Extraction Form,
Date Published: Oct 05, 2020 03:35AM
Description: A systematic review to assess the efficacy and comparative effectiveness of pharmacological interventions for pregnant and postpartum women with psychiatric disorders.
Contributor(s): To be announced after the final report has been completed.
DOI: DOI pending.
Funding Source: AHRQ
Methodology Description: Systematic review

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Platelet-Rich Plasma for Wound Care in the Medicare Population


Public Project Complete

Statistics: 49 Studies, 5 Key Questions, 3 Extraction Forms,
Date Published: Oct 02, 2020 01:12PM
Description: Objectives. To evaluate the effectiveness of autologous platelet-rich plasma (PRP) in individuals with lower extremity diabetic ulcers, lower extremity venous ulcers, and pressure ulcers. Data sources. MEDLINE, Embase, Cochrane Central Registrar of Controlled Trials, Cochrane Database of Systematic Reviews, PsycINFO, Scopus and various grey literature sources from database inception to June 11, 2020. Review methods. We included randomized controlled trials (RCTs) and comparative observational studies that compared PRP to any other wound care without PRP in adult patients. Pairs of independent reviewers selected and appraised studies. Meta-analysis was conducted when appropriate and the strength of evidence (SOE) was determined based on a priori plan. Results. We included 27 studies (22 randomized, 5 comparative observational studies, total of 1,796 patients). 15 studies enrolled patients with lower extremity diabetic ulcers, 11 enrolled patients with lower extremity venous ulcers, and 2 enrolled patients with pressure ulcers in any location. Followup after intervention ranged from no followup to 11 months. The available studies suffered from important limitations, such as inadequate description of offloading and wound care procedures, wound characteristics, platelet-rich plasma formulation techniques, concentration and volume; inadequate length of followup; and lack of stratification by comorbidities and other patient characteristics including older adults. Compared with management without PRP, PRP therapy increased complete wound closure or healing in lower extremity diabetic ulcers (RR: 1.20; 95% CI: 1.09 to 1.32, moderate SOE), shortened the time to complete wound closure, and reduced wound area and depth (low SOE), although Medicare-eligible older adults were underrepresented in the included studies. No significant changes were found in terms of wound infection, amputation, wound recurrence, or hospitalization. In patients with lower extremity venous ulcers, the SOE was insufficient to estimate an effect on critical outcomes, such as complete wound closure or time to complete wound closure. Similarly, evidence was insufficient to estimate an effect on any outcome in pressure ulcers. There was no statistically significant difference in death, total adverse events or serious adverse events between PRP and management without PRP. Conclusions. Autologous platelet-rich plasma based on moderate SOE increases complete wound closure or healing, and low SOE shortens healing time and reduces wound size in individuals with lower extremity diabetic ulcers. The evidence is insufficient to estimate an effect of autologous platelet-rich plasma on wound healing in individuals with lower extremity venous ulcers or pressure ulcers.
Contributor(s): Wenchun Qu, M.D. Zhen Wang, Ph.D. Christine Hunt, D.O. Allison S. Morrow, B.A. Meritxell Urtecho, M.D. Mustapha Amin, M.D. Sahrish Shah, M.B.B.S. Bashar Hasan, M.D. Rami Abd-Rabu, M.B.B.S. Zack Ashmore, M.D. Eva Kubrova, M.D. Larry J. Prokop, M.L.S. M. Hassan Murad, M.D., M.P.H.
DOI: DOI pending.
Funding Source: AHRQ
Methodology Description: We developed an analytic framework to guide the process of the systematic review. We followed the established methodologies of systematic reviews as outlined in Agency for Healthcare Research and Quality (AHRQ) Methods Guide for Comparative Effectiveness Reviews. The reporting complies with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statements. The study protocol is published on AHRQ website and registered in the international prospective register of systematic reviews (PROSPERO #: CRD42020172817). The full report details our literature search strategy, inclusion and exclusion criteria, data synthesis, assessments of risk of bias, and strength of evidence (SOE). We assigned SOE rating as high, moderate, low, or ‘insufficient evidence to estimate an effect’. High was rated when we were very confident that the estimate of effect lies close to the true effect (the body of evidence has few or no deficiencies and is judged to be stable). Moderate was rated if we were moderately confident that the estimate of effect lies close to the true effect (the body of evidence has some deficiencies and is judged to be likely stable). Low, we had limited confidence that the estimate of effect lies close to the true effect (the body of evidence has major or numerous deficiencies and is likely unstable), and insufficient if we had no evidence, are unable to estimate an effect, or have no confidence in the estimate of effect.

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Care Interventions for People Living With Dementia (PLWD) and Their Caregivers [Entered Retrospectively]


Public Project Complete

Statistics: 634 Studies, 1 Key Question, 1 Extraction Form,
Date Published: Sep 25, 2020 01:08PM
Description: Structured Abstract Objective. To understand the evidence base for care interventions for people living with dementia (PLWD) and their caregivers, and to assess the potential for broad dissemination and implementation of that evidence. Data sources. We searched Ovid Medline, Ovid Embase, Ovid PsycINFO, CINAHL, and the Cochrane Central Register of Controlled Trials (CENTRAL) to identify randomized controlled trials, nonrandomized controlled trials, and quasi-experimental designs published and indexed in bibliographic databases through March, 2020. Review methods. We searched for nondrug interventions targeting PLWD, their informal or formal caregivers, or health systems. Two investigators screened abstracts and full-text articles of identified references for eligibility. Eligible studies included randomized controlled trials and quasi-experimental observational studies enrolling people with Alzheimer’s disease or related dementias or their informal or formal caregivers. We extracted basic study information from all eligible studies. We assessed risk of bias, and summarized results for studies not judged to be NIH Stage Model 0 to 2 (pilot or small sample size studies) or to have high risk of bias. We grouped interventions into categories based on intervention target. Results. We identified 9217 unique references, of which 627 unique studies with an additional 267 companion articles were eligible. We classified interventions into 37 major categories. With few exceptions, we did not combine data quantitatively due to variability of interventions, comparison groups, outcomes measured, and study timing. Low-strength evidence shows that an intensive multicomponent intervention for informal caregiver support, with education, group discussion, in-home and phone support, and caregiver feedback (i.e. discrete adaptations of REACH II), may improve informal caregiver depression at 6 months. Low-strength evidence also shows that collaborative care models (i.e. Care Ecosystems or discrete adaptations of the ACCESS models) may improve quality of life for PLWD and health system-level markers, including improvements in guideline-based quality indicators and reducing emergency room visits. The literature does not allow for further determination of whether the very small to small average effects in quality of life applied to all enrolled PLWD or if larger effects were concentrated in an unidentified subgroup. For all other interventions and outcomes, we found the evidence insufficient to draw conclusions. Insufficient evidence does not mean that the intervention is determined to be of no value to PLWD or their caregivers. Rather, it means that due to the uncertainty of the evidence, we could not draw meaningful conclusions at this time. Conclusions. Despite hundreds of studies, very little evidence supports widespread dissemination of any general care approaches for PLWD or caregivers. This review demonstrates the need for larger, longer-term, and more rigorous studies of interventions.
Contributor(s): Mary Butler, Ph.D., M.B.A. Joseph E. Gaugler, Ph.D. Kristine M.C. Talley, Ph.D., R.N., G.N.P.-B.C., F.G.S.A. Hamdi I. Abdi, M.P.H. Priyanka J. Desai, Ph.D., M.S.P.H. Susan Duval, Ph.D. Mary L. Forte, Ph.D., D.C. Victoria A. Nelson, M.Sc. Weiwen Ng, M.P.H. Jeannine M. Ouellette, M.F.A. Edward Ratner, M.D. Jayati Saha, Ph.D., M.P.H. Tetyana Shippee, Ph.D. Brittin L. Wagner, Ph.D. Timothy J. Wilt, M.D., M.P.H. Lobsang Yeshi, M.Sc.
DOI: DOI pending.
Funding Source: AHRQ Contract No. 290-2015-00008-I
Methodology Description: None Provided

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The diagnostic accuracy of digital PCR, ARMS and NGS for detecting KRAS mutation in cell-free DNA of patients with colorectal cancer: a systematic review and meta-analysis


Public Project Complete

Statistics: 33 Studies, 1 Key Question, 1 Extraction Form,
Date Published: Sep 22, 2020 12:18PM
Description: It is required to determine KRAS mutation status in tumor before anti-EGFR therapy is given to patients with colorectal cancer. However, in some recurrent or metastatic colorectal cancer patients, tumor tissue is not available. As an alternative, KRAS mutation detection in cell-free DNA/liquid biopsy samples has been intensively studied using highly sensitive methods. The aim of this systemic review and meta-analysis was to investigate the accuracy of KRAS mutation detection in cell-free DNA sample from patients with colorectal cancer, compared to paired tissue sample.
Contributor(s): Peng Ye, MD, PhD, Peiling Cai, PhD, Jing Xie, MD, Yuanyuan Wei, MD, PhD
DOI: DOI pending.
Funding Source: National Natural Science Foundation of China
Methodology Description: Literature search was performed in Pubmed, Embase, and Cochrane Library. After removing duplicates from the 170 publications found during literature search, eligible studies were identified using the following exclusion criteria: 1) not a human study; 2) not describing KRAS mutation; 3) no liquid biopsy samples or tissue samples included; 4) did not use any techniques among digital PCR, ARMS and NGS; 5) not colorectal cancer; 6) reviews, abstracts, letter to the editor, comments, case reports, or studies with un-interpretable data. Quality of the publications and relevant data were assessed and extracted by two independent researchers. Meta-DiSc and STATA software were used to pool the accuracy parameters from the extracted data.

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