Recently Published Projects

Published on June 27, 2021
Integrating Palliative Care in Ambulatory Care of Non-Cancer Serious Chronic Illness
39 Studies • 30 Key Questions • 39 Extraction Forms
Project created on June 27, 2021
Last updated on June 27, 2021
Objectives: 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.
Published on June 27, 2021
Care Interventions for People Living With Dementia (PLWD) and Their Caregivers [Entered Retrospectively]
634 Studies • 1 Key Questions • 634 Extraction Forms
Project created on June 27, 2021
Last updated on June 27, 2021
Objectives: 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.
Published on June 27, 2021
Therapies for Clinically Localized Prostate Cancer [Entered Retrospectively]
67 Studies • 1 Key Questions • 67 Extraction Forms
Project created on June 27, 2021
Last updated on June 27, 2021
Objectives: 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.
Published on June 27, 2021
Platelet-Rich Plasma for Wound Care in the Medicare Population
49 Studies • 5 Key Questions • 49 Extraction Forms
Project created on June 27, 2021
Last updated on June 27, 2021
Objectives: 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.
Published on June 27, 2021
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
33 Studies • 1 Key Questions • 33 Extraction Forms
Project created on June 27, 2021
Last updated on June 27, 2021
Objectives: 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.