Patient and caregiver engagement in the Patient-Centered Outcomes Research Institute (PCORI) Health Care Horizon Scanning System (HCHSS) process.

OBJECTIVE: The Patient-Centered Outcomes Research Institute (PCORI) horizon scanning system is an early warning system for healthcare interventions in development that could disrupt standard care. We report preliminary findings from the patient engagement process. METHODS: The system involves broadly scanning many resources to identify and monitor interventions up to 3 years before anticipated entry into U.S. health care. Topic profiles are written on included interventions with late-phase trial data and circulated with a structured review form for stakeholder comment to determine disruption potential. Stakeholders include patients and caregivers recruited from credible community sources. They view an orientation video, comment on topic profiles, and take a survey about their experience. RESULTS: As of March 2020, 312 monitored topics (some of which were archived) were derived from 3,500 information leads; 121 met the criteria for topic profile development and stakeholder comment. We invited fifty-four patients and caregivers to participate; thirty-nine reviewed at least one report. Their perspectives informed analyst nominations for fourteen topics in two 2019 High Potential Disruption Reports. Thirty-four patient stakeholders completed the user-experience survey. Most agreed (68 percent) or somewhat agreed (26 percent) that they were confident they could provide useful comments. Ninety-four percent would recommend others to participate. CONCLUSIONS: The system has successfully engaged patients and caregivers, who contributed unique and important perspectives that informed the selection of topics deemed to have high potential to disrupt clinical care. Most participants would recommend others to participate in this process. More research is needed to inform optimal patient and caregiver stakeholder recruitment and engagement methods and reduce barriers to participation.

Developing and Testing the Agency for Healthcare Research and Quality's National Guideline Clearinghouse Extent of Adherence to Trustworthy Standards (NEATS) Instrument.

In 2011, the Institute of Medicine (IOM) (now the National Academy of Medicine) published standards for trustworthy guidelines and recommended that the National Guideline Clearinghouse (NGC) of the Agency for Healthcare Research and Quality clearly indicate the extent to which guidelines adhere to these standards. To accomplish this, the authors developed and tested the NGC Extent of Adherence to Trustworthy Standards (NEATS) instrument. The standards were operationalized as an instrument containing 15 items that cover disclosure of the funding source; disclosure and management of conflicts of interest; multidisciplinary input; incorporation of patient perspectives; rigorous systematic review; recommendations accompanied by rationale, assessment of benefits and harms, clear linkage to the evidence, and assessment of strength of evidence and strength of recommendation; clear articulation of recommendations; external review by diverse stakeholders; and plans for updating. After multiple rounds of feedback from experts on clinical practice guideline development, the external validity and interrater reliability of the instrument were evaluated. For each item, 80% to 100% of survey respondents judged it to be a good measure of the IOM standards. All external stakeholders stated that NEATS was suitable for its intended goal. Interrater reliability for the final NEATS instrument had a weighted κ of 0.73. The NEATS instrument is a focused tool that provides a concise evaluation of a guideline's adherence to the IOM standards for trustworthy guidelines. It has good external validity among guideline developers and good interrater reliability across trained reviewers.

An evidence-based prehospital guideline for external hemorrhage control: American College of Surgeons Committee on Trauma.

This report describes the development of an evidence-based guideline for external hemorrhage control in the prehospital setting. This project included a systematic review of the literature regarding the use of tourniquets and hemostatic agents for management of life-threatening extremity and junctional hemorrhage. Using the GRADE methodology to define the key clinical questions, an expert panel then reviewed the results of the literature review, established the quality of the evidence and made recommendations for EMS care. A clinical care guideline is proposed for adoption by EMS systems. Key words: tourniquet; hemostatic agents; external hemorrhage.

In-facility delirium prevention programs as a patient safety strategy: a systematic review.

Delirium, an acute decline in attention and cognition, occurs among hospitalized patients at rates estimated to range from 14% to 56% and increases the risk for morbidity and mortality. The purpose of this systematic review was to evaluate the effectiveness and safety of in-facility multicomponent delirium prevention programs. A search of 6 databases (including MEDLINE, EMBASE, and CINAHL) was conducted through September 2012. Randomized, controlled trials; controlled clinical trials; interrupted time series; and controlled before-after studies with a prospective postintervention portion were eligible for inclusion. The evidence from 19 studies that met the inclusion criteria suggests that most multicomponent interventions are effective in preventing onset of delirium in at-risk patients in a hospital setting. Evidence was insufficient to determine the benefit of such programs in other care settings. Future comparative effectiveness studies with standardized protocols are needed to identify which components in multicomponent interventions are most effective for delirium prevention.

Preventing in-facility pressure ulcers as a patient safety strategy: a systematic review.

Complications from hospital-acquired pressure ulcers cause 60,000 deaths and significant morbidity annually in the United States. The objective of this systematic review is to review evidence regarding multicomponent strategies for preventing pressure ulcers and to examine the importance of contextual aspects of programs that aim to reduce facility-acquired pressure ulcers. CINAHL, the Cochrane Library, EMBASE, MEDLINE, and PreMEDLINE were searched for articles published from 2000 to 2012. Studies (any design) that implemented multicomponent initiatives to prevent pressure ulcers in adults in U.S. acute and long-term care settings and that reported pressure ulcer rates at least 6 months after implementation were selected. Two reviewers extracted study data and rated quality of evidence. Findings from 26 implementation studies (moderate strength of evidence) suggested that the integration of several core components improved processes of care and reduced pressure ulcer rates. Key components included the simplification and standardization of pressure ulcer-specific interventions and documentation, involvement of multidisciplinary teams and leadership, use of designated skin champions, ongoing staff education, and sustained audit and feedback.

Chapter 2: medical tests guidance (2) developing the topic and structuring systematic reviews of medical tests: utility of PICOTS, analytic frameworks, decision trees, and other frameworks.

Topic development and structuring a systematic review of diagnostic tests are complementary processes. The goals of a medical test review are to identify and synthesize evidence to evaluate the impacts alternative testing strategies on health outcomes and to promote informed decision making. A common challenge is that the request for a review may state the claim for the test ambiguously. Due to the indirect impact of medical tests on clinical outcomes, reviewers need to identify which intermediate outcomes link a medical test to improved clinical outcomes. In this paper, we propose the use of five principles to deal with challenges: the PICOTS typology (patient population, intervention, comparator, outcomes, timing, setting), analytic frameworks, simple decision trees, other organizing frameworks and rules for when diagnostic accuracy is sufficient.

Stereotactic body radiation therapy: scope of the literature.

Stereotactic body radiation therapy (SBRT) is derived from the techniques of stereotactic radiosurgery used to treat lesions in the brain and spine. It combines multiple finely collimated radiation beams and stereotaxy to deliver a high dose of radiation to an extracranial target in the body in a single dose or a few fractions. This review provides a broad overview of the current state of SBRT for solid malignant tumors. Reviewers identified a total of 124 relevant studies. To our knowledge, no published comparative studies address the relative effectiveness and safety of SBRT versus other forms of external-beam radiation therapy. Stereotactic body radiation therapy seems to be widely diffused as a treatment of various types of cancer, although most studies have focused only on its use for treating thoracic tumors. Comparative studies are needed to provide evidence that the theoretical advantages of SBRT over other radiation therapies actually occur in the clinical setting; this area is currently being studied in only 1 small trial.

Autologous hematopoietic cell transplantation for multiple sclerosis: a systematic review.

BACKGROUND AND OBJECTIVES: The purpose of this systematic review was to evaluate the safety and efficacy of autologous hematopoietic cell transplantation in patients with progressive multiple sclerosis (MS) refractory to conventional medical treatment. METHODS: Eight case series met our a priori inclusion criteria for the primary outcome of progression-free survival. Individual study quality was rated using an 11-item scale for case series. The strength of the overall body of evidence for each outcome was rated using a system developed by the ECRI Institute. Data from different studies were statistically combined using meta-analysis. An additional six studies were included for a summary of mortality and morbidity. RESULTS: For secondary progressive MS, immunoablative therapy with autologous bone marrow/peripheral blood stem cell transplantation was associated with higher progression-free survival (up to 3 years following treatment) when using intermediate-intensity conditioning regimens compared with high-intensity conditioning regimens. The evidence was insufficient to determine whether the treatment was effective in patients with other types of MS. Treatment-related mortality was about 2.7%. CONCLUSIONS: Patients with secondary progressive MS refractory to conventional medical treatment have longer progression-free survival following autologous stem cell transplantation with intermediate-intensity conditioning regimens than with high-intensity conditioning regimens.

Systematic review: comparative effectiveness of core-needle and open surgical biopsy to diagnose breast lesions.

BACKGROUND: Most women undergoing breast biopsy are found not to have cancer. PURPOSE: To compare the accuracy and harms of different breast biopsy methods in average-risk women suspected of having breast cancer. DATA SOURCES: Databases, including MEDLINE and EMBASE, searched from 1990 to September 2009. STUDY SELECTION: Studies that compared core-needle biopsy diagnoses with open surgical diagnoses or clinical follow-up. DATA EXTRACTION: Data were abstracted by 1 of 3 researchers and verified by the primary investigator. DATA SYNTHESIS: 33 studies of stereotactic automated gun biopsy; 22 studies of stereotactic-guided, vacuum-assisted biopsy; 16 studies of ultrasonography-guided, automated gun biopsy; 7 studies of ultrasonography-guided, vacuum-assisted biopsy; and 5 studies of freehand automated gun biopsy met the inclusion criteria. Low-strength evidence showed that core-needle biopsies conducted under stereotactic guidance with vacuum assistance distinguished between malignant and benign lesions with an accuracy similar to that of open surgical biopsy. Ultrasonography-guided biopsies were also very accurate. The risk for severe complications is lower with core-needle biopsy than with open surgical procedures (<1% vs. 2% to 10%). Moderate-strength evidence showed that women in whom breast cancer was initially diagnosed by core-needle biopsy were more likely than women with cancer initially diagnosed by open surgical biopsy to be treated with a single surgical procedure (random-effects odds ratio, 13.7 [95% CI, 5.5 to 34.6]). LIMITATION: The strength of evidence was rated low for accuracy outcomes because the studies did not report important details required to assess the risk for bias. CONCLUSION: Stereotactic- and ultrasonography-guided core-needle biopsy procedures seem to be almost as accurate as open surgical biopsy, with lower complication rates. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Continuous positive airway pressure reduces risk of motor vehicle crash among drivers with obstructive sleep apnea: systematic review and meta-analysis.

CONTEXT: Obstructive sleep apnea (OSA) is associated with an increased risk of motor vehicle crash. OBJECTIVE: We performed a systematic review of the literature concerning the impact of continuous positive airway pressure (CPAP) treatment on motor vehicle crash risk among drivers with OSA. The primary objective was to determine whether CPAP use could reduce the risk of motor vehicle crash among drivers with OSA. A secondary objective involved determining the time on treatment required for CPAP to improve driver safety. DATA SOURCES: We searched seven electronic databases (MEDLINE, PubMed (PreMEDLINE), EMBASE, PsycINFO, CINAHL, TRIS, and the Cochrane library) and the reference lists of all obtained articles. STUDY SELECTION: We included studies (before-after, case-control, or cohort) that addressed the stated objectives. We evaluated the quality of each study and the interplay between the quality, quantity, robustness, and consistency of the evidence. We also tested for publication bias. DATA EXTRACTION: Data were extracted by two independent analysts. When appropriate, data were combined in a fixed or random effects meta-analysis. RESULTS: A meta-analysis of 9 observational studies examining crash risk of drivers with OSA pre- vs. post-CPAP found a significant risk reduction following treatment (risk ratio = 0.278, 95% CI: 0.22 to 0.35; P < 0.001). Although crash data are not available to assess the time course of change, daytime sleepiness improves significantly following a single night of treatment, and simulated driving performance improves significantly within 2 to 7 days of CPAP treatment. CONCLUSIONS: Observational studies indicate that CPAP reduces motor vehicle crash risk among drivers with OSA.

Long-term opioid management for chronic noncancer pain.

BACKGROUND: Opioid therapy for chronic noncancer pain (CNCP) is controversial due to concerns regarding long-term effectiveness and safety, particularly the risk of tolerance, dependence, or abuse. OBJECTIVES: To assess safety, efficacy, and effectiveness of opioids taken long-term for CNCP. SEARCH STRATEGY: We searched 10 bibliographic databases up to May 2009. SELECTION CRITERIA: We searched for studies that: collected efficacy data on participants after at least 6 months of treatment; were full-text articles; did not include redundant data; were prospective; enrolled at least 10 participants; reported data of participants who had CNCP. Randomized controlled trials (RCTs) and pre-post case-series studies were included. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted safety and effectiveness data and settled discrepancies by consensus. We used random-effects meta-analysis' to summarize data where appropriate, used the I(2) statistic to quantify heterogeneity, and, where appropriate, explored heterogeneity using meta-regression. Several sensitivity analyses were performed to test the robustness of the results. MAIN RESULTS: We reviewed 26 studies with 27 treatment groups that enrolled a total of 4893 participants. Twenty five of the studies were case series or uncontrolled long-term trial continuations, the other was an RCT comparing two opioids. Opioids were administered orally (number of study treatments groups [abbreviated as "k"] = 12, n = 3040), transdermally (k = 5, n = 1628), or intrathecally (k = 10, n = 231). Many participants discontinued due to adverse effects (oral: 22.9% [95% confidence interval (CI): 15.3% to 32.8%]; transdermal: 12.1% [95% CI: 4.9% to 27.0%]; intrathecal: 8.9% [95% CI: 4.0% to 26.1%]); or insufficient pain relief (oral: 10.3% [95% CI: 7.6% to 13.9%]; intrathecal: 7.6% [95% CI: 3.7% to 14.8%]; transdermal: 5.8% [95% CI: 4.2% to 7.9%]). Signs of opioid addiction were reported in 0.27% of participants in the studies that reported that outcome. All three modes of administration were associated with clinically significant reductions in pain, but the amount of pain relief varied among studies. Findings regarding quality of life and functional status were inconclusive due to an insufficient quantity of evidence for oral administration studies and inconclusive statistical findings for transdermal and intrathecal administration studies. AUTHORS' CONCLUSIONS: Many patients discontinue long-term opioid therapy (especially oral opioids) due to adverse events or insufficient pain relief; however, weak evidence suggests that patients who are able to continue opioids long-term experience clinically significant pain relief. Whether quality of life or functioning improves is inconclusive. Many minor adverse events (like nausea and headache) occurred, but serious adverse events, including iatrogenic opioid addiction, were rare.

Machine learning for screening prioritization in systematic reviews: comparative performance of Abstrackr and EPPI-Reviewer.

BACKGROUND: Improving the speed of systematic review (SR) development is key to supporting evidence-based medicine. Machine learning tools which semi-automate citation screening might improve efficiency. Few studies have assessed use of screening prioritization functionality or compared two tools head to head. In this project, we compared performance of two machine-learning tools for potential use in citation screening. METHODS: Using 9 evidence reports previously completed by the ECRI Institute Evidence-based Practice Center team, we compared performance of Abstrackr and EPPI-Reviewer, two off-the-shelf citations screening tools, for identifying relevant citations. Screening prioritization functionality was tested for 3 large reports and 6 small reports on a range of clinical topics. Large report topics were imaging for pancreatic cancer, indoor allergen reduction, and inguinal hernia repair. We trained Abstrackr and EPPI-Reviewer and screened all citations in 10% increments. In Task 1, we inputted whether an abstract was ordered for full-text screening; in Task 2, we inputted whether an abstract was included in the final report. For both tasks, screening continued until all studies ordered and included for the actual reports were identified. We assessed potential reductions in hypothetical screening burden (proportion of citations screened to identify all included studies) offered by each tool for all 9 reports. RESULTS: For the 3 large reports, both EPPI-Reviewer and Abstrackr performed well with potential reductions in screening burden of 4 to 49% (Abstrackr) and 9 to 60% (EPPI-Reviewer). Both tools had markedly poorer performance for 1 large report (inguinal hernia), possibly due to its heterogeneous key questions. Based on McNemar's test for paired proportions in the 3 large reports, EPPI-Reviewer outperformed Abstrackr for identifying articles ordered for full-text review, but Abstrackr performed better in 2 of 3 reports for identifying articles included in the final report. For small reports, both tools provided benefits but EPPI-Reviewer generally outperformed Abstrackr in both tasks, although these results were often not statistically significant. CONCLUSIONS: Abstrackr and EPPI-Reviewer performed well, but prioritization accuracy varied greatly across reports. Our work suggests screening prioritization functionality is a promising modality offering efficiency gains without giving up human involvement in the screening process.

Computer-aided detection mammography for breast cancer screening: systematic review and meta-analysis.

CONTEXT: Mammography is generally accepted as the best available breast cancer screening method; however, some cancers detectable on mammography images are missed. Computer-aided detection (CAD) systems for mammography are intended to reduce false negatives by marking suspicious areas of the mammograms for reviewers to consider. Although the prospect of improving the sensitivity of screening mammograms has led to the diffusion of CAD for mammography, little is known about its diagnostic accuracy. OBJECTIVE: To assess the diagnostic performance of CAD for screening mammography in terms of sensitivity and specificity and incremental recall, biopsy, and cancer diagnosis rates. DATA SOURCES: Published literature identified by systematic literature searches of 17 databases, including MEDLINE, EMBASE, and the Cochrane Library, searched through 25 September 2008. STUDY SELECTION: A reviewer and an information specialist selected full-length English-language articles that enrolled asymptomatic women for routine breast cancer screening and provided data needed for our analyses using criteria established a priori. We identified 75 potentially relevant publications, of which 7 (9%) were included. DATA EXTRACTION: Data were extracted and internal validity was assessed by a single review author, and forms were approved by the co-authors. RESULTS: Three studies (n = 347,324) reported sensitivity and specificity, or data to calculate them, and five studies (n = 51,162) reported data to calculate incremental rates of cancer diagnoses and recall and biopsy of women who did not have breast cancer. The pooled sensitivity was 86.0% (95% CI 84.2-87.6%) and specificity was 88.2% (95% CI 88.1-88.3%). Of the 100,000 women screened, CAD yielded an additional 50 (95% CI 30-80) correct breast cancer diagnoses, 1,190 (95% CI 1,090-1,290) recalls of healthy women, and 80 (95% CI 60-100) biopsies of healthy women. A total of 96% (95% CI 93.9-97.3%) of women recalled based upon CAD and 65.1% (95% CI 52.3-76.0%) of women biopsied based upon CAD were healthy. No studies reported patient-oriented clinical outcomes.

AHRQ EPC Series on Improving Translation of Evidence: Use of a Clinical Pathway for C. Difficile Treatment to Facilitate the Translation of Research Findings into Practice.

BACKGROUND: In 2018 the Agency for Healthcare Research and Quality (AHRQ) Evidence-based Practice Center (EPC) Program issued a call for strategies to disseminate AHRQ EPC systematic reviews. In this pilot, findings from the 2016 AHRQ EPC report on Clostridioides difficile infection were translated into a treatment pathway and disseminated via a cloud-based platform and electronic health record (EHR). METHODS: An existing 10-step framework was used for developing and disseminating evidence-based clinical pathways. The development of the EHR intervention was informed by the Five Rights model for clinical decision support and human-computer interaction design heuristics. The researchers used observations and time measurements to describe the impact of the EPC report on pathway development and examined provider adoption using counts of pathway views. RESULTS: Two main themes emerged: (1) discrepancies between the EPC report and existing guidelines prompted critical discussions about available treatments, and (2) lack of guideline and pathway syntheses in the EPC report necessitated a rapid literature review. Pathway development required 340 hours: 205 for the rapid literature review, 63 for pathway development and EHR intervention design, and 5 for technical implementation of the intervention. Pathways were viewed 1,069 times through the cloud-based platform and 47 times through a hyperlink embedded in key EHR ordering screens. CONCLUSION: Pathways can be an approach for disseminating AHRQ EPC report findings within health care systems; however, reports should include guideline and pathway syntheses to meet their full potential. Embedding hyperlinks to pathway content within the EHR may be a viable and low-effort solution for promoting awareness of evidence-based resources.

Systematic review and meta-analysis of bariatric surgery for pediatric obesity.

OBJECTIVE: The prevalence of morbid obesity has risen sharply in recent years, even among pediatric patients. Bariatric surgery is used increasingly in an effort to induce weight loss, improve medical comorbidities, enhance quality of life, and extend survival. We performed a systematic review and meta-analysis of all published evidence pertaining specifically to bariatric surgery in pediatric patients. METHODS: We systematically searched MEDLINE, EMBASE, 13 other databases, and article bibliographies to identify relevant evidence. Included studies must have reported outcome data for > or =3 patients aged < or =21, representing > or =50% of pediatric patients enrolled at that center. We only included English language articles on currently performed procedures when data were separated by procedure, and there was a minimum 1-year follow-up for weight and body mass index (BMI). RESULTS: Eight studies of laparoscopic adjustable gastric banding (LAGB) reported data on 352 patients (mean BMI 45.8); 6 studies of Roux-en-Y gastric bypass (RYGB) included 131 patients (mean BMI 51.8); 5 studies of other surgical procedures included 158 patients (mean BMI 48.8). Average patient age was 16.8 years (range, 9-21). Meta-analyses of BMI reductions at longest follow-up indicated sustained and clinically significant BMI reductions for both LAGB and RYGB. Comorbidity resolution was sparsely reported, but surgery did appear to resolve some medical conditions including diabetes and hypertension. For LAGB, band slippage and micronutrient deficiency were the most frequently reported complications, with sporadic cases of band erosion, port/tube dysfunction, hiatal hernia, wound infection, and pouch dilation. For RYGB, more severe complications have been documented, such as pulmonary embolism, shock, intestinal obstruction, postoperative bleeding, staple line leak, and severe malnutrition. CONCLUSIONS: Bariatric surgery in pediatric patients results in sustained and clinically significant weight loss, but also has the potential for serious complications.

Long-term opioid therapy for chronic noncancer pain: a systematic review and meta-analysis of efficacy and safety.

Opioid therapy for chronic noncancer pain (CNCP) is controversial due to concerns regarding long-term efficacy and adverse events (including addiction). We systematically reviewed the clinical evidence on patients treated with opioids for CNCP for at least six months. Of 115 studies identified by our search of eleven databases (through April 7, 2007), 17 studies (patients [n]=3,079) met inclusion criteria. Studies evaluated oral (studies [k]=7; n=1,504), transdermal (k=3; n=1, 993), and/or intrathecal (k=8; n=177) opioids. Many patients withdrew from the clinical trials due to adverse effects (oral: 32.5% [95% confidence interval (CI), 26.1%-39.6%]; intrathecal: 6.3% [95% CI, 2.9%-13.1%]; transdermal: 17.5% [95% CI, 6.5%-39.0%]), or due to insufficient pain relief (oral: 11.9% [95% CI, 7.8%-17.7%]; intrathecal: 10.5% [95% CI, 3.5%-27.4%]; transdermal: 5.8% [95% CI, 4.2%-7.3%]). Signs of opioid addiction were reported in only 0.05% (1/2,042) of patients and abuse in only 0.43% (3/685). There was an insufficient amount of data on transdermal opioids to quantify pain relief. For patients able to remain on oral or intrathecal opioids for at least six months, pain scores were reduced long-term (oral: standardized mean difference [SMD] 1.99, 95% CI, 1.17-2.80; intrathecal: SMD 1.33, 95% CI, 0.97-1.69). We conclude that many patients discontinue long-term opioid therapy due to adverse events or insufficient pain relief; however, weak evidence suggests that oral and intrathecal opioids reduce pain long-term in the relatively small proportion of individuals with CNCP who continue treatment.

AHRQ series on complex intervention systematic reviews-paper 3: adapting frameworks to develop protocols.

BACKGROUND: Once a proposed topic has been identified for a systematic review and has undergone a question formulation stage, a protocol must be developed that specifies the scope and research questions in detail and outlines the methodology for conducting the systematic review. RATIONALE: Framework modifications are often needed to accommodate increased complexity. We describe and give examples of adaptations and alternatives to traditional analytic frameworks. DISCUSSION: This article identifies and describes elements of frameworks and how they can be adapted to inform the protocol and conduct of systematic reviews of complex interventions. Modifications may be needed to adapt the population, intervention, comparators, and outcomes normally used in protocol development to successfully describe complex interventions; in some instances, alternative frameworks may be better suited. Possible approaches to analytic frameworks for complex interventions that illustrate causal and associative linkages are outlined, including time elements, which systematic reviews of complex interventions may need to address. The need for and specifics of the accommodations vary with details of a specific systematic review. This in turn helps determine whether traditional frameworks are sufficient, can be refined, or if alternate frameworks must be adopted.