The Impact of Health Care Algorithms on Racial and Ethnic Disparities : A Systematic Review.

BACKGROUND: There is increasing concern for the potential impact of health care algorithms on racial and ethnic disparities. PURPOSE: To examine the evidence on how health care algorithms and associated mitigation strategies affect racial and ethnic disparities. DATA SOURCES: Several databases were searched for relevant studies published from 1 January 2011 to 30 September 2023. STUDY SELECTION: Using predefined criteria and dual review, studies were screened and selected to determine: 1) the effect of algorithms on racial and ethnic disparities in health and health care outcomes and 2) the effect of strategies or approaches to mitigate racial and ethnic bias in the development, validation, dissemination, and implementation of algorithms. DATA EXTRACTION: Outcomes of interest (that is, access to health care, quality of care, and health outcomes) were extracted with risk-of-bias assessment using the ROBINS-I (Risk Of Bias In Non-randomised Studies - of Interventions) tool and adapted CARE-CPM (Critical Appraisal for Racial and Ethnic Equity in Clinical Prediction Models) equity extension. DATA SYNTHESIS: Sixty-three studies (51 modeling, 4 retrospective, 2 prospective, 5 prepost studies, and 1 randomized controlled trial) were included. Heterogenous evidence on algorithms was found to: a) reduce disparities (for example, the revised kidney allocation system), b) perpetuate or exacerbate disparities (for example, severity-of-illness scores applied to critical care resource allocation), and/or c) have no statistically significant effect on select outcomes (for example, the HEART Pathway [history, electrocardiogram, age, risk factors, and troponin]). To mitigate disparities, 7 strategies were identified: removing an input variable, replacing a variable, adding race, adding a non-race-based variable, changing the racial and ethnic composition of the population used in model development, creating separate thresholds for subpopulations, and modifying algorithmic analytic techniques. LIMITATION: Results are mostly based on modeling studies and may be highly context-specific. CONCLUSION: Algorithms can mitigate, perpetuate, and exacerbate racial and ethnic disparities, regardless of the explicit use of race and ethnicity, but evidence is heterogeneous. Intentionality and implementation of the algorithm can impact the effect on disparities, and there may be tradeoffs in outcomes. PRIMARY FUNDING SOURCE: Agency for Healthcare Quality and Research.

Critical Appraisal for Racial and Ethnic Equity in Clinical Prediction Models Extension: Development of a Critical Appraisal Tool Extension to Assess Racial and Ethnic Equity-Related Risk of Bias for Clinical Prediction Models.

Introduction: Despite mounting evidence that the inclusion of race and ethnicity in clinical prediction models may contribute to health disparities, existing critical appraisal tools do not directly address such equity considerations. Objective: This study developed a critical appraisal tool extension to assess algorithmic bias in clinical prediction models. Methods: A modified e-Delphi approach was utilized to develop and obtain expert consensus on a set of racial and ethnic equity-based signaling questions for appraisal of risk of bias in clinical prediction models. Through a series of virtual meetings, initial pilot application, and an online survey, individuals with expertise in clinical prediction model development, systematic review methodology, and health equity developed and refined this tool. Results: Consensus was reached for ten equity-based signaling questions, which led to the development of the Critical Appraisal for Racial and Ethnic Equity in Clinical Prediction Models (CARE-CPM) extension. This extension is intended for use along with existing critical appraisal tools for clinical prediction models. Conclusion: CARE-CPM provides a valuable risk-of-bias assessment tool extension for clinical prediction models to identify potential algorithmic bias and health equity concerns. Further research is needed to test usability, interrater reliability, and application to decision-makers.

Interventions to Reduce Hospital Length of Stay in High-risk Populations: A Systematic Review.

Importance: Many strategies to reduce hospital length of stay (LOS) have been implemented, but few studies have evaluated hospital-led interventions focused on high-risk populations. The Agency for Healthcare Research and Quality (AHRQ) Learning Health System panel commissioned this study to further evaluate system-level interventions for LOS reduction. Objective: To identify and synthesize evidence regarding potential systems-level strategies to reduce LOS for patients at high risk for prolonged LOS. Evidence Review: Multiple databases, including MEDLINE and Embase, were searched for English-language systematic reviews from January 1, 2010, through September 30, 2020, with updated searches through January 19, 2021. The scope of the protocol was determined with input from AHRQ Key Informants. Systematic reviews were included if they reported on hospital-led interventions intended to decrease LOS for high-risk populations, defined as those with high-risk medical conditions or socioeconomically vulnerable populations (eg, patients with high levels of socioeconomic risk, who are medically uninsured or underinsured, with limited English proficiency, or who are hospitalized at a safety-net, tertiary, or quaternary care institution). Exclusion criteria included interventions that were conducted outside of the hospital setting, including community health programs. Data extraction was conducted independently, with extraction of strength of evidence (SOE) ratings provided by systematic reviews; if unavailable, SOE was assessed using the AHRQ Evidence-Based Practice Center methods guide. Findings: Our searches yielded 4432 potential studies. We included 19 systematic reviews reported in 20 articles. The reviews described 8 strategies for reducing LOS in high-risk populations: discharge planning, geriatric assessment, medication management, clinical pathways, interdisciplinary or multidisciplinary care, case management, hospitalist services, and telehealth. Interventions were most frequently designed for older patients, often those who were frail (9 studies), or patients with heart failure. There were notable evidence gaps, as there were no systematic reviews studying interventions for patients with socioeconomic risk. For patients with medically complex conditions, discharge planning, medication management, and interdisciplinary care teams were associated with inconsistent outcomes (LOS, readmissions, mortality) across populations. For patients with heart failure, clinical pathways and case management were associated with reduced length of stay (clinical pathways: mean difference reduction, 1.89 [95% CI, 1.33 to 2.44] days; case management: mean difference reduction, 1.28 [95% CI, 0.52 to 2.04] days). Conclusions and Relevance: This systematic review found inconsistent results across all high-risk populations on the effectiveness associated with interventions, such as discharge planning, that are often widely used by health systems. This systematic review highlights important evidence gaps, such as the lack of existing systematic reviews focused on patients with socioeconomic risk factors, and the need for further research.

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.

Effect of Intensive Blood Pressure Lowering on Cardiovascular Outcomes: A Systematic Review Prepared for the 2020 U.S. Department of Veterans Affairs/U.S. Department of Defense Guidelines.

BACKGROUND: Recent clinical trials suggest that treating patients with hypertension to lower blood pressure (BP) targets improves cardiovascular outcomes. PURPOSE: To summarize the effects of intensive (or targeted) systolic BP (SBP) and diastolic BP (DBP) lowering with pharmacologic treatment on cardiovascular outcomes and harms in adults with hypertension. DATA SOURCES: Multiple databases, including MEDLINE and EMBASE, were searched for relevant systematic reviews (SRs) published in English from 15 December 2013 through 25 March 2019, with updated targeted searches through 8 January 2020. STUDY SELECTION: 8 SRs of randomized controlled trials examining either a standardized SBP target of -10 mm Hg (1 SR) or BP lowering below a target threshold (7 SRs). DATA EXTRACTION: One investigator abstracted data, assessed study quality, and performed GRADE assessments; a second investigator checked abstractions and assessments. DATA SYNTHESIS: The main outcome of interest was reduction in composite cardiovascular outcomes. High-strength evidence showed benefit of a 10-mm Hg reduction in SBP for cardiovascular outcomes among patients with hypertension in the general population, patients with chronic kidney disease, and patients with heart failure. Evidence on reducing SBP for cardiovascular outcomes in patients with a history of cardiovascular disease (moderate strength) or diabetes mellitus (high strength) to a lower SBP target was mixed. Low-strength evidence supported intensive lowering to a 10-mm Hg reduction in SBP for cardiovascular outcomes in patients with a history of stroke. All reported harms were considered, including general adverse events, serious adverse events, cognitive impairment, fractures, falls, syncope, hypotension, withdrawals due to adverse events, and acute kidney injury. Safety results were mixed or inconclusive. LIMITATIONS: This was a qualitative synthesis of new evidence with existing meta-analyses. Data were sparse for outcomes related to treating DBP to a lower target or for patients older than 60 years. CONCLUSION: Overall, current clinical literature supports intensive BP lowering in patients with hypertension for improving cardiovascular outcomes. In most subpopulations, intensive lowering was favored over less-intensive lowering, but the data were less clear for patients with diabetes mellitus or cardiovascular disease. PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs, Veterans Health Administration.

Imaging Tests for the Diagnosis and Staging of Pancreatic Adenocarcinoma: A Meta-Analysis.

Imaging tests are central to the diagnosis and staging of pancreatic adenocarcinoma. We performed a systematic review and meta-analysis of the pertinent evidence on 5 imaging tests (computed tomography (CT), magnetic resonance imaging, CT angiography, endoscopic ultrasound with fine-needle aspiration, and combined positron emission tomography with CT). Searches of several databases up to March 1, 2014, yielded 9776 articles, and 24 provided comparative effectiveness of 2 or more imaging tests. Multiple reviewers applied study inclusion criteria, extracted data from each study, rated the risk of bias, and graded the strength of evidence. Data included accuracy of diagnosis and resectability in primary untreated pancreatic adenocarcinoma, including tumor stage, nodal stage, metastases, and vascular involvement. Where possible, study results were combined using bivariate meta-analysis. Studies were at low or moderate risk of bias. Most comparisons between imaging tests were insufficient to permit conclusions, due to imprecision or inconsistency among study results. However, moderate-grade evidence revealed that CT and magnetic resonance imaging had similar sensitivities and specificities for both diagnosis and vascular involvement. Other conclusions were based on low-grade evidence. In general, more direct evidence is needed to inform decisions about imaging tests for pancreatic adenocarcinoma.

Assessing equivalence and noninferiority.

OBJECTIVE: For systematic reviews, no guidance exists for what review methods support valid conclusions of equivalence (EQ) and noninferiority (NI). To provide such guidance, we convened a workgroup of 13 experienced systematic reviewers from seven evidence-based practice centers (EPCs) and the Agency for Healthcare Research and Quality (AHRQ). STUDY DESIGN AND SETTING: The Lead EPC first performed two methods projects intended to assist the workgroup in clarifying the context, prioritizing the issues, targeting the scope, and summarizing the state of the art. RESULTS: Based on expert opinion, we devised guidance in four areas: 1) Unique risk of bias issues for trials self-identifying as EQ-NI trials; 2) Setting the reviewer's minimum important difference; 3) Analytic foundations for concluding EQ or NI; and 4) Language considerations when concluding EQ or NI. CONCLUSION: This article summarizes the main recommendations, and the full guidance chapter appears on the AHRQ Web site.

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.

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.