Executive summary of the KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease: known knowns and known unknowns.

The Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (CKD) updates the KDIGO 2012 guideline and has been developed with patient partners, clinicians, and researchers around the world, using robust methodology. This update, based on a substantially broader base of evidence than has previously been available, reflects an exciting time in nephrology. New therapies and strategies have been tested in large and diverse populations that help to inform care; however, this guideline is not intended for people receiving dialysis nor those who have a kidney transplant. The document is sensitive to international considerations, CKD across the lifespan, and discusses special considerations in implementation. The scope includes chapters dedicated to the evaluation and risk assessment of people with CKD, management to delay CKD progression and its complications, medication management and drug stewardship in CKD, and optimal models of CKD care. Treatment approaches and actionable guideline recommendations are based on systematic reviews of relevant studies and appraisal of the quality of the evidence and the strength of recommendations which followed the "Grading of Recommendations Assessment, Development, and Evaluation" (GRADE) approach. The limitations of the evidence are discussed. The guideline also provides practice points, which serve to direct clinical care or activities for which a systematic review was not conducted, and it includes useful infographics and describes an important research agenda for the future. It targets a broad audience of people with CKD and their healthcare, while being mindful of implications for policy and payment.

Opportunistic Screening for Coronary Artery Disease: An Untapped Population Health Resource.

BACKGROUND: Coronary artery disease is the leading cause of death in the United States. At-risk asymptomatic adults are eligible for screening with electrocardiogram-gated coronary artery calcium (CAC) CT, which aids in risk stratification and management decision-making. Incidental CAC (iCAC) is easily quantified on chest CT in patients imaged for noncardiac indications; however, radiologists do not routinely report the finding. OBJECTIVE: To determine the clinical significance of CAC identified incidentally on routine chest CT performed for noncardiac indications. DESIGN: An informationist developed search strategies in MEDLINE, Embase, and SCOPUS, and two reviewers independently screened results at both the abstract and full text levels. Data extracted from eligible articles included age, rate of iCAC identification, radiologist reporting frequency, impact on downstream medical management, and association of iCAC with patient outcomes. RESULTS: From 359 unique citations, 83 research publications met inclusion criteria. The percentage of patients with iCAC ranged from 9% to 100%. Thirty-one investigations measured association(s) between iCAC and cardiovascular morbidity and mortality, and 29 identified significant correlations, including nonfatal myocardial infarction, fatal myocardial infarction, major adverse cardiovascular event, cardiovascular death, and all-cause death. iCAC was present in 20% to 100% of the patients in these cohorts, but when present, iCAC was reported by radiologists in only 31% to 44% of cases. Between 18% and 77% of patients with iCAC were not on preventive medications in studies that reported these data. Seven studies measured the effect of reporting on guideline directed medical therapy, and 5 (71%) reported an increase in medication prescriptions after diagnosis of iCAC, with one confirming reductions in low-density lipoprotein levels. Twelve investigations reported good concordance between CAC grade on noncardiac CT and Agatston score on electrocardiogram-gated cardiac CT, and 10 demonstrated that artificial intelligence tools can reliably calculate an Agatston score on noncardiac CT. CONCLUSION: A body of evidence demonstrates that patients with iCAC on routine chest CT are at risk for cardiovascular disease events and death, but they are often undiagnosed. Uniform reporting of iCAC in the chest CT impression represents an opportunity for radiology to contribute to early identification of high-risk individuals and potentially reduce morbidity and mortality. AI tools have been validated to calculate Agatston score on routine chest CT and hold the best potential for facilitating broad adoption.

Realist Review of Care Models That Include Primary Care for Adult Childhood Cancer Survivors.

Appropriate models of survivorship care for the growing number of adult survivors of childhood cancer are unclear. We conducted a realist review to describe how models of care that include primary care and relevant resources (eg, tools, training) could be effective for adult survivors of childhood cancer. We first developed an initial program theory based on qualitative literature (studies, commentaries, opinion pieces) and stakeholder consultations. We then reviewed quantitative evidence and consulted stakeholders to refine the program theory and develop and refine context-mechanism-outcome hypotheses regarding how models of care that include primary care could be effective for adult survivors of childhood cancer. Effectiveness for both resources and models is defined by survivors living longer and feeling better through high-value care. Intermediate measures of effectiveness evaluate the extent to which survivors and providers understand the survivor's history, risks, symptoms and problems, health-care needs, and available resources. Thus, the models of care and resources are intended to provide information to survivors and/or primary care providers to enable them to obtain/deliver appropriate care. The variables from our program theory found most consistently in the literature include oncology vs primary care specialty, survivor and provider knowledge, provider comfort treating childhood cancer survivors, communication and coordination between and among providers and survivors, and delivery/receipt of prevention and surveillance of late effects. In turn, these variables were prominent in our context-mechanism-outcome hypotheses. The findings from this realist review can inform future research to improve childhood cancer survivorship care and outcomes.

Ineligibility for and Refusal to Participate in Randomized Controlled Trials That Have Studied Impact on Suicide-Related Outcomes in the United States: A Meta-Analysis.

Objective: Ineligibility for and refusal to participate in randomized controlled trials (RCTs) can potentially lead to unrepresentative study samples and limited generalizability of findings. We examined the rates of exclusion and refusal in RCTs that have studied impact on suicide-related outcomes in the US.Data Sources: PubMed, the Cochrane Library, the Campbell Collaboration Library of Systematic Reviews, CINAHL, PsycINFO, and Education Resources Information Center were searched from January 1990 to May 2020 using the terms (suicide prevention) AND (clinical trial).Study Selection: Of 8,403 studies retrieved, 36 RCTs assessing effectiveness on suicide-related outcomes in youth (≤ 25 years old) conducted in the US were included.Data Extraction: Study-level data were extracted by 2 independent investigators for a random-effects meta-analysis and meta-regression.Results: The study participants (N = 13,264) had a mean (SD) age of 14.87 (1.58) years and were 50% male, 23% African American, and 24% Hispanic. The exclusion rate was 36.4%, while the refusal rate was 25.5%. The exclusion rate was significantly higher in the studies excluding individuals not exceeding specified cutoff points of suicide screening tools (51.2%; adjusted linear coefficient [ß] = 1.30, standard error [SE] = 0.15; P = .041) and individuals not meeting the age or school grade criterion (45.9%; ß = 1.37, SE = 0.13; P = .005).Conclusions: The rates of exclusion and refusal in youth prevention interventions studying impact on suicide-related outcomes were not as high compared to the rates found in other mental and behavioral interventions. While there was strong racial/ethnic group representation in RCTs examining youth suicide-related outcomes, suicide severity and age limited eligibility.

Implementation and Effectiveness of Integrating Palliative Care Into Ambulatory Care of Noncancer Serious Chronic Illness: Mixed Methods Review and Meta-Analysis.

PURPOSE: To perform a mixed methods review to evaluate the effectiveness and implementation of models for integrating palliative care into ambulatory care for US adults with noncancer serious chronic illness. METHODS: We searched 3 electronic databases from January 2000 to May 2020 and included qualitative, mixed methods studies and randomized and nonrandomized controlled trials. For each study, 2 reviewers abstracted data and independently assessed for quality. We conducted meta-analyses as appropriate and graded strength of evidence (SOE) for quantitative outcomes. RESULTS: Quantitative analysis included 14 studies of 2,934 patients. Compared to usual care, models evaluated were not more effective for improving patient health-related quality of life (HRQOL) (standardized mean difference [SMD] of 4 of 8 studies, 0.19; 95% CI, ‒0.03 to 0.41) (SOE: moderate) or for patient depressive symptom scores (SMD of 3 of 9 studies, ‒0.09; 95% CI, ‒0.35 to 0.16) (SOE: moderate). Models might have little to no effect on patient satisfaction (SOE: low) but were more effective for increasing advance directive (AD) documentation (relative risk, 1.62; 95% CI, 1.35 to 1.94) (SOE: moderate). Qualitative analysis included 5 studies of 146 patients. Patient preferences for appropriate timing of palliative care varied; costs, additional visits, and travel were considered barriers to implementation. CONCLUSION: Models might have little to no effect on decreasing overall symptom burden and were not more effective than usual care for improving HRQOL or depressive symptom scores but were more effective for increasing AD documentation. Additional research should focus on identifying and addressing characteristics and implementation factors critical to integrating models to improve ambulatory, patient-centered outcomes.

Advance Care Planning Shared Decision-Making Tools for Non-Cancer Chronic Serious Illness: A Mixed Method Systematic Review.

CONTEXT: Shared decision-making tools can facilitate advance care planning and goals of care conversations in non-cancer serious illness. More information on integrating these tools in ambulatory care could better support clinicians and patients/caregivers in these conversations. OBJECTIVES: We evaluated effectiveness and implementation of integrating palliative care shared decision-making tools into ambulatory care for U.S. adults with serious, life-threatening illness and their caregivers. DATA SOURCES: We searched PubMed, CINAHL, and the Cochrane Central Register of Controlled Trials (2000 - May 2020) for quantitative controlled, qualitative, and mixed-methods studies. REVIEW METHODS: Two reviewers screened articles, abstracted data, and independently assessed risk of bias or study quality. For quantitative trials, we graded strength of evidence for key outcomes: patient/caregiver satisfaction, depression or anxiety, concordance between patient preferences for care and care received, and healthcare utilization, including advance directive documentation. RESULTS: We included 6 quantitative effectiveness randomized, controlled trials and 5 qualitative implementation studies across primary care and specialty populations. Shared decision-making tools all addressed goals-of-care communication or advance care planning. Palliative care shared decision-making tools may be effective for improving patient satisfaction with communication and advance directive documentation. We were unable to draw conclusions about concordance between preferences and care received. Patients and caregivers preferred advance care planning discussions grounded in patient and caregiver experiences with individualized timing. CONCLUSIONS: For non-cancer serious illness, advance care planning shared decision-making tools may improve several outcomes. Future trials should evaluate concordance with care received and other health care utilization. KEY MESSAGE: This mixed-methods review concludes that when integrating palliative care into ambulatory care for serious illness and conditions other than cancer, advance care planning shared decision-making tools may improve patient satisfaction and advance directive documentation.

Informing Patient-Centered Care Through Stakeholder Engagement and Highly Stratified Quantitative Benefit-Harm Assessments.

OBJECTIVES: In a previous project aimed at informing patient-centered care for people with multiple chronic conditions, we performed highly stratified quantitative benefit-harm assessments for 2 top priority questions. In this current work, our goal was to describe the process and approaches we developed and to qualitatively glean important elements from it that address patient-centered care. METHODS: We engaged patients, caregivers, clinicians, and guideline developers as stakeholder representatives throughout the process of the quantitative benefit-harm assessment and investigated whether the benefit-harm balance differed based on patient preferences and characteristics (stratification). We refined strategies to select the most applicable, valid, and precise evidence. RESULTS: Two processes were important when assessing the balance of benefits and harms of interventions: (1) engaging stakeholders and (2) stratification by patient preferences and characteristics. Engaging patients and caregivers through focus groups, preference surveys, and as co-investigators provided value in prioritizing research questions, identifying relevant clinical outcomes, and clarifying the relative importance of these outcomes. Our strategies to select evidence for stratified benefit-harm assessments considered consistency across outcomes and subgroups. By quantitatively estimating the range in the benefit-harm balance resulting from true variation in preferences, we clarified whether the benefit-harm balance is preference sensitive. CONCLUSIONS: Our approaches for engaging patients and caregivers at all phases of the stratified quantitative benefit-harm assessments were feasible and revealed how sensitive the benefit-harm balance is to patient characteristics and individual preferences. Accordingly, this sensitivity can suggest to guideline developers when to tailor recommendations for specific patient subgroups or when to explicitly leave decision making to individual patients and their providers.

Outcome preferences of older people with multiple chronic conditions and hypertension: a cross-sectional survey using best-worst scaling.

BACKGROUND: Older people with hypertension and multiple chronic conditions (MCC) receive complex treatments and face challenging trade-offs. Patients' preferences for different health outcomes can impact multiple treatment decisions. Since evidence about outcome preferences is especially scarce among people with MCC our aim was to elicit preferences of people with MCC for outcomes related to hypertension, and to determine how these outcomes should be weighed when benefits and harms are assessed for patient-centered clinical practice guidelines and health economic assessments. METHODS: We sent a best-worst scaling preference survey to a random sample identified from a primary care network of Kaiser Permanente (Colorado, USA). The sample included individuals age 60 or greater with hypertension and at least two other chronic conditions. We assessed average ranking of patient-important outcomes using conditional logit regression (stroke, heart attack, heart failure, dialysis, cognitive impairment, chronic kidney disease, acute kidney injury, fainting, injurious falls, low blood pressure with dizziness, treatment burden) and studied variation across individuals. RESULTS: Of 450 invited participants, 217 (48%) completed the survey, and we excluded 10 respondents who had more than two missing choices, resulting in a final sample of 207 respondents. Participants ranked stroke as the most worrisome outcome and treatment burden as the least worrisome outcome (conditional logit parameters: 3.19 (standard error 0.09) for stroke, 0 for treatment burden). None of the outcomes were always chosen as the most or least worrisome by more than 25% of respondents, indicating that all outcomes were somewhat worrisome to respondents. Predefined subgroup analyses according to age, self-reported life-expectancy, degree of comorbidity, number of medications and antihypertensive treatment did not reveal meaningful differences. CONCLUSIONS: Although some outcomes were more worrisome to patients than others, our results indicate that none of the outcomes should be disregarded for clinical practice guidelines and health economic assessments.

Methods and Risks of Bias in Natural Experiments in Obesity: Opportunities for the Future Informed by a Systematic Review.

OBJECTIVE: This paper promotes rigorous methods and designs currently underutilized in obesity research, informed by a recent systematic review of the methods and risks of bias in studies of policies, programs, and built environment changes for obesity prevention and control. METHODS: To determine the current state of the field, relevant databases from 2000 to 2017 were searched to identify studies that fit the inclusion criteria. Study design, analytic approach, and other details of study methods were abstracted. These findings inform recommendations for obesity researchers and the field as a whole. RESULTS: Previously identified were 156 natural experiment studies. Most were cross-sectional (35%), pre-post single group comparison (31%), or difference-in-differences designs (29%). Few used rigorous causal designs such as interrupted time series with more than two time points, propensity score methods, or instrumental variables. The potential relevance for obesity research is discussed, and recommendations for obesity researchers are provided. CONCLUSIONS: To strengthen natural experiment study designs and enhance the validity of results, researchers should carefully consider and control for confounding and selection of comparison groups and consider study designs that address these biases.

Balance of benefits and harms of different blood pressure targets in people with multiple chronic conditions: a quantitative benefit-harm assessment.

OBJECTIVE: Recent studies suggest that a systolic blood pressure (SBP) target of 120 mm Hg is appropriate for people with hypertension, but this is debated particularly in people with multiple chronic conditions (MCC). We aimed to quantitatively determine whether benefits of a lower SBP target justify increased risks of harm in people with MCC, considering patient-valued outcomes and their relative importance. DESIGN: Highly stratified quantitative benefit-harm assessment based on various input data identified as the most valid and applicable from a systematic review of evidence and based on weights from a patient preference survey. SETTING: Outpatient care. PARTICIPANTS: Hypertensive patients, grouped by age, gender, prior history of stroke, chronic heart failure, chronic kidney disease and type 2 diabetes mellitus. INTERVENTIONS: SBP target of 120 versus 140 mm Hg for patients without history of stroke. PRIMARY AND SECONDARY OUTCOME MEASURES: Probability that the benefits of a SBP target of 120 mm Hg outweigh the harms compared with 140 mm Hg over 5 years (primary) with thresholds >0.6 (120 mm Hg better), <0.4 (140 mm Hg better) and 0.4 to 0.6 (unclear), number of prevented clinical events (secondary), calculated with the Gail/National Cancer Institute approach. RESULTS: Considering individual patient preferences had a substantial impact on the benefit-harm balance. With average preferences, 120 mm Hg was the better target compared with 140 mm Hg for many subgroups of patients without prior stroke, especially in patients over 75. For women below 65 with chronic kidney disease and without diabetes and prior stroke, 140 mm Hg was better. The analyses did not include mild adverse effects, and apply only to patients who tolerate antihypertensive treatment. CONCLUSIONS: For most patients, a lower SBP target was beneficial, but this depended also on individual preferences, implying individual decision-making is important. Our modelling allows for individualised treatment targets based on patient preferences, age, gender and co-morbidities.

Systematic Review of Natural Experiments for Childhood Obesity Prevention and Control.

CONTEXT: The National Academy of Medicine recommends childhood obesity prevention efforts making healthier options the passive choice. This review evaluated the effectiveness of population-level policies and programs from natural experiments for childhood obesity prevention. EVIDENCE ACQUISTION: The search included PubMed, CINAHL, PsycINFO, and EconLit from 2000 to 2017 for policies evaluated by natural experiments reporting childhood BMI outcomes. The studies were analyzed in 2017-2018. Interventions were classified by environmental focus (food/beverage, physical activity, or both) and stratified by setting (school, community, both). Risk of bias was evaluated for each study. EVIDENCE SYNTHESIS: Of 33 natural experiments, most (73%) took place in the school setting only. The most common environmental focus in any setting was food/beverage (48%). All four studies that focused on both food/beverage and physical activity in schools demonstrated decreased prevalence of overweight/obesity or BMI z-score by 0.04-0.17. BMI decreased in all four studies in both school and community settings. The largest effect size was a decrease in BMI z-score of 0.5, but most were <0.25. The risk of bias was high for most (76%) studies. Most (63%) of the eight studies with low/medium risk of bias took place in the school setting focused on the food/beverage environment; effects on BMI were mixed. CONCLUSIONS: Natural experiments evaluating school-based policies focusing on both the food/beverage and physical activity environments (versus targeting only one) consistently showed improvement in BMI. However, most studies had high risk of bias, highlighting the need for improved methods for evaluation of natural experiments for childhood obesity prevention.

Effectiveness of Policies and Programs to Combat Adult Obesity: a Systematic Review.

BACKGROUND: This systematic review identifies programs, policies, and built-environment changes targeting prevention and control of adult obesity and evaluates their effectiveness. METHODS: We searched PubMed, CINAHL, PsycINFO, and EconLit from January 2000 to March 2018. We included natural experiment studies evaluating a program, policy, or built-environment change targeting adult obesity and reporting weight/body mass index (BMI). Studies were categorized by primary intervention target: physical activity/built environment, food/beverage, messaging, or multiple. Two reviewers independently assessed the risk of bias for each study using the Effective Public Health Practice Project tool. RESULTS: Of 158 natural experiments targeting obesity, 17 reported adult weight/BMI outcomes. Four of 9 studies reporting on physical activity/built environment demonstrated reduced weight/BMI, although effect sizes were small with low strength of evidence and high risk of bias. None of the 5 studies targeting the food/beverage environment decreased weight/BMI; strength of evidence was low, and 2 studies were rated high risk of bias. DISCUSSION: We identified few natural experiments reporting on the effectiveness of programs, policies, and built-environment changes on adult obesity. Overall, we found no evidence that policies intending to promote physical activity and healthy eating had beneficial effects on weight/BMI and most studies had a high risk of bias. Limitations include few studies met our inclusion criteria; excluded studies in children and those not reporting on weight/BMI outcomes; weight/BMI reporting was very heterogeneous. More high-quality research, including natural experiments studies, is critical for informing the population-level effectiveness of obesity prevention and control initiatives in adults.

The study of effect moderation in youth suicide-prevention studies.

PURPOSE: Suicide is now the second leading cause of death among persons between the ages of adolescents and emerging adults and rates have increased despite more funding and broader implementation of youth suicide-prevention programs. A systematic review was conducted focusing on identifying youth suicide-prevention studies within the United States. This paper reports on the methods utilized for understanding possible moderators of suicide-prevention program outcomes. METHODS: We searched six databases from 1990 through August 2017 to identify studies of suicide-preventive interventions among those under age 26 years. Two independent team members screened search results and sequentially extracted information related to statistical methods of moderation analyses. RESULTS: 69 articles were included in the systematic review of which only 17 (24.6%) explored treatment effect heterogeneity using moderation analysis. The most commonly used analytic tool was regression with an interaction term. The moderators studied included demographic characteristics such as gender and ethnicity as well as individual characteristics such as traumatic stress exposure and multiple prior suicide attempts. CONCLUSIONS: With a greater emphasis from the federal government and funding agencies on precision prevention, understanding which prevention programs work for specific subgroups is essential. Only a small percentage of the reviewed articles assessed moderation effects. This is a substantial research gap driven by sample size or other limitations which have impeded the identification of intervention effect heterogeneity.

Methods for Evaluating Natural Experiments in Obesity: A Systematic Review.

Background: Given the obesity pandemic, rigorous methodological approaches, including natural experiments, are needed. Purpose: To identify studies that report effects of programs, policies, or built environment changes on obesity prevention and control and to describe their methods. Data Sources: PubMed, CINAHL, PsycINFO, and EconLit (January 2000 to August 2017). Study Selection: Natural experiments and experimental studies evaluating a program, policy, or built environment change in U.S. or non-U.S. populations by using measures of obesity or obesity-related health behaviors. Data Extraction: 2 reviewers serially extracted data on study design, population characteristics, data sources and linkages, measures, and analytic methods and independently evaluated risk of bias. Data Synthesis: 294 studies (188 U.S., 106 non-U.S.) were identified, including 156 natural experiments (53%), 118 experimental studies (40%), and 20 (7%) with unclear study design. Studies used 106 (71 U.S., 35 non-U.S.) data systems; 37% of the U.S. data systems were linked to another data source. For outcomes, 112 studies reported childhood weight and 32 adult weight; 152 had physical activity and 148 had dietary measures. For analysis, natural experiments most commonly used cross-sectional comparisons of exposed and unexposed groups (n = 55 [35%]). Most natural experiments had a high risk of bias, and 63% had weak handling of withdrawals and dropouts. Limitation: Outcomes restricted to obesity measures and health behaviors; inconsistent or unclear descriptions of natural experiment designs; and imperfect methods for assessing risk of bias in natural experiments. Conclusion: Many methodologically diverse natural experiments and experimental studies were identified that reported effects of U.S. and non-U.S. programs, policies, or built environment changes on obesity prevention and control. The findings reinforce the need for methodological and analytic advances that would strengthen evaluations of obesity prevention and control initiatives. Primary Funding Source: National Institutes of Health, Office of Disease Prevention, and Agency for Healthcare Research and Quality. (PROSPERO: CRD42017055750).

Patient- and Caregiver-Reported Assessment Tools for Palliative Care: Summary of the 2017 Agency for Healthcare Research and Quality Technical Brief.

CONTEXT: Assessment tools are data collection instruments that are completed by or with patients or caregivers and which collect data at the individual patient or caregiver level. OBJECTIVES: The objectives of this study are to 1) summarize palliative care assessment tools completed by or with patients or caregivers and 2) identify needs for future tool development and evaluation. METHODS: We completed 1) a systematic review of systematic reviews; 2) a supplemental search of previous reviews and Web sites, and/or 3) a targeted search for primary articles when no tools existed in a domain. Paired investigators screened search results, assessed risk of bias, and abstracted data. We organized tools by domains from the National Consensus Project Clinical Practice Guidelines for Palliative Care and selected the most relevant, recent, and highest quality systematic review for each domain. RESULTS: We included 10 systematic reviews and identified 152 tools (97 from systematic reviews and 55 from supplemental sources). Key gaps included no systematic review for pain and few tools assessing structural, cultural, spiritual, or ethical/legal domains, or patient-reported experience with end-of-life care. Psychometric information was available for many tools, but few studies evaluated responsiveness (sensitivity to change) and no studies compared tools. CONCLUSION: Few to no tools address the spiritual, ethical, or cultural domains or patient-reported experience with end-of-life care. While some data exist on psychometric properties of tools, the responsiveness of different tools to change and/or comparisons between tools have not been evaluated. Future research should focus on developing or testing tools that address domains for which few tools exist, evaluating responsiveness, and comparing tools.

Data Linkage Strategies to Advance Youth Suicide Prevention: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop.

BACKGROUND: Linking national, state, and community data systems to data from prevention programs could allow for longer-term assessment of outcomes and evaluation of interventions to prevent suicide. PURPOSE: To identify and describe data systems that can be linked to data from prevention studies to advance youth suicide prevention research. DATA SOURCES: A systematic review, an environmental scan, and a targeted search were conducted to identify prevention studies and potentially linkable external data systems with suicide outcomes from January 1990 through December 2015. STUDY SELECTION: Studies and data systems had to be U.S.-based and include persons aged 25 years or younger. Data systems also had to include data on suicide, suicide attempt, or suicidal ideation. DATA EXTRACTION: Information about participants, intervention type, suicide outcomes, primary analytic method used for linkage, statistical approach, analyses performed, and characteristics of data systems was abstracted by 2 reviewers. DATA SYNTHESIS: Of 47 studies (described in 59 articles) identified in the systematic review, only 6 were already linked to data systems. A total of 153 unique and potentially linkable data systems were identified, but only 66 were classified as "fairly accessible" and had data dictionaries available. Of the data systems identified, 19% were established primarily for research, 11% for clinical care or operations, 29% for administrative services (such as billing), and 52% for surveillance. About one third (37%) provided national data, 12% provided regional data, 63% provided state data, and 41% provided data below the state level (some provided coverage for >1 geographic unit). LIMITATION: Only U.S.-based studies published in English were included. CONCLUSION: There is untapped potential to evaluate and enhance suicide prevention efforts by linking suicide prevention data with existing data systems. However, sparse availability of data dictionaries and lack of adherence to standard data elements limit this potential. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Validity of the Agency for Health Care Research and Quality Patient Safety Indicators and the Centers for Medicare and Medicaid Hospital-acquired Conditions: A Systematic Review and Meta-Analysis.

BACKGROUND: The Agency for Health Care Research and Quality Patient Safety Indicators (PSIs) and Centers for Medicare and Medicaid Services Hospital-acquired Conditions (HACs) are increasingly being used for pay-for-performance and public reporting despite concerns over their validity. Given the potential for these measures to misinform patients, misclassify hospitals, and misapply financial and reputational harm to hospitals, these need to be rigorously evaluated. We performed a systematic review and meta-analysis to assess PSI and HAC measure validity. METHODS: We searched MEDLINE and the gray literature from January 1, 1990 through January 14, 2015 for studies that addressed the validity of the HAC measures and PSIs. Secondary outcomes included the effects of present on admission (POA) modifiers, and the most common reasons for discrepancies. We developed pooled results for measures evaluated by ≥3 studies. We propose a threshold of 80% for positive predictive value or sensitivity for pay-for-performance and public reporting suitability. RESULTS: Only 5 measures, Iatrogenic Pneumothorax (PSI 6/HAC 17), Central Line-associated Bloodstream Infections (PSI 7), Postoperative hemorrhage/hematoma (PSI 9), Postoperative deep vein thrombosis/pulmonary embolus (PSI 12), and Accidental Puncture/Laceration (PSI 15), had sufficient data for pooled meta-analysis. Only PSI 15 (Accidental Puncture and Laceration) met our proposed threshold for validity (positive predictive value only) but this result was weakened by considerable heterogeneity. Coding errors were the most common reasons for discrepancies between medical record review and administrative databases. POA modifiers may improve the validity of some measures. CONCLUSION: This systematic review finds that there is limited validity for the PSI and HAC measures when measured against the reference standard of a medical chart review. Their use, as they currently exist, for public reporting and pay-for-performance, should be publicly reevaluated in light of these findings.

Comparative Effect of Contrast Media Type on the Incidence of Contrast-Induced Nephropathy: A Systematic Review and Meta-analysis.

BACKGROUND: Iodine contrast media are essential components of many imaging procedures. An important potential side effect is contrast-induced nephropathy (CIN). PURPOSE: To compare CIN risk for contrast media within and between osmolality classes in patients receiving diagnostic or therapeutic imaging procedures. DATA SOURCES: PubMed, EMBASE, Cochrane Library, Clinical Trials.gov, and Scopus through June 2015. STUDY SELECTION: Randomized, controlled trials that reported CIN-related outcomes in patients receiving low-osmolar contrast media (LOCM) or iso-osmolar contrast media for imaging. DATA EXTRACTION: Independent study selection and quality assessment by 2 reviewers and dual extraction of study characteristics and results. DATA SYNTHESIS: None of the 5 studies that compared types of LOCM reported a statistically significant or clinically important difference among study groups, but the strength of evidence was low. Twenty-five randomized, controlled trials found a slight reduction in CIN risk with the iso-osmolar contrast media agent iodixanol compared with a diverse group of LOCM that just reached statistical significance in a meta-analysis (pooled relative risk, 0.80 [95% CI, 0.65 to 0.99]; P = 0.045). This comparison's strength of evidence was moderate. In a meta regression of randomized, controlled trials of iodixanol, no relationship was found between route of administration and comparative CIN risk. LIMITATIONS: Few studies compared LOCM. Procedural details about contrast administration were not uniformly reported. Few studies specified clinical indications or severity of baseline renal impairment. CONCLUSION: No differences were found in CIN risk among types of LOCM. Iodixanol had a slightly lower risk for CIN than LOCM, but the lower risk did not exceed a criterion for clinical importance. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Effectiveness of Prevention Strategies for Contrast-Induced Nephropathy: A Systematic Review and Meta-analysis.

BACKGROUND: N-acetylcysteine, sodium bicarbonate, statins, and ascorbic acid have been studied for reducing contrast-induced nephropathy (CIN). PURPOSE: To evaluate the comparative effectiveness of interventions to reduce CIN in adults receiving contrast media. DATA SOURCES: MEDLINE, EMBASE, Cochrane Library, ClinicalTrials.gov, and Scopus databases through June 2015. Risk of bias and overall strength of evidence (SOE) of studies were assessed. STUDY SELECTION: Randomized, controlled trials of N-acetylcysteine, sodium bicarbonate, statins, or ascorbic acid that used intravenous (IV) or intra-arterial contrast media and defined CIN with enough data for meta-analysis. DATA EXTRACTION: Two reviewers independently extracted data and assessed study quality. DATA SYNTHESIS: Low-dose N-acetylcysteine plus IV saline compared with IV saline (risk ratio [RR], 0.75 [95% CI, 0.63 to 0.89]; low SOE), N-acetylcysteine plus IV saline compared with IV saline in patients receiving low-osmolar contrast media (RR, 0.69 [CI, 0.58 to 0.84]; moderate SOE), and statins plus N-acetylcysteine plus IV saline versus N-acetylcysteine plus IV saline (RR, 0.52 [CI, 0.29 to 0.93]; low SOE) had clinically important and statistically significant benefits. The following 3 comparisons suggested a clinically important difference that was not statistically significant: sodium bicarbonate versus IV saline in patients receiving low-osmolar contrast media (RR, 0.65 [CI, 0.33 to 1.25]; low SOE), statins plus IV saline versus IV saline (RR, 0.68 [CI, 0.39 to 1.20]; low SOE), and ascorbic acid versus IV saline (RR, 0.72 [CI, 0.48 to 1.01]; low SOE). Strength of evidence was generally insufficient for comparisons of the need for renal replacement, cardiac events, and mortality. LIMITATION: Too few studies were done in patients receiving IV contrast media. CONCLUSION: The greatest reduction in CIN was seen with N-acetylcysteine plus IV saline in patients receiving LOCM and with statins plus N-acetylcysteine plus IV saline. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Data Linkage Strategies to Advance Youth Suicide Prevention.

OBJECTIVES: Linking national, State, and community data systems, such as those used for medical service billing, to existing data from suicide prevention efforts could facilitate the assessment of longer term outcomes. Our objective was to identify and describe data systems that can be linked to data from studies of youth suicide prevention interventions and to identify analytic approaches to advance youth suicide prevention research. DATA SOURCES: We conducted a systematic review to identify studies of suicide prevention interventions and three types of searches to identify data systems providing suicide-related outcomes: (1) a literature search, (2) an environmental scan of gray literature, and (3) a targeted search, through contact with relevant individuals, in six States, two cities, and one tribal community. REVIEW METHODS: Two independent reviewers screened all results. Studies and data systems had to be based in the United States; include individuals between 0 and 25 years of age; and include suicide, suicide attempt, or suicide ideation as an outcome. RESULTS: Of the 47 studies (described in 59 articles) of suicide prevention interventions identified in our systematic review, only 6 studied outcomes by linking to external data systems and only 12 explored treatment heterogeneity through the effects of moderators such as gender or race/ethnicity. We identified 153 unique and potentially linkable external data systems, 66 of which we classified as "fairly accessible" with data dictionaries available. CONCLUSIONS: There is potential for linking existing data systems with suicide prevention efforts to assess the broader and extended impact of suicide prevention interventions. However, sparse availability of data dictionaries and lack of adherence to standard data elements limit the potential utility of linking prevention efforts with data systems.