Cumulative Systolic Blood Pressure and Incident Stroke Type Variation by Race and Ethnicity.

Importance: Stroke risk varies by systolic blood pressure (SBP), race, and ethnicity. The association between cumulative mean SBP and incident stroke type is unclear, and whether this association differs by race and ethnicity remains unknown. Objective: To examine the association between cumulative mean SBP and first incident stroke among 3 major stroke types-ischemic stroke (IS), intracerebral hemorrhage (ICH), and subarachnoid hemorrhage (SAH)-and explore how these associations vary by race and ethnicity. Design, Setting, and Participants: Individual participant data from 6 US longitudinal cohorts (January 1, 1971, to December 31, 2019) were pooled. The analysis was performed from January 1, 2022, to January 2, 2024. The median follow-up was 21.6 (IQR, 13.6-31.8) years. Exposure: Time-dependent cumulative mean SBP. Main Outcomes and Measures: The primary outcome was time from baseline visit to first incident stroke. Secondary outcomes consisted of time to first incident IS, ICH, and SAH. Results: Among 40 016 participants, 38 167 who were 18 years or older at baseline with no history of stroke and at least 1 SBP measurement before the first incident stroke were included in the analysis. Of these, 54.0% were women; 25.0% were Black, 8.9% were Hispanic of any race, and 66.2% were White. The mean (SD) age at baseline was 53.4 (17.0) years and the mean (SD) SBP at baseline was 136.9 (20.4) mm Hg. A 10-mm Hg higher cumulative mean SBP was associated with a higher risk of overall stroke (hazard ratio [HR], 1.20 [95% CI, 1.18-1.23]), IS (HR, 1.20 [95% CI, 1.17-1.22]), and ICH (HR, 1.31 [95% CI, 1.25-1.38]) but not SAH (HR, 1.13 [95% CI, 0.99-1.29]; P = .06). Compared with White participants, Black participants had a higher risk of IS (HR, 1.20 [95% CI, 1.09-1.33]) and ICH (HR, 1.67 [95% CI, 1.30-2.13]) and Hispanic participants of any race had a higher risk of SAH (HR, 3.81 [95% CI, 1.29-11.22]). There was no consistent evidence that race and ethnicity modified the association of cumulative mean SBP with first incident stroke and stroke type. Conclusions and Relevance: The findings of this cohort study suggest that cumulative mean SBP was associated with incident stroke type, but the associations did not differ by race and ethnicity. Culturally informed stroke prevention programs should address modifiable risk factors such as SBP along with social determinants of health and structural inequities in society.

Prediction of Multiple Individual Primary Cardiovascular Events Using Pooled Cohorts.

Introduction: Most current clinical risk prediction scores for cardiovascular disease prevention use a composite outcome. Risk prediction scores for specific cardiovascular events could identify people who are at higher risk for some events than others informing personalized care and trial recruitment. We sought to predict risk for multiple different events, describe how those risks differ, and examine if these differences could improve treatment priorities. Methods: We used participant-level data from five cohort studies. We included participants between 40 and 79 years old who had no history of myocardial infarction (MI), stroke, or heart failure (HF). We made separate models to predict 10-year rates of first atherosclerotic cardiovascular disease (ASCVD), first fatal or nonfatal MI, first fatal or nonfatal stroke, new-onset HF, fatal ASCVD, fatal MI, fatal stroke, and all-cause mortality using established ASCVD risk factors. To limit overfitting, we used elastic net regularization with alpha = 0.75. We assessed the models for calibration, discrimination, and for correlations between predicted risks for different events. We also estimated the potential impact of varying treatment based on patients who are high risk for some ASCVD events, but not others. Results: Our study included 24,505 people; 55.6% were women, and 20.7% were non-Hispanic Black. Our models had C-statistics between 0.75 for MI and 0.85 for HF, good calibration, and minimal overfitting. The models were least similar for fatal stroke and all MI (0.58). In 1,840 participants whose risk of MI but not stroke or all-cause mortality was in the top quartile, we estimate one blood pressure-lowering medication would have a 2.4% chance of preventing any ASCVD event per 10 years. A moderate-strength statin would have a 2.1% chance. In 1,039 participants who had top quartile risk of stroke but not MI or mortality, a blood pressure-lowering medication would have a 2.5% chance of preventing an event, but a moderate-strength statin, 1.6%. Conclusion: We developed risk scores for eight key clinical events and found that cardiovascular risk varies somewhat for different clinical events. Future work could determine if tailoring decisions by risk of separate events can improve care.

Associations Between Vascular Risk Factor Levels and Cognitive Decline Among Stroke Survivors.

Importance: Incident stroke is associated with accelerated cognitive decline. Whether poststroke vascular risk factor levels are associated with faster cognitive decline is uncertain. Objective: To evaluate associations of poststroke systolic blood pressure (SBP), glucose, and low-density lipoprotein (LDL) cholesterol levels with cognitive decline. Design, Setting, and Participants: Individual participant data meta-analysis of 4 US cohort studies (conducted 1971-2019). Linear mixed-effects models estimated changes in cognition after incident stroke. Median (IQR) follow-up was 4.7 (2.6-7.9) years. Analysis began August 2021 and was completed March 2023. Exposures: Time-dependent cumulative mean poststroke SBP, glucose, and LDL cholesterol levels. Main Outcomes and Measures: The primary outcome was change in global cognition. Secondary outcomes were change in executive function and memory. Outcomes were standardized as t scores (mean [SD], 50 [10]); a 1-point difference represents a 0.1-SD difference in cognition. Results: A total of 1120 eligible dementia-free individuals with incident stroke were identified; 982 (87.7%) had available covariate data and 138 (12.3%) were excluded for missing covariate data. Of the 982, 480 (48.9%) were female individuals, and 289 (29.4%) were Black individuals. The median age at incident stroke was 74.6 (IQR, 69.1-79.8; range, 44.1-96.4) years. Cumulative mean poststroke SBP and LDL cholesterol levels were not associated with any cognitive outcome. However, after accounting for cumulative mean poststroke SBP and LDL cholesterol levels, higher cumulative mean poststroke glucose level was associated with faster decline in global cognition (-0.04 points/y faster per each 10-mg/dL increase [95% CI, -0.08 to -0.001 points/y]; P = .046) but not executive function or memory. After restricting to 798 participants with apolipoprotein E4 (APOE4) data and controlling for APOE4 and APOE4 × time, higher cumulative mean poststroke glucose level was associated with a faster decline in global cognition in models without and with adjustment for cumulative mean poststroke SBP and LDL cholesterol levels (-0.05 points/y faster per 10-mg/dL increase [95% CI, -0.09 to -0.01 points/y]; P = .01; -0.07 points/y faster per 10-mg/dL increase [95% CI, -0.11 to -0.03 points/y]; P = .002) but not executive function or memory declines. Conclusions and Relevance: In this cohort study, higher poststroke glucose levels were associated with faster global cognitive decline. We found no evidence that poststroke LDL cholesterol and SBP levels were associated with cognitive decline.

Monitoring policy in the context of preventive treatment of cardiovascular disease.

Preventing chronic diseases is an essential aspect of medical care. To prevent chronic diseases, physicians focus on monitoring their risk factors and prescribing the necessary medication. The optimal monitoring policy depends on the patient's risk factors and demographics. Monitoring too frequently may be unnecessary and costly; on the other hand, monitoring the patient infrequently means the patient may forgo needed treatment and experience adverse events related to the disease. We propose a finite horizon and finite-state Markov decision process to define monitoring policies. To build our Markov decision process, we estimate stochastic models based on longitudinal observational data from electronic health records for a large cohort of patients seen in the national U.S. Veterans Affairs health system. We use our model to study policies for whether or when to assess the need for cholesterol-lowering medications. We further use our model to investigate the role of gender and race on optimal monitoring policies.

Carpal Tunnel Syndrome as a Test Case for Value Assessment During the Presurgical Period: The Impact of Structure and Processes of Care.

BACKGROUND: Few performance measures assess presurgical value (quality and utilization). OBJECTIVES: Using carpal tunnel syndrome (CTS) as a case study: (1) develop a model to evaluate presurgical quality and utilization and (2) identify opportunities for value improvement. RESEARCH DESIGN: A retrospective cohort study utilizing Veterans Affairs (VA) national administrative data. SUBJECTS: Patients who were evaluated in a VA primary care clinic on at least 1 occasion for CTS and received carpal tunnel release over a 7-year period. MEASURES: We modeled facility-level performance on 2 outcomes: surgical delay (marker of quality) and number of presurgical encounters (utilization) for CTS, and examined association between patient, facility, and care process variables and performance. RESULTS: Among 41,912 Veterans undergoing carpal tunnel release at 127 VA medical centers, the median facility-level predicted probability of surgical delay was 48%, with 16 (13%) facilities having significantly less delay than the median and 13 (10%) facilities having greater delay. The median facility-level predicted number of presurgical encounters was 8.8 visits, with 22 (17%) facilities having significantly fewer encounters and 22 (17%) facilities having more. Care processes had a stronger association with both outcomes than structural variables included in the models. Processes associated with the greatest deviations in predicted delay and utilization included receipt of repeat electrodiagnostic testing, use of 2 or more nonoperative treatments, and community referral outside of VA. CONCLUSIONS: Using CTS as a test case, this study demonstrates the potential to assess presurgical value and identify modifiable care processes associated with presurgical delay and utilization performance.

Blood Pressure and Later-Life Cognition in Hispanic and White Adults (BP-COG): A Pooled Cohort Analysis of ARIC, CARDIA, CHS, FOS, MESA, and NOMAS.

BACKGROUND: Ethnic differences in cognitive decline have been reported. Whether they can be explained by differences in systolic blood pressure (SBP) is uncertain. OBJECTIVE: Determine whether cumulative mean SBP levels explain differences in cognitive decline between Hispanic and White individuals. METHODS: Pooled cohort study of individual participant data from six cohorts (1971-2017). The present study reports results on SBP and cognition among Hispanic and White individuals. Outcomes were changes in global cognition (GC) (primary), executive function (EF) (secondary), and memory standardized as t-scores (mean [SD], 50 [10]); a 1-point difference represents a 0.1 SD difference in cognition. Median follow-up was 7.7 (Q1-Q3, 5.2-20.1) years. RESULTS: We included 24,570 participants free of stroke and dementia: 2,475 Hispanic individuals (median age, cumulative mean SBP at first cognitive assessment, 67 years, 132.5 mmHg; 40.8% men) and 22,095 White individuals (60 years,134 mmHg; 47.3% men). Hispanic individuals had slower declines in GC, EF, and memory than White individuals when all six cohorts were examined. Two cohorts recruited Hispanic individuals by design. In a sensitivity analysis, Hispanic individuals in these cohorts had faster decline in GC, similar decline in EF, and slower decline in memory than White individuals. Higher time-varying cumulative mean SBP was associated with faster declines in GC, EF, and memory in all analyses. After adjusting for time-varying cumulative mean SBP, differences in cognitive slopes between Hispanic and White individuals did not change. CONCLUSION: We found no evidence that cumulative mean SBP differences explained differences in cognitive decline between Hispanic and White individuals.

The Need for Brevity During Shared Decision Making (SDM) for Cancer Screening: Veterans' Perspectives on an "Everyday SDM" Compromise.

Introduction. Detailed or "full" shared decision making (SDM) about cancer screening is difficult in the primary care setting. Time spent discussing cancer screening is time not spent on other important issues. Given time constraints, brief SDM that is incomplete but addresses key elements may be feasible and acceptable. However, little is known about how patients feel about abbreviated SDM. This study assessed patient perspectives on a compromise solution ("everyday SDM"): 1) primary care provided makes a tailored recommendation, 2) briefly presents qualitative information on key tradeoffs, and 3) conveys full support for decisional autonomy and desires for more information. Methods. We recruited a stratified random sample of Veterans from an academic Veterans Affairs medical center who were eligible for lung cancer screening, oversampling women and minority patients, to attend a 6-hour deliberative focus group. Experts informed participants about cancer screening, factors that influence screening benefits, and the role of patient preferences. Then, facilitator-led small groups elicited patient questions and informed opinions about the everyday SDM proposal, its acceptability, and their recommendations for improvement. Results. Thirty-six Veterans with a heavy smoking history participated (50% male, 83% white). There was a strong consensus that everyday SDM was acceptable if patients were the final deciders and could get more information on request. Participants broadly recommended that clinicians only mention downsides directly related to screening and avoid discussion of potential downstream harms (such as biopsies). Discussion. Although further testing in more diverse populations and different conditions is needed, these patients found the everyday SDM approach to be acceptable for routine lung cancer screening discussions, despite its use of an explicit recommendation and presentation of only qualitative information.

Correction: Benefit and harm of intensive blood pressure treatment: Derivation and validation of risk models using data from the SPRINT and ACCORD trials.

[This corrects the article DOI: 10.1371/journal.pmed.1002410.].

Eye Outcomes in Veteran Affairs Diabetes Trial (VADT) After 17 Years.

OBJECTIVE: The objective of this study was to assess the long-term role of intensive glycemic control (INT) compared with standard glycemic control in accumulated eye procedures in patients with advanced diabetes. RESEARCH DESIGN AND METHODS: We compared the effect of treatment assignment on the accumulated number of eye procedures during the intervention period of the Veteran Affairs Diabetes Trial (VADT) (2000-2008) (median follow-up 5.6 years), the interim VADT follow-up study (2000-2013), and the full 17 years of VADT follow-up (2000-2017). We further analyzed data using various cardiovascular markers in two models. Model I included total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, systolic and diastolic blood pressure, and BMI. Model II included these covariates plus age and diabetic retinopathy (DR) severity score at baseline of the original trial. RESULTS: The final analysis of the data showed a mild but nonsignificant increase in number of procedures and in retinal or retinal plus cataract surgery during the three periods of the study. CONCLUSIONS: We found no significant benefit of INT during the original trial period in eye-related procedures, such as various procedures for DR, or during the 17 years of follow-up in cataract surgery. However, after adjusting data for some known vascular markers, the increase in the number of eye procedures with INT becomes more prevalent. This finding indicates that INT might not have a protective role in events requiring surgery in individuals with advanced diabetes.

The Impact of Community Care Referral on Time to Surgery for Veterans With Carpal Tunnel Syndrome.

BACKGROUND: The US Department of Veterans Affairs (VA) enacted policies offering Veterans care in the community, aiming to improve access challenges. However, the impact of receipt of community care on wait times for Veterans receiving surgical care is poorly understood. OBJECTIVES: To compare wait times for surgery for Veterans with carpal tunnel syndrome who receive VA care plus community care (mixed care) and those who receive care solely within the VA (VA-only). RESEARCH DESIGN: Retrospective cohort study. SUBJECTS: Veterans undergoing carpal tunnel release (CTR) between January 1, 2010 and December 31, 2016. MEASURES: Our primary outcome was time from primary care physician (PCP) referral to CTR. RESULTS: Of the 29,242 Veterans undergoing CTR, 23,330 (79.8%) received VA-only care and 5912 (20.1%) received mixed care. Veterans receiving mixed care had significantly longer time from PCP referral to CTR (median mixed care: 378 days; median VA-only care: 176 days, P<0.001). After controlling for patient and facility covariates, mixed care was associated with a 37% increased time from PCP referral to CTR (adjusted hazard ratio, 0.63; 95% confidence interval, 0.61-0.65). Each additional service provided in the community was associated with a 23% increase in time to surgery (adjusted hazard ratio, 0.77; 95% confidence interval, 0.76-0.78). CONCLUSIONS: VA-only care was associated with a shorter time to surgery compared with mixed care. Moreover, there were additional delays for each service received in the community. With likely increases in Veterans seeking community care, strategies must be used to identify and mitigate sources of delay through the spectrum of care between referral and definitive treatment.

Surgical Timing for Carpal Tunnel Syndrome: A Comparison of Health Care Delivery in the Veterans Administration and Private Sector.

PURPOSE: The U.S. Department of Veterans Affairs (VA) health care system monitors time from referral to specialist visit. We compared wait times for carpal tunnel release (CTR) at a VA hospital and its academic affiliate. METHODS: We selected patients who underwent CTR at a VA hospital and its academic affiliate (AA) (2010-2015). We analyzed time from primary care physician (PCP) referral to CTR, which was subdivided into PCP referral to surgical consultation and surgical consultation to CTR. Electrodiagnostic testing (EDS) was categorized in relation to surgical consultation (prereferral vs postreferral). Multivariable Cox proportional hazard models were used to examine associations between clinical variables and surgical location. RESULTS: Between 2010 and 2015, VA patients had a shorter median time from PCP referral to CTR (VA: 168 days; AA: 410 days), shorter time from PCP referral to surgical consultation (VA: 43 days; AA: 191 days), but longer time from surgical consultation to CTR (VA: 98 days; AA: 55 days). Using multivariable models, the VA was associated with a 35% shorter time to CTR (AA hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.52-0.82) and 75% shorter time to surgical consultation (AA HR, 0.25; 95% CI, 0.20-0.03). Receiving both prereferral and postreferral EDS was associated with almost a 2-fold prolonged time to CTR (AA HR, 0.49; 95% CI, 0.36-0.67). CONCLUSIONS: The VA was associated with shorter overall time to CTR compared with its AA. However, the VA policy of prioritizing time from referral to surgical consultation may not optimally incentivize time to surgery. Repeat EDS was associated with longer wait times in both systems. CLINICAL RELEVANCE: Given differences in where delays occur in each health care system, initiatives to improve efficiency will require targeting the appropriate sources of preoperative delay. Judicious use of EDS may be one avenue to decrease wait times in both systems.

Combined risk modelling approach to identify the optimal carotid revascularisation approach.

BACKGROUND: Carotid endarterectomy (CEA) results in fewer perioperative strokes, but more myocardial infarctions (MI) than carotid artery stenting (CAS). We explored a combined modelling approach that stratifies patients by baseline stroke and MI. METHODS: Baseline registry-based risk models for perioperative stroke and MI were identified via literature search. We then selected treatment risk models in the Carotid Revascularisation Stenting versus Endarterectomy (CREST) trial by serially adding covariates (baseline risk, treatment (CEA vs CAS), treatment-risk interaction and age-treatment interaction terms). Treatment risk models were externally validated using data from the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) CEA and carotid stenting registries and treatment models were recalibrated to the SVS-VQI population. Predicted net benefit was estimated by summing the predicted stroke and MI risk differences with CEA versus CAS. RESULTS: Perioperative treatment models had moderate predictiveness (c-statistic 0.69 for stroke and 0.68 for MI) and reasonable calibration across the risk spectrum for both stroke and MI within CREST. On external validation in SVS-VQI, predictiveness was substantially reduced (c-statistic 0.61 for stroke and 0.54 for MI) and models substantially overpredicted risk.Most patients (86.7%) were predicted to have net benefit from CEA in CREST (97.0% of symptomatic patients vs 75% of asymptomatic patients). DISCUSSION: A combined modelling approach that separates risk elements has potential to inform optimal treatment. However, our current approach is not ready for clinical application. These data support guidelines that suggest that CEA should be the preferred revascularisation modality in most patients with symptomatic carotid stenosis.

Sex Differences in Cognitive Decline Among US Adults.

Importance: Sex differences in dementia risk are unclear, but some studies have found greater risk for women. Objective: To determine associations between sex and cognitive decline in order to better understand sex differences in dementia risk. Design, Setting, and Participants: This cohort study used pooled analysis of individual participant data from 5 cohort studies for years 1971 to 2017: Atherosclerosis Risk in Communities Study, Coronary Artery Risk Development in Young Adults Study, Cardiovascular Health Study, Framingham Offspring Study, and Northern Manhattan Study. Linear mixed-effects models were used to estimate changes in each continuous cognitive outcome over time by sex. Data analysis was completed from March 2019 to October 2020. Exposure: Sex. Main Outcomes and Measures: The primary outcome was change in global cognition. Secondary outcomes were change in memory and executive function. Outcomes were standardized as t scores (mean [SD], 50 [10]); a 1-point difference represents a 0.1-SD difference in cognition. Results: Among 34 349 participants, 26 088 who self-reported Black or White race, were free of stroke and dementia, and had covariate data at or before the first cognitive assessment were included for analysis. Median (interquartile range) follow-up was 7.9 (5.3-20.5) years. There were 11 775 (44.7%) men (median [interquartile range] age, 58 [51-66] years at first cognitive assessment; 2229 [18.9%] Black) and 14 313 women (median [interquartile range] age, 58 [51-67] years at first cognitive assessment; 3636 [25.4%] Black). Women had significantly higher baseline performance than men in global cognition (2.20 points higher; 95% CI, 2.04 to 2.35 points; P < .001), executive function (2.13 points higher; 95% CI, 1.98 to 2.29 points; P < .001), and memory (1.89 points higher; 95% CI, 1.72 to 2.06 points; P < .001). Compared with men, women had significantly faster declines in global cognition (-0.07 points/y faster; 95% CI, -0.08 to -0.05 points/y; P < .001) and executive function (-0.06 points/y faster; 95% CI, -0.07 to -0.05 points/y; P < .001). Men and women had similar declines in memory (-0.004 points/y faster; 95% CI, -0.023 to 0.014; P = .61). Conclusions and Relevance: The results of this cohort study suggest that women may have greater cognitive reserve but faster cognitive decline than men, which could contribute to sex differences in late-life dementia.

Variation in Eligible Patients' Agreeing to and Receiving Lung Cancer Screening: A Cohort Study.

INTRODUCTION: Little is known about how clinicians make low-dose computed tomography lung cancer screening decisions in practice. Investigators assessed the factors associated with real-world decision making, hypothesizing that lung cancer risk and comorbidity would not be associated with agreeing to or receiving screening. Though these factors are key determinants of the benefit of lung cancer screening, they are often difficult to incorporate into decisions without the aid of decision tools. METHODS: This was a retrospective cohort study of patients meeting current national eligibility criteria and deemed appropriate candidates for lung cancer screening on the basis of clinical reminders completed over a 2-year period (2013-2015) at 8 Department of Veterans Affairs medical facilities. Multilevel mixed-effects logistic regression models (conducted in 2019-2020) assessed predictors (age, sex, lung cancer risk, Charlson Comorbidity Index, travel distance to facility, and central versus outlying decision-making location) of primary outcomes of agreeing to and receiving lung cancer screening. RESULTS: Of 5,551 patients (mean age=67 years, 97% male, mean lung cancer risk=0.7%, mean Charlson Comorbidity Index=1.14, median travel distance=24.2 miles), 3,720 (67%) agreed to lung cancer screening and 2,398 (43%) received screening. Lung cancer risk and comorbidity score were not strong predictors of agreeing to or receiving screening. Empirical Bayes adjusted rates of agreeing to and receiving screening ranged from 22% to 84% across facilities and from 19% to 85% across clinicians. A total of 33.7% of the variance in agreeing to and 34.2% of the variance in receiving screening was associated with the facility or the clinician offering screening. CONCLUSIONS: Substantial variation was found in Veterans agreeing to and receiving lung cancer screening during the Veterans Affairs Lung Cancer Screening Demonstration Project. This variation was not explained by differences in key determinants of patient benefit, whereas the facility and clinician advising the patient had a large impact on lung cancer screening decisions.

Effects of Random Measurement Error on Lung Cancer Screening Decisions: A Retrospective Cohort-Based Microsimulation Study.

BACKGROUND: Self-reported tobacco pack-year history plays a large role in decisions about low-dose CT screening for lung cancer, yet is challenging to measure accurately. RESEARCH QUESTION: To what extent does random measurement error in pack-year information impact screening decisions and screening effectiveness? STUDY DESIGN AND METHODS: Retrospective cohort study of 10,449 patients with pack-year history documented at least twice between October 2013 and July 2017 across 8 academic Veterans Affairs sites. Outcome measures included (1) observed reliability of pack-year information based on all repeat measures for the study population and (2) each person's statistically "true" pack-year information based on best linear unbiased predictor from a multilevel linear random effects model. To examine how unreliability leads to misclassification of screening eligibility and inaccuracy in estimating lung cancer risk, we simulated pack-year observations for each person, first comparing simulated pack-year and lung cancer risk values with true values, then comparing outcomes when basing screening decisions on unreliable pack-year information vs true information. RESULTS: Reliability of assessing pack-year information in routine practice varied across sites. Thus, we examined the clinical impact of two different levels of reliability, based on the range of intraclass correlation coefficients observed. Using a ≥ 30-pack-year threshold led to a high rate of eligibility misclassifications (48.1% misclassified with higher reliability pack-year information and 60.7% misclassified with lower reliability information). However, using a lung cancer risk threshold leads to fewer misclassifications (47.3%-49.7% misclassified when using lower reliability pack-year information) and maintains screening effectiveness better when using unreliable pack-year information. INTERPRETATION: Random error in real-world pack-year assessments leads to a substantial rate of misclassifying who should be offered CT screening if a ≥ 30-pack-year criterion is used. However, using a lung cancer risk threshold mitigates the impact of unreliable pack-year information. Decision-makers concerned about the impact of unreliable pack-year information should consider using risk-based approaches to CT screening.

Development of the Instrument to assess the Credibility of Effect Modification Analyses (ICEMAN) in randomized controlled trials and meta-analyses.

BACKGROUND: Most randomized controlled trials (RCTs) and meta-analyses of RCTs examine effect modification (also called a subgroup effect or interaction), in which the effect of an intervention varies by another variable (e.g., age or disease severity). Assessing the credibility of an apparent effect modification presents challenges; therefore, we developed the Instrument for assessing the Credibility of Effect Modification Analyses (ICEMAN). METHODS: To develop ICEMAN, we established a detailed concept; identified candidate credibility considerations in a systematic survey of the literature; together with experts, performed a consensus study to identify key considerations and develop them into instrument items; and refined the instrument based on feedback from trial investigators, systematic review authors and journal editors, who applied drafts of ICEMAN to published claims of effect modification. RESULTS: The final instrument consists of a set of preliminary considerations, core questions (5 for RCTs, 8 for meta-analyses) with 4 response options, 1 optional item for additional considerations and a rating of credibility on a visual analogue scale ranging from very low to high. An accompanying manual provides rationales, detailed instructions and examples from the literature. Seventeen potential users tested ICEMAN; their suggestions improved the user-friendliness of the instrument. INTERPRETATION: The Instrument for assessing the Credibility of Effect Modification Analyses offers explicit guidance for investigators, systematic reviewers, journal editors and others considering making a claim of effect modification or interpreting a claim made by others.

Dealing with the Lack of Time for Detailed Shared Decision-making in Primary Care: Everyday Shared Decision-making.

Policymakers and researchers are strongly encouraging clinicians to support patient autonomy through shared decision-making (SDM). In setting policies for clinical care, decision-makers need to understand that current models of SDM have tended to focus on major decisions (e.g., surgeries and chemotherapy) and focused less on everyday primary care decisions. Most decisions in primary care are substantive everyday decisions: intermediate-stakes decisions that occur dozens of times every day, yet are non-trivial for patients, such as whether routine mammography should start at age 40, 45, or 50. Expectations that busy clinicians use current models of SDM (here referred to as "detailed" SDM) for these decisions can feel overwhelming to clinicians. Evidence indicates that detailed SDM is simply not realistic for most of these decisions and without a feasible alternative, clinicians usually default to a decision-making approach with little to no personalization. We propose, for discussion and refinement, a compromise approach to personalizing these decisions (everyday SDM). Everyday SDM is based on a feasible process for supporting patient autonomy that also allows clinicians to continue being respectful health advocates for their patients. We propose that alternatives to detailed SDM are needed to make progress toward more patient-centered care.

Patient Preferences Regarding Informed Consent Models for Participation in a Learning Health Care System for Oncology.

PURPOSE: The expansion of learning health care systems (LHSs) promises to bolster research and quality improvement endeavors. Stewards of patient data have a duty to respect the preferences of the patients from whom, and for whom, these data are being collected and consolidated. METHODS: We conducted democratic deliberations with a diverse sample of 217 patients treated at 4 sites to assess views about LHSs, using the example of CancerLinQ, a real-world LHS, to stimulate discussion. In small group discussions, participants deliberated about different policies for how to provide information and to seek consent regarding the inclusion of patient data. These discussions were recorded, transcribed, and de-identified for thematic analysis. RESULTS: Of participants, 67% were female, 61% were non-Hispanic Whites, and the mean age was 60 years. Patients' opinions about sharing their data illuminated 2 spectra: trust/distrust and individualism/collectivism. Positions on these spectra influenced the weight placed on 3 priorities: promoting societal altruism, ensuring respect for persons, and protecting themselves. In turn, consideration of these priorities seemed to inform preferences regarding patient choices and system transparency. Most advocated for a policy whereby patients would receive notification and have the opportunity to opt out of including their medical records in the LHS. Participants reasoned that such a policy would balance personal protections and societal welfare. CONCLUSION: System transparency and patient choice are vital if patients are to feel respected and to trust LHS endeavors. Those responsible for LHS implementation should ensure that all patients receive an explanation of their options, together with standardized, understandable, comprehensive materials.