Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Extraction of line of therapy (LOT) information from electronic health record (EHR) and claims data is essential for determining longitudinal changes in systemic anticancer therapy (SACT) in real-world clinical settings. Objective: The aim of this retrospective cohort analysis was to validate and refine our previously described open source LOT algorithm by comparing algorithm output with results obtained through blinded manual chart review. Methods: We used structured EHR data and clinical documents to identify 500 adult patients treated for metastatic non-small cell lung cancer with SACT from 2011 through mid-2018, assigning patients to training (n=350) and test cohorts (n=150), randomly divided proportional to the overall ratio of simple:complex cases (n=254:246). Simple cases were patients who received one LOT and no maintenance therapy; complex cases received more than one LOT and/or maintenance therapy. Algorithmic changes were performed using the training cohort data, after which the refined algorithm was evaluated against the test cohort. Results: For the simple cases, 16 instances of discordance between LOT algorithm and chart review pre-refinement were reduced to 8 instances post-refinement; in the test cohort there was no discordance between algorithm and chart review. For the complex cases, algorithm refinement reduced discordance from 68 to 62 instances, with 37 instances in the test cohort. Percentage agreement between LOT algorithm output and chart review for patients who received one LOT was 89% pre-refinement, 93% post-refinement, and 93% for the test cohort, while the likelihood of precise matching between algorithm output and chart review decreased with increasing number of unique regimens. Several areas of discordance that arose from differing definitions of LOTs and maintenance therapy could not be objectively resolved because of a lack of precise definitions in the medical literature. Conclusions: Our findings identify common sources of discordance between an LOT algorithm and clinician documentation, providing for the possibility of targeted algorithm refinement.

Key Points: In individuals undergoing bariatric surgery, the magnitude of decline in GFR postbariatric surgery is directly associated with presurgery GFR. Reductions in GFR postsurgery were only weakly correlated with weight loss. In obese individuals, GFR-estimating equations performed best when deindexed and when applied in people with reduced kidney function. Background: Important questions remain about how bariatric ( i.e ., weight loss) surgery affects measured GFR (mGFR) and eGFR as well as what factors influence change in mGFR postsurgery. Methods: Data were pooled from all seven available studies (dates: 2004–2018) measuring GFR prebariatric and postbariatric surgery using gold standard methods. Change in postsurgery mGFR, factors that could influence change in mGFR, and effects on five GFR-estimating equations were analyzed using standard statistical methods. Results: The cohort included 105 individuals from the United States and Europe. Sixty-eight percent were female, 97% were White, the mean age was 50 years (range, 24–70), and the mean body mass index was 46±8 kg/m ² . The mean presurgery mGFR of 107 ml/min (range, 31–215) fell to 92 ml/min (−14%; 95% confidence interval, −21 to −10) postsurgery, with a strong linear relationship existing between presurgery mGFR and % change in GFR ( r =−0.51; −0.64 to −0.35). Individuals with presurgery mGFR ≥90, 60 to <90, and<60 ml/min had −25 (−32 to −19), 1 (−11 to 13), and 7 (0 to 14) ml/min mean postoperative changes in mGFR. Change in weight was significantly correlated with change in mGFR ( r =0.22; 0.03 to 0.40). After adjusting for sex, changes in mGFR postsurgery were associated with higher presurgical age (−0.6 ml/min per year; −1.1 to −0.2), mGFR (−0.5 ml/min per 1 ml/min; −0.6 to −0.4), and change in systolic BP (−0.3 ml/min per 1 mm Hg; −0.6 to 0.0). All GFR-estimating equations significantly underestimated postsurgical GFR reductions in people with preserved kidney function and had improved bias, precision, and accuracy when deindexed and applied to individuals with mGFR <90 ml/min. Conclusions: In individuals with obesity undergoing bariatric surgery, the magnitude of postsurgical decline in mGFR was directly associated with presurgery GFR and weakly correlated with weight loss. In addition, GFR-estimating equations' performance improved when deindexed and used in people with reduced kidney function, with the combined creatinine/cystatin C equations having the best overall performance.

Alzheimer’s disease and related dementias (ADRD) impact a woman’s life expectancy and her ability to participate in medical decision-making about breast cancer screening, necessitating the involvement of family caregivers. Making decisions about mammography screening for women with ADRD is stressful. There are no data that suggest that breast cancer screening helps women with ADRD live longer or better. Decision aids may improve the quality of decision-making about mammography for ADRD patients and may inform family caregivers about the risks, benefits, and need for decision-making around mammography screening. The Decisions about Cancer Screening in Alzheimer’s Disease (DECAD) trial, a randomized controlled clinical trial, will enroll 426 dyads of older women with ADRD (≥75 years) and a family caregiver from clinics and primary-care practices in Indiana to test a novel, evidence-based decision aid. This decision aid includes information about the impact of ADRD on life expectancy, the benefit of mammograms, and the impact on the quality of life for older women with ADRD. Dyads will be randomized to receive the decision aid or active control information about home safety. This trial will examine the effect on the caregiver’s decisional conflict (primary outcome) and the caregiver’s decision-making self-efficacy (secondary outcome). A second follow-up at 15 months will include a brief, semi-structured interview with the caregiver regarding the patient’s experience with mammograms and decision-making about mammograms. At the same time, a review of the patient’s electronic medical record (EMR) will look at discussions about mammography with their primary-care physician and mammogram orders, receipt, results, and burden (e.g., additional diagnostic procedures due to false-positive results, identification of an abnormality on the screening exam but further work-up declined, and identification of a clinically unimportant cancer). A third follow-up at 24 months will extract EMR data on mammogram orders, occurrences, results, and the burden of mammograms. We hypothesize that caregivers who receive the decision aid will have lower levels of decisional conflict and higher levels of decision-making self-efficacy compared to the control group. We also hypothesize that the DECAD decision aid will reduce mammography use among older women with ADRD. Clinical Trials Register, NCT03282097 . Registered on 13 September 2017.

Studies of dementia involving the oldest old are few in Sub-Saharan Africa. Survivors of the Ibadan arm of the Indianapolis-Ibadan Dementia Project who were enrolled in 1992 or 2001 were re-examined between 2021 and 2022. To revisit these subjects and evaluate them for the presence of cognitive and functional impairment and assign diagnoses as relevant as well as determine factors that mitigate development of dementia and cognitive impairment and thus promote healthy aging. Evaluation consisted of the CERAD neuropsychological battery, an informant interview, and a clinical examination by physicians with expertise in cognitive disorders of aging. Diagnoses were adjudicated by consensus between psychiatrists and neurologists using ICD-10 and DSM-IV criteria and diagnosis of Mild Cognitive Impairment based on the National Institute of Aging- criteria RESULT: One hundred and thirty-five of the original 4425 persons ever recruited were re-evaluated. Mean age was 93·0±2·8 years (range 89-106 years); 103 (76 %) were females, 29 (21 %) were diagnosed dementia, 25 (18 %) had AD, 44 (32·6 %) had diagnosis of Mild Cognitive Impairment (MCI) and 62 (45·9 %) were cognitively normal. Using logistic regression model for the combined dementia and MCI group with predictor variables collected during the 2001 evaluation wave, we found that cognitive score (Odds Ratio (OR)= 0·94, p = 0·024 (95 % CI:0.09-0.99), diastolic blood pressure (OR=1·04, p = 0·015 (95 % CI:1.01-1.07) and regular alcohol use (OR=0·42, p = 0·041(95 % CI:0.18-0.96) were associated with 20-year prevalence of cognitive impairment after adjusting for age, sex, and education. ApoE4 allele was neither a risk factor for dementia nor Cognitive Impairment in this cohort. Prevalence of cognitive impairment in this oldest old survivor cohort was associated with cognitive performance, diastolic blood pressure and regular use of alcohol 20 years before.

Background: Since 1964 when Indiana University performed its first kidney transplant, immunosuppression protocol was steroid-based until 2004 when steroid-free immunosuppression protocol was adopted. We describe clinical outcomes on our patients administered early steroid withdrawal (ESW) protocol (5 days) compared with our historical cohort (HC), who were on chronic steroid-based immunosuppression. Methods: We performed a retrospective study evaluating kidney transplant recipients between 1993 and 2003 (HC, n = 1689) and between 2005 and 2016 (ESW cohort, n = 2097) at the Indiana University program, with a median follow-up of 10.5 years and 6.1 years, respectively. Primary outcomes were patient and death-censored graft survival at 1, 3, and 5 years in both study cohorts. Secondary outcomes were 1-year rates of biopsy-proven acute rejection; graft function at 1, 3, and 5 years; and risk of post-transplant infection (BK virus and cytomegalovirus) in the ESW cohort. Cox proportional model and Kaplan-Meier estimates were used to estimate survival probabilities. Fisher exact tests were used to compare episodes of acute rejection in the ESW cohort. Results: No difference was observed in patient survival between the ESW and HC cohorts (P = .13). Compared with the ESW cohort, death-censored graft survival was significantly worse in the HC (5 year: 86.4% vs 90.6%, log-rank P < .001). One-year acute rejection reported in the ESW cohort alone was 15.7% and significantly worse in Black patients and younger patients (P < .05). Conclusions: In this sizeable single-center cohort study with significant ethnic diversity, ESW is a viable alternative to steroid-based immunosuppression protocol in kidney transplant recipients.