Comparison of the Ketogenic Ratio of Macronutrients With the Low-Carbohydrate Diet Score and Their Association With Risk of Type 2 Diabetes in Postmenopausal Women: A Secondary Analysis of the Women's Health Initiative.

BACKGROUND: Previous attempts to identify low-carbohydrate diets (LCDs) in epidemiological studies relied on the LCD Score, which is unable to identify ketogenic dieters. Ketogenic ratios of macronutrients are clinical equations proposed to predict ketogenic diets; however, their utility in epidemiological studies is unknown. OBJECTIVE: To determine the number of participants consuming a ketogenic diet, compare ketogenic ratios to the LCD Score, and evaluate their association with type 2 diabetes mellitus (T2DM). DESIGN: Secondary analysis of the Women's Health Initiative with 17.9 ± 6.03 years of follow-up. Baseline food frequency questionnaires were used to calculate the ketogenic ratio as follows: (0.9 × grams fat + 0.46 × grams protein) / (0.1 × grams fat + 0.58 × grams protein + grams net carbohydrate), a value ≥1.5 is the minimum threshold for a ketogenic diet. PARTICIPANTS/SETTING: One hundred twenty-five nine hundred eighty-two postmenopausal women without diabetes (aged 50 to 79 years) enrolled in the multicenter Women's Health Initiative observational study and clinical trials were included. MAIN OUTCOME MEASURES: Risk of self-reported incident T2DM. STATISTICAL ANALYSES PERFORMED: Cox proportional hazards models, adjusted for age, race, ethnicity, education, income, health insurance, relationship status, geographic region, Women's Health Initiative study component, female hormone use, smoking status, alcohol use, recreational physical activity, total energy intake, diet quality, body mass index, hyperlipidemia, and hypertension, were used to compare hazard ratios and 95% CIs for T2DM among quintiles of the ketogenic ratio. RESULTS: A total of 18,775 incident cases of T2DM occurred. The median ketogenic ratio was 0.35 (interquartile range 0.28 to 0.42) and 15 individuals (0.01%) exceeded the threshold for a ketogenic diet. Higher ketogenic ratio quintiles were associated with increased risk of T2DM in a dose-dependent manner. Comparing extreme quintiles of the ketogenic ratio, the hazard ratio for diabetes was 1.24 (95% CI 1.18 to 1.31; Ptrend < 0.001) in fully adjusted models. Similarly, comparing extreme quintiles, the hazard ratio for diabetes was 1.36 (95% CI 1.29 to 1.43; Ptrend < 0.001) for the LCD Score and 1.13 (95% CI 1.07 to 1.19; Ptrend < 0.001) for the simplified ketogenic ratio in fully adjusted models. CONCLUSIONS: Increasing ketogenic ratio values are associated with increased risk of T2DM and align well with LCD Scores; however, too few participants consumed a ketogenic diet to determine its association with T2DM.

Association of multiple sclerosis with risk of mortality among a nationally representative sample of adults in the United States.

Background: Multiple sclerosis (MS) has been associated with increased mortality ratios, but few studies have investigated the independent association of MS with mortality. Objective: To examine the prospective association of MS with risk of mortality in a nationally representative sample of U.S. adults. Methods: This prospective study included 23,053 adults aged 45-79 years who participated in the National Health Interview Survey in 2002 and 2008. Physician-diagnosed MS was reported by participants during household interviews. These participants were linked to death records from survey date through December 31, 2015. Results: Among the 23,053 participants included in this study, 120 reported a physician's diagnosis of MS, with a higher prevalence in females (0.85%) than in males (0.31%). During on average 9.4 years (maximum 13.8 years) of observation, 4208 deaths occurred. After adjustment for age, sex, race/ethnicity, socioeconomic factors, lifestyle factors, and BMI, participants with MS had an 80% higher risk of mortality (HR 1.80; 95% CI, 1.11-2.92), compared with those without MS. The association remained significant (HR 1.75; 95% CI, 1.07-2.87) after further adjustment for baseline diabetes, cardiovascular disease, chronic lung disease, and cancer. Conclusion: In this nationally representative sample of U.S. adults, MS was associated with an increased risk of mortality.

Characteristics and predictors of missed opportunities in lung cancer diagnosis: an electronic health record-based study.

PURPOSE: Understanding delays in cancer diagnosis requires detailed information about timely recognition and follow-up of signs and symptoms. This information has been difficult to ascertain from paper-based records. We used an integrated electronic health record (EHR) to identify characteristics and predictors of missed opportunities for earlier diagnosis of lung cancer. METHODS: Using a retrospective cohort design, we evaluated 587 patients of primary lung cancer at two tertiary care facilities. Two physicians independently reviewed each case, and disagreements were resolved by consensus. Type I missed opportunities were defined as failure to recognize predefined clinical clues (ie, no documented follow-up) within 7 days. Type II missed opportunities were defined as failure to complete a requested follow-up action within 30 days. RESULTS: Reviewers identified missed opportunities in 222 (37.8%) of 587 patients. Median time to diagnosis in cases with and without missed opportunities was 132 days and 19 days, respectively (P < .001). Abnormal chest x-ray was the clue most frequently associated with type I missed opportunities (62%). Follow-up on abnormal chest x-ray (odds ratio [OR], 2.07; 95% CI, 1.04 to 4.13) and completion of first needle biopsy (OR, 3.02; 95% CI, 1.76 to 5.18) were associated with type II missed opportunities. Patient adherence contributed to 44% of patients with missed opportunities. CONCLUSION: Preventable delays in lung cancer diagnosis arose mostly from failure to recognize documented abnormal imaging results and failure to complete key diagnostic procedures in a timely manner. Potential solutions include EHR-based strategies to improve recognition of abnormal imaging and track patients with suspected cancers.

Gleason score and laterality concordance between prostate biopsy and prostatectomy specimens.

OBJECTIVES: Prostate biopsy involvement and Gleason score guide treatment decisions in prostate cancer. We evaluated concordance in Gleason score and laterality between biopsy and radical retropubic prostatectomy (RRP) specimens and factors that influenced this relationship. MATERIALS AND METHODS: We reviewed 538 prostate cancer diagnoses at a Veterans Affairs medical center (2000-2005) to identify men with prostate biopsy and RRP specimens. During this time there was a move from limited (6 core) to extended (12 core) biopsy schemes. Discordance in Gleason score was defined as any change in Gleason score. RESULTS: 152 men underwent RRP with biopsy showing Gleason < 7 in 56%, 7 in 36%, and > 7 in 8%. Biopsy involvement was unilateral in 59% and bilateral in 41%. Compared to the biopsy, RRP Gleason score was concordant in 76 (50%), higher in 51 (34%), and lower in 25 (16%). Bilateral involvement was concordant in 97%, while unilateral involvement was concordant in only 20%. Both Gleason score and laterality were concordant in only 26%. Gleason concordance was higher in those with 8 or more cores compared to < 8 cores taken (54% vs. 34%, p = 0.046), but concordance was not affected by age, PSA, prostate volume, or length of time from biopsy to RRP. During later years, concordance did not improve despite taking more cores. CONCLUSIONS: Prostate biopsy underestimated prostatectomy Gleason score in 34% of men and bilateral involvement in 80% of those with unilateral disease on biopsy. Taking at least eight cores improves the accuracy of the prostate biopsy.

Gleason score and laterality concordance between prostate biopsy and prostatectomy specimens

Objectives: Prostate biopsy involvement and Gleason score guide treatment decisions in prostate cancer. We evaluated concordance in Gleason score and laterality between biopsy and radical retropubic prostatectomy (RRP) specimens and factors that influenced this relationship. Material and Methods: We reviewed 538 prostate cancer diagnoses at a Veterans Affairs medical center (2000-2005) to identify men with prostate biopsy and RRP specimens. During this time there was a move from limited (6 core) to extended (12 core) biopsy schemes. Discordance in Gleason score was defined as any change in Gleason score. Results: 152 men underwent RRP with biopsy showing Gleason < 7 in 56 percent, 7 in 36 percent, and > 7 in 8 percent. Biopsy involvement was unilateral in 59 percent and bilateral in 41 percent. Compared to the biopsy, RRP Gleason score was concordant in 76 (50 percent), higher in 51 (34 percent), and lower in 25 (16 percent). Bilateral involvement was concordant in 97 percent, while unilateral involvement was concordant in only 20 percent. Both Gleason score and laterality were concordant in only 26 percent. Gleason concordance was higher in those with 8 or more cores compared to < 8 cores taken (54 percent vs. 34 percent, p = 0.046), but concordance was not affected by age, PSA, prostate volume, or length of time from biopsy to RRP. During later years, concordance did not improve despite taking more cores. Conclusions: Prostate biopsy underestimated prostatectomy Gleason score in 34 percent of men and bilateral involvement in 80 percent of those with unilateral disease on biopsy. Taking at least eight cores improves the accuracy of the prostate biopsy.

Patient- and system-related barriers for the earlier diagnosis of colorectal cancer.

BACKGROUND: A cohort of colorectal cancer (CRC) patients represents an opportunity to study missed opportunities for earlier diagnosis. PRIMARY OBJECTIVE: To study the epidemiology of diagnostic delays and failures to offer/complete CRC screening. SECONDARY OBJECTIVE: To identify system- and patient-related factors that may contribute to diagnostic delays or failures to offer/complete CRC screening. SETTING: Rural Veterans Administration (VA) Healthcare system. PARTICIPANTS: CRC cases diagnosed within the VA between 1/1/2000 and 3/1/2007. DATA SOURCES: progress notes, orders, and pathology, laboratory, and imaging results obtained between 1/1/1995 and 12/31/2007. Completed CRC screening was defined as a fecal occult blood test or flexible sigmoidoscopy (both within five years), or colonoscopy (within 10 years); delayed diagnosis was defined as a gap of more than six months between an abnormal test result and evidence of clinician response. A summary abstract of the antecedent clinical care for each patient was created by a certified gastroenterologist (GI), who jointly reviewed and coded the abstracts with a general internist (TW). RESULTS: The study population consisted of 150 CRC cases that met the inclusion criteria. The mean age was 69.04 (range 35-91); 99 (66%) were diagnosed due to symptoms; 61 cases (46%) had delays associated with system factors; of them, 57 (38% of the total) had delayed responses to abnormal findings. Fifteen of the cases (10%) had prompt symptom evaluations but received no CRC screening; no patient factors were identified as potentially contributing to the failure to screen/offer to screen. In total, 97 (65%) of the cases had missed opportunities for early diagnosis and 57 (38%) had patient factors that likely contributed to the diagnostic delay or apparent failure to screen/offer to screen. CONCLUSION: Missed opportunities for earlier CRC diagnosis were frequent. Additional studies of clinical data management, focusing on following up abnormal findings, and offering/completing CRC screening, are needed.

Proposed interventions to decrease the frequency of missed test results.

Numerous studies have identified that delays in diagnosis related to the mishandling of abnormal test results are an import contributor to diagnostic errors. Factors contributing to missed results included organizational factors, provider factors and patient-related factors. At the diagnosis error conference continuing medical education conference in 2008, attendees attended two focus groups dedicated to identification of strategies to lower the frequency of missed results. The recommendations were reviewed and summarized. Improved standardization of the steps involved in the flow of test result information, greater involvement of patients to insure the follow up of test results, and systems re-engineering to improve the management and presentation of data. Focusing the initial interventions on the specific tests which have been identified as high risk for adverse impact on patient outcomes such as tests associated with a possible malignancy or acute coronary syndrome will likely have the most significant impact on clinical outcome and patient satisfaction with care.

Prevalence of delayed clinician response to elevated prostate-specific antigen values.

OBJECTIVE: To assess the frequency of delayed response to an abnormal prostate-specific antigen (PSA) value. PATIENTS AND METHODS: Retrospective review of prostate cancer cases diagnosed between January 1, 2000, and December 31, 2005, in a rural Department of Veterans Affairs health care system serving 44,000 veterans across 2 states. Clinician response was defined as a reference to the elevated PSA result in clinical notes, orders for further evaluation, treatment of presumed prostatitis, or a urology visit or referral. Delay was measured as days between an abnormal PSA result and clinician response. RESULTS: We identified 327 men who met inclusion criteria with an abnormal PSA value before prostate cancer diagnosis. At first PSA elevation, median age was 64 years; 94% were younger than 75 years. Of the 327 men, 253 (77.4%) had a timely (< or =30 days) response to an abnormal PSA value; 23 (7.0%) had between 31 and 180 days; 24 (7.3%), between 181 and 360 days; and 27 (8.3%), more than 360 days between an abnormal PSA measurement and clinician response. The delayed group had nearly an additional year's (309 days) lapse before completed urologic consultation and prostate gland biopsy (313 days) as compared with the timely group. The presence of urologic symptoms, abnormal results from rectal examination, higher PSA values, and higher PSA velocity (P<.05) were associated with timely clinician response to an abnormal PSA measurement. CONCLUSION: In a cohort of men with prostate cancer and an antecedent abnormal PSA value, 15.6% had more than 180 days between an abnormal PSA measurement and clinician response. These findings add to the growing literature demonstrating that missed results occur more frequently than is generally appreciated. Improved systems for clinical data management are needed.

The frequency of missed test results and associated treatment delays in a highly computerized health system.

BACKGROUND: Diagnostic errors associated with the failure to follow up on abnormal diagnostic studies ("missed results") are a potential cause of treatment delay and a threat to patient safety. Few data exist concerning the frequency of missed results and associated treatment delays within the Veterans Health Administration (VA). OBJECTIVE: The primary objective of the current study was to assess the frequency of missed results and resulting treatment delays encountered by primary care providers in VA clinics. METHODS: An anonymous on-line survey of primary care providers was conducted as part of the health systems ongoing quality improvement programs. We collected information from providers concerning their clinical effort (e.g., number of clinic sessions, number of patient visits per session), number of patients with missed abnormal test results, and the number and types of treatment delays providers encountered during the two week period prior to administration of our survey. RESULTS: The survey was completed by 106 out of 198 providers (54 percent response rate). Respondents saw and average of 86 patients per 2 week period. Providers encountered 64 patients with missed results during the two week period leading up to the study and 52 patients with treatment delays. The most common missed results included imaging studies (29 percent), clinical laboratory (22 percent), anatomic pathology (9 percent), and other (40 percent). The most common diagnostic delays were cancer (34 percent), endocrine problems (26 percent), cardiac problems (16 percent), and others (24 percent). CONCLUSION: Missed results leading to clinically important treatment delays are an important and likely underappreciated source of diagnostic error.