Leveraging web-based prediction calculators to set patient expectations for elective spine surgery: a qualitative study to inform implementation.

BACKGROUND: Prediction calculators can help set outcomes expectations following orthopaedic surgery, however effective implementation strategies for these tools are unknown. This study evaluated provider and patient perspectives on clinical implementation of web-based prediction calculators developed using national prospective spine surgery registry data from the Quality Outcomes Database. METHODS: We conducted semi-structured interviews in two health systems, Vanderbilt University Medical Center (VUMC) and Duke University Health System (DUHS) of orthopedic and neurosurgery health care providers (VUMC: n = 19; DUHS: n = 6), health care administrators (VUMC: n = 9; DUHS: n = 9), and patients undergoing elective spine surgery (VUMC: n = 16). Qualitative template analysis was used to analyze interview data, with a focus on end-user perspectives regarding clinical implementation of web-based prediction tools. RESULTS: Health care providers, administrators and patients overwhelmingly supported the use of the calculators to help set realistic expectations for surgical outcomes. Some clinicians had questions about the validity and applicability of the calculators in their patient population. A consensus was that the calculators needed seamless integration into clinical workflows, but there was little agreement on best methods for selecting which patients to complete the calculators, timing, and mode of completion. Many interviewees expressed concerns that calculator results could influence payers, or expose risk of liability. Few patients expressed concerns over additional survey burden if they understood that the information would directly inform their care. CONCLUSIONS: Interviewees had a largely positive opinion of the calculators, believing they could aid in discussions about expectations for pain and functional recovery after spine surgery. No single implementation strategy is likely to be successful, and strategies vary, even within the same healthcare system. Patients should be well-informed of how responses will be used to deliver better care, and concerns over how the calculators could impact payment and liability should be addressed prior to use. Future research is necessary to determine whether use of calculators improves management and outcomes for people seeking a surgical consult for spine pain.

The Ideal Threshold of Hemoglobin A1C in Diabetic Patients Undergoing Elective Lumbar Decompression Surgery.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To evaluate the association of Hemoglobin A1C (HbA1c) with surgical site infection (SSI) and patient-reported outcomes (PROs), and to identify optimal HbA1c thresholds to minimize the risk of SSI and maximize PROs. SUMMARY OF BACKGROUND DATA: Diabetes mellitus has been associated with worsened outcomes following spine surgery. HbA1c, a surrogate of glycemic control, is an important assessment tool in diabetic patients. METHODS: A single-center, retrospective cohort study using prospectively collected data was undertaken. Diabetic patients undergoing elective lumbar decompression surgery between October 2010 and May 2021 were included. HbA1c, demographics, comorbidities, and perioperative data were collected. Primary outcomes included: 1) SSI, and 2) PROs, including the Numeric Rating Scale (NRS)-back/leg pain and Oswestry Disability Index (ODI). Secondary outcomes included: complications, readmissions, and reoperations within 90-days postoperatively. The minimum clinically important difference (MCID) was set at a 30% improvement from baseline PROs. RESULTS: Of 1819 patients who underwent lumbar decompression surgery, 368 patients had diabetes mellitus, and 177 had a documented preoperative HbA1c value. Of patients with available HbA1c values, the mean age was 62.5±12.3, the mean HbA1c value was 7.2±1.5%, and SSI occurred in 3 (1.7%) patients only, which prevented further analysis of SSI and HbA1c. A significant association was seen with a higher HbA1c and failure to achieve NRS-Back pain MCID30 [Odds ratio(OR)=0.53, 95% confidence interval(CI) 0.42-0.78; P =0.001] and ODI MCID30 (OR=0.58, 95%CI 0.44-0.77; P =0.001), but not NRS-Leg pain MCID30 (OR=1.29, 95%CI 0.86-1.93; P =0.208). ROC-curve analysis and Youden's index revealed an HbA1c threshold of 7.8 for NRS-Back pain MCID30 (AUC=0.65, P <0.001) and 7.5 for ODI MCID30 (AUC=0.65, P =0.001). CONCLUSIONS: In diabetic patients undergoing elective lumbar decompression surgery, HbA1c levels above 7.8 and 7.5 were associated with less improvement of NRS-Back and ODI scores at 12-months postoperatively, respectively. To optimize PROs, We recommend a preoperative HbA1c of 7.5 or below for diabetic patients undergoing elective lumbar decompression surgery.

Baseline Characteristics and Secondary Medication Adherence Patterns Among Patients Receiving Tafamidis Prescriptions: A Retrospective Analysis Using a National Specialty Pharmacy Dispensing Database.

Introduction: Transthyretin amyloid cardiomyopathy (ATTR-CM) is a serious, underrecognized condition, which leads to heart failure and early mortality if left untreated. Until recently, heart transplantation was the only treatment for ATTR-CM. Regulatory approval of tafamidis transformed treatment for patients. In the phase 3 Transthyretin Amyloidosis Cardiomyopathy Clinical Trial (ATTR-ACT), which established the safety and efficacy of tafamidis, medication adherence was high with 97.2% of patients taking ≥80% of scheduled doses. Evidence of real-world adherence to cardiology drugs demonstrates low adherence and suboptimal outcomes; however, real-world adherence to tafamidis has not been investigated. The main objective of this study was to describe adherence patterns of patients filling tafamidis in the Symphony Health database. Methods: This retrospective analysis of the Symphony Health Solutions claims database used secondary adherence measures, including modified medication possession ratio (MPRm), days between fills adherence rate, and compliance rate, to assess adherence patterns of 2020 patients filling tafamidis free acid 61-mg capsules or tafamidis meglumine 4x20-mg capsules from June 1, 2019 to August 31, 2020. Results: Patients receiving a tafamidis formulation had characteristics consistent with the expected patient population; 71.6% were aged 75-84 years, 83.2% were male, and the highest proportion resided in the Northeast region (30.5%) of the United States. Adherence for tafamidis was high, as 75% to 100% of the patients across subgroups met or exceeded the commonly defined adherence threshold of 80%. Median number of refills ordered and received was six refills per patient. Most patients received refills with no gap (n=1633) or a gap <30 days (n=1267/1317 patients). Adherence was high across follow-up time, sex, and age subgroups. Adherence varied by geographic region, with the Northeast being significantly higher than the Midwest (mean MPRm 94.41% vs 88.21%, p=0.0007). Conclusion: These results provide evidence that real-world adherence to tafamidis in patients with ATTR-CM is high.

Optimal hemoglobin A1C target in diabetics undergoing elective cervical spine surgery.

BACKGROUND CONTEXT: Diabetes mellitus (DM) is a well-established risk factor for suboptimal outcomes following cervical spine surgery. Hemoglobin A1C (HbA1c), a surrogate for long-term glycemic control, is a valuable assessment tool in diabetic patients. PURPOSE: In patients undergoing elective cervical spine surgery, we sought to identify optimal HbA1c levels to: (1) maximize 1-year postoperative patient-reported outcomes (PROs), and (2) predict the occurrence of medical and surgical complications. STUDY DESIGN/SETTING: A retrospective cohort study using prospectively collected data was performed in a single academic center. PATIENT SAMPLE: Diabetic patients undergoing elective anterior cervical fusion and posterior cervical laminectomy and fusion (PCLF) between October 2010-March 2021 were included. OUTCOME MEASURES: Primary outcomes included Numeric Rating Scale (NRS)-Neck pain, NRS-Arm pain, and Neck Disability Index (NDI). Secondary outcomes included surgical site infection (SSI), complications, readmissions, and reoperations within 90-days postoperatively. METHODS: HbA1c, demographic, comorbidity, and perioperative variables were gathered in diabetic patients only. PROs were analyzed as continuous variables and minimum clinically difference (MCID) was set at 30% improvement from baseline. RESULTS: Of 1992 registry patients undergoing cervical surgery, 408 diabetic patients underwent cervical fusion surgery. Anterior: A total of 259 diabetic patients underwent anterior cervical fusion, 141 of which had an available HbA1c level within one year prior to surgery. Mean age was 55.8±10.1, and mean HbA1c value was 7.2±1.4. HbA1c levels above 6.1 were associated with failure to achieve MCID for NDI (AUC=0.77, 95%CI 0.70-0.84, p<.001), and HbA1c levels above 6.8 may be associated with increased odds of reoperation (AUC=0.61, 95%CI 0.52-0.69, p=.078). Posterior: A total of 149 diabetic patients underwent PCLF, 65 of which had an available HbA1c level within 1 year. Mean age was 63.6±9.2, and mean HbA1c value was 7.2±1.5. Despite a low AUC for NRS-Arm pain and readmission, HbA1c levels above 6.8 may be associated with failure to achieve MCID for NRS-Arm pain (AUC=0.61, 95%CI 0.49-0.73, p=.094), and HbA1c levels above 7.6 may be associated with higher readmission rate (AUC=0.63, 95%CI 0.50-0.75, p=.185). CONCLUSIONS: In a cohort of diabetic patients undergoing elective cervical spine surgery, HbA1c levels above 6.1 were associated with decreased odds of achieving MCID for NDI in anterior cervical fusion surgery. Though only moderate associations were seen for the select outcomes of reoperation (6.8), readmission (7.6), and MCID for NRS-Arm pain (6.8), preoperative optimization of HbA1c using these levels as benchmarks should be considered to reduce the risk of complications and maximize PROs for patients undergoing elective cervical spine surgery.

Temporal Trends in Diagnostic Testing Patterns for Wild-Type Transthyretin Amyloid Cardiomyopathy in the Medicare Fee-for-Service Population.

Wild-type transthyretin amyloid cardiomyopathy (ATTRwt-CM) is frequently misdiagnosed or diagnosed late in the disease course. ATTRwt-CM can be diagnosed invasively through tissue biopsy, but current diagnostic recommendations indicate technetium-99m pyrophosphate (99mTc-PYP) bone scintigraphy is an acceptable noninvasive alternative. The relative use of these confirmatory diagnostic tests in routine clinical practice is unknown. A retrospective observational study assessed temporal trends in biopsy and 99mTc-PYP scintigraphy and differences in patient characteristics using in/outpatient claims data from the US Medicare fee-for-service database. Claims prevalence for biopsy alone (≥1 claim for cardiac/extracardiac biopsy), imaging alone (≥1 claim for 99mTc-PYP scintigraphy), and both tests and patient demographic, geographic, and clinical characteristics were examined. Of patients (n = 1226) receiving an ATTRwt-CM diagnostic code, 29%, 47%, and 24% were diagnosed by biopsy alone, 99mTc-PYP scintigraphy alone, and both tests, respectively. Patients with claims for 99mTc-PYP scintigraphy alone were older than those with claims for biopsy alone (79.9 vs 76.5; p <0.001). Fewer patients in the southern United States and more patients in the northeastern United States had claims for 99mTc-PYP scintigraphy alone than biopsy alone (p <0.001). There was a temporal trend toward more claims for 99mTc-PYP scintigraphy alone (odds ratio 1.21; p <0.001) and both tests (odds ratio 1.10; p = 0.008) versus biopsy alone. From 2017 to 2019, claims increased for 99mTc-PYP scintigraphy alone. In conclusion, these data suggest a growing preference for the noninvasive imaging technique, which has high sensitivity/specificity, usability, and accessibility and may help facilitate earlier disease diagnosis. United States regional differences in the use of 99mTc-PYP scintigraphy highlight the need for education initiatives.

Omega-3 and polyunsaturated fat for prevention of depression and anxiety symptoms: systematic review and meta-analysis of randomised trials.

BACKGROUND: There is strong public belief that polyunsaturated fats protect against and ameliorate depression and anxiety. AIMS: To assess effects of increasing omega-3, omega-6 or total polyunsaturated fat on prevention and treatment of depression and anxiety symptoms. METHOD: We searched widely (Central, Medline and EMBASE to April 2017, trial registers to September 2016, ongoing trials updated to August 2019), including trials of adults with or without depression or anxiety, randomised to increased omega-3, omega-6 or total polyunsaturated fat for ≥24 weeks, excluding multifactorial interventions. Inclusion, data extraction and risk of bias were assessed independently in duplicate, and authors contacted for further data. We used random-effects meta-analysis, sensitivity analyses, subgrouping and Grading of Recommendations, Assessment, Development and Evaluations (GRADE) assessment. RESULTS: We included 31 trials assessing effects of long-chain omega-3 (n = 41 470), one of alpha-linolenic acid (n = 4837), one of total polyunsaturated fat (n = 4997) and none of omega-6. Meta-analysis suggested that increasing long-chain omega-3 probably has little or no effect on risk of depression symptoms (risk ratio 1.01, 95% CI 0.92-1.10, I2 = 0%, median dose 0.95 g/d, duration 12 months) or anxiety symptoms (standardised mean difference 0.15, 95% CI 0.05-0.26, I2 = 0%, median dose 1.1 g/d, duration 6 months; both moderate-quality evidence). Evidence of effects on depression severity and remission in existing depression were unclear (very-low-quality evidence). Results did not differ by risk of bias, omega-3 dose, duration or nutrients replaced. Increasing alpha-linolenic acid by 2 g/d may increase risk of depression symptoms very slightly over 40 months (number needed to harm, 1000). CONCLUSIONS: Long-chain omega-3 supplementation probably has little or no effect in preventing depression or anxiety symptoms. DECLARATION OF INTEREST: L.H. and A.A. were funded to attend the World Health Organization Nutrition Guidance Expert Advisory Group (NUGAG) Subgroup on Diet and Health meetings and present review results. The authors report no other conflicts of interest.

Omega-6 fats for the primary and secondary prevention of cardiovascular disease.

BACKGROUND: Omega-6 fats are polyunsaturated fats vital for many physiological functions, but their effect on cardiovascular disease (CVD) risk is debated. OBJECTIVES: To assess effects of increasing omega-6 fats (linoleic acid (LA), gamma-linolenic acid (GLA), dihomo-gamma-linolenic acid (DGLA) and arachidonic acid (AA)) on CVD and all-cause mortality. SEARCH METHODS: We searched CENTRAL, MEDLINE and Embase to May 2017 and clinicaltrials.gov and the World Health Organization International Clinical Trials Registry Platform to September 2016, without language restrictions. We checked trials included in relevant systematic reviews. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing higher versus lower omega-6 fat intake in adults with or without CVD, assessing effects over at least 12 months. We included full texts, abstracts, trials registry entries and unpublished studies. Outcomes were all-cause mortality, CVD mortality, CVD events, risk factors (blood lipids, adiposity, blood pressure), and potential adverse events. We excluded trials where we could not separate omega-6 fat effects from those of other dietary, lifestyle or medication interventions. DATA COLLECTION AND ANALYSIS: Two authors independently screened titles/abstracts, assessed trials for inclusion, extracted data, and assessed risk of bias of included trials. We wrote to authors of included studies. Meta-analyses used random-effects analysis, while sensitivity analyses used fixed-effects and limited analyses to trials at low summary risk of bias. We assessed GRADE quality of evidence for 'Summary of findings' tables. MAIN RESULTS: We included 19 RCTs in 6461 participants who were followed for one to eight years. Seven trials assessed the effects of supplemental GLA and 12 of LA, none DGLA or AA; the omega-6 fats usually displaced dietary saturated or monounsaturated fats. We assessed three RCTs as being at low summary risk of bias.Primary outcomes: we found low-quality evidence that increased intake of omega-6 fats may make little or no difference to all-cause mortality (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.88 to 1.12, 740 deaths, 4506 randomised, 10 trials) or CVD events (RR 0.97, 95% CI 0.81 to 1.15, 1404 people experienced events of 4962 randomised, 7 trials). We are uncertain whether increasing omega-6 fats affects CVD mortality (RR 1.09, 95% CI 0.76 to 1.55, 472 deaths, 4019 randomised, 7 trials), coronary heart disease events (RR 0.88, 95% CI 0.66 to 1.17, 1059 people with events of 3997 randomised, 7 trials), major adverse cardiac and cerebrovascular events (RR 0.84, 95% CI 0.59 to 1.20, 817 events, 2879 participants, 2 trials) or stroke (RR 1.36, 95% CI 0.45 to 4.11, 54 events, 3730 participants, 4 trials), as we assessed the evidence as being of very low quality. We found no evidence of dose-response or duration effects for any primary outcome, but there was a suggestion of greater protection in participants with lower baseline omega-6 intake across outcomes.Additional key outcomes: we found increased intake of omega-6 fats may reduce myocardial infarction (MI) risk (RR 0.88, 95% CI 0.76 to 1.02, 609 events, 4606 participants, 7 trials, low-quality evidence). High-quality evidence suggests increasing omega-6 fats reduces total serum cholesterol a little in the long term (mean difference (MD) -0.33 mmol/L, 95% CI -0.50 to -0.16, I2 = 81%; heterogeneity partially explained by dose, 4280 participants, 10 trials). Increasing omega-6 fats probably has little or no effect on adiposity (body mass index (BMI) MD -0.20 kg/m2, 95% CI -0.56 to 0.16, 371 participants, 1 trial, moderate-quality evidence). It may make little or no difference to serum triglycerides (MD -0.01 mmol/L, 95% CI -0.23 to 0.21, 834 participants, 5 trials), HDL (MD -0.01 mmol/L, 95% CI -0.03 to 0.02, 1995 participants, 4 trials) or low-density lipoprotein (MD -0.04 mmol/L, 95% CI -0.21 to 0.14, 244 participants, 2 trials, low-quality evidence). AUTHORS' CONCLUSIONS: This is the most extensive systematic assessment of effects of omega-6 fats on cardiovascular health, mortality, lipids and adiposity to date, using previously unpublished data. We found no evidence that increasing omega-6 fats reduces cardiovascular outcomes other than MI, where 53 people may need to increase omega-6 fat intake to prevent 1 person from experiencing MI. Although benefits of omega-6 fats remain to be proven, increasing omega-6 fats may be of benefit in people at high risk of MI. Increased omega-6 fats reduce serum total cholesterol but not other blood fat fractions or adiposity.

Omega-6 fats for the primary and secondary prevention of cardiovascular disease.

BACKGROUND: Omega-6 fats are polyunsaturated fats vital for many physiological functions, but their effect on cardiovascular disease (CVD) risk is debated. OBJECTIVES: To assess effects of increasing omega-6 fats (linoleic acid (LA), gamma-linolenic acid (GLA), dihomo-gamma-linolenic acid (DGLA) and arachidonic acid (AA)) on CVD and all-cause mortality. SEARCH METHODS: We searched CENTRAL, MEDLINE and Embase to May 2017 and clinicaltrials.gov and the World Health Organization International Clinical Trials Registry Platform to September 2016, without language restrictions. We checked trials included in relevant systematic reviews. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing higher versus lower omega-6 fat intake in adults with or without CVD, assessing effects over at least 12 months. We included full texts, abstracts, trials registry entries and unpublished studies. Outcomes were all-cause mortality, CVD mortality, CVD events, risk factors (blood lipids, adiposity, blood pressure), and potential adverse events. We excluded trials where we could not separate omega-6 fat effects from those of other dietary, lifestyle or medication interventions. DATA COLLECTION AND ANALYSIS: Two authors independently screened titles/abstracts, assessed trials for inclusion, extracted data, and assessed risk of bias of included trials. We wrote to authors of included studies. Meta-analyses used random-effects analysis, while sensitivity analyses used fixed-effects and limited analyses to trials at low summary risk of bias. We assessed GRADE quality of evidence for 'Summary of findings' tables. MAIN RESULTS: We included 19 RCTs in 6461 participants who were followed for one to eight years. Seven trials assessed the effects of supplemental GLA and 12 of LA, none DGLA or AA; the omega-6 fats usually displaced dietary saturated or monounsaturated fats. We assessed three RCTs as being at low summary risk of bias.Primary outcomes: we found low-quality evidence that increased intake of omega-6 fats may make little or no difference to all-cause mortality (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.88 to 1.12, 740 deaths, 4506 randomised, 10 trials) or CVD events (RR 0.97, 95% CI 0.81 to 1.15, 1404 people experienced events of 4962 randomised, 7 trials). We are uncertain whether increasing omega-6 fats affects CVD mortality (RR 1.09, 95% CI 0.76 to 1.55, 472 deaths, 4019 randomised, 7 trials), coronary heart disease events (RR 0.88, 95% CI 0.66 to 1.17, 1059 people with events of 3997 randomised, 7 trials), major adverse cardiac and cerebrovascular events (RR 0.84, 95% CI 0.59 to 1.20, 817 events, 2879 participants, 2 trials) or stroke (RR 1.36, 95% CI 0.45 to 4.11, 54 events, 3730 participants, 4 trials), as we assessed the evidence as being of very low quality. We found no evidence of dose-response or duration effects for any primary outcome, but there was a suggestion of greater protection in participants with lower baseline omega-6 intake across outcomes.Additional key outcomes: we found increased intake of omega-6 fats may reduce myocardial infarction (MI) risk (RR 0.88, 95% CI 0.76 to 1.02, 609 events, 4606 participants, 7 trials, low-quality evidence). High-quality evidence suggests increasing omega-6 fats reduces total serum cholesterol a little in the long term (mean difference (MD) -0.33 mmol/L, 95% CI -0.50 to -0.16, I2 = 81%; heterogeneity partially explained by dose, 4280 participants, 10 trials). Increasing omega-6 fats probably has little or no effect on adiposity (body mass index (BMI) MD -0.20 kg/m2, 95% CI -0.56 to 0.16, 371 participants, 1 trial, moderate-quality evidence). It may make little or no difference to serum triglycerides (MD -0.01 mmol/L, 95% CI -0.23 to 0.21, 834 participants, 5 trials), HDL (MD -0.01 mmol/L, 95% CI -0.03 to 0.02, 1995 participants, 4 trials) or low-density lipoprotein (MD -0.04 mmol/L, 95% CI -0.21 to 0.14, 244 participants, 2 trials, low-quality evidence). AUTHORS' CONCLUSIONS: This is the most extensive systematic assessment of effects of omega-6 fats on cardiovascular health, mortality, lipids and adiposity to date, using previously unpublished data. We found no evidence that increasing omega-6 fats reduces cardiovascular outcomes other than MI, where 53 people may need to increase omega-6 fat intake to prevent 1 person from experiencing MI. Although benefits of omega-6 fats remain to be proven, increasing omega-6 fats may be of benefit in people at high risk of MI. Increased omega-6 fats reduce serum total cholesterol but not other blood fat fractions or adiposity.