Association of Life Expectancy With Surveillance Colonoscopy Findings and Follow-up Recommendations in Older Adults.

Importance: Surveillance after prior colon polyps is the most frequent indication for colonoscopy in older adults. However, to our knowledge, the current use of surveillance colonoscopy, clinical outcomes, and follow-up recommendations in association with life expectancy, factoring in both age and comorbidities, have not been studied. Objective: To evaluate the association of estimated life expectancy with surveillance colonoscopy findings and follow-up recommendations among older adults. Design, Setting, and Participants: This registry-based cohort study used data from the New Hampshire Colonoscopy Registry (NHCR) linked with Medicare claims data and included adults in the NHCR who were older than 65 years, underwent colonoscopy for surveillance after prior polyps between April 1, 2009, and December 31, 2018, and had full Medicare Parts A and B coverage and no Medicare managed care plan enrollment in the year prior to colonoscopy. Data were analyzed from December 2019 to March 2021. Exposures: Life expectancy (<5 years, 5 to <10 years, or ≥10 years), estimated using a validated prediction model. Main Outcomes and Measures: The main outcomes were clinical findings of colon polyps or colorectal cancer (CRC) and recommendations for future colonoscopy. Results: Among 9831 adults included in the study, the mean (SD) age was 73.2 (5.0) years and 5285 (53.8%) were male. A total of 5649 patients (57.5%) had an estimated life expectancy of 10 or more years, 3443 (35.0%) of 5 to less than 10 years, and 739 (7.5%) of less than 5 years. Overall, 791 patients (8.0%) had advanced polyps (768 [7.8%]) or CRC (23 [0.2%]). Among the 5281 patients with available recommendations (53.7%), 4588 (86.9%) were recommended to return for future colonoscopy. Those with longer life expectancy or more advanced clinical findings were more likely to be told to return. For example, among patients with no polyps or only small hyperplastic polyps, 132 of 227 (58.1%) with life expectancy of less than 5 years were told to return for future surveillance colonoscopy vs 940 of 1257 (74.8%) with life expectancy of 5 to less than 10 years and 2163 of 2272 (95.2%) with life expectancy of 10 years or more (P < .001). Conclusions and Relevance: In this cohort study, the likelihood of finding advanced polyps and CRC on surveillance colonoscopy was low regardless of life expectancy. Despite this observation, 58.1% of older adults with less than 5 years' life expectancy were recommended to return for future surveillance colonoscopy. These data may help refine decision-making about pursuing or stopping surveillance colonoscopy in older adults with a history of polyps.

Preventing metastatic recurrence in low-risk ER/PR + breast cancer patients-a retrospective clinical study exploring the evolving challenge of persistence with adjuvant endocrine therapy.

PURPOSE: In the genomic era, more women with low-risk breast cancer will forego chemotherapy and rely on adjuvant endocrine therapy (AET) to prevent metastatic recurrence. However, some of these patients will unfortunately relapse. We sought to understand this outcome. Preliminary work suggested that early discontinuation of AET, also known as non-persistence, may play an important role. A retrospective analysis exploring factors related to our breast cancer patients' non-persistence with AET was performed. METHODS: Women who underwent Oncotype-DX® testing between 2011 and 2014 with minimum 5 years follow-up were included. 'Low risk' was defined as Oncotype score < 26. Outcomes of recurrence and persistence were determined by chart review. Patient, tumor and treatment factors were collected, and persistent versus non-persistent groups compared using multivariable ANOVA and Fisher Chi square exact test. RESULTS: We identified six cases of distant recurrence among low-risk patients with a median follow-up of 7.7 years. Among them, five of six patients (83%) were non-persistent with AET. The non-persistence rate in our cohort regardless of recurrence was 57/228 (25%). Non-persistent patients reported more severe side effects compared with persistent patients (p = 0.002) and were more likely to be offered a switch in endocrine therapy, rather than symptom-relief (p = 0.006). In contrast, persistent patients were 10.3 times more likely to have been offered symptom-alleviating medications compared with non-persistent patients (p < 0.001). A subset analysis revealed that patients who persisted with therapy had a higher Oncotype-DX® score than patients who discontinued early (p = 0.028). CONCLUSION: Metastatic recurrence in low-risk breast cancer patients may be primarily due to non-persistence with endocrine therapy. Further work is needed to optimize care for patients who struggle with side effects. To our knowledge, these are the first published data suggesting that Oncotype-DX® score may influence persistence with AET.

Sensitizing brain metastases to stereotactic radiosurgery using hyperbaric oxygen: A proof-of-principle study.

PURPOSE: Increased oxygen levels may enhance the radiosensitivity of brain metastases treated with stereotactic radiosurgery (SRS). This project administered hyperbaric oxygen (HBO) prior to SRS to assess feasibility, safety, and response. METHODS: 38 patients were studied, 19 with 25 brain metastases treated with HBO prior to SRS, and 19 historical controls with 27 metastases, matched for histology, GPA, resection status, and lesion size. Outcomes included time from HBO to SRS, quality-of-life (QOL) measures, local control, distant (brain) metastases, radionecrosis, and overall survival. RESULTS: The average time from HBO chamber to SRS beam-on was 8.3 ± 1.7 minutes. Solicited adverse events (AEs) were comparable between HBO and control patients; no grade III or IV serious AEs were observed. Radionecrosis-free survival (RNFS), radionecrosis-free survival before whole-brain radiation therapy (WBRT) (RNBWFS), local recurrence-free survival before WBRT (LRBWFS), distant recurrence-free survival before WBRT (DRBWFS), and overall survival (OS) were not significantly different for HBO patients and controls on Kaplan-Meier analysis, though at 1-year estimated survival rates trended in favor of SRS + HBO: RNFS - 83% vs 60%; RNBWFS - 78% vs 60%; LRBWFS - 95% vs 78%; DRBWFS - 61% vs 57%; and OS - 73% vs 56%. Multivariate Cox models indicated no significant association between HBO treatment and hazards of RN, local or distant recurrence, or mortality; however, these did show statistically significant associations (p < 0.05) for: local recurrence with higher volume, radionecrosis with tumor resection, overall survival with resection, and overall survival with higher GPA. CONCLUSION: Addition of HBO to SRS for brain metastases is feasible without evident decrement in radiation necrosis and other clinical outcomes.

Adoption of Telemedicine in a Rural US Cancer Center Amid the COVID-19 Pandemic: Qualitative Study.

BACKGROUND: The COVID-19 pandemic necessitated a rapid shift to telemedicine to minimize patient and provider exposure risks. While telemedicine has been used in a variety of primary and specialty care settings for many years, it has been slow to be adopted in oncology care. Health care provider and administrator perspectives on factors affecting telemedicine use in oncology settings are not well understood, and the conditions associated with the COVID-19 pandemic offered the opportunity to study the adoption of telemedicine and the resulting provider and staff perspectives on its use. OBJECTIVE: The aim of this paper is to study the factors that influenced telemedicine uptake and sustained use in outpatient oncology clinics at a US cancer center to inform future telemedicine practices. METHODS: We used purposive sampling to recruit a mix of oncology specialty providers, practice managers, as well as nursing and administrative staff representing 5 outpatient oncology clinics affiliated with the Dartmouth Cancer Center, a large regional cancer center in the northeast of United States, to participate in semistructured interviews conducted over 6 weeks in spring 2021. The interview guide was informed by the 5 domains of the Consolidated Framework for Implementation Research, which include inner and outer setting factors, characteristics of the intervention (ie, telemedicine modality), individual-level factors (eg, provider and patient characteristics), and implementation processes. In total, 11 providers, 3 leaders, and 6 staff participated following verbal consent, and thematic saturation was reached across the full sample. We used a mixed deductive and inductive qualitative analysis approach to study the main influences on telemedicine uptake, implementation, and sustainability during the first year of the COVID-19 pandemic across the 5 settings. RESULTS: The predominant influencers of telemedicine adoption in this study were individual provider experiences and assumptions about patient preference and accessibility. Providers' early telemedicine experiences, especially if negative, influenced preferences for telephone over video and affected sustained use. Telemedicine was most favorably viewed for lower-acuity cancer care, visits less dependent on physical exam, and for patient and caregiver education. A lack of clinical champions, leadership guidance, and vision hindered the implementation of standardized practices and were cited as essential for telemedicine sustainability. Respondents expressed anxiety about sustaining telemedicine use if reimbursements for telephonic visits diminished or ceased. Opportunities to enhance future efforts include a need to provide additional guidance supporting telemedicine use cases and evidence of effectiveness in oncology care and to address provider concerns with communication quality. CONCLUSIONS: In a setting of decentralized care processes, early challenges in telemedicine implementation had an outsized impact on the nature and amount of sustained use. Proactively designed telemedicine care processes with attention to patient needs will be essential to support a sustained role for telemedicine in cancer care.

Factors Influencing Telemedicine Use at a Northern New England Cancer Center During the COVID-19 Pandemic.

PURPOSE: To characterize the use of telemedicine for oncology care over the course of the COVID-19 pandemic in Northern New England with a focus on factors affecting trends. METHODS: We performed a retrospective observational study using patient visit data from electronic health records from hematology-oncology and radiation-oncology service lines spanning the local onset of the pandemic from March 18, 2020, through March 31, 2021. This period was subdivided into four phases designated as lockdown, transition, stabilization, and second wave. Generalized linear mixed regression models were used to estimate the effects of patient characteristics on trends for rates of telemedicine use across phases and the effects of visit type on patient satisfaction and postvisit ER or hospital admissions within 2 weeks. RESULTS: A total of 19,280 patients with 102,349 visits (13.1% audio-only and 1.4% video) were studied. Patient age (increased use in age < 45 and 85 years and older) and urban residence were associated with higher use of telemedicine, especially after initial lockdown. Recent cancer therapy, ER use, and hospital admissions in the past year were all associated with lower telemedicine utilization across pandemic phases. Provider clinical department corresponded to the largest differences in telemedicine use across all phases. ER and hospital admission rates in the 2 weeks after a telehealth visit were lower than those in in-person visits (0.7% v 1.3% and 1.2% v 2.7% for ER and hospital use, respectively; P < .001). Patient satisfaction did not vary across visit types. CONCLUSION: Telemedicine use in oncology during the COVID-19 pandemic varied according to the phase and patient, medical, and health system factors, suggesting opportunities for standardization of care and need for attention to equitable telemedicine access.

Colonoscopy utilization and outcomes in older adults: Data from the New Hampshire Colonoscopy Registry.

BACKGROUND: Colonoscopy is frequently performed in older adults, yet data on current use, and clinical outcomes of and follow-up recommendations after colonoscopy in older adults are lacking. METHODS: This was an observational study using the New Hampshire Colonoscopy Registry of adults age ≥65 years undergoing colonoscopy for screening, surveillance of prior polyps, or evaluation of symptoms. The main outcomes were clinical findings of polyps and colorectal cancer and recommendations for future colonoscopy by age. RESULTS: Between 2009 and 2019, there were 42,611 colonoscopies, of which 17,527 (41%) were screening, 19,025 (45%) surveillance, and 6059 (14%) for the evaluation of symptoms. Mean age was 71.1 years (SD 5.0), and 49.3% were male. The finding of colorectal cancer was rare (0.71%), with the highest incidence among diagnostic examinations (2.4%). The incidence of advanced polyps increased with patient age from 65-69 to ≥85 years for screening (7.1% to 13.6%; p = 0.05) and surveillance (9.4% to 12.0%; p < 0.001). Recommendations for future colonoscopy decreased with age and varied by findings at current colonoscopy. In patients without any significant findings, 85% aged 70-74 years, 61.9% aged 75-79 years, 39.1% aged 80-84 years, and 27.4% aged ≥85 years (p < 0.001) were told to continue colonoscopy. Among patients with advanced polyps, 97.2% aged 70-74 years, 89.6% aged 75-79 years, 78.4% aged 80-84 years, and 66.7% aged ≥85 years were told to continue colonoscopy (p < 0.001). CONCLUSIONS: Within this comprehensive statewide registry, clinical findings during colonoscopy varied by indication and increased with age. Overall rates of finding advanced polyps and colorectal cancer are low. Older adults are frequently recommended to continue colonoscopy despite advanced age and insignificant clinical findings on current examination. These data inform the potential benefits of ongoing colonoscopy, which must be weighed with the low but known potential immediate and long-term harms of colonoscopy, including cost, psychological distress, and long lag time to benefit exceeding life expectancy.

Pathogenic DPYD Variants and Treatment-Related Mortality in Patients Receiving Fluoropyrimidine Chemotherapy: A Systematic Review and Meta-Analysis.

BACKGROUND: Pathogenic variants of the DPYD gene are strongly associated with grade ≥3 toxicity during fluoropyrimidine chemotherapy. We conducted a systematic review and meta-analysis to estimate the risk of treatment-related death associated with DPYD gene variants. MATERIALS AND METHODS: We searched for reports published prior to September 17, 2020, that described patients receiving standard-dose fluoropyrimidine chemotherapy (5-fluorouracil or capecitabine) who had baseline testing for at least one of four pathogenic DPYD variants (c.1129-5923C>G [HapB3], c.1679T>G [*13], c.1905+1G>A [*2A], and c.2846A>T) and were assessed for toxicity. Two reviewers assessed studies for inclusion and extracted study-level data. The primary outcome was the relative risk of treatment-related mortality for DPYD variant carriers versus noncarriers; we performed data synthesis using a Mantel-Haenszel fixed effects model. RESULTS: Of the 2,923 references screened, 35 studies involving 13,929 patients were included. DPYD variants (heterozygous or homozygous) were identified in 566 patients (4.1%). There were 14 treatment-related deaths in 13,363 patients without identified DPYD variants (treatment-related mortality, 0.1%; 95% confidence interval [CI], 0.1-0.2) and 13 treatment-related deaths in 566 patients with any of the four DPYD variants (treatment-related mortality, 2.3%; 95% CI, 1.3%-3.9%). Carriers of pathogenic DPYD gene variants had a 25.6 times increased risk of treatment-related death (95% CI, 12.1-53.9; p < .001). After excluding carriers of the more common but less deleterious c.1129-5923C>G variant, carriers of c.1679T>G, c.1905+1G>A, and/or c.2846A>T had treatment-related mortality of 3.7%. CONCLUSION: Patients with pathogenic DPYD gene variants who receive standard-dose fluoropyrimidine chemotherapy have greatly increased risk for treatment-related death. IMPLICATIONS FOR PRACTICE: The syndrome of dihydropyrimidine dehydrogenase (DPD) deficiency is an uncommon but well-described cause of severe toxicity related to fluoropyrimidine chemotherapy agents (5-fluorouracil and capecitabine). Patients with latent DPD deficiency can be identified preemptively with genotyping of the DPYD gene, or with measurement of the plasma uracil concentration. In this systematic review and meta-analysis, the authors study the rare outcome of treatment-related death after fluoropyrimidine chemotherapy. DPYD gene variants associated with DPD deficiency were linked to a 25.6 times increased risk of fluoropyrimidine-related mortality. These findings support the clinical utility of DPYD genotyping as a screening test for DPD deficiency.

A Randomized Prospective Trial of Supine MRI-Guided Versus Wire-Localized Lumpectomy for Breast Cancer.

BACKGROUND: Wire-localized excision of non-palpable breast cancer is imprecise, resulting in positive margins 15-35% of the time. METHODS: Women with a confirmed diagnosis of non-palpable invasive breast cancer (IBC) or ductal carcinoma in situ (DCIS) were randomized to a new technique using preoperative supine magnetic resonance imaging (MRI) with intraoperative optical scanning and tracking (MRI group) or wire-localized (WL group) partial mastectomy. The main outcome measure was the positive margin rate. RESULTS: In this study, 138 patients were randomly assigned. Sixty-six percent had IBC and DCIS, 22% had IBC, and 12% had DCIS. There were no differences in patient or tumor characteristics between the groups. The proportion of patients with positive margins in the MRI-guided surgery group was half that observed in the WL group (12 vs. 23%; p = 0.08). The specimen volumes in the MRI and WL groups did not differ significantly (74 ± 33.9 mL vs. 69.8 ± 25.1 mL; p = 0.45). The pathologic tumor diameters were underestimated by 2 cm or more in 4% of the cases by MRI and in 9% of the cases by mammography. Positive margins were observed in 68% and 58% of the cases underestimated by 2 cm or more using MRI and mammography, respectively, and in 15% and 14% of the cases not underestimated using MRI and mammography, respectively. CONCLUSIONS: A novel system using supine MRI images co-registered with intraoperative optical scanning and tracking enabled tumors to be resected with a trend toward a lower positive margin rate compared with wire-localized partial mastectomy. Margin positivity was more likely when imaging underestimated pathologic tumor size.

Patterns of Opioid Use in the 12 Months Following Geriatric Fragility Fractures: A Population-Based Cohort Study.

OBJECTIVES: Fractures of the hip, distal radius, and proximal humerus are common in the Medicare population. This study's objective was to characterize patterns and duration of opioid use, including regional variations in use, after both surgical and nonoperative management. DESIGN: Population-based cohort study. SETTING AND PARTICIPANTS: A cohort of opioid-naïve community-dwelling US Medicare beneficiaries who survived a hip, distal radius, or proximal humerus fracture between January 1, 2007 and December 31, 2010. Cohort members were required to be opioid-naïve for 4 months prior to fracture. MEASURES: We analyzed the proportion of patients with an active opioid prescription in each month following the index fracture, and report continued fills at 12 months postfracture. We also compared opioid prescription use in fractures treated surgically and nonsurgically and characterized state-level variation in opioid prescription use at 3 months postfracture. RESULTS: There were 91,749 patients included in the cohort. Hip fracture patients had the highest rate of opioid use at 12 months (6.4%), followed by proximal humerus (5.7%), and distal radius (3.7%). Patients who underwent surgical fixation of proximal humerus and wrist fractures had higher rates of opioid use in each of the first 12 postoperative months compared with those managed nonoperatively. There was significant variation of opioid use at the state level, ranging from 7.6% to 18.2% of fracture patients filling opioid prescriptions 3 months after the index fracture. CONCLUSIONS/IMPLICATIONS: Opioid-naïve patients sustaining fragility fractures of the hip, proximal humerus, or distal radius are at risk to remain on opioid medications 12 months after their index injury, and surgical management of proximal humerus and distal radius fractures increases opioid use in the 12 months after the index fracture. There is significant state-level variation in opiate consumption after index fracture in nonvertebral geriatric fragility fractures. Opportunity exists for targeted quality improvement efforts to reduce the variation in opioid use following common geriatric fragility fractures.

Short-term Preoperative Diet Decreases Bleeding After Partial Hepatectomy: Results From a Multi-institutional Randomized Controlled Trial.

BACKGROUND: Our previous case series suggested that a 1-week, low-calorie and low-fat diet was associated with decreased intraoperative blood loss in patients undergoing liver surgery. OBJECTIVE: The current study evaluates the effect of this diet in a randomized controlled trial. METHODS: We randomly assigned 60 patients with a body mass index ≥25 kg/m(2) to no special diet or an 800-kcal, 20 g fat, and 70 g protein diet for 1 week before liver resection. Surgeons were blinded to diet assignment. Hepatic glycogen stores were evaluated using periodic acid Schiff (PAS) stains. RESULTS: Ninety four percent of the patients complied with the diet. The diet group consumed fewer daily total calories (807 vs 1968 kcal, P < 0.001) and fat (21 vs 86 g, P < 0.001) than the no diet group. Intraoperative blood loss was less in the diet group: mean blood loss 452 vs 863 mL (P = 0.021). There was a trend towards decreased transfusion in the diet group (138 vs 322 mL, P = 0.06). The surgeon judged the liver to be easier to manipulate in the diet group: 1.86 versus 2.90, P = 0.004. Complication rate (20% vs 17%), length of stay (median 5 vs 4 days) and mortality did not differ between groups. There was no difference in hepatic steatosis between groups. There was less glycogen in hepatocytes in the diet group (PAS stain score 1.61 vs 2.46, P < 0.0001). CONCLUSIONS: A short-course, low-fat, and low-calorie diet significantly decreases bleeding and makes the liver easier to manipulate in hepatic surgery.

Multi-level Influences on Breast Cancer Screening in Primary Care.

BACKGROUND: Use of breast cancer screening is influenced by factors associated with patients, primary care providers, practices, and health systems. OBJECTIVE: We examined the relative effects of these nested levels on four breast cancer screening metrics. DESIGN: A web-based survey was completed at 15 primary care practices within two health systems representing 306 primary care providers (PCPs) serving 46,944 women with a primary care visit between 1/2011-9/2014. Analyses occurred between 1/2017 and 5/2017. MAIN MEASURES: Across four nested levels (patient, PCP, primary care practice, and health system), frequency distributions and adjusted rates of primary care practice characteristics and survey results for four breast screening metrics (percent screened overall, and percent screened age 40-49, 50-74, and 75+) were reported. We used hierarchical multi-level mixed and random effects analysis to assess the relative influences of PCP, primary care practice, and health system on the breast screening metrics. KEY RESULTS: Overall, the proportion of women undergoing breast cancer screening was 73.1% (73.4% for ages 40-49, 76.5% for 50-74, and 51.1% for 75+). Patient ethnicity and number of primary care visits were strongly associated with screening rates. After adjusting for woman-level factors, 24% of the overall variation among PCPs was attributable to the primary care practice level, 35% to the health system level, and 41% to the residual variation among PCPs within practice. No specific provider-level characteristics were found to be statistically significant determinants of screening rates. CONCLUSIONS: After accounting for woman-level characteristics, the remaining variation in breast cancer screening was largely due to provider and health system variation.

Considering Spine Surgery: A Web-Based Calculator for Communicating Estimates of Personalized Treatment Outcomes.

STUDY DESIGN: Prospective evaluation of an informational web-based calculator for communicating estimates of personalized treatment outcomes. OBJECTIVE: To evaluate the usability, effectiveness in communicating benefits and risks, and impact on decision quality of a calculator tool for patients with intervertebral disc herniations, spinal stenosis, and degenerative spondylolisthesis who are deciding between surgical and nonsurgical treatments. SUMMARY OF BACKGROUND DATA: The decision to have back surgery is preference-sensitive and warrants shared decision making. However, more patient-specific, individualized tools for presenting clinical evidence on treatment outcomes are needed. METHODS: Using Spine Patient Outcomes Research Trial data, prediction models were designed and integrated into a web-based calculator tool: http://spinesurgerycalc.dartmouth.edu/calc/. Consumer Reports subscribers with back-related pain were invited to use the calculator via email, and patient participants were recruited to use the calculator in a prospective manner following an initial appointment at participating spine centers. Participants completed questionnaires before and after using the calculator. We randomly assigned previously validated questions that tested knowledge about the treatment options to be asked either before or after viewing the calculator. RESULTS: A total of 1256 consumer reports subscribers and 68 patient participants completed the calculator and questionnaires. Knowledge scores were higher in the postcalculator group compared to the precalculator group, indicating that calculator usage successfully informed users. Decisional conflict was lower when measured following calculator use, suggesting the calculator was beneficial in the decision-making process. Participants generally found the tool helpful and easy to use. CONCLUSION: Although the calculator is not a comprehensive decision aid, it does focus on communicating individualized risks and benefits for treatment options. Moreover, it appears to be helpful in achieving the goals of more traditional shared decision-making tools. It not only improved knowledge scores but also improved other aspects of decision quality. LEVEL OF EVIDENCE: 2.

Long-Term Results of Surgery Compared With Nonoperative Treatment for Lumbar Degenerative Spondylolisthesis in the Spine Patient Outcomes Research Trial (SPORT).

STUDY DESIGN: Randomized trial with a concurrent observational cohort study. OBJECTIVE: To compare 8-year outcomes between surgery and nonoperative care and among different fusion techniques for symptomatic lumbar degenerative spondylolisthesis (DS). SUMMARY OF BACKGROUND DATA: Surgical treatment of DS has been shown to be more effective than nonoperative treatment out to 4 years. This study sought to further determine the long-term (8-year) outcomes. METHODS: Surgical candidates with DS from 13 centers with at least 12 weeks of symptoms and confirmatory imaging were offered enrollment in a randomized controlled trial (RCT) or observational cohort study (OBS). Treatment consisted of standard decompressive laminectomy (with or without fusion) versus standard nonoperative care. Primary outcome measures were the Short Form-36 (SF-36) bodily pain and physical function scores and the modified Oswestry Disability Index at 6 weeks, 3 months, 6 months, and yearly up to 8 years. RESULTS: Data were obtained for 69% of the randomized cohort and 57% of the observational cohort at the 8-year follow up. Intent-to-treat analyses of the randomized group were limited by high levels of nonadherence to the randomized treatment. As-treated analyses in the randomized and observational groups showed significantly greater improvement in the surgery group on all primary outcome measures at all time points through 8 years. Outcomes were similar among patients treated with uninstrumented posterolateral fusion, instrumented posterolateral fusion, and 360° fusion. CONCLUSION: For patients with symptomatic DS, patients who received surgery had significantly greater improvements in pain and function compared with nonoperative treatment through 8 years of follow-up. Fusion technique did not affect outcomes. LEVEL OF EVIDENCE: 1.

Immediate Symptom Relief After a First Session of Massage Therapy or Reiki in Hospitalized Patients: A 5-Year Clinical Experience from a Rural Academic Medical Center.

OBJECTIVES: There is an increasing demand for and use of alternative and complementary therapies, such as reiki and massage therapy, in hospital-based settings. Most controlled studies and practice-based reports include oncology and surgical patient populations; thus the effect in a more heterogeneous hospitalized patient population is hard to estimate. We examined the immediate symptom relief from a single reiki or massage session in a hospitalized population at a rural academic medical center. DESIGN: Retrospective analysis of prospectively collected data on demographic, clinical, process, and quality of life for hospitalized patients receiving massage therapy or reiki. SETTINGS/LOCATION: A 396-bed rural academic and tertiary medical center in the United States. SUBJECTS: Hospitalized patients requesting or referred to the healing arts team who received either a massage or reiki session and completed both a pre- and post-therapy symptom questionnaire. INTERVENTIONS: First session of routine reiki or massage therapy during a hospital stay. OUTCOME MEASURES: Differences between pre- and postsession patient-reported scores in pain, nausea, fatigue, anxiety, depression, and overall well-being using an 11-point Likert scale. RESULTS: Patients reported symptom relief with both reiki and massage therapy. Analysis of the reported data showed reiki improved fatigue (-2.06 vs. -1.55 p < 0.0001) and anxiety (-2.21 vs. -1.84 p < 0.001) statistically more than massage. Pain, nausea, depression, and well being changes were not statistically different between reiki and massage encounters. Immediate symptom relief was similar for cancer and noncancer patients for both reiki and massage therapy and did not vary based on age, gender, length of session, and baseline symptoms. CONCLUSIONS: Reiki and massage clinically provide similar improvements in pain, nausea, fatigue, anxiety, depression, and overall well-being while reiki improved fatigue and anxiety more than massage therapy in a heterogeneous hospitalized patient population. Controlled trials should be considered to validate the data.

Medical Care Costs Were Similar Across the Low-dose Computed Tomography and Chest X-Ray Arms of the National Lung Screening Trial Despite Different Rates of Significant Incidental Findings.

BACKGROUND: The National Lung Screening Trial (NLST) reported lung cancer and all-cause mortality reductions for low-dose computed tomography (LDCT) versus chest x-ray (CXR) screening. Although LDCT lung screening has received a grade B from the United States Preventive Services Task Force and is a covered service under most health plans, concerns remain on the costs engendered by screening, and the impact of the high rate of significant incidental finding (SIF) detection on those costs. METHODS: We linked American College of Radiology Imaging Network NLST and Medicare fee-for-service claims data for participants from 23 sites for 2002-2009. We performed participant-level analyses using generalized linear regression models to estimate the adjusted annual mean of the 3-year total medical costs per person in each study arm and within screen outcome categories (ever positive with abnormalities suspicious for lung cancer, always negative for abnormalities suspicious for lung cancer, but with SIFs, and always negative without SIFs). RESULTS: The adjusted annual mean total per person costs were not significantly different between screening arms [LDCT, $11,029 (95% confidence interval, $10,107-$11,951); CXR, $10,905 (95% confidence interval, $10,059-$11,751)], despite higher proportions of individuals with SIFs in the LDCT versus the CXR arm (18% vs. 4%; P<0.0001). CONCLUSIONS: We found little difference in total annual per person costs between LDCT-screened and CXR-screened Medicare participants, despite the higher number of SIFs in the LDCT arm of the study.

Understanding the value of minimally invasive procedures for the treatment of lumbar spinal stenosis: the case of interspinous spacer devices.

BACKGROUND CONTEXT: Minimally invasive lumbar spinal stenosis procedures have uncertain long-term value. PURPOSE: This study sought to characterize factors affecting the long-term cost-effectiveness of such procedures using interspinous spacer devices ("spacers") relative to decompression surgery as a case study. STUDY DESIGN: Model-based cost-effectiveness analysis. PATIENT SAMPLE: The Medicare Provider Analysis and Review database for the years 2005-2009 was used to model a group of 65-year-old patients with spinal stenosis who had no previous spine surgery and no contraindications to decompression surgery. OUTCOME MEASURES: Costs, quality-adjusted life years (QALYs), and cost per QALY gained were the outcome measures. METHODS: A Markov model tracked health utility and costs over 10 years for a 65-year-old cohort under three care strategies: conservative care, spacer surgery, and decompression surgery. Incremental cost-effectiveness ratios (ICER) reported as cost per QALY gained included direct medical costsfor surgery. Medicare claims data were used to estimate complication rates, reoperation, and related costs within 3 years. Utilities and long-term reoperation rates for decompression were derived frompublished studies. Spacer failure requiring reoperation beyond 3 years and post-spacer health utilities are uncertain and were evaluated through sensitivity analyses. In the base-case, the spacer failure rate was held constant for years 4-10 (cumulative failure: 47%). In a "worst-case" analysis, the 10-year cumulative reoperation rate was increased steeply (to 90%). Threshold analyses were performed to determine the impact of failure and post-spacer health utility on the cost-effectiveness of spacer surgery. RESULTS: The spacer strategy had an ICER of $89,500/QALY gained under base-case assumptions, and remained under $100,000 as long as the 10-year cumulative probability of reoperation did not exceed 54%. Under worst-case assumptions, the spacer ICER was $482,000/QALY and fell below $100,000 only if post-spacer utility was 0.01 greater than post-decompression utility or the cost of spacer surgery was $1,600 less than the cost of decompression surgery. CONCLUSIONS: Spacers may provide a reasonably cost-effective initial treatment option for patients with lumbar spinal stenosis. Their value is expected to improve if procedure costs are lower in outpatient settings where these procedures are increasingly being performed. Decision analysis is useful for characterizing the long-term cost-effectiveness potential for minimally invasive spinal stenosis treatments and highlights the importance of complication rates and prospective health utility assessment.

Does reduction in sciatica symptoms precede improvement in disability and physical health among those treated surgically for intervertebral disc herniation? Analysis of temporal patterns in data from the Spine Patient Outcomes Research Trial.

BACKGROUND CONTEXT: Pain, pain-related disability, and functional limitations are common consequences of intervertebral disc herniation (IDH). We hypothesized that surgical treatment reduces pain, leading to improvement in pain-related disability and, ultimately, better physical health. PURPOSE: The present study aims to evaluate pathways for improvements in quality of life during the first year after surgery for IDH by studying temporal relationships between sciatica symptoms, pain-related disability, and physical health. DESIGN: This is a secondary analysis of a randomized controlled trial using an "as treated" dataset. PATIENT SAMPLE: The sample comprised 803 patients in the Spine Patient Outcomes Research Trial. OUTCOME MEASURES: We used the Sciatica Bothersome Index, Oswestry Disability Index, and the Medical Outcomes Study Short Form 36 physical component score. METHODS: We included 803 patients in the Spine Patient Outcomes Research Trial who underwent elective decompressive surgery for IDH between 2000 and 2004. Sciatica, pain-related disability, and physical health were assessed preoperatively and at 3 and 12 months postoperatively using the Sciatica Bothersome Index, Oswestry Disability Index, and Medical Outcomes Study Short Form 36 physical component score, respectively. Temporal associations of improvement in sciatica with pain-related disability and physical health were assessed using cross-lagged path analysis. p<.05 was considered significant. No funding was received in support of the present study. The authors declare no conflicts of interest. RESULTS: Preoperatively, mean scores were 16.2±5.2 for sciatica, 54.2±20.7 for pain-related disability, and 29.8±8.4 for physical health. After adjustment for patient age and symptom duration, cross-lagged path analysis showed that sciatica reduction at 3 months was correlated with pain-related disability reduction at 3 months (ρ=.76, p<.001), and pain-related disability at 3 months was predictive of physical health at 12 months (ß=-.33, p<.001) and sciatica at 12 months (ß=.22, p<.001). CONCLUSION: Three months after surgery, patients reported reduced sciatica and pain-related disability. Improvements in pain and pain-related disability occurred within 3 months. Early reduction in pain-related disability is important because path analysis indicated that disability at 3 months was predictive of sciatica and physical health at 1 year.

The role of a palliative care intervention in moderating the relationship between depression and survival among individuals with advanced cancer.

OBJECTIVE: Randomized controlled trials (RCTs) of early palliative care interventions in advanced cancer have positively impacted patient survival, yet the mechanisms remain unknown. This secondary analysis of 2 RCTs assessed whether an early palliative care intervention moderates the relationship between depressive symptoms and survival. METHOD: The relationships among mood, survival, and early palliative care intervention were studied among 529 advanced cancer patients who participated in 2 RCTs. The first (N = 322) compared intervention versus usual care. The second (N = 207) compared early versus delayed intervention (12 weeks after enrollment). The interventions included an in-person consultation, weekly nurse coach-facilitated phone sessions, and monthly follow-up. Mood was measured using the Center for Epidemiologic Studies-Depression (CES-D) scale. Cox proportional hazard analyses were used to examine the effects of baseline CES-D scores, the intervention, and their interaction on mortality risk while controlling for demographic variables, cancer site, and illness severity. RESULTS: The combined sample was 56% male (M = 64.7 years). Higher baseline CES-D scores were significantly associated with greater mortality risk (hazard ratio [HR] = 1.042, 95% confidence interval [CI] [1.017, 1.067], p = .001). However, participants with higher CES-D scores who received the intervention had a lower mortality risk (HR = .963, CI [0.933, 0.993], p = .018) even when controlling for demographics, cancer site, and illness-related variables. CONCLUSION: This study is the first to demonstrate that patients with advanced cancer who also have depressive symptoms benefit the most from early palliative care. Future research should be devoted to exploring the mechanisms responsible for these relationships. (PsycINFO Database Record