Morning light treatment for inflammatory bowel disease: a clinical trial.

BACKGROUND: Inflammatory bowel disease (IBD) affects over 3 million Americans and has a relapsing and remitting course with up to 30% of patients experiencing exacerbations each year despite the availability of immune targeted therapies. An urgent need exists to develop adjunctive treatment approaches to better manage IBD symptoms and disease activity. Circadian disruption is associated with increased disease activity and may be an important modifiable treatment target for IBD. Morning light treatment, which advances and stabilizes circadian timing, may have the potential to improve IBD symptoms and disease activity, but no studies have explored these potential therapeutic benefits in IBD. Therefore, in this study, we aim to test the effectiveness of morning light treatment for patients with IBD. METHODS: We will recruit sixty-eight individuals with biopsy-proven IBD and clinical symptoms and randomize them to 4-weeks of morning light treatment or 4-weeks of treatment as usual (TAU), with equivalent study contact. Patient-reported outcomes (IBD-related quality of life, mood, sleep), clinician-rated disease severity, and a biomarker of gastrointestinal inflammation (fecal calprotectin) will be assessed before and after treatment. Our primary objective will be to test the effect of morning light treatment versus TAU on IBD-related quality of life and our secondary objectives will be to test the effects on clinician-rated disease activity, depression, and sleep quality. We will also explore the effect of morning light treatment versus TAU on a biomarker of gastrointestinal inflammation (fecal calprotectin), and the potential moderating effects of steroid use, restless leg syndrome, and biological sex. DISCUSSION: Morning light treatment may be an acceptable, feasible, and effective adjunctive treatment for individuals with active IBD suffering from impaired health-related quality of life. TRIAL REGISTRATION: The study protocol was registered on ClinicalTrials.gov as NCT06094608 on October 23, 2023, before recruitment began on February 1, 2024.

A 4-week morning light treatment with stable sleep timing for individuals with fibromyalgia: a randomized controlled trial.

OBJECTIVES: Fibromyalgia is characterized by chronic widespread pain, mood, and sleep disturbance. Pharmacological treatments have modest efficacy and are associated with negative side effects, and alternative approaches are needed. Morning bright light treatment may assist in the management of fibromyalgia as it can reduce depressive symptoms, improve sleep, and advance circadian timing. METHODS: Sixty people with fibromyalgia (58 women, mean age 41.8 ± 13.3 years) were enrolled in a study comparing 4 weeks of a 1-hour daily morning bright light treatment (active treatment) to a morning dim light treatment (comparison treatment). Both light treatments included behavioral procedures to stabilize sleep timing. The morning bright light treatment was expected to produce larger improvements in pain and function than the dim light treatment and larger improvements in potential mediators (mood, sleep, and circadian timing). RESULTS: Both the bright and dim light treatment groups achieved significant but similar levels of improvement in pain intensity, pain interference, physical function, depressive symptoms, and sleep disturbance. Overall, the sample on average displayed a clinically meaningful improvement in the Fibromyalgia Impact Questionnaire-Revised score (mean reduction of 11.2 points), comparable to that reported following physical exercise treatments. Minimal side effects were observed. CONCLUSIONS: Findings indicate that the effects of a morning bright light treatment did not exceed those of a comparison dim light treatment; yet the changes on average in both conditions revealed clinically meaningful improvements. Future research is warranted to identify what elements of this trial may have contributed to the observed effects.

Trends in Incident Varenicline Prescribing Among Veterans Following the US Food and Drug Administration Drug Safety Warnings.

Objective: To evaluate national trends in incident varenicline and nicotine replacement therapy (NRT) prescribing among Department of Veterans Affairs (VA) beneficiaries before and after US Food and Drug Administration (FDA) warnings regarding neuropsychiatric side effects with varenicline use.Methods: All adult VA patients identified as smokers from 2007 to 2019 (N = 3,600,947) were determined and monthly counts of new varenicline and NRT users were calculated. An interrupted time-series analysis estimated the effect of the FDA warnings on varenicline and NRT prescribing overall and among Veterans with and without mental health disorders.Results: The incident use rate of varenicline decreased from a peak of 6.2 per 1,000 veteran smokers in October 2007 to 1.0 by July 2009 following the first FDA warning (pre-warning monthly slope = -0.27; P = .03). New NRT use increased from 10.7 per 1,000 veteran smokers in October 2007 to a peak of 12.6 per 1,000 in July 2009 (slope change = 0.71; P = .01), suggesting potential substitution. Following removal of the FDA boxed warning in December 2016, varenicline prescribing increased but did not return to pre-warning levels by December 2019. Among veterans with and without mental health disorders, varenicline use decreased 90% and 88%, respectively, following the first FDA warning, and both groups had comparable rates of new NRT use.Conclusions: Following the first FDA warning, incident use of varenicline declined significantly among veterans both with and without mental health disorders. Despite removal of the FDA boxed warning in December 2016, new use of varenicline had not returned to pre-warning levels 3 years following the removal.

Provider and clinical setting characteristics associated with tobacco pharmacotherapy dispensed in the Veterans Health Administration.

INTRODUCTION: While initiation rates of tobacco cessation pharmacotherapy have improved both inside and outside the Department of Veteran Affairs (VA), prescribing rates remain low. The objective of this study was to examine correlation of the characteristics of providers, clinics, and facilities with initiation of tobacco cessation pharmacotherapy. METHODS: This retrospective, observational study used VA outpatient electronic medical record data from federal fiscal year 2011. Logistic regression models estimated the adjusted odds ratio associated with provider characteristics for pharmacotherapy initiation. RESULTS: For the 639507 veterans who used tobacco, there were 30388 providers caring for them. Younger (p<0.001) and female (p<0.001) providers were more likely to initiate tobacco cessation pharmacotherapy. Compared to physicians, pharmacists were 74% more likely to initiate pharmacotherapy, while all groups of nurses were 5-8% and physicians' assistants were 12% less likely (p<0.001). Compared to those seen in primary care clinics, patients assessed in substance use treatment clinics were 16% more likely to have pharmacotherapy initiated (p<0.001), while those in psychiatry were 10% less likely (p<0.001), and those in outpatient surgery were 39% less likely to initiate pharmacotherapy (p<0.001). Compared to almost all other classes of VA facilities, patients seen in primary care community-based outpatient clinics (CBOCs) were 7-28% more likely to initiate pharmacotherapy (p<0.0001). CONCLUSIONS: While the VA is at the leading edge of providing tobacco cessation pharmacotherapy, targeting quality improvement efforts towards providers, clinics, and facilities with low prescribing rates will be essential to continue the declining rates of tobacco use among VA patients.

Comparison of 24-Month Outcomes After Treatment for Distal Radius Fracture: The WRIST Randomized Clinical Trial.

Importance: Distal radius fractures (DRFs) are common injuries among older adults and can result in substantial disability. Current evidence regarding long-term outcomes in older adults is scarce. Objective: To compare outcomes across treatment groups at 24 months among adults with DRFs who participated in the WRIST trial. Design, Setting, and Participants: The Wrist and Radius Injury Surgical Trial (WRIST) randomized, international, multicenter trial was conducted from April 1, 2012, through December 31, 2016. Participants were adults aged 60 years or older with isolated, unstable DRFs at 24 health systems in the US, Canada, and Singapore. Data analysis was performed from March 2019 to March 2021. Interventions: Participants were randomized to open reduction and volar locking plate system (VLPS), external fixation with or without supplementary pinning (EFP), and percutaneous pinning (CRPP). The remaining participants chose closed reduction and casting. Main Outcomes and Measures: The primary outcome was the 24-month Michigan Hand Outcomes Questionnaire (MHQ) summary score. Secondary outcomes were scores on the MHQ subdomains hand strength and wrist motion. Results: A total of 304 adults were recruited for the study, and 187 were randomized to undergo surgery, 65 to VLPS, 64 to EFP, and 58 to CRPP; 117 participants opted for closed reduction and casting. Assessments were completed at 24 months for 182 participants (160 women [87.9%]; mean [SD] age, 70.1 [8.5] years). Mean MHQ summary scores at 24 months were 88 (95% CI, 83-92) for VLPS, 83 (95% CI, 78-88) for EFP, 85 (95% CI, 79-90) for CRPP, and 85 (95% CI, 79-90) for casting, with no clinically meaningful difference across groups after adjusting for covariates (χ23 = 1.44; P = .70). Pain scores also did not differ across groups at 24 months (χ23 = 2.64; P = .45). MHQ summary scores changed from 82 (95% CI, 80-85) to 85 (95% CI, 83-88) (P = .12) between 12 and 24 months across groups. The rate of malunion was higher in the casting group (26 participants [59.1%]) than in the other groups (4 participants [8.0%] for VLPS, 8 participants [17.0%] for EFP, and 4 participants [9.8%] for CRPP; χ23 = 43.6; P < .001), but malunion was not associated with the 24-month outcome difference across groups. Conclusions and Relevance: The study did not find clinically meaningful patient-reported outcome differences 24 months after injury across treatment groups, with little change between 12 and 24 months. These findings suggest that long-term outcomes need not necessarily be considered in deciding between treatment options. Patient needs and recovery goals that fit to relative risks and benefits of each treatment type will be more valuable in treatment decision-making. Trial Registration: ClinicalTrials.gov Identifier: NCT01589692.

Prevalence of psychotropic and opioid prescribing among hospice beneficiaries in the United States, 2014-2016.

BACKGROUND/OBJECTIVES: Psychotropic and opioid medications are routinely prescribed for symptom management in hospice, but national estimates of prescribing are lacking. Changes in Medicare hospice payment in 2014 provide the first opportunity to examine psychotropic and opioid prescribing among hospice beneficiaries, and the factors associated with use of specific medication classes. DESIGN: Cross-sectional analysis of a 20% sample of traditional and managed Medicare with Part D enrolled in hospice, 2014-2016. SETTING: Beneficiaries enrolled in the Medicare hospice benefit. PARTICIPANTS: Medicare beneficiaries ≥65 newly enrolled in hospice between July 1, 2014 and December 31, 2016 (N = 554,022). MAIN OUTCOME: Prevalence of psychotropic and opioid medication prescribing by class and factors associated with prescribing. RESULTS: 70.3% of hospice beneficiaries were prescribed a psychotropic and 63.3% were prescribed an opioid. The most common psychotropic classes prescribed were: benzodiazepines (60.6%), antipsychotics (38.3%), antidepressants (18.4%), and antiepileptics (10.2%). Lorazepam (56.4%), morphine (52.8%), and haloperidol (28.6%) were received by the most beneficiaries. Prevalence of any psychotropic and opioid prescription was highest among beneficiaries who were female (76.7%), non-Hispanic white (76.6%), and those with cancer (78.9%). Compared to white beneficiaries, non-Hispanic black beneficiaries were less likely to receive nearly every class of medication, with significantly lower odds of receiving opioids (64.1% vs 57.9%; AOR 0.75, 95% CI 0.72-0.77) and benzodiazepines (61.6% vs 52.2%; AOR 0.66, 95% CI 0.64-0.68). Differences were seen across hospice diagnosis; those with cancer were more likely to receive opioids, benzodiazepines, and antipsychotics but less likely to receive antidepressants and antiepileptics. CONCLUSIONS: Psychotropic and opioid medications are frequently prescribed in hospice. Observed variations in prescribing across race and ethnicity may reflect disparities in prescribing as well as patient preferences for care. Further work is important to understand factors driving prescribing given limited studies surrounding medication prescribing in hospice.

Impact of Unilateral versus Bilateral Breast Reconstruction on Procedure Choices and Outcomes.

BACKGROUND: In choosing between implant-based and autologous breast reconstruction, surgeons and patients must weigh relative risks and benefits. However, differences in outcomes across procedure types may vary between unilateral versus bilateral reconstructions. Procedure-related differences in complications and patient-reported outcomes were evaluated for unilateral and bilateral reconstruction. METHODS: Complications and patient-reported outcomes (BREAST-Q and Patient-Reported Outcomes measurement Information System surveys) were assessed at 2 years for patients undergoing autologous or implant-based reconstructions. Stratified regression models compared outcomes between autologous and implant-based reconstructions, separately for unilateral and bilateral cohorts. RESULTS: Among 2125 patients, 917 underwent unilateral (600 implant and 317 autologous) and 1208 underwent bilateral (994 implant and 214 autologous) reconstructions. Complication rates were significantly higher in the autologous versus implant-based group for both unilateral (overall: OR, 2.50, p < 0.001; major: OR, 2.19, p = 0.001) and bilateral (overall: OR, 2.13, p < 0.001; major: OR, 1.69, p = 0.014) cohorts. In unilateral reconstruction, the autologous group demonstrated significantly better patient-reported outcomes versus implant-based group in satisfaction with breast (mean difference, 9.85; p < 0.001), psychosocial well-being (mean difference, 4.84; p = 0.006), and sexual well-being (mean difference, 11.42; p < 0.001). In bilateral reconstruction, the autologous group demonstrated significantly higher patient-reported outcomes only for satisfaction with breast (mean difference, 5.13; p = 0.001). CONCLUSIONS: Although autologous reconstruction is associated with significantly better patient-reported outcomes compared to implant-based techniques in unilateral reconstruction, procedure choice has far less impact in bilateral reconstruction. Autologous procedures have higher complications rates in both unilateral and bilateral settings. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Cost-effectiveness of real-world administration of tobacco pharmacotherapy in the United States Veterans Health Administration.

BACKGROUND AND AIMS: Cost-effectiveness studies in randomized clinical trials have shown that tobacco cessation pharmacotherapy is among the most cost-effective of health-care interventions. Clinical trial eligibility criteria and treatment protocols may not be followed in actual practice. This study aimed to determine whether tobacco cessation pharmacotherapy is cost-effective in real-world settings. DESIGN: A retrospective analysis of costs and outcomes. SETTING: Hospitals and clinics of the US Veterans Health Administration, USA. PARTICIPANTS: A total of 589 862 US veterans who screened positive for tobacco use in 2011. INTERVENTION AND COMPARATOR: Tobacco users who initiated smoking cessation pharmacotherapy in the 6 months after screening were compared with those who did not use pharmacotherapy in this period. Pharmacotherapy included nicotine replacement therapy, bupropion (if prescribed at 300 mg per day or specifically for tobacco cessation) or varenicline. MEASURES: Effectiveness was determined from responses to a subsequent tobacco screening conducted between 7 and 18 months after the treatment observation period. Cost of medications and prescribing health-care encounters was determined for the period between initial and follow-up tobacco use screening. Multivariate fixed-effects regression was used to assess the effect of initial treatment status on cost and outcome while controlling for differences in case-mix with propensity weighting to adjust for confounding by indication. FINDINGS: Thirteen per cent of participants received tobacco cessation pharmacotherapy within 6 months of initial screening. After an average of an additional 218.1 days' follow-up, those who initially received pharmacotherapy incurred $143.79 in additional treatment cost and had a 3.1% absolute increase in tobacco quit rates compared with those who were not initially treated. This represents an incremental cost-effectiveness ratio of $4705 per quit. The upper limit of the 99.9% confidence region was $5600 per quit. Without propensity adjustment, the cost-effectiveness ratio was $7144 per quit, with the upper limit of the 99.9% confidence region $9500/quit. CONCLUSIONS: Tobacco cessation pharmacotherapy provided by the US Veterans Health Administration in 2011/12 was cost-effective in this real-world setting, with an incremental cost-effectiveness ratio of $4705 per quit.

Self-Management in Long-Term Prostate Cancer Survivors: A Randomized, Controlled Trial.

PURPOSE: This randomized clinical trial compared a personally tailored, automated telephone symptom management intervention to improve self-management among long-term survivors of prostate cancer with usual care enhanced with a nontailored newsletter about symptom management. We hypothesized that intervention-group participants would have more confident symptom self-management and reduced symptom burden. METHODS: A total of 556 prostate cancer survivors who, more than 1 year after treatment, were experiencing symptom burden were recruited from April 2015 to February 2017 across four Veterans Affairs sites. Participants were randomly assigned to intervention (n = 278) or usual care (n = 278) groups. We compared differences in the primary (symptom burden according to Expanded Prostate Cancer Index Composite-26 [EPIC], confidence in self-management) and secondary outcomes between groups using intent-to-treat analyses. We compared domain-specific changes in symptom burden from baseline to 5 and 12 months among the intervention group according to the primary symptom focus area (urinary, bowel, sexual, general) of participants. RESULTS: Most of the prostate cancer survivors in this study were married (54.3%), were white (69.2%), were retired (62.4%), and underwent radiation therapy (56.7% v 46.2% who underwent surgery), and the mean age was 67 years. There were no baseline differences in urinary, bowel, sexual, or hormonal domain EPIC scores across groups. We observed higher EPIC scores in the intervention arm in all domain areas at 5 months, though differences were not statistically significant. No differences were found in secondary outcomes; however, coping appraisal was higher (2.8 v 2.6; P = .02) in intervention-arm patients at 5 months. In subgroup analyses, intervention participants reported improvement from baseline at 5 and 12 months in their symptom focus area domains. CONCLUSION: This intervention was well received among veterans who were long-term survivors of prostate cancer. Although overall outcome differences were not observed across groups, the intervention tailored to symptom area of choice may hold promise to improve associated burden.

Effectiveness of tobacco cessation pharmacotherapy in the Veterans Health Administration.

INTRODUCTION: In 2003, the Veterans Health Administration (VHA) implemented a directive that cessation pharmacotherapy be made available to all who use tobacco and are interested in quitting. Despite the efficacy of cessation pharmacotherapy shown in clinical trials, the generalisability of the results in real-world settings has been challenged. Hence, the specific aim of this study was to determine the effectiveness of cessation pharmacotherapies in the VHA. METHODS: This retrospective cohort study used VHA's electronic medical record data to compare quit rates among those who use tobacco and who did vs. did not receive any type of cessation pharmacotherapy. Included were 589 862 Veterans identified as current tobacco users during fiscal year 2011 who had not received cessation pharmacotherapy in the prior 12 months. Following a 6-month period to assess treatment, quit rates among those who were treated versus untreated were compared during the 7-18 months (12 months) post-treatment follow-up period. The estimated treatment effect was calculated from a logistic regression model adjusting for inverse probability of treatment weights (IPTWs) and covariates. Marginal probabilities of quitting were also obtained among those treated versus untreated. RESULTS: Adjusting for IPTWs and covariates, the odds of quitting were 24% higher among those treated versus untreated (OR=1.24, 95% CI 1.23 to 1.25, p<0.001). The marginal probabilities of quitting were 16.7% for the untreated versus 19.8% for the treated based on the weighted model. CONCLUSION: The increased quit rates among Veterans treated support the effectiveness and continuation of the VHA tobacco cessation pharmacotherapy policy.

Trends and Patient Characteristics Associated with Tobacco Pharmacotherapy Dispensed in the Veterans Health Administration.

Introduction: There is evidence suggesting that certain subgroups of people who use tobacco do not receive tobacco pharmacology as consistently as others. Methods: This retrospective, cohort study examined the trend in the use of cessation pharmacotherapy from 2004 to 2013 using Veterans Health Administration (VHA) administrative data. Among Veterans who used tobacco in the fiscal year (FY) 2011 and had not received pharmacotherapy in the prior year, multivariable Cox regression was used to assess the independent associations between patient clinical and demographic characteristics and pharmacotherapy initiation in the 6-months follow-up period. Results: Smoking cessation pharmacotherapy in the VHA increased from 13.8% in 2004 to 25.6% in 2013. In 2011, Veterans (N = 838309) who were more likely to newly receive pharmacotherapy included those with psychiatric disorders (depression, bipolar disorder, non-alcohol substance use disorder, other anxiety, and post-traumatic stress disorder), chronic pulmonary disease, peripheral vascular disorders, and younger Veterans (adjusted rate ratios (ARRs) ranged from 1.03 to 1.92, all p < .001). Veterans less likely to receive pharmacotherapy were those with schizophrenia or other psychosis, males, Hispanics, and those with a medical condition (uncomplicated diabetes, uncomplicated hypertension, fluid and electrolyte disorders, cardiac arrhythmia, valvular disease, hypothyroidism, acquired immunodeficiency syndrome/human immunodeficiency virus, deficiency anemia, renal failure, paralysis, coagulopathy, metastatic cancer, and other neurological disorders) (ARRs ranged from 0.74 to 0.93, all p < .001). Conclusions: Although VHA cessation pharmacotherapy use nearly doubled from 13.8% in 2004 to 25.6% in 2013, reaching undertreated subgroups, especially those with medical comorbidities, may improve cessation outcomes. Implications: Despite evidence that demographics influence the use of pharmacotherapy in smoking cessation, there is limited and contradictory information regarding how psychiatric and chronic medical illnesses affect pharmacotherapy use. Administrative data were used to determine trends and patient characteristics of those receiving pharmacotherapy to aid in smoking cessation in the Veterans Health Administration. From 2004 to 2013, pharmacotherapy use increased from 13.8% to 25.6% of current smokers. Factors associated with increased pharmacotherapy initiation were psychiatric disorders, chronic pulmonary disease, peripheral vascular disorders, and younger age. Veterans with schizophrenia or other psychosis, males, Hispanics, and most medical conditions were less likely to receive pharmacotherapy.

Efficacy and Tolerability of Guanylate Cyclase-C Agonists for Irritable Bowel Syndrome with Constipation and Chronic Idiopathic Constipation: A Systematic Review and Meta-Analysis.

OBJECTIVES: Linaclotide and plecanatide are guanylate cyclase-C (GCC) agonists for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Our objective is to evaluate the efficacy and tolerability of GCC agonists based on data from multiple randomized controlled trials (RCTs). METHODS: We searched PubMED, EMBASE, Cochrane databases, clinicaltrials.gov, major conference abstracts, Food and Drug Administration (FDA) websites, and United States Securities and Exchange Commission filings of drug sponsors to identify RCTs of CIC or IBS-C patients. We assessed efficacy based on FDA-approved composite responder endpoints, diarrhea as an adverse event, and study withdrawal owing to diarrhea for each therapy. Trial results were pooled using DerSimonian and Laird random effects model of meta-analysis and exact logistic regression when appropriate with 95% confidence intervals. Meta-regression was performed to compare outcomes between therapies adjusting for placebo event rate. RESULTS: Eight linaclotide trials (five CIC; three IBS-C) and seven plecanatide trials (four CIC; three IBS-C) evaluating 10,369 patients met inclusion criteria. FDA publications documented that different definitions for diarrhea were used in linaclotide vs. plecanatide trials. Both drugs were efficacious in treating CIC (linaclotide 72 µg (Odds ratio (OR)=3.11, 95% CI 1.81-5.34); linaclotide 145 µg (OR=3.25, 2.15-4.91); plecanatide 3 mg (OR=1.99, 1.57-2.51)) and IBS-C (linaclotide 290 µg (OR=2.43, 1.48-3.98); plecanatide 3 mg (OR=1.87, 1.47-2.38); plecanatide 6 mg (OR=1.92, 1.48-2.48)). Diarrhea occurred in excess of placebo in treating CIC (linaclotide 72 µg (OR=3.07, 1.97-4.77); linaclotide 145 µg (OR=3.70, 2.69-5.10); plecanatide 3 mg (OR=3.86, 1.83-8.12)) and IBS-C (linaclotide 290 µg (OR=8.02, 5.20-12.37); plecanatide 3 mg (OR=5.55, 1.62-19.00); plecanatide 6 mg (OR=4.13, 1.57-10.83)). Based on meta-regression, there were no statistically significant differences between therapies in odds ratios for efficacy, diarrhea, or diarrhea-related study withdrawals. CONCLUSIONS: Both linaclotide and plecanatide demonstrate similar efficacy and tolerability in treating IBS-C and CIC. No differences in odds of diarrhea were seen between linaclotide and plecanatide.

Complications and Patient-Reported Outcomes after Abdominally Based Breast Reconstruction: Results of the Mastectomy Reconstruction Outcomes Consortium Study.

BACKGROUND: Abdominal flap reconstruction is the most popular form of autologous breast reconstruction. The current study compared complications and patient-reported outcomes after pedicled transverse rectus abdominis myocutaneous (TRAM), free TRAM, deep inferior epigastric perforator (DIEP), and superficial inferior epigastric artery (SIEA) flaps. METHODS: Patients undergoing abdominally based breast reconstruction at 11 centers were prospectively evaluated for abdominal donor-site and breast complications. Patient-reported outcomes were measured by the BREAST-Q and Patient-Reported Outcomes Measurement Information System surveys. Mixed-effects regression models were used to assess the effects of procedure type on outcomes. RESULTS: Seven hundred twenty patients had 1-year follow-up and 587 had 2-year follow-up. Two years after reconstruction, SIEA compared with DIEP flaps were associated with a higher rate of donor-site complications (OR, 2.7; p = 0.001); however, SIEA flaps were associated with higher BREAST-Q abdominal physical well-being scores compared with DIEP flaps at 1 year (mean difference, 4.72, on a scale from 0 to 100; p = 0.053). This difference was not significant at 2 years. Abdominal physical well-being scores at 2 years postoperatively were lower in the pedicled TRAM flap group by 7.2 points (p = 0.006) compared with DIEP flaps and by 7.8 points (p = 0.03) compared with SIEA flaps, and in the free TRAM flap group, scores were lower by 4.9 points (p = 0.04) compared with DIEP flaps. Bilateral reconstruction had significantly lower abdominal physical well-being scores compared with unilateral reconstruction. CONCLUSIONS: Although all abdominally based flaps are viable breast reconstruction options, DIEP and SIEA flaps are associated with higher abdominal physical well-being than pedicled and free TRAM flaps. Although SIEA flaps offer the advantage of not violating the fascia, higher rates of donor-site complications may diminish patient satisfaction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Impact of Bilateral Prophylactic Mastectomy and Immediate Reconstruction on Health-Related Quality of Life in Women at High Risk for Breast Carcinoma: Results of the Mastectomy Reconstruction Outcomes Consortium Study.

BACKGROUND: Although bilateral prophylactic mastectomy (BPM) can reduce the risk of breast cancer, the decision to proceed surgically can have significant consequences and requires careful deliberation. To facilitate decision making for women at high risk for breast carcinoma, the risks and benefits of BPM should be well-elucidated. We sought to determine the effects of BPM and immediate reconstruction on health-related quality-of-life outcomes among a multisite cohort of women at high risk for breast carcinoma. METHODS: Patient-reported outcome data were prospectively collected as part of the Mastectomy Reconstruction Outcomes Consortium Study, and data on a subgroup of 204 high-risk women who elected to have BPM and immediate reconstruction were evaluated. Baseline scores were compared with scores at 1 or 2 years after reconstruction. RESULTS: Satisfaction with breasts and psychosocial well-being were significantly higher at both 1 and 2 years (p < 0.01); however, anxiety was significantly lower at 1 or 2 years (p < 0.01) and physical well-being of the chest and upper body was significantly worse at 1 year (p < 0.01). CONCLUSION: Our results highlight the impact of BPM and immediate reconstruction on health-related quality-of-life outcomes in this setting. BPM and reconstruction can result in significant, positive, lasting changes in a woman's satisfaction with her breasts, as well as her psychosocial well-being. Furthermore, presurgery anxiety was significantly reduced by 1 year post-reconstruction and remained reduced at 2 years. With this knowledge, women at high risk for breast carcinoma, and their providers, will be better equipped to make the best individualized treatment decisions.

Optimizing veteran-centered prostate cancer survivorship care: study protocol for a randomized controlled trial.

BACKGROUND: Although prostate cancer is the most common cancer among veterans receiving care in the Veterans Health Administration (VA), more needs to be done to understand and improve survivorship care for this large population. This study, funded by VA Health Services Research & Development (HSR&D), seeks to address the need to improve patient-centered survivorship care for veterans with prostate cancer. METHODS/DESIGN: This is a two-armed randomized controlled trial (RCT) with a target enrollment of up to 325 prostate cancer survivors per study arm (total anticipated n = 600). Patients will be recruited from four VA sites. Patient eligibility criteria include age range of 40-80 years, one to ten years post-treatment, and currently experiencing prostate cancer symptom burden. We will compare the "Building Your New Normal" program, a personally-tailored automated telephone symptom management intervention for improving symptom self-management to usual care enhanced with a non-tailored newsletter about symptom management. Primary outcomes include changes in symptom burden, bother, and health services utilization at five and 12 months after enrollment. Secondary outcomes include long-term psychosocial outcomes (e.g. subjective health, perceived cancer control). We will use multivariable regression analysis to evaluate the impact of the intervention on primary and secondary outcomes. We will conduct a process evaluation to understand the effective intervention components and explore possibilities for broader implementation and dissemination. DISCUSSION: Our central hypothesis is that intervention group participants will have improved and more confident symptom self-management and prostate cancer quality of life following the intervention and that these outcomes will translate to more efficient use of health services. The study results will provide much needed information about how to optimize the quality of care, and life, of veteran prostate cancer survivors. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT01900561 ; Registered on 22 July 2013.

Real-Time Characterization of Diminutive Colorectal Polyp Histology Using Narrow-Band Imaging: Implications for the Resect and Discard Strategy.

BACKGROUND & AIMS: Narrow-band imaging (NBI) allows real-time histologic classification of colorectal polyps. We investigated whether endoscopists without prior training in NBI can achieve the following thresholds recommended by the American Society for Gastrointestinal Endoscopy: for diminutive colorectal polyps characterized with high confidence, a ≥90% negative predictive value for adenomas in the rectosigmoid and a ≥90% agreement in surveillance intervals. METHODS: Twenty-six endoscopists from 2 tertiary care centers underwent standardized training in NBI interpretation. Endoscopists made real-time predictions of diminutive colorectal polyp histology and surveillance interval predictions based on NBI. Their performance was evaluated by comparing predicted with actual findings from histologic analysis. Multilevel logistic regression was used to assess predictors of performance. Cumulative summation analysis was used to characterize learning curves. RESULTS: The endoscopists performed 1451 colonoscopies and made 3012 diminutive polyp predictions (74.3% high confidence) using NBI. They made 898 immediate post-procedure surveillance interval predictions. An additional 505 surveillance intervals were determined with histology input. The overall negative predictive value for high-confidence characterizations in the rectosigmoid was 94.7% (95% confidence interval: 92.6%-96.8%) and the surveillance interval agreement was 91.2% (95% confidence interval: 89.7%-92.7%). Overall, 97.0% of surveillance interval predictions would have brought patients back on time or early. High-confidence characterization was the strongest predictor of accuracy (odds ratio = 3.42; 95% confidence interval: 2.72-4.29; P < .001). Performance improved over time, however, according to cumulative summation analysis, only 7 participants (26.9%) identified adenomas with sufficient sensitivity such that further auditing is not required. CONCLUSIONS: With standardized training, gastroenterologists without prior expertise in NBI were able to meet the negative predictive value and surveillance interval thresholds set forth by the American Society for Gastrointestinal Endoscopy. The majority of disagreement in surveillance interval brought patients back early. Performance improves with time, but most endoscopists will require ongoing auditing of performance. ClinicalTrials.gov ID NCT02441998.

Understanding the recovery phase of breast reconstructions: Patient-reported outcomes correlated to the type and timing of reconstruction.

INTRODUCTION: During preoperative discussions with breast reconstruction patients, questions often arise about what to expect during the recovery period. However, there is a paucity of data elucidating post-breast reconstruction pain, fatigue, and physical morbidity. This information is important to patient and physician understanding of reconstructive choices and the postoperative recovery process. We sought to evaluate how recovery may vary for patients based on the timing and type of reconstruction. MATERIALS AND METHODS: Patients were recruited as part of the Mastectomy Reconstruction Outcomes Consortium (MROC) study, which is a prospective, multicentered National Institute of Health (NIH)-funded study (1RO1CA152192). Here, patients completed the Numerical Pain Rating Scale (NPRS), McGill Pain Questionnaire, and Breast-Q preoperatively, at 1 week, and 3 months postoperatively. Pain, fatigue, and upper body morbidity were evaluated by the type and timing of reconstruction. RESULTS: A total of 2013 MROC study participants had completed a 3-month follow-up, and therefore they were included for the analysis. A total of 1583 (78.6%) and 1517 patients (75.3%) completed surveys at 1 week and 3 months, respectively, post reconstruction. Across all procedure groups, fatigue and physical well-being scores did not return to preoperative levels by 3 months. At 3 months, pain measured by the NPRS differed across procedure types (P = 0.01), with tissue expander/implant (TE/I) having more pain than direct to implant (P < 0.01). Similarly, at 3 months, chest and upper body physical morbidity, as measured by BREAST-Q, differed by procedure types (P < 0.001), with generally less morbidity for autologous reconstruction as compared with TE/Is. CONCLUSIONS: For all reconstructive procedure groups, patients did not fully recover at 3 months post surgery. In addition, postoperative pain and upper body physical morbidity vary significantly by reconstructive procedure with patients undergoing TE/I reporting the most distress.

Integrating massage therapy within the palliative care of veterans with advanced illnesses: an outcome study.

AIMS: To describe the integration of massage therapy into a palliative care service and to examine the relationship between massage and symptoms in patients with advanced illnesses. METHODS: Between April 1, 2009, and July 31, 2010, 153 patients received massage at the VA Ann Arbor Health Care System. Data on pain, anxiety, dyspnea, relaxation, and inner peace were collected pre and post massage. Diagnoses, chronic pain, and social support were also abstracted. Analysis of covariance was used to examine changes over time. RESULTS: All short-term changes in symptoms showed improvement and all were statistically significant. Pain intensity decreased by 1.65 (0-10 scale, P < .001), anxiety decreased by 1.52 (0-10 scale, P < .001), patients' sense of relaxation increased by 2.92 (0-10 scale, P < .001), and inner peace improved by 1.80 (0-10 scale, P < .001). CONCLUSION: Massage is a useful tool for improving symptom management and reducing suffering in palliative care patients.

Validation of key behaviourally based mental health diagnoses in administrative data: suicide attempt, alcohol abuse, illicit drug abuse and tobacco use.

BACKGROUND: Observational research frequently uses administrative codes for mental health or substance use diagnoses and for important behaviours such as suicide attempts. We sought to validate codes (International Classification of Diseases, 9th edition, clinical modification diagnostic and E-codes) entered in Veterans Health Administration administrative data for patients with depression versus a gold standard of electronic medical record text ("chart notation"). METHODS: Three random samples of patients were selected, each stratified by geographic region, gender, and year of cohort entry, from a VHA depression treatment cohort from April 1, 1999 to September 30, 2004. The first sample was selected from patients who died by suicide, the second from patients who remained alive on the date of death of suicide cases, and the third from patients with a new start of a commonly used antidepressant medication. Four variables were assessed using administrative codes in the year prior to the index date: suicide attempt, alcohol abuse/dependence, drug abuse/dependence and tobacco use. RESULTS: Specificity was high (≥ 90%) for all four administrative codes, regardless of the sample. Sensitivity was ≤75% and was particularly low for suicide attempt (≤ 17%). Positive predictive values for alcohol dependence/abuse and tobacco use were high, but barely better than flipping a coin for illicit drug abuse/dependence. Sensitivity differed across the three samples, but was highest in the suicide death sample. CONCLUSIONS: Administrative data-based diagnoses among VHA records have high specificity, but low sensitivity. The accuracy level varies by different diagnosis and by different patient subgroup.

The effect of study design biases on the diagnostic accuracy of magnetic resonance imaging for detecting silicone breast implant ruptures: a meta-analysis.

BACKGROUND: The U.S. Food and Drug Administration has recommended that all silicone breast implant recipients undergo serial screening to detect implant rupture with magnetic resonance imaging. The authors performed a systematic review and meta-analysis to examine the effect of study design biases on the estimation of magnetic resonance imaging diagnostic accuracy measures. METHODS: Studies were identified using the MEDLINE, EMBASE, ISI Web of Science, and Cochrane library databases. Two reviewers independently screened potential studies for inclusion and extracted data. Study design biases were assessed using the Quality of Diagnostic Accuracy Studies tool and the Standards for Reporting of Diagnostic Accuracy Studies checklist. Meta-analyses estimated the influence of biases on diagnostic odds ratios. RESULTS: Among 1175 identified articles, 21 met the inclusion criteria. Most studies using magnetic resonance imaging (10 of 16) and ultrasound (10 of 13) examined symptomatic subjects. Magnetic resonance imaging studies evaluating symptomatic subjects had 14-fold higher diagnostic accuracy estimates compared with studies using an asymptomatic sample (relative diagnostic odds ratio, 13.8; 95 percent confidence interval, 1.83 to 104.6) and 2-fold higher diagnostic accuracy estimates compared with studies using a screening sample (relative diagnostic odds ratio, 1.89; 95 percent confidence interval, 0.05 to 75.7). CONCLUSIONS: Many of the published studies using magnetic resonance imaging or ultrasound to detect silicone breast implant rupture are flawed with methodologic biases. These methodologic shortcomings may result in overestimated magnetic resonance imaging diagnostic accuracy measures and should be interpreted with caution when applying the data to a screening population.