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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
April 14, 2018

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Diagnosing Nonceliac Gluten Sensitivity in Children
Lower Vaccination Rates in Children Following an Autism Spectrum Disorder Diagnosis
Precipitants of Adolescent Suicide
Psychological Interventions Might Alleviate Some Menopausal Symptoms
Cognitive Charts as a Screening Tool for Dementia
High Cardiovascular Fitness in Midlife Tied to Lower Dementia Risk Later
Does Saline Irrigation during ERCP Reduce Biliary Stone Disease Recurrence?
A Simple Warning Light Reduces Fluoroscopy Exposure during ERCP
The Effect of Modest Alcohol Use in Patients with Nonalcoholic Steatohepatitis
Efficacy of Epilepsy Surgery in Children
Embracing Minimally Invasive Surgical Treatment for Endometrial Cancer
Prognosis for BRCA-Mutated Breast Cancer

Am J Gastroenterol 2018 Mar; 113:421
Diagnosing Nonceliac Gluten Sensitivity in Children
Findings highlight the importance of the double-blind, placebo-controlled gluten challenge in diagnosing NCGS.
Nonceliac gluten sensitivity (NCGS) is marked by intestinal and extraintestinal symptoms associated with gluten ingestion in people without celiac disease or wheat allergy. Eliminating gluten from the diet is increasingly popular in adults and children with abdominal symptoms.
To determine the prevalence of NCGS in children, researchers evaluated over 1100 children with functional gastrointestinal disorders (and no celiac disease or wheat allergy) and conducted a double-blind, placebo-controlled crossover trial among the 28 children who screened positive for NCGS (i.e., reported a 30% symptom reduction on a gluten-free diet). The 28 crossover trial participants, who remained on a gluten-free diet, were randomly assigned to a diet additive of gluten or rice starch (placebo) for 2 weeks, followed by a 1-week washout period, and then the alternate additive for 2 weeks. Participants underwent thorough diagnostic evaluations before and during the trial, including standardized questionnaires to evaluate symptoms.
Of the 28 children evaluated, 11 (39%) had NCGS based on validated criteria. The overall estimated prevalence of NCGS in children who are referred for GI symptoms, based on this trial, is between 0.4% and 1.0%.
COMMENT: This trial is the first of its kind in children. The primary drawback in researching NCGS is that there is no blood test that is diagnostic for this disorder. Instead, researchers must rely on questionnaires and visual analog scales to assess symptoms. In this study, they chose an arbitrary 30% decrease in symptoms to indicate gluten sensitivity. Most importantly, though, using this gluten challenge test enabled clinicians to reassure 60% of families and children presenting with chronic gastrointestinal symptoms that a gluten-free diet was unnecessary.
CITATION(S): Francavilla R et al. Randomized double-blind placebo-controlled crossover trial for the diagnosis of non-celiac gluten sensitivity in children. Am J Gastroenterol 2018 Mar; 113:421.
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JAMA Pediatr 2018 Mar 26
Lower Vaccination Rates in Children Following an Autism Spectrum
Disorder Diagnosis

Children with ASD and their younger siblings were undervaccinated compared with unaffected children.
Despite overwhelming evidence showing that no link exists between vaccination and autism spectrum disorder (ASD), parental concerns and vaccination hesitancy persist.
To examine whether a diagnosis of ASD affects subsequent childhood vaccination receipt, investigators retrospectively reviewed immunization records of over 3700 children (18% girls) born between 1995 and 2010 who received a diagnosis of ASD by age 5 years and a matched group of nearly 600,000 children without ASD (42% girls). Immunization records of younger siblings of both groups were also reviewed.
Children with ASD were significantly less likely to have received all vaccinations recommended at between ages 4 and 6 years (DTaP, IPV, MMR, VZV) compared with controls (82% vs. 94%). This was also true for receipt of specific vaccines, including MMR (84% vs. 96%). Vaccination rates did not differ between groups for the vaccines recommended at ages 11 to 12 (HPV, MCV4, Tdap). Vaccination rates were significantly lower in the younger siblings of children with ASD compared with the younger siblings of children without ASD, and the difference in the proportion of siblings fully vaccinated was greatest for siblings aged <12 months (73% vs. 85%) but was also significant for siblings aged 1 to 2 years (60% vs. 71%) and those aged 4 to 6 years (83% vs. 95%).
COMMENT: Undervaccinated children are at risk for serious and possibly fatal diseases. Although most parents understand the importance of vaccination and immunize their children completely, in families with children who have ASD, vaccination rates may be lower, particularly among young children. Healthcare providers should expand their conversations with these families to better inform them about the known risks for autism, vaccines not among them.
CITATION(S): Zerbo O et al. Vaccination patterns in children after autism spectrum disorder diagnosis and in their younger siblings. JAMA Pediatr 2018 Mar 26; [e-pub].
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MMWR Morb Mortal Wkly Rep 2018 Mar 23; 67:329
Precipitants of Adolescent Suicide
About 68% of teens had multiple precipitants, including depressed mood, prior ideation or attempts, interpersonal crises, and, in 13%, recently restricted use of technology.
Suicide rates among U.S. adolescents increased by 24% from 2011 to 2015, when it became the third leading cause of death in this age group. Using data from Utah for this period (where the rate had increased by 136%), investigators examined the 150 suicides among persons aged 10 to 17 years (male, 77%; ages 15–17, 75%).
Suffocation (mostly hanging/inhalations) or firearms, in almost equal numbers, accounted for >90% of the deaths. Among 142 decedents with available data, 68% had two or more precipitating circumstances, including mental health diagnosis, depressed mood near time of death, or both (59%); histories of suicidal ideation, prior attempt, or both (30%); a crisis within 2 weeks of death involving family (22%) or intimate partner (11%); cutting history (21%); and alcohol or one or more drugs in urine detected at death (20%). Among the 50 individuals with known mental health diagnoses, 84% were in treatment at time of death. In 13%, family conflicts were associated in some way with recent restrictions on use of technology (smartphones, computers, etc.).
COMMENT: We clearly need both improved understanding as to why suicide rates have been increasing and better “impending sign” education of clinicians, teachers, parents, and peers, all of whom should be encouraged to report or arrange for help when concerned or alarmed. Still, simply being in treatment does not necessarily improve coping, create protective environments, or deter suicide. Notably, for some adolescents, family crises rising to the level of restricting technology use may signify a particularly dangerous red line.
CITATION(S): Annor FB et al. Characteristics of and precipitating circumstances surrounding suicide among persons aged 10–17 years — Utah, 2011–2015. MMWR Morb Mortal Wkly Rep 2018 Mar 23; 67:329.
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BJOG 2018 Mar 15
Psychological Interventions Might Alleviate Some Menopausal Symptoms
Meta-analysis showed mindfulness training, cognitive-behavioral therapy, and behavior-based therapy to be helpful in relieving hot-flash bother.
Many women prefer not to use hormones (or cannot, for medical reasons such as breast cancer) to alleviate menopausal symptoms. In this meta-analysis of 12 randomized controlled trials (combined sample, 1016 women), researchers examined the effectiveness of psychological interventions — mindfulness-based, cognitive-behavioral, and behavior-based therapies — for alleviating such symptoms. Trial participants (including breast cancer survivors) used standardized scales to report hot-flash frequency, associated bother, general menopausal symptoms, and sexual activity. Control groups primarily consisted of women on waiting lists to receive these interventions. No studies continued beyond 1 year.
All psychological therapies showed modest, statistically significant, short-term (<20 weeks) benefits for hot-flash bother and general menopausal symptoms as well as a medium-term (≥20 weeks) benefit for hot-flash bother, but no significant benefit for short- or medium-term hot-flash frequency. Among subgroups, psychological interventions improved short- and medium-term hot-flash bother in women with both induced and natural menopause. No adverse effects occurred in any study. Analysis of effects on sexual function was not possible, as only two studies addressed this issue.
COMMENT: As the authors note, participants could not be blinded to the interventions, raising risk for bias. The finding that scores for hot-flash bother, but not frequency, improved with psychological interventions suggests that the beneficial effects of these therapies are most likely rooted in how women cope with uncomfortable symptoms rather than in reduction of the symptoms themselves. For women who have geographic (or electronic) and financial access, psychological strategies may be helpful in coping with menopause symptoms.
CITATION(S): van Dreil CMG et al. Mindfulness, cognitive behavioural and behaviour-based therapy for natural and treatment-induced menopausal symptoms: A systematic review and meta-analysis. BJOG 2018 Mar 15; [e-pub].
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CMAJ 2017 Dec 4; 189:E1472
Cognitive Charts as a Screening Tool for Dementia
Cognitive decline charts may assist in screening for dementia in older adults.
Cognitive charts using percentile curves — similar to pediatric growth charts — could help determine whether a patient has developed dementia, suggests an article in the Canadian Medical Association Journal.
Researchers used a Canadian cohort of over 6000 healthy adults aged 65 and older and 1200 adults with dementia to construct the QuoCo tool. The model considers the patient's age, years of education, and scores on the Mini-Mental State Examination (MMSE) at 0, 5, and 10 years. For identifying patients with dementia in the training sample, the charts had a sensitivity of 80%, a specificity of 89%, and a negative predictive value of 99%, compared with a fixed MMSE cut point for dementia.
A decline in the charts should prompt further clinical evaluation, the authors write.
COMMENT — NEUROLOGY: These validated cognitive charts provide an opportunity to track cognitive changes over time, especially in a busy clinical setting. The presence of cognitive decline could prompt clinicians to refer for further evaluation for dementia. However, since the cognitive charts were developed comparing healthy controls and those with dementia, they may not be as effective in distinguishing between normal cognition and mild cognitive impairment in patients with subtle cognitive changes. The charts were developed to be used in those 65 years and older; their utility in mid-life has not been determined.
CITATION(S): Bernier PJ et al. Validation and diagnostic accuracy of predictive curves for age-associated longitudinal cognitive decline in older adults. CMAJ 2017 Dec 4; 189:E1472.
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Neurology 2018 Mar 14
High Cardiovascular Fitness in Midlife Tied to Lower Dementia Risk Later
Greater cardiovascular fitness in midlife is linked to reduced risk for later dementia.
Women with a high level of cardiovascular fitness at midlife may have a reduced risk for dementia years later, a Neurology study suggests.
Nearly 200 Swedish women aged 38 to 60 underwent a cycling test that measured cardiovascular fitness based on maximal exertion capacity. They were then followed for an average of 29 years, during which 23% were diagnosed with dementia (at a mean age of 80) using objective assessments that included repeated neuropsychiatric evaluations.
Compared with women who had medium cardiovascular fitness at baseline, those with high fitness levels had an 88% lower risk for dementia during follow-up. Additionally, those with high fitness were about 11 years older when they developed dementia, relative to medium-fitness women.
The researchers write, “Improved cardiovascular fitness in midlife might be a modifiable factor to delay or prevent dementia. Findings are not causal, and future research needs to focus on whether improved fitness could have positive effects on dementia risk.”
COMMENT — NEUROLOGY: These results provide additional support for optimizing midlife cardiovascular fitness to optimize brain health and potentially delay dementia onset in women, although the study is limited by the attrition rate (15% were alive at the end of the study) and a lack of longitudinal fitness measures. Genetic contribution to risk also was not assessed. Promoting a healthy lifestyle that includes cardiovascular fitness remains a promising strategy for brain health, but more research is still needed (NEJM JW Neurol Jan 2018 and NEJM JW Neurol May 2018).
CITATION(S): Hörder H et al. Midlife cardiovascular fitness and dementia: A 44-year longitudinal population study in women. Neurology 2018 Mar 14; [e-pub].
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Am J Gastroenterol 2018 Apr; 113:548
Does Saline Irrigation During ERCP Reduce Biliary Stone Disease Recurrence?
Possibly, and given its simplicity, safety, and low cost, a saline flush is worth considering.
A relative paucity of data exists on the recurrence rate of common bile duct (CBD) stones after endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy and duct clearance. In the current prospective study, researchers randomized some 150 patients to undergo ERCP for CBD stones with or without preventive saline irrigation of the bile ducts after duct clearance. Irrigation entailed 100 mL of sterile saline flushed into the biliary tree via a catheter. Follow-up was performed via labs, imaging, and ERCP over a 12-month period.
The incidence of residual CBD stones within 6 months was 7% in irrigation recipients and 23% in nonrecipients (P=0.01). Multivariate analysis demonstrated that saline irrigation and the presence of only one CBD stone were significantly associated with lower recurrence risk. There were no between-group differences in adverse events.
COMMENT: The idea that a simple saline flush could reduce stone recurrence is appealing, as flushing can be performed quickly and inexpensively. The concept makes intuitive sense — what is likely being flushed out are microscopic stone fragments that could potentially develop into stones. One concern about this study is that the overall rates of stone recurrence are very high in both groups — certainly higher than I see in my high-volume ERCP practice — and this is somewhat hard to reconcile. Furthermore, some of the patients who were classified as having recurrent stones had labs and imaging suggestive of stones but did not clearly have symptoms of stone disease. This lessens the impact of the study, as some of these stones may have been clinically insignificant, may have simply gone on to pass through the previously performed sphincterotomy, or both. Still, preventive saline irrigation of the bile ducts is at least worth considering given its low cost and low-risk profile.
CITATION(S): Ahn DW et al. Effects of saline irrigation of the bile duct to reduce the rate of residual common bile duct stones: A multicenter, prospective, randomized study. Am J Gastroenterol 2018 Apr; 113:548.
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Gastrointest Endosc 2018 Mar 17
A Simple Warning Light Reduces Fluoroscopy Exposure During ERCP
The overall reduction in radiation dose per patient was equivalent to 21 chest radiographs.
Modern fluoroscopy units create high-resolution images during endoscopic retrograde cholangiopancreatography (ERCP) with relatively low radiation exposure for patients. Still, all procedures that use radiation should adhere to the ALARA (as low as reasonably achievable) principle to minimize fluoroscopy use.
To test if a simple light — placed atop the endoscopy monitor in view of the endoscopist — could serve as a reminder to minimize fluoroscopy use during ERCP, investigators conducted a single-center, prospective, randomized trial involving 200 patients undergoing the procedure with or without use of the light, which flashed when the fluoroscope pedal was depressed.
The median fluoroscopy time (FT) was reduced when the light was used versus not used (142.5 vs. 175.0 seconds; P=0.045), as was the dose-area product (DAP; 856.8 vs. 1054.4 μGy•m2; P=0.043). On multivariable analysis, use of the light reduced FT by 15.4% (27 seconds; P=0.042) and DAP by 15.2% (160.3 μGy•m2). The overall reduction in the radiation dose per patient was 0.42 mSv, roughly the amount received from 21 chest radiographs. The light was not felt to interfere with the ERCP procedures.
COMMENT: This study shows that awareness of a problem is part of the solution. A simple light that indicated use of fluoroscopy allowed endoscopists to complete ERCP procedures with less radiation exposure without compromising clinical care. Of note, modern fluoroscopy units often come with such a light as a standard feature, but many operators may ignore it if it is not directly in their line of sight. In my experience, training in radiation safety reduces fluoroscopy use during ERCP, but many gastroenterology fellows receive no such instruction. All physicians using fluoroscopy should take a basic radiation safety course to understand fluoroscopy risk and ensure safe usage. With practice, most ERCP procedures can be accomplished with a minimum of fluoroscopy, and simple tricks such as reducing the frame rate and using spot fluoroscopy can dramatically reduce exposure to patients and staff.
Note to readers: At the time we reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made.
CITATION(S): Zeng HZ et al. A pilot single-center prospective randomized trial to assess the short-term effect of a flashing warning light on reducing fluoroscopy time and radiation exposure during ERCP. Gastrointest Endosc 2018 Mar 17; [e-pub].
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Clin Gastroenterol Hepatol 2018 Mar 14
The Effect of Modest Alcohol Use in Patients with Nonalcoholic Steatohepatitis
Longitudinal data suggest that having 1 or 2 drinks daily worsens liver histology.
Although there is evidence that cardiovascular health is improved with modest alcohol use, it is discouraged among patients with liver disease, owing to the potential for synergistic liver injury. Nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH) is one of the most common causes of liver disease, and up to two thirds of these patients continue to drink alcohol. What is the effect of this?
Included were some 285 participants in the NASH Clinical Research Network (NASH-CRN) aged 21 or older and not receiving medical therapy. All had detailed data available on alcohol use from AUDIT and Skinner Lifetime Drinking History questionnaires and had undergone at least two liver biopsies. At each follow-up visit, detailed drinking histories were obtained. Investigators evaluated associations between baseline drinking and change in drinking status during follow-up and their effect on liver histology.
About 60% were modest alcohol users (≤2 drinks/day) and 40% were abstinent. Over a 47-month median follow-up between liver biopsies, modest drinkers had a lower median reduction in steatosis grade (P=0.04) and lower odds of NASH resolution, compared with nondrinkers (adjusted odds ratio, 0.32).
COMMENT: This ancillary study that was a part of the longitudinal NASH-CRN cohort demonstrates that modest alcohol use among NASH patients leads to worsening liver histology. This valuable observation should help clinicians in advising their NASH patients to avoid long-term alcohol use.
CITATION(S): Ajmera V et al. Among patients with nonalcoholic fatty liver disease, modest alcohol use is associated with less improvement in histologic steatosis and steatohepatitis. Clin Gastroenterol Hepatol 2018 Mar 14; [e-pub].
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N Engl J Med 2017 Oct 26; 377:1639
Efficacy of Epilepsy Surgery in Children
A randomized, controlled trial demonstrates a marked advantage of surgery over medical treatment alone for seizure control, behavior, and quality of life for children with intractable focal epilepsy.
Despite level I evidence for large benefits from epilepsy surgery for anterior medial temporal lobe epilepsy in adults and adolescents, only a small minority of candidate patients are offered surgery. Less evidence is available on children, who have the most to gain from mitigating the severe effects of recurrent seizures on the developing brain. Addressing this issue, investigators completed a single-center, randomized, controlled trial in patients aged 18 years or younger with all types of medically intractable focal epilepsy, comparing 1-year outcomes of surgical treatment versus continued medical therapy alone. After completing a comprehensive presurgical evaluation with noninvasive tests, patients were randomized to either undergo surgery within 1 month (57 patients) or wait 1 year or longer for surgery (59 patients). Outcomes were measured in blinded fashion at 12 months following surgery or randomization.
The primary outcome of complete freedom from seizures was observed in 44 (77%) of 57 patients in the surgical group. Among the 47 who actually underwent surgical resection, 44 (94%) achieved seizure freedom — all 14 with temporal resection and 6 with hypothalamic hamartomas ablation, 11 of 12 with extratemporal resection, and 13 of 15 with hemispherectomy. Only three control patients awaiting resective surgery and one awaiting corpus callosotomy were seizure-free at 12 months. Of the secondary outcomes, compared with the medical group, the surgery group had significantly reduced seizure severity and improved behavior and quality of life and no decline in intelligence quotient, which was decreased from baseline in the medical group. Neither group showed significant change on the Vineland Social Maturity Scale.
COMMENT: Why epilepsy surgery is so underutilized remains a frustrating problem. One may postulate that physicians, other providers, and patients do not accurately understand the benefit-to-harm ratio associated with epilepsy surgery. This must change. Maybe it would help if the risks of not having surgery were better understood, including a large cumulative relative risk for epilepsy-associated injury and mortality and profound developmental and social consequences that are largely irreversible after childhood. I hope that this study providing Class I evidence of efficacy for all outcomes and no unexpected deficits can help begin to change minds and practice.
CITATION(S): Dwivedi R et al. Surgery for drug-resistant epilepsy in children. N Engl J Med 2017 Oct 26; 377:1639.
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Obstet Gynecol 2018 Jan 9; 131:304
Embracing Minimally Invasive Surgical Treatment for Endometrial Cancer
Large U.S. analysis indicates adoption of laparoscopic techniques has improved postoperative outcomes.
Although minimally invasive (laparoscopic, including robotic) approaches have been shown to improve perioperative outcomes for benign and malignant gynecologic conditions, the move away from open surgical approaches (laparotomy) was jump-started by the FDA's approval of robotic hysterectomy in 2005. To assess trends in surgical route and perioperative outcomes of treatment for endometrial cancer from 2008 through 2014, investigators queried a large database encompassing 750 U.S. hospitals (>12,000 women; mean age, 62; mean body-mass index [BMI], 35 m/k2; proportion with BMI ≥40, 27%).
During the study period, use of minimally invasive surgery rose from 24% to 71% of procedures (P<0.001), and the proportion of women with any complication fell from 13% to 7% (P<0.05). Although open surgery tended to require less time than minimally invasive surgery (likelihood of operative time <2 hours, 38% vs. 27%), incidence of major complications within the first 30 postoperative days (9% vs. 3%), median length of hospital stay (3 days vs. 1 day), and rates of transfusion (14% vs. 2%), readmission (9% vs. 3%), and death (0.8% vs. 0.2%) were all higher with open surgery (P<0.001 for all comparisons).
COMMENT: This report clarifies that embracing minimally invasive surgery has made the management of endometrial cancer substantially safer. Nonetheless, more than one quarter of hysterectomies in this setting are still performed via laparotomy (with notable disparities along racial/ethnic and socioeconomic lines). Accordingly, understanding the remaining barriers to minimally invasive surgery in this patient population is a priority. As prevention is the best medicine, weight loss, progestin-containing contraceptives, and breast-feeding must also be considered in the fight against endometrial cancer.
CITATION(S): Casarin J et al. Adoption of minimally invasive surgery and decrease in surgical morbidity for endometrial cancer treatment in the United States. Obstet Gynecol 2018 Jan 9; 131:304.
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Lancet Oncol 2018 Jan 11
Prognosis for BRCA-Mutated Breast Cancer
Survival is similar between BRCA mutation carriers versus those with sporadic disease.
To determine whether clinical outcome is different between BRCA-mutated versus non–BRCA-mutated breast cancer, U.K. investigators conducted a prospective cohort study (POSH) of 2733 young women (median age, 36 years) who received a histologic diagnosis of invasive breast cancer between 2000 and 2008 and were evaluated for BRCA mutations. A total of 338 (12%) had BRCA mutations, of which 60% were BRCA1 and 40% were BRCA2.
During the time of study recruitment, BRCA testing and risk-reducing surgery were not routinely recommended in the U.K. Of the cohort, 90% received adjuvant chemotherapy, and equal fractions received mastectomy or breast-conserving therapy. Patients were followed for more than 8 years on average, during which time 651 breast-cancer deaths had occurred.
Overall survival (OS) was similar between those harboring a BRCA mutation and those with sporadic breast cancer at 2 years (97.0% and 96.6%, respectively), 5 years (83.8% and 85.0%), and 10 years (73.4% and 70.1%). Of note, a large subset of patients (558) with triple-negative breast cancer (TNBC) seemed to have an OS advantage at 2 years, but not at 5 or 10 years.
COMMENT: These findings assure us that the prognosis is similar with BRCA-mutated breast cancer or sporadic breast cancer. That said, emerging data suggest that older agents such as platinum chemotherapy incorporated into adjuvant programs may confer benefit for patients with BRCA-mutated disease, particularly in TNBC. Also, PARP inhibitors are being studied in adjuvant trials for patients with early-stage, BRCA-mutated tumors. It is likely, and hoped, that the results of ongoing clinical trials involving novel agents in the adjuvant setting will ultimately lead to distinct treatments for women with BRCA-mutated tumors.
CITATION(S): Copson ER et al. Germline BRCA mutation and outcome in young-onset breast cancer (POSH): A prospective cohort study. Lancet Oncol 2018 Jan 11; [e-pub].

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