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SHOULD PEDIATRICIANS INVESTIGATE THE SYMPTOMS OF OBSESSIVE-COMPULSIVE DISORDER IN CHILDREN WITH FEEDING DIFFICULTIES?

Author/s: 
Bozzini, A.B., Malzyner, G., Maximino, P., Machado, R.H.V., Ramos, C.C., Ribeiro, L., Fisberg, M.

OBJECTIVE:

To review current evidence on the relationship between obsessive-compulsive disorder and feeding difficulties.

METHODS:

Review the Science Direct and PubMed databases between 2007 and 2017 in English, Portuguese and Spanish. The search terms, used in association, were "obsessive compulsive disorder" and "picky eating/feeding difficulty". Cohort, case control and cross sectional studies were included that analyzed children, adolescents and/or adults of any sample size from any country in the world. Opinion articles were excluded.

RESULTS:

Around 245 articles were selected, and only 4 were included in this review, according to previous criteria. Results from the studies essentially described that there is indeed a difference in "picky" behaviors between subjects with and without obsessive-compulsive disorder. Patients with obsessive-compulsive disorder tend to have exacerbated symptoms of disgust, anxiety and a higher eating behavior inflexibility score.

CONCLUSIONS:

Obsessive-compulsive disorder and feeding difficulties patients share common symptoms. The present study alerts health professionals who follow patients with feeding difficulties as to the importance of investigating possible psychiatric comorbidities.

Use of anastrozole for breast cancer prevention (IBIS-II): long-term results of a randomised controlled trial

Author/s: 
Cuzick, J, Sestak, I, Forbes, JF, Dowsett, M, Cawthorn, S, Mansel, RE, Loibl, S, Bonanni, B, Evans, DG, Howell, A, IBIS-II Investigators

BACKGROUND:

Two large clinical trials have shown a reduced rate of breast cancer development in high-risk women in the initial 5 years of follow-up after use of aromatase inhibitors (MAP.3 and International Breast Cancer Intervention Study II [IBIS-II]). Here, we report blinded long-term follow-up results for the IBIS-II trial, which compared anastrozole with placebo, with the objective of determining the efficacy of anastrozole for preventing breast cancer (both invasive and ductal carcinoma in situ) in the post-treatment period.

METHODS:

IBIS-II is an international, randomised, double-blind, placebo-controlled trial. Postmenopausal women at increased risk of developing breast cancer were recruited and were randomly assigned (1:1) to either anastrozole (1 mg per day, oral) or matching placebo daily for 5 years. After treatment completion, women were followed on a yearly basis to collect data on breast cancer incidence, death, other cancers, and major adverse events (cardiovascular events and fractures). The primary outcome was all breast cancer.

FINDINGS:

3864 women were recruited between Feb 2, 2003, and Jan 31, 2012. 1920 women were randomly assigned to 5 years anastrozole and 1944 to placebo. After a median follow-up of 131 months (IQR 105-156), a 49% reduction in breast cancer was observed for anastrozole (85 vs 165 cases, hazard ratio [HR] 0·51, 95% CI 0·39-0·66, p<0·0001). The reduction was larger in the first 5 years (35 vs 89, 0·39, 0·27-0·58, p<0·0001), but still significant after 5 years (50 vs 76 new cases, 0·64, 0·45-0·91, p=0·014), and not significantly different from the first 5 years (p=0·087). Invasive oestrogen receptor-positive breast cancer was reduced by 54% (HR 0·46, 95% CI 0·33-0·65, p<0·0001), with a continued significant effect in the period after treatment. A 59% reduction in ductal carcinoma in situ was observed (0·41, 0·22-0·79, p=0·0081), especially in participants known to be oestrogen receptor-positive (0·22, 0·78-0·65, p<0·0001). No significant difference in deaths was observed overall (69 vs 70, HR 0·96, 95% CI 0·69-1·34, p=0·82) or for breast cancer (two anastrozole vs three placebo). A significant decrease in non-breast cancers was observed for anastrozole (147 vs 200, odds ratio 0·72, 95% CI 0·57-0·91, p=0·0042), owing primarily to non-melanoma skin cancer. No excess of fractures or cardiovascular disease was observed.

INTERPRETATION:

This analysis has identified a significant continuing reduction in breast cancer with anastrozole in the post-treatment follow-up period, with no evidence of new late side-effects. Further follow-up is needed to assess the effect on breast cancer mortality.

FUNDING:

Cancer Research UK, the National Health and Medical Research Council Australia, Breast Cancer Research Foundation, Sanofi Aventis, and AstraZeneca.

Keywords 
breast cancer anastrozole female

Testosterone Treatment in Adult Men With Age-Related Low Testosterone: A Clinical Guideline From the American College of Physicians

Author/s: 
Qaseem, A., Horwitch, CA, Vijan, S, Etxeandia-Ikobaltzeta, I, Kansagara, D, Clinical Guidelines Committee of the American College of Physicians

DESCRIPTION:

The American College of Physicians (ACP) developed this guideline to provide clinical recommendations based on the current evidence of the benefits and harms of testosterone treatment in adult men with age-related low testosterone. This guideline is endorsed by the American Academy of Family Physicians.

METHODS:

The ACP Clinical Guidelines Committee based these recommendations on a systematic review on the efficacy and safety of testosterone treatment in adult men with age-related low testosterone. Clinical outcomes were evaluated by using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system and included sexual function, physical function, quality of life, energy and vitality, depression, cognition, serious adverse events, major adverse cardiovascular events, and other adverse events.

TARGET AUDIENCE AND PATIENT POPULATION:

The target audience includes all clinicians, and the target patient population includes adult men with age-related low testosterone.

RECOMMENDATION 1A:

ACP suggests that clinicians discuss whether to initiate testosterone treatment in men with age-related low testosterone with sexual dysfunction who want to improve sexual function (conditional recommendation; low-certainty evidence). The discussion should include the potential benefits, harms, costs, and patient's preferences.

RECOMMENDATION 1B:

ACP suggests that clinicians should reevaluate symptoms within 12 months and periodically thereafter. Clinicians should discontinue testosterone treatment in men with age-related low testosterone with sexual dysfunction in whom there is no improvement in sexual function (conditional recommendation; low-certainty evidence).

RECOMMENDATION 1C:

ACP suggests that clinicians consider intramuscular rather than transdermal formulations when initiating testosterone treatment to improve sexual function in men with age-related low testosterone, as costs are considerably lower for the intramuscular formulation and clinical effectiveness and harms are similar.

RECOMMENDATION 2:

ACP suggests that clinicians not initiate testosterone treatment in men with age-related low testosterone to improve energy, vitality, physical function, or cognition (conditional recommendation; low-certainty evidence).

Keywords 
testosterone guidelines age-related testosterone deficiency

Craniosacral therapy for chronic pain: a systematic review and meta-analysis of randomized controlled trials

Author/s: 
Haller, H, Lauche, R, Sundberg, T, Dobos, G, Cramer, H

OBJECTIVES:

To systematically assess the evidence of Craniosacral Therapy (CST) for the treatment of chronic pain.

METHODS:

PubMed, Central, Scopus, PsycInfo and Cinahl were searched up to August 2018. Randomized controlled trials (RCTs) assessing the effects of CST in chronic pain patients were eligible. Standardized mean differences (SMD) and 95% confidence intervals (CI) were calculated for pain intensity and functional disability (primary outcomes) using Hedges' correction for small samples. Secondary outcomes included physical/mental quality of life, global improvement, and safety. Risk of bias was assessed using the Cochrane tool.

RESULTS:

Ten RCTs of 681 patients with neck and back pain, migraine, headache, fibromyalgia, epicondylitis, and pelvic girdle pain were included. CST showed greater post intervention effects on: pain intensity (SMD = -0.32, 95%CI = [- 0.61,-0.02]) and disability (SMD = -0.58, 95%CI = [- 0.92,-0.24]) compared to treatment as usual; on pain intensity (SMD = -0.63, 95%CI = [- 0.90,-0.37]) and disability (SMD = -0.54, 95%CI = [- 0.81,-0.28]) compared to manual/non-manual sham; and on pain intensity (SMD = -0.53, 95%CI = [- 0.89,-0.16]) and disability (SMD = -0.58, 95%CI = [- 0.95,-0.21]) compared to active manual treatments. At six months, CST showed greater effects on pain intensity (SMD = -0.59, 95%CI = [- 0.99,-0.19]) and disability (SMD = -0.53, 95%CI = [- 0.87,-0.19]) versus sham. Secondary outcomes were all significantly more improved in CST patients than in other groups, except for six-month mental quality of life versus sham. Sensitivity analyses revealed robust effects of CST against most risk of bias domains. Five of the 10 RCTs reported safety data. No serious adverse events occurred. Minor adverse events were equally distributed between the groups.

DISCUSSION:

In patients with chronic pain, this meta-analysis suggests significant and robust effects of CST on pain and function lasting up to six months. More RCTs strictly following CONSORT are needed to further corroborate the effects and safety of CST on chronic pain.

Keywords 
chronic pain Complementary Therapies Craniosacral therapy meta-analysis systematic review

Association of household secondhand smoke exposure and mortality risk in patients with heart failure

Author/s: 
He, X, Zhao, J, He, J, Dong, Y, Liu, C

BACKGROUND:

Secondhand smoke (SHS) exposure is a well-established cardiovascular risk factor, yet association between SHS and prognosis of heart failure remains uncertain.

METHOD:

Data were obtained from the US National Health and Nutrition Examination Surveys III from 1988 to 1994. Currently nonsmoking adults with a self-reported history of heart failure were included. Household SHS exposure was assessed by questionnaire. Participants were followed up through December 31, 2011. Cox proportional-hazards models were used to assess the association of household SHS exposure and mortality risk. Potential confounding factors were adjusted.

RESULTS:

Of 572 currently nonsmoking patients with heart failure, 88 were exposed to household SHS while 484 were not. There were totally 475 deaths during follow-up. In univariate analysis, household SHS was not associated with mortality risk (hazard ratio [HR]: 0.98, 95% confidence interval [CI]: 0.76-1.26, p = 0.864). However, after adjustment for demographic variables, socioeconomic variables and medication, heart failure patients in exposed group had a 43% increase of mortality risk compared with those in unexposed group (HR: 1.43, 95% CI: 1.10-1.86, p = 0.007). Analysis with further adjustment for general health status and comorbidities yielded similar result (HR: 1.47, 95% CI: 1.13-1.92, p = 0.005).

CONCLUSION:

Household SHS exposure was associated with increased mortality risk in heart failure patients.

Keywords 
heart failure mortality secondhand smoke

Building a Group-Based Opioid Treatment (GBOT) blueprint: a qualitative study delineating GBOT implementation

Author/s: 
Sokol, R, Albanese, M, Chew, A, Early, J, Grossman, E, Roll, D, Sawin, G, Wu, DJ, Schuman-Olivier, Z

BACKGROUND:

Group-Based Opioid Treatment (GBOT) has recently emerged as a mechanism for treating patients with opioid use disorder (OUD) in the outpatient setting. However, the more practical "how to" components of successfully delivering GBOT has received little attention in the medical literature, potentially limiting its widespread implementation and utilization. Building on a previous case series, this paper delineates the key components to implementing GBOT by asking: (a) What are the core components to GBOT implementation, and how are they defined? (b) What are the malleable components to GBOT implementation, and what conceptual framework should providers use in determining how to apply these components for effective delivery in their unique clinical environment?

METHODS:

To create a blueprint delineating GBOT implementation, we integrated findings from a previously conducted and separately published systematic review of existing GBOT studies, conducted additional literature review, reviewed best practice recommendations and policies related to GBOT and organizational frameworks for implementing health systems change. We triangulated this data with a qualitative thematic analysis from 5 individual interviews and 2 focus groups representing leaders from 5 different GBOT programs across our institution to identify the key components to GBOT implementation, distinguish "core" and "malleable" components, and provide a conceptual framework for considering various options for implementing the malleable components.

RESULTS:

We identified 6 core components to GBOT implementation that optimize clinical outcomes, comply with mandatory policies and regulations, ensure patient and staff safety, and promote sustainability in delivery. These included consistent group expectations, team-based approach to care, safe and confidential space, billing compliance, regular monitoring, and regular patient participation. We identified 14 malleable components and developed a novel conceptual framework that providers can apply when deciding how to employ each malleable component that considers empirical, theoretical and practical dimensions.

CONCLUSION:

While further research on the effectiveness of GBOT and its individual implementation components is needed, the blueprint outlined here provides an initial framework to help office-based opioid treatment sites implement a successful GBOT approach and hence potentially serve as future study sites to establish efficacy of the model. This blueprint can also be used to continuously monitor how components of GBOT influence treatment outcomes, providing an empirical framework for the ongoing process of refining implementation strategies.

Keywords 
Buprenorphine-naloxone GBOT Group psychotherapy Group visit Implementation science Shared medical appointment Group-Based Opioid Treatment

Routine Childhood Vaccines Given in the First 11 Months After Birth

Author/s: 
Jacobson, RM

The US Advisory Committee on Immunization Practices recommends that infants beginning at birth receive several vaccines directed against a variety of infectious diseases that currently pose threats of morbidity and mortality to infants and those around them, including the 3-dose hepatitis B (HepB) series. The first dose is due at birth. This series protects against maternal-infant transmission of the HepB virus and against exposure the rest of the infant's life. At age 2 months infants are to receive not only their second dose of HepB vaccine but also a series of vaccines directed against diphtheria, tetanus, pertussis, pneumococcus, rotavirus, poliovirus, and Haemophilus influenzae type b. At 4 months, infants are to repeat those vaccines except for the HepB vaccine. At age 6 months infants are to finish the HepB series and receive the third doses of the other vaccines received at 2 and 4 months except for the rotavirus vaccine, depending on the brand used. Also, starting at 6 months, depending on the time of year, infants are to begin a 2-dose series against influenza separated by 28 days. Each of these vaccines is due at a time when the vaccine works to protect against an immediate risk and to provide long-term protection. These vaccine-preventable diseases vary in terms of the nature of exposure, the form of the morbidity, the risk of mortality, and the ability of routine vaccination to prevent or ameliorate harm.

Keywords 
vaccines infants immunizations

Oseltamivir plus usual care versus usual care for influenza-like illness in primary care: an open-label, pragmatic, randomised controlled trial

Author/s: 
Butler, CC, van der Velden, AW, Bongard, E, Saville, BR, Holmes, J, Coenen, S, Cook, J, Francis, NA, Lewis, RJ, Godycki-Cwirko, M, Llor, C, Chlabicz, S, Lionis, C, Seifert, B, Sundvall, PD, Colliers, A, Aabenhus, R, Bjerrum, L, Jonassen Harbin, N, Lindbæk M, Glinz, D, Bucher, HC, Kovacs, B, Radzeviciene Jurgute, R, Touboul Lundgren, P, Little, P, Murphy, AW, De Sutter, A, Openshaw, P, de Jong, MD, Connor, JT, Matheeussen, V, Ieven, M, Goossens, H, Verheij, TJ

BACKGROUND:

Antivirals are infrequently prescribed in European primary care for influenza-like illness, mostly because of perceived ineffectiveness in real world primary care and because individuals who will especially benefit have not been identified in independent trials. We aimed to determine whether adding antiviral treatment to usual primary care for patients with influenza-like illness reduces time to recovery overall and in key subgroups.

METHODS:

We did an open-label, pragmatic, adaptive, randomised controlled trial of adding oseltamivir to usual care in patients aged 1 year and older presenting with influenza-like illness in primary care. The primary endpoint was time to recovery, defined as return to usual activities, with fever, headache, and muscle ache minor or absent. The trial was designed and powered to assess oseltamivir benefit overall and in 36 prespecified subgroups defined by age, comorbidity, previous symptom duration, and symptom severity, using a Bayesian piece-wise exponential primary analysis model. The trial is registered with the ISRCTN Registry, number ISRCTN 27908921.

FINDINGS:

Between Jan 15, 2016, and April 12, 2018, we recruited 3266 participants in 15 European countries during three seasonal influenza seasons, allocated 1629 to usual care plus oseltamivir and 1637 to usual care, and ascertained the primary outcome in 1533 (94%) and 1526 (93%). 1590 (52%) of 3059 participants had PCR-confirmed influenza infection. Time to recovery was shorter in participants randomly assigned to oseltamivir (hazard ratio 1·29, 95% Bayesian credible interval [BCrI] 1·20-1·39) overall and in 30 of the 36 prespecified subgroups, with estimated hazard ratios ranging from 1·13 to 1·72. The estimated absolute mean benefit from oseltamivir was 1·02 days (95% [BCrI] 0·74-1·31) overall, and in the prespecified subgroups, ranged from 0·70 (95% BCrI 0·30-1·20) in patients younger than 12 years, with less severe symptoms, no comorbidities, and shorter previous illness duration to 3·20 (95% BCrI 1·00-5·50) in patients aged 65 years or older who had more severe illness, comorbidities, and longer previous illness duration. Regarding harms, an increased burden of vomiting or nausea was observed in the oseltamivir group.

INTERPRETATION:

Primary care patients with influenza-like illness treated with oseltamivir recovered one day sooner on average than those managed by usual care alone. Older, sicker patients with comorbidities and longer previous symptom duration recovered 2-3 days sooner.

FUNDING:

European Commission's Seventh Framework Programme.

Keywords 
influenza flu Tamiful oseltamivir

Final Update Summary: Abdominal Aortic Aneurysm: Screening

Author/s: 
U. S. Preventive Services Task Force

IMPORTANCE:

An abdominal aortic aneurysm (AAA) is typically defined as aortic enlargement with a diameter of 3.0 cm or larger. The prevalence of AAA has declined over the past 2 decades among screened men 65 years or older in various European countries. The current prevalence of AAA in the United States is unclear because of the low uptake of screening. Most AAAs are asymptomatic until they rupture. Although the risk for rupture varies greatly by aneurysm size, the associated risk for death with rupture is as high as 81%.

OBJECTIVE:

To update its 2014 recommendation, the USPSTF commissioned a review of the evidence on the effectiveness of 1-time and repeated screening for AAA, the associated harms of screening, and the benefits and harms of available treatments for small AAAs (3.0-5.4 cm in diameter) identified through screening.

POPULATION:

This recommendation applies to asymptomatic adults 50 years or older. However, the randomized trial evidence focuses almost entirely on men aged 65 to 75 years.

EVIDENCE ASSESSMENT:

Based on a review of the evidence, the USPSTF concludes with moderate certainty that screening for AAA in men aged 65 to 75 years who have ever smoked is of moderate net benefit. The USPSTF concludes with moderate certainty that screening for AAA in men aged 65 to 75 years who have never smoked is of small net benefit. The USPSTF concludes that the evidence is insufficient to determine the net benefit of screening for AAA in women aged 65 to 75 years who have ever smoked or have a family history of AAA. The USPSTF concludes with moderate certainty that the harms of screening for AAA in women aged 65 to 75 years who have never smoked and have no family history of AAA outweigh the benefits.

RECOMMENDATIONS:

The USPSTF recommends 1-time screening for AAA with ultrasonography in men aged 65 to 75 years who have ever smoked. (B recommendation) The USPSTF recommends that clinicians selectively offer screening for AAA with ultrasonography in men aged 65 to 75 years who have never smoked rather than routinely screening all men in this group. (C recommendation) The USPSTF recommends against routine screening for AAA with ultrasonography in women who have never smoked and have no family history of AAA. (D recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for AAA with ultrasonography in women aged 65 to 75 years who have ever smoked or have a family history of AAA. (I statement).

Keywords 
abdominal aortic aneurysm recommendation AAA ultrasonography risk smoke

Diagnosis of Pulmonary Embolism with d-Dimer Adjusted to Clinical Probability

Author/s: 
Kearon, C, de Wit, K, Parpia, S, Schulman, S, Afilalo, M, Hirsch, A, Spencer, FA, Sharma, S, D'Aragon, F, Deshaies, JF, Le Gal, G, Lazo-Langer, A, Wu, C, Rudd-Scott, L, Bates, SM, Julian, JA, PEGeD Study Investigators

BACKGROUND:

Retrospective analyses suggest that pulmonary embolism is ruled out by a d-dimer level of less than 1000 ng per milliliter in patients with a low clinical pretest probability (C-PTP) and by a d-dimer level of less than 500 ng per milliliter in patients with a moderate C-PTP.

METHODS:

We performed a prospective study in which pulmonary embolism was considered to be ruled out without further testing in outpatients with a low C-PTP and a d-dimer level of less than 1000 ng per milliliter or with a moderate C-PTP and a d-dimer level of less than 500 ng per milliliter. All other patients underwent chest imaging (usually computed tomographic pulmonary angiography). If pulmonary embolism was not diagnosed, patients did not receive anticoagulant therapy. All patients were followed for 3 months to detect venous thromboembolism.

RESULTS:

A total of 2017 patients were enrolled and evaluated, of whom 7.4% had pulmonary embolism on initial diagnostic testing. Of the 1325 patients who had a low C-PTP (1285 patients) or moderate C-PTP (40 patients) and a negative d-dimer test (i.e., <1000 or <500 ng per milliliter, respectively), none had venous thromboembolism during follow-up (95% confidence interval [CI], 0.00 to 0.29%). These included 315 patients who had a low C-PTP and a d-dimer level of 500 to 999 ng per milliliter (95% CI, 0.00 to 1.20%). Of all 1863 patients who did not receive a diagnosis of pulmonary embolism initially and did not receive anticoagulant therapy, 1 patient (0.05%; 95% CI, 0.01 to 0.30) had venous thromboembolism. Our diagnostic strategy resulted in the use of chest imaging in 34.3% of patients, whereas a strategy in which pulmonary embolism is considered to be ruled out with a low C-PTP and a d-dimer level of less than 500 ng per milliliter would result in the use of chest imaging in 51.9% (difference, -17.6 percentage points; 95% CI, -19.2 to -15.9).

CONCLUSIONS:

A combination of a low C-PTP and a d-dimer level of less than 1000 ng per milliliter identified a group of patients at low risk for pulmonary embolism during follow-up. (Funded by the Canadian Institutes of Health Research and others; PEGeD ClinicalTrials.gov number, NCT02483442.).

Keywords 
pulmonary embolism PE d-dimer CT computed tomography
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