Case report: 65-year-old man with metachronous left sided adrenal metastasis of hepatocellular carcinoma.

INTRODUCTION AND IMPORTANCE: Due to therapeutic advances and improvements in follow-up care, the diagnosis and treatment of extrahepatic metastases of hepatocellular carcinoma [HCC] have gained clinical significance. However, adrenal gland metastases of HCC remain a rare clinical encounter. Several systemic and local treatment options are discussed in current literature. Adrenalectomy in cases of isolated adrenal metastases with well-controlled intrahepatic lesions has been shown to benefit patients in case series. PRESENTATION OF THE CASE: This 65-year-old patient presented with suspected metachronous left sided adrenal metastasis seven years after bisegmentectomy for HCC and after undergoing trans-arterial chemoembolization [TACE] for multifocal intrahepatic recurrences while being listed for liver transplantation "beyond Milan criteria". Adrenalectomy was suggested for histopathological confirmation of the suspected metastasis and re-consideration for liver transplant. The resection was performed laparoscopically and metastasis of HCC was confirmed in histopathological analysis. Postoperatively, the patient recovered quickly. However, the patient decided against re-listing for liver transplantation. CLINICAL DISCUSSION: Current literature suggests, that minimally-invasive adrenalectomy should be considered in patients with no more than two extrahepatic lesions, a Child-Pugh-Score of less than A5, low alpha-fetoprotein [AFP] levels <100 ng/ml and size <3 cm. The oncological goal should be to achieve a tumor free extrahepatic situation with a potential oncological benefit. CONCLUSION: Our patient presented as an ideal candidate for resection of the adrenal gland metastasis and could have been re-assessed postoperatively for liver transplantation. Still, more research is needed to improve patient-selection for metastasectomy in HCC.

Determination and prospective validation of cut-off values for the diagnosis of liver cirrhosis for point shear-wave elastography/acoustic radiation force impulse imaging using the ACUSON Sequoia ultrasound system.

OBJECTIVES: Point shear-wave elastography (pSWE) alias acoustic radiation force impulse (ARFI) imaging is a well-established ultrasound-based technique for the non-invasive assessment of liver tissue stiffness. As cut-off values for liver cirrhosis cannot be transferred from one ultrasound system to another, this study aimed at determining cut-off values for the newly developed Siemens ACUSON Sequoia ultrasound system. METHODS: In a pilot study phase, two independent examiners conducted 10 pSWE measurements in an elasticity phantom and 32 healthy individuals for the determination of inter-examiner agreement. Afterwards, 22 cirrhotic patients and 57 patients with chronic liver disease undergoing liver biopsy underwent pSWE. Patient characteristics and stiffness values were compared for individuals with and without liver cirrhosis. Diagnostic accuracies of cut-off values for the diagnosis of liver cirrhosis were calculated using areas under the receiver operating characteristics analysis and Youden's index. In a subsequent validation study phase, these cut-off values were validated prospectively in 107 cirrhotic and 68 non-cirrhotic patients. RESULTS: Inter-examiner agreement was excellent for measurements in the elasticity phantom (intra-class correlation coefficient [ICC] = 0.998; P  < 0.001), and good for measurements in patients (ICC = 0.844; P  < 0.001). The best cut-off value for the diagnosis of liver cirrhosis was 1.405 m/s with an AUC of 0.872, a sensitivity of 88.2% and a specificity of 88.2% ( P  < 0.001). CONCLUSION: ARFI elastography using the Siemens ACUSON Sequoia showed a good inter-examiner agreement. The optimal cut-off value was lower than the cut-off values described for former generations of ultrasound devices. These preliminary results should be confirmed in larger patient collectives with histology as the reference standard.

Clinical application of the 21-gene oncotype recurrence score in an older cohort: A single center experience.

BACKGROUND: In early luminal breast cancer, the Oncotype DX® Recurrence Score (RS) prognostic and predictive value with regards to chemotherapy (CHT) application benefit has been broadly validated. In older patients its value has not been deeply addressed. This study aimed to evaluate the benefits of RS testing and to look at differences in treatment allocation for these patients when compared with younger ones. METHODS: We included data from consecutive patients with early luminal HER2-negative breast cancer, treated between 2010 and 2022 at the University Hospital Basel and Cantonal Hospital Baselland, Switzerland. The older cohort included 63 (19%) patients aged ≥70, and the younger cohort 263 (81%) patients aged <70. RESULTS: Older breast cancer patients had more co-morbidities (N = 36, 57% vs. N = 92, 35%, p = 0.002) and a higher clinical risk status (N = 49, 78% vs. N = 155, 59%; p = 0.01) when compared to younger patients. Histopathologic characteristics were significantly different between the two cohorts. Although older patients had a higher clinical risk status (78% vs. 59%) (p = 0.01), most of them (74%) received no CHT. Specifically, adjuvant CHT was administered less frequently in older than in younger patients (13% vs. 22%; p = 0.01). Moreover, older patients were less likely to complete CHT (>4 cycles: 78% vs. 97%). CONCLUSION: Breast cancer patients aged ≥70 have higher clinical risk status, more co-morbidities, higher clinical stage (driven by larger tumor size), and more often RS ≥26. However, they receive fewer adjuvant RT and CHT than those aged <70. RS maintains its independent prognostic value in older patients. However, assessing the predictive value of additional CHT benefit remains challenging due to significant differences in CHT administration. Although therapy decision-making in older patients with breast cancer still follows RS-based guidelines, clinical practice indicates an individualized treatment approach.

Pegylated liposomal doxorubicin (PLD) in daily practice-A single center experience of treatment with PLD in patients with comorbidities and older patients with metastatic breast cancer.

PURPOSE: Real-world data about pegylated liposomal doxorubicin (PLD) in patients with metastatic breast cancer (MBC) are limited. We have aimed to highlight the role of PLD in daily practice focusing on older patients and patients with comorbidities with MBC. METHODS: We analyzed electronic records of all patients with advanced/metastatic breast cancer treated with single-agent PLD at the University Hospital Basel between 2003 and 2021. Primary endpoint was time to next chemotherapy or death (TTNC). Secondary endpoints were overall survival (OS), progression-free survival (PFS), and overall response rate (ORR). We performed univariate and multivariate analysis for clinical variables. RESULTS: 112 patients with MBC having received single-agent PLD in any treatment line were analyzed, including 34 patient who were older than 70 years and 61 patients with relevant comorbidities. Median TTNC, OS, and PFS for treatment with PLD were 4.6, 11.9, and 4.4 months, respectively. ORR was 13.6%. Age >70 years predicted shorter OS (median 11.2 months) in multivariate analysis (hazard ratio [HR] 1.83, 95% CI 1.07-3.11, p = 0.026). Age and comorbidities did not significantly affect other endpoints. Unexpectedly, hypertension predicted longer TTNC (8.3 months, p = 0.04) in univariate analysis, maintained in multivariate analysis as a trend for both TTNC (HR 0.62, p = 0.07) and OS (HR 0.63, p = 0.1). CONCLUSION: Age predicted shorter OS significantly but median OS was not relevantly shorter in older patients. PLD remains a treatment option in patients with comorbidities and older patients with MBC. However, our real-world results of PLD appear underwhelming compared to relevant phase II trials through all age groups, pointing to an efficacy-effectiveness gap, possibly due to sampling bias.

The amount of liver tissue is essential for accurate histological staging in patients with autoimmune hepatitis.

The gold standard for the evaluation of liver fibrosis is histology. However, the heterogenous distribution of fibrosis limits the sensitivity of histology. The collection of two samples with a 16G needle is therefore recommended to reduce the risk of sampling error. The aim of this study was to investigate whether this standard is also applicable to patients with autoimmune hepatitis (AIH). This retrospective study included patients with AIH, who underwent mini-laparoscopic biopsy at our center between 2011 and 2020 (n = 32). Diagnosis was verified by usage of the simplified AIH score (≥ 6). Patients were categorized into three groups, based on the number of portal fields (PF) in the collected liver tissue (< 10 PF, 10 - 19 PF, ≥ 20 PF). We correlated the histological staging for these groups with the mini-laparoscopic fibrosis score (MLFS). Furthermore, non-invasive methods for the assessment of fibrosis were correlated with the histological staging (acoustic radiation force impulse (ARFI) and FIB-4 score). MLFS correlated well with histological staging (r = 0.649, p = 0.0001). The correlation between MLFS and histology improved with higher numbers of histologically analyzed portal fields (< 10 PF: r = 0.400, p = 0.378; 10 - 19 PF: r = 0.5467, p = 0.023; ≥ 20 PF: r = 0.956, p = 0.0002). The probability of collecting at least 10 or 20 portal fields was dependent on the number and diameter of the samples. For all patients with at least two 16G biopsies, 10 or more PF were available. With three 16G biopsies, at least 20 PF were obtained for all patients. ARFI correlated with MLFS and histological staging only in patients with low/moderate-grade inflammation as defined by ALT < 10xULN (upper limit of normal) (MLFS: r = 0.723; p = 0.004; histology: r = 0.619, p = 0.018). FIB-4 did not correlate with histological staging. The amount of liver tissue obtained by liver biopsy is crucial to minimalize the risk of sampling error and thus underestimation of fibrosis. This study was the first to investigate the amount of liver tissue required for histological staging in AIH. Our data suggest that diagnostic accuracy is likely to be higher with 20 PF compared to the generally recommended 10 PF. We therefore recommend to perform three biopsies with a 16G needle in (suspected) AIH patients. ARFI correlated well with histological staging unless inflammatory activity is high.

Pathologic and clinical tumor size discordance in early-stage cervical cancer: Does it matter?

OBJECTIVE: The objective of this study was to assess the rate of discordance between clinical and pathologic tumor size for women with stage IB1 cervical cancer (FIGO 2009 criteria), assess risk factors for discordance, and determine the impact of discordance on oncologic outcomes. METHODS: This was a secondary analysis of a prior multi-institutional retrospective review of patients diagnosed with stage IB1 (FIGO 2009 staging) cervical cancer undergoing radical hysterectomy between 2010 and 2017. Demographic, clinicopathologic, and oncologic data were collected. Pathologic upstaging was defined as having a preoperative diagnosis of stage IB1 cervical cancer with pathology demonstrating a tumor size >4 cm. Demographic and clinicopathologic data was compared using chi-square, fisher exact or 2-sided t-test. Survival was estimated using the Kaplan-Meier method. RESULTS: Of the 630 patients, 77 (12%) were upstaged. Patients who were upstaged had lower rates of preoperative conization (p < .001) or preoperative tumor sizes ≤2 cm (p < .001). Upstaged patients had increased odds of deep stromal invasion, lymphovascular space invasion, positive margins and positive lymph nodes. Almost 88% of upstaged patients received adjuvant therapy compared to 29% of patients with tumors ≤4 cm (odds 18.49, 95% CI 8.99-37.94). Finally, pathologic upstaging was associated with an increased hazard of recurrence (hazard ratio [HR] 1.95, 95% CI 1.03-3.67) and all-cause death (HR 2.31, 95% CI 1.04-5.11). CONCLUSIONS: Pathologic upstaging in stage IB1 cervical cancer is relatively common. Upstaging is associated with an 18-fold increased risk of receipt of adjuvant therapy. Patients undergoing preoperative conization and those with tumors <2 cm had lower risks of upstaging. Improvement in preoperative assessment of tumor size may better inform primary treatment decisions.

The benefit of bilateral inferior alveolar nerve block in managing postoperative nausea and vomiting (PONV) after mandibular osteotomy.

INTRODUCTION: The purpose of our study was to evaluate the benefit of bilateral inferior alveolar nerve block (BIANB) in managing postoperative pain, nausea and vomiting and opioid and antiemetic consumption in mandibular osteotomy. MATERIAL AND METHODS: 51 patients operated for bilateral sagittal split osteotomy (BSSO) were included in this prospective randomized controlled, double-blind, superiority trial. In the first group (n = 25), standard protocol was applied (general anesthesia and postoperative multimodal analgesia). The second group (n = 26) received bilateral inferior alveolar nerve block anesthesia at the start of surgery in addition to routine protocol. Postoperative monitoring was conducted every 4 h over the first 24 h and targeted the following criteria: postoperative nausea and vomiting (PONV), the visual analog scale (VAS) for pain, consumption of morphine (cumulative dose) and antiemetic agents, need for removal of guiding elastics. RESULTS: PONV was significantly lower in the BIANB group (15.4 % VS 40 %, p = 0.049), as were mean VAS scores for pain (1 VS 1.57, p = 0.045) and medians of morphine bolus (8 [6-16] VS 5.5 [1-8], p = 0.033). We found no significant difference in incidence of guiding elastic removal, and antiemetic consumption. DISCUSSION: The use of BIANB in BSSO improved postoperative patient comfort in terms of PONV and pain. Furthermore, it led to a decrease in opioid consumption. In conclusion, it is an additional therapeutic means of improving patients' postoperative comfort.

Intraperitoneal chemotherapy following neoadjuvant chemotherapy and optimal interval tumor reductive surgery for advanced ovarian cancer.

OBJECTIVES: Intraperitoneal (IP) chemotherapy following neoadjuvant chemotherapy (NACT) and interval tumor reductive surgery (TRS) for advanced ovarian cancer is feasible, however, the impact on disease outcomes remains unclear. We compare outcomes of patients treated with IP chemotherapy versus intravenous (IV) chemotherapy following NACT and interval TRS. METHODS: In this retrospective review, patients with advanced ovarian cancer were included if they received NACT followed by optimal interval TRS between 1/2004 and 4/2017. Patients were excluded if they had an ECOG PS >1, received >6 cycles of NACT or postoperative chemotherapy, and/or received bevacizumab during primary therapy. Primary outcomes were progression free survival (PFS) and overall survival (OS). RESULTS: There were 134 patients included in this study, 37 (28%) received IP and 97 (72%) received IV chemotherapy postoperatively. Patients in the IV group were older (median 66.3 vs 59.7 years, p = 0.0039) though there were no differences in BMI, race, BRCA status, stage, or histology. Median PFS was 3 months longer in the IP group (14.5 versus 11.5 months, p = 0.028) however there was no significant difference in OS. On univariate analysis, increasing number of NACT cycles (HR 1.914, 95% CI 1.024-3.497) and residual disease at completion of TRS (HR 1.541, 95% CI 1.042-2.248) were associated with decreased PFS; IP chemotherapy was associated with increased PFS (HR 0.633, 95% CI 0.414-0.944). These associations remained on multivariate analysis. Toxicity was comparable between the groups. CONCLUSIONS: IP after NACT and optimal interval TRS was associated with in improved PFS compared to IV chemotherapy without significant differences in toxicity.

[Impact of bowel preparation on surgical site infections and anastomotic leakage after elective colon resection: results of a retrospective study with 260 patients]. / Einfluss der Darmvorbereitung auf Wundinfektionen und Anastomoseninsuffizienzen bei elektiven Kolonresektionen: Ergebnisse einer retrospektiven Studie mit 260 Patienten.

BACKGROUND: Bowel preparation is performed in different ways prior to elective colon surgery. The aim of this study was to evaluate the influence of different bowel preparations on surgical site infections, anastomotic leakage and postoperative ileus in elective colon surgery. MATERIAL AND METHODS: A retrospective analysis was performed in this institution with patients who underwent elective colon surgery from 2013-2019. Patients received different types of bowel preparation and were divided into three different groups: no mechanical bowel preparation (MBP-), mechanical bowel preparation without oral antibiotics (MBP+/OABP-) and with oral antibiotics (MBP+/OABP+). These groups were compared with respect to surgical site infections, anastomotic leakage, and the duration of postoperative ileus. RESULTS: A total of 260 consecutive patients (MBP- n = 48, MBP+/OABP- n = 145 and MBP+/OABP+ n = 67) were analyzed. With a combined bowel preparation, the rate of surgical site infections could be considerably reduced (MBP- vs. MBP+/OABP+ 16.7% vs. 4.5%, p = 0.05). The type of bowel preparation was identified as the only factor associated with the incidence of surgical site infections; however, the type of bowel preparation did not have an influence on the rate of anastomotic leakages or duration of postoperative ileus in univariate and multivariate analyses. CONCLUSION: Bowel preparation with mechanical cleansing and oral antibiotics (MBP+/OABP+) is beneficial due to a significant reduction of surgical site infections.

'Maths on the move': Effectiveness of physically-active lessons for learning maths and increasing physical activity in primary school students.

OBJECTIVES: This study evaluated the benefit of physically-active lessons for learning maths multiplication-tables. The impact of the intervention on general numeracy, physical activity (PA), aerobic fitness, body mass index (BMI) and school-day moderate to vigorous PA (MVPA) was also assessed. DESIGN: Randomised controlled cross-over trial. METHOD: Year 3 students (n=172, mean age 8.4±0.3 years, 48% male) were recruited from 10 classes across two urban primary schools. Participants were randomly assigned to a seated classroom (Classroom) group or physically-active lessons in the playground (Playground) and crossed over to the alternative condition in the subsequent school term. The 6-week intervention comprised 3×30min sessions/week. Multiplication-tables (teacher-designed test) and general maths (standardised test) were assessed pre- and post-intervention. Aerobic fitness was assessed via the shuttle-run. Pre- to post-intervention change scores were compared for analysis and effect sizes (ES) calculated. Total PA and MVPA were assessed with accelerometers in a subset of participants. RESULTS: Multiplication scores improved significantly more in Playground than Classroom groups (ES=0.23; p=0.045), while no significant differences were observed in general numeracy (ES=0.05; p=0.66). Total PA and MVPA were substantially higher during Playground than Classroom lessons (ES: total PA=7.4, MVPA=6.5; p<0.001) but there were no differences in PA/MVPA between the groups throughout the rest of the school day. Aerobic fitness improved more in Playground than Classroom groups (ES=0.3; p<0.001) while the change in BMI was not different between groups (p=0.39). CONCLUSIONS: Physically-active lessons may benefit the learning of maths multiplication-tables while favourably contributing to school-day PA/MVPA.

[Primary biliary cholangitis-established and novel therapies]. / Primär biliäre Cholangitis ­ etablierte und neue Therapien.

BACKGROUND: Patients with primary biliary cholangitis (PBC, formerly primary biliary cirrhosis) and insufficient treatment response or risk factors exhibit a remarkably increased risk for disease progression and associated complications. Furthermore, extrahepatic manifestations may considerably reduce quality of life in affected patients. OBJECTIVES: This article presents an overview on standard therapy with ursodeoxycholic acid (UDCA) and further therapeutic options in patients with insufficient treatment response. In addition, symptom-orientated therapies will be presented in a practical and compact way. METHODS: The current European and German guidelines from 2017 in addition to several research papers and expert opinions are the basis for this review. RESULTS: Every PBC patient should be treated with UDCA life-long. In case of insufficient response to UDCA, obeticholic acid (OCA) has been approved as second line therapy since 2016. Fibrates and budesonide present off-label options for certain patient subpopulations. Pruritus should initially be treated with colestyramine. In case of insufficient efficacy or intolerance, rifampicin represents the most effective off-label option. If fatigue is present, differential diagnoses shall be excluded and coping strategies combined with regular physical activity can have a positive effect. CONCLUSION: UDCA and OCA are effective and approved drugs for treating PBC. Patients with insufficient treatment response or risk factors have to be treated consequently. Due to the improved anti-cholestatic treatment options, therapies to reduce fatigue and pruritus are increasingly important.

Letrozole may be a valuable maintenance treatment in high-grade serous ovarian cancer patients.

OBJECTIVES: Endocrine therapy is used as maintenance in estrogen receptor (ER) positive breast cancers and has been proposed in low-grade serous ovarian cancers (LGSOC). Here we examine a rationale for its use as maintenance in high-grade serous ovarian cancers (HGSOC). METHODS: We accessed the TCGA PANCAN dataset to evaluate the expression of ESR1. ESR1 expression data on all cancers (n=8901) and HGSOC (n=527) were followed by investigation of ER expression via immunohistochemistry (IHC) (n=4071). The same was performed in an independent cohort for matched primary and recurrent HGSOC (n=80). Finally, newly diagnosed ER+ HGSOC patients were offered a maintenance therapy with Letrozole. RESULTS: ESR1 was strongly expressed in similar levels in HGSOC as in breast cancer. We found a strong ER expression via IHC in both the primary and matched recurrent HGSOC, particularly in the Platinum-resistant subgroup. The additional use of Letrozole as maintenance treatment was associated with a significantly prolonged recurrence free interval (after 24months 60% when taking Letrozole versus 38.5% in the control group; p=0.035; RFS: IC50 reached by one subject versus 13.2months). This effect was also present in patients treated additionally with Bevacizumab; 20.8% of patients had no recurrence after 12months compared to 87.5% when taking Letrozole in addition to Bevacizumab (p=0.026). CONCLUSIONS: Primary HGSOC have a slightly higher ESR1 than and a similar ER expression breast cancer where aromatase inhibitor maintenance is routine for decades. Here we demonstrate evidence for the usefulness of Letrozole in HGSOC, particularly in patients with chemotherapy resistance or residual disease.

Genome-wide association study of Arabidopsis thaliana leaf microbial community.

Identifying the factors that influence the outcome of host-microbial interactions is critical to protecting biodiversity, minimizing agricultural losses and improving human health. A few genes that determine symbiosis or resistance to infectious disease have been identified in model species, but a comprehensive examination of how a host genotype influences the structure of its microbial community is lacking. Here we report the results of a field experiment with the model plant Arabidopsis thaliana to identify the fungi and bacteria that colonize its leaves and the host loci that influence the microbe numbers. The composition of this community differs among accessions of A. thaliana. Genome-wide association studies (GWAS) suggest that plant loci responsible for defense and cell wall integrity affect variation in this community. Furthermore, species richness in the bacterial community is shaped by host genetic variation, notably at loci that also influence the reproduction of viruses, trichome branching and morphogenesis.

Aggressive Breast Cancer during Pregnancy with a Rare Form of Metastasis in the Maternal Placenta.

Breast cancer is the second most common cancer diagnosed during pregnancy. Here we describe a 29-year-old patient with a recurrence of breast cancer with simultaneous brain, pulmonary and placenta metastasis. An overview of the literature on placenta metastases is provided together with a report on the interdisciplinary medical management.

Changes in eating, physical activity and related behaviors in a primary care-based weight loss intervention.

OBJECTIVE: To examine changes in eating behaviors and physical activity, as well as predictors of weight loss success, in obese adults who participated in a 2-year behavioral weight loss intervention conducted in a primary care setting. DESIGN: A longitudinal, randomized controlled, multisite trial. SUBJECTS: Three hundred ninety obese (body mass index, 30-50 kg m(-2)) adults, ≥ 21 years, in the Philadelphia region. METHODS: Participants were assigned to one of three interventions: (1) Usual Care (quarterly primary care provider (PCP) visits that included education on diet and exercise); (2) Brief Lifestyle Counseling (quarterly PCP visits plus monthly lifestyle counseling (LC) sessions about behavioral weight control); or (3) Enhanced Brief LC (the previous intervention with a choice of meal replacements or weight loss medication). RESULTS: At month 24, participants in both Brief LC and Enhanced Brief LC reported significantly greater improvements in mean (± s.e.) dietary restraint than those in Usual Care (4.4 ± 0.5, 4.8 ± 0.5 and 2.8 ± 0.5, respectively; both P-values ≤ 0.016). The percentage of calories from fat, along with fruit and vegetable consumption, did not differ significantly among the three groups. At month 24, both the Brief LC and Enhanced Brief LC groups reported significantly greater increases than usual care in energy expenditure (kcal per week) from moderately vigorous activity (+593.4 ± 175.9, +415.4 ± 179.6 and -70.4 ± 185.5 kcal per week, respectively; both P-values ≤ 0.037). The strongest predictor of weight loss at month 6 (partial R(2)=33.4%, P<0.0001) and at month 24 (partial R(2)=19.3%, P<0.001) was food records completed during the first 6 months. Participants who achieved a 5% weight loss at month 6 had 4.7 times greater odds of maintaining a ≥ 5% weight loss at month 24. CONCLUSIONS: A behavioral weight loss intervention delivered in a primary care setting can result in significant weight loss, with corresponding improvements in eating restraint and energy expenditure. Moreover, completion of food records, along with weight loss at month 6, is a strong predictor of long-term weight loss.

Effect of lifestyle intervention on cardiometabolic risk factors: results of the POWER-UP trial.

OBJECTIVE: To investigate the effects of three weight loss interventions on cardiometabolic risk factors, including blood pressure, lipids, glucose and markers of insulin resistance and inflammation. We also examined whether categories of incremental weight change conferred greater improvements on these parameters. METHODS: This 2-year trial was conducted in a primary care setting and included 390 obese participants who were randomly assigned to one of three interventions: (1) Usual Care (quarterly primary care provider (PCP) visits that included education about weight management); (2) Brief Lifestyle Counseling (quarterly PCP visits plus monthly behavioral counseling provided by a trained auxiliary health-care provider); or (3) Enhanced Brief Lifestyle Counseling (the same care as described for the previous intervention, plus weight loss medications or meal replacements). The primary outcome was change in cardiometabolic risk factors among groups. RESULTS: At month 24, participants in Enhanced Brief Lifestyle Counseling lost significantly more weight than those in Usual Care (4.6 vs 1.7 kg), with no other significant differences between groups. Enhanced Brief Lifestyle Counseling produced significantly greater improvements in high-density lipoprotein (HDL) cholesterol and triglyceride levels at one or more assessments, compared with the other two interventions. Markers of insulin resistance also improved significantly more in this group throughout the 2 years. Collapsing across the three groups, greater weight loss was associated with greater improvements in triglycerides, HDL cholesterol and markers of insulin resistance and inflammation at month 24, but was not significantly associated with reductions in blood pressure, total cholesterol and low-density lipoprotein cholesterol at any time. CONCLUSIONS: Enhanced Brief Lifestyle Counseling, which produced the largest weight loss, was generally associated with the greatest improvements in cardiovascular risk factors. These findings suggest that an intensive weight loss intervention, delivered in a primary care setting, can help obese individuals improve some cardiometabolic risk factors.

The impact of a primary care-based weight loss intervention on the quality of life.

OBJECTIVE: This study investigated changes in the quality of life of men and women who participated in a primary care-based weight loss intervention program. METHODS: Participants were enrolled in a 2-year randomized clinical trial (POWER-UP) conducted at the University of Pennsylvania and in six affiliated primary care practices. Inclusion criteria included the presence of obesity (body mass index of 30-50 kg m(-2)) and at least two components of the metabolic syndrome. MAIN OUTCOME MEASURES: Quality of life was assessed by three measures: the Short Form Health Survey (SF-12); the Impact of Weight on Quality of Life-Lite; and the EuroQol-5D. RESULTS: Six months after the onset of treatment, and with a mean weight loss of 3.9 ± 0.3 kg, participants reported significant improvements on all measures of interest with the exception of the Mental Component Score of the SF-12. These changes remained significantly improved from baseline to month 24, with the exception of the EuroQol-5D. Many of these improvements were correlated with the magnitude of weight loss and, for the most part, were consistent across gender and ethnic group. CONCLUSIONS: Individuals with obesity and components of the metabolic syndrome reported significant improvements in most domains of the quality of life with a modest weight loss of 3.7% of initial weight, which was achieved within the first 6 months of treatment. The majority of these improvements were maintained at month 24, when participants had lost 3.0% of their weight.

Managing obesity in primary care practice: an overview with perspective from the POWER-UP study.

Primary care practitioners (PCPs) have been encouraged to screen all adults for obesity and to offer behavioral weight loss counseling to the affected individuals. However, there is limited research and guidance on how to provide such intervention in primary care settings. This led the National Heart, Lung and Blood Institute in 2005 to issue a request for applications to investigate the management of obesity in routine clinical care. Three institutions were funded under a cooperative agreement to undertake the practice-based opportunities for weight reduction (POWER) trials. The present article reviews selected randomized controlled trials, published before the initiation of POWER, and then provides a detailed overview of the rationale, methods and results of the POWER trial conducted at the University of Pennsylvania (POWER-UP). POWER-UP's findings are briefly compared with those from the two other POWER trials, conducted at Johns Hopkins University and Harvard University/Washington University. The methods of delivering behavioral weight loss counseling differed markedly across the three trials, as captured by an algorithm presented in the article. Delivery methods ranged from having medical assistants and PCPs from the practices provide counseling to using a commercially available call center, coordinated with an interactive website. Evaluation of the efficacy of primary care-based weight loss interventions must be considered in light of costs, as discussed in relation to the recent treatment model proposed by the Centers for Medicare and Medicaid Services.