PANTHER: AZD8931, inhibitor of EGFR, ERBB2 and ERBB3 signalling, combined with FOLFIRI: a Phase I/II study to determine the importance of schedule and activity in colorectal cancer.

BACKGROUND: Epidermal growth factor receptor (EGFR) is a therapeutic target to which HER2/HER3 activation may contribute resistance. This Phase I/II study examined the toxicity and efficacy of high-dose pulsed AZD8931, an EGFR/HER2/HER3 inhibitor, combined with chemotherapy, in metastatic colorectal cancer (CRC). METHODS: Treatment-naive patients received 4-day pulses of AZD8931 with irinotecan/5-FU (FOLFIRI) in a Phase I/II single-arm trial. Primary endpoint for Phase I was dose limiting toxicity (DLT); for Phase II best overall response. Samples were analysed for pharmacokinetics, EGFR dimers in circulating exosomes and Comet assay quantitating DNA damage. RESULTS: Eighteen patients received FOLFIRI and AZD8931. At 160 mg bd, 1 patient experienced G3 DLT; 160 mg bd was used for cohort expansion. No grade 5 adverse events (AE) reported. Seven (39%) and 1 (6%) patients experienced grade 3 and grade 4 AEs, respectively. Of 12 patients receiving 160 mg bd, best overall response rate was 25%, median PFS and OS were 8.7 and 21.2 months, respectively. A reduction in circulating HER2/3 dimer in the two responding patients after 12 weeks treatment was observed. CONCLUSIONS: The combination of pulsed high-dose AZD8931 with FOLFIRI has acceptable toxicity. Further studies of TKI sequencing may establish a role for pulsed use of such agents rather than continuous exposure. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov number: NCT01862003.

Mindfulness in persons with anorexia nervosa and the relationships between eating disorder symptomology, anxiety and pain.

Mindfulness is useful for some psychiatric illnesses, but limited research exists among persons with anorexia nervosa (AN). This study aimed to determine the relationship between mindfulness, eating disorder symptomology and indicators of health in women with AN (n = 59) entering residential treatment. Participants completed a self-administered survey, including the Cognitive Affective Mindfulness Scale and other measures. Additional data from medical records were collected. Greater mindfulness was associated with less eating disorder symptoms (p = .049). This relationship was most profound in individuals with AN, including restrictive and binge-purge subtypes compared to individuals with atypical AN (interaction p-value = 0.044). Greater mindfulness was significantly associated with less shape (p = .023) and weight concern (p = .047). Expectedly, anxiety was inversely associated with eating disorder symptoms (p = .001). Greater pain was associated with less eating disorder symptoms (p = .024). Overall, mindfulness may be a protective factor against some eating disorder symptomology.

Effectiveness of integrative medicine group visits in chronic pain and depressive symptoms: A randomized controlled trial.

BACKGROUND: Current treatment options for chronic pain and depression are largely medication-based, which may cause adverse side effects. Integrative Medical Group Visits (IMGV) combines mindfulness techniques, evidence based integrative medicine, and medical group visits, and is a promising adjunct to medications, especially for diverse underserved patients who have limited access to non-pharmacological therapies. OBJECTIVE: Determine the effectiveness of IMGV compared to a Primary Care Provider (PCP) visit in patients with chronic pain and depression. DESIGN: 9-week single-blind randomized control trial with a 12-week maintenance phase (intervention-medical groups; control-primary care provider visit). SETTING: Academic tertiary safety-net hospital and 2 affiliated federally-qualified community health centers. PARTICIPANTS: 159 predominantly low income racially diverse adults with nonspecific chronic pain and depressive symptoms. INTERVENTIONS: IMGV intervention- 9 weekly 2.5 hour in person IMGV sessions, 12 weeks on-line platform access followed by a final IMGV at 21 weeks. MEASUREMENTS: Data collected at baseline, 9, and 21 weeks included primary outcomes depressive symptoms (Patient Health Questionnaire 9), pain (Brief Pain Inventory). Secondary outcomes included pain medication use and utilization. RESULTS: There were no differences in pain or depression at any time point. At 9 weeks, the IMGV group had fewer emergency department visits (RR 0.32, 95% CI: 0.12, 0.83) compared to controls. At 21 weeks, the IMGV group reported reduction in pain medication use (Odds Ratio: 0.42, CI: 0.18-0.98) compared to controls. LIMITATIONS: Absence of treatment assignment concealment for patients and disproportionate group attendance in IMGV. CONCLUSION: Results demonstrate that low-income racially diverse patients will attend medical group visits that focus on non-pharmacological techniques, however, in the attention to treat analysis there was no difference in average pain levels between the intervention and the control group. TRIAL REGISTRATION: clinicaltrials.gov NCT02262377.

Lessons Learned and Strategies for Recruitment of Diverse, Low-income Patients into an Integrative Medical Group Visit Clinical Trial.

OBJECTIVE: Description of recruitment methods and lessons learned in a randomized controlled trial of underserved patients using an integrative medical group visits intervention. METHODS: Comparison of the demographic characteristics of participants screened and consented to the study as well as description of recruitment methods used. OUTCOME MEASURES: This paper examines the characteristics of patients who were eligible compared to those who were not, characteristics of patients at the different sites, and patient characteristics over time (by comparing various cohorts) based on our experiences recruiting underserved patients. RESULTS: We screened 338 patients, with 205 (60.6%) meeting eligibility criteria and 159 patients randomized and consented. 133 patients were found ineligible, with the most common reasons being low depression scores (n = 20), manic symptoms (n = 20), and psychotic symptoms (n = 19), and alcohol use (n = 15). We found demographic differences in patients recruited by different methods and at different sites- patients referred by provider letter were older than those referred by self-referral or provider referral (mean age/SD vs. mean age/SD, p = 0.0001). For site-specific differences, patients at DH were older (53 SD = 12.3) than those at the Boston Medical Center (49 SD = 11.3) and CSHC (p = 0.048) in pair-wise comparisons. Patients at DH were also more likely to be white (25%) as compared to BMC (18%) and DH (7%), while those at CSHC were more likely to be black (70%) (p = 0.008).

Engaging women with an embodied conversational agent to deliver mindfulness and lifestyle recommendations: A feasibility randomized control trial.

OBJECTIVE: This randomized controlled trial evaluates the feasibility of using an Embodied Conversational Agent (ECA) to teach lifestyle modifications to urban women. METHODS: Women were randomized to either 1) an ECA (content included: mindfulness, stress management, physical activity, and healthy eating) or 2) patient education sheets mirroring same content plus a meditation CD/MP3 once a day for one month. General outcome measures included: number of stress management techniques used, physical activity levels, and eating patterns. RESULTS: Sixty-one women ages 18 to 50 were enrolled. On average, 51% identified as white, 26% as black, 23% as other races; and 20% as Hispanic. The major stress management techniques reported at baseline were: exercise (69%), listening to music (70%), and social support (66%). After one month, women randomized to the ECA significantly decreased alcohol consumption to reduce stress (p=0.03) and increased daily fruit consumption by an average of 2 servings compared to the control (p=0.04). CONCLUSION: It is feasible to use an ECA to promote health behaviors on stress management and healthy eating among diverse urban women. PRACTICE IMPLICATIONS: Compared to patient information sheets, ECAs provide promise as a way to teach healthy lifestyle behaviors to diverse urban women.

Design of the integrative medical group visits randomized control trial for underserved patients with chronic pain and depression.

BACKGROUND: Given the public health crisis of opioid overprescribing for pain, there is a need for evidence-based non pharmacological treatment options that effectively reduce pain and depression. We aim to examine the effectiveness of the Integrative Medical Group Visits (IMGV) model in reducing chronic pain and depressive symptoms, as well as increasing pain self-management. METHODS: This paper details the study design and implementation of an ongoing randomized controlled trial of the IMGV model as compared to primary care visits. The research aims to determine if the IMGV model is effective in achieving: a) a reduction in self-reported pain and depressive symptoms and 2) an improvement in the self-management of pain, through increasing pain self-efficacy and reducing use of self-reported pain medication. We intend to recruit 154 participants to be randomized in our intervention, the IMGV model (n=77) and to usual care (n=77). CONCLUSIONS: Usual care of chronic pain through pharmacological treatment has mixed evidence of efficacy and may not improve quality of life or functional status. We aim to conduct a randomized controlled trial to evaluate the effectiveness of the IMGV model as compared to usual care in reducing self-reported pain and depressive symptoms as well as increasing pain management skills.

Stress Management and Relaxation Techniques use among underserved inpatients in an inner city hospital.

OBJECTIVE: Little is known about the use of Stress Management and Relaxation Techniques (SMART) in racially diverse inpatients. We hope to identify socioeconomic status (SES) factors, health behavior factors, and clinical factors associated with the use of SMART. DESIGN AND MAIN OUTCOME MEASURES: We conducted a secondary analysis of baseline data from 623 hospitalized patients enrolled in the Re-Engineered Discharge (RED) clinical trial. We assessed socio-demographic characteristics and use of SMART. We used bivariate and multivariate logistic regression to test the association of SMART with socio-demographic characteristics, health behaviors, and clinical factors. RESULTS: A total of 26.6% of participants reported using SMART and 23.6% used mind body techniques. Thirty six percent of work disabled patients, 39% of illicit drug users, and 38% of participants with depressive symptoms used SMART. Patients who both reported illicit drug use and screened positive for depression had significantly increased odds of using SMART [OR=4.94, 95% CI (1.59, 15.13)]. Compared to non-Hispanic whites, non-Hispanic blacks [0.55 (0.34-0.87)] and Hispanic/other race individuals [0.40 (0.20-0.76)] were less likely to use SMART. CONCLUSIONS: We found greater utilization of SMART among all racial groups compared to previous national studies. In the inner city inpatient setting, patients with depression, illicit drug use, and work disability reported higher rates of using SMART.

Medication and Dietary Supplement Interactions among a Low-Income, Hospitalized Patient Population Who Take Cardiac Medications.

Purpose. To identify characteristics associated with the use of potentially harmful combinations of dietary supplements (DS) and cardiac prescription medications in an urban, underserved, inpatient population. Methods. Cardiac prescription medication users were identified to assess the prevalence and risk factors of potentially harmful dietary supplement-prescription medication interactions (PHDS-PMI). We examined sociodemographic and clinical characteristics for crude (χ (2) or t-tests) and adjusted multivariable logistic regression associations with the outcome. Results. Among 558 patients, there were 121 who also used a DS. Of the 110 participants having a PHDS-PMI, 25% were asked about their DS use at admission, 75% had documentation of DS in their chart, and 21% reported the intention to continue DS use after discharge. A multivariable logistic regression model noted that for every additional medication or DS taken the odds of having a PHDS-PMI increase and that those with a high school education are significantly less likely to have a PHDS-PMI than those with a college education. Conclusion. Inpatients at an urban safety net hospital taking a combination of cardiac prescription medications and DS are at a high risk of harmful supplement-drug interactions. Providers must ask about DS use and should consider the potential for interactions when having patient discussions about cardiac medications and DS.

Medical reconciliation of dietary supplements: don't ask, don't tell.

OBJECTIVE: To explore inpatient reconciliation of dietary supplement (DS) use and determine characteristics associated with DS documentation. METHODS: We analyzed DS use among 558 inpatients recruited from the Re-Engineered Discharge clinical trial to identify: (1) if patients self-reported DS and (2) if DS use was documented at admission. We examined socio-demographics for association with documentation using chi squares and t-tests. Logistic regression was performed to assess adjusted associations with DS documentation. RESULTS: Sixty percent reported DS use (n=333). Among users, 36% had admission DS documentation, 20% were asked about use at admission, 18% reported disclosing use to a provider, and 48% reported they would continue to use DS. Overall, 6% of participants were asked, disclosed, and had documentation of DS. Logistic regression revealed increased age associated with lower odds of DS documentation. Identifying as Hispanic or African American reduces DS documentation odds compared to those identifying as white. CONCLUSIONS: There is lack of consistent DS medical reconciliation in the inpatient setting. While more than half of patients used DS prior to hospitalization, most were not asked about use on admission. PRACTICE IMPLICATIONS: This study adds to literature on medical reconciliation which requires that providers inquire and document patient DS use.

Health literacy and complementary and alternative medicine use among underserved inpatients in a safety net hospital.

Little is known about the relationship between health literacy and complementary and alternative medicine (CAM) use in low-income racially diverse patients. The authors conducted a secondary analysis of baseline data from 581 participants enrolled in the Re-Engineered Discharge clinical trial. The authors assessed sociodemographic characteristics, CAM use, and health literacy. They used bivariate and multivariate logistic regression to test the association of health literacy with four patterns of CAM use. Of the 581 participants, 50% reported using any CAM, 28% used provider-delivered CAM therapies, 27% used relaxation techniques, and 21% used herbal medicine. Of those with higher health literacy, 55% used CAM. Although there was no association between health literacy and CAM use for non-Hispanic Black participants, non-Hispanic White (OR = 3.68, 95% CI [1.27, 9.99]) and Hispanic/other race (OR = 3.40, 95% CI [1.46, 7.91]) participants were significantly more likely to use CAM if they had higher health literacy. For each racial/ethnic group, there were higher odds of using relaxation techniques among those with higher health literacy. Underserved hospitalized patients use CAM. Regardless of race, patients with high health literacy make greater use of relaxation techniques.

Complementary and alternative medicine use among patients with thyroid cancer.

BACKGROUND: To report on the incidence and predictors of use of complementary and alternative medicine (CAM) among patients with thyroid cancer. METHODS: Data were collected using a web-based online anonymous survey under Institutional Review Board approval from Boston University. This report is based on 1327 responses from subjects with thyroid cancer. Patient factors were compared by univariate and multivariate analyses. RESULTS: After excluding multivitamin and prayer use, 74% (n=941) used CAM. Respondents were primarily over age 40, white, and female and held a college degree. The top five modalities were massage therapy, chiropraxy, special diets, herbal tea, and yoga. Few patients reported perceiving a particular modality had a negative effect on treatment. CAM was more often used for treatment of symptoms (73%) than as part of thyroid cancer treatment (27%). Multivariable logistic regression demonstrated that patients reporting a poor health status, higher education, cardiovascular disease, pulmonary symptoms, or persistent, recurrent, or metastatic disease were more likely to use CAM for treatment of thyroid cancer symptoms. Nearly one third of respondents reported their CAM use was not known, prescribed, or asked about by their physicians. CONCLUSIONS: In comparison to national surveys of the general U.S. population, patients with thyroid cancer use CAM therapies twice as often and report their use far less often. Physicians who treat patients with thyroid cancer should be aware of these data to further assist in their assessment and care.

A systematic review of the reporting of adverse events associated with medical herb use among children.

PURPOSE: Information about the safety of herbal medicine often comes from case reports published in the medical literature, thus necessitating good quality reporting of these adverse events. The purpose of this study was to perform a systematic review of the comprehensiveness of reporting of published case reports of adverse events associated with herb use in the pediatric population. METHODS: Electronic literature search included 7 databases and a manual search of retrieved articles from inception through 2010. We included published case reports and case series that reported an adverse event associated with exposure to an herbal product by children under the age of 18 years old. We used descriptive statistics. Based on the International Society of Epidemiology's "Guidelines for Submitting Adverse Events Reports for Publication," we developed and assigned a guideline adherence score (0-17) to each case report. RESULTS: Ninety-six unique journal papers were identified and represented 128 cases. Of the 128 cases, 37% occurred in children under 2 years old, 38% between the ages of 2 and 8 years old, and 23% between the ages of 9 and 18 years old. Twenty-nine percent of cases were the result of an intentional ingestion while 36% were from an unintentional ingestion. Fifty-two percent of cases documented the Latin binomial of the herb ingredients; 41% documented plant part. Thirty-two percent of the cases reported laboratory testing of the herb, 20% documented the manufacturer of the product, and 22% percent included an assessment of the potential concomitant therapies that could have been influential in the adverse events. Mean guideline adherence score was 12.5 (range 6-17). CONCLUSIONS: There is considerable need for improvement in reporting adverse events in children following herb use. Without better quality reporting, adverse event reports cannot be interpreted reliably and do not contribute in a meaningful way to guiding recommendations for medicinal herb use.

A systematic review of the prevalence of herb usage among racial/ethnic minorities in the United States.

Clinical studies display a wide range of herb use prevalence among racial/ethnic minorities in the United States. We searched databases indexing the literature including CINAHL, EMBASE, Global Health, CAB Abstracts, and Medline. We included studies that reported herbal medicine prevalence among ethnic minorities, African American, Hispanic, or Asian adults living in the United States. Data from 108 included studies found the prevalence of herb use by African Americans was 17 % (range 1-46 %); for Hispanics, 30 % (4-100 %); and for Asians, 30 % (2-73 %). Smaller studies were associated with higher reported herb use (p = 0.03). There was a significant difference (p = 0.01) between regional and national studies with regional studies reporting higher use. While herb usage surveys in racial/ethnic minorities show great variability, indications suggest high prevalence. More research is needed to understand herb use among ethnic/racial minorities, reasons for use, and barriers to disclosure of use to clinicians.

Non-Insertive Acupuncture and Neonatal Abstinence Syndrome: A Case Series from an Inner City Safety Net Hospital.

OBJECTIVE: We report on the safety of non-insertive acupuncture (NIA) in 54 newborns diagnosed with Neonatal Abstinence Syndrome (NAS) in a busy inner city hospital. METHODS: For this case series, a retrospective chart review was conducted. Data on participant demographics, number of NIA treatments, provider referrals, and outcomes of interest (sleeping, feeding, and adverse events) were collected. RESULTS: Of the 54 newborns receiving NIA, 86% were non-Hispanic White; 87% were on Medicaid, and gestational age ranged from 33.2 to 42.1 weeks. Out of 54 chart reviews, a total of 92 NIA sessions were documented ranging from 1 to 6 sessions per infant. Of the total number of treatments (n = 92), 73% were requested by a physician. Chart reviews reported restless infants calmed down during NIA, babies slept through or fell asleep immediately following NIA, and better feeding was noted following NIA. There were no adverse events noted in the medical records. CONCLUSIONS: This retrospective chart review shows potential for the use of NIA as an adjunctive treatment in newborns with NAS symptoms during hospitalization. More research is necessary to study whether the incorporation of NIA can result in positive outcomes in newborns withdrawing from narcotics.

Outcomes of Pseudomonas eradication therapy in patients with non-cystic fibrosis bronchiectasis.

Pseudomonas aeruginosa infection is associated with poorer outcomes in non-cystic fibrosis bronchiectasis. It is unknown whether early eradication improves outcomes. This retrospective study assessed clinical and microbiological outcomes of eradication therapy following initial Pseudomonas infection. All patients undergoing Pseudomonas eradication therapy from 2004 to 2010 were identified retrospectively and assessed for microbiological eradication, exacerbation frequency, hospital admissions, clinical symptoms and lung function. 30 patients were identified with median follow-up time 26.4 months. Eradication therapy involved intravenous antibiotics (n = 12), intravenous antibiotics followed by oral ciprofloxacin (n = 13) or ciprofloxacin alone (n = 5), combined with 3 months of nebulised colistin. Pseudomonas was initially eradicated from sputum in 24 patients (80.0%). 13/24 patients remained Pseudomonas-free and 11/24 were subsequently reinfected (median time 6.2 months). Exacerbation frequency was significantly reduced from 3.93 per year pre-eradication and 2.09 post-eradication (p = 0.002). Admission rates were similar, at 0.39 per year pre-eradication and 0.29 post-eradication (p = NS). 20/30 patients reported initial clinical improvement, whilst at one-year follow up, 19/21 had further improved or remained stable. Lung function was unchanged. This study demonstrates that Pseudomonas can be eradicated from a high proportion of patients, which may lead to prolonged clearance and reduced exacerbation rates. This important outcome requires confirmation in a prospective study.

Reducing stress in school-age girls through mindful yoga.

INTRODUCTION: School-age children report much stress in their daily lives, which may lead to psychological and physical problems. Mindfulness-based Stress Reduction is a program of awareness-based practices effective with adults. The purpose of this study was to investigate the efficacy of mindfulness training through yoga with school-age girls to reduce perceived stress, enhance coping abilities, self-esteem, and self-regulation, and explore the relationship between the dose of the intervention and outcomes. METHOD: Fourth- and fifth-grade girls were recruited from two public schools and randomly assigned to intervention and wait-list control groups. The intervention group met 1 hour a week for 8 weeks and completed 10 minutes of daily homework. RESULTS: Self-esteem and self-regulation increased in both groups. The intervention group was more likely to report greater appraisal of stress (p < .01) and greater frequency of coping (p < .05). Homework accounted for 7% of the variance in reported stress. DISCUSSION: Consistent with reports of mindfulness training, greater awareness of the feelings associated with stress may enhance coping abilities. However, it is possible that the increasing awareness of stressors in itself increased stress, possibly as part of the process of developing mindfulness or related to cognitive, emotional, or social development. Mindfulness in children may differ from mindfulness in adults and warrants further investigation.

The role of psychosomatic medicine in global health care.

This article reviews the principles and skills involved with psychosomatic medicine and their potential ability to improve global health care. New awareness of the escalating global public health impact of noncommunicable diseases, including chronic medical conditions and mental disorders, has stimulated interest in determining how best to organize health services. Home to the biopsychosocial model, the field of psychosomatic medicine is well-suited to inform such efforts by virtue of its emphasis on cross-disciplinary collaboration and specialized knowledge at the interface of medicine and psychiatry that takes into account individual and contextual influences on health. Consistent with the principles of psychosomatic medicine, promising strategies to improve global health care include integrating mental health care into primary care, applying the chronic care model in programs aimed at enhancing disease self-management, and using innovative models such as Internet-based therapy and telemedicine to increase access to quality care.

Yoga for children.

There is an increasing interest in the use of yoga for children to calm the mind and increase health and well being. Despite scant but increasing evidence supporting the efficacy of yoga in children, special yoga programs within schools are being developed for children and adolescents. This increasing popularity of the potential benefits of yoga may encourage parents to consider yoga for their children and request referrals or clarification of the purported effects. A description of the philosophical basis of yoga, the basic components of a yoga practice, safety concerns, and how to locate and evaluate a yoga program for children will be addressed.

Do students develop better motivational interviewing skills through role-play with standardised patients or with student colleagues?

OBJECTIVE: Smoking is the leading cause of preventable death in the USA and reducing the number of smokers by 50% is among the goals of the Healthy People 2010 initiative. Despite its importance, few medical students receive formal training in smoking cessation counselling. Motivational interviewing is a patient-centred, but directive, method of counselling that has been found to be more effective than giving brief advice for motivating smokers to quit. We wanted to determine whether using standardised patients to teach this skill to Year 3 medical students would be more effective than using student role-plays. METHODS: We conducted a randomised, controlled trial of 93 Year 3 family medicine clerkship students at our medical school between July 2003 and July 2004. The control group (n=46) practised motivational interviewing with one another and the intervention group (n=47) practised with standardised patients trained in motivational interviewing for smoking cessation. At the end of the study all the students conducted an interview with a different standardised patient that was videotaped. The primary outcome was analysis by a trained masked evaluator of the quality of a final videotaped interview using the motivational interviewing treatment integrity code (MITI), which assesses the quality of the interview according to 6 different criteria. RESULTS: There was no significant difference between the control and intervention groups in the final analyses of the interviews. CONCLUSIONS: According to MITI scores, standardised patient role-plays are similar in effectiveness to student role-plays when teaching basic motivational interviewing skills for smoking cessation to Year 3 medical students.