Case-control study of environmental toxins and risk of amyotrophic lateral sclerosis involving the national ALS registry.

Objective: Neurotoxic chemicals are suggested in the etiology of amyotrophic lateral sclerosis (ALS). We examined the association of environmental and occupational risk factors including persistent organochlorine pesticides (OCPs) and ALS risk among cases from the Centers for Disease Control and Prevention National ALS Registry and age, sex, and county-matched controls. Methods: Participants completed a risk factor survey and provided a blood sample for OCP measurement. ALS cases were confirmed through the Registry. Conditional logistic regression assessed associations between ALS and risk factors including OCP levels. Results: 243 matched case-control pairs (61.7% male, mean [SD] age = 62.9 [10.1]) were included. Fifteen of the 29 OCPs examined had sufficient detectable levels for analysis. Modest correlations of self-reported years of exposure to residential pesticide mixtures and OCP serum levels were found (p<.001). Moreover, occupational exposure to lead including soldering and welding with lead/metal dust and use of lead paint/gasoline were significantly related to ALS risk (OR = 1.77, 95% CI: 1.11-2.83). Avocational gardening was a significant risk factor for ALS (OR = 1.57, 95% CI: 1.04-2.37). ALS risk increased for each 10 ng/g of α-Endosulfan (OR = 1.42, 95% CI: 1.14-1.77) and oxychlordane (OR = 1.24, 95% CI: 1.01-1.53). Heptachlor (detectable vs. nondetectable) was also associated with ALS risk (OR = 3.57, 95% CI: 1.50-8.52). Conclusion: This national case-control study revealed both survey and serum levels of OCPs as risk factors for ALS. Despite the United States banning many OCPs in the 1970s and 1980s, their use abroad and long half-lives continue to exert possible neurotoxic health effects.

Acupuncture in cancer care: recommendations for safe practice (peer-reviewed expert opinion).

BACKGROUND: Up-to-date recommendations for the safe practice of acupuncture in integrative oncology are overdue with new cancer treatments and an increase in survivors with late effects of disease; 17 years have elapsed since Filshie and Hester's 2006 guidelines. During 2022/2023 an expert panel assembled to produce updated recommendations aiming to facilitate safe and appropriate care by acupuncturists working with people with cancer. METHODS: A core development team comprising three integrative oncology professionals comprehensively updated pre-existing unpublished recommendations. Twelve invited international experts (senior acupuncturists with and without experience of working in oncology settings, oncologists, physicians and nurses trained in integrative oncology, researchers, academics, and professional body representatives) reviewed the recommendations. In multiple iterations, the core team harmonised comments for final ratification. To aid dissemination and uptake the panel represents national and international integrative oncology associations and major cancer treatment centres in Europe, USA, Australia, and the Middle East. RESULTS: These recommendations facilitate safe care by articulating contra-indications, cautions, and risks for patients both on and off treatment (surgery, SACT, radiotherapy). Situations where acupuncture may be contra-indicated or practices need adapting are identified. "Red and Amber Flags" highlight where urgent referral is essential. CONCLUSION: These are the first international, multidisciplinary peer-reviewed recommendations for safe acupuncture practice in integrative oncology. Concerns about safety remain a significant barrier to appropriate referral from oncology teams, to use by acupuncturists and to uptake by patients. Disseminating trustworthy, widely accessible guidance should facilitate informed, confident practice of acupuncture in and outside of oncology healthcare settings.

Integrative Oncology Care of Symptoms of Anxiety and Depression in Adults With Cancer: Society for Integrative Oncology-ASCO Guideline.

PURPOSE: To provide evidence-based recommendations to health care providers on integrative approaches to managing anxiety and depression symptoms in adults living with cancer. METHODS: The Society for Integrative Oncology and ASCO convened an expert panel of integrative oncology, medical oncology, radiation oncology, surgical oncology, palliative oncology, social sciences, mind-body medicine, nursing, methodology, and patient advocacy representatives. The literature search included systematic reviews, meta-analyses, and randomized controlled trials published from 1990 through 2023. Outcomes of interest included anxiety or depression symptoms as measured by validated psychometric tools, and adverse events. Expert panel members used this evidence and informal consensus with the Guidelines into Decision Support methodology to develop evidence-based guideline recommendations. RESULTS: The literature search identified 110 relevant studies (30 systematic reviews and 80 randomized controlled trials) to inform the evidence base for this guideline. RECOMMENDATIONS: Recommendations were made for mindfulness-based interventions (MBIs), yoga, relaxation, music therapy, reflexology, and aromatherapy (using inhalation) for treating symptoms of anxiety during active treatment; and MBIs, yoga, acupuncture, tai chi and/or qigong, and reflexology for treating anxiety symptoms after cancer treatment. For depression symptoms, MBIs, yoga, music therapy, relaxation, and reflexology were recommended during treatment, and MBIs, yoga, and tai chi and/or qigong were recommended post-treatment. DISCUSSION: Issues of patient-health care provider communication, health disparities, comorbid medical conditions, cost implications, guideline implementation, provider training and credentialing, and quality assurance of natural health products are discussed. While several approaches such as MBIs and yoga appear effective, limitations of the evidence base including assessment of risk of bias, nonstandardization of therapies, lack of diversity in study samples, and lack of active control conditions as well as future research directions are discussed.Additional information is available at www.asco.org/survivorship-guidelines.

Effects of Mindful Self-Compassion Program on Psychological Well-being and Levels of Compassion in People Affected by Breast Cancer.

Context: Preliminary studies have suggested that Mindful Self-Compassion (MSC) programs can reduce psychological problems, such as anxiety and depression, but they have rarely been investigated in people with cancer. Objective: The study intended to investigate the effects of a standard MSC program on psychological well-being and levels of compassion in people with breast cancer. Design: The study was an internal service evaluation that used a pre-post, quasi-experimental design. Setting: The study took place at Breast Cancer Haven, a national cancer-support charity, in London, UK. Participants: Of the 63 people who attended the courses, 38 completed the questionnaires both at baseline and postintervention (60%). Of the 49 participants who provided demographic details, 43 were living with breast cancer; one had bowel cancer; and five didn't have cancer. Of those 49 participants, 44 were females and 5 were males; 43% were aged 29-50 years and 57% were aged 51-69 years; and 73% were of European American/White ethnicity. Intervention: Participants took part in a standard MSC program exploring mindfulness and self-compassion for eight weeks, three hours each week, plus a four-hour retreat. Outcome Measures: At baseline and postintervention, participants completed four questionnaires measuring: (1) self-compassion-the Self-Compassion Scale - Short Form (SCS-SF), (2) satisfaction with life-the Satisfaction with Life Scale (SWLS), (3) stress and depression-Depression, Anxiety, and Stress Scale (DASS), and (4) mindfulness-Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). They also completed a short feedback form about their course experiences. Results: The study found statistically significant increases in self-compassion (n = 37), with P < .001; satisfaction with life (n = 36), with P < .001; and mindfulness (n = 35), with P < .001, between baseline and postintervention as well as significant decreases in stress (n = 38), with P < .001, and depression (n = 36), with P < .001 (Wilcoxon signed rank test). Participants stated that while they had found the course to be challenging, they also had found new ways to be aware of and respond to their needs for kindness and self-compassion. They felt the course had changed their lives for the future. Conclusions: The findings support the beneficial effects of a standard MSC course on the psychological well-being of people with breast cancer. Further larger, more rigorous mixed-method studies are required to corroborate these preliminary findings.

The Rhode Island Climate Change and Health Program: Building Knowledge and Community Resilience.

Climate change acts as a risk multiplier, meaning vulnerable populations bear a disproportionate burden of its effects. Improving climate resiliency is a key strategy to help the Rhode Island Department of Health meet its overarching goals of addressing the socio-economic and environmental determinants of health for all Rhode Islanders. The Climate Change and Health Program focuses on both the immediate health impacts of climate change and building resiliency. Part of the US Centers for Disease Control and Prevention's Climate Ready States and Cities Initiative, the Program has partnered with community groups and other state and local agencies to bring technical assistance, educational resources, and funding to support community resilience to the challenges presented by the already changing climate. Specific projects discussed include the extreme heat communications plan and outdoor worker campaign; community-driven resiliency projects in response to flooding and natural hazards, and improving resilience in senior citizen housing.

Evaluation of a charity-led secondary breast cancer support day: a model of survivorship care.

It has been estimated that there are 36,000 women living with secondary breast cancer in the UK. Many feel isolated and unsupported, their information needs unmet and unaware of available support services such as palliative care or support groups that could help to improve their quality of life. To try to address these needs, a monthly support day was established in 2014 by the national UK breast cancer charity Breast Cancer Haven (BCH) at their Yorkshire centre. The support day provides an opportunity for personal introductions and discussion with other people with secondary breast cancer, to obtain information about breast cancer-related topics of their choice, to eat a healthy lunch and to experience a visualisation/relaxation session. To evaluate how helpful this support day was to its participants, they were asked to complete a feedback form at the end of the day. A total of 171 forms were completed from 26 support days during the period February 2014-July 2018. Participants stated that they found the support day helpful, relaxing, informative, supportive and enjoyable. All except two felt it met their needs and expectations and the majority found the length of the day just right. The personal introduction and discussion session were most frequently cited as the most useful part of the day, with the majority of participants (N = 144, 96.7%) rating it as very or moderately helpful. These findings show that the BCH support day, developed to address the needs of people with secondary breast cancer, is a model of survivorship care that can have a positive impact on their lives.

Mindfulness for the self-management of fatigue, anxiety, and depression in women with metastatic breast cancer: a mixed methods feasibility study.

The impact of living with metastatic breast cancer (MBC) is considerable and psychosocial support can be beneficial. Mindfulness-based stress reduction (MBSR) can help self-management of anxiety, depression, quality of life (QoL), and fatigue and has been evaluated in early-stage breast cancer but not MBC. This study investigated the acceptability and feasibility of providing MBSR for women with MBC and of introducing MBSR into a National Health Service (NHS) setting. A mixed methods convergent design was used. Eligible women with MBC, an Eastern Cooperative Oncology Group (ECOG) score of 0 to 2, stable disease, and life expectancy of at least 6 months were invited to attend (by their oncologist) an 8-week MBSR course. Qualitative interviews with patients, a focus group, and interview with NHS staff were held to explore acceptability and feasibility of MBSR. Questionnaires at baseline, during (weeks 4, 8), and after (weeks 16, 24) the course measured fatigue, anxiety and depression, mindfulness, disease-specific QoL, and generic preference based QoL. Of 100 women approached, 20 joined the study. One woman dropped out prior to the intervention due to illness progression. Nineteen women took part in 3 MBSR courses. Recruitment to 2 of the 3 courses was slow. Commitment to 8 weeks was a reason for non-participation, and proved challenging to participants during the course. Participants found the course acceptable and reported many cumulative and ongoing benefits. These included feeling less reactive to emotional distress and more accepting of the disruption to life that occurs with living with MBC. There was high attendance, completion of course sessions, adherence to home practice, excellent follow-up rates, and high questionnaire return rates. MBSR was acceptable to MBC patients, who perceived benefits such as improved anxiety and QoL; but the MBSR course requires a considerable time commitment. There is scope to tailor the intervention so that it is less intensive.

[Experimental program personalized care in patients with head and neck cancer]. / Expérimentation du parcours personnalisé des patients atteints d'un cancer des voies aéro-digestives supérieures.

OBJECTIVE: Describe the implementation and preliminary results of the "Experimental Program Personalized care" in patients with Head and Neck cancer. MATERIALS AND METHODS: After being selected a graduate nurse status, called coordination, participated in the development of forms of detection needs and concerns of patients, in collaboration with various health professionals. RESULTS: Between January 2011 and December 2012, 200 new patients with head and neck cancer were included: 62% with advanced cancer and 38% of early stage. No patient refused to participate in this experiment. At least one consultation with a psychiatrist was necessary for 82% of patients with advanced cancer. Social problems were the second axis of the needs of patients. CONCLUSION: By identifying the needs of patients and organizing their support, this evaluation optimizes not only the therapeutic care for the patient but also the management of human resources within the team.

Transoral robotic-assisted free flap reconstruction after radiation therapy in hypopharyngeal carcinoma: report of two cases.

The objective was to assess the feasibility and safety of transoral robotic surgery (TORS)-assisted free flap reconstruction for hypopharyngeal carcinoma after radiation therapy. The study evaluated the feasibility, surgical margins, the need for a tracheotomy, a nasogastric tube as well as surgery-related complications. Two patients underwent TORS-assisted free flap reconstruction after radiation therapy. The resection margins were free of tumor in both patients. A tracheotomy was performed in one patient who had been decannulated on the sixth postoperative day. One patient resumed satisfactory oral feeding in the fourth postoperative month and the second patient on postoperative day 7. No intraoperative complication and one postoperative complication (neck hematoma) were reported. After a follow-up period of 24 and 30 months, no local recurrence was observed. TORS is feasible for hypopharyngeal resection and assisted free flap reconstruction after radiation therapy. It represents a further step in the development of minimally invasive surgery for the treatment of head and neck cancers with laryngeal preservation.

Mindfulness-based stress reduction in breast cancer: a qualitative analysis.

There have been few qualitative investigations evaluating Mindfulness-Based Stress Reduction (MBSR) in breast cancer populations. The nested qualitative analysis reported here explores the acceptability and the perceived effect of MBSR. As part of a larger randomised controlled evaluative trial, 92 participants with stages 0 to III breast cancer completed a short proforma following week 8 of a MBSR programme conducted at The Haven, an integrated cancer support centre in London, UK in 2005-2006. Following thematic analysis, the most positive experiences from participants (n = 92) were reported to be; 1) being calmer, centred, at peace, connected and more confident; 2) the value of mindfulness practice; 3) being more aware; 4) coping with stress, anxiety and panic; 5) accepting things as they are, being less judgemental of myself and others; 6) improved communication and personal relationships and 7) making time and creating space for myself. All participants asked (n = 39) said that following MBSR training they had become more mindful. These understandings will be able to help shape the future teaching of MBSR in breast cancer.

A randomised controlled pilot feasibility study of the physical and psychological effects of an integrated support programme in breast cancer.

A pilot study was conducted to assess recruitment and effectiveness of an integrated support programme in women with breast cancer. Twelve participants were randomised to receive medical care with or without the support programme. Psychosocial questionnaires and immune/hormonal assays were completed at baseline, three and six months. Recruitment was problematic. In the intervention group, mental fatigue was significantly improved (p = 0.016) compared to controls; increased NK cell activity suggested an improvement in immune function. Total stress (p = 0.009), anxiety (p = 0.032) and endocrine-specific (p = 0.032) symptoms were significantly improved in the controls. A large-scale randomisation trial appears warranted, dependent upon effective recruitment.

Effectiveness of mindfulness-based stress reduction in mood, breast- and endocrine-related quality of life, and well-being in stage 0 to III breast cancer: a randomized, controlled trial.

PURPOSE: To assess the effectiveness of mindfulness-based stress reduction (MBSR) for mood, breast- and endocrine-specific quality of life, and well-being after hospital treatment in women with stage 0 to III breast cancer. PATIENTS AND METHODS: A randomized, wait-listed, controlled trial was carried out in 229 women after surgery, chemotherapy, and radiotherapy for breast cancer. Patients were randomly assigned to the 8-week MBSR program or standard care. Profile of Mood States (POMS; primary outcome), Functional Assessment of Cancer Therapy-Breast (FACT-B), Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) scales and the WHO five-item well-being questionnaire (WHO-5) evaluated mood, quality of life, and well-being at weeks 0, 8, and 12. For each outcome measure, a repeated-measures analysis of variance model, which incorporated week 0 measurements as a covariate, was used to compare treatment groups at 8 and 12 weeks. RESULTS: There were statistically significant improvements in outcome in the experimental group compared with control group at both 8 and 12 weeks (except as indicated) for POMS total mood disturbance (and its subscales of anxiety, depression [8 weeks only], anger [12 weeks only], vigor, fatigue, and confusion [8 weeks only]), FACT-B, FACT-ES, (and Functional Assessment of Cancer Therapy subscales of physical, social [8 weeks only], emotional, and functional well-being), and WHO-5. CONCLUSION: MSBR improved mood, breast- and endocrine-related quality of life, and well-being more effectively than standard care in women with stage 0 to III breast cancer, and these results persisted at three months. To our knowledge, this study provided novel evidence that MBSR can help alleviate long-term emotional and physical adverse effects of medical treatments, including endocrine treatments. MBSR is recommended to support survivors of breast cancer.

Functional results of Vibrant Soundbridge middle ear implants in conductive and mixed hearing losses.

OBJECTIVE: Our purpose was to evaluate the results of Vibrant Soundbridge (VSB) in conductive or mixed hearing loss. MATERIALS AND METHODS: Twenty-five adult patients (29 ears) with a mixed or conductive hearing loss and various etiologies were included in this retrospective study. The preoperative ipsilateral pure tone average was 71 ± 3.0 dB, and the average bone conduction threshold was 42 ± 2.8 dB (n = 29). The transducer was placed on the long apophysis of the incus (n = 16), in the round window (n = 10) or on the stapes (n = 3). RESULTS: No complications were noted. The bone conduction threshold remained unchanged. VSB was activated in all cases. The postoperative pure tone average without VSB was 63 ± 3.9 dB (n = 24) and with VSB in free-field condition 24 ± 2.1 dB (n = 22). CONCLUSIONS: VSB is safe and efficacious for auditory rehabilitation in conductive and mixed hearing losses.

The relationship between water intake and foetal growth and preterm delivery in a prospective cohort study.

BACKGROUND: Interpretation of previous associations between water intake and adverse birth outcomes is challenging given that amount and type of water consumed can be non-specific markers of exposure or underlying behavioural characteristics. We examined the relationship between water intake measures and adverse birth outcomes in participants from three study sites in the United States. METHODS: Using a prospective cohort study, we examined daily intake of bottled, cold tap, total tap, and total water in relation to birth weight and risk of small-for-gestational-age (SGA) among term births and risk of preterm delivery. RESULTS: Based on water consumption data collected between 20-24 weeks of gestation, the adjusted mean birth weight was 27 (95% confidence interval [CI]: -34, 87), 39 (95% CI: -22, 99), and 50 (95% CI: -11, 110) grams higher for the upper three total water intake quartiles (> 51-78, > 78-114, and > 114 ounces/day) compared to the lowest quartile (≤ 51 ounces/day). Adjusted birth weight results were similar for bottled water, cold tap water, and total tap water intake. An exposure-response gradient was not detected for either preterm delivery or SGA with increasing total water intake and total tap water intake, but adjusted relative risks for all three upper quartiles were below 1.0 (range: 0.6-0.9) for SGA. CONCLUSION: These data suggest that high water intake may be associated with higher mean birth weight following adjustment for confounding.

Comparison of gestational age at birth based on last menstrual period and ultrasound during the first trimester.

Reported last menstrual period (LMP) is commonly used to estimate gestational age (GA) but may be unreliable. Ultrasound in the first trimester is generally considered a highly accurate method of pregnancy dating. The authors compared first trimester report of LMP and first trimester ultrasound for estimating GA at birth and examined whether disagreement between estimates varied by maternal and infant characteristics. Analyses included 1867 singleton livebirths to women enrolled in a prospective pregnancy cohort. The authors computed the difference between LMP and ultrasound GA estimates (GA difference) and examined the proportion of births within categories of GA difference stratified by maternal and infant characteristics. The proportion of births classified as preterm, term and post-term by pregnancy dating methods was also examined. LMP-based estimates were 0.8 days (standard deviation = 8.0, median = 0) longer on average than ultrasound estimates. LMP classified more births as post-term than ultrasound (4.0% vs. 0.7%). GA difference was greater among young women, non-Hispanic Black and Hispanic women, women of non-optimal body weight and mothers of low-birthweight infants. Results indicate first trimester report of LMP reasonably approximates gestational age obtained from first trimester ultrasound, but the degree of discrepancy between estimates varies by important maternal characteristics.

Drinking water disinfection by-product exposure and fetal growth.

BACKGROUND: Previous studies suggest that elevated exposure to drinking water disinfection by-products (DBPs)--in particular, total trihalomethanes (TTHMs)--may lead to fetal growth restriction. We examined the effects of exposure to TTHMs, haloacetic acids, and total organic halide on the probability of delivering a small-for-gestational-age (SGA) infant and on birth weight at term. METHODS: Women early in pregnancy (< or =12 weeks' gestation) or planning a pregnancy were enrolled in a prospective pregnancy study conducted in 3 US communities from 2000 through 2004. Weekly (or biweekly) water samples were collected at each site as well as individual-level participant data. Associations between DBP exposures (TTHMs, haloacetic acids, total organic halide) and fetal growth were assessed using log-binomial regression for SGA (n = 1958) and linear regression for term birth weight (n = 1854). We conducted a Bayesian analysis to examine associations between individual DBP species and fetal growth. RESULTS: Haloacetic acids and total organic halide were not associated with SGA or term birth weight. The probability of delivering an SGA infant was elevated when comparing women with an average third-trimester residential TTHM concentration > or =80 microg/L to women with exposure <80 microg/L (risk ratio = 2.0 [95% confidence interval = 1.1-3.6]), but not when examining other exposure contrasts. Bayesian analyses did not support a consistent association between any DBP species and fetal growth, although these analyses were based on small sample sizes. CONCLUSIONS: Our results do not suggest an adverse effect of haloacetic acid or total organic halide exposure on fetal growth. An association of TTHM with SGA was seen only for average residential concentrations above the current regulatory standard.

Drinking water disinfection by-product exposure and duration of gestation.

BACKGROUND: Recent studies suggest elevated exposure to drinking water disinfection by-products (DBPs) may be associated with decreased risk of preterm birth. We examined this association for exposure to total trihalomethanes (TTHMs), 5 haloacetic acids (HAA5), and total organic halides. METHODS: Analysis included 2039 women in a prospective pregnancy study conducted from 2000 through 2004 in 3 study sites. Water samples were collected and analyzed for DBP concentrations. Participant data were collected through interviews, an early ultrasound, and birth records. We assessed the associations between DBPs and preterm birth (<37-weeks' gestation) using log-binomial regression. Discrete-time hazard analysis was used to model the conditional odds of delivery each week in relation to DBP exposure. RESULTS: Average second trimester DBP levels were associated with lower risk of preterm birth. Adjusted risk ratios for TTHM levels of 33.1-55.0, 55.1-66.3, 66.4-74.8, and 74.9-108.8 microg/L versus 2.2-4.6 microg/L were 0.8 (95% confidence intervals = 0.5-1.3), 0.9 (0.6-1.4), 0.7 (0.4-1.1), and 0.5 (0.3-0.9), respectively. Risk ratios for HAA5 levels of 17.9-22.0, 22.1-31.5, 31.6-40.4, and 40.5-52.8 microg/L versus 0-0.9 microg/L were 1.1 (0.8-1.7), 0.8 (0.5-1.2), 0.5 (0.3-0.8), and 0.7 (0.4-1.1), respectively. The conditional odds of delivery each week were decreased for the highest TTHM and HAA5 exposure groups versus the low exposure group for gestational weeks 33-40. CONCLUSIONS: The probability of preterm birth was not increased with high DBP exposure.

How to summarise and report written qualitative data from patients: a method for use in cancer support care.

GOALS OF WORK: The goal of this study is the determination of key themes to aid the analysis of qualitative data collected at three cancer support centres in England, using the Measure Yourself Concerns and Wellbeing (MYCaW) questionnaire. PATIENTS AND METHODS: People with cancer who use complementary therapies experience and value a wide range of treatment effects, yet tools are urgently required to quantitatively measure these outcomes. MYCaW is an individualised questionnaire used in cancer support centres providing complementary therapies, scoring 'concerns or problems' and 'well-being' and collecting qualitative data about other major events in a patient's life and what has been most important to the patient. Content analysis on 782 MYCaW questionnaires from people at these cancer support centres was carried out. The 'concerns,' 'other things going on in their life' and 'important aspects of centre' were thematically categorised and externally validated by a focus group, and the inter-rater reliability was calculated. MAIN RESULTS: Clinical information from a cancer patient's perspective was collected that is not measured on standard quality-of-life questionnaires; furthermore, some themes acknowledge the multi-faceted aspects of complementary and alternative medicine provision, rather than information only relating to the therapeutic intervention. Categories for qualitative MYCaW analysis have been established providing a tool for future research and/or service delivery improvement within cancer support centres such as these. CONCLUSIONS: The established themes provide a framework to aid analysis of qualitative aspects of complementary therapy care for people with cancer, improving our understanding of how the patient's cancer experience can be aided by complementary therapies in specialised cancer centres.

Endometriosis among women exposed to polybrominated biphenyls.

PURPOSE: We examined the association between endometriosis and exposure to polybrominated biphenyls (PBBs) and polychlorinated biphenyls (PCBs) among women inadvertently exposed to PBBs in 1973. METHODS: Serum PBBs and PCBs were measured in the late 1970s. Women self-reported endometriosis at interview in 1997. We constructed Cox models to estimate the relative incidence of endometriosis in relation to PBB and PCB levels. RESULTS: Seventy-nine of 943 women (9%) reported endometriosis. Compared with women with low PBB exposure (or=4 ppb) (HR = 0.90; 95% CI, 0.51-1.59) exposure did not have increased incidence of endometriosis. Increased incidence of endometriosis was suggested among women exposed to moderate PCB (5-8 ppb) (HR = 1.67; 95% CI, 0.91-3.10) and high PCB (>or=8 ppb) (HR = 1.68; 95% CI, 0.95-2.98) levels compared with low PCB exposure (

Assessment of clinical, service, and cost outcomes of a conversion program of sumatriptan to rizatriptan ODT in primary care patients with migraine headaches.

OBJECTIVE: Managed care organizations can increase the value of drug therapy by negotiating discounts on drug acquisition costs with pharmaceutical manufacturers and promoting use of preferred drugs, including the conversion of patients to preferred medications. This investigation was designed to assess conversion success, migraine drug utilizations, and patient satisfaction with a clinical pharmacist-managed conversion program from sumatriptan to rizatriptan ODT, both formulary drugs. METHODS: This was a retrospective cohort study conducted in a managed care organization for patients aged 18 years or older who had picked up at least one outpatient prescription for any sumatriptan dosage form at the pharmacy between January 2002 and June 2002. Patients. pharmacy and medical data were reviewed to assess eligibility (e.g., no history of rizatriptan failure) for conversion from sumatriptan to rizatriptan orally disintegrating tablet (ODT). There was no copayment difference for members for rizatriptan ODT versus sumatriptan. A questionnaire was developed to assess 2 domains: (1) patient satisfaction with the medication conversion process and (2) preference for rizatriptan ODT or sumatriptan. A random sample of 315 patients who initiated conversion to rizatriptan ODT was surveyed. Electronic pharmacy claims were reviewed to determine the number of patients who were successfully converted from sumatriptan to rizatriptan ODT. Pharmacy expenditures and total health care utilization and expenditures in the 180 days prior to (baseline) and after the conversion (followup) to rizatriptan ODT were compared for the cohorts of subjects who were successfully converted and those patients who were not successfully converted. RESULTS: Therapeutic conversion from sumatriptan to rizatriptan ODT was attempted in 457 patients; 214 (47%) were successfully converted. The only difference between the 2 cohorts at baseline for the 6 months prior to attempted conversion was a higher mean number of sumatriptan doses per patient per month (PPPM) in the 243 failed conversions (mean 3.5, SD 2.9) compared with the 214 successful conversions (mean 2.8, SD 2.8, P =0.003). The median triptan doses increased by 1.0 PPPM in both cohorts (P =0.882), from 2.0 to 3.0 doses PPPM in the group of successful conversions and from 2.7 to 4.0 in the group of unsuccessful conversions. The survey response rate was 55% for both successful and for unsuccessful conversions. More than 90% of the patients in both cohorts were satisfied with the level of care provided by the clinical pharmacy staff during medication conversion, and there was no difference between the 2 cohorts in patient satisfaction (P=0.761). Rizatriptan ODT was preferred by 68.0% and 8.5% of successful and failed conversion subjects, respectively (P <0.001). Using representative group purchase prices, triptan expenditures for successful conversion subjects were reduced by a median of -2 dollars (6 %) PPPM while triptan expenditures for unsuccessful conversions increased by a median of 8 dollars (P <0.001). There were no differences for either cohort in median PPPM changes in migraine-related office visits (0.0 median change in office visits, P =0.748) or office-visit costs (0 dollars median change, P =0.861) for preconversion versus postconversion attempts Regression modeling identified that lower total counts of sumatriptan doses filled during baseline period was an independent predictor of successful conversion to rizatriptan ODT (P <0.001). There was an average of 3.5 triptan medication fills per patient for successful conversion during the 6-month follow-up period, with 78% of these subjects filling at least 2 prescriptions for rizatriptan ODT during this period. CONCLUSIONS: This conversion program for sumatriptan to rizatriptan ODT was successful in converting almost half of primary care patients to the preferred product despite the absence of a copayment incentive for members to agree to the conversion. There were no measurable medical or economic consequences of the conversion, and patient satisfaction with the quality of care was maintained. Future efforts are likely to have a higher success rate if focused on converting patients with less-severe migraine headaches, as measured by the need for baseline rescue medication, since lower acuity was the only independent predictor of successful conversion in this conversion program for 2 triptan drugs.