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  • 1
    In: Obstetrics & Gynecology, 2018, Vol.132(3), pp.612-618
    Description: OBJECTIVE:: To evaluate whether prophylactic pregabalin reduces pain experienced with medication abortion. METHODS:: We conducted a randomized, double-blind, placebo-controlled trial of women initiating medication abortion with mifepristone and buccal misoprostol up to 70 days of gestation. Participants were randomized to 300 mg oral pregabalin or a placebo immediately before misoprostol. The primary outcome was maximum pain on an 11-point numerical rating scale, reported using real-time electronic surveys over 72 hours. Secondary outcomes included pain at each time point, ibuprofen and narcotic use, side effects, and satisfaction. We estimated that 110 women would be required to have 80% power to detect a difference in pain of 1.3 points. RESULTS:: Between June 2015 and October 2016, 241 women were screened and 110 were randomized (56 pregabalin, 54 placebo). Three were lost to follow-up. The primary outcome of mean maximum pain in the pregabalin group was 5.0±2.6 vs 5.5±2.2 in the placebo group (P=.32). Excluding medication taken before the study capsule, ibuprofen was used by 64% (35/55) of the pregabalin group vs 87% (45/52) placebo (P〈.01). Narcotics were used by 29% (16/55) of the pregabalin group vs 50% (26/52) placebo (P〈.03). More dizziness (P〈.001), sleepiness (P〈.04), and blurred vision (P〈.05) occurred in the pregabalin group. Satisfaction scores for the analgesic regimen were higher in the pregabalin group (very satisfied: 47% vs 22%; P=.006). CONCLUSION:: Compared with placebo, 300 mg pregabalin coadministered with misoprostol during medication abortion did not significantly decrease maximum pain scores. Women who received pregabalin were less likely to require any ibuprofen or narcotic and were more likely to report higher satisfaction with analgesia, despite an increase in dizziness, sleepiness, and blurred vision. CLINICAL TRIAL REGISTRATION:: ClinicalTrials.gov, NCT02782169.
    Keywords: Abortion, Induced -- Adverse Effects ; Analgesics -- Therapeutic Use ; Pain -- Prevention & Control ; Pregabalin -- Therapeutic Use;
    ISSN: 0029-7844
    E-ISSN: 1873233X
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  • 2
    In: Obstetrics & Gynecology, 2017, Vol.130(2), pp.387-392
    Description: OBJECTIVE:: To evaluate the efficacy of a paracervical block to decrease pain during osmotic dilator insertion before second-trimester abortion. METHODS:: In this double-blind, randomized trial, 41 women undergoing Laminaria insertion before a second-trimester abortion received either a paracervical block with 18 mL 1% lidocaine and 2 mL sodium bicarbonate or a sham block. Women were between 14 and 23 6/7 weeks of gestation. The primary outcome was pain immediately after insertion of Laminaria. Women assessed their pain on a 100-mm visual analog scale. Secondary outcomes included assessment of pain at other times during the insertion procedure and overall satisfaction with pain control. To detect a 25-mm difference in pain immediately after Laminaria insertion, at an α of 0.05 and 80% power, we aimed to enroll 20 patients in each arm. RESULTS:: From May 2015 to December 2015, 20 women received a paracervical block and 21 received a sham block. Groups were similar in demographics, including parity, history of surgical abortion, and number of Laminaria placed. The paracervical block reduced pain after Laminaria insertion (median scores 13 mm [interquartile range 2–39] compared with 54 mm [interquartile range 27–61], P=.01, 95% CI −47.0 to −4.0). Women who received a paracervical block also reported higher satisfaction with overall pain control throughout the entire Laminaria insertion procedure (median scores 95 mm [interquartile range 78–100] compared with 70 mm [interquartile range 44–90], P=.05, 95% CI 0.0–37.0). CONCLUSION:: Paracervical block is effective at reducing the pain of Laminaria insertion. Additionally, a paracervical block increases overall patient satisfaction with pain control during Laminaria placement. CLINICAL TRIAL REGISTRATION:: ClinicalTrials.gov, NCT02454296.
    Keywords: Abortion, Induced–Methods ; Adult–Methods ; Anesthesia, Obstetrical–Administration & Dosage ; Double-Blind Method–Administration & Dosage ; Female–Administration & Dosage ; Gestational Age–Administration & Dosage ; Hawaii–Administration & Dosage ; Humans–Administration & Dosage ; Laminaria–Administration & Dosage ; Lidocaine–Administration & Dosage ; Pain Measurement–Administration & Dosage ; Patient Satisfaction–Administration & Dosage ; Pregnancy–Administration & Dosage ; Pregnancy Trimester, Second–Administration & Dosage ; Sodium Bicarbonate–Administration & Dosage ; Abridged ; Sodium Bicarbonate ; Lidocaine;
    ISSN: 0029-7844
    E-ISSN: 1873233X
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  • 3
    In: Cancer, 01 August 2016, Vol.122(15), pp.2408-2417
    Description: The findings of the current randomized controlled trial indicate that, compared with controls, a peer‐counseling intervention significantly improves quality of life and maintains marital adjustment in patients with breast cancer. Having a peer counselor may prevent or improve psychosocial morbidity after diagnosis.
    Keywords: Breast Neoplasms ; Counseling ; Quality Of Life ; Patient‐Navigation ; Posttraumatic Stress
    ISSN: 0008-543X
    E-ISSN: 1097-0142
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  • 4
    Language: English
    In: The American Journal of Surgery, October 2016, Vol.212(4), pp.691-699
    Description: This study examines the impact of marriage and next of kin identity on timing of diagnosis, treatment, and survival in cancer patients. Retrospective review of patients with 5 solid tumor types treated at an academic medical center from 2002 to 2012. Exposures of interest were marriage status at time of diagnosis and familial relationship with next of kin (NOK). Association with overall survival determined via Cox regressions and with early diagnosis (stage I to II) and receipt of surgery via logistic regressions. Marriage was not associated with early diagnosis for any cancer type. After adjustment, being married was associated with significantly higher odds of receiving surgery only for pancreatic cancer and with improved survival for breast and lung cancers. Having a nuclear relationship with NOK was not associated with any outcomes. Marriage status was associated with improved outcomes for certain cancers whereas familial relationship with NOK was not.
    Keywords: Cancer ; Social Connectedness ; Outcomes ; Marriage ; Survival
    ISSN: 0002-9610
    E-ISSN: 1879-1883
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  • 5
    Language: English
    In: Hawai'i journal of medicine & public health : a journal of Asia Pacific Medicine & Public Health, July 2017, Vol.76(7), pp.178-182
    Description: Emergency contraceptive pills (ECPs) are medications used after unprotected intercourse, underprotected intercourse, or sexual assault to decrease the risk of pregnancy. Availability of ECPs in Hawai'i's retail pharmacies was last assessed in 2007, following over-the-counter access to levonorgestrel ECPs (LNG-ECP) for women age 18 years or older and prior to U.S. Food and Drug Administration (FDA) approval of prescription-only ulipristal acetate (UPA). We conducted a county-by-county subanalysis from a larger observational population-based study on statewide availability of ECPs in Hawai'i's pharmacies. In the original study, researchers called all 198 unique retail pharmacies in Hawai'i between December 2013 and June 2014. Only 3% of pharmacies had UPA immediately available on-site in the state, with UPA available on Kaua'i and O'ahu only. At least one form of LNG-ECPs was available in 82% of pharmacies in 2013-2014, roughly the same as 2007 (81%) (P=0.9) when Lana'i and Moloka'i lacked access. Currently, only Moloka'i lacks retail pharmacy access to ECPs. When controlling for general inflation, the 2013-2014 mean price for name brand LNG-ECP fell within the reported range of 2007 prices. Generic LNG-ECPs were substantially lower in price than name brand LNG-ECPs in 2007 and 2013-2014. Availability of UPA is limited and significantly lower compared to LNG-ECPs. Availability of LNG-ECPs statewide has remained stable and the arrival of generics has decreased prices.
    Keywords: Availability ; Emergency Contraception ; Hawai‘i ; Pharmacies ; Ulipristal Acetate ; United States ; Contraceptives, Postcoital -- Therapeutic Use ; Health Services Accessibility -- Standards ; Pharmacy -- Statistics & Numerical Data
    E-ISSN: 2165-8242
    Source: MEDLINE/PubMed (U.S. National Library of Medicine)
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  • 6
    Language: English
    In: Journal of Pediatric and Adolescent Gynecology, February 2017, Vol.30(1), pp.29-34
    Description: To assess the values and beliefs regarding sexual behavior, sexual decision-making, and reproductive health learning preferences among teens in Hawaii. Survey regarding teens' knowledge, attitudes, and beliefs about sexual behaviors and preferences for learning about reproductive health. University of Hawaii Department of Obstetrics and Gynecology clinics in Honolulu, Hawaii. Female patients and their male or female companions ages 14-19 years. A 30-question anonymous survey. The main outcome was to describe the norms, attitudes, beliefs, and preferences of teens in this setting with regard to sexual health and sexual health education. For this, we provide a description of response frequencies and a comparison of mean scores across demographic characteristics. We analyzed a total of 100 surveys. Teens endorsed more values and norms protective against sexually transmitted infection than those protective against pregnancy. Younger teens expressed more protective values as a result of the influence of perceived parental values, whereas older teens expressed less protective values on the basis of the influence of peers. Respondents expressed comfort talking with their clinician about sexual health, and also expressed a slight preference that their clinicians initiate these conversations. The influence of parental values and peer norms on sexual behavior must be taken into consideration when designing interventions to address adolescent sexual health. Additionally, teens' greater concern about the consequences of sexually transmitted infection could be leveraged by clinicians to initiate broader conversations about sexual health, and a variety of modalities, including online resources and in-person conversations, should be used to meet the diversity of preferences expressed by teens across demographic groups.
    Keywords: Adolescents ; Pregnancy ; Sexually Transmitted Infections ; Surveys ; Norms ; Attitudes ; Behaviors ; Prevention ; Medicine
    ISSN: 1083-3188
    E-ISSN: 1873-4332
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  • 7
    Language: English
    In: Hawai'i journal of medicine & public health : a journal of Asia Pacific Medicine & Public Health, March 2018, Vol.77(3), pp.60-65
    Description: This pilot study assessed the feasibility of conducting a larger randomized controlled trial comparing the proportion of adolescents using a levonorgestrel intrauterine device (LNG IUD) at six months postpartum when it is inserted immediately after vaginal delivery (within 10 minutes after placental expulsion) compared to insertion four to six weeks postpartum. Pregnant adolescents (14 to 19 years) who desired a LNG IUD for postpartum contraception were randomized to insertion of the LNG IUD either within 10 minutes of delivery of the placenta or at 4-6 weeks postpartum. Study follow-up visits were conducted at 4-6 weeks postpartum, 10 weeks postpartum, and 6 months postpartum. From November 2013 to June 2015, eleven adolescents were randomized - six participants to the immediate postpartum LNG IUD insertion group, and five to the delayed insertion group. All six women in the immediate insertion group had successful immediate postpartum insertion; two of five women in the delayed insertion group had an IUD inserted. At six months postpartum, four of six women in the immediate insertion group had a LNG IUD in place; of the five women in the delayed group, three did not have a LNG IUD in place and two were pregnant. The study was discontinued after 19 months because of suboptimal enrollment. Though insertion of a LNG IUD immediately after delivery is an appropriate option for some adolescents, a larger prospective study comparing immediate to delayed LNG IUD insertion is unlikely to be feasible at our institution.
    Keywords: Adolescent Contraception ; Intrauterine Device (IUD) ; Long-Acting Reversible Contraception (Larc) ; Postpartum Contraception ; Contraceptive Agents, Female ; Intrauterine Devices, Medicated ; Levonorgestrel ; Postpartum Period ; Contraception -- Methods
    E-ISSN: 2165-8242
    Source: MEDLINE/PubMed (U.S. National Library of Medicine)
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  • 8
    Language: English
    In: Contraception, September 2018, Vol.98(3), pp.205-209
    Description: To determine if offering patients a choice of adjunctive nonpharmacologic pain management during first-trimester aspiration abortion results in lower pain scores when compared with standard care. We enrolled women receiving first-trimester aspiration abortion at the University of Hawaii. We randomized patients to standard care (control) or standard care plus a choice of nonpharmacologic pain management options (intervention). Standard care was ibuprofen 800 mg orally at least 30 min preprocedure, lidocaine paracervical block and anticipatory guidance from the provider. We measured pain on a 100-mm visual analog scale immediately postprocedure with adequate sample size to detect a 20-mm difference in pain scores. Seventy-four women participated in the trial and reported an overall mean pain score of 61.9±27.0. Participants in the control and intervention groups reported similar overall mean pain scores (control 60.6±28.8, intervention 63.3±28.5). We found procedure time, complications, provider-perceived case difficulty and patient satisfaction with pain management to be similar between groups. Providers underestimated participant pain compared to participants' own scores (mean physician estimate of participant pain: 46.3±18.5, mean participant pain score: 61.9±27.0, p〈.01). Intervention group participants most frequently selected ambient music (59%) as the nonpharmacologic intervention. Forty-one percent (15/37) of participants in the intervention group chose more than one nonpharmacologic intervention. Participants in the control group reported similar pain scores to participants in the intervention group. Procedure time and difficulty were similar between the two groups. Incorporating patient choice into a nonpharmacologic pain management model did not result in lower pain scores. This approach did increase the patient's visit time. Abortion providers frequently use nonpharmacologic pain management in the United States, and these techniques did not negatively impact patient pain scores in our study.
    Keywords: Abortion ; First-Trimester ; Nonpharmacologic ; Pain Management ; Medicine
    ISSN: 0010-7824
    E-ISSN: 1879-0518
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  • 9
    In: Journal of Antimicrobial Chemotherapy, 2016, Vol. 72(1), pp.268-272
    Description: OBJECTIVES: The increase in infections caused by drug-resistant ESBL-producing Enterobacteriaceae (ESBL-ENT) is a global concern. The characteristics and outcomes of patients infected with ESBL-ENT were examined in a pooled analysis of Phase 3 clinical trials of ceftolozane/tazobactam in patients with complicated urinary tract infections (ASPECT-cUTI) and complicated intra-abdominal infections (ASPECT-cIAI).METHODS: Trials were randomized and double blind. The ASPECT-cUTI regimen was 7 days of either intravenous ceftolozane/tazobactam (1.5 g) every 8 h or levofloxacin (750 mg) once daily. The ASPECT-cIAI regimen was 4-14 days of either intravenous ceftolozane/tazobactam (1.5 g) plus metronidazole (500 mg) or meropenem (1 g) every 8 h. Baseline cultures were obtained in both indications. Enterobacteriaceae were selected for ESBL characterization based on predefined criteria and were verified genotypically. Outcomes were assessed at the test-of-cure visit 5-9 days post-therapy in ASPECT-cUTI and 24-32 days post-randomization in ASPECT-cIAI among microbiologically evaluable (ME) patients.RESULTS: Of 2076 patients randomized, 1346 were included in the pooled ME population and 150 of 1346 (11.1%) had ESBL-ENT at baseline. At US FDA/EUCAST breakpoints of ≤2/≤1 mg/L, 81.8%/72.3% of ESBL-ENT (ESBL-Escherichia coli, 95%/88.1%; ESBL-Klebsiella pneumoniae, 56.7%/36.7%) were susceptible to ceftolozane/tazobactam versus 25.3%/24.1% susceptible to levofloxacin and 98.3%/98.3% susceptible to meropenem at CLSI/EUCAST breakpoints. Clinical cure rates for ME patients with ESBL-ENT were 97.4% (76/78) for ceftolozane/tazobactam [ESBL-E. coli, 98.0% (49 of 50); ESBL-K. pneumoniae, 94.4% (17 of 18)], 82.6% (38 of 46) for levofloxacin and 88.5% (23 of 26) for meropenem.CONCLUSIONS: Randomized trial data demonstrated high clinical cure rates with ceftolozane/tazobactam treatment of cIAI and cUTI caused by ESBL-ENT.
    Keywords: Medicine ; Pharmacy, Therapeutics, & Pharmacology;
    ISSN: 0305-7453
    E-ISSN: 1460-2091
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  • 10
    Language: English
    In: Contraception, May 2016, Vol.93(5), pp.452-454
    Description: To determine pharmacy availability of ulipristal acetate (UPA) and compare to availability of levonorgestrel-containing emergency contraceptive pills (LNG-ECPs). We conducted an observational population-based study utilizing a telephone-based secret shopper methodology. Researchers called all 198 unique retail pharmacies in Hawaii on December 2013–June 2014, representing themselves as patients and physicians. Only 2.6% of pharmacies had UPA immediately available, though 22.8% reported ability to order UPA. In contrast, 82.4% reported immediate availability of LNG-ECPs. No significant difference in availability was reported to patients and physicians. Availability of UPA is limited and significantly lower compared to LNG-ECPs. The study period did overlap with a change in distributor for UPA, likely capturing some disruption of the supply chain. Systems-based interventions are needed to address barriers to obtaining UPA.
    Keywords: Ulipristal Acetate ; Emergency Contraception ; Pharmacies ; Availability ; United States ; Hawaii ; Medicine
    ISSN: 0010-7824
    E-ISSN: 1879-0518
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