Experiences with pain of early medical abortion: qualitative results from Nepal, South Africa, and Vietnam.

BACKGROUND: Medical abortion (MA) has become an increasingly popular choice for women even where surgical abortion services are available. Pain is often cited by women as one of the worst aspects of the MA experience, yet we know little about women's experience with pain management during the process, particularly in low resource settings. The aim of this study is to better understand women's experiences of pain with MA and strategies for improving quality of care. METHODS: This qualitative study was conducted as part of a three-arm randomized, controlled trial in Nepal, Vietnam, and South Africa to investigate the effect of prophylactic pain management on pain during MA through 63 days' gestation. We purposively sampled seven parous and seven nulliparous women with a range of reported maximum pain levels from each country, totaling 42 participants. Thematic content analysis focused on MA pain experiences and management of pain compared to menstruation, labor, and previous abortions. RESULTS: MA is relatively less painful compared to giving birth and relatively more painful than menstruation, based on four factors: pain intensity, duration, associated symptoms and side effects, and response to pain medications. We identified four types of pain trajectories: minimal overall pain, brief intense pain, intermittent pain, and constant pain. Compared to previous abortion experiences, MA pain was less extreme (but sometimes longer in duration), more private, and less frightening. There were no distinct trends in pain trajectories by treatment group, parity, or country. Methods of coping with pain in MA and menstruation are similar in each respective country context, and use of analgesics was relatively uncommon. The majority of respondents reported that counseling about pain management before the abortion and support during the abortion process helped ease their pain and emotional stress. CONCLUSIONS: Pain management during MA is increasingly essential to ensuring quality abortion care in light of the growing proportion of abortions completed with medication around the world. Incorporating a discussion about pain expectations and pain management strategies into pre-MA counseling and providing access to information and support during the MA process could improve the quality of care and experiences of MA patients. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12613000017729 , registered January 8, 2013.

Two prophylactic medication approaches in addition to a pain control regimen for early medical abortion < 63 days' gestation with mifepristone and misoprostol: study protocol for a randomized, controlled trial.

BACKGROUND: Pain is often cited as one of the worst features of medical abortion. Further, inadequate pain management may motivate some women to seek unnecessary clinical care. There is a need to identify effective methods for pain control in this setting. METHODS/DESIGN: We propose a randomized, placebo-controlled trial. 576 participants (288 nulliparous; 288 parous) from study sites in Nepal, South Africa and Vietnam will be randomly allocated to one of three treatments: (1) ibuprofen 400 mg PO and metoclopramide 10 mg PO; (2) tramadol 50 mg PO and a placebo; or (3) two placebo pills, to be taken immediately before misoprostol and repeated once four hours later. All women will be provided with supplementary analgesia for use as needed during the medical abortion. We hypothesize that women receiving prophylactic analgesia will report lower maximal pain scores in the first 8 h following misoprostol administration compared to women receiving placebos for medical abortion through 63 days' gestation. Our primary objective is to determine whether prophylactic administration of ibuprofen and metoclopramide or tramadol provides superior pain relief compared to analgesia administration after pain begins, measured during the first eight hours after misoprostol administration. Secondary objectives include identifying covariates associated with higher reported pain scores; determining any impact of the study medicines on medical abortion success; and, qualitatively exploring women's physical experiences of medical abortion, especially related to pain, and how can they be improved. Data sources include medical records, participant symptom diaries and interview data obtained on the day of enrollment, during the medical abortion, and at follow-up. Participants will be contacted via telephone on day 3 and return for follow-up will occur approximately 14 days after mifepristone, concluding study participation. A subset of 42 women will also be invited to undergo in-depth qualitative interviews following study completion. DISCUSSION: Although pain is one of the most common side effects encountered with medical abortion, little is known about optimal pain management for this process. This multi-arm trial design offers an efficient approach to evaluating two prophylactic pain management regimens compared to use of pain medication as needed. TRIAL REGISTRATION: ACTRN12613000017729 (Prospectively registered 8/1/2013).

A study of the impact of an interprofessional education module in Vietnam on students' readiness and competencies.

INTRODUCTION: The literature puts forward a range of challenges of interprofessional education (IPE) related to its planning, initiation, implementation, and especially to IPE assessment. The present study aims to map changes in students' readiness and interprofessional collaboration competence (IPCC) in implementing an innovative IPE module. Potential differences in impact related to the health education programs and IPCC scores resulting from self-, peer-, and tutor assessments will also be analysed. METHODS: A pre-post design was adopted. The student's readiness for interprofessional learning was assessed using the Readiness for Interprofessional Learning Scale, and the student's IPCC score was calculated based on self-, peer-, and tutor assessments with the interprofessional collaborator assessment rubric. RESULTS: Students' mean post-test readiness scores and mean post-test IPCC scores were significantly higher than the total and subscales/domain pre-test scores (p<0.01). No significant within-subject differences were observed in students' readiness total or subscale scores when comparing health educational programs. However, significant differences were observed in students' mean total IPCC scores between programs (p<0.01). Significant differences in students' average IPCC scores were found when comparing self-, peer- and tutor assessment scores in six domains (p<0.01). Also, significant correlations between peer and tutor assessment scores were observed (p<0.01). CONCLUSION: The IPE module, designed and implemented to focus on patient-centred practice within a primary care context, positively impacted students' readiness and IPCC development. These results offer insights to expand the implementation of the IPE module to all health educational programs.

Results from a study using misoprostol for management of incomplete abortion in Vietnamese hospitals: implications for task shifting.

BACKGROUND: Complications following spontaneous or induced abortion are a major cause of maternal morbidity. To manage these complications, post-abortion care (PAC) services should be readily available and easy to access. Standard PAC treatment includes surgical interventions that are highly effective but require surgical providers and medical centers that have the necessary space and equipment. Misoprostol has been shown to be an effective alternative to surgical evacuation and can be offered by lower level clinicians. This study sought to assess whether 400 mcg sublingual misoprostol could effectively evacuate the uterus after incomplete abortion and to confirm its applicability for use at lower level settings. METHODS: All women presenting with incomplete abortion at one of three hospitals in Vietnam were enrolled. Providers were not asked to record if the abortion was spontaneous or induced. It is likely that all were spontaneous given the legal status and easy access to abortion services in Vietnam. Participants were given 400 mcg sublingual misoprostol and instructed to hold the pills under their tongue for 30 minutes and then swallow any remaining fragments. They were then asked to return one week later to confirm their clinical status. Study clinicians were instructed to confirm a complete expulsion clinically. All women were asked to complete a questionnaire regarding satisfaction with the treatment. RESULTS: Three hundred and two women were enrolled between September 2009 and May 2010. Almost all participants (96.3%) had successful completions using a single dose of 400 mcg misoprostol. The majority of women (87.2%) found the side effects to be tolerable or easily tolerable. Most women (84.3%) were satisfied or very satisfied with the treatment they received; only one was dissatisfied (0.3%). Nine out of ten women would select this method again and recommend it to a friend (91.0% and 90.0%, respectively). CONCLUSIONS: This study confirms that 400 mcg sublingual misoprostol effectively evacuates the uterus for most women experiencing incomplete abortion. The high levels of satisfaction and side effect tolerability also attest to the ease of use of this method. From these data and given the international consensus around the effectiveness of misoprostol for incomplete abortion care, it seems timely that use of the drug for this indication be widely expanded both throughout Vietnam and wherever access to abortion care is limited. TRIAL REGISTRATION: ClinicalTrials.gov, NCT00670761.

Preparation of Bacillus subtilis cell samples and generation of an SDS-PAGE.

Bacillus subtilis is a critical host for producing recombinant proteins. However, the SDS-PAGE process, including the sample preparation steps, varies among B. subtilis-related studies, making it impossible to compare findings. Hence, this paper provides a simple guide to culture and collect B. subtilis cells through an OD600 measurement and a protocol for SDS-PAGE. These techniques were applied to check the expression of a BgaB, a reporter protein and LukF-PV, a potential vaccine candidate against S. aureus, in the cytoplasm of B. subtilis under the control of a strong promoter, Pgrac212. This protocol could be helpful for scientists in preparing samples and generating an SDS-PAGE experiment, as well as favoring the unification of research about protein expression in B. subtilis.

Comparative incidence of acute kidney injury in patients on vancomycin therapy in combination with cefepime, piperacillin-tazobactam or meropenem.

Recent studies have shown that the incidence of nephrotoxicity increases when vancomycin is combined with a beta-lactam antibiotic. The objective of this study was to compare the incidence of acute kidney injury (AKI) in adult patients who received vancomycin with either piperacillin-tazobactam (VPT), cefepime (VC), or meropenem (VM). This was a single center retrospective chart review. Patients were included if they were 18 years or older, received 48 hours of combination therapy and antibiotics were started within 24 hours of each other. Exclusion criteria were receiving more than one combination of antibiotics, serum creatinine > 1.2 mg/dL, AKI at the time of inclusion, or any form of renal replacement therapy. Two hundred patients met inclusion criteria. A total of 27 (13%) patients experienced AKI. The incidence of AKI was 21.6%, 9%, and 7.4% in the VPT, VC and VM groups, respectively. A patient who received VPT was 5 times more likely to develop AKI when compared to a patient who received VC (adjusted OR 5.09 95% CI (1.51-17.08), p = 0.008) and 7 times more likely to develop AKI when compared to VM (adjusted OR 7.03 95% CI (1.97-28.08), p = 0.002). This study found a statistically significant difference in the incidence of AKI in patient receiving VPT when compared to VC or VM. This finding supports the need for careful monitoring of renal function in patients receiving VPT therapy and routine evaluation for de-escalation of antimicrobial therapy.

Two prophylactic pain management regimens for medical abortion ≤63 days' gestation with mifepristone and misoprostol: A multicenter, randomized, placebo-controlled trial.

OBJECTIVE: To determine if either prophylactic tramadol 50 mg or ibuprofen 400 mg/metoclopramide 10 mg result in lower maximal pain compared to placebo in women ≤63 days' gestation having a mifepristone-misoprostol medical abortion. STUDY DESIGN: We conducted a randomized, placebo-controlled trial in Nepal, South Africa, and Vietnam. Participants seeking medical abortion received active treatment or placebo, taken at time of misoprostol and repeated 4 hours later. All had access to additional analgesia. The primary outcome was mean maximum pain score within 8 hours. Participants self-assessed maximum pain using an 11-point numeric rating scale recorded in paper diaries; we analyzed these data using intention-to-treat analysis. Secondary outcomes included use of additional analgesia, side effects, and satisfaction. RESULTS: We enrolled 563 patients between June 2016 and October 2017; 5 participants failed to follow up. Mean adjusted maximum pain scores within 8 hours in both active arms were lower than placebo (tramadol: n = 188, 6.78 (95% confidence interval [CI] 6.46, 7.11); ibuprofen/metoclopramide: n = 187, 6.43 (95% CI 6.10, 6.75); placebo: n = 188, 7.42 (95% CI 7.10, 7.74); p = 0.0001). Additional analgesia was used by 97 (52.2%) participants in the tramadol group, 80 (43.0%) in the ibuprofen/metoclopramide group, and 103 (55.7%) in the placebo group, p = 0.04. More dizziness (p = 0.004), headache (p = 0.03), and vomiting (p < 0.001) occurred in the tramadol group. More participants reported experienced pain was the same or less than expected in the ibuprofen/metoclopramide group (p = 0.05); overall abortion satisfaction did not differ by group (p = 0.44). CONCLUSIONS: Compared with placebo, tramadol or ibuprofen/metoclopramide co-administered with misoprostol and repeated 4 h later resulted in lower mean maximum pain scores that failed to achieve clinical significance. Women who received ibuprofen/metoclopramide were least likely to use additional analgesia and reported fewer side effects. IMPLICATIONS: Given that tramadol, ibuprofen, and metoclopramide are inexpensive, globally available; and, ibuprofen and metoclopramide are included on the World Health Organization Essential Medicines List, these medicines could be considered for prophylactic pain management during medical abortion.

Building HIV healthcare worker capacity through telehealth in Vietnam.

Development of a robust technical assistance system is an essential component of a sustainable HIV response. Vietnam's National HIV Program is transitioning from a largely donor-funded programme to one primarily supported by domestic resources. Telehealth interventions are increasingly being used for training, mentoring and expert consultation in high-resource settings and hold significant potential for use as a tool to build HIV health worker capacity in low and middle-income countries. We designed, implemented and scaled up a novel HIV telehealth programme for Vietnam, with the goal of building a sustainable training model to support the country's HIV workforce needs. Over a 4-year period, HIV telehealth programmes were initiated in 17 public institutions with participation of nearly 700 clinical sites across 62 of the 63 provinces in the country. The telehealth programme was used to deliver certificate training courses, provide clinical mentoring and case-based learning, support programme implementation, provide coaching in quality improvement and disseminate new guidelines and policies. Programme evaluation demonstrated improved health worker self-reported competence in HIV care and treatment and high satisfaction among the programme participants. Lessons learnt from Vietnam's experience with telehealth can inform country programmes looking to develop a sustainable approach to HIV technical assistance and health worker capacity building.

Attributable mortality from extensively drug-resistant gram-negative infections using propensity-matched tracer antibiotic algorithms.

BACKGROUND: Tracer antibiotic algorithms using administrative data were investigated to estimate mortality attributable to extensively drug-resistant gram-negative infections (GNIs). METHODS: Among adult inpatients coded for GNIs, colistin cases and 2 comparator cohorts (non-carbapenem ß-lactams or carbapenems) treated for ≥4 consecutive days, or died while receiving the antibiotic, were separately propensity score-matched (1:2). Attributable mortality was the in-hospital mortality difference among propensity-matched groups. Infection characteristics and sepsis severity influences on attributable mortality were examined. Algorithm accuracy was assessed by chart review. RESULTS: Of 232,834 GNIs between 2010 and 2013 at 79 hospitals, 1,023 per 3,350 (30.5%) colistin and 9,188 per 105,641 (8.7%) ß-lactam (non-carbapenem) comparator cases died. Propensity-matched colistin and ß-lactam case mortality was 29.2% and 16.6%, respectively, for an attributable mortality of 12.6% (95% confidence interval 10.8-14.4%). Attributable mortality varied from 11.0% (7.5%-14.7%) for urinary to 15.5% (12.6%-18.4%) for respiratory (P < .0001), and 4.6% (2.1%-7.4%) for early (≤4 days) to 16.6% (14.3%-18.9%) for late-onset infections (P < .0001). Attributable mortality decreased to 7.5% (5.6%-9.4%) using a carbapenem comparator cohort but increased 9-fold in patients coded for severe sepsis or septic shock (P < .0001). Our colistin algorithm had a positive predictive value of 60.4% and sensitivity of 65.3%. CONCLUSIONS: Mortality attributable to treatment-limiting resistance during GNIs varied considerably by site, onset, and severity of infection.

HIV-associated neurocognitive disorders: perspective on management strategies.

Potent combination antiretroviral therapy (ART) has resulted in dramatic improvements in AIDS-associated morbidity and mortality. Although combination ART has resulted in a significant reduction in HIV-associated dementia, the most severe of the HIV-associated neurocognitive disorders (HAND), the overall prevalence of HAND among this population is estimated at 40%. It has been recognized that the central nervous system (CNS) serves as a reservoir for HIV, and neuronal damage begins at the time of acute infection and persists due to chronic infection of microglial and perivascular macrophages. Although combination ART has resulted in virologic control in the plasma compartment, virologic breakthrough can potentially ensue within the CNS compartment due to limited ART drug exposure. The purpose of this review is to discuss the definition, clinical spectrum, and risk factors associated with HAND, review the pathogenesis of HAND, and address the pharmacologic challenges associated with ART drug exposure in the CNS compartment.