211 results on '"Vallely, A."'
Search Results
2. Five-Year Survival of Transcatheter Aortic Valve Implantation in High-Risk Patients
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Paul G. Bannon, Michael Seco, Martin K.C. Ng, Jun Wu, Andrew B Haymet, Scott Murray, Michael P. Vallely, Michael K. Wilson, Mark Raymond Adams, Chris Brown, Cristina Cristoloveanu, and Bruce Cartwright
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Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Prosthesis Design ,National Death Index ,Transcatheter Aortic Valve Replacement ,chemistry.chemical_compound ,Quality of life ,Humans ,Medicine ,Aged ,Retrospective Studies ,Aged, 80 and over ,Creatinine ,business.industry ,Standard treatment ,Australia ,EuroSCORE ,Aortic Valve Stenosis ,medicine.disease ,Confidence interval ,Surgery ,Stenosis ,Treatment Outcome ,chemistry ,Aortic Valve ,Heart Valve Prosthesis ,Cohort ,Quality of Life ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background Although transcatheter aortic valve implantation (TAVI) has become the standard treatment for severe aortic stenosis in high-risk patients in Australia, there is still limited data on long term survival. Methods All patients undergoing TAVI at a single tertiary institution between September 2009 and December 2015 were included. The primary outcome was survival, by linkage of patients with the National Death Index of the Australian Institute of Health and Welfare. Post-procedure data and echocardiographic measurements were retrospectively analysed for all patients. Results A total of 186 patients were included. It was a high-risk patient population (mean EuroSCORE 31.5±20.5, mean age 83.0±8.2 years). Valve prostheses used were Edwards SAPIEN (ES) (Edwards, Irvine, CA, USA) in 16.1%, Edwards SAPIEN XT (ESXT) in 74.2%, and Medtronic CoreValve (MCV) (Medtronic, Minneapolis, MN, USA) in 9.7%. Median survival time for the entire cohort was 68.2 months (95% Confidence Interval [CI]; Lower Limit [LL] 58.0 months, Upper Limit [UL] not defined). The 2- and 5-year estimates of survival were 85% (LL 80%, UL 90%) and 56% (LL 48%, UL 66%), respectively. There was no statistically significant difference in median survival between the ES and ESXT valves, or implantation approach. Survival was greater in patients with creatinine 200 μmol/L (68.8 months [LL 61.4, UL n/a] vs 48.0 months [LL 25.5, UL n/a]). Over the study period, there was a statistically significant trend in increasing mean transvalvular gradient (ES: 1.66 mmHg/yr, p=0.0058; ESXT: 2.50 mmHg/yr, p≤0.001) and maximum velocity (ESXT: 0.16 m/s/yr, p=0.004) and decreasing valve area (ESXT: -0.07 cm2/yr, p Conclusions This study has demonstrated acceptable survival in a high-risk cohort of patients undergoing TAVI, with comparable results to larger international experiences. There was a trend for worsening haemodynamics that needs to be monitored. Future studies need to examine patient quality of life and the performance of newer generation prostheses.
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- 2021
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3. Early neonatal death review from two provinces in Papua New Guinea: A retrospective analysis
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Cherolyn Polomon, Andrew Vallely, Lucy Au, Michaela A Riddell, Caroline S.E. Homer, Moses Laman, Rachel Smith, William Pomat, Joshua P. Vogel, Alice Mengi, and Lisa M Vallely
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medicine.medical_specialty ,Resuscitation ,Perinatal Death ,Psychological intervention ,Papua New Guinea ,03 medical and health sciences ,0302 clinical medicine ,Pregnancy ,030225 pediatrics ,Infant Mortality ,Humans ,Medicine ,030212 general & internal medicine ,Retrospective Studies ,business.industry ,Infant, Newborn ,Retrospective cohort study ,medicine.disease ,Infant mortality ,Premature birth ,Pediatrics, Perinatology and Child Health ,Emergency medicine ,Premature Birth ,Female ,Health education ,business ,Neonatal resuscitation - Abstract
Aim To determine the causes of early neonatal death and the avoidable factors associated with these deaths among women participating in a cluster-randomised crossover trial in Papua New Guinea. Methods Early neonatal deaths were identified by retrospective chart review of the Women and Newborn Trial of Antenatal Interventions and Management study participants between July 2017 and January 2020. Causes of death and avoidable factors were identified using the Perinatal Problem Identification Program system. Results There were 35 early neonatal deaths among 2499 livebirths (14 per 1000 births). Fifty-seven percent (20/35) of deaths occurred on the first day of life. Idiopathic preterm birth was the leading obstetric cause of perinatal death (29%; 10/35). Extreme multi-organ immaturity (23%; 8/35) and hypoxic ischaemic encephalopathy (17%; 6/35) were the most common final causes of neonatal death. Forty-six avoidable factors were identified among 26 deaths, including delays in care-seeking, insufficient resources at health facilities, poor intrapartum care and immediate care of the newborn, including neonatal resuscitation. Conclusion In this study, potentially preventable causes and avoidable factors were identified in the majority of early neonatal deaths. Addressing these factors will require health system strengthening, particularly the upskilling of primary level health staff, as well as targeted health education of women and the community.
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- 2021
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4. Mycoplasma genitalium and Other Reproductive Tract Infections in Pregnant Women, Papua New Guinea, 2015–2017
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Alexandra J. Umbers, Ruth Fidelis, Elissa Kennedy, Christopher Morgan, Leanne J. Robinson, Simon Erskine, Brendan S. Crabb, Kerryanne Tokmun, Michelle J. L. Scoullar, Steven G Badman, Nicholas C. Wong, Philippe Boeuf, Healthy Mothers Healthy Babies Study Team, Stanley Luchters, Freya J. I. Fowkes, Peter Siba, Andrew Vallely, Catriona S. Bradshaw, Lisa M Vallely, Elisa Mokany, Glenda Fehler, James G. Beeson, Pele Melepia, Elizabeth Peach, William Pomat, and Arthur Elijah
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Epidemiology ,Gonorrhea ,lcsh:Medicine ,Mycoplasma genitalium ,Chlamydia trachomatis ,medicine.disease_cause ,urologic and male genital diseases ,Reproductive Tract Infections ,0302 clinical medicine ,Pregnancy ,030212 general & internal medicine ,bacteria ,Reproductive health ,biology ,Obstetrics ,Anti-Bacterial Agents ,Infectious Diseases ,Coinfection ,vulvovaginal candidiasis ,Female ,Macrolides ,Bacterial vaginosis ,bacterial vaginosis ,Microbiology (medical) ,medicine.medical_specialty ,030231 tropical medicine ,Sexually Transmitted Diseases ,lcsh:Infectious and parasitic diseases ,03 medical and health sciences ,Papua New Guinea ,Drug Resistance, Bacterial ,medicine ,Trichomonas vaginalis ,Humans ,lcsh:RC109-216 ,Mycoplasma Infections ,Treponema pallidum ,sexually transmitted infections ,Mycoplasma genitalium and Other Reproductive Tract Infections in Pregnant Women, Papua New Guinea, 2015–2017 ,business.industry ,Research ,lcsh:R ,Chlamydia Infections ,biology.organism_classification ,medicine.disease ,Neisseria gonorrhoeae ,Syphilis ,fungi ,Pregnant Women ,business - Abstract
Much about the range of pathogens, frequency of coinfection, and clinical effects of reproductive tract infections (RTIs) among pregnant women remains unknown. We report on RTIs (Mycoplasma genitalium, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Treponema pallidum subspecies pallidum, bacterial vaginosis, and vulvovaginal candidiasis) and other reproductive health indicators in 699 pregnant women in Papua New Guinea during 2015–2017. We found M. genitalium, an emerging pathogen in Papua New Guinea, in 12.5% of participants. These infections showed no evidence of macrolide resistance. In total, 74.1% of pregnant women had >1 RTI; most of these infections were treatable. We detected sexually transmitted infections (excluding syphilis) in 37.7% of women. Our findings showed that syndromic management of infections is greatly inadequate. In total, 98.4% of women had never used barrier contraception. These findings will inform efforts to improve reproductive healthcare in Papua New Guinea.
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- 2021
5. Adverse pregnancy and neonatal outcomes associated with Neisseria gonorrhoeae: systematic review and meta-analysis
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Andrew Vallely, Handan Wand, Rebecca Guy, William Pomat, Dianne Egli-Gany, John M. Kaldor, Alice R. Rumbold, Bronwyn Silver, Lisa M Vallely, Nicola Low, and Caroline S.E. Homer
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medicine.medical_specialty ,Fetal Membranes, Premature Rupture ,610 Medicine & health ,Dermatology ,Review ,Cochrane Library ,03 medical and health sciences ,Gonorrhea ,0302 clinical medicine ,systematic review ,360 Social problems & social services ,Pregnancy ,medicine ,Humans ,030212 general & internal medicine ,Pregnancy Complications, Infectious ,Perinatal Mortality ,030505 public health ,business.industry ,Obstetrics ,Infant, Newborn ,Odds ratio ,premature birth ,Infant, Low Birth Weight ,medicine.disease ,Ophthalmia Neonatorum ,Neisseria gonorrhoeae ,meta-analysis ,Abortion, Spontaneous ,Low birth weight ,Infectious Diseases ,Premature birth ,Meta-analysis ,Cohort ,Female ,medicine.symptom ,0305 other medical science ,business ,Cohort study - Abstract
ObjectiveTo examine associations betweenNeisseria gonorrhoeae(NG) infection during pregnancy and the risk of preterm birth, spontaneous abortion, premature rupture of membranes, perinatal mortality, low birth weight and ophthalmia neonatorum.Data sourcesWe searched Medline, EMBASE, the Cochrane Library and Cumulative Index to Nursing and Allied Health Literature for studies published between 1948 and 14 January 2020.MethodsStudies were included if they reported testing for NG during pregnancy and compared pregnancy, perinatal and/or neonatal outcomes between women with and without NG. Two reviewers independently assessed papers for inclusion and extracted data. Risk of bias was assessed using established checklists for each study design. Summary ORs with 95% CIs were generated using random effects models for both crude and, where available, adjusted associations.ResultsWe identified 2593 records and included 30 in meta-analyses. Women with NG were more likely to experience preterm birth (OR 1.55, 95% CI 1.21 to 1.99, n=18 studies); premature rupture of membranes (OR 1.41, 95% CI 1.02 to 1.92, n=9); perinatal mortality (OR 2.16, 95% CI 1.35 to 3.46, n=9); low birth weight (OR 1.66, 95% CI 1.12 to 2.48, n=8) and ophthalmia neonatorum (OR 4.21, 95% CI 1.36 to 13.04, n=6). Summary adjusted ORs were, for preterm birth 1.90 (95% CI 1.14 to 3.19, n=5) and for low birth weight 1.48 (95% CI 0.79 to 2.77, n=4). In studies with a multivariable analysis, age was the variable most commonly adjusted for. NG was more strongly associated with preterm birth in low-income and middle-income countries (OR 2.21, 95% CI 1.40 to 3.48, n=7) than in high-income countries (OR 1.38, 95% CI 1.04 to 1.83, n=11).ConclusionsNG is associated with a number of adverse pregnancy and newborn outcomes. Further research should be done to determine the role of NG in different perinatal mortality outcomes because interventions that reduce mortality will have the greatest impact on reducing the burden of disease in low-income and middle-income countries.PROSPERO registration numberCRD42016050962.
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- 2021
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6. Perinatal death audit and classification of stillbirths in two provinces in Papua New Guinea: A retrospective analysis
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Joshua P. Vogel, Michaela A Riddell, Caroline S.E. Homer, Lucy Au, William Pomat, Lisa M Vallely, Cherolyn Polomon, Delly Babona, Rachel Smith, John W. Bolnga, Andrew Vallely, and Alice Mengi
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Adult ,medicine.medical_specialty ,Perinatal Death ,Psychological intervention ,Cohort Studies ,Papua New Guinea ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Pre-Eclampsia ,Pregnancy ,Breech presentation ,medicine ,Humans ,030212 general & internal medicine ,Breech Presentation ,reproductive and urinary physiology ,Randomized Controlled Trials as Topic ,Retrospective Studies ,Cause of death ,Asphyxia Neonatorum ,030219 obstetrics & reproductive medicine ,Obstetrics ,business.industry ,Infant, Newborn ,Obstetrics and Gynecology ,Retrospective cohort study ,General Medicine ,Patient Acceptance of Health Care ,Stillbirth ,medicine.disease ,female genital diseases and pregnancy complications ,Infant mortality ,3. Good health ,Cohort ,Female ,business ,Cohort study - Abstract
Objective To undertake a retrospective perinatal death audit and assessment of avoidable factors associated with stillbirths among a cohort of women in two provinces in Papua New Guinea. Methods We used data from an ongoing cluster-randomized crossover trial in 10 sites among 4600 women in Papua New Guinea (from 2017 to date). The overarching aim is to improve birth outcomes. All stillbirths from July 2017 to January 2020 were identified. The Perinatal Problem Identification Program was used to analyze each stillbirth and review associated avoidable factors. Results There were 59 stillbirths among 2558 births (23 per 1000 births); 68% (40/59) were classified "fresh" and 32% as "macerated". Perinatal cause of death was identified for 63% (37/59): 30% (11/37) were due to intrapartum asphyxia and traumatic breech birth and 19% (7/37) were the result of pre-eclampsia. At least one avoidable factor was identified for 95% (56/59) of stillbirths. Patient-associated factors included lack of response to reduced fetal movements and delay in seeking care during labor. Health personnel-associated factors included poor intrapartum care, late diagnosis of breech presentation, and prolonged second stage with no intervention. Conclusion Factors associated with stillbirths in this setting could be avoided through a package of interventions at both the community and health-facility levels.
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- 2020
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7. Minimally-invasive versus transcatheter aortic valve implantation: systematic review with meta-analysis of propensity-matched studies
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Paul G. Bannon, Kei Woldendorp, M. Doyle, Michael K. Wilson, Michael P. Vallely, Tristan D. Yan, and Martin K.C. Ng
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Pulmonary and Respiratory Medicine ,Aortic valve ,medicine.medical_specialty ,Transcatheter aortic ,business.industry ,Acute kidney injury ,Statistical difference ,030204 cardiovascular system & hematology ,medicine.disease ,03 medical and health sciences ,0302 clinical medicine ,medicine.anatomical_structure ,Postoperative stroke ,Aortic valve replacement ,Statistical significance ,Internal medicine ,Meta-analysis ,medicine ,Cardiology ,Original Article ,030212 general & internal medicine ,business - Abstract
BACKGROUND: Minimally invasive aortic valve replacement (MiAVR) and transcatheter aortic valve implantation (TAVI) provide aortic valve replacement (AVR) by less invasive methods than conventional surgical AVR, by avoiding complete sternotomy. This study directly compares and analyses the available evidence for early outcomes between these two AVR methods. METHODS: Electronic databases were searched from inception until August 2019 for studies comparing MiAVR to TAVI, according to predefined search criteria. Propensity-matched studies with sufficient data were included in a meta-analysis. RESULTS: Eight studies with 9,744 patients were included in the quantitative analysis. Analysis of risk-matched patients showed no difference in early mortality (RR 0.76, 95% CI, 0.37–1.54, P=0.44). MiAVR had a signal towards lower rate of postoperative stroke, although this did not reach statistical significance (OR 0.42, 95% CI, 0.13–1.29, P=0.13). MiAVR had significantly lower rates of new pacemaker (PPM) requirement (OR 0.29, 95% CI, 0.16–0.52, P
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- 2021
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8. Health communication messaging about HPV vaccine in Papua New Guinea
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Jamee Newland, Herick Aeno, Glen D. L. Mola, Lisa M Vallely, Sophie Ase, Peter Aggleton, Angela Kelly-Hanku, John M. Kaldor, Andrew Vallely, and Voletta Fiya
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Cervical cancer ,medicine.medical_specialty ,business.industry ,Public Health, Environmental and Occupational Health ,Information Dissemination ,New guinea ,Cancer ,medicine.disease ,03 medical and health sciences ,0302 clinical medicine ,030220 oncology & carcinogenesis ,Family medicine ,medicine ,Health education ,030212 general & internal medicine ,Rural area ,Human papillomavirus ,business ,Health communication - Abstract
Objective:The type of health education messages that communities and individuals seek to have communicated about the human papillomavirus (HPV) vaccine is important if vaccine programmes are to succeed, especially in settings such as Papua New Guinea (PNG), which have a high burden of cervical cancer, low health literacy and negative experiences of earlier vaccination programmes. This study sought to identify the health education messages that are viewed as most appropriate in such a context.Methodology:A qualitative study using gender-specific focus group discussions ( N = 21) and semi-structured interviews ( N = 82) was undertaken in three sites in PNG. Sites included both rural and urban locations in Milne Bay, Eastern Highlands and Western Highlands Provinces.Results:Two divergent discourses emerged. One group of participants, largely young people, felt communication messages should stress that HPV is a preventable sexually transmitted infection, which can cause cervical cancer. The other group, mainly members of the older population, believed that messaging should focus on the vaccine as a prevention strategy for cervical cancer. A small minority wanted both aspects of the vaccine discussed.Conclusion:Sensitivity needs to be taken when engaging with communities which have negative experiences of earlier infant immunisation programmes. Ensuring that the health communication needs and priorities of different sections of the populations are taken into account is key to the successful introduction and roll-out of HPV vaccination in this setting.
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- 2019
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9. Women's knowledge of maternal danger signs during pregnancy: Findings from a cross-sectional survey in Papua New Guinea
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R. Emori, Lisa M Vallely, Suparat Phuanukoonnon, Hebe N. Gouda, Caroline S.E. Homer, and Andrew Vallely
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Adult ,Rural Population ,Health Knowledge, Attitudes, Practice ,medicine.medical_specialty ,Adolescent ,Cross-sectional study ,Danger sign ,Papua New Guinea ,03 medical and health sciences ,0302 clinical medicine ,Health facility ,Pregnancy ,Surveys and Questionnaires ,Maternity and Midwifery ,Humans ,Childbirth ,Medicine ,Vaginal bleeding ,Health worker ,030219 obstetrics & reproductive medicine ,030504 nursing ,business.industry ,Obstetrics and Gynecology ,New guinea ,medicine.disease ,Pregnancy Complications ,Cross-Sectional Studies ,Family medicine ,Female ,Pregnant Women ,medicine.symptom ,0305 other medical science ,business - Abstract
To explore knowledge of pregnancy related danger signs among women attending antenatal clinics in Papua New Guinea.Cross-sectional survey undertaken as part of a wider integrated health and demographic survey.Three sites in Papua New Guinea: Hiri District (Central Province), Karkar (Madang Province) and Asaro (Eastern Highlands Province).482 women aged 15-44 years.Almost all (95.2%; 459/482) women attended for antenatal care at least once; 68.2% attended four or more times. Among women who attended the antenatal clinic, 53.6% (246/459) reported receiving information about danger signs in pregnancy from a health worker. Of these 60.2% (148/246) could recall at least one danger sign. In addition, 16.4% (35/213) of women who did not receive information from the antenatal clinic reported pregnancy related danger signs. Among the 183 women who reported danger signs, 47.5% (87/183) reported fever; 39.3% (72/183) reported vaginal bleeding and 36.6% (67/183) reported swelling of the face, legs and arms. Women who reported receiving information at the antenatal clinic were significantly more likely know any danger signs, compared with women who did not receive information at the antenatal clinic (OR 7.68 (95%CI: 4.93, 11.96); p = 0.001). Knowledge of danger signs was significantly associated with secondary school education, compared with none or only primary education (OR 3.08 (95% CI: 2.06, 4.61); p = 0.001).Every antenatal clinic visit should be used opportunistically to provide women with information about key danger signs during pregnancy and childbirth. Recognising maternal danger signs, together with the importance of seeking early transfer to the health facility and the importance of attending for a health facility birth are critical to improving outcomes for mothers and babies especially in low income settings such as Papua New Guinea.
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- 2019
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10. O16.1 High burden of reproductive tract infections and poor sexual and reproductive health in pregnancy and postpartum in Papua New Guinea
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Arthur Elijah, Elisa Mokany, S Badman, Nicholas C. Wong, Glenda Fehler, Alexandra J. Umbers, H Study Team, Pele Melepia, Peter Siba, Catriona S. Bradshaw, Kerryanne Tokmun, Stanley Luchters, Michelle J. L. Scoullar, E Kearney, Ruth Fidelis, Elissa Kennedy, Philippe Boeuf, Simon Erskine, James G. Beeson, Andrew Vallely, Lisa M Vallely, Willie Pomat, Christopher Morgan, Leanne J. Robinson, Brendan S. Crabb, Freya J. I. Fowkes, and Elizabeth Peach
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medicine.medical_specialty ,Pregnancy ,Obstetrics ,business.industry ,medicine.disease_cause ,medicine.disease ,medicine ,Childbirth ,Vaginal smear ,Trichomonas vaginalis ,Syphilis ,Bacterial vaginosis ,Chlamydia trachomatis ,business ,Reproductive health - Abstract
There is a pressing need for detailed knowledge of the range of pathogens, extent of co-infection and clinical impact of reproductive tract infections (RTIs) among pregnant women. We present prevalence and correlates of RTIs (Mycoplasma genitalium, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Treponema pallidum subspecies pallidum, bacterial vaginosis and vulvovaginal candidiasis) in a longitudinal study of women in pregnancy and postpartum in Papua New Guinea (PNG). 699 pregnant women were recruited at their first antenatal clinic visit and followed up at childbirth, one, six and twelve months postpartum. Self-collected vaginal swabs were tested for M.genitalium using real-time PlexPCR® (SpeeDx) which provides results for five point mutations associated with macrolide resistance. Urine samples or vaginal swabs were tested for C.trachomatis, N.gonorrhoea and T.vaginalis using GeneXpert. A vaginal smear was examined for BV and VVC. Routine antenatal services tested for syphilis using Alere DetermineTM Syphilis. Most pregnant women (74.1%) had at least one RTI, with a curable current sexually-transmitted infection (STI) detected in 37.7%. We found M. genitalium, an emerging pathogen in PNG, in 12.5% of pregnant women, decreasing to 6.1% at six months postpartum, with no evidence of macrolide resistance. Prevalence of other curable STIs (C. trachomatis, N. gonorrhoeae and T. vaginalis) were all high in in pregnancy (19.1%, 5.5% and 20.1% respectively), with prevalence decreasing immediately postpartum but rising again by 12 months postpartum. Clinical symptoms missed at least 75% of infections and there was little use of contraception; 98.4% report never having used barrier contraception. This study highlights a high prevalence of a RTIs in pregnancy and postpartum. Most of these infections are curable when diagnosis is made available and syndromic management alone is insufficient. This high prevalence of disease negatively affects sexual and reproductive health and these findings have important public health implications in PNG and the region.
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- 2021
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11. Risk factors and knowledge associated with high unintended pregnancy rates and low family planning use among pregnant women in Papua New Guinea
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Stanley Luchters, Primrose Homiehombo, Alexandra J. Umbers, Lucy Au, Leanne J. Robinson, Elizabeth Peach, William Pomat, Angela Kelly-Hanku, Brendan S. Crabb, Lisa M Vallely, Arthur Elijah, Michelle J. L. Scoullar, Christopher Morgan, Pele Melepia, Andrew Vallely, Freya J. I. Fowkes, James G. Beeson, Elissa Kennedy, and Peter Siba
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Adult ,Male ,medicine.medical_specialty ,Disease prevention ,Adolescent ,Pregnancy Rate ,Epidemiology ,Cross-sectional study ,Science ,Article ,Papua New Guinea ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Pregnancy ,Medicine and Health Sciences ,Prevalence ,medicine ,Humans ,Prospective Studies ,030212 general & internal medicine ,Young adult ,Teenage pregnancy ,Public health ,030219 obstetrics & reproductive medicine ,Multidisciplinary ,business.industry ,Pregnancy, Unplanned ,medicine.disease ,Pregnancy rate ,Contraception ,Cross-Sectional Studies ,Risk factors ,Family planning ,Family Planning Services ,Medicine ,Female ,Pregnant Women ,business ,Unintended pregnancy ,Demography - Abstract
Unintended pregnancy is a major driver of poor maternal and child health in resource-limited settings. Data on pregnancy intention and use of family planning (FP) is scarce in Papua New Guinea (PNG), but are needed to inform public health strategies to improve FP accessibility and uptake. Data from a facility-based cross-sectional sample of 699 pregnant women assessed prevalence and predictors of unintended pregnancy and modern FP use among pregnant women in East New Britain Province, PNG. More than half (55%) the women reported their pregnancy as unintended. Few (18%) reported ever having used a modern FP method, and knowledge of different methods was low. Being single, separated or divorced (AOR 9.66; 95% CI 3.27–28.54), educated to a tertiary or vocational level (AOR 1.78 CI 1.15–2.73), and gravidity > 1 (AOR 1.43 for each additional pregnancy CI 1.29–1.59) were associated with unintended pregnancy; being accompanied by a male partner to ANC was associated with a reduced unintended pregnancy (0.46 CI 0.30–0.73). Factors associated with modern FP use included male partner involvement (AOR 2.26 CI 1.39–3.67) and gravidity > 1 (AOR 1.54 for each additional pregnancy CI 1.36–1.74). FP use also varied by the facility women attended. Findings highlight an urgent need for targeted interventions to improve FP knowledge, uptake and access, and male partner involvement, to reduce unintended pregnancies and their complications.
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- 2021
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12. Feasibility and acceptability of implementing early infant diagnosis of HIV in Papua New Guinea at the point of care: a qualitative exploration of health worker and key informant perspectives
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Andrew J Vallely, Suzanne Crowe, Steven G Badman, Martha Kupul, Angela Kelly-Hanku, Mark Stoové, Andrew Vallely, Xiang-Sheng Chen, David Anderson, Tin Maung Zaw, Stanley Luchters, Steven Badman, Yasmin Mohamed, Janet Gare, Selina Silim, Claire Nightingale, Paul Agius, Hla Htay, Win Lei Yee, Zure Kombati, Htay Htay Tin, Win Thein, and Latt Latt Kyaw
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medicine.medical_specialty ,Point-of-Care Systems ,Human immunodeficiency virus (HIV) ,HIV Infections ,Myanmar ,paediatric infectious disease & immunisation ,medicine.disease_cause ,03 medical and health sciences ,Papua New Guinea ,0302 clinical medicine ,Nursing ,Acquired immunodeficiency syndrome (AIDS) ,medicine ,Humans ,hiv & aids ,030212 general & internal medicine ,Human resources ,Qualitative Research ,Point of care ,international health services ,business.industry ,Public health ,public health ,New guinea ,Infant ,General Medicine ,medicine.disease ,Infectious Disease Transmission, Vertical ,Test (assessment) ,Early Diagnosis ,Key informants ,Medicine ,Feasibility Studies ,Female ,business ,030217 neurology & neurosurgery - Abstract
IntroductionEarly infant diagnosis (EID) of HIV and timely initiation of antiretroviral therapy can significantly reduce morbidity and mortality among HIV-positive infants. Access to EID is limited in many low-income and middle-income settings, particularly those in which standard care involves dried blood spots (DBS) sent to centralised laboratories, such as in Papua New Guinea (PNG). We conducted a qualitative exploration of the feasibility and acceptability of implementing a point-of-care (POC) EID test (Xpert HIV-1 Qualitative assay) among health workers and key stakeholders working within the prevention of mother-to-child transmission of HIV (PMTCT) programme in PNG.MethodsThis qualitative substudy was conducted as part of a pragmatic trial to investigate the effectiveness of the Xpert HIV-1 Qualitative test for EID in PNG and Myanmar. Semistructured interviews were undertaken with 5 health workers and 13 key informants to explore current services, experiences of EID testing, perspectives on the Xpert test and the feasibility of integrating and scaling up POC EID in PNG. Coding was undertaken using inductive and deductive approaches, drawing on existing acceptability and feasibility frameworks.ResultsHealth workers and key informants (N=18) felt EID at POC was feasible to implement and beneficial to HIV-exposed infants and their families, staff and the PMTCT programme more broadly. All study participants highlighted starting HIV-positive infants on treatment immediately as the main advantage of POC EID compared with standard care DBS testing. Health workers identified insufficient resources to follow up infants and caregivers and space constraints in hospitals as barriers to implementation. Participants emphasised the importance of adequate human resources, ongoing training and support, appropriate coordination and a sustainable supply of consumables to ensure effective scale-up of the test throughout PNG.ConclusionsImplementation of POC EID in a low HIV prevalence setting such as PNG is likely to be both feasible and beneficial with careful planning and adequate resources.Trial registration number12616000734460.
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- 2020
13. High burden of Mycoplasma genitalium and other reproductive tract infections among pregnant women in Papua New Guinea
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Pele Melepia, James G. Beeson, Elizabeth Peach, William Pomat, Alexandra J. Umbers, Ruth Fidelis, Stanley Luchters, Lisa M Vallely, Nicholas C. Wong, Elisa Mokany, Andrew Vallely, Kerryanne Tokmun, Simon Erskine, Catriona S. Bradshaw, Michelle J. L. Scoullar, Philippe Boeuf, Brendan S. Crabb, Steven G Badman, Christopher Morgan, Leanne J. Robinson, Freya J. I. Fowkes, Elissa Kennedy, Glenda Fehler, Peter Siba, and Arthur Elijah
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medicine.medical_specialty ,biology ,business.industry ,Obstetrics ,medicine.disease_cause ,medicine.disease ,biology.organism_classification ,Neisseria gonorrhoeae ,Medicine ,Trichomonas vaginalis ,Syphilis ,Bacterial vaginosis ,business ,Chlamydia trachomatis ,Mycoplasma genitalium ,Pathogen ,Reproductive health - Abstract
There is a pressing need for detailed knowledge of the range of pathogens, extent of co-infection and clinical impact of reproductive tract infections (RTIs) among pregnant women. Here, we report on RTIs (Mycoplasma genitalium, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Treponema pallidum subspecies pallidum, bacterial vaginosis and vulvovaginal candidiasis) and other sexual and reproductive health indicators among 699 pregnant women in Papua New Guinea (PNG). We found widespread M. genitalium infection (12.5% of women), the first time this pathogen has been reported in PNG, with no evidence of macrolide resistance. Most pregnant women (76.2%) had at least one RTI, most of which are treatable. Excluding syphilis, sexually-transmitted infections were detected in 37.8% women. Syndromic management of infections is greatly inadequate and there was remarkably little use of contraception; 98.4% report never having used barrier contraception. This work has implications for improving maternal and child health in PNG.ARTICLE SUMMARY LINEThis first report of Mycoplasma genitalium in Papua New Guinea finds a high burden (12.5%) among 699 pregnant women. Additionally, more than one in two women were positive for a treatable reproductive tract infection associated with poor health outcomes.
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- 2020
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14. Performance of clinical screening algorithms comprising point-of-care HPV-DNA testing using self-collected vaginal specimens, and visual inspection of the cervix with acetic acid, for the detection of underlying high-grade squamous intraepithelial lesions in Papua New Guinea
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Lisa M Vallely, Benny Kombuk, John M. Kaldor, Antonia Kumbia, Marion Saville, Julia M.L. Brotherton, Glen D. L. Mola, Sepehr N. Tabrizi, Grace Tan, Handan Wand, Josephine Gabuzzi, Andrew Vallely, Angela Kelly-Hanku, Gloria Munnull, Steven G Badman, Claire Ryan, Zure Kombati, Suzanne M. Garland, Rebecca Guy, Pamela J Toliman, and Selina Silim
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Self-collect ,medicine.medical_treatment ,Uterine Cervical Neoplasms ,Cryotherapy ,Cervix Uteri ,0302 clinical medicine ,Cytology ,030212 general & internal medicine ,Early Detection of Cancer ,Acetic Acid ,Cervical cancer ,Middle Aged ,Visual inspection ,Squamous intraepithelial lesion ,Infectious Diseases ,medicine.anatomical_structure ,HPV, Human Papillomavirus ,030220 oncology & carcinogenesis ,Vagina ,LMICs, Low- and Middle-Income Countries ,Screening ,Female ,Squamous Intraepithelial Lesions of the Cervix ,Algorithm ,Algorithms ,Adult ,PNG, Papua New Guinea ,HPV ,Point-of-Care Systems ,Cytological Techniques ,Sensitivity and Specificity ,Article ,WHO, World Health Organization ,Specimen Handling ,lcsh:Infectious and parasitic diseases ,Papua New Guinea ,03 medical and health sciences ,Virology ,medicine ,Humans ,lcsh:RC109-216 ,HSIL, High-grade Squamous Intraepithelial Lesion ,Visual inspection with acetic acid ,Cervix ,VIA, Visual Inspection with Acetic Acid ,Point of care ,business.industry ,medicine.disease ,DNA, Viral ,Self-Examination ,Indicators and Reagents ,business ,DNA, Deoxyribonucleic Acid - Abstract
The performance of different clinical screening algorithms comprising point-of-care HPV-DNA testing using self-collected vaginal (‘V’) specimens, and visual inspection of the cervix with acetic acid (VIA) was evaluated in Papua New Guinea.Women aged 30–59 years provided V specimens that were tested at point-of-care using the Xpert HPV Test (Cepheid, Sunnyvale, CA). A clinician-collected cervical (‘C’) specimen was then collected for point-of-care Xpert testing, and liquid-based cytology (LBC). Following this, VIA examination was conducted, blind to HPV test results, and ablative cervical cryotherapy provided if indicated. Detection of high-grade squamous intraepithelial lesion (HSIL) by LBC was the reference standard used to evaluate clinical screening algorithms.Of 1005 women, 36 had HSIL+. Xpert HPV Test performance using V specimens (sensitivity 91.7%, specificity 87.0%, PPV 34.0%, NPV 99.3%) was superior to VIA examination alone (51.5%, 81.4%, 17.5%, 95.6% respectively) in predicting underlying HSIL+. A screening algorithm comprising V specimen HPV testing followed by VIA examination had low sensitivity (45.5%) but comparable specificity, PPV and NPV to HPV testing alone (96.3%, 45.5%, 96.3% respectively).A ‘test-and-treat’ screening algorithm based on point-of-care HPV testing of V specimens had superior performance compared with either VIA examination alone, or a combined screening algorithm comprising HPV testing plus VIA. Keywords: Cervical cancer, HPV, Screening, Self-collect, Papua New Guinea, Visual inspection with acetic acid
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- 2018
15. Operational experiences associated with the implementation of near point-of-care early infant diagnosis of HIV in Myanmar: a qualitative study
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Hla Htay, Win Lei Yee, Angela Kelly-Hanku, Claire Nightingale, David A. Anderson, Yasmin Mohamed, Moe Myat Aye, Win Thein, Stanley Luchters, Andrew Vallely, Latt Latt Kyaw, Htay Htay Tin, Win Win Yee, and Steven G Badman
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Referral ,Cost effectiveness ,Point-of-Care Systems ,HIV Infections ,GeneXpert ,Myanmar ,Health informatics ,Turnaround time ,Health administration ,Health care ,medicine ,Humans ,Viral load ,Prevention of mother-to-child transmission ,business.industry ,Health Policy ,Nursing research ,Australia ,ART initiation ,Infant ,HIV ,Early infant diagnosis ,medicine.disease ,Early Diagnosis ,Point-of-care ,Implementation science ,Medical emergency ,Public aspects of medicine ,RA1-1270 ,business ,Research Article ,Qualitative research - Abstract
Background Timely diagnosis and early initiation of life-saving antiretroviral therapy are critical factors in preventing mortality among HIV-infected infants. However, resource-limited settings experience numerous challenges associated with centralised laboratory-based testing, including low rates of testing, complex sample referral pathways and unacceptably long turnaround times for results. Point-of-care (POC) HIV testing for HIV-exposed infants can enable same-day communication of results and early treatment initiation for HIV-infected infants. However, complex operational issues and service integration can limit utility and must be well understood prior to implementation. We explored and documented the challenges and enabling factors in implementing the POC Xpert® HIV-1 Qual test (Cepheid, Sunnyvale, CA, USA) for early infant diagnosis (EID) as part of routine services in four public hospitals in Myanmar. Methods This sub-study was part of a randomised controlled stepped-wedge trial (Australian and New Zealand Clinical Trials Registry, number 12616000734460) designed to investigate the impact of POC testing for EID in Myanmar and Papua New Guinea. Infants recruited during the intervention phase underwent POC testing at the participating hospitals as part of routine care. Semi-structured interviews with 23 caregivers, 12 healthcare providers and 10 key informants were used to explore experiences of POC-EID testing. The research team and hospital staff documented and discussed implementation challenges throughout the study. Results Overall, caregivers and healthcare workers were satisfied with the short turnaround time of the POC test. Occasional delays in POC testing were mostly attributable to late receipt of samples by laboratory technicians and communication constraints among healthcare staff. Hospital staff valued technical assistance from the research group and the National Health Laboratory. Despite staff shortages and infrastructure challenges such as unreliable electricity supply and cramped space, healthcare workers and caregivers found the implementation of the POC test to be feasible at pilot sites. Conclusions As plans for national scale-up evolve, there needs to be a continual focus on staff training, communication pathways and infrastructure. Other models of care, such as allowing non-laboratory-trained personnel to perform POC testing, and cost effectiveness should also be evaluated.
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- 2021
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16. Self-collection for HPV-based cervical screening: a qualitative evidence meta-synthesis
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Lise Lafferty, Angela Kelly-Hanku, Rebecca Guy, Andrew Vallely, Ye Zhang, and Hawa Camara
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HPV testing ,medicine.medical_specialty ,Uterine Cervical Neoplasms ,Health literacy ,03 medical and health sciences ,0302 clinical medicine ,Health care ,Humans ,Mass Screening ,Medicine ,030212 general & internal medicine ,Framework synthesis ,Early Detection of Cancer ,Qualitative Research ,Cervical cancer ,030505 public health ,Cervical screening ,business.industry ,Public health ,Papillomavirus Infections ,Qualitative meta-synthesis ,Public Health, Environmental and Occupational Health ,medicine.disease ,Family medicine ,Female ,Public aspects of medicine ,RA1-1270 ,Biostatistics ,0305 other medical science ,business ,Self-collection ,Research Article ,Qualitative research ,Intrapersonal communication - Abstract
Background Cervical cancer is the fourth most common cancer affecting women worldwide, with 85% of the burden estimated to occur among women in low and middle-income countries (LMICs). Recent developments in cervical cancer screening include a novel self-collection method for the detection of oncogenic HPV strains in the collected samples. The purpose of this review is to synthesise qualitative research on self-collection for HPV-based testing for cervical screening and identify strategies to increase acceptability and feasibility in different settings, to alleviate the burden of disease. Methods This review includes qualitative studies published between 1986 and 2020. A total of 10 databases were searched between August 2018 and May 2020 to identify qualitative studies focusing on the perspectives and experiences of self-collection for HPV-based cervical screening from the point of view of women, health care workers and other key stakeholders (i.e., policymakers). Two authors independently assessed studies for inclusion, quality, and framework thematic synthesis findings. The Socio-Ecological Model (SEM) was used to synthesize the primary studies. Results A total of 1889 publications were identified, of which 31 qualitative studies were included. Using an adapted version of SEM, 10 sub-themes were identified and classified under each of the adapted model’s constructs: (a) intrapersonal, (b) interpersonal, and (c) health systems/public policy. Some of the themes included under the intrapersonal (or individual) construct include the importance of self-efficacy, and values attributed to self-collection. Under the intrapersonal construct, the findings centre around the use of self-collection and its impact on social relationships. The last construct of health systems focuses on needs to ensure access to self-collection, the need for culturally sensitive programs to improve health literacy, and continuum of care. Conclusion This review presents the global qualitative evidence on self-collection for HPV-based testing and details potential strategies to address socio-cultural and structural barriers and facilitators to the use of self-collection. If addressed during the design of an HPV-based cervical cancer screening testing intervention program, these strategies could significantly increase the acceptability and feasibility of the intervention and lead to more effective and sustainable access to cervical screening services for women worldwide.
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- 2021
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17. Maternal intramuscular dexamethasone versus betamethasone before preterm birth (ASTEROID): a multicentre, double-blind, randomised controlled trial
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Caroline A Crowther, Pat Ashwood, Chad C Andersen, Philippa F Middleton, Thach Tran, Lex W Doyle, Jeffrey S Robinson, Jane E Harding, Caroline Crowther, Chad Andersen, Philippa Middleton, Vincent Ball, Carol Holst, Kaye Robinson, Sasha Zhang, Jeffrey Robinson, Yee Khong, Andrew McPhee, Katie Groom, Jane Alsweiler, Deb Eaglen, Jane Harding, Helga Hauch, Alenna Vallely, Sonia Angus, Feisal Chenia, Alison Drew, John Gavranich, Ann Green, Susan Jack, Kassam Mahomed, Rebecca Sebastian, Laura Turner, Michelle Baldwin, Amanda Dennis, Eleanor Fisher, Karen Gee, Michael Gee, David Strong, Donna Boord, Nicole Edge, Michelle Marsh, Casie Staehr, Jackie Chaplin, Glenn Gardener, Peter Gray, Elizabeth Hurrion, Luke Jardine, Janet Kan, Lisa Lynn, Leith Poulsen, Anne Tremellen, Tracey Codner, Wendy Cubis, Sue Downward, Cathy Dunn, Jacquelyn Furey, Di Hansen, Bessy Lampropoulos, Emily Masson, Michael Peek, Susan Sellar, Karen Butterley, Michelle Chadwick, Caroline Davis, Tony DePaoli, Leesa Green, Tammy Matzolic, Gregory Woodhead, Vikki Biggs, Amanda Henry, Anne Lainchbury, Erin Nesbitt-Hawes, Ju Lee Oei, Christina Rodrigues, Antonia Shand, Lee Sutton, Alec Welsh, Jennifer Bowen, Linda Hayes-Cameron, Glynis Howard, Claire Jacobs, Jill Milligan, Jonathan Morris, Kristen Rickard, Jocelyn Sedgley, Katrina White-Matthews, Julie Blandthorn, Fiona Brownfoot, Alice Burnett, Kate Callanan, Noni Davis, Cinzia Deluca, Lex Doyle, Julianne Duff, Kelly Howard, Esther Hutchinson, Elaine Kelly, Louise Kornman, Carl Kuschel, Dianna Maxwell, Marion McDonald, Megan Poth, Julie Co, Greg Davis, Bob Fonsesca, Joseph Khouri, Lynne Roberts, Clare Rowe, Cherie Boniface, Christine Boynton, Christine Davies, Corrine Dickinson, Liza Edmonds, Susan Ireland, Guan Koh, Prasanna Kumar, Annemarie Lawrence, Ros Lock, David Watson, Vineesh Bahtia, Sarah Cash, Daniela Gagliardi, Michaela Gooding, Kate Gowling, Rosalie Grivell, Ross Haslam, Bevan Headley, Melanie Johnson, Namiko Kobayashi, Anu Kochar, Payam Nikpoor, Lucy Simmonds, Kasia Siwicki, Michael Stark, Sophie Trenowden, Crowther, Caroline A, Ashwood, Pat, Andersen, Chad C, Middleton, Philippa F, Tran, Thach, Doyle, Lex W, Robinson, Jeffrey S, Harding, Jane E, Simmonds, Lucy, and ASTEROID Study Group
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medicine.medical_specialty ,weight infants ,Prenatal care ,outcomes ,03 medical and health sciences ,0302 clinical medicine ,children ,030225 pediatrics ,Developmental and Educational Psychology ,countries ,Medicine ,care ,030212 general & internal medicine ,Dexamethasone ,Pregnancy ,Intention-to-treat analysis ,business.industry ,Obstetrics ,Gestational age ,medicine.disease ,mortality ,antenatal corticosteroids ,income ,age ,Premature birth ,Pediatrics, Perinatology and Child Health ,Gestation ,Betamethasone ,business ,medicine.drug - Abstract
Summary Background Antenatal corticosteroids given to women before preterm birth improve infant survival and health. However, whether dexamethasone or betamethasone have better maternal, neonatal, and childhood health outcomes remains unclear. We therefore aimed to assess whether administration of antenatal dexamethasone to women at risk of preterm birth reduced the risk of death or neurosensory disability in their children at age 2 years compared with betamethasone. We also aimed to assess whether dexamethasone reduced neonatal morbidity, had benefits for the mother, or affected childhood body size, blood pressure, behaviour, or general health compared with betamethasone. Methods In this multicentre, double-blind, randomised controlled trial, we recruited pregnant women from 14 maternity hospitals in Australia and New Zealand that could provide care to preterm babies. Women were eligible for study inclusion if they were at risk of preterm birth before 34 weeks of gestation, had a singleton or twin pregnancy, and had no contraindications to antenatal corticosteroids. We randomly assigned women (1:1) to receive two intramuscular injections of either 12 mg dexamethasone (dexamethasone sodium phosphate) or 11·4 mg betamethasone (Celestone Chronodose), 24 h apart. The randomisation schedule used balanced, variable blocks that were stratified by hospital, gestational age, and number of fetuses (singleton or twins). We masked all participants, staff, and assessors to treatment groups. Analyses were by intention to treat. The primary outcome was death or neurosensory disability at age 2 years (corrected for prematurity). This study is registered with ANZCTR, ACTRN12608000631303. Findings Between Jan 28, 2009, and Feb 1, 2013, we randomly assigned 1346 (78%) women who were pregnant with 1509 fetuses to groups: 679 (50%) women were assigned to receive dexamethasone and 667 (50%) women were assigned to receive betamethasone. 27 (4%) fetuses, infants, or children in the dexamethasone group and 28 (4%) fetuses, infants, or children in the betamethasone group died before age 2 years. The primary outcome of death or neurosensory disability at age 2 years was determined for 603 (79%) of 763 fetuses whose mothers received dexamethasone and 591 (79%) of 746 fetuses whose mothers received betamethasone. We found a similar incidence of death or neurosensory disability in the dexamethasone (198 [33%] of 603 infants) and betamethasone groups (192 [32%] of 591 infants; adjusted relative risk [adjRR] 0·97, 95% CI 0·83 to 1·13; p=0·66). 18 (3%) of 679 women in the dexamethasone group and 28 of 667 (4%) women in the betamethasone group reported side-effects. Discomfort at the injection site, the most frequent side-effect, was less likely in the dexamethasone group than in the betamethasone group (six [1%] women vs 17 [3%] women; p=0·02). Interpretation The incidence of survival without neurosensory disability at age 2 years did not differ between dexamethasone and betamethasone treatment. Our findings indicate that either antenatal corticosteroid can be given to women before preterm birth to improve infant and child health. Funding National Health and Medical Research Council (Australia).
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- 2019
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18. Extracorporeal membrane oxygenation support in refractory perioperative anaphylactic shock to rocuronium: a report of two cases
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Michael K. Wilson, Matheus Carelli, Fabio Ramponi, Michael Seco, Paul Forrest, and Michael P. Vallely
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Adult ,Male ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,03 medical and health sciences ,Extracorporeal Membrane Oxygenation ,0302 clinical medicine ,Refractory ,Extracorporeal membrane oxygenation ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Elective surgery ,Rocuronium ,Perioperative Period ,Anaphylaxis ,Advanced and Specialized Nursing ,business.industry ,030208 emergency & critical care medicine ,General Medicine ,Perioperative ,medicine.disease ,Advanced life support ,Anesthesia ,Anaphylactic shock ,Female ,Cardiology and Cardiovascular Medicine ,business ,Safety Research ,Neuromuscular Nondepolarizing Agents ,medicine.drug - Abstract
In recent years, extracorporeal membrane oxygenation has become increasingly common in the treatment of in-hospital cardiac arrest in non-cardiac surgery patients. This includes cardiac arrest secondary to perioperative anaphylactic shock refractory to standard advanced life support protocols, which is a rare but catastrophic event associated with significant mortality. Neuromuscular blocking drugs are most commonly implicated in perioperative anaphylaxis, with rocuronium playing a major role. In this article, we report two cases of young and otherwise fit and well patients who experienced a perioperative arrest secondary to rocuronium anaphylaxis before elective surgery; both patients did not respond to conventional advanced life support, but survived neurologically intact after institution of urgent veno-arterial extracorporeal membrane oxygenation.
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- 2019
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19. A diagnostic evaluation of a molecular assay used for testing and treating anorectal chlamydia and gonorrhoea infections at the point-of-care in Papua New Guinea
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Rebecca Guy, Avi J Hakim, Simon Pekon, David M. Whiley, Barne Willie, Steven G Badman, Selina Silim, Philip Cunningham, John M. Kaldor, Janet Gare, Damian Weikum, Andrew Vallely, A. Amos-Kuma, Angela Kelly-Hanku, Josephine Gabuzzi, Rebecca Narokobi, and Basil Donovan
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Adult ,Male ,0301 basic medicine ,Microbiology (medical) ,medicine.medical_specialty ,Adolescent ,Point-of-care testing ,030106 microbiology ,Gonorrhea ,medicine.disease_cause ,Men who have sex with men ,Papua New Guinea ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,parasitic diseases ,medicine ,Humans ,Prospective Studies ,030212 general & internal medicine ,Child ,Prospective cohort study ,Anus Diseases ,GeneXpert MTB/RIF ,Chlamydia ,business.industry ,General Medicine ,Chlamydia Infections ,Middle Aged ,medicine.disease ,Rectal Diseases ,Infectious Diseases ,Molecular Diagnostic Techniques ,Point-of-Care Testing ,Neisseria gonorrhoeae ,Female ,business ,Chlamydia trachomatis - Abstract
Objectives Papua New Guinea has among the highest prevalences of sexually transmissible infections (STIs) globally with no services able to accurately test for anorectal Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections. Here we prospectively evaluated the diagnostic performance of a molecular CT/NG assay used at the point-of-care (POC) with the aim of enhancing anorectal STI screening and same-day treatment. Methods Men who have sex with men, transgender women and female sex workers taking part in Papua New Guinea's first large-scale biobehavioural study were enrolled and asked to provide a self-collected anorectal swab for POC GeneXpert CT/NG testing. Same-day treatment was offered if positive. A convenience sample of 396 unique and randomly selected samples were transported to Australia for comparison using the Cobas 4800 CT/NG test (Roche Molecular Diagnostics, Pleasanton, CA, USA). Results A total of 326 samples provided valid results by Cobas whereas 70 samples provided invalid results suggesting inhibition. The positive, negative and overall percentage agreements of GeneXpert CT/NG for the detection of C. trachomatis were 96.7% (95% CI 92.3%–98.9%), 95.5% (95% CI 91.3%–98.0%) and 96.0% (95% CI 93.3%–97.8%), and for N. gonorrhoeae were 93.0% (95% CI 86.1%–97.1%), 100.0% (95% CI 98.3%–100.0%) and 97.8% (95% CI 95.6%–99.1%), respectively. Conclusions The overall rate of agreement between the GeneXpert and Cobas CT/NG assays was high with 96.0% for C. trachomatis and 97.8% for N. gonorrhoeae. Results from this study data suggest that the GeneXpert CT/NG assay is suitable for testing self-collected anorectal specimens at the POC and that same-day treatment was feasible.
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- 2019
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20. Evaluation of self-collected vaginal specimens for the detection of high-risk human papillomavirus infection and the prediction of high-grade cervical intraepithelial lesions in a high-burden, low-resource setting
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Steven G Badman, Marion Saville, Julia M.L. Brotherton, Andrew Vallely, Samuel Phillips, Sepehr N. Tabrizi, John M. Kaldor, Pamela J Toliman, and G. Tan
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Adult ,0301 basic medicine ,Microbiology (medical) ,medicine.medical_specialty ,Point-of-care testing ,030106 microbiology ,Uterine Cervical Neoplasms ,Cervical intraepithelial neoplasia ,Sensitivity and Specificity ,Specimen Handling ,Papua New Guinea ,03 medical and health sciences ,0302 clinical medicine ,Cytology ,Positive predicative value ,Humans ,Medicine ,030212 general & internal medicine ,Human papillomavirus ,Early Detection of Cancer ,Cervical cancer ,Gynecology ,Human papillomavirus 16 ,Cervical screening ,Human papillomavirus 18 ,business.industry ,Papillomavirus Infections ,General Medicine ,Middle Aged ,Uterine Cervical Dysplasia ,medicine.disease ,Infectious Diseases ,medicine.anatomical_structure ,Point-of-Care Testing ,Vagina ,Female ,business - Abstract
Objectives To compare the performance of self-collected vaginal (V) specimens with clinician-collected cervical (C) specimens for detection of high-risk human papillomavirus (hrHPV) and cervical disease using the Cepheid Xpert HPV, Roche Cobas 4800 HPV and Hologic Aptima HPV assays. Methods Women aged 30–59 years (n = 1005) were recruited at two clinics in Papua New Guinea, and they provided specimens for testing at point-of-care using the Xpert HPV Test, and for subsequent testing using the Cobas HPV (n = 981) and Aptima HPV (n = 983) assays. Liquid-based cytology was performed on C specimens to predict underlying high-grade squamous intraepithelial lesions (HSIL). V specimen results of each assay were evaluated against a constructed reference standard and for detection of HSIL or worse. Results There was substantial (κ >0.6) agreement in hrHPV detection between V and C specimens across all three assays. The sensitivity, specificity, and positive and negative predictive values of Xpert HPV using self-collected V specimens for the detection of HPV type 16 according to the constructed reference standard were 92.1%, 93.1%, 63.6% and 98.9%, respectively; compared with 90.4%, 94.3%, 67.8% and 98.7% for Cobas 4800 HPV; and 63.2%, 97.2%, 75.0% and 95.3% for Aptima HPV. Similar results were observed for all hrHPV types (combined) and for HPV types 18/45, on all three assays. The detection of any hrHPV using self-collected specimens had high sensitivity (86%–92%), specificity (87%–94%) and negative predictive value (>98%) on all assays for HSIL positivity. Conclusions Xpert HPV, using self-collected vaginal specimens, has sufficient accuracy for use in point-of-care ‘test-and-treat' cervical screening strategies in high-burden, low-resource settings.
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- 2019
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21. Risk factors for infection with soil-transmitted helminths during an integrated community level water, sanitation, and hygiene and deworming intervention in Timor-Leste
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Naomi E. Clarke, Ross M. Andrews, Alice Richardson, Darren J. Gray, Susana Vaz Nery, Rebecca J. Traub, Gail M. Williams, Archie C. A. Clements, Suzy J. Campbell, Andrew Vallely, and James S. McCarthy
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Adult ,Male ,0301 basic medicine ,Adolescent ,Sanitation ,Necator americanus ,Timor-Leste ,media_common.quotation_subject ,030231 tropical medicine ,Context (language use) ,Necatoriasis ,Deworming ,Soil ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,Hygiene ,Environmental health ,Ascariasis ,medicine ,Animals ,Humans ,Child ,Aged ,Randomized Controlled Trials as Topic ,media_common ,Anthelmintics ,biology ,Ascaris ,Infant ,Water ,Middle Aged ,biology.organism_classification ,medicine.disease ,030104 developmental biology ,Infectious Diseases ,Child, Preschool ,Latrine ,Female ,Parasitology - Abstract
Water, sanitation and hygiene interventions have been advocated as important complements to deworming programs to improve soil-transmitted helminth control. Evidence for the impact of water, sanitation and hygiene on soil-transmitted helminth infections is mixed, and based mainly on cross-sectional studies. In this study, we assessed associations between individual- and household-level water, sanitation and hygiene variables and soil-transmitted helminth infections, using data collected during the 2 year follow-up study period of the WASH for WORMS randomised controlled trial in Timor-Leste. Data were collected across four surveys, conducted at 6 monthly intervals in 23 communities. We analysed water, sanitation and hygiene and sociodemographic variables as risk factors for infection with Necator americanus, Ascaris spp., and undifferentiated soil-transmitted helminth infection, using generalised linear mixed models to account for clustering at community, household and participant levels. Water, sanitation and hygiene risk factors were examined both concurrently and with a 6 month lag period that coincided with the most recent deworming. The analysis included 2333 participants. Factors associated with N. americanus infection included age group, male sex (adjusted odds ratio (aOR) 3.1, 95% confidence interval (CI) 2.4–4.2), working as a farmer (aOR 1.7, 95% CI 1.2–2.4), and completing secondary school or higher (aOR 0.29, 95% CI 0.16–0.53). Risk factors for Ascaris spp. infection included age group, living in a dwelling with more than six people (aOR 1.6, 95% CI 1.1–2.3), having a tube well or borehole as the household water source (aOR 3.7, 95% CI 1.3–10.8), and using a latrine shared between households 6 months previously (aOR 2.3, 95% CI 1.2–4.3). Handwashing before eating was protective against infection with any soil-transmitted helminth (aOR 0.79, 95% CI 0.65–0.95). In the context of regular deworming, few water, sanitation and hygiene-related factors were associated with soil-transmitted helminth infections. Future research examining the role of water, sanitation and hygiene in soil-transmitted helminth transmission is required, particularly in low transmission settings after cessation of deworming. Identifying improved indicators for measuring water, sanitation and hygiene behaviours is also a key priority.
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- 2019
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22. WASH for WORMS: A Cluster-Randomized Controlled Trial of the Impact of a Community Integrated Water, Sanitation, and Hygiene and Deworming Intervention on Soil-Transmitted Helminth Infections
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Archie C. A. Clements, Darren J. Gray, Gail M. Williams, Edmund Weking, James S. McCarthy, Naomi E. Clarke, Salvador Amaral, Andrew Vallely, Suzy J. Campbell, Alice Richardson, Susana Vaz Nery, Rebecca J. Traub, Stacey Llewellyn, and Ross M. Andrews
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Adult ,Male ,Adolescent ,Sanitation ,media_common.quotation_subject ,030231 tropical medicine ,Helminthiasis ,Psychological intervention ,Necator americanus ,law.invention ,Deworming ,Soil ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Water Supply ,Hygiene ,law ,Virology ,Environmental health ,medicine ,Cluster Analysis ,Humans ,Open defecation ,Child ,media_common ,Anthelmintics ,biology ,business.industry ,Water ,Articles ,medicine.disease ,biology.organism_classification ,Infectious Diseases ,Child, Preschool ,Female ,Parasitology ,Public Health ,business - Abstract
Water, sanitation, and hygiene (WASH) interventions have been proposed as an important complement to deworming programs for sustainable control of soil-transmitted helminth (STH) infections. We aimed to determine whether a community-based WASH program had additional benefits in reducing STH infections compared with community deworming alone. We conducted the WASH for WORMS cluster-randomized controlled trial in 18 rural communities in Timor-Leste. Intervention communities received a WASH intervention that provided access to an improved water source, promoted improved household sanitation, and encouraged handwashing with soap. All eligible community members in intervention and control arms received albendazole every 6 months for 2 years. The primary outcomes were infection with each STH, measured using multiplex real-time quantitative polymerase chain reaction. We compared outcomes between study arms using generalized linear mixed models, accounting for clustering at community, household, and individual levels. At study completion, the integrated WASH and deworming intervention did not have an effect on infection with Ascaris spp. (relative risk [RR] 2.87, 95% confidence interval [CI]: 0.66–12.48, P = 0.159) or Necator americanus (RR 0.99, 95% CI: 0.52–1.89, P = 0.987), compared with deworming alone. At the last follow-up, open defecation was practiced by 66.1% (95% CI: 54.2–80.2) of respondents in the control arm versus 40.2% (95% CI: 25.3–52.6) of respondents in the intervention arm (P = 0.005). We found no evidence that the WASH intervention resulted in additional reductions in STH infections beyond that achieved with deworming alone over the 2-year trial period. The role of WASH on STH infections over a longer period of time and in the absence of deworming remains to be determined.
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- 2019
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23. S10.3 Point-of-care HPV testing and treatment for cervical cancer screening and elimination in Papua New Guinea
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Andrew Vallely
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Cervical cancer ,medicine.medical_specialty ,Cervical screening ,GeneXpert MTB/RIF ,medicine.diagnostic_test ,Obstetrics ,business.industry ,Cancer ,medicine.disease ,Vaccination ,medicine.anatomical_structure ,Health care ,medicine ,Pap test ,business ,Cervix - Abstract
Papua New Guinea (PNG) has among the highest estimated burdens of cervical cancer globally, but lacks national programs for cervical screening or human papillomavirus (HPV) vaccination. Following the disappointing performance of visual inspection of the cervix with acetic acid (VIA) for cervical screening in this setting, we evaluated a novel same-day ‘test-and-treat’ screening model based on point-of-care HPV-DNA testing of self-collected vaginal specimens followed by same-day thermal ablation of the cervix. Self-collected specimens tested at point-of-care on the GeneXpert platform (Xpert HPV; Cepheid, Sunnyvale, CA) had comparable performance to laboratory-based assays both for the detection of high-risk oncogenic HPV types and for detection of underlying pre-cancer and cancer. This strategy was highly acceptable among women and health care workers; highly cost-effective compared to screening based on VIA or Pap test cytology; and with suitable training and support, feasible to implement in routine primary care facilities in this setting. We further showed that if 70% of women aged 30–54 years were screened twice in their lifetime as recommended by WHO, this point-of-care ‘test and treat’ model could reduce both cervical cancer incidence and mortality in PNG by more than 50%. This approach represents a promising new model for cervical screening in PNG and other high-burden, low-income countries embarking on a path towards cervical cancer elimination.
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- 2021
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24. Economic evaluation of point-of-care testing and treatment for sexually transmitted and genital infections in pregnancy in low- and middle-income countries: A systematic review
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William Pomat, Virginia Wiseman, Andrew Vallely, Louise M. Causer, Olga P. M. Saweri, Rabiah al Adawiyah, and Neha Batura
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Bacterial Diseases ,Cost effectiveness ,Economics ,Maternal Health ,Social Sciences ,Economic Geography ,Treponematoses ,0302 clinical medicine ,Medical Conditions ,Electronics Engineering ,Pregnancy ,Medicine and Health Sciences ,Medicine ,030212 general & internal medicine ,Pregnancy Complications, Infectious ,Virus Testing ,2. Zero hunger ,Multidisciplinary ,Chlamydia ,Trichomoniasis ,Geography ,030503 health policy & services ,1. No poverty ,Obstetrics and Gynecology ,Cost-effectiveness analysis ,3. Good health ,Infectious Diseases ,Point-of-Care Testing ,Comparators ,Low and Middle Income Countries ,Engineering and Technology ,Female ,Bacterial vaginosis ,0305 other medical science ,Research Article ,Neglected Tropical Diseases ,medicine.medical_specialty ,Point-of-care testing ,Science ,Urology ,Cost-Effectiveness Analysis ,Sexually Transmitted Diseases ,03 medical and health sciences ,Health Economics ,Diagnostic Medicine ,Humans ,Syphilis ,Developing Countries ,business.industry ,Genitourinary Infections ,medicine.disease ,Tropical Diseases ,Economic Analysis ,Health Care ,Family medicine ,Economic evaluation ,Earth Sciences ,Women's Health ,Electronics ,business - Abstract
Background Sexually transmitted and genital infections in pregnancy are associated with adverse pregnancy and birth outcomes. Point-of-care tests for these infections facilitate testing and treatment in a single antenatal clinic visit and may reduce the risk of adverse outcomes. Successful implementation and scale-up depends on understanding comparative effectiveness of such programmes and their comparative costs and cost effectiveness. This systematic review synthesises and appraises evidence from economic evaluations of point-of-care testing and treatment for sexually transmitted and genital infections among pregnant women in low- and middle-income countries. Methods Medline, Embase and Web of Science databases were comprehensively searched using pre-determined criteria. Additional literature was identified by searching Google Scholar and the bibliographies of all included studies. Economic evaluations were eligible if they were set in low- and middle-income countries and assessed antenatal point-of-care testing and treatment for syphilis, chlamydia, gonorrhoea, trichomoniasis, and/or bacterial vaginosis. Studies were analysed using narrative synthesis. Methodological and reporting standards were assessed using two published checklists. Results Sixteen economic evaluations were included in this review; ten based in Africa, three in Latin and South America and three were cross-continent comparisons. Fifteen studies assessed point-of-care testing and treatment for syphilis, while one evaluated chlamydia. Key drivers of cost and cost-effectiveness included disease prevalence; test, treatment, and staff costs; test sensitivity and specificity; and screening and treatment coverage. All studies met 75% or more of the criteria of the Drummond Checklist and 60% of the Consolidated Health Economics Evaluation Reporting Standards. Conclusions Generally, point-of-care testing and treatment was cost-effective compared to no screening, syndromic management, and laboratory-based testing. Future economic evaluations should consider other common infections, and their lifetime impact on mothers and babies. Complementary affordability and equity analyses would strengthen the case for greater investment in antenatal point-of-care testing and treatment for sexually transmitted and genital infections.
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- 2021
25. Anaortic, Off-Pump, Total-Arterial Coronary Artery Bypass Grafting Surgery
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James B. Edelman, Michael K. Wilson, Fabio Ramponi, Michael P. Vallely, and Michael Seco
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medicine.medical_specialty ,Bypass grafting ,Cardiothoracic surgeons ,business.industry ,Retrospective cohort study ,medicine.disease ,law.invention ,Surgery ,Coronary artery disease ,medicine.anatomical_structure ,law ,Cardiopulmonary bypass ,Incomplete revascularization ,medicine ,business ,Surgical revascularization ,Artery - Abstract
The debate of on-pump versus off-pump coronary artery bypass grafting (CABG) has been continuing as long as surgical revascularization has been performed. Whilst the most common CABG technique used today remains cardiopulmonary bypass with an arrested heart, many centers pursue off-pump CABG and continue to refine the surgical technique. An alternative to the dichotomous on- and off-pump groups is to consider the range of coronary bypass techniques in relation to their degree of aortic manipulation. A retrospective cohort study, limited to surgeons with a minimum of 100 completed off-pump cases, also found reduced 10-year survival, higher risk of incomplete revascularization and higher rates of repeat revascularization, further supporting this argument. The fellowship's goal is to provide newly graduated cardiothoracic surgeons from around the world with an educational opportunity to enhance their clinical understanding and to acquire theoretical and practical knowledge in the surgical management of patients with coronary artery disease, with special interest in off-pump and minimally invasive techniques.
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- 2021
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26. Ambiguous bodies, uncertain diseases: knowledge of cervical cancer in Papua New Guinea
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John M. Kaldor, Andrew Vallely, G M Mola, Lisa M Vallely, Angela Kelly-Hanku, Pamela J Toliman, Voletta Fiya, Herick Aeno, and Sophie Ase
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Adult ,Cultural Studies ,Health Knowledge, Attitudes, Practice ,Adolescent ,media_common.quotation_subject ,Culture ,Uterine Cervical Neoplasms ,Disease ,Affect (psychology) ,Developmental psychology ,Papua New Guinea ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Arts and Humanities (miscellaneous) ,Intervention (counseling) ,Humans ,Medicine ,030212 general & internal medicine ,Qualitative Research ,media_common ,Cervical cancer ,030505 public health ,business.industry ,Papillomavirus Infections ,Uncertainty ,Public Health, Environmental and Occupational Health ,HPV infection ,New guinea ,Ambiguity ,Focus Groups ,Middle Aged ,medicine.disease ,Women's Health ,Female ,0305 other medical science ,business ,Social psychology ,Qualitative research - Abstract
Within their local realities, people experience and interpret disease in diverse ways that do not necessarily correlate or converge with Western biomedical interventions. In the high cervical cancer burden setting of Papua New Guinea, understanding how people experience and interpret cervical cancer is necessary for effective intervention. Drawing on work by Street on the production of unstable biomedical knowledge, we explored how ambiguity and uncertainty, coupled with cultural taboos and linguistic limitations, affect what and how people 'know' about women's reproductive organs and their associated disease.A qualitative research approach was used to explore and understand how people in PNG articulate matters of health and disease as they relate to cervical cancer and HPV infection. Specifically, how unstable biomedical knowledge is produced and sustained. We employed a mixed-methods approach in collecting data from 208 (147 women) participants between 2011 and 2012 across 3 provinces in PNG.We found that knowledge and awareness about cervical cancer were poor. Five thematic areas emerged in our analysis, which included the gendered knowledge of women's reproductive health, the burden of cervical cancer in the community and the role (or limitation) of language. We further identified four ways in which ambiguity and uncertainty operate on both sociocultural and biological levels, and in the intersection between to produce unstable biomedical knowledge. These included poor knowledge of where the cervix is located and the uncertainty or unreliability of (lay) diagnoses of disease.Local understandings of cervical cancer reflected the limitations of Tok Pisin as a lingua franca as well as the wider uncertain biomedical environment where diagnoses are assembled and shared. There is a clear need to improve understanding of the female reproductive organs in order that people, women in particular, can be better informed about cervical cancer and ultimately better receptive to intervention strategies.
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- 2017
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27. HPV vaccination in Papua New Guinea to prevent cervical cancer in women: Gender, sexual morality, outsiders and the de-feminization of the HPV vaccine
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Herick Aeno, Lisa M Vallely, Glen D. L. Mola, Voletta Fiya, Pamela J Toliman, Jamee Newland, Andrew Vallely, John M. Kaldor, Angela Kelly-Hanku, Sophie Ase, and Peter Aggleton
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Male ,medicine.medical_specialty ,Sexual Behavior ,Uterine Cervical Neoplasms ,Context (language use) ,Disease ,Article ,lcsh:Infectious and parasitic diseases ,03 medical and health sciences ,Papua New Guinea ,0302 clinical medicine ,Sex Factors ,Virology ,parasitic diseases ,medicine ,Humans ,lcsh:RC109-216 ,030212 general & internal medicine ,Papillomavirus Vaccines ,Mortality ,Cervical cancer ,Government ,Cervical screening ,business.industry ,Papillomavirus Infections ,Vaccination ,virus diseases ,medicine.disease ,Focus group ,Infectious Diseases ,030220 oncology & carcinogenesis ,Family medicine ,population characteristics ,Female ,business ,geographic locations ,Qualitative research - Abstract
Papua New Guinea has among the highest estimated burden of cervical cancer globally, but currently lacks national cervical screening or human papillomavirus (HPV) vaccination programmes. The Papua New Guinean government is committed to introducing the HPV vaccine for primary prevention, but locally-relevant research evidence is not available to guide implementation. Experience from earlier Papua New Guinean health programmes suggests that appropriate engagement with local health cosmologies and cultures for health/wellbeing, illness/disease, and recognition of the role of 'outsiders' in preventing, promoting or contributing to sickness, are essential to the successful introduction of biomedical interventions in this setting. We describe findings from a multi-site qualitative study undertaken in three provinces in Papua New Guinea (2012-14). Twenty-one gender specific focus group discussions and 82 semi-structured interviews, with a total of 208 participants, were conducted. There was strong community support for the introduction of the HPV vaccine for cervical cancer prevention in Papua New Guinea. Significantly, and despite being officially discussed in the context of a planned future intervention focusing on vaccinating young girls to prevent cervical cancer, the intervention was de-feminised, where both girls and boys were supported to be vaccinated in any HPV programme in Papua New Guinea.
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- 2019
28. Point-of-care testing and treatment of sexually transmitted infections to improve birth outcomes in high-burden, low-income settings: Study protocol for a cluster randomized crossover trial (the WANTAIM Trial, Papua New Guinea)
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Steven G Badman, Glen D. L. Mola, Moses Laman, Rebecca Guy, Lisa M Vallely, Leanne J. Robinson, Nicola Low, David M. Whiley, Christopher Morgan, Virginia Wiseman, Michaela A Riddell, Stanley Luchters, Pamela J Toliman, Neha Batura, Elizabeth Peach, Caroline S.E. Homer, William Pomat, Rosanna W. Peeling, John M. Kaldor, Andrew Vallely, Suzanne M. Garland, Grace Kariwiga, Angela Kelly-Hanku, Delly Babona, John W. Bolnga, Sepehr N. Tabrizi, Wilfred Peter, Peter Siba, Handan Wand, Stephen J. Rogerson, and Jacob Morewaya
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Pediatrics ,medicine.medical_specialty ,Point-of-care testing ,Psychological intervention ,Medicine (miscellaneous) ,610 Medicine & health ,Disease cluster ,General Biochemistry, Genetics and Molecular Biology ,Study Protocol ,Papua New Guinea ,03 medical and health sciences ,0302 clinical medicine ,360 Social problems & social services ,cluster randomised crossover trial ,medicine ,sexually transmitted infection ,low birth weight ,030212 general & internal medicine ,0303 health sciences ,Pregnancy ,030306 microbiology ,business.industry ,preterm birth ,Articles ,medicine.disease ,Crossover study ,3. Good health ,Low birth weight ,Gestation ,pregnancy ,medicine.symptom ,Bacterial vaginosis ,business - Abstract
Background: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and bacterial vaginosis have been associated with preterm birth and low birth weight, and are highly prevalent among pregnant women in many low- and middle-income settings. There is conflicting evidence on the potential benefits of screening and treating these infections in pregnancy. Newly available diagnostic technologies make it possible, for the first time, to conduct definitive field trials to fill this knowledge gap. The primary aim of this study is to evaluate whether antenatal point-of-care testing and immediate treatment of these curable sexually transmitted and genital infections (STIs) leads to reduction in preterm birth and low birth weight. Methods: The Women and Newborn Trial of Antenatal Interventions and Management (WANTAIM) is a cluster-randomised crossover trial in Papua New Guinea to compare point-of-care STI testing and immediate treatment with standard antenatal care (which includes the WHO-endorsed STI ‘syndromic’ management strategy based on clinical features alone without laboratory confirmation). The unit of randomisation is a primary health care facility and its catchment communities. The primary outcome is a composite measure of two events: the proportion of women and their newborns in each trial arm, who experience either preterm birth (delivery Conclusions: WANTAIM is the first randomised trial to evaluate the effectiveness, cost-effectiveness, acceptability and health system requirements of point-of-care STI testing and treatment to improve birth outcomes in high-burden settings. If the intervention is proven to have an impact, the trial will hasten access to these technologies and could improve maternal and neonatal health in high-burden settings worldwide. Registration: ISRCTN37134032.
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- 2019
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29. Toward stroke-free coronary surgery: The role of the anaortic off-pump bypass technique
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Fabio Ramponi, Michael Seco, Antonio M. Calafiore, Mario Gaudino, Russel John Legay Brereton, Michael P. Vallely, and John D. Puskas
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Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Coronary Artery Bypass, Off-Pump ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,law.invention ,Coronary artery disease ,03 medical and health sciences ,0302 clinical medicine ,law ,medicine.artery ,Internal medicine ,Ascending aorta ,Cardiopulmonary bypass ,medicine ,Humans ,Coronary Artery Bypass ,Stroke ,Aorta ,Aged ,business.industry ,Perioperative ,Guideline ,medicine.disease ,Clamp ,medicine.anatomical_structure ,030228 respiratory system ,Cardiology ,Surgery ,Cardiology and Cardiovascular Medicine ,business ,Artery - Abstract
Surgical coronary revascularization remains the preferred strategy in a significant portion of patients with coronary artery disease due to superior long-term outcomes. However, there is a significant risk of perioperative neurologic injury that has influenced guideline recommendations. These complications occur in 1%-5% of patients, ranging from overt neurologic deficits with permanent disability, to subtle cerebral defects noted on neuroimaging that may result in slow cognitive and functional decline. The primary mechanism by which these events occur is thromboembolism from manipulation of the ascending aorta. This occurs during cardiopulmonary bypass, aortic cross-clamping, and partial occlusion clamping (side clamp). Elderly patients and patients with aortic atheroma are, therefore, at significantly increased risk. Initial surgical techniques addressed this by aggressively debriding or replacing the ascending aorta during coronary artery bypass grafting (CABG). Strategies then moved toward minimizing aortic manipulation through pump-assisted beating heart surgery and off-pump surgery with partial occlusion clamping or proximal anastomosis devices. Finally, anaortic off-pump CABG aims to avoid all manipulation of the ascending aorta through advanced off-pump grafting techniques combined with in situ and composite grafts. This has been demonstrated to result in the greatest reduction in risk. Establishing successful anaortic off-pump CABG programs requires subspecialization and focused interest groups dedicated to advancing CABG outcomes.
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- 2021
30. Ending AIDS in the Asia-Pacific region by 2030: are we on track? Policy, epidemiological and intervention insights
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Heather Marie A. Schmidt, Jason J. Ong, Angela Kelly-Hanku, Kimberly Elizabeth Green, Rena Janamnuaysook, Lei Zhang, and Andrew Vallely
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Male ,medicine.medical_specialty ,Acquired Immunodeficiency Syndrome ,Asia ,business.industry ,Public Health, Environmental and Occupational Health ,Human immunodeficiency virus (HIV) ,Sex workers ,Asia pacific region ,medicine.disease_cause ,medicine.disease ,Transgender women ,Men who have sex with men ,Sexual and Gender Minorities ,Infectious Diseases ,Policy ,Acquired immunodeficiency syndrome (AIDS) ,Intervention (counseling) ,Epidemiology ,Medicine ,Humans ,Female ,Homosexuality, Male ,business ,Demography - Abstract
The Asia–Pacific region is home to nearly 6 million people living with HIV. Across the region, key populations – men who have sex with men, transgender women, people who inject drugs, sex workers, prisoners – and their sexual partners make up the majority of those living with HIV. While significant progress has been made in the past 5 years towards UNAIDS’s 90–90–90 goals (90% of people with HIV diagnosed, 90% on antiretroviral therapy, 90% virologically suppressed), significant gaps remain. The papers in this Special Issue address important questions: are we on track to end the AIDS epidemic in the Asia–Pacific region? And can countries in this region reach the new UNAIDS targets for 2030?
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- 2020
31. Cryobiopsy for Identification of Usual Interstitial Pneumonia and Other Interstitial Lung Disease Features. Further Lessons from COLDICE, a Prospective Multicenter Clinical Trial
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Annabelle Mahar, Christopher Grainge, Martin J. Phillips, Ellie Mulyadi, Tamera J. Corte, Jonathan P. Williamson, Ganesh Raghu, Wendy A Cooper, Paul J. Torzillo, Edmund M.T. Lau, Jeffrey L. Myers, Michael P. Vallely, Simon Lai, and Lauren K. Troy
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Pulmonary and Respiratory Medicine ,Male ,medicine.medical_specialty ,Biopsy ,Lung biopsy ,Critical Care and Intensive Care Medicine ,Cryosurgery ,Diagnosis, Differential ,03 medical and health sciences ,Idiopathic pulmonary fibrosis ,0302 clinical medicine ,Usual interstitial pneumonia ,Predictive Value of Tests ,Bronchoscopy ,medicine ,Humans ,030212 general & internal medicine ,Prospective Studies ,Aged ,Lung ,medicine.diagnostic_test ,business.industry ,Interstitial lung disease ,Reproducibility of Results ,respiratory system ,Middle Aged ,medicine.disease ,Idiopathic Pulmonary Fibrosis ,respiratory tract diseases ,Clinical trial ,medicine.anatomical_structure ,030228 respiratory system ,Female ,Radiology ,business - Abstract
Rationale: Transbronchial lung cryobiopsy (TBLC) is an emerging technique for interstitial lung disease diagnosis. Good histopathologic agreement between TBLC and surgical lung biopsy (SLB) was dem...
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- 2020
32. Towards stroke-free coronary surgery: the role of the anaortic off-pump bypass technique
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Mario Gaudino, Michael P. Vallely, John Brereton, John D. Puskas, Fabio Ramponi, Michael Seco, and A. M. Calafiore
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Aorta ,medicine.medical_specialty ,Percutaneous ,business.industry ,Disease ,medicine.disease ,Asymptomatic ,medicine.anatomical_structure ,Bypass surgery ,medicine.artery ,Internal medicine ,Ascending aorta ,medicine ,Cardiology ,medicine.symptom ,business ,Stroke ,Artery - Abstract
Coronary artery and cerebrovascular disease represent a major cause of cardiovascular morbidity and mortality worldwide. Despite technological advancements in percutaneous interventions, surgical revascularization remains the preferred strategy in patients with left main or multivessel disease and in those with complex lesions with high SYNTAX score. As a result, an increasing number of older patients with diffuse atherosclerotic extracoronary disease are referred for coronary artery bypass grafting (CABG). Cerebrovascular complications after isolated coronary surgery occurs in 1-5% of patients; the magnitude of injury ranges from overt neurologic lesions with varying degree of permanent disability to “asymptomatic” cerebral events detected by dedicated neuro-imaging, nevertheless associated with significant long term cognitive and functional decline. Thromboembolic events due to manipulation of an atherosclerotic aorta are universally recognized as the leading etiology of early postoperative stroke following CABG. Coronary bypass surgery performed on an arrested heart relies on considerable aortic instrumentation associated with significant atheroembolic risk especially in older patients presenting with diffuse aortic calcifications. Surgical techniques to deal with a calcified ascending aorta during isolated coronary surgery have evolved over the last forty years. Moving away from aggressive aortic debridement or replacement, surgeons have developed strategies aimed to minimize aortic manipulation: from pump-assisted beating heart surgery with the use of composite grafts to complete avoidance of aortic manipulation with “anaortic” off-pump coronary artery bypass grafting, a safe and effective approach in significantly reducing the risk of intraoperative stroke.
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- 2020
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33. A New Scrupulosity Scale for the Dimensional Obsessive-Compulsive Scale (DOCS): Validation With Clinical and Nonclinical Samples
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Thröstur Björgvinsson, Joseph T. La Torre, Chad T. Wetterneck, Monnica T. Williams, Traleena M. Rouleau, and Anne Vallely
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050103 clinical psychology ,Obsessive-Compulsive Disorder ,Psychometrics ,05 social sciences ,Reproducibility of Results ,medicine.disease ,Scrupulosity ,Confirmatory factor analysis ,Exploratory factor analysis ,030227 psychiatry ,Religiosity ,03 medical and health sciences ,Clinical Psychology ,0302 clinical medicine ,Convergent validity ,Internal consistency ,Scale (social sciences) ,medicine ,Obsessive compulsive scale ,Humans ,0501 psychology and cognitive sciences ,Obsessive Behavior ,Psychology ,Factor Analysis, Statistical ,Clinical psychology - Abstract
Scrupulous obsessions are a prominent presentation of obsessive-compulsive disorder (OCD). Previous conceptualizations of scrupulosity have indicated that it belongs to the unacceptable thoughts dimension, which pertains to sexual, violent, and religious obsessive themes. However, research suggests that scrupulous symptoms may differ from other unacceptable thoughts symptoms, necessitating the need for targeted and thorough assessment. We added a Scrupulous or Religious Thoughts subscale (DOCS-SR) to the Dimensional Obsessive-Compulsive Scale (DOCS) and tested its factorial structure, psychometric properties, and clinical correlates in a nonclinical and clinical sample. In the first study, nonclinical participants (N = 203) completed the DOCS-SR, which was subjected to an exploratory factor analysis. Analyses revealed that the DOCS-SR reflected a one-factor solution and possessed acceptable internal consistency, as well as strong convergent validity with clinical correlates of OCD. In the second study, we administered the DOCS, as well as the DOCS-SR to a clinical sample (N = 314). An exploratory factor analysis and confirmatory factor analysis both suggested that the four subscales and additional DOCS-SR represented a five-factor solution. Internal consistency and convergent validity were strong. The DOCS Unacceptable Thoughts subscale and the DOCS-SR shared a moderate correlation but evidenced differences in associations with other correlates. This suggested both convergent and divergent validity. Collectively, our results support the utility of examining the individual components of the unacceptable thoughts dimension of OCD for effective assessment and treatment planning.
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- 2020
34. Assessing potential for aortoiliac vascular injury from venoarterial extracorporeal membrane oxygenation cannulae: An in vitro particle image velocimetry study
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Alice C. Boone, Jo P. Pauls, Maximilian V. Malfertheiner, John F. Fraser, Jacky Y. Suen, Michael P. Vallely, and Andrew B Haymet
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medicine.medical_specialty ,medicine.medical_treatment ,0206 medical engineering ,Biomedical Engineering ,Medicine (miscellaneous) ,Bioengineering ,02 engineering and technology ,030204 cardiovascular system & hematology ,Iliac Artery ,Biomaterials ,03 medical and health sciences ,Extracorporeal Membrane Oxygenation ,0302 clinical medicine ,Ischemia ,medicine.artery ,Internal medicine ,medicine ,Extracorporeal membrane oxygenation ,Cannula ,Humans ,Aorta, Abdominal ,Thrombus ,business.industry ,Abdominal aorta ,Models, Cardiovascular ,Extremities ,Equipment Design ,General Medicine ,Vascular System Injuries ,medicine.disease ,020601 biomedical engineering ,Thrombosis ,Peripheral ,Particle image velocimetry ,Flow velocity ,Cardiology ,Rheology ,business ,Blood Flow Velocity - Abstract
Background: Limb ischemia is a major complication associated with peripheral veno‐arterial extracorporeal membrane oxygenation (VA ECMO). The high velocity jet from arterial cannulae can cause “sandblasting” injuries to the arterial endothelium, with the potential risk of distal embolization and end organ damage. Aim: The aim of this study was to identify, for a range of clinically relevant VA ECMO cannulae and flow rates, any regions of peak flow velocity on the aortic wall which may predispose to vascular injury, and any regions of low velocity flow which may predispose to thrombus formation. Methods: A silicone model of the aortic and iliac vessels was sourced and the right external iliac artery was cannulated. Cannulae ranged from 15 – 21 Fr in size. Simulated steady state ECMO flow rates were instituted using a magnetically levitated pump (CentriMag pump). Adaptive particle image velocimetry was performed for each cannula at 3, 3.5, 4 and 4.5 L/min. Results: For all cannulae, in both horizontal and vertical side hole orientations, the peak velocity on the aortic wall ranged from 0.3 m/s ‐ 0.45 m/s, and the regions of lowest velocity flow were 0.05 m/s. The magnitude of peak velocity flow on the aortic wall was not different between a single pair versus multiple pairs of side holes. Maximum velocity flow on the aortic wall occurred earlier at a lower pump flow rate in the vertical orientation of distal side holes compared to a horizontal position. The presence of multiple paired side holes was associated with fewer low velocity flow regions, and some retrograde flow, in the distal abdominal aorta compared to cannulae with a single pair of side holes. Conclusion: From this in vitro visualization study, the selection of a cannula design with multiple versus single pairs of side holes did not change the magnitude of peak velocity flow delivered to the vessel wall. Cannulae with multiple side holes were associated with fewer regions of low velocity flow in the distal abdominal aorta. Further in vivo studies, and ideally clinical data would be required to assess any correlation of peak velocity flows with incidence of vascular injury, and any low velocity flow regions with incidence of thrombosis.
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- 2020
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35. Qualitative Evidence Synthesis on Self-Collection for Human Papillomavirus–Based Cervical Screening: Protocol for Systematic Review
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Lise Lafferty, Rebecca Guy, Angela Kelly-Hanku, Andrew Vallely, Hawa Camara, and Ye Zhang
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Sexually transmitted disease ,Computer applications to medicine. Medical informatics ,R858-859.7 ,MEDLINE ,CINAHL ,03 medical and health sciences ,0302 clinical medicine ,systematic review ,qualitative evidence synthesis ,Global health ,medicine ,Protocol ,cervical screening ,030212 general & internal medicine ,Cervical cancer ,Medical education ,Cervical screening ,General Medicine ,medicine.disease ,self-collection ,Systematic review ,Data extraction ,030220 oncology & carcinogenesis ,Medicine ,HPV-based testing ,Psychology - Abstract
Background Cervical cancer is the fourth most common cancer affecting women worldwide. In the 1980s, it was found that the sexually transmitted disease human papillomavirus causes over 90% of all cervical cancer cases. Since that discovery, diagnostic technologies have been developed for the detection of human papillomavirus DNA in cervical samples. However, significant sociocultural and structural barriers remain. Considerable strides have taken place in recent years to address these barriers, such as the self-collection for human papillomavirus–based cervical screening method. Objective The purpose of this review is to synthesize qualitative evidence around the self-collection method and identify strategies to increase acceptability and feasibility in different settings. This qualitative synthesis will be used to better understand how to conceptualize and implement more effective, accessible, and socially and culturally acceptable cervical screening programs and policies globally. Methods A systematic search will be conducted in Global Health, Cochrane, CINAHL (Cumulative Index to Nursing and Allied Health Literature), ProQuest, ScienceDirect, EMBASE, EMCARE, Medline (OVID), Scopus, and Web of Science. Published and peer-reviewed articles will be included. Two reviewers will independently screen and assess the studies. The data will be coded and analyzed using a thematic synthesis process. The socioecological model will be used to organize emergent themes at the micro and macro levels. The results will be presented in narrative and tabular form. Results The article search and data extraction were completed in May 2020. The data were analyzed in June 2020. The review will be submitted for publication in Fall 2020. Conclusions This review will present the global evidence of the perspectives and experiences of various key stakeholders and how these perspectives and experiences impact their decision-making process to perform or accept self-collection for human papillomavirus–based cervical screening. The review will provide guidance to implementation researchers as well as implications for future research. Trial Registration PROSPERO International Prospective Register of Systematic Reviews CRD42019109073; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=109073 International Registered Report Identifier (IRRID) DERR1-10.2196/21093
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- 2020
36. High Prevalence of Chlamydia and Gonorrhea and the Need for Sexually Transmitted Infection Testing Among Men Who Have Sex With Men and Transgender Women in Papua New Guinea
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Herick Aeno, Andrew Vallely, Simon Pekon, Ruthy Neo-Boli, Kauntim mi tu Study Team, Angela Kelly-Hanku, Sophie Ase, Steven G Badman, Damian Weikum, Avi J Hakim, Chelsea Iwamoto, and Barne Willie
- Subjects
Microbiology (medical) ,Male ,Gonorrhea ,Prevalence ,Sexually Transmitted Diseases ,Chlamydia trachomatis ,HIV Infections ,Dermatology ,medicine.disease_cause ,Transgender Persons ,Article ,Men who have sex with men ,03 medical and health sciences ,Papua New Guinea ,Sexual and Gender Minorities ,0302 clinical medicine ,Medicine ,Humans ,030212 general & internal medicine ,Cities ,Homosexuality, Male ,Child ,030505 public health ,Chlamydia ,business.industry ,Public Health, Environmental and Occupational Health ,Odds ratio ,Chlamydia Infections ,medicine.disease ,Infectious Diseases ,Neisseria gonorrhoeae ,Syphilis ,Female ,0305 other medical science ,business ,Demography - Abstract
BACKGROUND: Papua New Guinea has among the highest prevalence of sexually transmitted infections in the world but no estimates of Chlamydia trachomatis, Neisseria gonorrhoeae, or hepatitis B virus (HBV) are available among men who have sex with men (MSM) or transgender women (TGW). METHODS: We conducted respondent-driven sampling surveys among MSM and TGW in Port Moresby, Lae, and Mt Hagen (2016–2017) to characterize the prevalence of these infections. Eligibility criteria were as follows: aged ≥12 years, born male, could speak English or Tok Pisin, and had oral or anal sex with another person born male in the past 6 months. Participants were surveyed face-to-face and offered testing for anorectal and genital chlamydia and gonorrhea, syphilis, HIV, and HBV. All results are respondent-driven sampling weighted. RESULTS: We enrolled 400 participants in Port Moresby, 352 in Lae, and 111 in Mt Hagen. Chlamydia prevalence rates in the 3 cities regardless of anatomical site were 19.9%, 19.2%, and 24.3%, respectively. Gonorrhea prevalence rates regardless of anatomical site were 10.3%, 9.4%, and 9.6%, respectively. Hepatitis B virus prevalence rates were 11.7%, 13.8%, and 13.6%, respectively. In multivariable analysis, syphilis was associated with having either chlamydia or gonorrhea in Port Moresby (adjusted odds ratio, 4.0; 95% confidence interval, 2.0–7.9) and Lae (adjusted odds ratio, 2.4; 95% confidence interval, 1.2–5.0). CONCLUSIONS: There is a large unmet need among MSM and TGW in Papua New Guinea for chlamydia and gonorrhea detection and treatment. The high prevalence of HBV reinforces the importance of ensuring introduction and scale-up of HBV treatment and immunization. Urgent efforts are needed to introduce laboratory-based diagnosis for chlamydia and gonorrhea to ensure these populations have access to much needed treatment services.
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- 2020
37. Histopathological Features of Transbronchial Lung Cryobiopsy Associated with Usual Interstitial Pneumonia Pattern on Surgical Biopsy: Further Lessons from the COLDICE Study
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L.K. Troy, A. Mahar, J.L. Myers, E.M.T. Lau, C. Grainge, T.J. Corte, J.P. Williamson, M.P. Vallely, P.J. Torzillo, M.J. Phillips, G. Raghu, W.A. Cooper, and null The COLDICE Study Investigators
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medicine.medical_specialty ,Lung ,medicine.anatomical_structure ,Usual interstitial pneumonia ,business.industry ,Surgical biopsy ,medicine ,Radiology ,medicine.disease ,business - Published
- 2020
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38. Routine screening and rates of metabolic syndrome in patients treated with clozapine and long-acting injectable antipsychotic medications: a cross-sectional study
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J Vallely, Brian Hallahan, S Maher, Aaron Liew, James McLoughlin, A Tummon, S Sabri, Colm McDonald, and A Lydon
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medicine.medical_specialty ,Waist ,Cross-sectional study ,medicine.medical_treatment ,History and Philosophy of Science ,Internal medicine ,medicine ,Humans ,Antipsychotic ,Clozapine ,Applied Psychology ,Metabolic Syndrome ,business.industry ,medicine.disease ,Psychiatry and Mental health ,Blood pressure ,Cross-Sectional Studies ,Delayed-Action Preparations ,Cohort ,Schizophrenia ,Antipsychotic Medications ,Metabolic syndrome ,business ,medicine.drug ,Antipsychotic Agents - Abstract
ObjectivesTo examine the rate of monitoring of metabolic syndrome and actual rates of metabolic syndrome in two patient cohorts [clozapine treatment and long-acting injectable (LAI) antipsychotic] who are reviewed on an equally regular basis (1–4 weekly) for administration of treatment.MethodsClinical and laboratory data are examined on 119 patients treated with clozapine and 116 patients treated with LAI antipsychotic medications to determine the rates of metabolic syndrome and evidence of monitoring for metabolic syndrome in the previous 6 months. Individuals with insufficient data from these cohorts were invited to attend for metabolic screening to determine actual rates of metabolic syndrome in these two cohorts of patients.ResultsAll metabolic parameters were monitored to a significantly greater extent in the clozapine cohort (>90%), compared to those treated with LAI antipsychotic medications (p < 0.001). Metabolic syndrome was present in 38.9% of those treated with clozapine compared to 31.1% of patients treated with LAI antipsychotic medications (X2 = 0.54, p = 0.46).ConclusionsThese findings suggest that a robust screening plan should be in place to monitor for metabolic syndrome in individuals treated with LAI antipsychotic medications. This screening should include measurement of body weight, waist circumference, fasting glucose, lipids and fasting insulin levels. Early recognition of abnormal metabolic parameters allows early intervention, therefore, improving long-term cardiovascular outcomes.
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- 2020
39. Feasibility and acceptability of clean birth kits containing misoprostol for self-administration to prevent postpartum hemorrhage in rural Papua New Guinea
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Andrea Whittaker, Handan Wand, Primrose Homiehombo, Elizabeth Walep, Glen D. L. Mola, Lisa M Vallely, Christopher Morgan, Caroline S.E. Homer, Angela Kelly-Hanku, Michael Moses, John M. Kaldor, Marynne Tom, Andrew Vallely, Eluo Nataraye, and Caroline Ninnes
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Adult ,Rural Population ,medicine.medical_specialty ,Psychological intervention ,Self Administration ,Papua New Guinea ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Pregnancy ,Oxytocics ,medicine ,Humans ,Childbirth ,Prospective Studies ,030212 general & internal medicine ,Young adult ,Prospective cohort study ,Misoprostol ,Home Childbirth ,030219 obstetrics & reproductive medicine ,Obstetrics ,business.industry ,Postpartum Hemorrhage ,Obstetrics and Gynecology ,New guinea ,General Medicine ,medicine.disease ,Practice Guidelines as Topic ,Female ,Self-administration ,business ,medicine.drug - Abstract
Objective To determine the feasibility and acceptability of providing clean birth kits (CBKs) containing misoprostol for self-administration in a rural setting in Papua New Guinea. Methods A prospective intervention study was conducted between April 8, 2013, and October 24, 2014. Eligible participants were women in the third trimester of pregnancy who attended a prenatal clinic in Unggai Bena. Participants received individual instruction and were then given a CBK containing 600 μg misoprostol tablets for self-administration following an unsupervised birth if they could demonstrate their understanding of correct use of items in the CBK. Data regarding the use and acceptability of the CBK and misoprostol were collected during postpartum follow-up. Results Among 200 participants, 106 (53.0%) had an unsupervised birth, and 99 (93.4%) of these women used the CBK. All would use the CBK again and would recommend it to others. Among these 99 women, misoprostol was self-administered by 98 (99.0%), all of whom would take the drug again and would recommend it to others. Conclusion The findings strengthen the case for community-based use of misoprostol to prevent postpartum hemorrhage in remote communities. Large-scale interventions should be planned to further evaluate impact and acceptability.
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- 2016
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40. Loss to follow up of pregnant women with HIV and infant HIV outcomes in the prevention of maternal to child transmission of HIV programme in two high-burden provinces in Papua New Guinea: a retrospective clinical audit
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Primrose Homiehombo, Stanley Luchters, Angela Kelly-Hanku, Ghanashyan Sethy, Agnes Mek, Claire Nightingale, John M. Kaldor, Justine Nankinga, Lisa M Vallely, Mary Bagita, Minh D. Pham, and Andrew Vallely
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Clinical audit ,medicine.medical_specialty ,Multivariate analysis ,HIV & AIDS ,HIV Infections ,paediatric infectious disease & immunisation ,Logistic regression ,Papua New Guinea ,Acquired immunodeficiency syndrome (AIDS) ,Pregnancy ,Medicine and Health Sciences ,paediatric infectious disease & ,medicine ,Humans ,RETENTION ,Pregnancy Complications, Infectious ,Retrospective Studies ,Clinical Audit ,international health services ,business.industry ,Obstetrics ,Public health ,clinical audit ,public health ,immunisation ,Infant ,General Medicine ,CARE ,medicine.disease ,Infectious Disease Transmission, Vertical ,AIDS ,HIV & ,Regimen ,Serodiscordant ,Medicine ,HIV/AIDS ,TRIAL ,Female ,Pregnant Women ,business ,Follow-Up Studies - Abstract
IntroductionDespite early adoption of the WHO guidelines to deliver lifelong antiretroviral (ARV) regimen to pregnant women on HIV diagnosis, the HIV prevention of mother to child transmission programme in Papua New Guinea remains suboptimal. An unacceptable number of babies are infected with HIV and mothers not retained in treatment. This study aimed to describe the characteristics of this programme and to investigate the factors associated with programme performance outcomes.MethodsWe conducted a retrospective analysis of clinical records of HIV-positive pregnant women at two hospitals providing prevention of mother to child transmission services. All women enrolled in the prevention of mother to child transmission programme during the study period (June 2012–June 2015) were eligible for inclusion. Using logistic regression, we examined the factors associated with maternal loss to follow-up (LTFU) before birth and before infant registration in a paediatric ARV programme.Results763 of women had records eligible for inclusion. Demographic and clinical differences existed between women at the two sites. Almost half (45.1%) of the women knew their HIV-positive status prior to the current pregnancy. Multivariate analysis showed that women more likely to be LTFU by the time of birth were younger (adjusted OR (AOR)=2.92, 95% CI 1.16 to 7.63), were newly diagnosed with HIV in the current/most recent pregnancy (AOR=3.50, 95% CI 1.62 to 7.59) and were in an HIV serodiscordant relationship (AOR=2.94, 95% CI 1.11 to 7.84). Factors associated with maternal LTFU before infant registration included being primipara at the time of enrolment (AOR=3.13, 95% CI 1.44 to 6.80) and being newly diagnosed in that current/most recent pregnancy (AOR=2.49, 95% CI 1.31 to 4.73). 6.6% (50 of 763) of exposed infants had a positive HIV DNA test.ConclusionsOur study highlighted predictors of LTFU among women. Understanding these correlates at different stages of the programme offers important insights for targets and timing of greater support for retention in care.
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- 2020
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41. Youth-centred research to help prevent and mitigate the adverse health and social impacts of pregnancy amongst young Papua New Guineans
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Elissa Kennedy, John M. Kaldor, Stephen Bell, Lisa M Vallely, Kirsten I. Black, Caroline Ninnes, Angela Kelly-Hanku, Mary Bagita, Glen Mola, Andrew Vallely, and William Pomat
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Adult ,Male ,medicine.medical_specialty ,Adolescent ,Sexual Behavior ,sexual health ,Qualitative property ,Health Promotion ,Abortion ,lcsh:RC870-923 ,maternal health ,young people ,03 medical and health sciences ,Papua New Guinea ,Young Adult ,0302 clinical medicine ,Pregnancy ,Environmental health ,health inequities ,medicine ,Humans ,Maternal Health Services ,030212 general & internal medicine ,reproductive health ,Developing Countries ,Reproductive health ,youth ,030219 obstetrics & reproductive medicine ,Adolescent pregnancy ,lcsh:HQ1-2044 ,business.industry ,Public health ,Obstetrics and Gynecology ,lcsh:Diseases of the genitourinary system. Urology ,medicine.disease ,Outreach ,Maternal Mortality ,Reproductive Medicine ,Adolescent Behavior ,lcsh:The family. Marriage. Woman ,Pregnancy in Adolescence ,Female ,business ,Psychology ,qualitative research ,Unintended pregnancy ,Qualitative research - Abstract
Despite persistent international attention, adolescent pregnancy remains a major public health concern in low- and middle-income countries, like Papua New Guinea (PNG), where health inequities related to social and cultural norms, gender power imbalance, education and socio-economic deprivation affect young and unmarried women in particular. In PNG – where there is high adolescent fertility, high early childbearing and high maternal mortality ratio, and evidence of high rates of unintended pregnancy and abortion among young women – adolescent pregnancy is a policy priority. Yet there are no youth-specific sexual, reproductive and maternal health services or community-based outreach programmes. There is limited in-depth qualitative data on young women's and young men's experiences of pregnancy, the social contexts within which these pregnancies occur, young people's contraception practices and experiences with existing sexual, reproductive and maternal health services. These issues inhibit the design and delivery of youth-friendly health services and outreach support programmes that could prevent or mitigate adverse health and social outcomes associated with adolescent pregnancy. In this commentary article, we propose the need for novel youth-centred research to inform the development of policies, health services and outreach programmes that pay honest and respectful attention to young people's lived experiences of pregnancy. Whilst we focus on the situation in PNG, these ideas are relevant to diverse low resource settings where the harmful impacts of health inequities among young people persist and are particularly detrimental.
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- 2018
42. S961 Risk of New or Recurrent Cancer After Vedolizumab or Ustekinumab Exposure in Patients With Inflammatory Bowel Disease and Previous Cancer
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Jordan E. Axelrad, Margaret Vallely, Shannon Chang, Jillian M. Pecoriello, David Hudesman, Cameron Zenger, Simon Hong, and Alice S. Pang
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Oncology ,medicine.medical_specialty ,Hepatology ,business.industry ,Gastroenterology ,Cancer ,medicine.disease ,Inflammatory bowel disease ,Vedolizumab ,Internal medicine ,Ustekinumab ,Recurrent Cancer ,medicine ,In patient ,business ,medicine.drug - Published
- 2021
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43. Neurocognitive and Psychiatric Issues Post Cardiac Surgery
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Michael Seco, Richard Seamark, Michael P. Vallely, Stuart M. Grieve, Paul G. Bannon, Ben Indja, and Jason Kaplan
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Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,Neuropsychiatry ,Stress Disorders, Post-Traumatic ,03 medical and health sciences ,0302 clinical medicine ,Quality of life ,medicine ,Humans ,Cognitive Dysfunction ,Cardiac Surgical Procedures ,Cognitive decline ,Psychiatry ,Rehabilitation ,business.industry ,Delirium ,Perioperative ,medicine.disease ,Cardiac surgery ,Quality of Life ,Cardiology and Cardiovascular Medicine ,business ,Neurocognitive ,Postoperative cognitive dysfunction ,030217 neurology & neurosurgery - Abstract
Neurocognitive and psychiatric complications are common following cardiac surgery and impact on patient quality of life, recovery from surgery, participation in rehabilitation and long-term mortality. Postoperative cognitive decline, depressive disorders, post-traumatic stress disorder and neurocognitive impairment related to silent brain infarcts have all been linked to the perioperative period of cardiac surgery, and potentially have serious consequences. The accurate assessment of these conditions, particularly in determining the aetiology, and impact on patients is difficult due to the poorly recognised nature of these complications as well as similarities in presentation with postoperative delirium. This review aims to summarise current understanding surrounding psychiatric disturbances following cardiac surgery including the impact on patient quality of life and long-term outcomes.
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- 2017
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44. Long-term prognosis and cost-effectiveness of left ventricular assist device as bridge to transplantation: A systematic review
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Michael Byrom, Michael K. Wilson, Paul G. Bannon, Michael Seco, John F. Fraser, Michael P. Vallely, and Dong Fang Zhao
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Waiting time ,medicine.medical_specialty ,Cost effectiveness ,Cost-Benefit Analysis ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,Cardiac allograft vasculopathy ,03 medical and health sciences ,Postoperative Complications ,0302 clinical medicine ,Internal medicine ,Preoperative Care ,medicine ,Humans ,030212 general & internal medicine ,Stroke ,Heart Failure ,Heart transplantation ,business.industry ,Prognosis ,medicine.disease ,Surgery ,Treatment Outcome ,Meta-analysis ,Ventricular assist device ,Cardiology ,Heart Transplantation ,Bridge to transplantation ,Heart-Assist Devices ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background This systematic review aimed to evaluate the clinical outcomes and cost-effectiveness of left ventricular assist devices (LVADs) used as bridge to transplantation (BTT), compared to orthotopic heart transplantation (OHT) without a bridge. Method Systematic searches were performed in electronic databases with available data extracted from text and digitized figures. Meta-analysis of short and long-term term post-transplantation outcomes was performed with summation of cost-effectiveness analyses. Results Twenty studies reported clinical outcomes of 4575 patients (1083 LVAD BTT and 3492 OHT). Five studies reported cost-effectiveness data on 837 patients (339 VAD BTT and 498 OHT). There was no difference in long-term post-transplantation survival (HR 1.24, 95% CI 1.00–1.54), acute rejection (HR 1.10, 95% CI 0.93–1.30), or chronic rejection and cardiac allograft vasculopathy (HR 0.99, 95% CI 0.73–1.36). No differences were found in 30-day post-operative mortality (OR 0.91, 95% CI 0.42–2.00), stroke (OR 1.64, 95% CI 0.43–6.27), renal failure (OR 1.43, 95% CI 0.58–3.54), bleeding (OR 1.56, 95% CI 0.78–3.13), or infection (OR 2.44, 95% CI 0.81–7.38). Three of the five studies demonstrated incremental cost-effectiveness ratios below the acceptable maximum threshold. The total cost of VAD BTT ranged from $316,078 to $1,025,500, and OHT ranged from $179,051 to $802,200. Conclusion LVADs used as BTT did not significantly alter post-transplantation long-term survival, rejection, and post-operative morbidity. LVAD BTT may be cost-effective, particularly in medium and high-risk patients with expected prolonged waiting times, renal dysfunction, and young patients.
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- 2017
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45. Coronary Artery Bypass Grafting With and Without Manipulation of the Ascending Aorta
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Andre Lamy, Michael K. Wilson, David P. Taggart, Michael P. Vallely, Michael Seco, J. James B. Edelman, Michael Byrom, Dong Fang Zhao, Paul G. Bannon, John D. Puskas, and Vinod H. Thourani
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medicine.medical_specialty ,Aorta ,business.industry ,medicine.medical_treatment ,Percutaneous coronary intervention ,Atrial fibrillation ,030204 cardiovascular system & hematology ,medicine.disease ,Intensive care unit ,Confidence interval ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,law ,Internal medicine ,medicine.artery ,Anesthesia ,Ascending aorta ,Cardiology ,medicine ,Cardiopulmonary bypass ,030212 general & internal medicine ,Cardiology and Cardiovascular Medicine ,business ,Stroke - Abstract
Background Coronary artery bypass grafting (CABG) remains the standard of treatment for 3-vessel and left main coronary disease, but is associated with an increased risk of post-operative stroke compared to percutaneous coronary intervention. It has been suggested that CABG techniques that eliminate cardiopulmonary bypass and reduce aortic manipulation may reduce the incidence of post-operative stroke. Objectives A network meta-analysis was performed to compare post-operative outcomes between all CABG techniques, including anaortic off-pump CABG (anOPCABG), off-pump with the clampless Heartstring device (OPCABG-HS), off-pump with a partial clamp (OPCABG-PC), and traditional on-pump CABG with aortic cross-clamping. Methods A systematic search of 6 electronic databases was performed to identify all publications reporting the outcomes of the included operations. Studies reporting the primary endpoint, 30-day post-operative stroke rate, were included in a Bayesian network meta-analysis. Results There were 13 included studies with 37,720 patients. At baseline, anOPCABG patients had higher previous stroke than did the OPCABG-PC (7.4% vs. 6.5%; p = 0.02) and CABG (7.4% vs. 3.2%; p = 0.001) patients. AnOPCABG was the most effective treatment for decreasing the risk of post-operative stroke (–78% vs. CABG, 95% confidence interval [CI]: 0.14 to 0.33; –66% vs. OPCABG-PC, 95% CI: 0.22 to 0.52; –52% vs. OPCABG-HS, 95% CI: 0.27 to 0.86), mortality (–50% vs. CABG, 95% CI: 0.35 to 0.70; –40% vs. OPCABG-HS, 95% CI: 0.38 to 0.94), renal failure (–53% vs. CABG, 95% CI: 0.31 to 0.68), bleeding complications (–48% vs. OPCABG-HS, 95% CI: 0.31 to 0.87; –36% vs. CABG, 95% CI: 0.42 to 0.95), atrial fibrillation (–34% vs. OPCABG-HS, 95% CI: 0.49 to 0.89; –29% vs. CABG, 95% CI: 0.55 to 0.87; –20% vs. OPCABG-PC, 95% CI: 0.68 to 0.97), and shortening the length of intensive care unit stay (–13.3 h; 95% CI: –19.32 to –7.26; p Conclusions Avoidance of aortic manipulation in anOPCABG may decrease the risk of post-operative stroke, especially in patients with higher stroke risk. In addition, the elimination of cardiopulmonary bypass may reduce the risk of short-term mortality, renal failure, atrial fibrillation, bleeding, and length of intensive care unit stay.
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- 2017
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46. S0352 Endoscopic Biopsies During Presentation for Esophageal Food Impaction: An Important Opportunity for Timely Diagnosis of Eosinophilic Esophagitis
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Rita M. Knotts, Margaret Vallely, Abraham Khan, and Melissa Magrath
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medicine.medical_specialty ,Hepatology ,business.industry ,General surgery ,Food impaction ,Gastroenterology ,Medicine ,Presentation (obstetrics) ,business ,Eosinophilic esophagitis ,medicine.disease ,Timely diagnosis - Published
- 2020
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47. Congenital tricuspid valve dysplasia in a septuagenarian
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Martin Brown, Lynn Khor, and Michael P. Vallely
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medicine.medical_specialty ,Tricuspid valve ,business.industry ,Congenital Heart Disease ,medicine.disease ,Surgery ,medicine.anatomical_structure ,Dysplasia ,Images Cardio ,medicine ,Congenital tricuspid valve dysplasia ,AcademicSubjects/MED00200 ,Cardiology and Cardiovascular Medicine ,business - Published
- 2020
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48. Sexually transmitted infections in pregnancy: a narrative review of the global research gaps, challenges, and opportunities
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Juliana Grant, R Matthew Chico, Adriane Wynn, Jeffrey D. Klausner, Anne Cc. Lee, Nicola Low, Chrysovalantis Stafylis, Chelsea Morroni, Rose L. Molina, Andrew Vallely, Nava Yeganeh, Andrew Medina-Marino, Doreen Ramogola-Masire, and Weiming Tang
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wc_142 ,wc_140 ,Chlamydia trachomatis ,HIV Infections ,law.invention ,Gonorrhea ,0302 clinical medicine ,Randomized controlled trial ,Pregnancy ,law ,030212 general & internal medicine ,610 Medicine & health ,wa_105 ,wa_900 ,Infectious Diseases ,Premature Birth ,Female ,Narrative review ,Trichomonas Vaginitis ,0305 other medical science ,360 Social problems & social services ,Adult ,Microbiology (medical) ,medicine.medical_specialty ,Adolescent ,Sexually Transmitted Diseases ,MEDLINE ,Reviews ,Dermatology ,wa_310 ,World health ,03 medical and health sciences ,Intervention (counseling) ,Trichomonas vaginalis ,medicine ,Humans ,030505 public health ,business.industry ,Infant, Newborn ,Public Health, Environmental and Occupational Health ,Chlamydia Infections ,medicine.disease ,Infectious Disease Transmission, Vertical ,Neisseria gonorrhoeae ,Clinical trial ,Family medicine ,Observational study ,Pregnant Women ,wq_256 ,business - Abstract
Curable sexually transmitted infections in pregnant women may cause poor maternal and newborn outcomes worldwide. Syndromic management is practiced in many settings yet fails to identify most infections. Etiologic screening has promise, but further effectiveness and cost-effectiveness studies are needed. Supplemental digital content is available in the text., Background Sexually transmitted infections (STI), such as chlamydial, gonorrheal, and trichomonal infections, are prevalent in pregnant women in many countries and are widely reported to be associated with increased risk of poor maternal and neonatal outcomes. Syndromic STI management is frequently used in pregnant women in low- and middle-income countries, yet its low specificity and sensitivity lead to both overtreatment and undertreatment. Etiologic screening for chlamydial, gonorrheal, and/or trichomonal infection in all pregnant women combined with targeted treatment might be an effective intervention. However, the evidence base is insufficient to support the development of global recommendations. We aimed to describe key considerations and knowledge gaps regarding chlamydial, gonorrheal, and trichomonal screening during pregnancy to inform future research needed for developing guidelines for low- and middle-income countries. Methods We conducted a narrative review based on PubMed and clinical trials registry searches through January 20, 2020, guidelines review, and expert opinion. We summarized our findings using the frameworks adopted by the World Health Organization for guideline development. Results Adverse maternal-child health outcomes of potential interest are wide-ranging and variably defined. No completed randomized controlled trials on etiologic screening and targeted treatment were identified. Evidence from observational studies was limited, and trials of presumptive STI treatment have shown mixed results. Subgroups that might benefit from specific recommendations were identified. Evidence on harms was limited. Cost-effectiveness was influenced by STI prevalence and availability of testing infrastructure and high-accuracy/low-cost tests. Preliminary data suggested high patient acceptability. Discussion Preliminary data on harms, acceptability, and feasibility and the availability of emerging test technologies suggest that etiologic STI screening deserves further evaluation as a potential tool to improve maternal and neonatal health outcomes worldwide.
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- 2020
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49. New Onset Atrial Fibrillation Following Transcatheter and Surgical Aortic Valve Replacement: A Systematic Review and Meta-Analysis
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Kei Woldendorp, Stuart M. Grieve, Ben Indja, and Michael P. Vallely
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Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Population ,030204 cardiovascular system & hematology ,Global Health ,Transcatheter Aortic Valve Replacement ,03 medical and health sciences ,0302 clinical medicine ,Postoperative stroke ,Postoperative Complications ,Aortic valve replacement ,Risk Factors ,Internal medicine ,Atrial Fibrillation ,medicine ,Prevalence ,Humans ,030212 general & internal medicine ,education ,education.field_of_study ,business.industry ,Atrial fibrillation ,Aortic Valve Stenosis ,medicine.disease ,New onset atrial fibrillation ,Cardiac surgery ,Meta-analysis ,Heart Valve Prosthesis ,Cardiology ,Cardiology and Cardiovascular Medicine ,Complication ,business - Abstract
Background New-onset atrial fibrillation (NOAF) is a well-recognised, although variably reported complication following surgical aortic valve replacement (SAVR). Rates of NOAF following transcatheter aortic valve implantation (TAVI) seem to be notably less than SAVR, even though this population is typically older and of higher risk. The aim of this study was to determine the prevalence of NOAF in both these populations and associated postoperative outcomes. Methods We conducted a systematic review and meta-analysis of studies reporting rates of NOAF post SAVR or TAVI, along with early postoperative outcomes. Twenty-five (25) studies with a total of 13,010 patients were included in the final analysis. Results The prevalence of NOAF post SAVR was 0.4 (95% CI 0.36–0.44) and post TAVI 0.15 (95% CI 0.11–0.18). NOAF was associated with an increased risk of postoperative cerebrovascular accident (CVA) for SAVR and TAVI (RR 1.44 95% CI 1.01–2.06 and RR 2.24 95% CI 1.46–3.45 respectively). NOAF was associated with increased mortality in the TAVI group (RR 3.02 95% CI 1.55–5.9) but not the SAVR group (RR 1.00, 95% CI 0.54–1.84). Hospital length of stay was increased for both TAVI and SAVR patients with NOAF (MD 2.54 days, 95% CI 2.0–3.00) and (MD 1.64 days, 95% CI 0.04–3.24 respectively). Conclusions The prevalence of NOAF is significantly less following TAVI, as compared to SAVR. While NOAF is associated with increased risk of postoperative stroke for both groups, for TAVI alone NOAF confers increased risk of early mortality.
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- 2019
50. Cost and cost-effectiveness of point-of-care testing and treatment for sexually transmitted and genital infections in pregnancy in low-income and middle-income countries: a systematic review protocol
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Rabiah al Adawiyah, Olga P. M. Saweri, Willie Pomat, Neha Batura, Virginia Wiseman, Louise M. Causer, and Andrew Vallely
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medicine.medical_specialty ,Cost effectiveness ,Point-of-care testing ,Cost-Benefit Analysis ,Point-of-Care Systems ,MEDLINE ,Sexually Transmitted Diseases ,costs ,03 medical and health sciences ,0302 clinical medicine ,Health Economics ,Pregnancy ,Economic cost ,Protocol ,Medicine ,Humans ,030212 general & internal medicine ,Pregnancy Complications, Infectious ,cost-effectiveness ,Developing Countries ,Poverty ,sexually transmitted infections ,Protocol (science) ,genital infections ,business.industry ,General Medicine ,Publication bias ,medicine.disease ,3. Good health ,Systematic review ,point-of-care ,Point-of-Care Testing ,Research Design ,Family medicine ,Female ,Bacterial vaginosis ,business ,030217 neurology & neurosurgery - Abstract
IntroductionThe economic and health burden of sexually transmitted and genital infections (henceforth, STIs) in low-income and middle-income countries (LMICs) is substantial. Left untreated, STIs during pregnancy may result in several adverse pregnancy and birth outcomes. Timely diagnosis and treatment at point-of-care (POC) can potentially improve these outcomes. Despite the availability and promotion of POC diagnostics for STIs as a key component of antenatal care in LMICs, their widespread use has been limited, owing to the high economic costs faced by individuals and health systems. To date, there have been no systematic reviews which explore the cost or cost-effectiveness of POC testing and treatment of STIs in pregnancy in LMICs. The objective of this protocol is to outline the methods that will compare, synthesise and appraise the existing literature in this domain.Methods and analysisWe will conduct literature searches in MEDLINE, Embase and Web of Science. To find additional literature, we will search Google Scholar and hand search reference lists of included papers. Two reviewers will independently search databases, screen titles, abstracts and full texts; when necessary a third reviewer will resolve disputes. Only cost and cost-effectiveness studies of POC testing and treatment of STIs, including syphilis, chlamydia, trichomonas, gonorrhoea and bacterial vaginosis, in pregnancy in LMICs will be included. Published checklists will be used to assess quality of reporting practices and methodological approaches. We will also assess risk of publication bias. Interstudy heterogeneity will be assessed and depending on variation between studies, a meta-analysis or narrative synthesis will be conducted.Ethics and disseminationEthical approval is not required as the review will use published literature. The results will be published in a peer-reviewed open source journal and presented at an international conference.PROSPERO registration numberCRD42018109072.
- Published
- 2019
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