scholarly journals Does the effectiveness of IUI in couples with unexplained subfertility depend on their prognosis of natural conception? A replication of the H2Oil study

2020 ◽  
Author(s):  
R van Eekelen ◽  
K Rosielle ◽  
N van Welie ◽  
K Dreyer ◽  
M van Wely ◽  
...  
Keyword(s):  
Study Design ◽  
Research Question ◽  
Secondary Analysis ◽  
Expectant Management ◽  
Ongoing Pregnancy ◽  
Relative Benefit ◽  
Effect Of Treatment ◽  
Natural Conception ◽  
The Absolute

Abstract STUDY QUESTION Can we replicate the finding that the benefit of IUI-ovarian stimulation (IUI-OS) compared to expectant management for couples with unexplained subfertility depends on the prognosis of natural conception? SUMMARY ANSWER The estimated benefit of IUI-OS did not depend on the prognosis of natural conception but did depend on when treatment was started after diagnosis, with starting IUI-OS later yielding a larger absolute and relative benefit of treatment. WHAT IS KNOWN ALREADY IUI-OS is often the first-line treatment for couples with unexplained subfertility. Two randomized controlled trials (RCTs) compared IUI-OS to expectant management using different thresholds for the prognosis of natural conception as inclusion criteria and found different results. In a previous study (a Dutch national cohort), it was found that the benefit of IUI-OS compared to expectant management seemed dependent on the prognosis of natural conception, but this finding warrants replication. STUDY DESIGN, SIZE, DURATION We conducted a secondary analysis of the H2Oil study (n = 1119), a multicentre RCT that evaluated the effect of oil-based contrast versus water-based contrast during hysterosalpingography (HSG). Couples were randomized before HSG and followed up for 3–5 years. We selected couples with unexplained subfertility who received HSG and had follow-up or pregnancy data available. Follow-up was censored at the start of IVF, after the last IUI cycle or at last contact and was truncated at a maximum of 18 months after the fertility workup. PARTICIPANTS/MATERIALS, SETTING, METHODS The endpoint was time to conception leading to an ongoing pregnancy. We used the sequential Cox approach comparing in each month the ongoing pregnancy rates over the next 6 months of couples who started IUI-OS to couples who did not. We calculated the prognosis of natural conception for individual couples, updated this over consecutive failed cycles and evaluated whether prognosis modified the effect of starting IUI-OS. We corrected for known predictors of conception using inverse probability weighting. MAIN RESULTS AND THE ROLE OF CHANCE Data from 975 couples were available. There were 587 couples who received at least one IUI-OS cycle within 18 months after HSG of whom 221 conceived leading to an ongoing pregnancy (rate: 0.74 per couple per year over a median follow-up for IUI of 5 months). The median period between HSG and starting IUI-OS was 4 months. Out of 388 untreated couples, 299 conceived naturally (rate: 0.56 per couple per year over a median follow-up of 4 months). After creating our mimicked trial datasets, starting IUI-OS was associated with a higher chance of ongoing pregnancy by a pooled, overall hazard ratio of 1.50 (95% CI: 1.19–1.89) compared to expectant management. We did not find strong evidence that the effect of treatment was modified by a couple’s prognosis of achieving natural conception (Akaike’s Information Criterion (AIC) decreased by 1 point). The effect of treatment was dependent on when couples started IUI-OS (AIC decreased by more than 2 points). The patterns of estimated absolute chances over time for couples with increasingly better prognoses were different from the previous study but the finding that starting later yields a larger benefit of treatment was similar. We found IUI-OS increased the absolute chance of pregnancy by at least 5% compared to expectant management. The absolute chance of pregnancy after IUI-OS seems less variable between couples and starting times of treatment than the absolute chance after expectant management. LIMITATIONS, REASONS FOR CAUTION This is a secondary analysis, as the H2Oil trial was not designed with this research question in mind. Owing to sample size restrictions, it remained difficult to distinguish between the ranges of prognoses in which true benefit was found. WIDER IMPLICATIONS OF THE FINDINGS We replicated the finding that starting IUI-OS later after diagnosis yields a larger absolute and relative benefit of treatment. We did not replicate the dependency of the effect of IUI-OS on the prognosis of natural conception and could not identify clear thresholds for the prognosis of natural conception when IUI-OS was and/or was not effective. Because many of these couples still have good chances of natural conception at the time of diagnosis, we suggest clinicians should advise couples to delay the start of IUI-OS for several months to avoid unnecessary treatment. STUDY FUNDING/COMPETING INTEREST(S) The H2Oil study (NTR 3270) was an investigator-initiated study that was funded by the two academic institutions (AMC and VUmc) of the Amsterdam UMC. The follow-up study (NTR 6577) was also an investigator-initiated study with funding by Guerbet, France. The funders had no role in study design, collection, analysis and interpretation of the data. B.W.M. is supported by an Investigator grant (GNT1176437) from the Australian National Health and Medical Research Council (NHMRC). K.D. reports receiving travel and speaker fees from Guerbet. B.W.M. reports consultancy for ObsEva, Merck, Merck KGaA, iGenomix and Guerbet. V.M. reports receiving travel- and speaker fees as well as research grants from Guerbet.

scholarly journals Septum resection in women with a septate uterus: a cohort study

2020 ◽  
Vol 35 (7) ◽  
pp. 1578-1588 ◽  
Author(s):  
J F W Rikken ◽  
K W J Verhorstert ◽  
M H Emanuel ◽  
M Y Bongers ◽  
T Spinder ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Live Birth ◽  
Classification System ◽  
Pregnancy Loss ◽  
Expectant Management ◽  
Reproductive Outcomes ◽  
Ongoing Pregnancy ◽  
Septate Uterus ◽  
Definition Of

Abstract Study question Does septum resection improve reproductive outcomes in women with a septate uterus? Summary answer In women with a septate uterus, septum resection does not increase live birth rate nor does it decrease the rates of pregnancy loss or preterm birth, compared with expectant management. What is known already The septate uterus is the most common uterine anomaly with an estimated prevalence of 0.2–2.3% in women of reproductive age, depending on the classification system. The definition of the septate uterus has been a long-lasting and ongoing subject of debate, and currently two classification systems are used worldwide. Women with a septate uterus may be at increased risk of subfertility, pregnancy loss, preterm birth and foetal malpresentation. Based on low quality evidence, current guidelines recommend removal of the intrauterine septum or, more cautiously, state that the procedure should be evaluated in future studies. Study design, size, duration We performed an international multicentre cohort study in which we identified women mainly retrospectively by searching in electronic patient files, medical records and databases within the time frame of January 2000 until August 2018. Searching of the databases, files and records took place between January 2016 and July 2018. By doing so, we collected data on 257 women with a septate uterus in 21 centres in the Netherlands, USA and UK. Participants/materials, setting, methods We included women with a septate uterus, defined by the treating physician, according to the classification system at that time. The women were ascertained among those with a history of subfertility, pregnancy loss, preterm birth or foetal malpresentation or during a routine diagnostic procedure. Allocation to septum resection or expectant management was dependent on the reproductive history and severity of the disease. We excluded women who did not have a wish to conceive at time of diagnosis. The primary outcome was live birth. Secondary outcomes included pregnancy loss, preterm birth and foetal malpresentation. All conceptions during follow-up were registered but for the comparative analyses, only the first live birth or ongoing pregnancy was included. To evaluate differences in live birth and ongoing pregnancy, we used Cox proportional regression to calculate hazard rates (HRs) and 95% CI. To evaluate differences in pregnancy loss, preterm birth and foetal malpresentation, we used logistic regression to calculate odds ratios (OR) with corresponding 95% CI. We adjusted all reproductive outcomes for possible confounders. Main results and the role of chance In total, 257 women were included in the cohort. Of these, 151 women underwent a septum resection and 106 women had expectant management. The median follow-up time was 46 months. During this time, live birth occurred in 80 women following a septum resection (53.0%) compared to 76 women following expectant management (71.7%) (HR 0.71 95% CI 0.49–1.02) and ongoing pregnancy occurred in 89 women who underwent septum resection (58.9%), compared to 80 women who had expectant management (75.5%) (HR 0.74 (95% CI 0.52–1.06)). Pregnancy loss occurred in 51 women who underwent septum resection (46.8%) versus 31 women who had expectant management (34.4%) (OR 1.58 (0.81–3.09)), while preterm birth occurred in 26 women who underwent septum resection (29.2%) versus 13 women who had expectant management (16.7%) (OR 1.26 (95% CI 0.52–3.04)) and foetal malpresentation occurred in 17 women who underwent septum resection (19.1%) versus 27 women who had expectant management (34.6%) (OR 0.56 (95% CI 0.24–1.33)). Limitations, reasons for caution Our retrospective study has a less robust design compared with a randomized controlled trial. Over the years, the ideas about the definition of the septate uterus has changed, but since the 257 women with a septate uterus included in this study had been diagnosed by their treating physician according to the leading classification system at that time, the data of this study reflect the daily practice of recent decades. Despite correcting for the most relevant patient characteristics, our estimates might not be free of residual confounding. Wider implications of the findings Our results suggest that septum resection, a procedure that is widely offered and associated with financial costs for society, healthcare systems or individuals, does not lead to improved reproductive outcomes compared to expectant management for women with a septate uterus. The results of this study need to be confirmed in randomized clinical trials. Study funding/competing interest(s) A travel for JFWR to Chicago was supported by the Jo Kolk Studyfund. Otherwise, no specific funding was received for this study. The Department of Obstetrics and Gynaecology, University Medical Centre, Groningen, received an unrestricted educational grant from Ferring Pharmaceutical Company unrelated to the present study. BWM reports grants from NHMRC, personal fees from ObsEva, personal fees from Merck, personal fees from Guerbet, other payment from Guerbet and grants from Merck, outside the submitted work. The other authors declare no conficts of interest. Trial registration number N/A

P–753 A randomised controlled trial comparing expectant management versus intrauterine insemination in couples with unexplained subfertility and a poor prognosis for natural conception

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
J Wessel ◽  
M Mochtar ◽  
H Verhoeve ◽  
J Maas ◽  
J P D Bruin ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Poor Prognosis ◽  
Intrauterine Insemination ◽  
Controlled Trial ◽  
Expectant Management ◽  
Pregnancy Rates ◽  
Ongoing Pregnancy ◽  
Management Group ◽  
Natural Conception ◽  
Randomised Controlled

Abstract Study question Does 6 months expectant management reduces ongoing pregnancy rates compared to intrauterine insemination with ovarian stimulation (IUI-OS) in couples with unexplained subfertility? Summary answer In couples with unexplained subfertility and a poor prognosis for natural conception, 6 months of expectant management decreases ongoing pregnancy rates as compared to IUI-OS. What is known already In couples with unexplained subfertility and a poor prognosis, IUI-OS is a first line treatment. We have previously shown that in couples with unexplained subfertility and a good prognosis for natural conception (>30% in 12 months), 6 months expectant management does not reduce pregnancy changes. However, in couples with a poor prognosis for natural conception, effectiveness of IUI-OS is uncertain. Study design, size, duration We performed a non-inferiority multicentre randomised controlled trial (RCT) within the infrastructure of the Dutch Consortium for Healthcare Evaluation and Research in Obstetrics and Gynaecology. We studied couples with unexplained subfertility and a poor prognosis for natural conception. The couples were allocated in a 1:1 ratio to six months expectant management or six months IUI-OS with either clomiphene citrate or gonadotrophins. Participants/materials, setting, methods We intended to include 1091 couples. The trial was halted pre-maturely due to slow inclusion after randomisation of 178 couples. The primary outcome was ongoing pregnancy leading to a live birth with multiple pregnancy and miscarriage rate as important secondary outcomes. We calculated relative risks with 95% CI and a corresponding hazard-rate for ongoing-pregnancy-over-time based on intention-to-treat. Main results and the role of chance Between October 2016 and September 2020 92 couples were allocated to expectant management and 86 to IUI-OS. Baseline characteristics were equally distributed. Mean female age was 34 years, median duration of subfertility was 21 months. Within 6 months after randomisation, women allocated to expectant management had a lower ongoing pregnancy rate than women allocated to IUI-OS (12/92 [13.0%] vs 29/86 women [33.7%], risk ratio 0.39 (95%CI 0.21 to 0.71)). There were two ongoing twin pregnancies in the expectant management group versus none in the IUI-OS group. Of 15 clinical pregnancies in the expectant management group three miscarried (20%), of 36 clinical pregnancies in the IUI-OS group seven miscarried (19.4%) (RR 1.03 (95% CI 0.31 to 3.45)). For the outcome ongoing pregnancy, the hazard ratio for expectant management versus IUI-OS was 0.34 (95%CI 0.18 to 0.67). Limitations, reasons for caution Our trial did not reach the planned sample size and therefore the results are limited by the number of participants. As 8 women are still pregnant, in this abstract we report ongoing pregnancy rates. Live birth rates will be presented at the conference. Wider implications of the findings: In couples with unexplained subfertility and a poor prognosis for natural conception, expectant management is inferior to IUI-OS. We advise the basic work-up for subfertility to contain a prognostic assessment, and when subfertility is unexplained and natural fertility prospects are poor IUI-OS should be the preferred treatment. Trial registration number NTR5599

The impact of increasing interbody fusion levels at the fractional curve on lordosis, curve correction, and complications in adult patients with scoliosis

2020 ◽  
pp. 1-10
Author(s):  
Dominic Amara ◽  
Praveen V. Mummaneni ◽  
Shane Burch ◽  
Vedat Deviren ◽  
Christopher P. Ames ◽  
...  
Keyword(s):  
Postoperative Complications ◽  
Revision Surgery ◽  
Lumbar Lordosis ◽  
Interbody Fusion ◽  
Pelvic Incidence ◽  
Secondary Analysis ◽  
Lumbar Interbody Fusion ◽  
Curve Correction ◽  
Surgery Rates

OBJECTIVERadiculopathy from the fractional curve, usually from L3 to S1, can create severe disability. However, treatment methods of the curve vary. The authors evaluated the effect of adding more levels of interbody fusion during treatment of the fractional curve.METHODSA single-institution retrospective review of adult patients treated for scoliosis between 2006 and 2016 was performed. Inclusion criteria were as follows: fractional curves from L3 to S1 > 10°, ipsilateral radicular symptoms concordant on the fractional curve concavity side, patients who underwent at least 1 interbody fusion at the level of the fractional curve, and a minimum 1-year follow-up. Primary outcomes included changes in fractional curve correction, lumbar lordosis change, pelvic incidence − lumbar lordosis mismatch change, scoliosis major curve correction, and rates of revision surgery and postoperative complications. Secondary analysis compared the same outcomes among patients undergoing posterior, anterior, and lateral approaches for their interbody fusion.RESULTSA total of 78 patients were included. There were no significant differences in age, sex, BMI, prior surgery, fractional curve degree, pelvic tilt, pelvic incidence, pelvic incidence − lumbar lordosis mismatch, sagittal vertical axis, coronal balance, scoliotic curve magnitude, proportion of patients undergoing an osteotomy, or average number of levels fused among the groups. The mean follow-up was 35.8 months (range 12–150 months). Patients undergoing more levels of interbody fusion had more fractional curve correction (7.4° vs 12.3° vs 12.1° for 1, 2, and 3 levels; p = 0.009); greater increase in lumbar lordosis (−1.8° vs 6.2° vs 13.7°, p = 0.003); and more scoliosis major curve correction (13.0° vs 13.7° vs 24.4°, p = 0.01). There were no statistically significant differences among the groups with regard to postoperative complications (overall rate 47.4%, p = 0.85) or need for revision surgery (overall rate 30.7%, p = 0.25). In the secondary analysis, patients undergoing anterior lumbar interbody fusion (ALIF) had a greater increase in lumbar lordosis (9.1° vs −0.87° for ALIF vs transforaminal lumbar interbody fusion [TLIF], p = 0.028), but also higher revision surgery rates unrelated to adjacent-segment pathology (25% vs 4.3%, p = 0.046). Higher ALIF revision surgery rates were driven by rod fracture in the majority (55%) of cases.CONCLUSIONSMore levels of interbody fusion resulted in increased lordosis, scoliosis curve correction, and fractional curve correction. However, additional levels of interbody fusion up to 3 levels did not result in more postoperative complications or morbidity. ALIF resulted in a greater lumbar lordosis increase than TLIF, but ALIF had higher revision surgery rates.

Obesity management through Ayurveda - A Case Study

2017 ◽  
Vol 2 (4) ◽  
Author(s):  
Dheeraj Kumar Tyagi ◽  
Shivakumar .
Keyword(s):  
Clinical Findings ◽  
Dietary Habit ◽  
Unhealthy Lifestyle ◽  
Lifestyle Management ◽  
Before And After ◽  
Effect Of Treatment ◽  
And Control

Lifestyle disorders are one of the biggest threats for the population living unhealthy lifestyle. Sthoulya (Obesity) is one such disorder which creates lot of physical as well as mental disorder to the sufferer. Due to changing lifestyle, comforts and dietary habit lots of individuals changed their life totally. Obesity is a growing disease in developed and developing countries. Prevalence is drastically hike in past few years. Ayurveda, the science of life with which we can manage and control lots of lifestyle disorders. Focusing on dietary and lifestyle management along with treatment, we can overcome the hazards of obesity which is growing in a uncontrolled manner. The available data is based on the clinical findings only. Aim and objective: To assess the effect of “Guru Cha Atarpanam Chikitsa” in the management of Sthoulya. Setting: Swastharakshana evam Yoga, OPD and IPD, SDMCAH, Hassan. Method: Udwarthana, Parisheka, Shamana Aushadhis, Ahara, and Vihara was followed within the treatment duration and effect of treatment was assessed before and after treatment, advised for follow up. Results: The treatment adopted is effective in the management of Sthoulya and to improve the quality of life.

scholarly journals THE RELATIONSHIP BETWEEN INFLAMMATORY DIETARY PATTERN AND INCIDENCE OF PERIODONTITIS

2021 ◽  
pp. 1-36
Author(s):  
Ahmed A. Alhassani ◽  
Frank B. Hu ◽  
Bernard A. Rosner ◽  
Fred K. Tabung ◽  
Walter C. Willett ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Periodontal Disease ◽  
Secondary Analysis ◽  
Hazard Ratio ◽  
Reduced Rank Regression ◽  
Rank Regression ◽  
Increased Risk ◽  
Cox Proportional Hazard Models ◽  
Study Population

ABSTRACT The long-term inflammatory impact of diet could potentially elevate the risk of periodontal disease through modification of systemic inflammation. The aim of the present study was to prospectively investigate the associations between a food based, reduced rank regression (RRR) derived, empirical dietary inflammatory pattern (EDIP) and incidence of periodontitis. The study population was composed of 34,940 men from the Health Professionals Follow-Up Study, who were free of periodontal disease and major illnesses at baseline (1986). Participants provided medical and dental history through mailed questionnaires every 2 years, and dietary data through validated semi-quantitative food frequency questionnaires every 4 years. We used Cox proportional hazard models to examine the associations between EDIP scores and validated self-reported incidence of periodontal disease over a 24-year follow-up period. No overall association between EDIP and the risk of periodontitis was observed; the hazard ratio comparing the highest EDIP quintile (most proinflammatory diet) to the lowest quintile was 0.99 (95% confidence interval: 0.89 -1.10, p-value for trend = 0.97). A secondary analysis showed that among obese non-smokers (i.e. never and former smokers at baseline), the hazard ratio for periodontitis comparing the highest EDIP quintile to the lowest was 1.39 (95% confidence interval: 0.98 -1.96, p-value for trend = 0.03). In conclusion, no overall association was detected between EDIP and incidence of self-reported periodontitis in the study population. From the subgroups evaluated EDIP was significantly associated with increased risk of periodontitis only among nonsmokers who were obese. Hence, this association must be interpreted with caution.

scholarly journals Design of a prospective follow-up study on early parenthood and smoking behaviour during pregnancy in Finnish primary healthcare

2021 ◽  
pp. 140349482110224
Author(s):  
Mikael O. Ekblad ◽  
Hanna P. Wallin ◽  
Marjukka Pajulo ◽  
Päivi E. Korhonen
Keyword(s):  
Pregnant Women ◽  
Study Design ◽  
Primary Healthcare ◽  
Routine Data ◽  
Smoking Behaviour ◽  
Self Report ◽  
Health Clinic ◽  
Follow Up Study ◽  
Study Population

Aims: The primary aim of the study is to explore different factors affecting parents’ smoking behaviour, and especially how smoking may be connected with individual differences in the psychological process of becoming a parent. In the current paper, we present the study design together with basic information on the study population. Methods: The Central Satakunta Maternity and Child Health Clinic (KESALATU) Study is an ongoing prospective follow-up study in primary healthcare of the Satakunta region of southwest Finland. Families were recruited during their first maternity clinic visit between 1 September 2016 and 31 December 2019, and participation will continue until the child is 1.5 years of age. The study combines different sources and types of data: e.g. routine data obtained from primary healthcare clinic records, specific parental self-report data and data from a new exhaled carbon monoxide meter indicating maternal smoking. The data are collected using frequently repeated assessments both during pregnancy and postnatally. The methods cover the following areas of interest: family background factors (including smoking and alcohol use), self-reported parental–foetal/infant attachment and mentalization, self-reported stress, depression and quality of life. Results: 589 pregnant women and their partners were asked to participate in the study during the collection time period. The final study population consisted of 248 (42.1%) pregnant women and 160 (27.1%) partners. Conclusions: The new methods and study design have the potential to increase our understanding about the link between early parenting psychology, prenatal psychosocial risk factors and parental health behaviour.

scholarly journals Using Ultrasound and Inflammation to Improve Prediction of Ischemic Stroke: A Secondary Analysis of the Multi-Ethnic Study of Atherosclerosis

2021 ◽  
pp. 37-43
Author(s):  
Hediyeh Baradaran ◽  
Alen Delic ◽  
Ka-Ho Wong ◽  
Nazanin Sheibani ◽  
Matthew Alexander ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Goodness Of Fit ◽  
Primary Outcome ◽  
Stroke Risk ◽  
Secondary Analysis ◽  
Predictor Variables ◽  
Baseline Model ◽  
Fit Statistics ◽  
Ischemic Stroke Risk

Introduction: Current ischemic stroke risk prediction is primarily based on clinical factors, rather than imaging or laboratory markers. We examined the relationship between baseline ultrasound and inflammation measurements and subsequent primary ischemic stroke risk. Methods: In this secondary analysis of the Multi-Ethnic Study of Atherosclerosis (MESA), the primary outcome is the incident ischemic stroke during follow-up. The predictor variables are 9 carotid ultrasound-derived measurements and 6 serum inflammation measurements from the baseline study visit. We fit Cox regression models to the outcome of ischemic stroke. The baseline model included patient age, hypertension, diabetes, total cholesterol, smoking, and systolic blood pressure. Goodness-of-fit statistics were assessed to compare the baseline model to a model with ultrasound and inflammation predictor variables that remained significant when added to the baseline model. Results: We included 5,918 participants. The primary outcome of ischemic stroke was seen in 105 patients with a mean follow-up time of 7.7 years. In the Cox models, we found that carotid distensibility (CD), carotid stenosis (CS), and serum interleukin-6 (IL-6) were associated with incident stroke. Adding tertiles of CD, IL-6, and categories of CS to a baseline model that included traditional clinical vascular risk factors resulted in a better model fit than traditional risk factors alone as indicated by goodness-of-fit statistics. Conclusions: In a multiethnic cohort of patients without cerebrovascular disease at baseline, we found that CD, CS, and IL-6 helped predict the occurrence of primary ischemic stroke. Future research could evaluate if these basic ultrasound and serum measurements have implications for primary prevention efforts or clinical trial inclusion criteria.

scholarly journals Pharmacokinetic-pharmacodynamic modelling of atazanavir in hair among adolescents on antiretroviral treatment in Zimbabwe

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Bernard Ngara ◽  
Simbarashe Zvada ◽  
Tariro Dianah Chawana ◽  
Charles Fungai Brian Nhachi ◽  
Simbarashe Rusakaniko
Keyword(s):  
Viral Load ◽  
Secondary Analysis ◽  
Maximal Effect ◽  
Viral Load Suppression ◽  
Regression Methods ◽  
Pharmacodynamic Modelling ◽  
Pkpd Model ◽  
Drug Potency ◽  
Adherence Monitoring

Abstract Background Drug potency is a pharmacological parameter defining dose or concentration of drug required to obtain 50% of the drug’s maximal effect. Pharmacokinetic-pharmacodynamic modelling and simulation allows estimation of potency and evaluate strategies improving treatment outcome. The objective of our study is to determine potency of atazanavir in hair, defined as atazanavir level in hair associated with 50% probability of failing to achieve viral load below 1000 copies/ml among adolescents, and explore the effect of participant specific variables on potency. Methods A secondary analysis was performed on data from a previous study conducted in HIV-infected adolescents failing 2nd line ART from Harare central hospital, Zimbabwe, between 2015 and 2016. We simulated atazanavir concentrations in hair using NONMEM (version 7.3) ADVAN 13, based on a previously established pharmacokinetic model. Logistic regression methods were used for PKPD analysis. Simulations utilising PKPD model focused on estimation of potency and exploring the effect of covariates. Results The potency of atazanavir in hair was found to be 4.5 ng/mg hair before adjusting for covariate effects. Participants at three months follow-up, reporting adequate adherence, having normal BMI-for-age, and cared for by mature guardians had increased potency of atazanavir in hair of 2.6 ng/mg, however the follow-up event was the only statistically significant factor at 5% level. Conclusion Atazanavir in hair in the range 2.6 to 4.5 ng/mg is associated with above 50% probability of early viral load suppression. Adherence monitoring to adolescents with lower potency of atazanavir is recommended. The effect self-reported adherence level, BMI-for-age, and caregiver status require further evaluation.

Customised gold weight eyelid implantation in paralytic lagophthalmos

2008 ◽  
Vol 122 (10) ◽  
pp. 1088-1091 ◽  
Author(s):  
N Jayashankar ◽  
K P Morwani ◽  
M J Shaan ◽  
S R Bhatia ◽  
K T Patil
Keyword(s):  
Visual Acuity ◽  
Prospective Study ◽  
Study Design ◽  
Study Group ◽  
Upper Eyelid ◽  
Eyelid Closure ◽  
Gold Weight ◽  
One Year ◽  
A Prospective Study

AbstractGold eyelid implantation is widely considered the procedure of choice to reanimate the upper eyelid in paralytic lagophthalmos. Commercially supplied implants are not readily available in all places and are sometimes cumbersome to import.Objective:We aimed to devise a method whereby every surgeon performing gold eyelid implantation could have easy and quick access to the implant. Furthermore, we aimed to develop a means of creating an implant of the exact weight required for complete eyelid closure.Study design and setting:A prospective study was performed from 1997 to 2005 in a tertiary research hospital, involving 50 subjects requiring gold upper eyelid implantation and using the technique in question.Results:Only patients with a minimum follow up of one year were included in the study group. Symptoms improved in 96 per cent of subjects, who were able to dispense with eyedrops and eye ointments. Visual acuity improved in 92 per cent of patients. There were two extrusions amongst the early cases.Conclusion and significance:Customised gold eyelid implantation offers an alternative in regions where commercial implants are not easily obtained.

The Definition, Diagnosis, and Management of Growth-Discordant Twins: An International Census Survey

1991 ◽  
Vol 40 (3-4) ◽  
pp. 345-351 ◽  
Author(s):  
I. Blickstein
Keyword(s):  
Stress Testing ◽  
Expectant Management ◽  
Doppler Velocimetry ◽  
Diagnosis And Management ◽  
Clear Cut ◽  
Biophysical Profile ◽  
Per Se ◽  
Discordant Twins ◽  
Discordant Twin

AbstractIn order to establish a protocol considering the definition, diagnosis, and management of growth-discordant twin gestations, a questionnaire was sent to 96 authors of twin-related obstetric articles. The views of the 61 responders comprise this international census survey. The data suggest that a clear cut-off value for discordancy is still needed; however, the data indirectly supported a two-grade definition, namely, mild (> 15% and < 25% birth-weight disparity) and severe (> 25%) growth discordants. Expectant management was advocated by the majority of participants with out-patient follow-up for mild discordants, while severe discordants may preferably be hospitalized. Follow-up should be done by non-stress testing (daily - 2/wk), biophysical profile (1-2/wk), Doppler velocimetry (1/wk - bi-weekly) and sonographic biometry (bi-weekly). The opinions considering termination of pregnancy because of intertwin growth discordancy were divided; however, discordancy per se, was not considered an indication for cesarean delivery. An adapted management flowchart that summarizes the survey's data is presented and may be used as a standard for future investigations.

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