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1.
Hum Reprod ; 36(4): 1007-1020, 2021 03 18.
Article in English | MEDLINE | ID: mdl-33534895

ABSTRACT

STUDY QUESTION: Does a single oral dose of nolasiban 900 mg administered 4 h before embryo transfer (ET) increase pregnancy rates in women undergoing IVF? SUMMARY ANSWER: In an individual patient data (IPD) meta-analysis of three clinical trials, a single oral dose of nolasiban 900 mg was associated with an increased ongoing pregnancy rate of an absolute 5% (relative 15%). WHAT IS KNOWN ALREADY: Several clinical studies have shown that blocking activation of oxytocin receptors by an oxytocin receptor (OTR) antagonist has the potential to decrease uterine contractions, increase endometrial perfusion and enhance endometrial decidualisation and other parameters of endometrial receptivity. It has been hypothesised that antagonism of oxytocin receptors could improve the likelihood of successful embryo implantation and thus increase pregnancy and live birth rates following ET. STUDY DESIGN, SIZE, DURATION: This is an analysis of three randomised, double-blind, placebo-controlled trials, which randomised 1836 subjects between 2015 and 2019. We describe the results of a meta-analysis of individual participant data (IPD) from all three trials and the pre-specified analyses of each individual trial. PARTICIPANT/MATERIAL, SETTING, METHODS: Participants were patients undergoing ET following IVF/ICSI in 60 fertility centres in 11 European countries. Study subjects were below 38 years old and had no more than one previously failed cycle. They were randomised to a single oral dose of nolasiban 900 mg (n = 846) or placebo (n = 864). In IMPLANT 1, additional participants were also randomised to nolasiban 100 mg (n = 62) or 300 mg (n = 60). Fresh ET of one good quality embryo (except in IMPLANT 1 where transfer of two embryos was allowed) was performed on Day 3 or Day 5 after oocyte retrieval, approximately 4 h after receiving the study treatment. Serum hCG levels were collected at 14 days post oocyte retrieval (Week 2) and for women with a positive hCG result, ultrasound was performed at Week 6 post-ET (clinical pregnancy) and at Week 10 post-ET (ongoing pregnancy). Pregnant patients were followed for maternal (adverse events), obstetric (live birth, gestational age at delivery, type of delivery, incidence of twins) and neonatal (sex, weight, height, head circumference, Apgar scores, congenital anomalies, breast feeding, admission to intensive care and specific morbidities e.g. jaundice, respiratory distress syndrome) outcomes. MAIN RESULTS AND THE ROLE OF CHANCE: In an IPD meta-analysis of the clinical trials, a single oral dose of nolasiban 900 mg was associated with an absolute increase of 5.0% (95% CI 0.5, 9.6) in ongoing pregnancy rate and a corresponding increase of 4.4% (95% CI -0.10, 8.93) in live birth rate compared to placebo. Similar magnitude increases were observed for D3 or D5 transfers but were not significantly different from the placebo. Population pharmacokinetics (PK) demonstrated a correlation between higher exposures and pregnancy. LIMITATIONS, REASON FOR CAUTION: The meta-analysis was not a pre-specified analysis. While the individual trials did not show a consistent significant effect, they were not powered based on an absolute increase of 5% in ongoing pregnancy rate. Only a single dose of up to 900 mg nolasiban was administered in the clinical trials; higher doses or extended regimens have not been tested. Only fresh ET has been assessed in the clinical trials to date. WIDER IMPLICATIONS OF THE FINDINGS: The finding support the hypothesis that oxytocin receptor antagonism at the time of ET can increase pregnancy rates following IVF. The overall clinical and population PK data support future evaluation of higher doses and/or alternate regimens of nolasiban in women undergoing ET following IVF. STUDY FUNDING/COMPETING INTERESTS: The trials were designed, conducted and funded by ObsEva SA. A.H., O.P., E.G., E.L. are employees and stockholders of ObsEva SA. E.L. is a board member of ObsEva SA. G.G. reports honoraria and/or non-financial support from ObsEva, Merck, MSD, Ferring, Abbott, Gedeon-Richter, Theramex, Guerbet, Finox, Biosilu, Preglem and ReprodWissen GmbH. C.B. reports grants and honoraria from ObsEva, Ferring, Abbott, Gedeon Richter and MSD. P.P. reports consulting fees from ObsEva. H.T. reports grants and or fees from ObsEva, Research Fund of Flanders, Cook, MSD, Roche, Gedeon Richter, Abbott, Theramex and Ferring. H.V. reports grants from ObsEva and non-financial support from Ferring. P.T. is an employee of Cytel Inc., who provides statistical services to ObsEva. J.D. reports consulting fees and other payments from ObsEva and, Scientific Advisory Board membership of ObsEva. TRIAL REGISTRATION NUMBERS: ClinicalTrials.gov: NCT02310802, NCT03081208, NCT03758885. TRIAL REGISTRATION DATES: December 2014 (NCT02310802), March 2017 (NCT03081208), November 2018 (NCT03758885). FIRST PATIENT'S ENROLMENT: January 2015 (NCT02310802), March 2017 (NCT03081208), November 2018 (NCT03758885).


Subject(s)
Receptors, Oxytocin , Sperm Injections, Intracytoplasmic , Adult , Embryo Transfer , Europe , Female , Fertilization in Vitro , Humans , Infant, Newborn , Oximes , Oxytocin , Pregnancy , Pregnancy Rate , Pyrrolidines , Randomized Controlled Trials as Topic
2.
Spinal Cord ; 55(4): 331-340, 2017 Apr.
Article in English | MEDLINE | ID: mdl-27845358

ABSTRACT

STUDY DESIGN: In 2014, the adult spinal cord injury (SCI) common data element (CDE) recommendations were made available. This project was a review of the adult SCI CDE for relevance to children and youth with SCI. OBJECTIVES: The objective of this study was to review the National Institute of Neurologic Disorders and Stroke (NINDS) adult SCI CDEs for relevance to children and youth with SCI. SETTING: International. METHODS: The pediatric working group consisted of international members with varied fields of expertise related to pediatric SCI. The group convened biweekly meetings for 6 months in 2015. All of the adult SCI CDEs were reviewed, evaluated and modified/created for four age groups: 0-5 years, 6-12 years, 13-15 years and 16-18 years. Whenever possible, results of published research studies were used to guide recommendations. In the absence of empirical support, grey literature and international content expert consensus were garnered. Existing pediatric NINDS CDEs and new CDEs were developed in areas where adult recommendations were not appropriate. After internal working group review of domain recommendations, these pediatric CDEs were vetted during a public review from November through December 2015. RESULTS: Version 1.0 of the pediatric SCI CDEs was posted in February 2016. CONCLUSION: The pediatric SCI CDEs are incorporated directly into the NINDS SCI CDE sets and can be found at https://commondataelements.ninds.nih.gov.


Subject(s)
Common Data Elements , Spinal Cord Injuries , Adolescent , Child , Child, Preschool , Humans , Infant , Infant, Newborn , National Institute of Neurological Disorders and Stroke (U.S.) , Spinal Cord Injuries/diagnosis , Spinal Cord Injuries/epidemiology , Spinal Cord Injuries/therapy , United States
4.
Acta Psychiatr Scand ; 129(6): 427-36, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24237622

ABSTRACT

OBJECTIVE: To develop an understanding of the stability of mental health during imprisonment through review of existing research evidence relating physical prison environment to mental state changes in prisoners. METHOD: A systematic literature search was conducted looking at changes in mental state and how this related to various aspects of imprisonment and the prison environment. RESULTS: Fifteen longitudinal studies were found, and from these, three broad themes were delineated: being imprisoned and aspects of the prison regime; stage of imprisonment and duration of sentence; and social density. Reception into prison results in higher levels of psychiatric symptoms that seem to improve over time; otherwise, duration of imprisonment appears to have no significant impact on mental health. Regardless of social density, larger prisons are associated with poorer mental state, as are extremes of social density. CONCLUSION: There are large gaps in the literature relating prison environments to changes in mental state; in particular, high-quality longitudinal studies are needed. Existing research suggests that although entry to prison may be associated with deterioration in mental state, it tends to improve with time. Furthermore, overcrowding, ever more likely as prison populations rise, is likely to place a particular burden on mental health services.


Subject(s)
Mental Disorders/psychology , Prisoners/psychology , Social Environment , Humans
5.
J Appl Microbiol ; 117(2): 417-29, 2014 Aug.
Article in English | MEDLINE | ID: mdl-24833433

ABSTRACT

AIMS: To determine whether poultry litter marker gene LA35 is correlated with pathogens and fecal indicator bacteria (FIB) in run-off from poultry litter-amended plots. METHODS AND RESULTS: A rainfall simulator with various vegetative filter strip lengths was employed to evaluate the correlation of a microbial source tracking (MST) marker for poultry feces/litter (the 16S rRNA gene of Brevibacterium sp. LA35 [LA35] measured by quantitative PCR) with pathogens and FIB in run-off. LA35 was correlated with Staphylococcus aureus, Escherichia coli, Enterococcus spp. and Bacteroidales levels. Salmonella was present at low concentration in litter, but became undetectable by qPCR in run-off. Escherichia coli, LA35 and Staph. aureus exhibited mass-based first flush behaviour in the run-off. CONCLUSIONS: Correlation of LA35 with FIB and pathogens in run-off from poultry litter-amended fields suggest comparable transport mechanisms and that LA35 is a useful tracer for harmful bacteria in the environment released from poultry litter. SIGNIFICANCE AND IMPACT OF THE STUDY: To protect human health, an effective marker for poultry fecal contamination should exhibit similar fate and transport characteristics compared to pathogens. This study is among the first to demonstrate such a relationship in run-off for a MST marker.


Subject(s)
Bacteria/isolation & purification , Genes, Bacterial , Poultry/microbiology , Animals , Bacteroidetes/genetics , Bacteroidetes/isolation & purification , Brevibacterium/genetics , Brevibacterium/isolation & purification , Enterococcus/genetics , Enterococcus/isolation & purification , Escherichia coli/genetics , Escherichia coli/isolation & purification , Feces/microbiology , Genetic Markers , RNA, Ribosomal, 16S/genetics , Rain , Salmonella/genetics , Salmonella/isolation & purification , Soil Microbiology , Staphylococcus aureus/genetics , Staphylococcus aureus/isolation & purification , Water Microbiology
6.
Nat Plants ; 10(3): 402-411, 2024 03.
Article in English | MEDLINE | ID: mdl-38388675

ABSTRACT

Trait prioritization studies have guided research, development and investment decisions for public-sector crop breeding programmes since the 1970s, but the research design, methods and tools underpinning these studies are not well understood. We used PRISMA-ScR (Preferred Reporting Items for Systematic review and Meta-Analysis Protocols) to evaluate research on trait ranking for major crops over the past 40 years (1980-2023). Data extraction and descriptive analysis on 657 papers show uneven attention to crops, lack of systematic sex disaggregation and regional bias. The lack of standardized trait data taxonomy across studies, and inconsistent research design and data collection practices make cross-comparison of findings impossible. In addition, network mapping of authors and donors shows patterns of concentration and the presence of silos within research areas. This study contributes to the next generation of innovation in trait preference studies to produce more inclusive, demand-driven varietal design that moves beyond trait prioritization focused on productivity and yield.


Subject(s)
Crops, Agricultural , Plant Breeding , Systematic Reviews as Topic , Meta-Analysis as Topic , Bias , Phenotype , Crops, Agricultural/genetics
7.
J Pharm Policy Pract ; 14(1): 73, 2021 Aug 31.
Article in English | MEDLINE | ID: mdl-34465394

ABSTRACT

BACKGROUND: One in four people experience a mental health problem every year and improving mental health care is an international priority. In the course of their work, pharmacists frequently encounter people with mental health problems. The experience of mental health teaching, including Mental Health First Aid (MHFA) training, in undergraduate pharmacy (MPharm) students in the UK and Ireland is not well documented. Students' viewpoints, contextualised with curricular overviews provided by staff, were analysed to understand their experience. METHODS: An anonymous, online questionnaire was distributed to MPharm students and staff in the UK and Ireland. Students were asked closed questions regarding their course and exposure to MHFA, which were analysed using descriptive statistics. Open questions were included to enable explanations and these data were used to contextualise the quantitative findings. One member of staff from each university was invited to answer a modified staff version of the questionnaire, to provide a curriculum overview and staff perspective. RESULTS: 232 students and 13 staff, from 22 universities, responded. Three-quarters of students did not agree with the statement that 'mental health was embedded throughout the MPharm'. Most students (80.6%) stated that they were taught neuropharmacology whilst 44.8% stated that their course included communicating with people about their mental health. One-third (33.2%) of students stated that their degree 'adequately prepared them to help people with their mental health'. Twenty-six students (11.6%) had completed MHFA training of which 89% would endorse inclusion of this within the MPharm. Of those who had not completed the training, 81% expressed a desire to do so. Those who completed MHFA training self-reported greater preparedness than those who did not, but student numbers were small. CONCLUSIONS: Mental health teaching for pharmacy undergraduates is more focussed on theoretical aspects rather than applied skills. MHFA was viewed by students as one way to enhance skill application. The association of the increased self-reported preparedness of those who completed MHFA could be confounded by a positive environmental cultural. MPharm programmes need sufficient focus on real-world skills such as communication and crisis response, to complement the fundamental science.

8.
Br J Cancer ; 102(3): 577-82, 2010 Feb 02.
Article in English | MEDLINE | ID: mdl-20051949

ABSTRACT

BACKGROUND: Enzyme-linked immunoassays of full-length (M65) and/or caspase-cleaved (M30) cytokeratin 18 (CK18) released from epithelial cells undergoing necrosis and/or apoptosis, respectively, may have prognostic or predictive biomarker utility in a range of solid tumour types. Characterisation of baseline levels of circulating full length and cleaved CK18 specifically in patients with pancreatic cancer. METHODS: Plasma samples from 103 patients with pancreatic cancer stored at -80 degrees C were assayed for M65 and M30 levels. The median (inter-quartile range (IQR)) duration of plasma storage was 34 (23-57) months. Patients with metastatic disease (n=19) were found to have greater median (IQR) M65 levels (1145 (739-1698) U l(-1)) compared with the locally advanced (n=20; 748 (406-1150) U l(-1)) and resected (n=64; 612 (331-987) U l(-1)) patients (P=0.002). Elevated M65 levels were associated with poorer overall survival on univariate (P<0.001) but not multivariate (P=0.202) analysis. M65 concentrations also exhibited significant associations with concurrent serum-bilirubin levels (P<0.001) and the duration of plasma storage (P<0.001). CONCLUSIONS: Baseline plasma CK18 levels in pancreatic cancer are affected by the presence of obstructive jaundice and prolonged plasma storage. Clinical biomarker studies utilising serial CK18 levels are warranted in pancreatic cancer, provided consideration is given to these potentially confounding factors.


Subject(s)
Biomarkers, Tumor/blood , Keratin-18/blood , Pancreatic Neoplasms/diagnosis , Aged , Apoptosis , CA-19-9 Antigen/blood , Enzyme-Linked Immunosorbent Assay , Female , Humans , Male , Middle Aged , Necrosis , Pancreatic Neoplasms/blood , Pancreatic Neoplasms/mortality
9.
Protein Sci ; 10(3): 560-71, 2001 Mar.
Article in English | MEDLINE | ID: mdl-11344324

ABSTRACT

The DNA-repair protein XPA is required to recognize a wide variety of bulky lesions during nucleotide excision repair. Independent NMR solution structures of a human XPA fragment comprising approximately 40% of the full-length protein, the minimal DNA-binding domain, revealed that one-third of this molecule was disordered. To better characterize structural features of full-length XPA, we performed time-resolved trypsin proteolysis on active recombinant Xenopus XPA (xXPA). The resulting proteolytic fragments were analyzed by electrospray ionization interface coupled to a Fourier transform ion cyclotron resonance mass spectrometry and SDS-PAGE. The molecular weight of the full-length xXPA determined by mass spectrometry (30922.02 daltons) was consistent with that calculated from the sequence (30922.45 daltons). Moreover, the mass spectrometric data allowed the assignment of multiple xXPA fragments not resolvable by SDS-PAGE. The neural network program Predictor of Natural Disordered Regions (PONDR) applied to xXPA predicted extended disordered N- and C-terminal regions with an ordered internal core. This prediction agreed with our partial proteolysis results, thereby indicating that disorder in XPA shares sequence features with other well-characterized intrinsically unstructured proteins. Trypsin cleavages at 30 of the possible 48 sites were detected and no cleavage was observed in an internal region (Q85-I179) despite 14 possible cut sites. For the full-length xXPA, there was strong agreement among PONDR, partial proteolysis data, and the NMR structure for the corresponding XPA fragment.


Subject(s)
DNA Repair/physiology , DNA-Binding Proteins/chemistry , DNA-Binding Proteins/physiology , Amino Acid Motifs/genetics , Amino Acid Motifs/physiology , Amino Acid Sequence , Animals , Electrophoresis, Polyacrylamide Gel , Hydrolysis , Neural Networks, Computer , Protein Structure, Secondary , Spectrometry, Mass, Electrospray Ionization , Spectroscopy, Fourier Transform Infrared , Trypsin , Xenopus laevis , Xeroderma Pigmentosum Group A Protein
10.
Clin Ther ; 20(4): 744-59, 1998.
Article in English | MEDLINE | ID: mdl-9737834

ABSTRACT

A multicenter, open-label prospective trial was performed to determine the clinical and microbiologic efficacy of ofloxacin (OFLX) otic solution in the treatment of subjects > or =12 years with chronic suppurative otitis media (CSOM) and a chronically perforated tympanic membrane in the infected ear(s). A total of 207 patients at 27 centers in the United States and Central America received OFLX 0.5 mL instilled ototopically twice daily for 14 consecutive days. The primary clinical end point was cure (dry ear) or failure (not dry ear). The primary microbiologic end point was eradication of baseline pathogens. Because there was no comparator and there were few data in the literature regarding clinical efficacy in patients treated with other regimens, the efficacy of OFLX was compared with data recorded in the clinical records of historical-practice control (HPC) or current-practice control (CPC) subjects. The incidence of clinical cure in clinically evaluable OFLX-treated patients (91%; 148 of 162 subjects) was significantly higher than in HPC subjects (67%; 124 of 185 subjects) or CPC subjects (70%; 38 of 54 subjects). OFLX eradicated all baseline pathogens isolated in microbiologically evaluable subjects. These pathogens were predominantly Staphylococcus aureus, Pseudomonas aeruginosa, and Proteus mirabilis. The most common treatment-related adverse event, bitter taste, occurred in 17% (35 of 207) of OFLX-treated subjects. Thus OFLX 0.5 mL administered twice daily for 14 days was effective in resolving the signs and symptoms of CSOM in subjects > or =12 years, was significantly more effective than therapies used to treat HPC or CPC subjects, and was well tolerated.


Subject(s)
Anti-Infective Agents/therapeutic use , Ofloxacin/therapeutic use , Otitis Media, Suppurative/drug therapy , Adolescent , Adult , Aged , Anti-Infective Agents/adverse effects , Child , Chronic Disease , Female , Humans , Male , Middle Aged , Ofloxacin/adverse effects , Otitis Media, Suppurative/microbiology , Patient Compliance , Prospective Studies , Retrospective Studies
11.
J Mol Graph Model ; 19(1): 26-59, 2001.
Article in English | MEDLINE | ID: mdl-11381529

ABSTRACT

Proteins can exist in a trinity of structures: the ordered state, the molten globule, and the random coil. The five following examples suggest that native protein structure can correspond to any of the three states (not just the ordered state) and that protein function can arise from any of the three states and their transitions. (1) In a process that likely mimics infection, fd phage converts from the ordered into the disordered molten globular state. (2) Nucleosome hyperacetylation is crucial to DNA replication and transcription; this chemical modification greatly increases the net negative charge of the nucleosome core particle. We propose that the increased charge imbalance promotes its conversion to a much less rigid form. (3) Clusterin contains an ordered domain and also a native molten globular region. The molten globular domain likely functions as a proteinaceous detergent for cell remodeling and removal of apoptotic debris. (4) In a critical signaling event, a helix in calcineurin becomes bound and surrounded by calmodulin, thereby turning on calcineurin's serine/threonine phosphatase activity. Locating the calcineurin helix within a region of disorder is essential for enabling calmodulin to surround its target upon binding. (5) Calsequestrin regulates calcium levels in the sarcoplasmic reticulum by binding approximately 50 ions/molecule. Disordered polyanion tails at the carboxy terminus bind many of these calcium ions, perhaps without adopting a unique structure. In addition to these examples, we will discuss 16 more proteins with native disorder. These disordered regions include molecular recognition domains, protein folding inhibitors, flexible linkers, entropic springs, entropic clocks, and entropic bristles. Motivated by such examples of intrinsic disorder, we are studying the relationships between amino acid sequence and order/disorder, and from this information we are predicting intrinsic order/disorder from amino acid sequence. The sequence-structure relationships indicate that disorder is an encoded property, and the predictions strongly suggest that proteins in nature are much richer in intrinsic disorder than are those in the Protein Data Bank. Recent predictions on 29 genomes indicate that proteins from eucaryotes apparently have more intrinsic disorder than those from either bacteria or archaea, with typically > 30% of eucaryotic proteins having disordered regions of length > or = 50 consecutive residues.


Subject(s)
Protein Conformation , Proteins/chemistry , Proteins/physiology , Models, Molecular , Protein Folding , Protein Structure, Tertiary , Proteins/genetics , Structure-Activity Relationship
12.
Med Sci Sports Exerc ; 29(10): 1318-24, 1997 Oct.
Article in English | MEDLINE | ID: mdl-9346162

ABSTRACT

This randomized, double-blind, placebo-controlled study was designed to determine the influence of carbohydrate supplementation on the natural killer cell response to 2.5 h of high-intensity running (76.7 +/- 0.4% VO2max). Thirty experienced marathon runners (VO2max 53.4 +/- 1.0 mL x kg[-1] x min[-1], age 41.5 +/- 1.4 yr) were randomized into carbohydrate supplement (N = 17) and placebo (N = 13) groups. Subjects rested for 10-15 min before a blood sample at 0715, and then ingested 0.75 L of carbohydrate beverage (Gatorade) or placebo. At 0730, subjects began running at 75-80% VO2max for 2.5 h and drank 0.25 L of carbohydrate or placebo fluid every 15 min. Immediately after the 2.5 h run (1000), another blood sample was taken, followed by 1.5 h, 3 h, and 6-h recovery samples. Carbohydrate supplementation versus placebo had a significant effect on the pattern of change in glucose, cortisol, and the blood concentration of natural killer cells ([F (4,25) = 3.79, P = 0.015], but not natural killer cell activity following 2.5 h of intensive running.


Subject(s)
Dietary Carbohydrates/pharmacology , Killer Cells, Natural/drug effects , Running/physiology , Adult , Analysis of Variance , Blood Glucose/metabolism , Catecholamines/blood , Dietary Carbohydrates/administration & dosage , Double-Blind Method , Female , Humans , Hydrocortisone/blood , Killer Cells, Natural/immunology , Male , Middle Aged , Placebos
13.
Arch Otolaryngol Head Neck Surg ; 125(5): 537-45, 1999 May.
Article in English | MEDLINE | ID: mdl-10326811

ABSTRACT

OBJECTIVE: To determine the safety and efficacy of ofloxacin otic solution in the treatment of acute otorrhea in children with tympanostomy tubes. DESIGN: Multicenter study with an open-label, prospective ofloxacin arm and retrospective historical and current practice arms. SETTING: Ear, nose, and throat pediatric and general practice clinics and office-based practices. SUBJECTS: Children younger than 12 years with acute purulent otorrhea of presumed bacterial origin and tympanostomy tubes. INTERVENTION: Instillation of 0.3% ofloxacin, 0.25 mL, twice daily for 10 days in the prospective arm; review of medical records in the retrospective arms. MAIN OUTCOME MEASURES: The primary index of clinical efficacy was absence (cure) or presence (failure) of otorrhea at 10 to 14 days after therapy. The primary index of microbiologic efficacy (in the ofloxacin arm only) was eradication of pathogens isolated at baseline. Safety was evaluated in the ofloxacin arm only. RESULTS: Significantly more clinically evaluable ofloxacin-treated subjects were cured (84.4%; 119/141) than were historical practice subjects (64.2%; 140/218) (P< or =.001) or current practice subjects (70%; 33/47) (P< or =.03). All baseline pathogens were eradicated in 103 (96.3%) of 107 microbiologically evaluable ofloxacin subjects. Adverse events considered "possibly" or "probably" treatment related occurred in 29 (12.8%) of 226 ofloxacin-treated subjects. CONCLUSION: Ofloxacin is safe and significantly more effective than treatments used in historical or current practice for acute purulent otorrhea in children with tympanostomy tubes.


Subject(s)
Anti-Infective Agents/therapeutic use , Ofloxacin , Ofloxacin/therapeutic use , Otitis Media with Effusion/drug therapy , Tympanoplasty , Administration, Topical , Adolescent , Anti-Infective Agents/administration & dosage , Child , Child, Preschool , Female , Humans , Infant , Male , Ofloxacin/administration & dosage , Prospective Studies , Retrospective Studies , Treatment Outcome
14.
Aust N Z J Public Health ; 22(1): 115-9, 1998 Feb.
Article in English | MEDLINE | ID: mdl-9599862

ABSTRACT

Evaluation of the North Coast Stay on Your Feet falls prevention program is described as a case study of a comprehensive evaluation design for multi-strategic community interventions. Qualitative and quantitative methods were used to evaluate the program at formative, process and outcome levels. Formative evaluation used literature review, focus groups, mail-out and telephone survey methods to gather evidence from publications, older people, health workers, local business, media and government bodies. It included an analysis of demographic and hospital databases and identified incidence, causal pathways, knowledge, attitudes, behaviour, consequences and effectiveness of potential strategies. Process evaluation employed auditing, monitoring and telephone surveys to maintain an inventory of intervention activities and to track the reach of the program. Outcome evaluation involved a longitudinal study of intervention and control cohorts, surveyed before, during and after the intervention by telephone to monitor changes in knowledge, attitudes, risk and falls incidence. The survey instrument was designed for both formative and outcome evaluation, and analysis reflected the research design by incorporating repeat measures and adjusting for bias and confounding. Outcome validity was cross-checked via hospital admission rates. A novel, integrated framework for presenting inputs, activities and outcomes from all stages of the program is described. This framework facilitated feedback to stakeholders and enabled subsequent rapid adjustment of the intervention. Rigorous evaluation combined with clear presentation of findings helped to engender intersectoral support and obtain funding grants for extended implementation and evaluation. It also helped Stay on Your Feet to become a model for other falls prevention programs within Australia and internationally.


Subject(s)
Accidental Falls/prevention & control , Health Promotion/organization & administration , Program Development/methods , Program Evaluation/methods , Adult , Aged , Australia , Case-Control Studies , Female , Health Knowledge, Attitudes, Practice , Humans , Longitudinal Studies , Male , Middle Aged , Outcome Assessment, Health Care , Risk Factors , Surveys and Questionnaires
15.
Fam Med ; 18(5): 293-5, 1986.
Article in English | MEDLINE | ID: mdl-3556881

ABSTRACT

Many patients have questions or concerns about sex, but few talk directly about the subject with their physician. Including a sexual history during the physician-patient encounter is one way to indicate to the patient that discussing sexual concerns is appropriate. We observed that physicians at the University of Iowa Family Practice Center were divided into two groups: those who routinely include a sexual history with a new patient and those who do not. Those physicians who claimed to routinely take a sexual history reported 33.3% of their patients had some type of sexual question, concern, or problem; those who claimed they do not include such a history reported only 9.5% had a sexual concern (P less than 0.05). Female physicians were less apt to take a sexual history than male physicians (11.8% v. 60%; P less than 0.001). We conclude that education in sexual history taking is an important part of the family practice curriculum for resident training.


Subject(s)
Medical History Taking , Sexual Dysfunction, Physiological/diagnosis , Family Practice , Female , Humans , Male , Physician-Patient Relations , Sexual Behavior
16.
Otolaryngol Clin North Am ; 20(4): 853-76, 1987 Nov.
Article in English | MEDLINE | ID: mdl-3320872

ABSTRACT

This article has overviewed complications of rhinoplasty. Generally, these complications fall into two categories: aesthetic (that is, cosmetic sequelae that may require a revision rhinoplasty) and nonaesthetic. Of the nonaesthetic complications, infection has the widest span of severity. A localized Staphylococcus aureus abscess or Pseudomonas infection of the nose may occur postoperatively. Owing to the proximity of the nose to the cranium, a cavernous sinus thrombosis or basilar meningitis may result. Postoperative toxic-shock syndrome is a rare occurrence that surgeons should be aware of; most cases have occurred with the presence of nasal packing, but a case using only plastic nasal splints has been reported also. Bacteremia seems to be uncommon during rhinoplasty. Infection after rhinoplasty is generally much less frequent than one would expect from an operation in an unsterile field. Antibiotics are frequently utilized electively. Postoperative nasal-periorbital edema and ecchymosis are regarded as unavoidable but may be lessened significantly by postoperative head elevation and cold packs. The possibility of postoperative bleeding must be evaluated by the surgeon preoperatively. This sequela usually occurs either within 72 hours postoperatively or at around 10 days postoperatively. Many different causes exist for chronic postoperative nasal obstruction, from poorly supported nasal valves closing upon inspiration to an enhanced allergic rhinitis leading to chronic nasal mucosal edema. The latter may be treated by injection of steroid into the turbinates. Among aesthetic complications, supratip prominence, saddle deformity, and persistent hump are among the more commonly reported. Supratip prominence--"polly-beak"--can be caused by inadequate reduction of tip cartilaginous or soft-tissue elements, especially in relation to the reduction of the dorsum. An over-reduced dorsum will leave an otherwise normal nasal tip with a relative prominence. An accumulation of blood or a mucous cyst occurring under the skin of the tip will produce a prominence. Poor tip projection, tip ptosis, and alar collapse are the result of overreduction of tip elements. A dislocated alar cartilage can appear as an asymmetric nasal bossa. Saddle-nose deformity occurs after overaggressive bony and/or cartilaginous hump removal. Infractured nasal bones that subsequently drop into the piriform aperture can create a bony saddle. Persistent hump is due to inadequate reduction of a bony or cartilaginous hump. If the septal cartilage reduction is disproportionate to the bony septum reduction, the appearance of either a hump or a saddle is possible.(ABSTRACT TRUNCATED AT 400 WORDS)


Subject(s)
Rhinoplasty/adverse effects , Consumer Behavior , Hemorrhage/etiology , Humans , Nasal Bone/surgery , Nasal Septum/surgery , Rhinoplasty/methods , Surgical Flaps , Surgical Wound Infection/etiology
18.
J Reprod Med ; 44(10): 908-12, 1999 Oct.
Article in English | MEDLINE | ID: mdl-10554759

ABSTRACT

BACKGROUND: Trophoblastic pulmonary embolization usually occurs after evacuation of a molar pregnancy when the uterus is larger than dates and the human chorionic gonadotropin level is > 100,000 mIU/mL. It has a dramatic onset, with dyspnea, tachypnea, bilateral pulmonary infiltrates and low Po2 levels. Treatment requires supportive measures only. Intubation is rarely required. The clinical course is short-lived, with gradual improvement after 48 hours and complete resolution in 72 hours. There are no long-term sequelae. Differential diagnosis includes pulmonary embolization, fluid overload and aspiration. CASE: A 27-year-old, Caucasian woman, gravida 4, para 2, spontaneous abortion 1, developed presumed trophoblastic pulmonary embolization following abdominal hysterectomy for an invasive mole. The clinical course was typical of this condition, with spontaneous clearing in 72 hours with supportive measures only. CONCLUSION: Trophoblastic pulmonary embolization can occur following abdominal hysterectomy for invasive mole as well as after molar evacuation and should be considered part of the differential diagnosis if patients present postoperatively with acute respiratory distress.


Subject(s)
Hydatidiform Mole/surgery , Hysterectomy/adverse effects , Pulmonary Embolism/etiology , Trophoblasts , Uterine Neoplasms/surgery , Adult , Embolism, Amniotic Fluid/diagnosis , Female , Humans , Pregnancy , Pulmonary Embolism/diagnosis , Treatment Outcome
19.
Ugeskr Laeger ; 144(40): 2938-40, 1982 Oct 04.
Article in Danish | MEDLINE | ID: mdl-7179564

ABSTRACT

PIP: The frequency of hemorrhagic disturbance was calculated retrospectively among 207 sterilized women prior to and after sterilization. Significantly more women experienced metrorrhagia requiring curettage in the 7-year period after sterilization than during the 7-year period prior to it. 75 patients who were sterilized between the ages of 27-30 years were compared with nonsterilized women of the same age bracket. 6 years poststerilization significantly more women who had been sterilized had undergone curettage due to hemorrhagic disturbances than among the nonsterilized women. 15.5% of the women had hysterectomy during the observation period, almost 1/2 of which were due to these disturbances. (author's modified)^ieng


Subject(s)
Metrorrhagia/etiology , Sterilization, Tubal/adverse effects , Adult , Female , Humans , Postoperative Complications , Retrospective Studies
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