bluuebunny/crossref_metadata_2025_split huggingface dataset:
EU Regulation of Medical Devices and Pharmaceuticals in Comparative Perspective
Authors: Altenstetter Christa , Permanand Govin 
Published: October 2007

AbstractThis paper provides a comparison of European Union regulatory policy for pharmaceuticals and medical devices. The discussion highlights key similarities and differences in regulatory approach for the two sectors. More importantly, it explores the balance that has been struck between public health, health care, and industrial policy as “competing” objectives within the respective regulatory regimes. It is argued that, despite both sectors being affected by the same institutional rules and constraints at the EU level, and both being central to the delivery of high‐quality health care in Europe, there are a surprising number of differences between the regulatory frameworks. That this stems in part from their different “launch” times, hence different institutional conditions of regulation, and commensurate political climates, as well as reflecting different aims and goals among member‐state and EU‐level policy makers, are among the paper's main conclusions.
Discerning Immunity for Governmental Entities: Analyzing Legislative Choices
Authors: Centner Terence J. 
Published: October 2007

AbstractIn 2006, three disagreements about the scope of immunity for governmental entities were considered by the U.S. Supreme Court. Governmental entities were seeking to avoid liability for their actions, claiming the defense of sovereign immunity. Other lawsuits involving governmental immunity under state constitutional and statutory provisions disclose controversies concerning the responsibilities of governments to injured persons. The complicated jurisprudence governing immunity for governmental entities shows two alternatives for legislatures. They have the ability to increase liability by waiving immunity or to add defenses that defeat liability. The trend seems to be to waive immunity for governmental entities while adding statutory defenses that are available to both the private sector and governmental entities.
The relaxing effect of perivascular tissue on porcine retinal arterioles in vitro is mimicked by N‐methyl‐D‐aspartate and is blocked by prostaglandin synthesis inhibition
Authors: Holmgaard Kim , Aalkjær Christian , Lambert John D. C. , Hessellund Anders , Bek Toke 
Published: October 2007

Abstract.Purpose:  Retinal hyperperfusion resulting from disturbances in the regulation of arteriolar tone is involved in the pathophysiology of a variety of retinal diseases. The mechanisms underlying this regulation of tone involve cellular components in both the vascular wall and the perivascular tissue. However, previous in vitro studies of the influence of perivascular retinal tissue on retinal tone regulation have been hampered by the release of an endogenous relaxing factor that renders the arteriole insensitive to vasoconstrictors. The purpose of the present study was to test whether N‐methyl‐D‐aspartate (NMDA) and γ‐amino butyric acid (GABA) receptors, and a cyclooxygenase (COX) product influence this effect of perivascular retinal tissue in vitro.Methods:  Porcine retinal arterioles were mounted in a wire myograph for isometric force measurements. The contractile effect of the prostaglandin analogue U46619 was studied on vessels with preserved perivascular retinal tissue and after this tissue had been removed. The influence of the perivascular tissue was studied after addition of NMDA (a specific agonist for a subtype of the glutamate receptor), DL‐amino‐5‐phosphonovaleric acid (DL‐APV, an antagonist at the same receptor), the natural inhibitory transmitter GABA, and picrotoxin (an antagonist at ionotropic GABA receptors). These experiments were made in the absence and presence of the COX inhibitor, ibuprofen.Results:  U46619 caused a concentration‐dependent contraction of isolated retinal arterioles. This vasoconstriction was significantly smaller in the presence of perivascular tissue. The NMDA‐receptor antagonist, DL‐APV, reduced this attenuating influence of the perivascular tissue on the response to U46619, and the response could be modified by NMDA and GABA, but not by picrotoxin. However, ibuprofen totally blocked the attenuating influence of the perivascular tissue on the response to U46619.Conclusions:  The inhibition of vascular contractility induced by perivascular retinal tissue in vitro involves NMDA‐receptors and an effect of GABA‐mimetic substance on retinal tissue. The generation of these effects involves a COX product.
Digital fundus image grading with the non‐mydriatic VisucamPRO NM versus the FF450plus camera in diabetic retinopathy
Authors: Neubauer Aljoscha S. , Rothschuh Antje , Ulbig Michael W. , Blum Marcus 
Published: October 2007

Abstract.Purpose:  Grading diabetic retinopathy in clinical trials is frequently based on 7‐field stereo photography of the fundus in diagnostic mydriasis. In terms of image quality, the FF450plus camera (Carl Zeiss Meditec AG, Jena, Germany) defines a high‐quality reference. The aim of the study was to investigate if the fully digital fundus camera VisucamPRO NM could serve as an alternative in clinical trials requiring 7‐field stereo photography.Methods:  A total of 128 eyes of diabetes patients were enrolled in the randomized, controlled, prospective trial. Seven‐field stereo photography was performed with the VisucamPRO NM and the FF450plus camera, in random order, both in diagnostic mydriasis. The resulting 256 image sets from the two camera systems were graded for retinopathy levels and image quality (on a scale of 1–5); both were anonymized and blinded to the image source.Results:  On FF450plus stereoscopic imaging, 20% of the patients had no or mild diabetic retinopathy (ETDRS level ≤ 20) and 29% had no macular oedema. No patient had to be excluded as a result of image quality. Retinopathy level did not influence the quality of grading or of images. Excellent overall correspondence was obtained between the two fundus cameras regarding retinopathy levels (κ 0.87) and macular oedema (κ 0.80). In diagnostic mydriasis the image quality of the Visucam was graded slightly as better than that of the FF450plus (2.20 versus 2.41; p < 0.001), especially for pupils < 7 mm in mydriasis.Conclusions:  The non‐mydriatic VisucamPRO NM offers good image quality and is suitable as a more cost‐efficient and easy‐to‐operate camera for applications and clinical trials requiring 7‐field stereo photography.
Clinical decision‐making during 5 years of antipsychotic treatment
Authors: Levander S. , Eberhard J. , Lindström E. 
Published: October 2007

Objective:  Explore how clinicians select drug treatment based on symptoms, side effects and patient factors, including patient participation in the process, and the association between these factors and attitudes towards drugs.Method:  A cohort of 166 patients initially treated with risperidone was followed with yearly assessments over 5 years. At the end of the study, 101 patients were evaluated of whom 58 were still treated with risperidone.Results:  More women than men remained in the study, and on the initial medication. The most common reason for medication switch was lack of efficacy. Clinicians and patients agreed well in their global ratings of medication effects and side effects. Robust associations between switch decisions and patient characteristics including symptoms and side effects could not be identified. The effects of switches were rated as better by the clinicians than by the patients. Negative drug attitudes were associated with pronounced positive symptoms (threshold effect), whereas the corresponding association with ‘lack of judgment and insight’ was linear over the whole range.Conclusion:  The decision‐making process appears to have many unknown components, and may benefit from more active patient involvement by using structured clinician and patient rating scales for monitoring the treatment. Such shared decision‐making may improve compliance.
Costs of schizophrenia during 5 years
Authors: Lindström E. , Eberhard J. , Neovius M. , Levander S. 
Published: October 2007

Objective:  To explore the direct and indirect costs in a cohort of 225 risperidone‐treated patients with schizophrenia followed up annually during 5 years.Method:  Data on costs for medication, hospitalization, sheltered living and productivity losses, as well as degree of social isolation, were collected.Results:  The direct costs were dominated by hospitalization and sheltered living expenses, while drug costs only represented 7% of the direct costs. Indirect costs represented 43% of the total costs during the 5 years. About 12% worked full‐time, and 12% worked part‐time, implying large productivity losses. As a consequence of the national mental health care reform, a substantial shift of costs from hospital care to sheltered living took place on the national level, but the reduction of hospital days for the study patients over time was much larger suggesting that the switch from first to second generation compounds was therapeutically successful. A high degree of social isolation was seen, with more than 20% being completely without social contacts and 30% seeing friends/relatives less often than once a week.Conclusion:  The economic costs of schizophrenia are high and driven by the need for assisted living and hospitalizations, together with productivity losses. In addition, the intangible costs, such as social contacts, are also high.
Obstetric complications and postpartum psychosis: a follow‐up study of 1.1 million first‐time mothers between 1975 and 2003 in Sweden
Authors: Nager A. , Sundquist K. , Ramírez‐León V. , Johansson L. M. 
Published: October 2007

Objective: The severity of postpartum psychosis calls for further research on the association between obstetric variables and this psychiatric disorder.Method: A total of 1 133 368 Swedish first‐time mothers were included during a 29‐year period yielding 1413 hospitalized cases of postpartum psychosis. Several obstetric variables were analysed separately after adjustment for possible confounders.Results: Respiratory disorder in the neonate, severe birth asphyxia, preterm birth, caesarean section, perinatal death and SGA infant were associated with an increased risk of postpartum psychosis. After adjustment for previous hospitalization for psychiatric disorder only preterm birth and acute caesarean section remained significant risk factors for postpartum psychosis (relative risks were 1.20 and 1.31 respectively). The relative risk of postpartum psychosis among first‐time mothers with previous hospitalization for psychiatric disorder was increased more than 100‐fold.Conclusion: Careful clinical risk assessments of postpartum psychosis are crucial among women with a history of psychiatric disorder whereas obstetric variables have a minor importance.
Social functioning as an outcome measure in schizophrenia studies
Authors: Burns T. , Patrick D. 
Published: October 2007

Objective:  Deficits in social functioning are a core feature of schizophrenia.Method:  A literature search of English language articles published between January 1990 and December 2006 was undertaken to identify: i) scales used most frequently to assess social functioning in schizophrenia; and ii) the most frequently used social functioning scales in randomized, controlled trials of antipsychotics. A further search (without time limits) examined their psychometric properties.Results:  A total of 301 articles employed social functioning scales in the assessment of schizophrenia. These contained 87 potentially relevant measures. Only 14 randomized, controlled studies of antipsychotic agents were identified that examined social functioning. Scales varied greatly in terms of measurement approach, number and types of domains covered and scoring systems. A striking lack of data on psychometric properties was observed.Conclusion:  Limited consensus on the definition and measurement of social functioning exists. The Personal and Social Performance Scale is proposed as a useful tool in future research.
Biomechanical interactions in tooth–implant‐supported fixed partial dentures with variations in the number of splinted teeth and connector type: a finite element analysis
Authors: Lin Chun‐Li , Wang Jen‐Chyan , Chang Wen‐Jen 
Published: October 2007

AbstractObjective: The aim of this study was to investigate the biomechanical interactions in tooth–implant‐supported fixed partial dentures (FPDs) under several loading conditions with different numbers of splinted teeth and connector types (rigid and non‐rigid) by adopting the three‐dimensional (3D) non‐linear finite element (FE) approach.Material and methods: A 3D FE FPD model was constructed containing one Frialit‐2 implant in the mandibular second‐molar region splinted to the first and second premolars. Frictional contact elements were used to simulate realistic interface conditions within the implant system and the non‐rigid connector function. The main effects for each level of the three investigated factors (loading condition, number of splinted teeth and connector type) in terms of the stress values and dissimilar mobility of the natural teeth and implant were computed for all models.Results: The results indicated that load condition was the main factor affecting the stress developed in the implant, bone and prosthesis when comparing the type of connector and the number of splinted teeth. The stress values were significantly reduced in centric or lateral contact situations once the occlusal forces on the pontic were decreased. However, the prosthesis stress for the non‐rigid connections was increased more than 3.4‐fold relative to the rigid connections. Moreover, the average tooth‐to‐implant displacement ratios (RTID) with a non‐rigid connection were obviously larger than those for rigid connections under axial loading forces. Adding an extra tooth to support a three‐unit tooth–implant FPD only exploited its function when the prosthesis withstood lateral occlusal forces.Conclusions: The load condition is the main factor affecting stress distribution in different components (bone, prosthesis and implant) of tooth–implant‐supported FPDs. Minimizing the occlusal loading force on the pontic area through selective grinding procedures could reduce the stress values obviously. A non‐rigid connector may more efficiently compensate for the dissimilar mobility between the implant and natural teeth under axial loading forces but with the risk of increasing unfavorable stresses in the prosthesis.
Effect of bone conditioning on primary stability of FRIALIT‐2® implants
Authors: Proff P. , Bayerlein T. , Rottner K. , Mai R. , Fanghänel J. , Gedrange T. 
Published: October 2007

AbstractBackground: Primary stability is crucial to implants used for orthodontic anchorage. Bone condensing to enhance primary stability is controversial.Material and methods: Fourteen Frialit‐2®‐stepped screw and cylinder implants were placed in the median palatine sutures of 22 cadaveric human heads. In half of both types, the implant bed was prepared using a Frialit® Bone Condenser. Primary implant stability was evaluated using non‐invasive resonance frequency analysis. Moreover, the bone–implant contact area was examined histomorphometrically and radiographically.Results: Bone condensing yielded a slightly, yet not significantly increased implant stability quotient compared with a conventional technique. In spongy bone, a significant histomorphometric increase of bone–implant contact (P<0.0001) and a significant increase of radiographic density was revealed for both implant types, while no significant changes were observed within the compact area.Conclusion: The study shows that bone condensing yields an improved histologic implant–bone contact only in spongy bone, which was paralleled by radiographic–densitometric findings.
Changing risk factors for fluorosis among South Australian children
Authors: Spencer A. John , Do Loc G. 
Published: October 2007

Abstract –  Background:  Research in the last decade has shown changing exposure patterns to discretionary fluorides and declining prevalence of fluorosis among South Australian children, raising the question of how risk factors for fluorosis have changed.Objective:  To examine and compare risk factors for fluorosis among representative samples of South Australian children in 1992/1993 and 2002/2003.Methods:  Similar sampling strategies and data collection methods were employed in the Child Fluoride Study (CFS) Marks 1 (1992/1993) and 2 (2002/2003). Participants in each CFS round were examined for fluorosis using the Thylstrup and Fejerskov (TF) Index. Exposure history was collected for fluoride in water, toothpaste, fluoride supplements and infant formula, allowing for a fluorosis risk assessment analysis. Data were re‐weighted to represent the child population at each time. Changes in prevalence of fluorosis, defined as having a TF score of 1+ on maxillary central incisors, fluoride exposure and risk factors between the two rounds were evaluated.Result:  A total of 375 and 677 children participated in the 1992/1993 and 2002/2003 rounds respectively. Prevalence of fluorosis declined significantly from 45.3% to 25.9%. Reduced use of fluoride supplements and increased use of 400–550‐ppm children F toothpaste were the most substantial fluoride exposure changes. Early toothpaste use, residence in fluoridated areas and fluoride supplement use were the risk factors in 1992/1993. Early toothpaste use and fluoride supplement use were not risk factors, leaving fluoridated water as the only risk factor among the common variables in 2002/2003. In an analysis stratified by the type of fluoridated toothpaste in 2002/2003, the large amount of toothpaste used was a risk factor in those who used 1000‐ppm fluoridated toothpaste, and eating/licking toothpaste when toothpaste use started was a risk factor among children who used either 1000‐ppm or 400–550‐ppm fluoridated toothpaste.Conclusion:  Introduction of the 400–550‐ppm F toothpaste and use of smaller amount of toothpaste restricted risk associated with early toothpaste use. Less use and possibly a stricter fluoride supplements regimen also restricted fluorosis risk. Periodic monitoring of risk of fluorosis is required to adjust guidelines for fluoride use in caries prevention.
Determinants of perceived need for dental pain medication
Authors: Pau Allan , Croucher Ray , Marcenes Wagner 
Published: October 2007

Abstract –  Objectives:  To describe the perceived inability to cope (PIC) and impact on quality of life (QOL) in dental pain patients, and investigate their effect on perceived need for pain medication.Methods:  Fully structured self‐complete questionnaire survey of a sample of patients with current experience of dental pain/discomfort and sensitivity. Subjects were recruited from a dental teaching hospital’s emergency and restorative clinics. Questions were asked on pain intensity, PIC, impact on QOL and perceived need for pain medication.Results:  Of 318 subjects approached, 199 (63%) completed usable questionnaires. In expressing PIC, 48.2% of the sample reported that they felt dependent on somebody else doing something about the pain, whereas 69.3% reported feeling helpless in their effort to try and do something about the pain. The prevalence of impact on QOL ranged from 55.8% reporting feeling like isolating oneself from other people to 77.9% for feeling grumpy, irritable, bad‐tempered or miserable. Logistic regression analysis identified impact on QOL (OR = 1.17, 95% CI = 1.06–1.30), PIC (OR = 1.10, 95% CI = 1.01–1.21) and pain intensity (OR = 1.26, 95% CI = 1.05–1.50) as independent significant predictors of perceived need for pain medication.Conclusions:  Pain intensity and PIC can enhance the ability of QOL measures in differentiating population groups into those who perceive the need for pain medication and those who do not.
A comprehensive evaluation of the validity of Child‐OIDP: further evidence from Peru
Authors: Bernabé Eduardo , Sheiham Aubrey , Tsakos Georgios 
Published: October 2007

Abstract –  Objective:  To comprehensively assess the psychometric properties of the child version of the Oral Impacts on Daily Performance (Child‐OIDP), by reporting additional validation methodologies and highlighting underlying constructs.Methods:  Four of seven public schools linked to the Mother‐Child Health Centre from Puente Piedra (Lima, Peru) were randomly selected as clusters. All their 903 11‐ to 12‐year‐old children were invited to participate. The Child‐OIDP was cross‐culturally adapted to Spanish and its content, face, criterion and construct validity as well as internal and external reliability evaluated in successive pilot studies and a main study.Results:  For criterion validity, Child‐OIDP scores were associated to self‐perceived oral health status, self‐perceived dental treatment need and satisfaction with oral health status (P < 0.001 in all cases). In relation to construct validity, an exploratory factor analysis provided three factors with eigenvalues greater than 1, which represented the physical, psychological and social health components. Cronbach’s alpha varied between 0.62 and 0.65, whereas test–retest reliability was 0.85 (intra‐class correlation coefficient).Conclusions:  The Spanish(Peru) Child‐OIDP is a valid and reliable interviewer‐administered instrument to measure the impact of the oral conditions on quality of life. This study provides new evidence in support of the psychometric properties of the Child‐OIDP.
Social disparities in periodontitis among United States adults 1999–2004
Authors: Borrell Luisa N. , Crawford Natalie D. 
Published: October 2007

Abstract – Objectives: To investigate whether race/ethnicity, income, and education are independently associated with periodontitis; and to investigate the effect of adjusting for income and education on the association between race/ethnicity and periodontitis in the National Health and Examination Nutrition Surveys 1999–2004.Methods: Analyses were limited to records of non‐Hispanic black, non‐Hispanic white or Mexican‐American adults (n = 10 648). SUDAAN was used to estimate the strength of the association of race/ethnicity, education, and income with the prevalence of periodontitis before and after adjusting for selected characteristics and risk factors.Results: The prevalence of periodontitis was 3.6%, with Black people (7.2%) exhibiting significantly higher prevalence than Mexican Americans (4.4%) and White people (3.0%,P < 0.01). After adjusting for selected sociodemographic characteristics, black adults, those with less than a high school education and those with low income were 1.94 (95% CI 1.46–2.58), 2.06 (95% CI 1.47–2.89) and 1.89 (95% CI 1.18–3.04) times more likely to have periodontitis than White people, those with more than a high school diploma and those with high income, respectively.Conclusions: This study indicates that inequalities in periodontitis associated with race/ethnicity, education and income continue to be pervasive in the US over the years.