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PubMed2005

Major mesh-related complications following hernia repair: events reported to the Food and Drug Administration.

Mesh material affects complications following hernia repair. Medical device reports on the use of surgical mesh for hernia repair were reviewed from the Food and Drug Administration's (FDA) Manufacturer User Facility Device Experience Database from January 1996 to September 2004. We analyzed 252 adverse event reports related to the use of surgical mesh for hernia repair. Adverse events included infection (42%, 107 reports), mechanical failure (18%, 46), pain (9%, 23), reaction (8%, 20), intestinal complications (7%, 18), adhesions (6%, 14), seroma (4%, 9), erosion (2%, 6), and other (4%, 9). Compared to all other mesh types, Sepra/polypropylene mesh had more mechanical failures (80 vs 14%, p < 0.05), biomaterial mesh had more reactions (57 vs 7%, p < 0.05), polytetrafluoroethylene (PTFE)/polypropylene mesh had more intestinal complications (14 vs 7%, p < 0.05), and PTFE mesh tended to have more infections (75 vs 41% all other, p = 0.07). Death occurred in 2% (5). We conclude that specific mesh materials are related to specific complications.

Humans↗

PubMed2005

Collaborative filtering to improve navigation of large radiology knowledge resources.

OBJECTIVE: Collaborative filtering is a knowledge-discovery technique that can help guide readers to items of potential interest based on the experience of prior users. This study sought to determine the impact of collaborative filtering on navigation of a large, Web-based radiology knowledge resource. MATERIALS AND METHODS: Collaborative filtering was applied to a collection of 1,168 radiology hypertext documents available via the Internet. An item-based collaborative filtering algorithm identified each document's six most closely related documents based on 248,304 page views in an 18-day period. Documents were amended to include links to their related documents, and use was analyzed over the next 5 days. RESULTS: The mean number of documents viewed per visit increased from 1.57 to 1.74 (P < 0.0001). CONCLUSIONS: Collaborative filtering can increase a radiology information resource's utilization and can improve its usefulness and ease of navigation. The technique holds promise for improving navigation of large Internet-based radiology knowledge resources.

Algorithms↗

PubMed2006

Pediatric telepsychiatry in ontario: Caregiver and service provider perspectives.

Families in rural areas face significant geographic and economic obstacles to obtaining pediatric mental health services. Telepsychiatry promises the possibility of extending specialized expertise into areas that have no resident psychiatrists. In this study, user perspectives and experiences of a pediatric telepsychiatry program serving rural communities in Ontario, Canada, were explored. Qualitative, exploratory methods were utilized because of the complex nature of mental health services needs and provision in rural communities. Focus groups with rural mental health service providers and interviews with family caregivers of children receiving a telepsychiatry consultation were conducted. The purpose of this research was to evaluate the benefits and limitations of providing pediatric psychiatric services via video-technology to inform future program development and health policy. Whereas participants in the study indicated that their experiences with the telepsychiatry service had been positive, the need for additional local services to support treatment recommendations was emphasized.

Adolescent↗

PubMed1973

Basic ergonomics.

In this article, originally presented as a paper at a symposium on Data Reduction, Communication and Presentation for Process Operation organised by the Institute of Measurement and Control at the University of Sussex, Brighton, the author gives examples of basic ergonomic approaches to the design of equipment for hospital use. He compares moving coil meters with a histogram display, digital display and display produced by a radio-active scanner. Other points covered include the individual's ability to remember and discriminate between shapes, the information required for decision making, the requirement for technological training, and the equipment user's past experience.

Journal Article↗

PubMed1990

Development of a robot arm and workstation for the disabled.

A robotic workstation for the severely physically disabled is being developed. The prototype system consists of a commercially available arm mounted in a workstation set up for various manipulative tasks. This system has been tested with eight disabled users in a hospital situation and is to undergo evaluation in the homes of disabled users. Based on experience with this system, a new arm has been designed and will be built into a redesigned workstation.

Computer Systems↗

PubMed1992

Evaluation of a robotic workstation for the disabled.

Experience with potential users is vital at all stages of the design of equipment for the disabled, not least in the field of rehabilitation robotics. The development of a robotic workstation for the disabled has progressed, over a period of 6 years, from the use of a cheap educational arm, to a specially engineered robot arm and workstation. The design and specification has been refined through constant evaluation by disabled users. Trials at a spinal injuries unit have given approval to the design and appearance of the latest robot arm and workstation, and have led to modifications to the user interface and software. Further trials have taken place in a user's home to investigate in greater depth the usefulness of a robotic workstation in a practical situation. The results of these trials are presented. It is proposed to refine the design of the arm for low-volume production, easy maintenance in the field and improved appearance.

Adult↗

PubMed1994

Effects of marijuana history on the subjective, psychomotor, and reinforcing effects of nitrous oxide in humans.

An experiment using marijuana users and non-users was conducted to assess whether the reinforcing, subjective, or psychomotor effects of nitrous oxide were influenced by a subject's drug history. Subjects in the first four sessions sampled 40% nitrous oxide in oxygen and 100% oxygen (placebo), and then over the next three sessions, chose which agent they wished to inhale. Choice distributions between the two groups did not differ significantly, and nitrous oxide choice rates were less than 50% in both groups. However, a history of marijuana use appeared to intensify some of the subjective effects induced by nitrous oxide inhalation.

Administration, Inhalation↗

PubMed2006

Emerging endoluminal therapies for gastroesophageal reflux disease: adverse events.

BACKGROUND: Endoluminal therapies are emerging as a new therapeutic option for the treatment of gastroesophageal reflux disease (GERD). Many of these endoluminal therapies are touted as short outpatient procedures with minimal complications. It is thought that these complications are uncommon and minor. This investigation sought to summarize the adverse events of these endoluminal therapies for the treatment of GERD. METHODS: The Manufacturer and User Facility Device Experience Database for the U.S. Food and Drug Administration's Center for Devices and Radiological Health Web site was searched to examine all voluntary adverse events reported on emerging endoluminal therapies. The adverse events can be divided into 3 categories: (1) radiofrequency ablation based, (2) injection based, and (3) suture based. RESULTS: There were a total of 50 adverse events reported on 4 specific therapies. Half of the complications were found to result from injection-based therapy and 44% of the complications were found to result from radiofrequency ablation-based therapy. There were 8 deaths reported (5 in the injection-based group and 3 in the radiofrequency ablation-based group). Sixty-four percent of the adverse events resulted in hospitalizations and 10% of these patients required surgery. CONCLUSIONS: Physicians must be aware that no endoluminal therapy is truly noninvasive. Complications and even deaths are associated with these treatments for GERD. Patients must be informed of all the potential risks and complications of these new technologies.

Catheter Ablation↗

PubMed2005

Muscle damage is linked to cytokine changes following a 160-km race.

Muscle damage and perceived soreness following the 160-km Western States Endurance Run were related to changes in plasma cytokines and use of nonsteroidal anti-inflammatory drugs (NSAIDS). Subjects included 60 ultramarathoners (mean+/-SE, age 45.3 +/- 1.1 years) who finished the race in under 30 h (26.3 +/- 0.4 h). Blood samples were collected the morning prior to and immediately following the race, and subjects recorded muscle soreness during the week following the race using a 10-point Likert scale (DOMS). Seven plasma cytokines were measured including IL-6, IL-10, IL-8, IL-1ra, granulocyte colony-stimulating factor (G-CSF), monocyte chemotactic protein 1 (MCP-1), and macrophage inflammatory protein 1beta (MIP-1beta). Cytokine changes were compared between NSAID users and nonusers, and correlated with creatine phosphokinase (CPK) and DOMS. Significant increases were measured for all seven cytokines, with the greatest fold increases seen for IL-6 (125x), IL-10 (24x), and G-CSF (12x). CPK was correlated with changes in IL-6, G-CSF, IL-10, IL-1ra, and MCP-1 (r = .49-.68), (P < .001), but not IL-8 or MIP-1beta. DOMS averaged 7.1 +/- 0.3 the day after the race, and 5.0 +/- 0.3, 2.5 +/- 0.2, and 1.6 +/- 0.1 3 days, 5 days, and 7 days post-race, respectively, and each was correlated with CPK (r = .40-.63, P < .001) and changes in IL-6, G-CSF, IL-10, and MCP-1 (r = .28-.77, P < .05). A comparison of NSAID users (72% of athletes) and nonusers showed no differences in CPK or DOMS, but did reveal greater increases in five of seven cytokines in the NSAID users (P < .05). In conclusion, muscle damage in athletes competing in a 160-km race was significantly correlated with post-race DOMS and increases in five of seven cytokines. NSAID users did not experience a reduction in muscle damage or DOMS, but did have higher post-race plasma levels in five of seven cytokines.

Adult↗

PubMed2005

Chronic treatment with a serotonin(2) receptor (5-HT(2)R) agonist modulates the behavioral and cellular response to (+)-3,4-methylenedioxymethamphetamine [(+)-MDMA].

3,4-Methylenedioxymethamphetamine [MDMA; ecstasy] evokes a multifaceted subjective experience in human users which includes stimulation, feelings of well-being, mood elevation, empathy towards others as well as distortions in time, sensation and perception. Aspects of this unique psychopharmacology of MDMA are thought to be related to its potent actions to release serotonin (5-HT) and indirectly stimulate the 5-HT(2A) receptor (5-HT(2A)R). In the present studies, we examined the interrelationship between down-regulation of 5-HT(2A)R expression and the behaviorally stimulatory effects generated by acute administration of (+)-MDMA, the most potent enantiomer of (+/-)-MDMA. Male Sprague-Dawley rats were chronically treated with the preferential 5-HT(2A)R agonist 2,5-dimethoxy-4-iodoamphetamine (DOI) which has been shown to down-regulate expression of the 5-HT(2A)R, but not the closely related 5-HT(2C)R. While chronic DOI treatment did not alter the functional sensitivity of either the 5-HT(2A)R or 5-HT(2C)R, this regimen enhanced (+)-MDMA-evoked hyperactivity. Subsequent analysis of c-Fos and 5-HT(2A)R immunoreactivity in brain sections demonstrated that DOI treatment decreased the number of (+)-MDMA-induced c-Fos immunopositive nuclei and 5-HT(2A)R immunostaining in select cortical and striatal areas. These results indicate that chronic DOI exposure results in an enhanced behavioral response to (+)-MDMA and in a pattern of neuronal activation which resembles that seen in psychostimulant sensitization. These data also suggest that expression of the 5-HT(2A)R in the NAc and PFC may play a role in the sensitivity to the locomotor-stimulating effects of (+)-MDMA and in the processes of neural regulation upon repeated psychostimulant administration.

Amphetamines↗

PubMed2004

Surgical stapler-associated fatalities and adverse events reported to the Food and Drug Administration.

BACKGROUND: Use of stapling devices has become standard practice in many operations, and these devices have many applications, including ligation and division, resection, anastomosis, and fascial closure. The Food and Drug Administration (FDA) regulates surgical staplers as a medical device. Manufacturers and health-care providers report adverse events occurring during the use of surgical staplers to the FDA. STUDY DESIGN: Two FDA adverse event databases, the Manufacturer and User Facility Device Experience database and the Alternative Summary Reporting database were searched for adverse events related to the use of surgical staplers. An FDA recall database, Oracle System Center Automated Retrieval, was searched for surgical stapler recalls and the reason for these recalls. RESULTS: We characterized adverse events from 112 death, 2,180 injury, and 22,804 malfunction reports from FDA adverse event databases. We described 22 recalls for these products that are listed in an FDA database. A majority of these recalls were related to manufacturing or design problems. CONCLUSIONS: The overall incidence of these events remains unknown; because these products are used so frequently, even uncommon adverse events may affect many patients. It is important for health-care providers to report adverse events to manufacturers so that they may work to improve the design of these devices and reduce use errors that contribute to the events.

Equipment Design↗

PubMed2003

Complications associated with global endometrial ablation: the utility of the MAUDE database.

OBJECTIVE: To investigate the number and type of complications associated with global endometrial ablation using public-access governmental databanks. METHODS: MEDLINE (PubMed) and the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) databases were searched for entries for the four US Food and Drug Administration-approved global endometrial ablation devices. RESULTS: Traditional MEDLINE and bibliography searches yielded reports of two cases of hemorrhage, one case of pelvic inflammatory disease, 20 cases of endometritis, two cases of first-degree skin burns, nine cases of hematometra, and 16 cases of vaginitis and/or cystitis. A search of the US Food and Drug Administration MAUDE database yielded reports of 85 complications in 62 patients. These included major complications: eight cases of thermal bowel injury, 30 cases of uterine perforation, 12 cases in which emergent laparotomy was required, and three intensive care unit admissions. One patient developed necrotizing fasciitis and eventually underwent vulvectomy, ureterocutaneous ostomy, and bilateral below-the-knee amputations. One of the patients with thermal injury to the bowel died. CONCLUSION: Use of the US Food and Drug Administration MAUDE database is helpful in identifying serious complications associated with global endometrial ablation not yet reported in the medical literature.

Databases, Factual↗

PubMed2005

Private obstetric practice in a public hospital: mythical trust in obstetric care.

There is evidence to suggest the decline of trusting relationships in modern healthcare systems. The primary aim of this study was to investigate the role of trust in medical transactions in Thailand, using obstetric care as a tracer service. The paper proposes an explanatory framework of trust for further investigation in other healthcare settings. The study site was a 1300-bed tertiary public hospital in Bangkok which it provides two forms of obstetric care: regular obstetric practice (RP) and private obstetric practice (PP). Forty pregnant women were selected and interviewed using a set of guiding questions. A thematic analysis of the interviews was undertaken to generate understanding and develop an explanatory framework. It was found that patients' trust in obstetric services was influenced by their perceptions of risk and uncertainty in pregnancy and childbirth, and that these perceptions were linked to their social class. Social class also influenced the accessibility and affordability of care to patients. Middle class pregnant women with relatively high-level concerns about risk and uncertainty preferred using PP service as a means to achieve interpersonal trust. These women thought that an informal payment would provide the basis for interpersonal trust between themselves and the chosen obstetricians. In practice, however, obstetricians involved in PP rarely acknowledged this reciprocal relationship and hardly expressed the additional courtesy expected by patients. As a result, PP service only created an expensive impersonal trust that was mistaken as interpersonal trust by patients. Negative outcomes from PP often caused disappointment that could eventually lead to medical litigation. The study suggests that there are some negative impacts of PP within the health system. Negative experiences among PP users may undermine trust not only in the specific doctor but also trust in health professionals and hospitals more generally. Steps need to be undertaken to protect and strengthen existing impersonal trust, which combine institutional trust based on good governance and service quality with trust in the professional standard of practice. The explanatory framework developed through this study provides a foundation for further studies of trust in different specialties and care settings.

Adult↗

PubMed2002

Safety of implantable contraceptives for women: data from observational studies.

Contraceptive implants are registered in over 60 countries and have been used by millions of women for three decades. This article reviews findings from observational studies on the safety of contraceptive implants and examines the risk of specific health outcomes. Fifty-five articles were reviewed, and the body of evidence for each health outcome was summarized. Available evidence suggests that contraceptive implants are safe and, overall, implant users do not experience adverse events at rates higher than women not using implants. With respect to specific outcomes, the evidence suggests no increased risks of pelvic inflammatory disease, decreased bone mineral density, anemia, thrombocytopenia, or death with implant use. The evidence was too limited to draw meaningful conclusions for neoplastic disease, cardiovascular events, and HIV/AIDS. Nonsignificantly elevated associations were reported for diabetes, serious mental disorders, and rheumatoid arthritis. Conditions for which risks were marginally, yet significantly, elevated were hypertension and gall bladder disease.

Bone Density↗

PubMed1976

Laboratory approaches to the identification of Enterobacteriaceae.

There are numerous approaches to the identification of the Enterobacteriaceae in the clinical laboratory. Accuracy in identifying organisms is related directly to the skill and experience of the user and to the number of tests inoculated. Many of the commercially available kits offer reproducibility, convenience, accuracy, and ease of storage, particularly for smaller hospital laboratories that have neither the facilities nor the expertise to prepare and exert quality control over microbiologic media. However, none of the kits offers the accuracy and few offer the flexibility available through the use of conventional media, the variety and duration of incubation of which are virtually unlimited. The proper use of any system requires training because accurate identification requires the concurrent examination of colonial morphology and biochemical reactions-manufacturer's flow charts, reaction tables, or printed recognition systems notwithstanding. Microbiologists should be wary of new systems before impartial evaluations have been performed and published in scientific journals; manufacturers' technical literature and salesmen's presentations are, for obvious reasons, seldom objective.

Bacteriological Techniques↗

PubMed1999

A 100-channel system for real time detection and storage of extracellular spike waveforms.

As extracellular electrode arrays with 100 or more active recording sites become more widely used for simultaneous recording of neural ensembles, practical data acquisition systems that can efficiently accommodate high electrode counts are needed. To reduce the high data rates associated with extracellular recordings from these arrays, various algorithms and systems have been designed to provide complete online detection and classification of extracellular spike waveforms. However, many of these algorithms require significant user supervision to ensure accurate performance. In this paper, we discuss the design and validation of a 100-channel PC-based system that can be used with arrays of extracellular electrodes such as the Utah Electrode Array. Instead of comprehensive online spike analysis, the system performs online detection and storage of the spike waveforms for offline classification. This strategy preserves the data of interest, reduces system complexity, and requires less user supervision during experiments.

Action Potentials↗

PubMed2006

Internet uses for health information seeking: A literature review.

BACKGROUND: With the widespread dissemination of the Internet throughout the world of health, it would be relevant to report on current knowledge about health information search on the Internet from the consumers' standpoint. METHODS: We conducted a bibliographical research over the past five years and distinguished between international and French studies. RESULTS: For a long time, the (mostly US) studies have been merely descriptive. The studies highlight that the factors associated with health searches on the Internet are similar to the factors underlying the digital divide. Consumer searches are deemed efficient although search skills are comparatively below standard. Attempts are underway to set up tools, circulate them widely, and ensure better quality information on the Internet. However, comprehension and literacy are still issues in some social groups. Regarding the impact on consumer health per se, a (positive) effect of the Internet seems to emerge but research should be continued. CONCLUSION: Many of the behaviors, uses or limits addressed in this paper pertain to any information search on the Internet but other problems or differences also occur in the specific area of health. Longitudinal investigations are needed, specifically to gain deeper insight into the impacts we have addressed, while rolling out a comprehensive approach to the temporal evolution of user practices and experiences. Specifically, the central issue is still to determine how (and for whom) the Internet alters information search behaviors and, in fine, to what extent this affects health behaviors and the recourse to healthcare.

Community Participation↗

PubMed2003

Interdisciplinary consensus on the use and technique of vacuum-assisted stereotactic breast biopsy.

PURPOSE: Quality assurance of stereotactic vacuum-assisted breast biopsy (VB). METHOD: A consensus was achieved based on the existing literature and the experience of VB users (Ethicon Endosurgery, Norderstedt). RESULTS: The imaging work-up must be completed according to existing standards before an indication for stereotactic VB is established. Indications include microcalcifications and small non-palpable masses; for the time being lesions very close to the skin and architectural distortions (radial scar) are considered less suitable. Acquisition of >20 cores (11 Gauge) should be routinely attempted (goals: as complete a removal of small lesions as possible, thereby increasing diagnostic confidence and reducing so-called 'underestimates'). The pre/post-fire and post-biopsy stereotactic images and a post-biopsy orthogonal mammogram must be documented. All cases with no or uncertain histopathological correlation require discussion in a regular interdisciplinary conference and a documented consensus concerning further work-up or therapy. Standardised documentation of the primary findings and follow-up mammography after approximately 6 months is requested. CONCLUSION: This consensus includes protocols for the establishment of an indication, performance indicators, interdisciplinary interpretation and therapeutic recommendation, documentation and follow-up. It does not replace official recommendations for percutaneous biopsy.

Biopsy, Needle↗