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At least 37 records · Page 2Linked to original sources

Miniature, low-dose, intrauterine drug-delivery systems.

The safety of systemically administered sex steroids continues to be a major focus of researchers. The negative results of the Women's Health Initiative study (WHI), and follow-up reports published in JAMA, evaluating the safety of estro-progestogen in postmenopausal women, elicited an unprecedented reaction in the press by women and doctors alike. From these publications, it is clear that research should focus on new progestogens and on alternative administration routes to minimize adverse drug effects. One approach to the improvement of safety, efficacy, and acceptability of steroid hormones, including patient compliance, is to develop long-acting implantable methods that deliver the lowest possible dose to the key target tissues. This therapeutic concept of "minimal intervention" has been known for several decades, but the practical applications of the method were lacking. Intrauterine drug-delivery systems can be developed to achieve minimal intervention fertility control without influencing normal ovarian function and/or causing adverse hormonal effects. With hormone replacement therapy in postmenopausal women, research suggests that progestogens delivered directly to the uterine mucosa could reduce side effects and minimize reversal of the beneficial effect of estrogens. Various "frameless" and "framed" intrauterine systems are currently being clinically evaluated. They are less troublesome than the available intrauterine systems and could therefore be suitable for use in the majority of women for contraception and treatment purposes (e.g., menorrhagia, hormone replacement). These systems require a single short office procedure, and have a low morbidity, which is undeniably linked with more invasive methods and systemic hormonal contraceptives. Due to the technological progress miniature, low-dose, long-term intrauterine drug-delivery systems offer enhanced effectiveness, reduced side effects, and optimal user compliance. Although there is minimal absorption in the systemic circulation, they deserve the status of a locally acting method that should be regarded as fundamentally advantageous, if effective, to systemically applied medications that may have potentially inherent ill side effects.

Adult↗

Electronic forms: benefits drawbacks of a World Wide Web-based approach to data entry.

It has long been realized that, compared to paper-based records, electronic record systems provide many advantages in the healthcare environment, including increased availability, improved legibility, long-term accessibility, (potentially) greater completeness, data encoding, and automated decision support and analysis. In spite of these recognized benefits, collection of patient data at the point of service generally does not occur, in large part because each such effort usually requires application-specific software and hardware, and, most significantly, provider time. Given the presence of WWW browsers now available on nearly every desktop, the support and access concerns for data entry applications can be substantially lessened. Despite these advantages, there are also downsides to the use of the WWW for data entry, including user interface issues and security. At CPMC, we are currently using web-based forms to gather patient charge data from physical and occupational therapists. Benefits of this approach have included a 98.2% user compliance rate for at least weekly data entry, and the reduction of charge posting from an average of 24.3 days to 2.3 days following the date of service. Drawbacks to WWW-based applications have included increased security exposure and persistent human tendencies to enter data in batches rather than at the time of service. A final conclusion was that, in the absence of a strong central mandate, providers must perceive a clear benefit in order to be willing to learn and use a new technology.

Attitude to Computers↗

Intravaginal ring delivery of the reverse transcriptase inhibitor TMC 120 as an HIV microbicide.

TMC 120 (Dapivirine) is a potent non-nucleoside reverse transcriptase inhibitor that is presently being developed as a vaginal HIV microbicide. To date, most vaginal microbicides under clinical investigation have been formulated as single-dose semi-solid gels, designed for application to the vagina before each act of intercourse. However, a clear rationale exists for providing long-term, controlled release of vaginal microbicides in order to afford continuous protection against heterosexually transmitted HIV infection and to improve user compliance. In this study we report on the incorporation of various pharmaceutical excipients into TMC 120 silicone, reservoir-type intravaginal rings (IVRs) in order to modify the controlled release characteristics of the microbicide. The results demonstrate that TMC 120 is released in zero-order fashion from the rings over a 28-day period and that release parameters could be modified by the inclusion of release-modifying excipients in the IVR. The hydrophobic liquid excipient isopropyl myristate had little effect on steady-state daily release rates, but did increase the magnitude and duration of burst release in proportion to excipient loading in the IVR. By comparison, the hydrophobic liquid poly(dimethylsiloxane) had little effect on TMC 120 release parameters. A hydrophilic excipient, lactose, had the surprising effect of decreasing TMC 120 burst release while increasing the apparent steady-state daily release in a concentration-dependent manner. Based on previous cell culture data and vaginal physiology, TMC120 is released from the various ring formulations in amounts potentially capable of maintaining a protective vaginal concentration. It is further predicted that the observed release rates may be maintained for at least a period of 1 year from a single ring device. TMC 120 release profiles and the mechanical properties of rings could be modified by the physicochemical nature of hydrophobic and hydrophilic excipients incorporated into the IVRs.

Administration, Intravaginal↗

Controlled release of antibodies for long-term topical passive immunoprotection of female mice against genital herpes.

Current methods for sexually transmitted diseases (STD) prophylaxis, which can be disruptive and inconvenient, must be used before each act of sexual intercourse, so a method that provides protection over the course of many acts is desirable. We used a mouse model of vaginally-transmitted herpes simplex virus 2 (HSV-2) infection to test polymeric controlled-release devices for sustained passive immunoprotection. Vaginal disks were prepared by dispersing a monoclonal antibody to HSV-2 (III-174) within a matrix of poly(ethylene-co-vinyl acetate); these disks released 2 to 40 micrograms/day of antibody into buffered water. When disks were placed in the vagina, large amounts of III-174 (5 to 3,000 ng) were recovered from the vaginal fluid over the next 8 days. Mice were vaginally challenged with 10 ID50 of HSV-2 either 3 or 7 days after disk placement; no mice receiving III-174 disks became infected, while 65% of control mice receiving identical disks with nonspecific IgG did. Controlled-release disks with III-174 provided significant protection against HSV-2 infection (p < 0.005). This new technology for long-term STD prophylaxis should increase user compliance, a factor limiting the efficacy of current methods.

Administration, Intravaginal↗

The vaginal ring and transdermal patch: new methods of contraception.

The most common method of reversible contraception used worldwide is the intrauterine device. However, in the Asia-Pacific the combined oral contraceptive pill and condoms, methods of contraception that require a high degree of day-to-day user compliance, are more popular. The combined vaginal ring and transdermal patch have been developed to overcome the need for daily compliance associated with combined pill use. They have the added advantages of non-oral delivery, thus avoiding gastro-intestinal interference with absorption, and in addition there is no hepatic first-pass effect. Both have been available internationally for some years and offer an alternative to the combined pill. This article reviews and summarises published data on these new methods.

Administration, Cutaneous↗

Clinical field testing of vulcanized Jaipur rubber feet for trans-tibial amputees in low-income countries.

The purpose of this study was to check out the performance and durability of vulcanized Jaipur rubber feet in tropical areas of the developing world. Forty-one MUKTI and 40 NISHA feet were followed for 16 (8 - 17) months. The user compliance was high and nearly all were satisfied. Failure of the prosthetic foot with the need for exchange at the end of the study amounted to 27% (22/81), which is equivalent to a mixed series of rubber feet previously reported (Jensen et al. 2006b). Failures were mostly related to skin fracture and gliding between sponge rubber layers of the heel block.

Adult↗

The combined contraceptive vaginal ring (NuvaRing): first experience in daily clinical practice in The Netherlands.

OBJECTIVES: The combined contraceptive vaginal ring (NuvaRing) has been shown to be safe and effective, with high levels of user compliance, acceptance and satisfaction. However, the data collected from registration studies may differ from the clinical situation. The Dutch NuvaRing Experience Project was initiated to gain insight into NuvaRing use in daily clinical practice. METHODS: A total of 1,130 women, recruited by 257 general practitioners, participated in this observational study. Data on compliance, acceptance, satisfaction, and adverse events were collected during the first 3 months of ring use via an online questionnaire. RESULTS: The results of this study were almost identical to those of the international registration studies. The majority of women complied with the prescribed regimen and were (very) satisfied with NuvaRing, primarily because of the once-a-month administration, low hormonal dose, and ease of use. Only one pregnancy was recorded throughout the study period. The bleeding pattern was better than with the pill, and there were few estrogen-related adverse events. Only a small proportion of women discontinued because of local adverse events such as discomfort during intercourse and expulsion. Following study completion, 80% of women continued with NuvaRing. CONCLUSIONS: In The Netherlands, the first clinical experiences with NuvaRing in daily practice confirm that the contraceptive ring is a reliable, safe, and convenient method of contraception.

Adolescent↗

The effect of high-efficiency particulate air respirator design on occupational health: a pilot study balancing risks in the real world.

OBJECTIVES: To quantify specific factors believed to increase healthcare worker (HCW) risk for contaminated sharps injuries (eg, visibility, communication, and range of motion); to quantify the degree to which respirators of various designs impacted those same factors; and to assess HCW opinions about the suitability of selected respirators with respect to patient care and user compliance criteria. DESIGN: Sharps injury data from seven hospitals were analyzed to determine the potential contribution of visibility, communication, and range of motion to reported injuries. Healthcare workers representing various clinical specialties and physical characteristics were examined at baseline and while wearing five different respirators to quantify the impact of respirator design on visibility, communication, and range of motion. Healthcare workers were interviewed and completed a survey assessing each respirator. SETTING: Hospital and ambulatory-care settings. PARTICIPANTS: Population-based and convenience sample. RESULTS: Communication, visibility, and range of motion were found to affect contaminated sharps injuries significantly. Selected high-efficiency particulate air (HEPA) respirators were found to have a negative impact on each of these variables. Healthcare workers involved in the study also reported compliance criteria problems with selected HEPA respirators, which may effect implementation of respiratory precautions adversely. CONCLUSION: Current HEPA respirators, because of their design, potentially increase the risk of bloodborne pathogen exposure through sharps injuries. We conclude that mandating respirators without regard to the potential impact of their design to the sharps injuries may be counterproductive to HCW safety, because they may increase, rather than decrease, overall occupational risk to HCWs.

Air Pollution, Indoor↗

Using Web-based reporting systems to evaluate health promotion: the experience of two statewide HIV prevention programs.

While Web-based reporting systems are becoming more common in public health for disease surveillance and for tracking interventions such as immunizations, their use for program evaluation is relatively new. This article describes two Web-based reporting systems developed to enable local agencies that conduct health promotion activities to enter process and outcome data for their own use, as well as for analysis by researchers and funders. The systems support the three major uses of evaluation: accountability, program improvement, and generating knowledge for the field. Annually, these programs obtain evaluation information on thousands of clients and individual and group sessions. Developing and introducing the Web-based systems was time-consuming and required significant State Health Department and local agency resources. Involvement of end users in the development process was critical to creating responsive systems that were accepted by staff in local agencies. Staff members from grantee agencies responded well to systems, as evidenced by high rates of user compliance (over 90%) and positive reactions (over 80%) on anonymous surveys. Concerns about resistance from contractors to use of the system, based on fears about breaches in client confidentiality or concerns about the difficulty in using the technology, were not borne out.

HIV Infections↗

Improving access to early treatment of malaria: a trial with primary school teachers as care providers.

The feasibility of improving access to early case detection and prompt and adequate management of acute episodes of malaria using school teachers was explored through an intervention trial in Ghana. Of all the 'fevers' diagnosed as presumptive malaria by the trained teachers, 93% met the case definition. However, a lower proportion (75%) of such correctly diagnosed cases were subsequently treated according to the treatment protocol provided. In a scaled up study, pre-packaging of the antimalarial drug improved the rate of adequate treatment to 97% of cases correctly diagnosed as presumptive malaria. Pre-packaging of chloroquine ensured a high level of user compliance (96.6%), even in the face of diminished supervision of the teachers. It is feasible for the health and education sectors to work in partnership to improve access to early case detection and adequate management of acute episodes of malaria.

Antimalarials↗

Levonorgestrel subdermal implants. Contraception on trial.

When they were introduced to the world market in the 1980s, levonorgestrel subdermal implants offered the promise of an exciting alternative to traditional hormonal contraception. They provide highly effective, long-acting protection from pregnancy, without the need for user compliance. Broad acceptability of the drug has been reported throughout the world. Recently, however, the implants have met with opposition. The drug is associated with a variety of adverse effects, and removal of implants can be problematic. Serious events have been reported in women using levonorgestrel subdermal implants, although causal relationships have not been demonstrated. Additionally, concerns have been raised over the potential for coercive use of the drug. Numerous law suits have been filed alleging serious problems with implants. As a result, the drug has received considerable negative media attention. Before the controversy over levonorgestrel subdermal implants erupted, contraceptive development had declined, resulting from limitations to profits and funding, legal threats, and changes in the insurance industry. The levonorgestrel subdermal implant experience may serve to accelerate this trend. While the introduction of levonorgestrel subdermal implants offered an alternative to the current array of medical contraception, its experience may serve to dampen future contraceptive development efforts. Costly litigation and much controversy involving the implants have acted to create disincentives to further research and development of new methods of medical contraception.

Administration, Cutaneous↗

Clinical field-testing of ATLAS prosthetic system for trans-femoral amputees.

The ATLAS prosthetic system was tested on 47 trans-femoral amputees in two tropical areas. Although the craftsmanship was not acceptable, 46% (16/35) were malaligned many with the foot dorsiflexed, the user compliance was good (91%, 32/35), and the satisfaction rate high (71%, 25/35). However, after 7-10 months failures occurred in 83% (29/35) mostly because of problems with the ATLAS knee mechanism. A modification was tested and 80% (12/15) had again failed at the knee after 6 (2-12) months. The ATLAS system in its current design should be abandoned for use for trans-femoral amputees.

Adolescent↗

Interval and postabortal contraception with the frameless GyneFix.

Intrauterine contraceptive devices (IUDs) have not suffered from the same negative influences in the developing world as in the first world. The method has too many basic advantages to be gainsaid including, most importantly, that it has the lowest lifetime cost of any effective method of contraception, and that user compliance is not an issue once the device is in place. However, the global community is not immune from trends that are seen in selected industrialized countries. Today, better methods of contraception are requested and the discomforts associated with earlier models of IUD, which were once acceptable, are less so today. Faced with the side-effects of oral contraception and the high cost in developing countries, many women who have completed their families undergo surgical sterilization as the only long-term method available to them, notwithstanding severe cultural and economic reservations about doing so. The development of the frameless device is a response to the growing need to develop high-performing, long-acting, reversible and acceptable contraceptives with a high continuation of use and to respond to the urgent need to reverse the legacy of neglect of immediate postabortal family planning.

Abortion, Induced↗

Managing care through managing information: are we headed in the right direction?

Healthcare organizations adopt HIMS to manage the large amount of data available in the patient medical record. The CPR, however, must be more than a mirror image of the paper record to yield analyzable data necessary to answer the consumer's questions about cost and quality of care. Although organizations strive to achieve standardization of medical recording required for analysis, they must also be attuned to factors necessary to achieve end-user compliance and comfort with data input. The closer organizations move to ease of conversion to computerized medical records, the further they may be moving away from data integrity. What is more, the optimal balance point may be different for each organization.

Attitude to Computers↗

Overview of infection control problems: principles in gastrointestinal endoscopy.

The practice of flexible gastrointestinal endoscopy has matured significantly in recent years. Unfortunately, two long-standing problems still exist: the complex physical nature inherent to the endoscopes and accessories, and user compliance with established reprocessing guidelines. Improvements have been made, but newer instruments remain comparatively fragile, expensive, and physically complex, and validated data on reprocessing specific instruments is generally lacking. The practice of flexible gastrointestinal endoscopy today, however, is demonstrably safe and beneficial, provided established practice procedures for reprocessing, with emphasis on instrument cleaning, are followed meticulously in each endoscopy center.

Endoscopy, Gastrointestinal↗

Aircrew visors and color vision performance: a comparative and preliminary pilot study analysis.

BACKGROUND: A very important aspect of visual performance to consider, for present and future recommendations regarding aircrew visors, concerns their impact on color vision. The literature has remained mostly inconclusive with respect to the human perceptual process of colors during actual mission employment. OBJECTIVE: This study uses active duty military aircrews to provide objective and valuable information on the effects of Short Wavelength Absorbing Filters (SWAFs), such as the High Contrast Visor (HCV), and some selected waveband type Laser Eye Protection (LEP) visors on color vision. It provides a direct comparison of several current and proposed aircrew eye protective visors with respect to their effects on color vision. The data analyzed in this study will also be used to support a recommendation regarding a new optimal visor for aircrew wear during air to air (and ground) engagements, for sun protection, and possible visual enhancement in order to improve user compliance. METHODS: Seven volunteers on active flying status each underwent comprehensive color vision testing with and without seven of the U. S. Air Force's (USAF's) current or proposed aircrew visors/filters. Spectral transmissions of these visors/filters were obtained to identify and determine their individual characteristics which included their ability to induce acquired color vision decrements in "color normal" individuals. RESULTS: The widely utilized USAF HCV significantly degraded color vision more than luminosity matched neutral density visors. Abrupt color vision decrements for specifically fielded LEP visors were also noted. Their objective data supported theoretical and speculated color vision effects. Even though low transmittance neutral density visors did have some effect on color vision, decrement severity was not considered significant enough to affect overall performance during color vision testing. CONCLUSIONS AND DISCUSSION: Because of their ability to significantly affect color vision, concerns regarding the use of HCV and LEP visors should entail age, baseline color vision, environmental, and mission factors. Further testing should be done to evaluate the definitive effects that these visors actually have on the recognition of color symbology of Multi Function and Electronic Flight Information Displays. Findings in this study also support theoretical opinions that encourage the fielding of a neutral density filter (mildly tinted) with an overall transmission of 25-49%. Its use by flyers during low and bright illuminant conditions may greatly enhance visual performance by encouraging wearer compliance while allowing colors to be perceived normally.

Adult↗

Positive efficiency findings using computer assisted ICD-encoding: 3.5 years of experience with the computerized patient record system PADS (Patient Archiving & Documentation System).

In daily routine there is a major discrepancy between what physicians do and what they document. From a medical information processing point of view amongst the more important functions physicians perform in their daily routine is the encoding of diagnoses using a standard vocabulary such as ICD-9. This paper presents evidence that through the use of the ICD-encoding module of a computerized patient record system (PADS, Patient Archiving and Documentation System) user compliance can be improved. "Bypassing" mechanisms can be partly reversed (up to 43%), more coded diagnoses are documented (by 51%) and those diagnoses documented are more complete (increase by 57%).

Germany↗