Using family and staff experiences of a botulinum toxin-A service to improve service quality.

BACKGROUND: The decision for families to proceed with botulinum toxin-A (BoNT-A) injections for managing childhood conditions involving hypertonia can be complex. Family-centred care is a service model that facilitates supporting families in this decision-making process. Understanding families' experiences of services is critical to developing family-centred care. The aim of this project was therefore to increase understanding of the experiences of families of children attending a BoNT-A service in order to improve the service and its family-centred approach to care. METHOD: Sixteen staff of a BoNT-A service participated in a patient journey mapping exercise. Nine families of the service participated in in-depth interviews. Interviews were audio-recorded and transcribed verbatim. Data from the staff session and interviews were analysed independently using grounded, hermeneutic thematic analysis. RESULTS: Staff sessions revealed 5 core themes that related to impacting on the family experience. Family interviews revealed 4 core themes, with 7 subthemes and 1 latent theme. CONCLUSIONS: Areas of importance identified by families relating to BoNT-A treatment included acknowledgement of individual needs, care coordination, empowerment of families and patients, consistency in service delivery, and the distressing nature of appointment and decision-making. Comparison of the data from the staff patient journey mapping and family interviews suggested that staff have a good but incomplete understanding of the factors important to families, highlighting the need for consumer engagement in establishing family-centred care. The themes identified can guide the provision of family-centred BoNT-A injection clinics.

EGF receptors as transcription factors: ridiculous or sublime?

The notion that a transmembrane receptor at the cell surface can somehow reappear as a transcription factor in the nucleus is bound to be controversial. However, there are two reported examples of this. If this hypothesis can withstand the inevitable and necessary battery of additional empirical tests, then our understanding of signal transduction needs to move in a new direction.

Evaluating paediatric brain injury services in NSW.

BACKGROUND: Rehabilitation professionals strive to provide high-quality evidence-based services for children. Developing systems to measure and monitor the benefits of our services, and health outcomes for children is complex and challenging. The Community Outcome Project aims to introduce systematic outcome measurement across the network of paediatric community-based brain injury services within the New South Wales Brain Injury Rehabilitation Program (BIRP) to support clinical practice and service evaluation. METHODS: A literature review informed the development of the evaluative framework and identified available paediatric outcome measures which may be appropriate. Extensive consultation with clinicians supported project planning and identified clinical priorities that the outcome measures needed to capture. Outcome measures were shortlisted by matching them to identified clinical priorities, and then trialled in clinical practice. Qualitative feedback regarding clinical utility and feasibility was obtained from clinical staff. The process has utilized change management strategies to ensure the success of the project and keep staff engaged. RESULTS: The process identified the three main clinical priorities for outcome measurement - family functioning, school performance and participation. Three outcome measures were chosen for the pilot project that is currently underway. They are Family Burden of Injury Interview, Academic Competence and Evaluation Scales and Child and Adolescent Scale of Participation. Plans for analyses of outcome data within the paediatric BIRP services are discussed. CONCLUSIONS: Extensive preparation is required to optimize staff engagement in a project that systematically introduces outcome measures that are useful to clinicians, clients and service providers. Managing the change required is a key focus of the project. Benefits and costs to clinicians and services will be discussed.

Signal transduction cascades regulating fungal development and virulence.

Cellular differentiation, mating, and filamentous growth are regulated in many fungi by environmental and nutritional signals. For example, in response to nitrogen limitation, diploid cells of the yeast Saccharomyces cerevisiae undergo a dimorphic transition to filamentous growth referred to as pseudohyphal differentiation. Yeast filamentous growth is regulated, in part, by two conserved signal transduction cascades: a mitogen-activated protein kinase cascade and a G-protein regulated cyclic AMP signaling pathway. Related signaling cascades play an analogous role in regulating mating and virulence in the plant fungal pathogen Ustilago maydis and the human fungal pathogens Cryptococcus neoformans and Candida albicans. We review here studies on the signaling cascades that regulate development of these and other fungi. This analysis illustrates both how the model yeast S. cerevisiae can serve as a paradigm for signaling in other organisms and also how studies in other fungi provide insights into conserved signaling pathways that operate in many divergent organisms.

Use of three-dimensional kinematic analysis following upper limb botulinum toxin A for children with hemiplegia.

BACKGROUND AND PURPOSE: To examine whether three-dimensional (3-D) kinematic analysis can detect changes in upper limb tasks (reach and hand-to-mouth) in children with hemiplegia, following upper limb botulinum toxin A injections. METHODS: Ten children with hemiplegic cerebral palsy (7 males, 3 females, aged 9-17 years). Subjects received botulinum toxin A (Botox) injections into elbow forearm muscles combined with 6 weeks of occupational therapy. Participants completed a 3-D kinematic analysis of two upper limb tasks, Melbourne Assessment of Unilateral Upper Limb Function and modified Ashworth scores measured at baseline, 2, 6 and 12 weeks post-injection. RESULTS: Post-injections, elbow flexor muscle tone was reduced for 12 weeks (p < 0.05). Group differences in active range of motion during 3-D analysis tasks could not be demonstrated at any time post-intervention. However, individual analyses found that at 2 weeks post-injection, three subjects had >15 degrees increases in active elbow extension and six subjects showed an increase of >25 degrees in forearm supination during performance of the reach and hand-to-mouth tasks, respectively. CONCLUSIONS: 3-D kinematics can detect changes in active movements during functional tasks following botulinum toxin A injections, suggesting this could be a potential objective outcome measure in a clinical trial.

Adenovirus-mediated p53 gene transfer in advanced non-small-cell lung cancer.

BACKGROUND: Preclinical studies in animal models have demonstrated tumor regression following intratumoral administration of an adenovirus vector containing wild-type p53 complementary DNA (Ad-p53). Therefore, in a phase I clinical trial, we administered Ad-p53 to 28 patients with non-small-cell lung cancer (NSCLC) whose cancers had progressed on conventional treatments. METHODS: Patients received up to six, monthly intratumoral injections of Ad-p53 by use of computed tomography-guided percutaneous fine-needle injection (23 patients) or bronchoscopy (five patients). The doses ranged from 10(6) plaque-forming units (PFU) to 10(11) PFU. RESULTS: Polymerase chain reaction (PCR) analysis showed the presence of adenovirus vector DNA in 18 (86%) of 21 patients with evaluable posttreatment biopsy specimens; vector-specific p53 messenger RNA was detected by means of reverse transcription-PCR analysis in 12 (46%) of 26 patients. Apoptosis (programmed cell death) was demonstrated by increased terminal deoxynucleotide transferase-mediated biotin uridine triphosphate nick-end labeling (TUNEL) staining in posttreatment biopsy specimens from 11 patients. Vector-related toxicity was minimal (National Cancer Institute's Common Toxicity Criteria: grade 3 = one patient; grade 4 = no patients) in 84 courses of treatment, despite repeated injections (up to six) in 23 patients. Therapeutic activity in 25 evaluable patients included partial responses in two patients (8%) and disease stabilization (range, 2-14 months) in 16 patients (64%); the remaining seven patients (28%) exhibited disease progression. CONCLUSIONS: Repeated intratumoral injections of Ad-p53 appear to be well tolerated, result in transgene expression of wild-type p53, and seem to mediate antitumor activity in a subset of patients with advanced NSCLC.

Serum beta 2-microglobulin and human immunodeficiency virus infection.

Serum beta 2-microglobulin (beta 2-M) was measured in two prospectively evaluated groups of homosexual men in 1983 and 1985. Serum beta 2-M was raised in 64% of patients with HIV infection, but in only 6.7% of uninfected homosexuals. Depression of the total lymphocyte count was only clinically useful when it reached less than 1.0 X 10(9)/l. In further studies all patients with AIDS and AIDS-related complex (ARC) had raised levels of serum beta 2-M. Mean levels of beta 2-M did not differ between patients with persistent generalized lymphadenopathy (PGL) and asymptomatic HIV-infected patients. Raised serum levels of beta 2-M accompanied major immune dysfunction in HIV infection. Serum beta 2-M levels of greater than 3.0 mg/l in HIV-infected homosexual men were associated with progression to AIDS.

Sympathoadrenal and renin-angiotensin systems in the development of two-kidney, one clip renal hypertension in rats.

The relative roles of the sympathetic nervous system and renin-angiotensin system in the development of two-kidney renal hypertension were studied using four groups of rats: Group I = vehicle control; Group II = 6-OH-dopamine (2 weeks prior to renal clipping then weekly throughout the study); Group III = adrenal medullectomy plus vehicle; Group IV = 6-OH-dopamine plus adrenal medullectomy. Six weeks after clipping of a single renal artery, plasma renin activity (PRA) was comparably elevated in all groups. However, mean blood pressure (MBP) of Group II was lower than that of Group I controls (154.7 +/- 6.8 vs 197.3 +/- 6.6 mm Hg respectively). The MBP of Group III (207.0 +/- 5.2 mm Hg) was not different from that of Group I whereas in Group IV (134.2 +/- 18.0 mm Hg) it was markedly lower. All groups of rats were given a single dose of captopril (30 mg/kg p.o.) to inhibit the renin-angiotensin system. Despite differences in starting MBP, captopril caused similar reductions (38-50%) of MBP and increases in PRA in all groups. Similar results were obtained in two-kidney renal hypertensive rats with hypertension of 12 weeks' duration. It is concluded that the sympathetic nervous system does not contribute to the elevated PRA in two-kidney renal hypertensive rats but does contribute significantly to the development of hypertension in this model.

A flow cytometric method to estimate the precursor frequencies of cells proliferating in response to specific antigens.

Fluorescent dyes that stain cell membranes or cytoplasm and then partition between daughter cells at division have been used in conjunction with flow cytometry to measure the proliferation of cells. In this paper, using peripheral blood mononuclear cells responding to tetanus toxoid, we describe an extension of this dye methodology to calculate the precursor frequency of antigen-specific T-cells. With mathematical deconvolution of the fluorescence histograms providing information about the proportion of cells in each of the daughter generations, information can be derived about the precursor frequency of cells in the original population that responded to the specific stimulus. Data from a model system with different proportions of fixed and viable cells indicate that the flow method returns accurate values for precursor frequency. Based on the characteristics of flow cytometric data acquisition, it is estimated that the flow method could detect proliferation of cells that represented, before addition of the stimulus, approximately 1/10(5) of the population. When comparing results to those from the limiting dilution technique, the flow cytometric method returns values that indicate higher precursor frequencies. Possible reasons for this discrepancy are discussed. The flow cytometric method offers the advantage of simplicity as well as the additional ability to phenotype the responding cells and determine their rate of proliferation. The flow method may find use as a simple, routine assay in the fields of allergy, transplant rejection, and autoimmunity and for quantitating responses to vaccination and cancer immunotherapy.

Pharmacokinetic-pharmacodynamic relationships of the bispecific antibody MDX-H210 when administered in combination with interferon gamma: a multiple-dose phase-I study in patients with advanced cancer which overexpresses HER-2/neu.

INTRODUCTION: MDX-H210 is a Fab'xFab' bispecific antibody (BsAb) constructed chemically by crosslinking Fab' mAb 520C9 (anti-HER-2/neu) and Fab' mAbH22 (anti-CD64). STUDY DESIGN AND OBJECTIVES: This was a dose escalation study of intravenous MDX-H210 (1-70 mg/m(2)), preceded 24 h beforehand by subcutaneous IFNgamma (50 microg/m(2) to up-regulate FcgammaRI) administered three times a week for 3 weeks. We investigated the pharmacokinetic-pharmacodynamic relationships between MDX-H210 C(max) and AUC and (i) MDX-H210 binding to peripheral blood monocytes and neutrophils, (ii) the peak plasma G-CSF, IL-6, IL-8 and TNFalpha concentrations, and (iii) the observed clinical toxicity. RESULTS: 23 patients (19F:4M; median age 51.5; range 25-72 y) with advanced HER-2/neu positive cancers (19 breast, three prostate and one lung) were studied. Plasma MDX-H210 concentrations over time, circulating numbers of monocytes and neutrophils, percent saturation of monocyte and neutrophil FcgammaRI, and plasma concentrations over time of G-CSF, IL-6, IL-8 and TNFalpha were measured and clinical toxicity monitored. The E(max) pharmacodynamic model best fitted the relationship of MDX-H210 C(max) and the maximum percent saturation of both monocytes (E(max)=74.6; EC(50)=0.9 microg/ml) and neutrophils (E(max)=66.2; EC(50)=2.3 microg/ml) on the first day of treatment. On the last day of treatment, day 19, these parameters were E(max)=57.0% and EC(50)=0.46 microg/ml for monocytes and E(max)=61.9% and EC(50)=0.26 microg/ml for neutrophils. No positive relationship was defined between the log MDX-H210 C(max) and the log peak plasma IL-6, G-CSF, TNF or IL-8 concentrations on day 1. On day 19 these plasma cytokine concentrations were undetectable post MDX-H210 therapy. There was no consistent relationship between MDX-H210 C(max) and the observed clinical toxicities. CONCLUSIONS: These data suggest that MDX-H210 C(max) and AUC could be related by the E(max) model to maximum percent FcgammaRI saturation on circulating monocytes and neutrophils in the patients studied. After day 1, the post MDX-H210 therapy cytokine response attenuated over time, consistent with desensitization. We did not find a relationship between log MDX-H210 C(max) and peak plasma cytokine concentrations or clinical toxicities.

Bispecific antibody-targeted phagocytosis of HER-2/neu expressing tumor cells by myeloid cells activated in vivo.

Studies from our laboratory and others have established that both mononuclear phagocytes and neutrophils mediate very efficient cytotoxicity when targeted through Fc receptors using a suitable monoclonal or bispecific antibody (BsAb). Cross-linking an Fc receptor for IgG (FcgammaR) triggers multiple anti-tumor activities including superoxide generation, cytokine and enzyme release, phagocytosis and antibody-dependent cellular cytotoxicity (ADCC). In this report, using unfractionated leukocytes and two color flow cytometric analysis, we describe the phagocytic capacity of peripheral blood polymorphonuclear cells (PMN) and monocytes isolated from patients enrolled in a phase I clinical trial of MDX-H210 given in combination with IFNgamma. MDX-H210 is a BsAb targeting the myeloid trigger molecule FcgammaRI and the HER-2/neu proto-oncogene product overexpressed on a variety of adenocarcinomas. In this trial, cohorts of patients received escalating doses of MDX-H210 3 times per week for 3 weeks. Interferon-gamma (IFNgamma) was given 24 h prior to each BsAb infusion. Our results demonstrate that monocytes from these patients were inherently capable of phagocytosing the HER-2/neu positive SK-BR-3 cell line and that addition of MDX-H210 into the assay significantly enhanced the number of targets phagocytosed. Two days after administration of an immunologically active dose of MDX-H210 (10 mg/m2), monocytes from these patients were able to phagocytose greater amounts of target cell material, indicating that these cells remained armed with functionally sufficient BsAb for at least 48 h. PMN from these patients very efficiently mediated phagocytosis through FcgammaRI after being treated with IFNgamma, but not before. We conclude that phagocytosis is not only an efficient mechanism of myeloid cell-mediated cytotoxicity, but may also be a mechanism by which antigens from phagocytosed cells can enter a professional antigen presenting cell for processing and presentation.

Isolation of intestinal spirochaetes from homosexuals.

Spirochaetes were isolated from rectal swabs of two homosexuals and the faeces of a third, using simple isolation techniques not previously applied to specimens of this type. The ease of culture of these organisms will enable their distribution and pathogenicity to be studied, particularly in relation to their significance in homosexuals.

A comparison of "U" and standard techniques for Norplant removal.

OBJECTIVE: To evaluate the "U" technique versus the manufacturer-recommended technique for Norplant removal. METHODS: We conducted a randomized comparison of the manufacturer-recommended method of removal and the "U" technique. The latter involves an incision between and parallel to the third and fourth implants and uses a modified vasectomy clamp to remove the implants by pulling perpendicular to the implant's axis. RESULTS: Twenty-one physicians (three experienced, 18 inexperienced) performed 200 Norplant removals. Inexperienced physicians took significantly less time for removal using the "U" technique than the standard technique (7.9 versus 10.5 minutes), even after controlling for other factors. Experienced physicians also required less time for removal using the "U" technique (3.1 versus 3.7 minutes), but the difference was not statistically significant after controlling for other factors. Both experienced and inexperienced physicians broke implants more frequently using the standard technique, although the difference was significant only for experienced physicians (relative risk 3.6, 95% confidence interval 1.2, 10.8). No differences were noted between the techniques with respect to tissue damage or patient reports of pain during or after removal. CONCLUSIONS: These results suggest that the "U" technique is an improvement over the standard technique, particularly for personnel who are not highly experienced in Norplant removal.

Latex condom breakage and slippage in a controlled clinical trial.

Although millions of couples rely on male latex condoms to protect against unintended pregnancy and sexually transmitted infections, their use is limited in part by questions about their performance. Rates of condom breakage and slippage, two measures of performance, vary broadly across studies. This variation in part reflects study variability and limitations, including sample size, reliance on subjects' memory, user populations, and products evaluated. In an effort to define condom performance in a group of monogamous couples typical of those using condoms for contraception, we conducted a clinical trial of a single brand of lubricated condoms (Durex Ramses). A total of 4637 attempts to use the condom were evaluated. Six breaks occurred before intercourse (nonclinical breaks), and 10 condoms broke during intercourse or were only noted to have broken upon withdrawal (clinical breaks), resulting in a nonclinical breakage rate of 0.13% (95% confidence interval, 0.05-0.28%), clinical breakage rate of 0.28% (0.15-0.48%), and a total breakage rate of 0.41% (0.25-0.64%). The rate of complete slippage was 0.63% (0.42-0.90%), and total failure (clinical breaks plus complete slips) was 1.04% (0.76-1.37%). These rates are lower than those in other studies with the exception of one, a prospective investigation in a population of female prostitutes. Results indicate that condoms can, in experienced, motivated populations, provide excellent performance and suggest that their efficacy at preventing pregnancy may equal that of the most reliable forms of contraception. Because this study involved a single condom brand, these results may not be generalizable to other brands.

PIP: Rates of condom slippage and breakage were recorded for 4637 attempts to use the condom during sexual intercourse by 92 monogamous couples who had sex at least 8 times per month and had no history of fertility-impairing conditions, including sexually transmitted infections. The couples were comprised of men age 18-50 years and women age 18-40 years. They were at risk of pregnancy, and condoms were their sole method of birth control during the study. Lubricated Durex Ramses condoms were tested in this clinical trial. The men and women were of mean ages 28.8 and 26.8 years, respectively, 75.0% White, and either married or never married in approximately equal proportions. Nearly all participants completed high school and 75% lived with their current partner or spouse. 70-75% were experienced condom users, having used a condom more than 50 times with their current partner. 6 breaks occurred before intercourse and 10 condoms broke during intercourse or were noted to have broken upon withdrawal. These breakages amount to a nonclinical breakage rate of 0.13%, a clinical breakage rate of 0.28%, and a total breakage rate of 0.41%. No breakage or slippage occurred during the 4 reported acts of anal intercourse. The rate of complete slippage was 0.63% and total failure, clinical breaks plus complete slips, was 1.04%. These rates are lower than those in other studies except for 1 prospective study in a population of female prostitutes.

Use and misuse of oral contraceptives: risk indicators for poor pill taking and discontinuation.

The contraceptive efficacy of oral contraceptives (OCs) depends on their proper and continued use, particularly with lower estrogen preparations. However, few studies have examined why women miss pills or discontinue OCs, and those that do tend to be small and to focus on adolescents. To address the issues of poor OC compliance and early OC discontinuation, we analyzed OC use in a convenience sample of 6,676 women between the ages of 16 and 30 from Denmark, France, Italy, Portugal, and the United Kingdom. Logistic regression was used to examine the independent effect of each factor. Poor compliance was associated with a lack of established routine for pill-taking (relative risk [RR] = 3.3), failure to read and understand written materials that came with the OC package (RR = 2.2), not receiving adequate information or help about OCs from their health care provider (RR = 1.5), and occurrence of certain side effects, including hirsutism (RR = 2.1), nausea (RR = 1.4), bleeding irregularities (RR = 1.3), and breast tenderness (RR = 1.2). Women who were inconsistent OC users, missing one or more pills per cycle, were almost three times as likely to experience an unintended pregnancy while using OCs than were women who took their OCs consistently. Factors that predicted early discontinuation (women who wished to continue contraceptive protection but discontinued OC use) were primarily side effects, including nausea (RR = 2.1), bleeding (RR = 1.9), breast tenderness (RR = 1.8), mood changes (RR = 1.8), and weight gain (RR = 1.4).(ABSTRACT TRUNCATED AT 250 WORDS)

PIP: To address the issues of poor oral contraceptive (OC) compliance and early OC discontinuation, OC use was analyzed in a convenience sample of 6676 women between the ages of 16 and 30 from Denmark, France, Italy, Portugal, and the United Kingdom, obtained from the Wyeth-Ayerst Contraceptive survey conducted in 1993. Logistic regression was used to examine the independent effect of each factor. 81% of the women used their OCs consistently. User characteristics accounted for inconsistent use. Poor compliance was associated with a lack of established routine for pill-taking and failure to read and understand written materials that came with the OC package. Those who understood little or none of the instructions were 2.4 times more likely to be among women who missed 2 or more pills per cycle. Other factors for inconsistent use included not receiving adequate information or help about OCs from their health care provider (RR = 1.5), and occurrence of certain side effects, including hirsutism (RR = 2.1), nausea (RR = 1.4), bleeding irregularities such as breakthrough bleeding and amenorrhea (RR = 1.3), and breast tenderness (RR = 1.2). Women who were inconsistent OC users, missing 1 or more pills per cycle, were 2.6 times as likely to experience an unintended pregnancy while using OCs than were women who took their OCs consistently. Factors that predicted early discontinuation (women who wished to continue contraceptive protection but discontinued OC use) were primarily side effects, including nausea (RR = 2.1), bleeding in the first 3 months (RR = 1.9), breast tenderness (RR = 1.8), mood changes (RR = 1.8), hair growth (RR = 1.7), and weight gain (RR = 1.4). Multiple side effects substantially increased the likelihood of discontinuation, with a single side effect increasing the risk by 50%, 2 by 220%, and 3 by 320%. Improved compliance can be facilitated if providers emphasize the need to continue to take OCs reliably even if side effects do occur.

The effect of desogestrel, gestodene, and other factors on spotting and bleeding.

Spotting and bleeding are among the most common side effects associated with oral contraceptive (OC) use and their occurrence is a prime determinant of whether a new user will continue to use OCs. Desogestrel and gestodene are two new progestins that were developed in part to minimize the occurrence of these side effects. Assessing the effect of these progestins is difficult, however, in part because their effects may be subtle, requiring a large sample size and possibly being overshadowed by other factors. To address these issues, we analyzed data from two comparative multicenter clinical trials that included 15,421 cycles among 2767 women. One study compared 75 micrograms gestodene + 30 micrograms ethinyl estradiol (EE) with 150 micrograms desogestrel + 30 micrograms EE, the other compared the same gestodene preparation with 150 micrograms desogestrel + 20 micrograms EE. Both studies found a higher risk of spotting or bleeding in all cycles among users of the desogestrel-containing preparation, with the differences ranging between 20% and 70% higher for the first study and 40% and 140% in the second. These differences were statistically significant in four of six cycles in each study and persisted after controlling for consistency and recency of OC use as well as smoking. After pooling the data and controlling for estrogen dose, the desogestrel-containing preparation was significantly associated with more frequent spotting or bleeding in five of six cycles. Smoking and consistency and recency of OC use were also independent predictors of spotting or bleeding.

Compliance and oral contraceptives: a review.

Compliance difficulties are more common among oral contraceptive (OC) users than generally appreciated by clinicians, in part because unintended pregnancy is a relatively infrequent consequence and in part because more common manifestations such as spotting and bleeding may not be recognized as resulting from poor compliance. While improving compliance is a shared responsibility of patients, clinicians, and manufacturers, the clinician is the focal point for these efforts. Counseling must be individualized, which requires knowledge of factors that predict compliance and an understanding of the patient's decision-making process as it relates to medications. Most OC compliance research has focused on adolescents, where predictors of poor compliance include multiple sex partners, low evaluation of personal health, degree of concern about pregnancy, and previous abortion. Good compliance has been linked with patient satisfaction with the clinician, the absence of certain side effects, establishing a regular daily routine to take OCs, and reading information distributed with OC packaging.

PIP: The findings of decades of research on user compliance of drug treatment regimens can be reduced to a simple statement that a third of users always comply, a third never complies, and a third sometimes complies. The efficacy of oral contraceptives (OC), however, relies on compliance even though poor compliance has no immediate or uniform consequences. Research on OC compliance has focused on adolescents because of their high pregnancy rates and their high reliance on OCs. Young women frequently use OCs in a sporadic fashion. While most adolescents are as compliant as older women, only 26% of those aged 14 and younger take their OC daily as compared to 40% of all other age groups. Attempts have been made to identify factors predicting noncompliance using 1) the individualistic model, which measures a number of factors using statistical techniques; 2) the health belief model which postulates that health-seeking behavior depends upon perception of health risk, and 3) the patient-provider model which highlights the importance of communication techniques. Factors which have been found to influence OC use are the occurrence of side effects, the routine followed, and failure to read and/or understand the packaging information. Little is known about the influence of patient-provider interactions, and only a few strategies to improve compliance have been studied. To improve compliance, health care providers should properly counsel women on their choice of method, side effects, OC misinformation and beneficial effects, correct use, missed pill instructions, and how to get additional information. Proper follow-up techniques should also be used. OC users can improve compliance by following a regular routine, carefully reading packaging information, knowing what to do if an OC is missed, and identifying a back-up method. Manufacturers should encourage research into compliance predictors and factors, incorporate findings into tools to help clinicians identify those at risk, use packaging that encourages compliance, and develop standardized and comprehensible written materials.

The male polyurethane condom: a review of current knowledge.

Condoms are one of the oldest form of contraceptive and the best recognized form of protection against sexually transmitted diseases. Their use, however, is limited by both behavioral factors and device-related factors, including complaints about decreased sensitivity and sexual enjoyment. To address these limitations, a male condom made of polyurethane was developed. Polyurethane is a strong impermeable material with good heat transfer characteristics that is less susceptible to deterioration during storage than latex. Because little information is available comparing polyurethane and latex condoms in terms of consumer preferences as well as breakage and slippage, we reviewed four pre-marketing studies of polyurethane condoms, one of which included comparison to latex. No significant differences in slippage and breakage rates between latex and polyurethane condoms were reported in the study that included a latex comparator, and other studies of polyurethane condoms alone resulted in rates in the same range as published for latex condoms. Subjectively, consumers expressed significantly greater preference for the polyurethane condom over latex in regard to appearance, lack of smell, likelihood of slippage, comfort, sensitivity, natural look, natural feel, and overall. While additional testing is needed, these preliminary results suggest that the male polyurethane condom reviewed performed at least as well as latex condoms and is preferred by consumers. If preference translates to greater use, the male polyurethane condom may address important barriers that have been linked with inadequate condom use in the past. These results, however, may not be generalizable to other brands of polyurethane condom currently under development.

PIP: A literature review of four pre-marketing studies of the Avanti male polyurethane condom was conducted to compare consumer preferences, breakage, and slippage of polyurethane and latex condoms. The condom manufacturer, London International, recruited participants for these studies throughout the UK. In the only study that had two comparison groups, the polyurethane condom had the highest overall consumer reference rating (7.4 vs. 6.8; p = 0.002) and the lower breakage and slippage rates (0.9% vs. 2.1% and 0.4% vs. 1.1%, respectively). Slippage and breakage rates in the other three studies were similar to those in the literature for latex condoms. Consumers preferred the polyurethane condom to the latex condom because they perceived it as having a natural feel and look with no smell and enhanced sensitivity and comfort. The number of patients lost to follow-up was low for all four studies (no greater than 9%). The leading reason for not using any of the different condoms provided to study participants was lack of opportunity (56%). Additional research is needed, particularly studies with a comparison latex group. Clinical trials of the male polyurethane condom examining contraceptive efficacy, breakage, and slippage data are currently being conducted among 800 couples recruited in many centers. Nevertheless, the findings of the literature review suggest that the Avanti polyurethane condom perform at least as well as the latex condom and that consumers prefer the polyurethane condom. If preference increases use, the Avanti polyurethane condom may overcome barriers that have been associated with poor condom use in the past.