Caring for continence in stroke care settings: a qualitative study of patients' and staff perspectives on the implementation of a new continence care intervention.

OBJECTIVES: Investigate the perspectives of patients and nursing staff on the implementation of an augmented continence care intervention after stroke. DESIGN: Qualitative data were elicited during semi-structured interviews with patients (n = 15) and staff (14 nurses; nine nursing assistants) and analysed using thematic analysis. SETTING: Mixed acute and rehabilitation stroke ward. PARTICIPANTS: Stroke patients and nursing staff that experienced an enhanced continence care intervention. RESULTS: Four themes emerged from patients' interviews describing: (a) challenges communicating about continence (initiating conversations and information exchange); (b) mixed perceptions of continence care; (c) ambiguity of focus between mobility and continence issues; and (d) inconsistent involvement in continence care decision making. Patients' perceptions reflected the severity of their urinary incontinence. Staff described changes in: (i) knowledge as a consequence of specialist training; (ii) continence interventions (including the development of nurse-led initiatives to reduce the incidence of unnecessary catheterisation among patients admitted to their ward); (iii) changes in attitude towards continence from containment approaches to continence rehabilitation; and (iv) the challenges of providing continence care within a stroke care context including limitations in access to continence care equipment or products, and institutional attitudes towards continence. CONCLUSION: Patients (particularly those with severe urinary incontinence) described challenges communicating about and involvement in continence care decisions. In contrast, nurses described improved continence knowledge, attitudes and confidence alongside a shift from containment to rehabilitative approaches. Contextual components including care from point of hospital admission, equipment accessibility and interdisciplinary approaches were perceived as important factors to enhancing continence care.

Psychometric properties of the pelvic organ prolapse symptom score.

OBJECTIVE: To assess the internal consistency, construct validity and sensitivity to change of a pelvic organ prolapse symptom score (POP-SS). DESIGN: Analysis of data from three prolapse studies, including symptomatic and asymptomatic women who completed the POP-SS. SETTING: (1) A community setting in New Zealand, (2) two gynaecology outpatient departments in Scotland and (3) a gynaecological surgery department in Scotland. POPULATION OR SAMPLE: (1) Participants from a survey of postnatal women at 12-year follow up, invited to complete a prolapse questionnaire and have prolapse assessment, (2) new gynaecology outpatients presenting with prolapse symptoms, randomised to pelvic floor muscle training (PFMT) or control and (3) women having anterior and/or posterior prolapse surgery, randomised to mesh insert or no mesh. METHOD: Data were analysed to assess internal consistency, construct validity and sensitivity to change of the POP-SS. MAIN OUTCOME MEASURES: Cronbach's alpha, significance of differences in POP-SS scores between studies and significance of difference in POP-SS scores pre- to post-intervention. RESULTS: For internal consistency, Cronbach's alpha ranged from 0.723 to 0.828. Women having surgery had higher POP-SS scores than those having conservative management (mean difference 5.0, 95% CI 3.1-6.9), who in turn had higher scores than the asymptomatic women (mean difference 5.9, 95% CI 4.4-7.4). Significant differences in POP-SS score were detected after surgery and PFMT. The improvement due to surgery was significantly greater than that associated with PFMT (z =-3.006, P = 0.003). CONCLUSION: The POP-SS has good internal consistency and construct validity and is sensitive to change.

Etretinate kinetics during chronic dosing in severe psoriasis.

Fourteen patients with various forms of psoriasis participated in a clinical study to characterize the pharmacokinetics of etretinate before, during, and after 6 months of therapy. A single 100 mg dose was initially given, followed 2 days later by approximately 170 days of multiple dosing with 25 mg one, two, three, or four times a day depending on the subject's response and tolerance. Blood samples were drawn for 48 hours after the initial dose, for 12 hours after dosing at monthly intervals, and for up to 8 months after administration of the last dose. Blood concentrations of etretinate were determined by a specific reverse-phase gradient elution HPLC assay. Blood concentrations after the first dose declined with an apparent t1/2 of approximately 7 hours, whereas those after the last dose declined with an apparent t1/2 of approximately 120 days. The lengthening of the t1/2 during chronic dosing appears to result from the cumulation of blood concentrations in the measurable range rather than from time-related alterations in drug kinetics. This is substantiated by the fact that etretinate blood concentration--time data for the entire course of therapy were fit by a nonlinear least-squares computer program designed to accommodate changes in the dosing regimen. A single polyexponential kinetic equation described the entire 6-month course of therapy as well as the 8-month washout without the need to invoke nonlinear kinetics. Although single-dose kinetic data for etretinate may not be good predictors of steady-state blood concentrations, etretinate appears to follow linear kinetics during these dosing regimens.

Effect of meals on the kinetics of etretinate.

Eight healthy men received 100 mg oral doses of etretinate separated by two-week washout periods in an open, randomized, crossover study. Etretinate was administered during a complete fast, with a standard high fat breakfast, a standard high carbohydrate breakfast, and 16 ounces of whole milk. Plasma samples were obtained at specific times over a 48-hour period. Plasma concentrations of etretinate as well as two of its major metabolites were determined by a specific, reverse-phase, high-performance liquid chromatography method. Plasma concentrations of etretinate were greater when administered with a high fat meal and whole milk compared to ingestion with a high carbohydrate meal or during a complete fast. In contrast, there was no increase in the plasma concentrations of the active metabolites following any of the meals. These data indicate that chronic dosing of etretinate with milk or a high fat meal compared with fasting conditions will result in higher concentrations of etretinate, which may ultimately lead to higher metabolite concentrations.

A randomized, double-blind, placebo-controlled, dose-response study of the analgesic effect of lornoxicam after surgical removal of mandibular third molars.

The aim of the present study was to investigate the dose-effect relationship of single doses of 4 to 32 mg of lornoxicam (LNX), a new nonsteroidal antiinflammatory drug belonging to the oxicam group, compared with placebo and 10 mg ketorolac (KET) in the treatment of pain after oral surgery. Also, it was the aim of the study to evaluate the relationship between adverse events and different doses of LNX. After the surgical removal of a mandibular third molar, test medication was taken when the patients experienced at least moderate pain. After medication, pain relief, pain intensity, and any discomfort from the medication were noted in a questionnaire. Paracetamol was used as rescue medication. A total of 278 patients completed the study according to the protocol. The primary efficacy parameter was total pain relief after 6 hours, and all active treatments showed significantly better effect than placebo, with LNX 16 and 32 mg being significantly superior to LNX 4 mg. All other efficacy parameters showed the same dose-effect relationship. A total of 37 adverse events were reported evenly distributed in the 6 treatment groups; only 3 of these were considered severe, and all disappeared without treatment. In conclusion, the study showed a dose-effect relationship of LNX without a rise in adverse events. The effect of 10 mg KET seemed to be at the level of 8 to 16 mg LNX.

Analgesic dose-response relationship of ibuprofen 50, 100, 200, and 400 mg after surgical removal of third molars: a single-dose, randomized, placebo-controlled, and double-blind study of 304 patients.

The purpose of this single-dose, randomized, placebo-controlled, and double-blind study was to evaluate the analgesic dose-response relationship of 50-mg, 100-mg, 200-mg, and 400-mg doses of ibuprofen after third molar surgery. Patients were instructed to take a single dose of either placebo or 50 mg, 100 mg, 200 mg, or 400 mg of ibuprofen when the postoperative pain was moderate to severe. Acetaminophen 500 mg was used as a rescue medication. Pain intensity, pain relief, and any possible adverse events were recorded on self-administered questionnaires hourly for 6 hours after intake of study medication. If rescue medication was taken, the time of intake was registered. A total of 304 patients entered the study, and 258 complied with the protocol. A positive analgesic dose-response relationship of 50-mg, 100-mg, 200-mg, and 400-mg doses of ibuprofen was observed when evaluated by pain intensity difference, sum of pain intensity difference, pain relief, total pain relief, and survival distribution of patients not taking rescue medication. Although significant pain relief was seen after a dose of 50 mg ibuprofen, ibuprofen 400 mg provided maximum pain relief and the longest duration of analgesic effect. Mild transient adverse events were reported by 6.8% of the patients. However, there was no significant difference in frequency between the placebo and 50 mg, 100 mg, 200 mg, and 400 mg ibuprofen dose groups.

Cardioprotection with a novel adenosine regulating agent mediated by intravascular adenosine.

Adenosine is cardioprotective in models of myocardial stunning and infarction, but the precise compartment within the heart in which adenosine elicits its cardioprotective effects has not been determined. The goals of the present study were to (i) investigate the effects of a novel adenosine regulating agent, GP531 (5-amino-1-beta-n-(5-benzylamino-5-deoxyribofuranosyl) imidazole-4-carboxamide), on post-ischemic myocardial function, and (ii) examine the contribution of endogenous adenosine in the intravascular and interstitial compartments in mediating the beneficial effects. Pigs were instrumented for measurement of myocardial segment shortening, and for sampling of coronary venous blood and myocardial interstitial fluid for determination of adenosine concentration. Myocardial dysfunction was induced by 4 x 8 min coronary occlusions, and recovery of regional function was monitored for 2 h. In control pigs, function recovered to 24 +/- 2% of baseline after 2 h. Treatment with GP531 improved functional recovery to 55 +/- 3%. GP531-mediated cardioprotection was prevented by adenosine receptor blockade with 8-sulfophenyltheophylline (23 +/- 2%). GP531 did not affect basal adenosine levels, but caused a 2-fold greater increase in vascular adenosine concentration with ischemia (54.6 +/- 10.6 vs. 28.1 +/- 8.0 microM in controls. P < 0.05). In contrast, the interstitial adenosine concentration was not significantly different in treated vs. untreated control pigs (9.4 +/- 3.9 vs. 15.0 +/- 1.8 microM in controls). These data indicate that (1) GP531 improves recovery of myocardial function following ischemia reperfusion injury via an adenosine receptor-dependent mechanism, and (2) the cardioprotection is associated with increased intravascular, but not interstitial, adenosine concentration during ischemia. Therefore, we conclude that cardioprotection elicited by GP531-enhanced endogenous adenosine is dependent on an intravascular site of action.

Tear concentrations of topically applied ciprofloxacin.

An open-label study of 20 normal, healthy volunteers was conducted to determine the tear concentrations after topical ocular application of ciprofloxacin 0.3% ophthalmic solution (Ciloxan). Tear samples were collected on Schirmer tear strips at 30 min, 2, 3, and 4 h, and were analyzed for ciprofloxacin using reverse-phase high-performance liquid chromatography. The results of this study showed the mean concentration, 4 h after dosing of ciprofloxacin, to be 16.0 micrograms/ml with 95% confidence limits of 8.15 and 23.79. It is concluded that concentrations of ciprofloxacin in tears were significantly greater than the minimum inhibitory concentrations for 90% of strains tested commonly reported for a majority of potential pathogens (i.e., < or = 2 micrograms/ml) 4 h after a single application of ciprofloxacin ophthalmic solution 0.3%.

Simultaneous determination of sulfasalazine and its metabolites sulfapyridine and N-acetylsulfapyridine in human serum by ion-pair high-performance liquid chromatography using a polymer-based column.

An HPLC method is described for the simultaneous and rapid determination of sulfasalazine (salicylazosulfapyridine) and two of its metabolites, sulfapyridine and N-acetylsulfapyridine, in human serum. The range of quantitation is 0.1 to 12 micrograms/mL for sulfasalazine and sulfapyridine and 0.25 to 12 micrograms/mL for N-acetylsulfapyridine. Serum is mixed with acetonitrile containing the internal standard sulfamethazine and the ion-pairing agent tetraethylammonium chloride. The acetonitrile extract is concentrated and analyzed by HPLC, using a new polymer-based column, and detected by UV spectroscopy at 270 nm. This paper is the first both to describe the simultaneous analysis of all three of the compounds from serum and to present sulfasalazine concentration-time data following oral administration to humans.

Effects of gavage versus dosed feed administration on the toxicokinetics of benzyl acetate in rats and mice.

Effects of gavage versus dosed feed administration on the toxicokinetics of benzyl acetate were studied in male F344 rats and B6C3F1 mice. Benzyl acetate was rapidly hydrolysed to benzyl alcohol and then oxidized to benzoic acid. After gavage administration of benzyl acetate in corn oil at 500 mg/kg (rats) and 1000 mg/kg (mice), high benzoic acid plasma concentrations were observed. In contrast, much lower benzoic acid plasma concentrations were found after dosed feed administration at about 615 mg/kg/day for rats and about 850 mg/kg/day for mice. Results show that although the daily doses of benzyl acetate are comparable, bolus gavage administration effectively saturated the benzoic acid elimination pathway whereas dosed feed administration did not. In contrast, hippuric acid plasma concentrations were similar after both gavage and dosed feed administration due to the depletion of the glycine supply pool. Study results could explain the different toxicity and carcinogenicity responses of benzyl acetate observed in 2-yr chronic gavage and dosed feed studies.

Determination of isotretinoin or etretinate and their major metabolites in human blood by reversed-phase high-performance liquid chromatography.

A method is described for the quantitative analysis of isotretinoin and its 4-oxo metabolite, or of etretinate and its principal metabolites, in human blood in the range 10-2000 ng/ml. Following a simple one-step extraction, the compounds are determined by reversed-phase high-performance liquid chromatography (HPLC) with gradient elution and detection at 365 nm. This highly specific method separates the cis and trans isomers of the parent compounds and their metabolites. Examples are given of the application of this method to clinical studies of these two therapeutically important retinoids.

Determination of mirfentanil hydrochloride (A-3508.HCl) in human plasma by liquid chromatography-mass spectrometry.

A method for the quantitation of mirfentanil hydrochloride (A-3508.HCl) in human plasma is presented for the first time, using LC-MS with single ion monitoring. The drug is extracted with a C-18 solid-phase cartridge and the extract is analysed using a 3 cm C-18 column connected to the ion source of a mass spectrometer via a thermospray interface. The intense ion produced by the protonated molecular ion at m/z 377 is detected by the mass spectrometer in positive-ion mode. The range of quantitation is 0.4-100 ng ml-1 from a 0.5 ml plasma sample. Results of assay validation are given. The method was used to analyse samples from a human pharmacokinetic study following intravenous administration of mirfentanil hydrochloride.

Oxypurine and 6-thiopurine nucleoside triphosphate formation in human erythrocytes.

A variety of oxypurines and 6-thiopurines could be transformed by intact erythrocytes to their nucleoside triphosphate forms when incubations were extended for up to 24 hrs. The specific nucleotide monophosphate kinases which accomplish these reactions in erythrocytes were not identified but their ability to utilize 6-thioIMP, 6-thioXMP and 6-methylthioGMP as substrates, albeit very slowly, is clearly implied by these results. S-methylation of 6-thiopurines was demonstrated in erythrocytes incubated with physiological amounts of methionine-(CH3-3H). 6-Methylthioguanosine triphosphate and 6-methylmercaptopurine riboside triphosphate were formed in micromolar amounts, probably from the corresponding thiopurine nucleotides by methyl transfer from S-adenosylmethionine.

Measuring stroke patients' health status in the early post-stroke phase using the SF36.

This paper aims to explore the self-perceived health status of stroke patients, the factors that contribute to the perception and the relevance of the findings to researchers and practitioners. Outcomes were measured at one, three and six months post-stroke for 153 stroke patients and pre-morbid characteristics were gathered from GPs. Health status was measured using the Short Form 36 (SF36). Stroke patients' health status was significantly worse than a general population for four health dimensions (physical functioning, role physical, vitality and social functioning). Regression analyses with the SF36 profile scores as dependent variables revealed one model where associations between independent and dependent variables were relatively strong (physical functioning), the remaining seven models yielded weak associations. Self-perceived health status was not strongly related to impairment, disability or cognitive function. There are implications for researchers and practitioners across a range of professions. Researchers should aim to identify factors that explain stroke patients' perception of their own health and the impact of their perception on rehabilitation. Practitioners should consider the possible effects of low vitality on treatment concordance.

A descriptive study of multidisciplinary mental health staff moving to the community: the demographic and educational issues.

Mental health care philosophy has moved from the containment of patients within institutions to the integration of clients within the community. 'Caring for People' (a Department of Health report) and the subsequent legislation enshrined the philosophical shift in law. Previous policy reports had indicated that staff required training to move from hospital-based service to a community-based service, but did not propose content, and no systematic study of the needs of mental health staff has been carried out. Therefore, this study aimed to identify the skill and information needs of a group of multidisciplinary staff in preparation for the movement from hospital to community settings. The study design was a descriptive survey sampling of a total multidisciplinary population in Scotland. Data were collected using questionnaires and semistructured interviews with a small volunteer subsample of respondents. This paper presents the first set of study findings related to the demographic and educational issues. Differences between hospital and community staff and between health care assistants and qualified staff are demonstrated for demographic and educational factors. Proposals are made for managers, professionals, educators and researchers.