Action research methodology in clinical pharmacy: how to involve and change

Introduction The focus in clinical pharmacy practice is and has for the last 30–35 years been on changing the role of pharmacy staff into service orientation and patient counselling. One way of doing this is by involving staff in change process and as a researcher to take part in the change process by establishing partnerships with staff. On the background of the authors’ widespread action research (AR)-based experiences, recommendations and comments for how to conduct an AR-study is described, and one of their AR-based studies illustrate the methodology and the research methods used. Methodology AR is defined as an approach to research which is based on a problem-solving relationship between researchers and clients, which aims at both solving a problem and at collaboratively generating new knowledge. Research questions relevant in AR-studies are: what was the working process in this change oriented study? What learning and/or changes took place? What challenges/pitfalls had to be overcome? What were the influence/consequences for the involved parts? When to use If you want to implement new services and want to involve staff and others in the process, an AR methodology is very suitable. The basic advantages of doing AR-based studies are grounded in their participatory and democratic basis and their starting point in problems experienced in practice. Limitations Some of the limitations in AR-studies are that neither of the participants in a project steering group are the only ones to decide. Furthermore, the collective process makes the decision-making procedures relatively complex.

     

Malignant mixed müllerian tumors of the ovary. Report of 13 cases.

Thirteen patients with verified malignant mixed Müllerian tumor of the ovary treated in Denmark during the 7-year period 1981-87 were reviewed. Two patients had homologous and 11 patients had heterologous tumors. Four patients with early stage disease underwent radical surgery; 9 patients had stage III disease. Median survival for all 13 patients was 12 months. Six patients received platinum-containing cytotoxic therapy; 2 of these patients without measurable disease became long-term survivors (survival times 42+ and 92+ months, respectively) and 3 of the 4 remaining patients with evaluable disease obtained an objective remission.     

Single-dose and steady-state pharmacokinetics of diltiazem administered in two different tablet formulations.

Single-dose and steady state pharmacokinetics of diltiazem administered in two different oral formulations were assessed with particular reference to rate and extent of absorption. Following single dose administration a significant difference in tmax was observed (2.9 +/- 1.9 and 6.8 +/- 2.6 hr respectively) whereas differences in AUC, t1/2 and Cmax were not significant. The AUC (mean +/- S.D.) values following single dose administration of Cardil and Cardizem were 678.4 +/- 321.5 and 948.6 +/- 580.6 ng.ml-1.hr respectively. The mean and the 95% confidence limits for the observed ratio AUCCardil/AUCCardizem are 0.89 and 0.44-1.34 respectively. At steady-state a significant difference between Cmax/Cmin and tmax was seen Cmax/Cmin being 4.9 and 3.2 respectively and Tmax being 2.7 +/- 2.0 and 6.0 +/- 2.8 hr respectively, whereas Cmax and AUC did not differ significantly. The AUC (mean +/- S.D.) values in steady state of Cardil and Cardizem were 880.1 +/- 399.8 and 1056.8 +/- 509.8 ng.ml-1.hr respectively. The mean and the 95% confidence limits for the observed ratio AUCCardil/AUCCardizem are 0.96 and 0.66-1.26 respectively. Although the observed ratios AUCCardil/AUCCardizem in both the single-dose and the steady-state study do not differ significantly from 1.0, the confidence limits exceed the acceptable values given by Poulsen & Juul (personal communication 1990) (a 20% decrease or increase of the ratio to 0.8 or 1.2).     

A longitudinal study of semen quality in pesticide spraying danish farmers

It was hypothesized that occupational exposure to pesticides during a spraying season causes changes in semen quality that might be detected in a longitudinal study. We analyzed the within-person changes in semen quality and reproductive hormones across a spraying season in groups of farmers using and not using pesticides. A total of 248 men collected two semen samples (participation rate: 32%). The median sperm concentration declined significantly from the first to the second sample in both groups, but there was no statistical difference in the decline between the two groups, unadjusted or adjusted. Only minor changes were found in sperm morphology, vitality, motility, sperm chromatin denaturation (SCSA), and reproductive hormones, and the differences in changes between the two groups were nonsignificant, or, in the opposite direction to the expected. There was no relation between the changes in sperm parameters in relation to pesticide exposure variables. In conclusion, use of pesticides by Danish farmers is not a likely cause of short-term effects on semen quality and reproductive hormones.     

Ouabain Enhancement of Compound 48/80 Induced Histamine Secretion from Rat Peritoneal Mast Cells: Dependence on Extracellular Sodium

Abstract: Purified populations of rat peritoneal mast cells were used to study the effect of ouabain on compound 48/80-induced histamine secretion and on ⁸⁶Rb⁺ uptake. ⁸⁶Rb⁺ was used as a tracer for extracellular K⁺. The calculated value of the ouabain-sensitive uptake of K⁺ and ⁸⁶Rb⁺ was considered a measure of the Na⁺–K⁺ pump activity of the cells. Ouabain caused an immediate inhibition of the pump activity and a time-dependent increase in histamine secretion in the absence of extracellular calcium. No effect on the secretion was observed in the presence of calcium. The effect of ouabain on the secretion occurs in the presence of sodium but not when sodium was replaced by lithium. Preservation by ouabain of a high intracellular sodium content in sodium-loaded cells was associated with preservation of the secretory response in a calcium-free medium. In the presence of lanthanum in a calcium-free medium, the pump activity was inhibited and the enhancement by ouabain of the secretion of histamine was blocked. A less marked inhibition of the pump was found in a calcium-free medium containing magnesium. The inhibition exerted by magnesium was concentration-dependent (0–5 mM) as was the counteraction of magnesium of the enhancement of ouabain of the secretion of histamine. These observations indicate that the enhancement by ouabain of the secretory response of mast cells preincubated in a calcium-free medium is associated with accumulation of sodium inside the cell. In addition to a decreased rate of sodium-calcium exchange caused by a decreased inward directed sodium gradient, the mechanism by which ouabain enhances the secretory response is likely to involve an increased binding of calcium to membrane binding sites.     

Identifying environmental risk to male reproductive function by occupational sperm studies: logistics and design options.

Malfunction of the male reproductive system might be a sensitive marker of environmental hazards, the effects of which may extend beyond reproductive function. The testis is more vulnerable to heat and ionising radiation than any other organ of the body and several xenobiotics are known to disrupt spermatogenesis after low level exposure. Studies of environmental impact on human health are often most informative and accurate when carried out in the workplace where exposures can be high and easy to document. Semen analysis provides readily obtainable information on testicular function. The main advantages in comparison with functional measures such as fertility rates and time taken to conceive are the possibilities to examine men independently of marriage and pregnancy, to find changes of fecundity with different exposures within the same person and to detect adverse effects when no alteration of fertility is yet taking place. In the implementation of an occupational sperm study considerable attention must be paid to logistic issues. A mobile laboratory unit for initial semen preparation and processing may in some situations increase worker compliance and the quality of sperm cell motility. The cross sectional design which has been used in almost all male reproductive studies so far has several severe limitations including selection bias because of differential participation, difficulties in defining a suitable reference group, and lack of information about the time dimension of the cause-effect relation. The longitudinal design deals adequately with most of these constraints. Semen samples are collected before, during, and possibly after exposure to the risk factor of interest and causal inferences are based upon change of semen variables within a man over time rather than upon differences between men. The logistics of the longitudinal study may benefit from pre-employment health examinations to enrol newly hired workers and require fewer participants to obtain comparable statistical power. In conclusion, andrological methods and epidemiological designs are available for the implementation of valid studies concerned with environmental impact on human testicular function. Occupational sperm studies should probably not be the first choice when the objective is initial screening of environmental impact on fertility but should be implemented when their is a need to corroborate or refuse earlier evidence that specific exposures have impact on testicular function.     

Epikeratophakia for keratoconus. Long-term results using fresh, free-hand made lamellar grafts.

Epikeratophakia using fresh, free-hand made corneal grafts was done in 16 patients with keratoconus. The follow-up period averaged 27.8 months (range 13-45 months). A significant improvement of visual acuity was obtained (p = 0.002), and 14 of the 16 eyes (87.5%) achieved a corrected visual acuity greater than or equal to 6/12. The spherical equivalent and the cylindrical refractive error were reduced (p less than 0.05), and a significant flattening of the central corneal curvature was obtained (p less than 0.002). The mean postoperative central corneal astigmatism was 4.25 D. Postoperatively, the mean central corneal thickness was 0.670 mm, and the mean central thickness of the epithelialized graft was 0.336 mm. Six patients reported some postoperative glare or blurring of vision, despite a visual acuity greater than or equal to 6/9 on the Snellen chart. No significant subjective or objective changes were noticed after the 6-month postoperative follow-up visit.     

Patients' desire for information about anaesthesia: Danish attitudes

Background : Patients' desire for information about anaesthesia has been examined in a number of Commonwealth countries but not in Scandinavia. A questionnaire was distributed to form a basis for giving Danish patients more appropriate preoperative information.
Methods : 201 preoperative patients in Denmark were asked to complete a questionnaire. The patients were divided into subgroups according to: age, gender, residential origin, ASA group, educational level, type of anaesthesia planned and number of previous anaesthetics.
Results : Patients from a city area required significantly more information than patients from a rural/urban area about pre-medication drugs, drips/catheters, pain/pain relief and complications. Men more than women preferred to know about dangerous complications. Information about pain /pain relief, duration of anaesthesia, and influence of anaesthesia on daily activities such as eating, drinking, mobilisation was given the highest priority, while unpleasant information such as about complications and needles was given the lowest priority. Meeting the anaesthetist and information about alternative methods of anaesthesia and premedication drugs were given only moderate priority. Ranking information in Denmark was significantly correlated with Scotland, Canada and Australia, despite profound differences in priority. More often than Danish patients, Australian patients felt they had right to know, and especially about complications.
Conclusion : Patients from a city area required more information than patients from a rural/urban area. Information about the influence on daily activities was preferred to unpleasant information. Ranking information in Denmark was correlated with a number of Commonwealth countries.     

The Reactivity of Psychosis Rating Form (RPRF): background,development and psychometrics

The ICD-10 and DSM-IV classifications have both given low priority to “reactivity” to acute stress as a classificatory principle for functional psychoses. In Scandinavia, reactivity is still considered an important factor in the development of such psychoses. Reactivity is a complex concept, and its various components are historically examined. The Reactivity of Psychosis Rating Form (RPRF) was developed in order to operationalize reactivity. Seven of the 10 elements of RPRF can be rated reliably. Factor analysis of the RPRF yields three factors: stressor, onset and change, that also show high interrater reliability. Our results indicate that RPRF has both construct and discriminant validity. Further studies with the RPRF may elucidate the true status of reactivity in functional psychoses.     

Is MED13L-related intellectual disability a recognizable syndrome?

Introduction

MED13L-related intellectual disability is characterized by moderate intellectual disability (ID), speech impairment, and dysmorphic facial features. We present 8 patients with MED13L-related intellectual disability and review the literature for phenotypical and genetic aspects of previously described patients.