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.

     

Acute myocardial infarction and cardiac perforation on non-gated CT

A 79-year-old man was referred to emergency department for vagueabdominal pain. In the past, the patient had cardiac arrhythmiasnecessitating a pacemaker placement. On admission, the patienthad a normal ausculation and the abdomen examination was unremarkable.Postero-anterior chest radiograph revealed normal cardiac sizeand a small left pleural effusion.     

The use of a new hydrophilic polymer, Kollicoat IR, in the formulation of solid dispersions of Itraconazole.

Kollicoat IR, a new pharmaceutical excipient developed as a coating polymer for instant release tablets, was evaluated as a carrier in solid dispersions of Itraconazole. The solid dispersions were prepared by hot stage extrusion. Modulated temperature differential scanning calorimetry and X-ray powder diffraction were used to evaluate the miscibility of the drug and the carrier. The pharmaceutical performance was evaluated by dissolution experiments, performed in simulated gastric fluid without pepsin (SGF(sp)). In the X-ray diffractograms no Itraconazole peaks were visible; the polymer on the other hand appeared to be semi-crystalline. Moreover, its crystallinity increased during the extrusion process due to exposure to heat and shear forces. Modulated temperature differential scanning calorimetry analysis showed that the drug and the polymer formed a two phase system. Separate clusters of glassy Itraconazole were present for drug loads of 40% or higher, indicating further phase separation. Dissolution measurements demonstrated a significantly increased dissolution rate for the solid dispersions compared to physical mixtures. Interestingly the physical mixture made up of glassy Itraconazole and Kollicoat IR (20/80, w/w) showed a dissolution rate and maximum that was much higher than that of the physical mixture made up of crystalline Itraconazole and that of pure glassy Itraconazole. The results of this study show that Kollicoat IR is a promising excipient for the formulation of solid dispersions of Itraconazole prepared by hot stage extrusion.     

rt-PA Lyse bei Patienten mit schwerer Lungenembolie und rechtskardialen Transitthromben Diagnostik und Verlaufskontrolle mit Hilfe der transösophagealen Echokardiographie

Zusammenfassung Bei Nachweis von rechtskardialen Thromben handelt es sich in den meisten F?llen um sogenannte ,,Transit-Thromben`` aus dem peripheren Venensystem, die nur kurz im rechten Herzen verweilen. Die Inzidenz von transthorakal echokardiographisch nachgewiesenen ,,Transit-Thromben`` bei Patienten mit Lungenembolie liegt bei etwa 3 – 4%. Unbehandelt ist die Letalit?tsrate dieser Patienten jedoch auf Grund der hohen Rate konsekutiver fulminanter Lungenembolien sehr hoch (30 – 40%). Bis vor einigen Jahren galt die operative Embolektomie als das Therapieverfahren der Wahl, das jedoch heute zunehmend durch die systemische, intraven?se Lysetherapie als Alternative ersetzt wird. Im Zeitraum von 1/94 bis 12/95 wurden in unserer Klinik 66 Patienten mit nachgewiesener Lungenembolie behandelt. Bei sieben dieser Patienten mit schwerer oder fulminanter Lungenembolie (10,6%; 5 M?nner, 55 – 74 Jahre alt) fanden sich rechtskardiale Thromben, die in allen F?llen mittels transthorakaler/ trans?sophagealer Echokardiographie (TEE) diagnostiziert wurden. In sechs F?llen sahen wir extrem mobile, wurmf?rmige Thromben im rechten Atrium, die zum Teil diastolisch tief in den rechten Ventrikel prolabierten. Bei einem Patienten waren die Thromben im rechten Ventrikel lokalisiert und fielen ventrikel-systolisch in den rechtsventrikul?ren Ausflu?trakt. In drei F?llen lie?en sich mittels TEE auch Thromben in der rechten Pulmonalarterie darstellen. Fünf Patienten wurden unmittelbar im Anschlu? an die TEE-Untersuchung ohne weitere angiographische Diagnostik mit einer systemischen, intraven?sen Lysetherapie mit 100 mg front-loaded rt-PA über 90 Minuten behandelt. Ein prim?r reanimationspflichtiger Patient erhielt als ,,Ultima Ratio`` 100 mg rt-PA als Bolus, eine weitere Patientin 50 mg rt-PA als Bolus gefolgt von 50 mg über 2 Stunden. Bei allen Patienten stabilisierte sich der h?modynamische Zustand innerhalb kürzester Zeit. In sechs F?llen konnte mittels TEE und einmal mittels transthorakaler Echokardiographie innerhalb von 15 Stunden die komplette Aufl?sung der rechtskardialen Thromben dokumentiert werden. Bei einem Patienten kam es zu einer intracerebralen Blutung und ein Patient verstarb nach 10 Tagen an den Folgen der protrahierten Reanimation mit hypoxischem Hirnschaden. Mittels TTE/TEE lassen sich rechtskardiale Transitthromben als koinzidenter Befund bei Patienten mit klinischen Hinweisen für eine fulminante Lungenembolie gut diagnostizieren sowie der Therapieerfolg verfolgen. In diesen F?llen ist die sofortige systemische Lysetherapie ohne weitere bildgebende Diagnostik durchzuführen, um einer weiteren Verschlechterung der klinischen Situation in Folge Transports und Umlagerung des Patienten mit der Gefahr des Abschwemmens des Transitthrombus vorzubeugen. Eingegangen: 15. Mai 1996 Akzeptiert: 23. Oktober 1996     

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Ohne Zusammenfassung     

Infarktbedingter kardiogener Schock

Cardiogenic shock remains the major cause of death among patients with acute myocardial infarction. Besides supportive therapy there is clear evidence that revascularization of the infarct related artery should be performed as soon as possible with percutaneous transluminal coronary angioplasty. Placement of coronary stents and administration of platelet glycoprotein IIb/IIIa antagonists may further improve outcome. Intra-aortic balloon pumping should be integral part of this treatment strategy but is unfortunately underused in clinical practice. Routine bypass surgery for cardiogenic shock patients is deferred and restricted to selected patients.     

The incubation time of relapses after treatment of multibacillary leprosy with rifampicin containing regimens

In order to determine the duration of follow-up needed to evaluate the efficacy of short-course bactericidal regimens for multibacillary leprosy, information is needed on the incubation time of relapses after stopping treatment. Several groups of patients, who had been on rifampicin-containing regimens, were followed up for periods ranging from 4 to 10 years, Two groups of relapses were observed: early relapses occurring within 3.5 years after stopping treatment, with a median incubation time of 1 year and 10 months (upper limit of 95% confidence interval: 2 years); and late relapses occurring more than 3.5 years after stopping treatment, with a median incubation of 5 years. Early relapses are probably due to insufficient treatment, and late relapses to persisting bacilli or to reinfection. It is concluded that the efficacy of short-course RMP-containing therapeutic regimens can be evaluated by observing the occurrence of early relapses, 50% of which occur before 2 years after the end of therapy.Corresponding author.     

Plasma metallothionein concentration in patients with liver disorders: special emphasis on the relation with primary biliary cirrhosis

The plasma metallothionein concentration was evaluated in healthy subjects and in patients with several types of liver disorders. Plasma metallothionein concentrations in controls varied between 2.4 and 4.8 ng/ml. Patients with disorders associated with increased liver copper concentrations (i.e., primary biliary cirrhosis and primary sclerosing cholangitis) had significantly (both p less than 0.002) elevated plasma metallothionein concentrations (range = 1.8 to 52.2 ng/ml), and a considerable number of these were above the maximum control level (21 of 41 patients). In contrast, patients with liver disorders not associated with increased liver copper concentrations (alcoholic and cryptogenic cirrhosis, and acute viral and chronic active hepatitis) generally had normal plasma metallothionein concentrations and only a few were above the maximum control level (11 of 64 patients, maximum = 8.8 ng/ml). The metallothionein concentrations in plasma samples from patients in stage I or II primary biliary cirrhosis were within or slightly above the control range, whereas most patients in stage III had elevated levels (p less than 0.002), and almost all patients in stage IV had clearly elevated (p less than 0.0001) concentrations. In primary biliary cirrhosis the plasma metallothionein concentration tended to increase during the evolution of the disorder, and the concentration correlated significantly with the serum total bilirubin concentration. In conclusion, the plasma metallothionein concentration is significantly elevated in patients with primary biliary cirrhosis and in patients with primary sclerosing cholangitis. Although related to the histological stage of primary biliary cirrhosis, the measurement of plasma metallothionein concentrations contributes little to the diagnosis or the evaluation of the severity of these disorders.(ABSTRACT TRUNCATED AT 250 WORDS)     

Distinction between renal and nonrenal hematuria using immunoperoxidase staining of erythrocytes in urine for Tamm-Horsfall protein]

A recently described immunocytochemical staining method to distinguish renal from non-renal haematuria was adapted for use in the standard clinical chemical laboratory. The method is based on the observation that only in case of renal haematuria are erythrocytes in urine coated with so-called Tamm-Horsfall protein, originating from the renal tubuli. Erythrocytes in urine were stained using an indirect immunoperoxidase method, resulting in cells with dark-brown stained surfaces. The staining methods were validated with material from clinically diagnosed cases of haematuria of renal or non-renal origin and compared with scores of the number of dysmorphic erythrocytes, another method to distinguish renal from non-renal haematuria. In specimens of presumed strictly renal haematuria 86% (SD 8.7; n = 26) of the erythrocytes stained immunocytochemically. However, in specimens of haematuria originating from bleeding in the renal pelvis few cells stained (6%; SD 5.8; n = 4). In specimens of purely non-renal haematuria only 13% (SD 13.5; n = 21) stained. Immunocytochemical staining of erythrocytes permitted a much better distinction between renal and non-renal haematuria, with better sensitivity and specificity, than the inspection of erythrocyte morphology. We conclude that immunochemical staining of erythrocytes in urine is a valuable method for distinguishing renal and non-renal haematuria.