Changes occurring in Health care delivery and Medicine are the result of social, economical, technological, scientific forces that have evolved in the 21st century. Among the most significant changes are shift in disease patterns, advanced technology, increased consumer expectations and high costs of health care. These factors have redefined medical practices to fit into the changing health delivery system. Thus, Nursing Profession is ‘accountable’ to the society. i. e.
obliged to the laws regulating the professional activity. This ‘accountability’ is usually spelt out in “Patient Care Documents” established by hospital associations and medical associations or councils of every country (Ann J. Zwemer, 1995). In addition, nursing profession has defined its standards of accountability through a formal code of ethics. Schizophrenia is a mental disorder with impairment in perception and expression of reality characterized by delusions and hallucinations.
Clozapine is an atypical antipsychotic drug widely used in refractory Schizophrenia. There seems to be a cultural and geographical variations in dose response relationship and tolerability to the drug making the dose response unpredictable. The effective and tolerable range is between 100 mg to 900 mg, which makes it difficult to make a predictive, significant and valid correlation. There has been no positive correlation with serum level too.
Thus, there is a need to search for a clinically viable and simple method for growth response monitoring of the drug and treatment of schizophrenia. Thus, there is need for evidence based medical practice in the treatment and care of schizophrenia that works by providing a safe framework in which medical professionals and patients can make tough decisions by safe guarding their concerns by a fair and scientifically sound process together. Analysis and Evaluation of the Evidence based practice in Schizophrenia care:
Evidence based practice is the conscientious, explicit and judicious use of current best evidence in making decisions about the case of individual patients (Sackett, 1996). The practice of evidence-based practice is the integration of individual clinical expertise with the best available external clinical evidence from systemic research. Individual clinical expertise is the proficiency and judgment that nurses acquire through clinical experience and practice. External clinical evidence is the relevant patient centered clinical research from the science of medicine.
This includes the accuracy and precision of diagnostic tests, prognostic markers, therapeutic, rehabilitative and preventive regimens (Sackett, 1996). External evidence sometimes replaces previously accepted treatments by virtue of accuracy and safety. Evidence based practice takes patient’s perspective also into account. Hence, evidence based practice involves a big process of question building and this process of question building takes into account clinical findings, aeotiology, diagnosis, prognosis, therapy and prevention of diseases.
This question building process gives the idea on the most important question, the question which is encountered very often in practice and the question’s relevance very often in practice and the question’s relevance to the patient situation. Evidence based practice is probably best understood as a decision – making framework that facilitates complex decisions across different and sometimes conflicting groups. It involves considering research and other forms of evidence on a routine basis when making health care decisions (Sackett, 1996).
Such decisions include choice of treatment, tests or risk management for individual patients, as well as policy decisions for large groups and populations. At a broader level, evidence based practice works by providing a safe framework in which different groups can make tough decisions by safe guarding their concerns by a fair and scientifically sound process. There are essential differences between traditional and evidence based nursing practice. Traditional medical practice has always drawn upon the personal experience, case studies and research of the physician.
In evidence based medical practice, health care decisions are based on a structured organized process to help physicians, nurses and patients alike to choose the best health care options and their consequences. Thus, the basic idea of evidence-based practice is to create a process of life long, self directed, problem based learning for nurses in which caring for their own patients is the prime motive (Sackett, 1996). This caring creates a need for clinically important information about diagnosis; prognosis, therapy and other health care issues.
In this process of evidence based medical practice, the nurses convert this information into answerable questions, tracking down with maximum efficiency, the best evidences which can answer these questions, critically analyze them for clinical applications, apply them, integrate them with their clinical expertise and evaluate their own performance. Of course, the best evidences are based on the conviction that a systematic documenting of a large number of high quality RCTs (Randomized with Concealment, Double blended, complete follow-up, intention to treat analysis) gives the least biased estimate.
Thus, this becomes level 1 evidence and recommendations based on level 1 evidence are Grade A. Various terminologies aid evidence based medical practice such as ‘Clinical practice guideline’ which assists practitioner and patient make decisions about appropriate health care and ‘Randomized controlled clinical trial’ where a group of patients is randomized into an experimental group and a control group. These groups are followed up for the variables and outcomes of interest. Nurses are under increasing pressure to keep up to date and to base their decisions more firmly on evidences as opposed to anecdotal information of the past.
Patients are much more informed than they were 10 years ago (Sackett, 1996). No nurse can tell a patient what to do without being questioned. The most important aspect of evidence-based practice is that it has provided a fair, scientifically rigorous method for making best-practice decisions. This has ensured professional transparency and accountability. Evidence based medicine does have limits. Absence of support structures for sustained evidence, lack of commitment to the process, insufficient evidence for too many problems do pose some challenges.
But, evidence based medicine provides a medical practice with a stronger application of the scientific method (Baum Neil H. , 2003). This also provides all groups involved in providing health care with a rigorous and acceptable framework for making complex decisions, at a time when effective decision is badly needed. In this context, the ultimate goal of medical profession is to care and cure keeping in view the trust issues in dealing with the patient. The nurse’s primary commitment is to the patient and profession.
Caring mentally ill patients undergoing therapy with antipsychotic drugs like clozapine and benzodiazepines involves careful monitoring of the patient’s physiological condition as well. Such drugs have marked side effects like sedation, hyper salivation, increase in transaminases, EEG changes, cardiovascular respiratory dysregulation, overweight, mild Parkinsonism, akathisia, tardive dysakinesia, increase of liver enzymes, hypotension, fever, ECG alterations, tachycardia, and delirious states. These drugs also pose the risk of seizures.
A review of the published literature on clozapine therapy gives us a base for further discussions. Clozapine induced sedation has been reported Clozapine treatment and can be a predictor in Clozapine therapy (Wichniak A, 2006). A study investigating the effect of Clozapine on working memory in 15 subjects with schizophrenia have found marked improvement in the cases. ( Galletly CA,2005). Adverse effects related to Clozapine have been assessed in a post-marketing drug surveillance program in two university psychiatric departments (Grohmann R, 1989).
Sedation, hypersalivation, increase in transaminases, and EEG changes were most frequently observed side effects. Four cases of severe cardiovascular and respiratory dysregulation were observed with the combination of clozapine and benzodiazepines. These cases and one case of sudden death under clozapine and haloperidol treatment have been presented in some detail. Tolerability of long term clozapine treatment of about 7-8 years has also been investigated in 27 female patients ( Schmauss M,1989).
All these patients had previously been treated with different neuroleptics but with inadequate response and distressing side effects. The average total dose of Clozapine being 385 g, the daily dose of Clozapine ranged from 75 to 600 mg, with the average daily dose being 225 mg. Seventy eight per cent of the investigated patients shoed hypersalivation and 63% showed overweight. Mild Parkinsonism was reported in 15% and akathisia in 11% of the patients. Clozapine did not seem to induce tardive dysakinesia (TD) in any of the patients within a treatment period of 7-8 years as per the study.
Another study has recorded that adverse effects occurred in 56% of patients with most frequent side effects being sedation (17%), EEG alterations (16%), increase of liver enzymes (8%), hypotension (7%), hypersalivation (5%), fever (5%), ECG alterations (4%), tachycardia (3%), gastro-intestinal (3%) and delirious states (2%) ( Naber D,1989). But another study on long term Clozapine shows that severe side-effects led to discontinuation of clozapine treatment only in 6 percent of the cases with no case of agranulocytosis (Leppig M,1989 ).
According to a recent study the efficacy of clozapine therapy in schizophrenic patients depends on a lot of factors involving the benefit/risk ratio including the clinical status of the patient, the patient’s request and his feeling ,his tolerability , the lack of dystonia and other extrapyramidal side effects. The most frequent side effects during therapy according to the study are sedation, EEG alteration, seizures, increase of liver enzymes, hypotension/collapse, hypersalivation, fever , ECG alteration, tachycardia, gastro-intestinal adverse effects, weight gain, and leucopoenia.
Although Clozapine is an atypical neuroleptic drug that has proved to be effective in alleviating psychotic symptoms refractory to treatment with standard neuroleptic drugs, an increased susceptibility to epileptic seizures during Clozapine treatment with hematological side effects has been described (Liukkonen J, 1992). Seizures are an important adverse effect of Clozapine therapy with a cumulative 10% risk of tonic-clonic seizures on prolonged treatment. The risk of seizures seem to be increased higher doses ( Devinsky O. 1994 ).
The vast majority of clozapine-related seizures are tonic-clonic, although myoclonic seizures also occur. In patients with clozapine-related seizures, either reducing the dose or adding an antiepileptic medication usually allows continuation of therapy. Evidence utilization alongside other non-evidential factors such as habits, traditions, competing perspectives, values: The evidence obtained is based on an open level, naturalistic, and prospective study, involving one hundred patients, referred for Clozapine therapy.
Data was obtained from patients and key relatives after informed consent. After therapy began, patients received a follow-up evaluation on day 90 and again on the last day of treatment duration of one year. Side effects were recorded using a checklist prepared for Clozapine-related side effects. Base line investigations included blood count, haemogram, liver function, kidney function, ECG. Blood monitoring was done once per week for 3 months and then once every two weeks following. Psychopathology measurement and outcome measurement was done using GCIS, GAF and PANSS.
The patients included 62 men and 38 women of low to middle socio-economical class, ranging in age from 28 to 56 years, averaging 34 years of age. 38% were married, 43% were single, and 19% were separated. The duration of illness prior to the study ranged from 5 to 21 years, averaging 7 years. Patients’ duration of illness before first psychiatric contact ranged between 5 months and 46 months, averaging 20 months. Prior to the study, 55% of the patients had a history of hospitalization, averaging 2 prior hospitalizations and the mean duration of hospitalization was 2 months.
A history of violence was recorded in 46% of patients and 72% had a history of behavioral disruption. 28% of the patients had attempted suicide. Some were unable to function in society- 66% were socially disabled and 74% had little or no occupational functionality. One fourth of the patients had a positive family history of some psychological disorder. Schizophrenia was diagnosed in 16% of those relatives: 5% in siblings, 8% in parents, and 3% among offspring. Other psychological disorders, including alcoholism, depression, and suicide attempts were confirmed in first-degree relatives among 9% of the patients.