Documentation Of Side Effects Research Articles

Definition, assessment and rate of psychotherapy side effects.

Psychotherapy is often seen as a first line treatment, because patients and therapists consider this mode of treatment harmless in comparison, for instance, to drug treatment. This assumption is supported by the fact that there are only limited scientific reports on psychotherapy side effects (1,2). There is, however, some evidence which suggests that psychotherapy can have frequent or serious negative consequences, like all effective treatments (3–5). There are several reasons why awareness of psychotherapy side effects is limited and research on this issue is insufficient. First, the psychotherapist is the “producer” of treatment and therefore responsible, if not liable, for all negative effects, which results in a perceptional bias towards positive rather than negative effects (6). Second, psychotherapy does not only focus on symptoms but also on social behavior, so that the spectrum of possible negative effects is much broader than in pharmacotherapy (7). Third, there is even no consensus on what to call negative: for instance, when evaluating a manuscript on psychotherapy side effects, a reviewer wrote: “a divorce can be both positive and negative, and crying in therapy can reflect a painful experience but can also be a positive and therapeutic event”. Fourth, there is a lack of differentiation between side effects and therapy failure or deterioration of illness (8). Fifth, there are no generally accepted instruments for the assessment of psychotherapy side effects and no rules on how to plan scientific studies or monitor side effects in randomized controlled clinical trials (2).

Antipsychotic prescribing in people with intellectual disabilities: a clinical audit

Purpose – Great controversy surrounds the prescribing of antipsychotics for people with an intellectual disability. This stems from a lack of research to support their use in this specific population together with their “off label” use to treat behaviour problems. This paper aims to review prescribing practice of antipsychotics by the Salford Intellectual Disability Psychiatry Department in accordance with standards adapted from nationally recognised guidelines.Design/methodology/approach – Data was collected from all 178 patients under this department including patient demographics, severity of intellectual disability, co‐morbid diagnoses and details of any antipsychotic drug use. Main standards of prescribing measured: indication of antipsychotic prescribing; documented review of medications; documentation of side effects; documentation of physical health parameters including weight, blood pressure, blood glucose, lipids.Findings – In total, 126 (72 per cent) were prescribed antipsychotics. 42 (33 per c...

Implementation of a standardized pain management in a pediatric surgery unit

Postoperative pain is still a major complication causing discomfort and significant suffering, especially for children. Therefore, every effort should be made to prevent pain and treat it effectively once it arises. Under-treatment of pediatric pain is often due to a lack of both knowledge about age-specific aspects of physiology and pharmacology and routine pain assessment. Factors for long term success require regularly assessing pain, as routinely as the other vital signs together with documentation of side effects. The fear of side effects mostly prevents the adequate usage of analgesics. Essential is selecting and establishing a simple concept for clinical routine involving a combination of non-pharmacological treatment strategies, non-opioid drugs, opioids and regional anesthesia.

Allergic reactions to patent blue dye V – the ALMANAC and NEW START experience (on behalf of the ALMANAC study group).

Abstract Abstract #1001 Background and methods
 Single reports of allergic reactions following injection of patent blue dye V - an isomer of isosulfan blue - as part of the sentinel node procedure have been well documented in small series. We report analysis from the systematic and prospective data collection of 5853 sentinel node biopsies as part of the ALMANAC trial (J Natl Cancer Inst 2006; 98(9):599-609) and NEW START sentinel node training program that has subsequently been rolled out in the UK. Prospective data collection includes documentation of side-effects after injection of patent blue dye V. The participating surgeon can specify the reaction in a free-text box. We summarised the specified reactions into local skin, allergic and cardiovascular reactions. We also charted whether the reactions necessitated any drug treatment (histamine antagonist, steroids or adrenaline / ephedrine) or triggered admission to the intensive care unit or a change of the procedure. Allergic reactions were classified into grade I (urticaria, blue hives +/- generalised rash), grade II (transient hypotension not requiring vasopressor support) and grade III (severe hypotension requiring vasopressor support).
 Results
 51 of 5853 (0.9 %) patients experienced 77 reactions to patent blue dye V. In 16 patients the type of reaction was not further specified. 5 patients were noted to have intense localised skin staining. Interestingly, 3 surgeons independently noted blue wheals distal to the blood pressure cuff. 21 patients experienced minor (grade I) allergic skin reactions. One was treated with hydrocortisone only, one with a histamine antagonist only, 6 with hydrocortison and a histamine antagonist. Grade II allergic reactions – transient hypotension not requiring vasopressor support – occurred in 4 patients, one of whom developed bronchospasm. 2 patients experienced grade III allergic reactions – severe hypotension treated with vasopressors. In 2 further patients the severity of the allergic reaction led to a change of the proposed procedure. In one patient who developed severe hypotension immediately after administration of patent blue dye V the procedure was abandoned. The patient was admitted to the intensive care unit for observation overnight but recovered without any sequelae. Another patient – who was in the ALMANAC audit phase where the sentinel node procedure was followed by the unit's conventional surgery - developed arrhythmias. The patient was meant to undergo an axillary node clearance but this was changed to axillary sampling as the final staging procedure.
 Conclusion
 Minor reactions after patent blue dye V injection are uncommon and were noted in 51 of 5853 (0.9 %) sentinel node biopsies. Severe allergic reactions requiring either vasopressor support or a change / abandoning of the procedure are even rarer - 4 of 5853 (0.07 %) procedures. It is, however, important that surgeon, anaesthetist and the unit are prepared for this eventuality. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 1001.

P02-159 Completed audit cycle on lithium monitoring on older adults in northumbria healthcare NHS trust, UK

Aims:The aim of this study was to audit the practise of Lithium monitoring on all patients over the age of 65 years, over a one-year period in North Tyneside General Hospital, against the recommended standards, and re-auditing the following year.Methods:During the audit; data was collected from the medical notes of all patients prescribed Lithium, over 65 years in North Tyneside General Hospital. This was from January 2004 - January 2005. The standards used were the recommendations of The British National Formulary. The monitoring of urea, electrolytes, TSH and Lithium were recorded. The presence of an ECG, documentation of side effects, information leaflets’ distribution and patients lost to follow up were noted. Following the audit, recommendations were made and prescribing Consultants were informed. A re-audit was conducted on all patients on Lithium the next year from January 2006 - June 2006, using the same designed tool.Results:22 patient's notes were audited and 29 notes re-audited. 41% were males and 59% females in the audit, with similar distribution in the re-audit. 54% were between 65-75 years and 45% over the age of 75years in the audit. 41% and 59% respectively in the re-audit. Blood monitoring followed the standards in 86% in the audit and 95% in the re-audit. 32% had documentation of side effects in the audit, increasing to 72% in the re-audit. While 23% patients were lost to follow up in the audit, all were followed up in the re-audit.Conclusions:The re-audit encouragingly showed significant improvement in practise.

Therapy-Associated Late Effects after Irradiation of Malignant Diseases in Childhood and Adolescence. Feasibility Analyses of a Prospective Multicenter Register Study

Radiogenic late effects in children and adolescents have been evaluated retrospectively in most analyses, with small patient numbers. The German Group of Pediatric Radiation Oncology (APRO) has generated a concept for a prospective evaluation of radiation-associated late effects in childhood. The aim of this study was to evaluate the feasibility of a nationwide central database for the documentation of radiation parameters and side effects of all children treated within therapy protocols of the German Society of Pediatric Oncology and Hematology (GPOH). A study center has been implemented in Muenster, the documentation has started in July 2001 in few centers in a pilot phase. Since February 2004 the documentation is done countrywide. Detailed documentation forms have been designed for treatment parameters and for doses applied at organs at risk. Furthermore, a uniform toxicity documentation, according to the RTOG/EORTC criteria, was chosen. Patients were reported from the study centers of the GPOH to the study center. All information was collected and analyzed in the study center. Till July 31, 2005, 438 documentations of radiation and 579 toxicity documentations of side effects have been collected in the study center. 46 centers for radiotherapy in Germany and one center each in Austria and in Switzerland took part in the documentation. The quality of documentation regarding completeness and plausibility fulfilled the expected criteria in most cases. This feasibility analysis showed that important information about organ dose levels and side effects was documented in a large number of patients (Figures 1 and 2). This prospective evaluation of radiotherapy and radiogenic side effects in children and adolescents will allow correlating doses at organs at risk and the incidence of acute and late sequelae in Germany. Further documentations and a longer follow-up are necessary to obtain powerful results.

A thermometry system for quality assurance and documentation of whole body hyperthermia procedures

Since December 2001, the Department of Oncology and Medical Physics, Haukeland University Hospital, Norway has been conducting whole body hyperthermia (WBH) studies, treating patients with either ovarian carcinoma or non-Hodgkin lymphomas. Accurate and reliable thermometry instrumentation is important in all types of hyperthermia procedures, particularly in WBH, where the target patient body temperature is 41.8°C. Reliable documentation of side-effects in clinical studies is also dependent on precise temperature monitoring, since in this temperature range even small, but systematic, inaccuracies (0.1–0.2°C) in the temperature monitoring is expected to affect the amount of side effects. Readily available heating and temperature data from previous treatment sessions of the same patient is also valuable for precise temperature control in future treatment sessions. The WBH thermometry system implemented at Haukeland University Hospital is described. It is based on commercially available components, including standard medical thermistor probes, and includes a temperature calibration and verification facility. The thermometry system is accurate, reliable, easy to use, comfortable for the patient and relatively inexpensive. By implementing the Steinhart-Hart polynomial fit to standard medical thermistor probe data, it is shown that the WBH treatment thermometers used can measure the patient body temperatures with a short- and long-term accuracy of ± 0.01°C.

Zotepin vs. Haloperidol bei paranoider Schizophrenie: eine Doppelblindstudie

The efficacy and tolerance of zotepine and haloperidol were examined in 40 patients suffering from paranoid schizophrenia (DSM III). The study period was 6 weeks. Psychopathology was assessed with BPRS and CGI. Documentation of side effects was done with DOTES. The safety parameters were pulse, blood pressure, leucocyte count, liver enzymes, ECG and EEG, determined at different times. Both treatment groups improved significantly without any differences in respect to efficacy. The patients who had been treated with zotepine had significantly fewer extrapyramidal side effects. However, transient increases in liver enzyme levels were seen more frequently in the zotepine group. There were no differences between the groups in respect to other side effects.