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Nursing activities and outcomes of care in the assessment, management, and documentation of children's pain.

This study describes how assessment and documentation of children's acute postoperative pain is managed by nurses in university hospitals in Finland. A survey was conducted of 303 nurses working in children's wards of university-affiliated hospitals, and at the same time a retrospective chart review of 50 consecutive cases of operation of acute appendicitis was carried out. Charts were analyzed by content analysis, and the results of the survey are reported with percentage distribution and nonparametric statistical calculations. The results indicate that nurses assess pain mainly by observing the child's behavior and changes in physiology. Pain measurement instruments are rarely used, and nurses do not recognize them. The documentation of pain care is unsystematic and does not support the continuity of care. There is a clear need for development of assessment and documentation practices in the studied hospitals. Future research should look at the postoperative care of pain at home as well as care in non-university-affiliated hospitals.

Adolescent↗

Digital overlay technique for documenting toric intraocular lens axis orientation.

PURPOSE: To describe a digital overlay technique for documenting toric intraocular lens (IOL) axis alignment. SETTING: Jules Stein Eye Institute and the Department of Ophthalmology, University of California at Los Angeles School of Medicine, Los Angeles, California, USA. METHODS: Digital overlay imaging was used to evaluate the alignment of Staar toric IOLs in 4 eyes of 3 patients who had regular corneal astigmatism at the time of cataract surgery. Lens axes were determined by computerized analysis of digitally scanned retroillumination photographs. A stock digital image of a Staar AA4203TF toric IOL was superimposed on corneal topography images to document IOL alignment with the steep corneal meridian. RESULTS: Digital overlay images demonstrated that 3 IOLs in the sample group were within 5 degrees and 1 was within 20 degrees of the intended axis at the time of the final postoperative examination. Slitlamp lens axis estimations were 3 to 18 degrees different from that determined by this technique. CONCLUSION: Digital overlay imaging of correctly oriented toric IOLs on computerized corneal topography maps represents an intuitive, accurate, and visually appealing method of documenting toric IOL axis alignment.

Aged↗

Integrating contextual information to enhance SOM-based text document clustering.

Exploration of text corpora using self-organizing maps has shown promising results in recent years. Topographic map approaches usually use the original vector space model known from Information Retrieval for text document representation. In this paper I present a two stage model using features based on sentence categories as alternative approach which includes contextual information. Algorithmic optimizations required by this computationally expensive model are shown and evaluated. Also a method for model independent comparison of document maps by evaluation of document distribution on maps is introduced and used to compare results obtained with both the new model and the vector space model.

Algorithms↗

Nursing documentation versus standardized assessment of cognitive status in hospitalized medical patients.

Although the literature discusses the importance of assessing cognitive status, little research has explored the concordance of nurses' documentation of cognitive status and standardized assessment. This study examined nurses documentation of cognitive status in 42 medically hospitalized individuals (mean age 51.9, SD = 10.1 years) using a variety of standardized measures. Although the chart review revealed no documentation of impaired cognitive status, impaired performance in 24 to 67% of the cognitive measures was identified. This study suggests nurses are missing cognitive impairment in hospitalized patients by limiting assessment to orientation. Use of a combination of several brief screening measures, such as the Clock Drawing Test and the standardized Mini-Mental State Examination, would provide timely, effective, and inexpensive assessment of cognitive status.

Cognition Disorders↗

Self-assessment questionnaires document substantial variability in the clinical expression of rotator cuff tears.

The goal of this investigation was to document the variability in the clinical expression of full-thickness rotator cuff tears with practical and standardized patient self-assessment tools. One-hundred twenty-three consecutive patients with full-thickness cuff tears diagnosed by standard cuff-imaging methods (sonography, arthrography, or magnetic resonance imagery) assessed their own shoulder function and health status with the Simple Shoulder Test and the Short Form 36, respectively. As a group, these patients were substantially compromised in their ability to perform the functions of the Simple Shoulder Test and in the Short Form 36 scales of physical role, physical function, and comfort. As individuals, however, their self-assessments varied widely. The standard deviations were often greater than 50% of the mean and the range of responses often covered the entire scale from the minimum possible score to the maximum possible score. These results show the importance of documenting the clinical expression of cuff tears in patients at initial evaluation and when treatment is being considered. The results also show the practicality of standardized self-assessment questionnaires in such documentation.

Activities of Daily Living↗

Rumination documented by using combined multichannel intraluminal impedance and manometry.

According to the Rome criteria, rumination is considered to be an esophageal functional disorder. Because documentation of rumination is difficult, it has been suggested that rumination is a clinical diagnosis. Even though a clinical diagnosis of rumination can be based only on history, this conclusion often leaves both the patient and the physician dissatisfied. In this article we describe the case of a 26-year-old man referred for evaluation of persistent regurgitation. By using combined multichannel intraluminal impedance and manometry we were able to document the sequence of events leading to regurgitation. These include an increase in intra-abdominal pressure identified in the pressure transducer located in the stomach, which initiates the reflux event identified by both impedance changes as well as common cavity phenomenon, followed by peristaltic fore contractions, which clear the intraesophageal content, a pattern highly suggestive for rumination. The opportunity to review these documented changes visually helps to make the patient aware of the functional aspects of the condition, avoiding unwarranted therapies and providing the opportunity to reinforce behavioral modifications.

Adolescent↗

Ten years of marketing approvals of anticancer drugs in Europe: regulatory policy and guidance documents need to find a balance between different pressures.

Despite important progress in understanding the molecular factors underlying the development of cancer and the improvement in response rates with new drugs, long-term survival is still disappointing for most common solid tumours. This might be because very little of the modest gain for patients is the result of the new compounds discovered and marketed recently. An assessment of the regulatory agencies' performance may suggest improvements. The present analysis summarizes and evaluates the type of studies and end points used by the EMEA to approve new anticancer drugs, and discusses the application of current regulations. This report is based on the information available on the EMEA web site. We identified current regulatory requirements for anticancer drugs promulgated by the agency and retrieved them in the relevant directory; information about empirical evidence supporting the approval of drugs for solid cancers through the centralised procedure were retrieved from the European Public Assessment Report (EPAR). We surveyed documents for drug applications and later extensions from January 1995, when EMEA was set up, to December 2004. We identified 14 anticancer drugs for 27 different indications (14 new applications and 13 extensions). Overall, 48 clinical studies were used as the basis for approval; randomised comparative (clinical) trial (RCT) and Response Rate were the study design and end points most frequently adopted (respectively, 25 out of 48 and 30 out of 48). In 13 cases, the EPAR explicitly reported differences between arms in terms of survival: the range was 0-3.7 months, and the mean and median differences were 1.5 and 1.2 months. The majority of studies (13 out of 27, 48%) involved the evaluation of complete and/or partial tumour responses, with regard to the end points supporting the 27 indications. Despite the recommendations of the current EMEA guidance documents, new anticancer agents are still often approved on the basis of small single arm trials that do not allow any assessment of an 'acceptable and extensively documented toxicity profile' and of end points such as response rate, time to progression or progression-free survival which at best can be considered indicators of anticancer activity and are not 'justified surrogate markers for clinical benefit'. Anticipating an earlier than ideal point along the drug approval path and the use of not fully validated surrogate end points in nonrandomised trials looks like a dangerous shortcut that might jeopardise consumers' health, leading to unsafe and ineffective drugs being marketed and prescribed. The present Note for Guidance for new anticancer agents needs revising. Drugs must be rapidly released for patients who need them but not be at the expense of adequate knowledge about the real benefit of the drugs.

Antineoplastic Agents↗

Liposomal amphotericin B compared with amphotericin B deoxycholate in the treatment of documented and suspected neutropenia-associated invasive fungal infections.

It has been suggested that a better outcome of neutropenia-associated invasive fungal infections can be achieved when high doses of lipid formulations of amphotericin B are used. We now report a randomized multicentre study comparing liposomal amphotericin B (AmBisome, 5 mg/kg/d) to amphotericin B deoxycholate (AmB, 1 mg/kg/d) in the treatment of these infections. Of 106 possible patients, 66 were enrolled and analysed for efficacy: nine had documented fungaemia, 17 had other invasive mould infections and 40 had suspected pulmonary aspergillosis. After completion of the course medication, in the AmBisome group (n = 32) 14 patients had achieved complete response, seven a partial response and 11 were failures as compared to 6, 13 and 15 patients (n = 34) treated with AmB (P=0.09); P=0.03 for complete responders. A favourable trend for AmBisome was found at day 14, in patients with documented infections and in patients with pulmonary aspergillosis (P=0.05 and P=0.096 respectively). Mortality rates were lower in patients treated with AmBisome (adjusted for malignancy status, P=0.03). More patients on AmB had a >100% increase of their baseline serum creatinine (P<0.001). The results indicate that, in neutropenic patients with documented or suspected invasive fungal infections AmBisome 5 mg/kg/d was superior to AmB 1 mg/kg/d with respect to efficacy and safety.

Adult↗

Nursing documentation in patient records: experience of the use of the VIPS model.

The VIPS model for the documentation of nursing care in patient records was scientifically developed and published in 1991, with the aim of supporting the systematic documentation of nursing care and promoting individualized care. As the model seemed to be accepted and used in many parts of Sweden, a study was conducted in order to gather further information on the validity of the model, to describe the clinical and educational experience of its use and to refine it. Experience of the use of the model was gathered from a review of the scientific papers and other reports on it, from questionnaires addressed to nurses (n = 514), from comments by key informants, and from interviews with faculty members at all the nursing schools in the country. The findings showed that an intense process of change and development was occurring regarding nursing documentation. However, there were limitations in the use of the entire nursing process, especially in the specification of patient problems and the formulation of nursing diagnoses and nursing interventions. The keywords (Swedish spelling) of the VIPS model had good content validity in different areas of nursing care. The findings also indicated the need for further elaboration and revision of some of the keywords. A revised version of the VIPS model based on these findings is presented.

Health Knowledge, Attitudes, Practice↗

What is recommended for healthy women during pregnancy? A comparison of seven prenatal clinical practice guideline documents.

BACKGROUND: Several countries have developed clinical practice guidelines for the content of prenatal care. This study examines the consistency of recommendations in clinical practice guidelines describing routine prenatal care. METHODS: The recommendations for low-risk women in seven guideline documents were examined: two from Australia, two from the United States, two from Canada, and one from Germany. The recommendations were listed into the four areas of "general health screening and health promotion during pregnancy," "organization of care," "clinical tests and screening," and "education specific for pregnancy." RESULTS: A total of 69 recommendations were identified within the seven documents, most of which fell within the "clinical tests and screening" domain. Notable differences were identified in the number of recommendations made within the same country. Of the 69 recommendations, only four were included in all seven documents. CONCLUSION: Little consistency was demonstrated within or among countries in terms of the content of their prenatal care guidelines, suggesting a need to reexamine their content and the evidence on which such recommendations are based.

Australia↗

The absence of interictal spikes with documented seizures suggests extratemporal epilepsy.

PURPOSE: To determine the demographic and clinical characteristics of patients who have documented epileptic seizures on long-term video-EEG monitoring who do not have interictal spikes. METHODS: The records of 1,223 monitoring studies from 919 patients who underwent noninvasive long-term video-EEG monitoring were reviewed. In 28 patients (3.0% of monitored patients, 4.4% of patients with electrographic evidence of epilepsy), no interictal spikes were found despite the occurrence of at least one recorded electrographic seizure. The demographic, medical, neuropsychological, and EEG data of these patients were compared with those of 28 matched control patients with documented interictal spikes. RESULTS: Extratemporal seizures were significantly more frequent in the patients with at least one recorded epileptic seizure but without interictal spikes compared with patients with epileptic seizures and interictal spikes (p = 0.031). The only other significant difference between the groups (p = 0.016) was a later age at seizure onset (18.3 vs. 10.7 years) for the patients without interictal spikes. Age at evaluation, gender, handedness, clinical seizure type, family history of epilepsy, history of febrile seizures, neuropsychological testing, and neurologic and psychiatric history did not differ between the two groups. CONCLUSIONS: In patients with documented epilepsy without interictal spikes on EEG monitoring, the possibility of an extratemporal focus should be considered.

Adolescent↗

Persistence of racial disparities in advance care plan documents among nursing home residents.

This paper analyzes the association between race and the presence of advance care plan documents (living wills, do not resuscitate (DNR) orders, and do not hospitalize (DNH) orders) in nursing home residents. We conducted secondary analysis of publicly available survey data from the 1996 Medical Expenditure Panel Survey-Nursing Home Component, a nationally representative survey of nursing home residents in the United States. There were 3,747 participants in the survey, weighted to represent 1.56 million nursing home residents in the United States. We found that 20% of U.S. nursing home residents in 1996 had documentation of living wills, 48% had DNR orders, and 4% had DNH orders. African Americans are about one-third as likely as Caucasians to have living wills and one-fifth as likely as Caucasians to have DNR orders; Hispanics are about one-third as likely as Caucasians to have DNR orders and just as likely as Caucasians to have living wills. In conclusion, we found that the presence of advance care plans is related to race, even after controlling for health and other demographic factors. These findings call attention to an area where further research is needed to determine whether residents' (and their families') preferences are being elicited and documented.

Advance Directives↗

[Frequency of decubitus ulcer in patients of a university medical center. Combination of routine documentation and cross-sectional study].

BACKGROUND AND OBJECTIVE: Pressure ulcer is a relevant issue for quality management and cost containment of hospitals. Cross-sectional studies are the typical design to estimate the frequency of pressure ulcers. The derived point prevalence rate is not as good for a case related reference value as the period prevalence rate. The interdisciplinary pressure ulcer project at the University Clinics in Essen combined a routine documentation with a cross-sectional survey, thus providing both measurements for the first time. PATIENTS AND METHODS: The routine and computer-based collection of information about pressure ulcers started in March 2003, using the patient administration system medico//s from Siemens. Findings are presented from 49,904 admissions, starting on 91/03/2004, discharged by 31/03/2004. The mean age was 48.7 +/- 22.4 years; 51.2 % were males, 48.8 % females. Additionally, a decubitus team examined patients from randomly selected wards each work-day. The real period prevalence rate was calculated using the observed period prevalence rate, the sensitivity and the point prevalence rate. RESULTS: In the routine documentation, 700 pressure ulcers had been recorded from 49,904 inpatient cases (period prevalence rate 1.4 %). The decubitus team did 5,415 examinations and 294 times detected at least one pressure ulcer (point prevalence rate 5.4 %). Estimated results in three different period prevalence rates: 3.0 % using sensitivity of the routine documentation, 3.7 % using sensitivity stratified for departments, and 2.3 % using the point prevalence rate for cases with short, medium, and long length of stay. CONCLUSIONS: The project presents for the first time reference values for pressure ulcer frequency in university clinics. A comparison with international rates is hindered by unpublished sensitivity values. In view of the higher point prevalence rate of 10 % present in the literature, a period prevalence rate of 5 % is a realistic reference value.

Academic Medical Centers↗

[Quality and management of preoperative patient information. Results of conventional and computer based documentation].

INTRODUCTION: Analysis of the quality of different modes of preoperative information management on the example of primary total hip arthroplasty. Comparison between a since 10 years used, computer based system and a conventional procedure with additional hand-written notes. METHODS: Retrospective analysis of respectively 50 with conventional and computer based system written preoperative patient information. The completeness of the documentation is examined according to the demands of current judgement. RESULTS: The results confirm, independent from the level of education, a complete documentation of all risks by applying the computer based system, whereas the conventional method leads to considerable lacks of documentation. DISCUSSION: The computer based system guarantees a high quality of preoperative patient information which cannot be obtained by the conventional method and therefore offers a protection against unjustified claims of liability.

Ambulatory Care Information Systems↗

Nineteen documented cases of Loxosceles reclusa envenomation.

OBJECTIVE: Our purpose was to review documented Loxosceles reclusa (brown recluse spider) envenomations and to describe the natural history. METHODS: This article is a retrospective review of 19 documented cases seen in a university dermatology clinic. The study included the cases of 11 female and 8 male patients between the ages of 15 and 54 years with documented cases of brown recluse spider bite between 1987 and 1993. Rest, ice compresses, elevation, and prophylactic antibiotics were used in all cases. Fourteen patients received dapsone and 11 received nonsteroidal anti-inflammatory drugs. Two patients were hospitalized. A 3-point scale of cutaneous lesion severity was developed. Analysis of the association between maximum lesion severity (mild, moderate, severe) and time to complete healing or final evaluation was statistically significant (P < .001). RESULTS: All patients presented with localized erythema. Most bites were on the extremities (18/19; 95%). The most common presenting symptom was pain at the bite site (10/19; 53%). Eleven patients (58%) had skin necrosis; 32% of them had areas of necrosis larger than 1 cm(2). Time to healing ranged from 5 days to more than 17 weeks (mean, 5.6 weeks). Average time to healing for grade 3 (severe) lesions was 74 days, for grade 2 (moderate) lesions 22 days, and for grade 1 (mild) lesions 8 days (in patients seen more than once). CONCLUSIONS: Brown recluse spider bites frequently induce necrotic, slowly healing lesions. Maximum lesion severity is a predictor of time to complete healing.

Adolescent↗

Concepts of disablement in documents guiding physical therapy practice.

PURPOSE: To describe disability concepts used within documents guiding physical therapist practice. METHODS: Content analysis was performed on the Guide to Physical Therapist Practice, second edition; A Normative Model of Physical Therapist Professional Education, version 2000; APTA House of Delegates Standards, Policies, Positions and Guidelines; APTA Board of Directors Policies, Positions and Guidelines; The Model Practice Act for Physical Therapy and The Illinois Physical Therapy Act. Using a word sense framework, text-in-context lists were compiled, from which contextual themes and counts for all occurrences of disability terms were developed. RESULTS: Across documents, contextual themes with number of occurrences were: disability as role performance limitations within specific contexts: 819; disability resulting from health status: 39, disability law: 29; and rights of individuals with disabilities: 25. CONCLUSIONS: Documents guiding physical therapist practice commonly conceptualize disability as individual limitations within specific contexts and infrequently conceptualize disability as a societal phenomenon affecting persons across most settings and circumstances. It is believed that a concept of disability that is more inclusive of broad, as well as specific, contexts of disability may lead to improved physical therapy management for individuals with a wide range of performance capacities.

Concept Formation↗

Clinical physiotherapy documentation in stroke rehabilitation: an ICIDH-2 beta-2 based analysis.

PURPOSE: To explore the focus of physiotherapists practising in stroke rehabilitation, through identification of central elements in clinical physiotherapy documentation. METHOD: A descriptive study in which the Motor Assessment Scale for Stroke (MAS) and 20 physiotherapy records were collected from the stroke unit of a rehabilitation hospital and classified according to the ICIDH-2 beta-2. The text was broken down into single units of functional descriptions and assigned classification codes. The coded units were counted and the distribution of the units on the ICIDH-2 beta-2 examined. RESULTS: In the physiotherapy records the majority of coded units belonged to the dimension of Body Functions, particularly to b7 Neuromusculoskeletal and movement related functions. In the MAS two thirds of the units belonged to Activities, with a3 Movement activities as the major group. There were no units related to Participation or Environmental Factors. CONCLUSIONS: Physical functioning and movement were the central elements in this sample of clinical documentation, thus confirming earlier perception of physiotherapy. Lack of documented information on participation and environment could have several reasons. However, physiotherapists in stroke rehabilitation may consider if patients' environment and participation in life situations should have a larger place in clinical physiotherapy.

Disability Evaluation↗

A review of the FDA draft guidance document for software validation: guidance for industry.

A Draft Guidance Document (Version 1.1) was issued by the United States Food and Drug Administration (FDA) to address the software validation requirement of the Quality System Regulation, 21 CFR Part 820, effective June 1, 1997. The guidance document outlines validation considerations that the FDA regards as applicable to both medical device software and software used to "design, develop or manufacture" medical devices. The Draft Guidance is available at the FDA web site http:@www.fda.gov/cdrh/comps/swareval++ +.html. Presented here is a review of the main features of the FDA document for Quality System Regulation (QSR), and some guidance for its implementation in industry.

Guidelines as Topic↗