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P21 protein expression and ras-oncogene mutations in gastric carcinoma: correlation with clinical data.

Ras oncogenes coding for P21 protein are frequently involved in the carcinogenesis of various human tumours. For gastric carcinomas, the role of these oncogenes has not yet been fully understood. Forty-five primary gastric carcinomas were investigated for point mutations in the hot spot regions codon 12 and 13 of exon 1 and codon 61 of exon 2 of H-, K- and N-ras gene. PCR-SSCP technique followed by direct sequencing was used. The expression of P21 protein was analysed immunohistochemically. The results were correlated to clinicopathologic data. There were no point mutations in the genes of the ras family. The incidence of P21 protein expression was 66.7% (30 of 45 cases). This expression was more common in carcinomas of the intestinal type than in carcinomas of the diffuse type. There was no correlation with tumour size, metastasis, localisation of the tumour in the stomach, histologic type, grade of malignancy, gender, or clinical outcome of the disease. Overexpression of ras oncoproteins without point mutation seems to occur frequently in gastric carcinoma, particularly in tumours of the intestinal type. There is no prognostic impact. P21 protein expression cannot be used in a predictive staging system.

Adenocarcinoma↗

[Pharmaceutical care for drug-related problems in inpatients].

UNLABELLED: Drug therapy-induced high morbidity results in pharmacists participating in the prevention and solution of drug-related problems (DRPs). OBJECTIVE: To assess DRP prevalence amongst inpatients, and the clinical results derived from pharmaceutical intervention. METHODS: DRPs detected during 6 months at Hospital Comarcal de Sant Bernabé were recorded and classified, and their severity established. Pharmaceutical intervention was evaluated by using two codes: impact and clinical significance. Interventions were reassessed by another pharmacist and a physician, and the degree of agreement was calculated. RESULTS: The prevalence of DRPs amongst inpatients was 10.8%. A total of 425 DRPs was detected, with a mean of 1.51 DRPs/patient. The highest percentage involved inappropriate drugs (26%), overdosing (22%), and inadequate dosing (22%). Eighty-four percent of DRPs were a severity level 2. Drugs mainly involved were antibiotics (21.6%), anti-ulcer agents (21.8%), and analgesic-anti-inflammatory compounds (8.1%). In all, 58% of interventions impacted on treatment effectiveness, and 42% on toxicity. Intervention acceptance was 91%. Seventy percent of interventions were appropriate and highly significant. The percentage of agreements in reassessments exceeded 88%. CONCLUSIONS: Pharmaceutical care allows DRPs to be prevented and solved. Methodology validation makes it safer in daily practice.

Adult↗

Inherent risks associated with manufacture of bioengineered ocular surface tissue.

OBJECTIVE: To review the potential health risks associated with bioengineered ocular surface tissue, which serves as a bellwether for other tissues. METHODS: All clinical trials using bioengineered ocular surface tissue published between July 1, 1996, and June 30, 2005, were reviewed with respect to materials used and statements of risk assessment, risk remediation, adverse events, manufacturing standards, and regulatory oversight. RESULTS: Ninety-five percent of investigational protocols used 1 or more animal-derived products and an overlapping 95% used 1 or more donor human tissues. Consideration of risks reveals a very low probability of potential harm but a significant risk of disability or death if such an event were to occur. Details of ethics approval, patient consent, and donor serologic test results were not consistently provided. No references were made to risk assessment or to codes of manufacturing and clinical practice. CONCLUSION: While a degree of risk is associated with bioengineered ocular surface tissue, investigational reports of this new technology have yet to address issues of risk management and regulatory oversight. CLINICAL RELEVANCE: Attention to risk and codes of manufacturing and clinical practice will be required for advancement of the technology. We suggest the adoption of international standards to address these issues.

Cell Culture Techniques↗

Cerebral microbleeds are associated with lacunar stroke defined clinically and radiologically, independently of white matter lesions.

BACKGROUND AND PURPOSE: Associations among microbleeds, white matter lesions (WMLs), and small deep infarcts on imaging have been reported. Because many of these imaging infarcts were asymptomatic, the relationship of microbleeds to clinical lacunar stroke is unclear. An association between microbleeds and clinically defined lacunar stroke might suggest a common causal microangiopathy. METHODS: Patients with lacunar, partial anterior circulation or posterior circulation stroke syndromes and older healthy subjects underwent MRI. Microhemorrhages, infarcts, hemorrhages, and WMLs were coded blind to clinical details. A final clinicoradiologic stroke subtype diagnosis was assigned. RESULTS: Among 308 subjects (67 older healthy and 241 with stroke), 54 patients had microbleeds (17%). Microbleeds were twice as frequent in lacunar than cortical strokes (26% versus 13%, P=0.03) or healthy older subjects (9%) and associated with increasing WML scores (P<0.0001). Lacunar and cortical stroke subtypes and healthy older subjects had similar WML scores. CONCLUSIONS: Microbleeds are associated with lacunar stroke defined clinicoradiologically more than other stroke subtypes but not simply by association with WMLs. This suggests that microbleeds and lacunar stroke have a similar microvascular abnormality.

Aged↗

Morbidity coding in general practice.

If research is to be of any use the phenomena being studied must be clearly defined. Almost 30 years ago the difficulty of classifying primary care problems using the International Classification of Diseases (ICD-8) was demonstrated. This led to the development of the International Classification of Health Problems in Primary Care-2-Defined which is based on ICD-9. Despite the work that has gone into the development of ICHPPC-2-Defined, relatively little work has been undertaken to assess the validity and reliability of its use. This paper describes the results of such a study conducted as a preliminary to the use of ICHPPC-2-Defined in a study of consulting patterns in general practice. The participating general practitioners were trained in the use of ICHPPC-2-Defined and then coded problems which they identified in a set of clinical vignettes. Following the coding exercise, a review session was held in which difficulties and errors in the use of ICHPPC-2-Defined were discussed. Subsequently, the general practitioners were required to code two more sets of vignettes, which included some problems repeated from the preceding sets. Comparisons were then made of changes in the validity and reliability of coding from one round to the next. The results of the study suggest that the reliability and validity of morbidity data collected using ICHPPC-2-Defined can be increased by training sessions for the coders which focus on the main sources of error in the use of ICHPPC-2-Defined.(ABSTRACT TRUNCATED AT 250 WORDS)

Australia↗

Does size matter?--Evaluation of value added content of two decades of successive coding schemes in secondary care.

Over the last two decades there has been a gradual evolution from the use of simple coding schemes to controlled clinical terminologies within clinical information systems in secondary care. This evolution has required significant resources in both the development of the different coding schemes and the cost of hardware, software and human effort in implementation. During this time there has been successively larger and more complex coding schemes available for use in the UK Health Service: Read Codes 4 byte set, Read Codes 5 byte set, ICD-10 and Clinical Terms Version 3. This study evaluates what added value these successive coding schemes have offered in terms of content coverage by testing concepts derived from aClinical Information System (CIS) that has been in use to support diabetic care since 1973 (Diabeta). The schemes are quantitatively evaluated by measuring their success in providing a concept match for every notion from the CIS and their relative merits are compared. Significant added value has accrued over the years in completeness of the schemes reflected in their increased size. There appears to be justification for the continued development of clinical terminologies to support secondary care.

Diabetes Mellitus↗

Resource management progress of the program in the NHS in England.

1. HISTORY. The program began in 1986 as the Resource Management Initiative and had just six pilot sites. In 1989, Ministers decided to establish a national Resource Management Programme covering all general acute Hospitals in England with more than 250 beds--some 250-260 sites in all. A range of community units also embarked on a program of pilot projects aimed at testing the RM principles in those services. 2. ELEMENTS OF THE PROGRAM. A site joining the program was expected to submit a case based on readiness for inclusion, supported by an outline project plan before approval could be given. The plan encompassed a range of elements, but was individual to each unit; the philosophy being that each unit was being assisted to reach its own objectives within an overall framework. The elements of the framework were as follows: a) A vision of what was expected to be achieved by the project and the benefits being sought; b) A focus on improving the quality of patient care in the unit; c) Involving clinicians in the management process; d) The availability of clinical information to support decision-making; this included the hardware and software for Case-Mix Management and Nurse Management Systems, but also extended to coding, classifying, and grouping systems. e) A greater awareness of the financial implications of clinical decisions; f) A project management approach to implementation; g) An approach based on developing both the organization and its staff, with training. 3. THE KEY TO RM IMPLEMENTATION IS CULTURAL CHANGE AT THE UNIT LEVEL. While steps to achieve this change can be planned and driven forward via the project plan, the very nature of the project means that a more flexible and "soft systems" view of success is appropriate. Local ownership of the process is essential and can lead to a very specific view of "success." 4. BENEFITS. Demonstrating primary causality is difficult as eight years have elapsed since the program was started, and this has coincided with a period of radical change. However certain matters are beyond dispute: The vast majority of units have adopted one form or other of Clinical Directorate structure. Many clinical staff are formally engaged in the operational and general management process. Some RM sites are advantageous when it comes to negotiating with their purchaser organizations because they have better quality data on which to base the process. The use of Casemix Management and Nurse Management Systems is seen in some RM sites as improving the quality of patient care provided. RM has focused attention on clinical coding and grouping. RM has exposed the need to develop or reassess Information Strategies at unit level. RM has stimulated staff training and development at site level and has been instrumental in improving the quality of training facilities, resources, and materials that are available. RM is recognized as having had a catalytic effect on changes associated with the NHS Reforms. 5. CONCLUSION. Good quality services require well-managed and competent provider organizations. The RM program was designed to assist the improvement of provider unit management. There is general agreement that the principles of RM should be taken forward in the broader context of provider development, with a focus on quality as well as financial issues.

England↗

The quality of cause-of-injury data: where hospital records fall down.

OBJECTIVES: This research identifies the level of specificity of cause-of-injury morbidity data in Australia. The research explores reasons for poor-quality data across different causes-of-injury areas, including a lack of clinical documentation and insufficient detail in the classification system. METHODS: The 2002/03 hospital morbidity dataset of 593,079 injury-related hospital admissions was analysed to examine the specificity of coded external cause-of-injury data. RESULTS: While overall specificity appeared high, the cause of 47,660 injuries was not specifically defined according to the code assigned. Only 56% of cases for whom injury was the result of an accidental fall were assigned a specific code to identify the causal detail; 19% were assigned an 'Other Specified' fall code, suggesting a lack of specific code availability; and 25% were assigned an 'Unspecified Fall' code, suggesting a lack of clinical documentation to facilitate code selection. CONCLUSIONS: To improve the quality of injury-related hospital morbidity data, two main areas to focus resources are: 1) the development of more specific cause-of-injury codes; and 2) the provision of more detailed documentation from clinicians. IMPLICATIONS: Clinicians and clinical coders need to work together to improve the quality of injury-related coded data through the provision of specific codes and improved clinical documentation. Accurate and comprehensive data pertaining to the circumstances surrounding hospitalised injury events will benefit injury prevention and surveillance initiatives, provide justification for resources related to injury hospitalisation, and assist in external cause research in Australia.

Adult↗

Validity of procedure codes in International Classification of Diseases, 9th revision, clinical modification administrative data.

BACKGROUND: Administrative hospital discharge data are widely used to assess quality of care in patients undergoing certain procedures. However, little is known about the validity of administrative coding of procedure data. We conducted a detailed chart review to evaluate the accuracy and completeness of information on procedures in administrative data. METHODS: We randomly selected 1200 hospital separations in the period April 1, 1996, to March 31, 1997, from administrative discharge data of 3 acute adult hospitals in Calgary, Alberta, Canada. Each separation record in administrative data contains up to 10 procedure coding fields. The corresponding medical charts were reviewed for recording presence or absence of procedures. We then determined sensitivity to quantify the accuracy of coding presence of procedures in administrative data when these are present in the chart data (criterion standard). RESULTS: The agreement between the 2 databases varied greatly across 35 procedures studied. The sensitivity ranged from 0% to 94%. Of 6 major procedures studied, validity of coding was generally good, with 5 procedures having coding sensitivity of 69% and over and only 1 (lysis of peritoneal adhesion) with a low sensitivity of 41%. In contrast, many minor procedures had low sensitivities. Of 29 minor procedures studied, sensitivity was lower than 50% for 15 procedures, between 50% and 79% for 10, and 80% and over for 4. CONCLUSION: Validity of information on procedures in administrative discharge data appears to be related to type of procedures. Major procedures that are usually performed in operating rooms are reasonably well-coded. Meanwhile, minor procedures that are routinely performed on wards or in radiology departments are generally undercoded.

Alberta↗

[Secondary cerebral vasculitis in suppurative meningitis. Clinical aspects and findings in color-coded transcranial duplex ultrasound].

Transcranial Doppler ultrasonography carried out in cases of bacterial meningitis has often shown a reversible increase in blood flow velocity in basal cerebral arteries, that is interpreted as caused by segmental vasospasm brought on by vasculitis. We report for the first time on findings of transcranial colour-coded duplex ultrasonography performed on a patient with pneumococcal meningitis who suffered a subcortical infarction in the territory of the right middle cerebral artery. Doppler ultrasonography revealed an increase in blood flow velocity of the right middle basal cerebral artery, while the B-scan revealed thickening of the main trunk on the right. These findings suggest an inflammatory thickening of the blood vessel wall with secondary narrowing of the lumen as a result of secondary vasculitis.

Adult↗

Profile of patients attending a Dublin adolescent antenatal booking clinic.

A structured computer-coded questionnaire was administered to 120 consecutive teenage mothers attending a public adolescent antenatal clinic in order to examine their sociodemographic characteristics and sexual behaviour. The mean age of teenagers attending the clinic was 17.7 years (range: 14-19); only 5 (4.1%) were under 16 years. The mean gestation at booking was 16.4 weeks (range: 6.34); 90 (75%) had unreliable menstrual dates; 29 (24.2%) were over 20 weeks, 18 (68.9%) of these saying that they were afraid to attend hospital earlier. Ninety seven (80.8%) said that they had just one sexual partner to date and 105 (87.5%) said that they were involved in a continuing relationship with the father of the baby. Conception occurred within the first year of the relationship in 110 (91.6%). One hundred and seventeen (88.2%) were from social classes III-V, 15 (12.5%) were still at secondary school and 59 (49.2%) were unemployed. Of the 105 (87.5%) who had left school 80% had not sat the Leaving Certificate and 10% had not undertaken any state examinations. Sixty seven (55.8%) continued to smoke and 29 (24.2%) to drink alcohol during pregnancy. Sixty two mothers (51.7%) had used contraception in the past; only 33 (27.5%) had used it always. The age of first coitus, fertility awareness and the use of contraception were significantly influenced by social class and education. This study highlights the necessity for early commencement of sexual education programmes.

Adolescent↗

Clinical and molecular advances in autosomal dominant cerebellar ataxias: from genotype to phenotype and physiopathology.

Major advances have been made in the understanding of autosomal dominant cerebellar ataxias since genetic markers came into use in the 1980s. The subsequent mapping of nine genes, six of which have been identified, involved in this clinically diverse group of disorders highlighted their great genetic heterogeneity. Evidence is now accumulating that, except for SCA8, the same molecular and physiopathological processes underlie these diseases and other neurodegenerative disorders sharing the same mutational basis, the expansion of a (CAG)n-polyglutamine coding sequence. The clinical overlap among the different genetic entities makes prediction of the molecular origin impossible in a single patient so that molecular characterisation is necessary. However, extended clinical and neuropathological comparisons have shown that each genetic entity has a characteristic constellation of signs and symptoms that are related to CAG repeat size and disease duration. The combined genetic and clinical information form the basis of a new classification that will aid better understanding of disease evolution, assure follow up and permit genetic counselling by the clinician.

Anticipation, Genetic↗

Accuracy in clinically evaluating pigmented lesions.

OBJECTIVE: To determine the ability of three doctors experienced in managing melanocytic lesions to diagnose correctly melanoma, dysplastic naevi, and various benign pigmented lesions. DESIGN: Independent clinical evaluation and histopathological assessment. SETTING: Pigmented lesion clinic, which patients attend without an appointment for early diagnosis of melanoma. PATIENTS: 86 Patients with lesions that were judged to be benign by at least one of the three doctors. INTERVENTIONS: The lesions were excised under local anaesthesia and sent for histopathological examination in coded bottles without clinical details. MAIN OUTCOME MEASURE: Comparison of clinical with histopathological diagnosis for each lesion. RESULTS: A total of 120 lesions were evaluated by at least two of the three doctors. The histopathological diagnoses were made by the same pathologist. The overall sensitivity (diagnostic accuracy) for the three doctors for all types of lesion was 50%. Of the 39 dysplastic naevi, only 19 were identified correctly by all observers, and a further 24 banal lesions were wrongly diagnosed as dysplastic by at least one doctor. Particular difficulty was experienced with small (less than 5 mm), flat lesions, which can be banal or potentially malignant. CONCLUSIONS: Critical diagnosis and management decisions concerning pigmented lesions should always be based on a combination of clinical and histopathological assessments and the history of the patient.

Diagnosis, Differential↗

Clinical outcomes and secondary diagnoses for infants born with hypoplastic left heart syndrome.

OBJECTIVE: To explore clinical outcomes and secondary diagnoses present at discharge for infants born with hypoplastic left heart syndrome (HLHS), from a national perspective. METHODS: We examined hospitalizations for infants < or =30 days of age who were born with HLHS, using hospital discharge data from the 1997 Kids Inpatient Database. To explore treatment choices, clinical outcomes, and resource use, we used International Classification of Diseases, 9th Revision, Clinical Modification diagnostic and procedure codes to classify discharges according to type of surgical intervention versus no surgical intervention. To investigate outcomes in more detail, we identified secondary diagnoses noted at discharge, using International Classification of Diseases, 9th Revision, Clinical Modification codes, and stratified results according to type of surgical intervention. RESULTS: Of a total of 550 patients with HLHS, 234 underwent the Norwood procedure, 17 underwent orthotopic heart transplantation, and 106 died in the hospital with no reported surgical intervention. Although we found no demographic variables to be significantly associated with the type of treatment received, discharged patients who died without surgical intervention were significantly more likely to have received care in hospitals identified as small (odds ratio [OR]: 1.5; 95% confidence interval [CI]: 1.03-3.1) or not children's hospitals (OR: 2.02; 95% CI: 1.13-3.6). Secondary diagnoses of cardiac arrest (OR: 2.0; 95% CI: 1.1-3.4) and seizures (OR: 2.6; 95% CI: 1.2-5.5) occurred more frequently in orthotopic heart transplantation cases than in Norwood procedure cases. CONCLUSIONS: These data from a national perspective reflect outcomes of infants with HLHS during a time when rates of initial survival after surgical intervention were considered to be improved. These findings may be useful to clinicians when they are considering and recommending initial medical and surgical strategies currently being proposed for the treatment of HLHS.

Cardiac Surgical Procedures↗