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Biomedical subjects

D J Cullen

Publications and source records attributed to D J Cullen.

At least 37 records · Page 2Linked to original sources

Prescribing of nonsteroidal anti-inflammatory drugs in general practice: determinants and consequences.

AIM: To use Prescribing Analysis and Costs data to investigate factors associated with differences in rates of nonsteroidal anti-inflammatory drug prescribing in Nottingham general practices. RESULTS: Poisson regression analysis revealed that the Age. Sex and Temporary Resident Prescribing Unit Index was the largest identifiable influence; larger practice size and a higher index of deprivation were also significantly associated with lower prescribing, whilst the number of partners was associated with higher levels of prescribing. However, even after correcting for the influence of age, sex and temporary residents, there was an 5.9-fold variation in rates of prescribing. A similar Poisson regression analysis to identify factors associated with admission to hospital with ulcer bleeding in the elderly over the preceding 57 months identified the rate of nonsteroidal anti-inflammatory drug (NSAID) prescribing as the only significant influence. CONCLUSION: The data are compatible with 1 hospital admission per 2823 NSAID prescriptions (95% confidence intervals 2098-8110) and they emphasize the need for strategies to reduce levels of NSAID prescribing.

Aged↗

Preventable adverse drug events in hospitalized patients: a comparative study of intensive care and general care units.

OBJECTIVES: To compare the frequency and preventability of adverse drug events and potential adverse drug events in intensive care units (ICUs) and non-ICUs. To evaluate systems factors involving the individual caregivers, care unit teams, and patients involved in each adverse drug event by comparing ICUs with non-ICUs and medical ICUs with surgical ICUs. DESIGN: Prospective cohort study. Participants included all 4,031 adult admissions to a stratified, random sample of 11 medical and surgical units in two tertiary care hospitals over a 6-month period. Units included two medical and three surgical ICUs and four medical and two surgical general care units. SETTING: Two tertiary care hospitals: Eleven medical and surgical units, including two medical and three surgical ICUs. PATIENTS: Adult admissions (n = 4,031). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Rate of preventable adverse drug events and potential adverse drug events, length of stay, charges, costs, and measures of the unit's environment. Incidents were detected by stimulated self-report by nurses and pharmacists and by daily review of all charts by nurse investigators. Incidents were subsequently classified by two independent reviewers as to whether they represented adverse drug events or potential adverse drug events and as to severity and preventability. Those individuals involved in the preventable adverse drug event and potential adverse drug event underwent detailed interviews by peer case-investigators. The rate of preventable adverse drug events and potential adverse drug events in ICUs was 19 events per 1000 patient days, nearly twice that rate of non-ICUs (p <.01). The medical ICU rate (25 events per 1000 patient days) was significantly (p <.05) higher than the surgical ICU rate (14 events per 1000 patient days). When adjusted for the number of drugs used in the previous 24 hrs or ordered since admission, there were no differences in rates between ICUs and non-ICUs. ICU acuity, length of stay, and severity of the adverse drug event were greater in ICUs than non-ICUs, but there were no differences between medical ICU and surgical ICU patients. Structured interviews indicated almost no differences between ICUs and non-ICUs for many characteristics of the patient, patient care team, systems, and individual caregivers. CONCLUSIONS: The rate of preventable and potential adverse drug events was twice as high in ICUs compared with non-ICUs. However, when adjusted for the number of drugs ordered, there was no greater likelihood for preventable adverse drug events and potential adverse drug events to occur in ICUs than in non-ICUs. Preventable adverse drug events and potential adverse drug events occurred in units that functioned normally and involved caregivers who were working under reasonably normal circumstances, not at the extremes of workload, stress, or a difficult environment.

Adult↗

Peptic ulcer bleeding in the elderly: relative roles of Helicobacter pylori and non-steroidal anti-inflammatory drugs.

BACKGROUND: Most ulcers are caused, one can deduce, by Helicobacter pylori or by use of non-steroidal anti-inflammatory drugs (NSAIDs). Whether both together are worse than one alone is something that is quite unknown. AIM: To study both factors in order to see wither they interact together positively. METHOD: A case control study of ulcer bleeding in elderly patients chosen without weeding. RESULTS: NSAID usage increased risk substantially. So did H pylori infection (but relative risk less than three). Neither seemed to interact. Their actions were discretely intact. CONCLUSION: H pylori effects ulcer bleeding in an adverse manner but does not make the risk of NSAIDs worse.

Aged↗

Enhanced eradication of Helicobacter pylori by pre- versus post-prandial amoxycillin suspension with omeprazole: implications for antibiotic delivery.

BACKGROUND: Strategies to improve antibiotic treatment of Helicobacter pylori infection are hampered by lack of knowledge about the route of antibiotic delivery. Post-prandial dosing with antibiotics prolongs their gastric residence time and improves their intragastric distribution, leading to improved local delivery compared with pre-prandial dosing. We aimed to assess whether pre- or post-prandial dosing. with amoxycillin suspension was more effective for H. pylori eradication in an amoxycillin/omeprazole regimen. METHODS: Seventy-nine patients with H. pylori infection were treated with omeprazole 40 mg o.m. for 28 days and amoxycillin suspension 500 mg q.d.s. for days 15-28, the amoxycillin being randomized to either 1 h before or immediately after food. RESULTS: The H. pylori eradication rate, for those completing the trial, was 67% (22/33) when amoxycillin suspension was given pre-prandially, compared with 39% (15/38) when it was given post-prandially (P < 0.05). Good compliance was achieved, with H. pylori eradication in 59% (28/46) of good compliers compared with 36% (9/25) of others completing the protocol (P < 0.05). CONCLUSION: When given with omeprazole, pre-prandial dosing with amoxycillin suspension is more effective for H. pylori eradication than post-prandial dosing. This is consistent with the hypothesis that systemic rather than local delivery of amoxycillin is important for H. pylori eradication.

Adult↗

Long-term follow-up of gastric histology after Helicobacter pylori eradication.

Helicobacter pylori causes chronic active gastritis and is thought to be associated with the development of gastric atrophy, intestinal metaplasia and carcinoma. As the effect of H. pylori eradication on this process is poorly understood, we sought to determine the long-term effects of H. pylori eradication on gastric histology. Fifty-four patients with duodenal ulceration associated with H. pylori infection received H. pylori eradication therapy in 1985/86 and either remained infected (n = 22) or had the infection eradicated (n = 32); patients were followed up by endoscopy with gastric antral biopsy for 7.1 years (mean). Histopathological analysis of gastric antral mucosa from patients rendered H. pylori-negative revealed a marked decrease in both inflammatory cells within the lamina propria and intraepithelial neutrophils and an increase in epithelial mucinogenesis. Gland atrophy remained unchanged in both H. pylori-positive and -negative patients. When examined for the presence and severity of intestinal metaplasia, there was neither a difference between the two patient groups nor a change with time. These data demonstrate that significant long-term improvements in gastric histology accompany H. pylori eradication when compared with histology in patients with persistent infection. Whether this confers a protective effect by reducing the risk of gastric carcinoma remains unknown.

Adult↗

Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group.

OBJECTIVES: To assess incidence and preventability of adverse drug events (ADEs) and potential ADEs. To analyze preventable events to develop prevention strategies. DESIGN: Prospective cohort study. PARTICIPANTS: All 4031 adult admissions to a stratified random sample of 11 medical and surgical units in two tertiary care hospitals over a 6-month period. Units included two medical and three surgical intensive care units and four medical and two surgical general care units. MAIN OUTCOME MEASURES: Adverse drug events and potential ADEs. METHODS: Incidents were detected by stimulated self-report by nurses and pharmacists and by daily review of all charts by nurse investigators. Incidents were subsequently classified by two independent reviewers as to whether they represented ADEs or potential ADEs and as to severity and preventability. RESULTS: Over 6 months, 247 ADEs and 194 potential ADEs were identified. Extrapolated event rates were 6.5 ADEs and 5.5 potential ADEs per 100 nonobstetrical admissions, for mean numbers per hospital per year of approximately 1900 ADEs and 1600 potential ADEs. Of all ADEs, 1% were fatal (none preventable), 12% life-threatening, 30% serious, and 57% significant. Twenty-eight percent were judged preventable. Of the life-threatening and serious ADEs, 42% were preventable, compared with 18% of significant ADEs. Errors resulting in preventable ADEs occurred most often at the stages of ordering (56%) and administration (34%); transcription (6%) and dispensing errors (4%) were less common. Errors were much more likely to be intercepted if the error occurred earlier in the process: 48% at the ordering stage vs 0% at the administration stage. CONCLUSION: Adverse drug events were common and often preventable; serious ADEs were more likely to be preventable. Most resulted from errors at the ordering stage, but many also occurred at the administration stage. Prevention strategies should target both stages of the drug delivery process.

Boston↗

Systems analysis of adverse drug events. ADE Prevention Study Group.

OBJECTIVE: To identify and evaluate the systems failures that underlie errors causing adverse drug events (ADEs) and potential ADEs. DESIGN: Systems analysis of events from a prospective cohort study. PARTICIPANTS: All admissions to 11 medical and surgical units in two tertiary care hospitals over a 6-month period. MAIN OUTCOME MEASURES: Errors, proximal causes, and systems failures. METHODS: Errors were detected by interviews of those involved. Errors were classified according to proximal cause and underlying systems failure by multidisciplinary teams of physicians, nurses, pharmacists, and systems analysts. RESULTS: During this period, 334 errors were detected as the causes of 264 preventable ADEs and potential ADEs. Sixteen major systems failures were identified as the underlying causes of the errors. The most common systems failure was in the dissemination of drug knowledge, particularly to physicians, accounting for 29% of the 334 errors. Inadequate availability of patient information, such as the results of laboratory tests, was associated with 18% of errors. Seven systems failures accounted for 78% of the errors; all could be improved by better information systems. CONCLUSIONS: Hospital personnel willingly participated in the detection and investigation of drug use errors and were able to identify underlying systems failures. The most common defects were in systems to disseminate knowledge about drugs and to make drug and patient information readily accessible at the time it is needed. Systems changes to improve dissemination and display of drug and patient data should make errors in the use of drugs less likely.

Boston↗

The incident reporting system does not detect adverse drug events: a problem for quality improvement.

OBJECTIVES: The objectives of this study were 1) to determine the frequency with which adverse drug events result in an incident report (IR) in hospitalized patients; and 2) to determine if there were differences between quality assurance administrators, nurse leaders in quality assurance, and staff nurses as to whether an incident report should or would be filed for each adverse drug event. STUDY DESIGN: All patients admitted to five patient care units (one medical intensive care unit, two surgical intensive care units, and two medical general care units) in one academic tertiary care hospital were studied between February and July 1993. The main outcome measures used were adverse drug events (ADEs) and IRs. Consensus voting was used by senior hospital administrators, nursing leaders, and staff nurses to determine whether an adverse drug event should have been reported and would have been reported. RESULTS: Of 54 adverse drug events identified by the study, only 3 patients (6%) had a corresponding incident report submitted to the hospital's quality assurance program or called into the pharmacy hotline. One additional ADE was identified by an IR, but not by the ADE study. Of the 55 ADEs, 15 were preventable, and 26 were serious or life-threatening, yet only 2 of the 26 led to an incident report. The three voting groups agreed that most ADEs justified an IR, but judged that in actual practice, an IR would infrequently have been filed. CONCLUSIONS: Voluntary reporting identified only a small fraction of ADEs. Using IRs for quality assurance/quality improvement will lead to significant bias when assessing quality of care.

Adverse Drug Reaction Reporting Systems↗

Basic fibroblast growth factor treatment for non-steroidal anti-inflammatory drug associated gastric ulceration.

An open, pilot study tested the safety and efficacy of an acid stable form of the angiogenic protein basic fibroblast growth factor (bFGF) for healing of non-steroidal anti-inflammatory drug (NSAID) associated gastric ulcers in five patients with nine gastric ulcers that were resistant to conventional treatment (4) or had relapsed (5). Oral bFGF treatment for four weeks was safe and well tolerated. There was no evidence of systemic absorption. After four weeks, four ulcers had healed and there was a 89 (3)% mean (SEM) reduction in the area of the others. A controlled, comparative trial of this novel growth factor treatment is warranted.

Anti-Inflammatory Agents, Non-Steroidal↗

How well does a journal's peer review process function? A survey of authors' opinions.

OBJECTIVE: To evaluate the authors' satisfaction or dissatisfaction with the peer review process of the Journal of Clinical Anesthesia. DESIGN: Anonymous questionnaires were sent to authors to survey their opinions about specific aspects of the peer review process. Authors were grouped by status of their manuscripts: AR (accept with revision), RR (reject but may resubmit), and RO (reject outright). PARTICIPANTS: Authors of unsolicited manuscripts submitted in 1991 to 1992. MAIN OUTCOME MEASURES: Factors that determine authors' satisfaction with the relevancy and benefit of peer review of their manuscript. RESULTS: Significantly more authors of AR manuscripts responded to our survey than did authors of rejected manuscripts and viewed the review process more favorably. Authors of AR manuscripts were more satisfied with specific aspects of the review process, which led to improvement in their manuscripts. More authors of RR manuscripts believed that our review process improved subsequent manuscript preparation than did authors of accepted manuscripts. CONCLUSIONS: The surveying of authors, important clients of the peer review process, should guide change necessary to better serve our authors and improve peer review.

Attitude↗

Duodenal ulcer treated with Helicobacter pylori eradication: seven-year follow-up.

The long-term benefits of Helicobacter pylori-eradication treatment (HET) in H pylori-associated duodenal ulcer are unclear. We followed up patients with duodenal ulcers from a trial of H pylori eradication in 1985-86. 63 of 78 patients (81%) were reviewed clinically and had upper gastrointestinal endoscopy with gastric antral biopsy. Of 35 patients previously rendered H pylori negative, 32 (92%) remained H pylori negative after 7.1 years (mean). All patients initially H pylori positive remained infected, unless HET was given in the interim. Duodenal ulceration was found in 20% (5 out of 25) of patients remaining H pylori-positive, compared with 3% (1 of 38) of H pylori-negative patients (p < 0.05). The reduction of duodenal ulcer relapse obtained from H pylori eradication in H pylori-associated duodenal ulcer extends to at least 7 years after treatment, and is likely to be due to freedom from H pylori infection. However, duodenal ulcer may recur in patients rendered H pylori negative, due to factors other than reinfection with H pylori.

Adult↗

ASA Physical Status and age predict morbidity after three surgical procedures.

OBJECTIVE: American Society of Anesthesiologists-Physical Status scores (ASA-PS) and age were used to adjust for case-mix differences when evaluating surgical morbidity and resource use after total hip replacement (THR), transurethral prostatectomy (TURP), or cholecystectomy. SUMMARY BACKGROUND DATA: Variations in complication rates or resource use among patients treated for a particular primary condition should be adjusted for coexistent disease. Age and ASA-PS scores are readily available and can be useful to stratify surgical patients for risk. METHODS: One thousand ninety patients at five academic medical centers in California and Massachusetts who underwent THR, TURP, or cholecystectomy between 1985 and 1987 were studied. Data were obtained from medical records and a self-administered questionnaire to measure length of stay (LOS), postoperative complication rates, and follow-up physician visits. Data were analyzed with one- and two-way analysis of variance with the Bonferroni correction. RESULTS: Increasing age and ASA-PS scores were associated significantly with increased LOS, complication rates, and frequency of post-discharge physician office visits. No interaction effect between age and ASA-PS scores was observed. CONCLUSIONS: Age and ASA-PS scores can predict postoperative morbidity, specific for each operation studied. Assessment of co-morbidity in surgical patients can be accomplished easily and with minimal expense. While remaining budget neutral, the distribution of reimbursements should be based on those preoperative risk factors that predict longer LOS and higher complication rates.

Adult↗

Detection of pooled secretions above endotracheal-tube cuffs: value of plain radiographs in sheep cadavers and patients.

OBJECTIVE: Mechanical ventilation is thought to increase the risk of nosocomial pneumonia by permitting leakage of bacteria-laden gastro-oropharyngeal secretions into the upper airways. The goal of this study was (a) to validate radiographic signs of pooled secretions above endotracheal-tube cuffs (supracuff liquid) in an animal model and (b) to determine whether suctionable pooled supracuff liquid can be identified on bedside radiographs of intubated patients. MATERIALS AND METHODS: Diagnostic criteria for supracuff liquid were initially validated by three radiologists interpreting 162 randomized radiographs made in an intubated sheep cadaver. The primary criteria included (a) replacement of the normal supracuff lucency with liquid opacity and (b) the formation of a sharp interface between the lucency of the upper edge of the cuff below and the liquid above. Graded infusions of 0, 3, 8, 13, and 23 ml of saline were made in triplicate into the space above the cuff, and radiographs were evaluated for the presence or absence of saline. The validated diagnostic criteria were used by two radiologists to estimate the frequency with which pooled liquid was seen on portable chest radiographs of 47 patients undergoing elective short-term postanesthetic mechanical ventilation. RESULTS: In the sheep-cadaver model, the diagnostic criteria for supracuff liquid allowed successful differentiation between no liquid, a small amount of liquid (3-8 ml), and a large amount of liquid (13-23 ml; c2, p < .0001). In a clinical study, radiographic signs of supracuff liquid were identified in 57% of 47 patients. In a small subset of patients (n = 18), the estimated liquid volume (mean +/- SEM) was calculated to be 7.8 +/- 1.1 ml (range = 2.1-18.4 ml). CONCLUSIONS: Radiography is a sensitive means of identifying small volumes of supracuff liquid above the inflated cuffs of endotracheal tubes. Potentially contaminating liquid pooled above the cuff of an endotracheal tube can be identified in about half of patients undergoing short-term mechanical ventilation. Our results suggest the suction of the supracuff space may be a reasonable prophylactic maneuver against nosocomial pneumonia. A much larger study is suggested to investigate the actual relation between pooled supracuff liquid and the development of nosocomial pneumonia.

Adult↗

Intermediate TISS: a new Therapeutic Intervention Scoring System for non-ICU patients.

OBJECTIVE: To modify the Therapeutic Intervention Scoring System (TISS) for intermediate and floor care nursing units. DESIGN: Prospective study. SETTING: University teaching hospital. PATIENTS: In-patients on medical and surgical nursing units. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Intermediate TISS retains 49 Original TISS items, adds 26 Intermediate TISS items, deletes 18 Original TISS items, and reweights 10 Original TISS items. Intermediate TISS score sums up the monitoring and therapeutic modalities used within the previous 24 hrs, each of which is assigned a weighted score from 1 to 4 points. A total of 3,073 patient days for 1,013 patients were simultaneously scored for Original TISS and Intermediate TISS over a 4-month period. A random sample of 435 patients was examined to identify those patients for whom Intermediate TISS added information over and above that obtained from Original TISS. Original TISS and Intermediate TISS correlated well, regression equation: Intermediate TISS = 4.4 + 1.4 x Original TISS (r2 = .83). We identified two groups of outliers, together constituting 96 of 435 patients: a) patients whose sum of new TISS items was unusually high relative to the sum of old TISS items included those patients with diabetes mellitus, those patients receiving serial electrocardiograms to rule out myocardial infarction and patients requiring cardiac or pulmonary therapy; b) those patients whose sum of new TISS items was low relative to the sum of old TISS items were largely surgical patients outside the intensive care unit (ICU), in whom Original TISS still worked well because it had been designed for surgical ICU patients. CONCLUSIONS: Intermediate TISS is useful to score medical patients receiving intermediate or floor care in non-ICU nursing units within the hospital.

Critical Care↗

When is Helicobacter pylori infection acquired?

Cross sectional surveys have shown an increasing prevalence of Helicobacter pylori (H pylori) infection with increasing age in Western populations. The aim of this study was to examine the pattern of acquisition of H pylori infection over a 21 year period in a group of 141 adults who had blood samples and serum stored in 1969, 1978, and 1990. A prevalence of H pylori antibody of 39% in 1969 serum samples, 40.9% in 1978, and 34.8% in 1990 was found when assessed by an enzyme linked immunosorbent assay (ELISA). Of the 86 subjects who were seronegative in 1969, only six (7%) were seropositive in 1990. These data suggest that a cohort effect may contribute to the pattern of increasing prevalence of H pylori infection seen with increasing age. Acquisition of infection in adults is rare. It is unlikely, therefore, that reinfection will occur after successful eradication.

Adult↗