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Biomedical subjects

C Peck

Publications and source records attributed to C Peck.

At least 19 recordsLinked to original sources
PubMed2007

Preventing postmarketing changes in recommended doses and marketing withdrawals.

Recent market withdrawals of prescription drug products have brought attention to premarketing safety research. Less known but related to some drug withdrawals are postmarketing dosage changes of newly marketed drugs, including both dosage reductions and increases. These events have serious effects on patients, manufacturers, and regulatory authorities. Most of these harmful events could be avoided by intensive employment of targeted clinical pharmacology investigations to optimize dosage prior to phase III testing and regulatory approval. In this paper, the frequency and implications of postmarketing dosing changes and market withdrawals are considered in light of approaches to preventing them.

Adverse Drug Reaction Reporting Systems↗
PubMed2006

The role of preoperative templating in total knee arthroplasty: comparison of three prostheses.

Templating of preoperative radiographs is routinely recommended prior to knee arthroplasty. We performed this study to assess the reproducibility and accuracy of the templates for three commonly used knee implants (PFC, Kinemax, Scorpio). Six lower limb surgeons templated 10 patients for each of the three designs. The inter- and intra-observer reliability and accuracy was calculated. There was marked variation in the reliability of the templating with the tibial insert scoring better than the femoral and the Kinemax being the most reproducible of the three. In general, the intra-observer scores (kappa=0.57-0.81) were better than the inter-observer ones (kappa=0.21-0.60). The Scorpio was the most accurately templated of the three implants, with the percentage correlating with what was actually implanted ranging from 55% to 62% for the femur and 72% to 75% for the tibia, with no templated sizes more than one size different from the actual implant. The other implants ranged from 38% to 42% for the femur and 53% to 58% for the tibia with both having up to 3% more than 1 size difference from the actual implant. We believe that the use of templating in total knee arthroplasty should be interpreted with caution and we urge the development of more accurate prosthesis sizing techniques.

Arthroplasty, Replacement, Knee↗
PubMed2001

Comparison of carotid endarterectomy at high- and low-volume hospitals.

BACKGROUND: Population-based studies have demonstrated better outcomes for carotid endarterectomies at high-volume hospitals. METHODS: This is a 2-year retrospective review of carotid procedures at two low-volume hospitals (n = 156) and one high-volume hospital (n = 404) in the metropolitan area of Portland, Oregon. RESULTS: There were no significant differences in 30-day mortality and stroke rates for carotid endarterectomies when comparing low- and high-volume hospitals (P = 0.59). These were comparable rates despite the fact that the low-volume hospitals had significantly older patients (P <0.001), more smokers (P <0.001), more patients with an indication of a previous nondisabling stroke (P <0.01), and fewer patients who were asymptomatic (P <0.01). CONCLUSION: The regionalization of carotid endarterectomy into high-volume hospitals is not justified by the findings of this study. Carotid endarterectomy performed by well-trained, experienced surgeons in low-volume hospitals is a safe procedure.

Age Factors↗
PubMed2001

'Don't call me sweetie!' Patients differ from nurses in their perceptions of caring.

Effective nursing care relies on congruent nurse-patient perception of needs. This study used Q methodology to compare nurses' and patients' perceptions of important nursing care behaviour. Q methodology applies statistical analysis to qualitative data through a technique of comparative rating using a forced choice format. The Care Q Sort, comprising fifty statements of nursing behaviour, was administered to nurses and patients from medical wards. Participants ranked the nursing behaviours from most to least important. Analysis was completed on 74 rankings. There was agreement for many behaviours but bimodal distributions for nurses' scores for some statements which may be attributable to different professional levels. An additional open comments section provided an experiential dimension to the research results. The findings will inform nursing practice and patient care planning.

Adolescent↗
PubMed2001

Assessing health system provision of adolescent preventive services: the Young Adult Health Care Survey.

BACKGROUND: Adolescents often do not receive recommended preventive counseling and screening services. Few measures are available to assess health care system performance in this area. OBJECTIVE: Develop a reliable, valid, and feasible method for measuring adherence to consensus guidelines for adolescent preventive counseling and screening services. METHODS: The 45-item Young Adult Health Care Survey (YAHCS) was tested with a diverse group of commercially and publicly insured adolescents enrolled in managed care organizations (n = 4,060). Psychometric, bivariate, and multivariate analyses were conducted to assess the reliability, validity, and patterns of variation in the preventive care measurement scales derived from the YAHCS. RESULTS: YAHCS measurement scales demonstrated strong construct validity (mean factor loading = 0.64) and reliability (mean Cronbach's alpha = 0.77). Average preventive counseling and screening scores ranged from 18.2% for discussing risky behavior topics to 50.4% for discussing diet, weight, and exercise topics. Adolescent demographic, health care use, and payer factors explained a small amount of variation across adolescent scores on YACHS scales (mean R2 = 0.086). Females and older teens were more likely to report private time with providers and counseling and screening on topics related to sex. Overall, the odds of receiving preventive counseling and screening for adolescents who reported having private time with providers, engaging in risky behaviors, or both were higher than for adolescents who did not meet privately or report risky behaviors (private visit OR, 3.60; 95% CI, 2.91-4.47; risky behaviors OR, 2.02; 95% CI, 1.62-2.52). CONCLUSIONS: The YAHCS provides a feasible, reliable, and valid method for assessing adherence to adolescent preventive services guidelines. It differentiates among varied aspects of preventive care provided to adolescents and is promising as a potential measure of health plan and provider quality. Improved performance on the YAHCS would indicate progress toward the achievement of Healthy People 2010 goals.

Adolescent↗
PubMed2001

Assessing health system provision of well-child care: The Promoting Healthy Development Survey.

BACKGROUND: Preventive care guidelines for children include parent education and counseling, developmental assessment, and screening for psychosocial and safety risks. Health care providers are in a unique position to identify and follow up on potential problems and to influence parenting knowledge, attitudes, and behavior to ensure the healthy development of young children. Few quality measures are available to assess health care system performance in this important area. OBJECTIVE: To develop a feasible, valid, and reliable methodology for evaluating health care system performance in providing family-centered anticipatory guidance and child and family assessment services on behalf of children from birth through 48 months old. Methods. The Promoting Healthy Development Survey (PHDS) was developed and tested with a diverse group of families in 3 managed care organizations (n = 1478). A standard mail administration protocol was used, including an informed consent with a waiver of documentation, 2 mailings, a postcard reminder, and telephone reminders. The 36-item parent survey assesses whether health care providers(1) talk with parents about topics recommended in Bright Futures and the American Academy of Pediatrics Guidelines for Health Supervision,(2) provide follow-up for children who may be at risk for developmental problems,(3) and address psychosocial well-being and safety within the family. The PHDS also assesses the degree to which parent's interactions with providers are family-centered, helpful, and facilitate parental confidence. Psychometric, bivariate, and multivariate analyses were conducted to assess the reliability, validity, and patterns of variation in the seven quality measures derived from the PHDS. RESULTS: Psychometric analyses demonstrated that the PHDS quality measure scales have strong construct validity (mean factor loading: 0.69) and internal consistency (mean Cronbach's alpha: 0.80). Parents reporting positive parenting behaviors had significantly higher scores on the anticipatory guidance quality measure compared with parents not reporting positive behaviors. Parents who reported that their questions on specific anticipatory guidance topics were answered were more likely to report higher confidence in related parenting activities (odds ratio [OR]: 5.9, 95% confidence interval [CI]: 3.4-10.2; OR: 8.3, 95% CI: 5-13.8)and were less likely to report concerns about their child's development in related areas compared with parents who reported they wished they had talked more with their child's doctor about these topics (OR: 0.46, 95% CI: 0.29-0.72; OR: 0.58, 95% CI: 0.37-0.89). The 7 PHDS quality measure scores for health plans ranged from 17 to 67 (on a 0-100 scale; where 100 is the best score possible) and varied significantly across health plans. Performance was highest for provision of anticipatory guidance information from health plans and lowest for family psychosocial assessment. Scores for families with Medicaid coverage were significantly higher on 2 of the PHDS measures and significantly lower for 3 measures compared with scores for families with commercial insurance. Age of child, whether child is first- born, parental marital status, education, income, and race were significant predictors for 1 or more of the PHDS quality measures (average R(2) = 0.05). CONCLUSIONS: The PHDS provides a comprehensive, psychometrically valid and reliable assessment of how well health plans and the health care providers working within these plans promote the healthy development of young children. The PHDS seems to differentiate among health care plans and among the different aspects of preventive care provided within a health plan. For the population studied here, there is significant room for improvement in ensuring families and children receive appropriate and family-centered care to promote the healthy development of children between 3 and 48 months old. Because the PHDS is conceptually based on national recommendations for child health supervision, improved performance on the PHDS would indicate greater adherence to these national recommendations and progress toward the achievement of Healthy People 2010 goals. The generalizability of the findings presented in this report are being examined using data collected in 5 statewide Medicaid samples (N = 11 696) and data from the National Survey of Early Childhood Health, which has incorporated most of the PHDS items.

Child Development↗
PubMed2000

The clinical role of noncontrast helical computed tomography in the diagnosis of acute appendicitis.

BACKGROUND: The accuracy of noncontrast helical computed tomography (CT) for appendicitis has recently been demonstrated. What is its clinical utility? METHODS: This was a retrospective review of 443 consecutive community hospital patients evaluated for acute appendicitis over an 18-month period using limited pelvic CT scan or clinical acumen alone. RESULTS: Appendicitis was pathologically proven in 158 patients. The negative appendectomy rate was 5.4%. The best radiological indicators for a positive CT for appendicitis were pericecal inflammation (88%) and appendicolith(57%). Appendiceal CT was found to have a 92% sensitivity, 99.6% specificity, and a 97.5% accuracy. There were 260 patients who had a negative CT; 243 of these were sent home. Alternative diagnoses were identified in 22% of patients. CONCLUSIONS: The liberal use of noncontrast helical CT results in a low negative appendectomy rate and a high degree of confidence that a negative CT will allow patients to be sent home safely.

Acute Disease↗
PubMed1997

An evaluation of the integration of pharmacokinetic and pharmacodynamic principles in clinical drug development. Experience within Hoffmann La Roche.

The integration of pharmacokinetic and pharmacodynamic principles into drug development has been proposed as a way of making it more rational and efficient. The use of these principles in drug development to make scientific and strategic decisions is defined as the 'pharmacokinetic-pharmacodynamic guided approach to drug development'. The objectives of this survey were: (i) to assess the extent the pharmacokinetic-pharmacodynamic guided approach to drug development has been used in a large multinational pharmaceutical company: (ii) to evaluate the impact of pharmacokinetic and/or pharmacodynamic results on clinical drug development; and (iii) to identify factors which prevented the full application of the pharmacokinetic-pharmacodynamic guided approach. This was done by looking at 18 projects in the current development portfolio at Hoffman La Roche and evaluating the use of this approach by interviewing the responsible clinical pharmacologist using a standardised questionnaire. (i) Benefits from using the pharmacokinetic-pharmacodynamic guided approach were reported in every project, independent of development phase and therapeutic area. This approach was more extensively used in the recent projects. The selection of dosages in clinical studies was found to be the most important application of pharmacokinetic-pharmacodynamic results in terms of an impact on drug development. (ii) Time savings, up to several months, could be quantified in 8 projects during the entry-into-man studies and in 6 projects during the phase II or III studies. In 4 projects, 1 clinical study was avoided. (iii) The most important scientific factor preventing the full application of the approach was the lack of knowledge on the predictive value of the pharmacodynamic or surrogate marker for effect (6 projects). The results of the survey have shown that the use of the pharmacokinetic-pharmacodynamic guided approach has contributed to making clinical drug development more rational and more efficient. Opportunities to apply the pharmacokinetic-pharmacodynamic approach should be identified in each project and a project specific strategy for the pharmacokinetic-pharmacodynamic guided approach should be defined during phase 0 of drug development.

Cost-Benefit Analysis↗
PubMed1996

Antidepressants and drug-metabolizing enzymes--expert group report.

Antidepressant drugs are extensively metabolized. Consequently, the biotransformation pattern of antidepressants has an important influence on their clinical properties, i.e., pharmacokinetics, toxicity, drug-drug interactions, side-effect profile and last but not least therapeutic efficacy. It was against this background that a multidisciplinary group of experts discussed the clinical relevance of the rapidly increasing body of knowledge of antidepressant-metabolizing enzymes. The variability of the response of a given individual to an antidepressant is determined genetically and by the environment. Genetic polymorphism of drug-metabolizing enzymes and inhibition by other substrates may affect the enzymatic biotransformation of antidepressants. In vitro assay techniques allow an estimation of the potential variability in clinical response to antidepressants and a reasonable prediction of the drug-drug interaction patterns. The results of in vitro tests should therefore be considered early in the development of an antidepressant as a background for designing clinical studies (treatment schedules and dosing). Physicians should have an understanding of the relevance of genetic polymorphism for clinical practice. Education is needed in order to fill the existing gaps in knowledge about antidepressant-enzyme interactions and their application in daily treatment practice. The information on potential drug interactions determined by genetic polymorphism and based on studies with enzymes should be increasingly contained in drug compendia.

Antidepressive Agents↗
PubMed1996

Increasing self-determination: teaching people with mental retardation to evaluate residential options.

The community living preferences of 4 institutionalized adults with mild mental retardation were identified using photographs that depicted a variety of residential characteristics. Individuals then were taught to obtain information regarding their preferences during tours of community group homes, to report that information to their social workers, and to evaluate the homes based on the information obtained. A multiple baseline across participants design showed that all 4 participants substantially increased their skills at asking questions, reporting information, and evaluating homes. the results indicate that people with mental retardation can take an active role in major lifestyle decisions that others have typically made for them.

Activities of Daily Living↗
PubMed1994

Does the speed of balloon deflation affect the complication rate of coronary angioplasty?

Two hundred consecutive coronary arteries in 157 patients undergoing angioplasty were randomized to fast or slow balloon deflation. Angioplasty was successful in 188 cases (101 with slow and 87 with fast deflation). There was no significant difference between the 2 groups with regard to the total number of dissections, although there was a greater number in the slow deflation group, and no difference in the number of minor dissections (National Heart, Lung, and Blood Institute types A and B). There was a significantly greater number of more severe dissections (types C to F) in the slow deflation group (20 vs 5; p = 0.013). It is proposed that the greater number of severe dissections is due to either increased turbulence or movement of the partially deflated balloon during slow deflation. Thus, slow balloon deflation during coronary angioplasty is associated with a higher complication rate than is conventional rapid deflation.

Aged↗
PubMed1993

Vision quality of elderly Oklahomans.

The purposes of this study are to determine if age related visual changes are affecting the ability of older adults to perform everyday tasks, to identify histories of eye diseases/eye surgeries, and to document eye care practices. Our sample was obtained from the Third Age Life Center at Baptist Medical Center in Oklahoma City. The survey was mailed to 14,856 members; 848 (6%) surveys were returned. Over 84% of the respondents have never been diagnosed with dry eye syndrome, glaucoma, macular degeneration, or diabetic retinopathy. Sixty percent rated their health and vision quality as good. Females expressed more vision problems than males. Advanced age (75 years or older) did increase likelihood of experiencing eye diseases and vision difficulties. The majority of respondents in this study appear to be experiencing healthy vision with minimal age-related changes and have not been diagnosed with the eye diseases characteristic of this age group. Evidence of regular eye examinations was reported, with 33% of the respondents reporting having eye exams once a year and 33% twice a year.

Aged↗
PubMed1992

Dog mastocytoma cells produce transforming growth factor beta 1.

Transforming growth factor-beta (TGF beta) promotes deposition of extracellular matrix and is associated with fibrotic conditions both in experimental animals and in humans. Although a role for mast cells has been suspected in the pathogenesis of fibrosis, no potent mediator capable of stimulating fibroblast growth or extracellular matrix deposition has been identified in mast cell supernatants. We report here the constitutive production of TGF beta 1 by four dog mastocytoma cell lines. TGF beta 1 was identified by characteristic biologic activity, blockade of biologic effect by specific neutralizing antibody, and by recognition of a band with the appropriate migration by western blot. TGF beta 1 mRNA, but not TGF beta 2 or TGF beta 3 mRNA, was also produced constitutively by all four cell lines. Quantitation by bioassay revealed baseline TGF beta secretion of approximately 1 ng/10(6) cells over 48 h. Stimulation of mastocytoma cells with phorbol ester increased the rate of release of TGF beta 1, most markedly in the first 30 min after stimulation, without increasing TGF beta 1 mRNA. Dog mastocytoma cells produced TGF beta 1 primarily in a latent form, inactive until treated with acid. Both pure TGF beta 1 and TGF beta-containing mastocytoma cell-conditioned media inhibited mitogenesis and proliferation in dog mastocytoma cell lines, suggesting that mast cell tumor lines would not grow preferentially based on their ability to produce TGF beta. These studies may make possible further investigation of the mechanism by which mast cells contribute to the induction of fibrosis.

Animals↗
PubMed1991

Implications of placebo theory for clinical research and practice in pain management.

We review three possible theoretical mechanisms for the placebo effect: conditioning, expectancy and endogenous opiates and consider the implications of the first two for clinical research and practice in the area of pain management. Methodological issues in the use of placebos as controls are discussed and include subtractive versus additive expectancy effects, no treatment controls, active placebo controls, the balanced placebo design, between- versus within-group designs, triple blind methodology and the double expectancy design. Therapeutically, the possibility of shaping negative placebo responses through placebo sag, overservicing and the use of placebos on their own are explored. Suggestions for using conditioned placebos strategically in conjunction with nonplacebos are made and ways of maximizing the placebo component of nonplacebo treatments are examined. Finally, the importance of investigating the placebo effect in its own right is advocated in order to better understand the long-neglected psychological aspects of the therapeutic transaction.

Chronic Disease↗