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Biomedical subjects

C Donovan

Publications and source records attributed to C Donovan.

At least 19 recordsLinked to original sources
PubMed2006

Safety analyses of adalimumab (HUMIRA) in global clinical trials and US postmarketing surveillance of patients with rheumatoid arthritis.

OBJECTIVE: To assess the safety of adalimumab in global clinical trials and postmarketing surveillance among patients with rheumatoid arthritis (RA). METHODS: Safety data for adalimumab treated patients from randomised controlled trials, open label extensions, and two phase IIIb open label trials were analysed. In addition, postmarketing spontaneous reports of adverse events in the United States were collected following Food and Drug Administration approval of adalimumab on 31 December 2002. RESULTS: As of 15 April 2005, the RA clinical trial safety database analysed covered 10,050 patients, representing 12,506 patient-years (PYs) of adalimumab exposure. The rate of serious infections, 5.1/100 PYs, was comparable to that reported on 31 August 2002 (4.9/100 PYs), and to published reports of RA populations naive to anti-tumour necrosis factor (TNF) therapy. Following implementation of tuberculosis (TB) screening in clinical trials, the rate of TB decreased. There were 34 cases of TB as of this analysis (0.27/100 PYs). The standardised incidence ratio for lymphoma was 3.19 (95% CI 1.78 to 5.26), consistent with the observed increased incidence in the general RA population. As of 30 June 2005, there were an estimated 78 522 PYs of exposure to adalimumab in the US postmarketing period. Seventeen TB cases were spontaneously reported (0.02/100 PYs) from the US. Rates of other postmarketing events of interest, such as congestive heart failure, systemic lupus erythematosus, opportunistic infections, blood dyscrasias, lymphomas, and demyelinating disease, support observations from clinical trials. CONCLUSION: Analyses of these data demonstrate that long term adalimumab treatment is generally safe and well tolerated in patients with RA.

Adalimumab↗
PubMed2001

How do teenagers and primary healthcare providers view each other? An overview of key themes.

BACKGROUND: Teenagers have often been asked for their opinions about health services. However, relatively few studies have involved quantitative and qualitative methods of assessing them. Furthermore, there have been no United Kingdom studies of providers' views on the health of teenagers or of providers' opinions about their role in teenage health. AIM: To determine how teenagers view primary care, to discover how primary care providers view teenage patients, and to note any differences in opinions between the two groups. DESIGN OF STUDY: Questionnaire survey, focus group discussions, and semi-structured interviews. SETTING: Two thousand two hundred and sixty-five teenage patients, 16 general practitioners (GPs), 12 practice nurses, and 12 general practice receptionists in South Wales valley communities. METHOD: Selected practices provided age-sex registers of patients aged between 14 and 18 years and questionnaires were sent to these patients. Focus groups were assembled from those teenagers who had completed and returned the questionnaire. Semi-structured interviews between one member of the study team and GP surgery staff, chosen randomly from staff lists in the selected surgeries. RESULTS: The teenagers reported a lack of knowledge of services available from primary care, a feeling of a lack of respect for teenage health concerns, poor communication skills in GPs, and a poor understanding of confidentiality issues. The providers did not always share these concerns and they also had differing views on communication and confidentiality issues. CONCLUSION: The data demonstrated important findings about how teenagers would like primary care services to be improved. There was an apparent gulf between teenagers' own opinions about health care and the opinions held by primary care providers.

Adolescent↗
PubMed2001

The Newfoundland and Labrador Heart Health Program dissemination story: the formation and functioning of effective coalitions.

Newfoundland and Labrador is the most easterly province of Canada (O'Loughlin et al., Figure 1) with a population of 537,000. Rural in nature, 50% of the population resides in widely-dispersed communities of less than 2500 people. The economy traditionally relied on the fishing industry, but with the closure of the once lucrative cod fishery in 1991, the poorest province in Canada faced a difficult economic climate with up to 20% unemployment rates. With little funding available to supplement or sustain expensive initiatives, the Demonstration Phase of the Newfoundland and Labrador Heart Health Program (1990-1996) focused on how community-based programs are developed and sustained, with a view to diffusion throughout the province. The whole province was defined as the demonstration site for the project, and a community mobilization strategy was used with extensive reliance on community health professionals and volunteer contributions.

Cardiovascular Diseases↗
PubMed2000

Surveillance transbronchial lung biopsies: implication for survival after lung transplantation.

OBJECTIVES: We wished to determine whether early rejection after lung transplantation as assessed by surveillance transbronchial biopsy predicts for survival. METHODS: Between 1990 and 1997, 96 consecutive patients had lung transplantation: 89 had a minimum 1-month follow-up. For 71 consecutive patients we have 1-year follow-up and for 69 patients we have the results of the first 3 biopsies. Cytomegalovirus status, bronchiolitis obliterans prevalence, and use of total lymphoid irradiation are noted. Biopsies were done at 1 week and 1, 3, and 6 months. Standard immunosuppression consisted of induction antilymphocyte globulin and high-dose methylprednisolone induction for 1 week and standard maintenance triple therapy. Acute rejection treatment was with pulse methylprednisolone. Bronchiolitis obliterans syndrome was treated with total lymphoid irradiation and a change to tacrolimus and mycophenolate. Blinded grading using International Society for Heart and Lung Transplantation classification was done retrospectively. RESULTS: Survival at 1 month and 1, 2, and 3 years for the 96-patient cohort with 1-year follow-up was 93%, 74%, 62%, and 56%. Survival was not significantly different for subsets with rejection on any combination of the first 3 biopsies (1/3, 2/3, 3/3) or absence of rejection on the first 3 biopsies. Ninety-one positive biopsy results were graded. Eighteen of 71 patients had one or more moderate or severe rejection episodes without survival difference relative to the others. There was no statistically significant association between acute rejection on the first 3 surveillance biopsy results and bronchiolitis obliterans. CONCLUSIONS: Intensive induction and maintenance immunotherapy with surveillance transbronchial biopsies and aggressive treatment of acute rejection is associated with a survival similar to that of patients without early acute rejection. This regimen appears to uncouple the association between early acute rejection and bronchiolitis obliterans. Further study may elucidate this mechanism.

Adolescent↗
PubMed2000

Teenagers' views on general practice consultations and other medical advice. The Adolescent Working Group, RCGP.

BACKGROUND: The provision of health services for teenagers is of current interest in relation to primary care. OBJECTIVES: The main objective of the study was to look at satisfaction with the teenager's last consultation and any reasons for dissatisfaction. A further objective was to look at common teenage health concerns to identify how many teenagers had been concerned about them, where they sought advice, and to look at ratings of this advice. METHOD: Questionnaires were completed as part of a continuing evaluation of a novel sex education programme in 38 schools in 1997 and provided the data. The particular items reported in this study were related to satisfaction with the last GP consultation and reasons for dissatisfaction, health concerns and who (if anybody) was approached to address these concerns, and comments on services used. 5152 teenagers (51.8% male and 47.8% female) completed the questionnaires in a school lesson under conditions of complete confidentiality. RESULTS: Over 86% of adolescents were apparently satisfied with their last consultation with a GP, although several possible reasons were identified for any dissatisfaction. Health concerns were identified and sources of help were considered and compared; no obvious levels of relative dissatisfaction with services were noted. A large number of teenagers identified apparent concerns but did not seek help for these concerns. CONCLUSIONS: Adolescents are largely satisfied with the services available in primary care. A number of teenagers do not seek help for their own individual concerns. Encouraging teenagers to attend when they perceive a health problem may help provide a more sensitive primary care service.

Adolescent↗
PubMed2000

The treatment of childhood social phobia: the effectiveness of a social skills training-based, cognitive-behavioural intervention, with and without parental involvement.

Fifty children aged 7-14 years with a principal diagnosis of social phobia were randomly assigned to either child-focused cognitive-behaviour therapy (CBT), CBT plus parent involvement, or a wait list control (WLC). The integrated CBT program involved intensive social skills training combined with graded exposure and cognitive challenging. At posttreatment, significantly fewer children in the treatment conditions retained a clinical diagnosis of social phobia compared to the WLC condition. In comparison to the WLC, children in both CBT interventions showed significantly greater reductions in children's social and general anxiety and a significant increase in parental ratings of child social skills performance. At 12-month follow-up, both treatment groups retained their improvement. There was a trend towards superior results when parents were involved in treatment, but this effect was not statistically significant.

Adolescent↗
PubMed1999

Social skills, social outcomes, and cognitive features of childhood social phobia.

Social skills, social outcomes, self-talk, outcome expectancies, and self-evaluation of performance during social-evaluative tasks were examined with 27 clinically diagnosed social phobic children ages 7-14 and a matched nonclinical group. Results showed that, compared with their nonanxious peers, social phobic children demonstrated lower expected performance and a higher level of negative self-talk on social-evaluative tasks. In addition, social phobic children showed social skills deficits as assessed by self- and parent report, an assertiveness questionnaire, and direct behavioral observation. Furthermore, compared with the control group, social phobic children were rated by themselves and others as significantly less socially competent with peers and were found to be less likely to receive positive outcomes from peers during behavioral observation. Implications for the assessment and treatment of childhood social phobia are discussed.

Adolescent↗
PubMed1999

Ethical and human rights concerns of Connecticut nurses: survey and implications for the profession.

A survey of a random sample of Connecticut registered nurses' experiences with issues of ethics and human rights found a strong focus on protecting patient rights and dignity, adequacy of staffing patterns, informed consent, and respecting advance directives. Ethics committees were commonly available but were infrequently used. Participants reported high levels of ethics education but also desired more such education. The character of the issues is consistent with other studies and largely reflects conflicts over which nurses do not have independent control. Consideration is given to issues of nurses' moral agency in health care organizations.

Adult↗
PubMed1998

Challenges in evaluating primary health care for teenagers. Research Sub-Committee of the Adolescent Working Party of the Royal College of General Practitioners, London, UK.

This paper concerns the evaluation of health care for teenagers and examines the role of primary care and its interaction with the teenage users of this service. It recognizes that the majority of health care for teenagers takes place within general practice. The challenge posed is to identify and put in place suitable evaluation tools. There are government targets to improve the health of teenagers by reducing teenage pregnancy, drug use, smoking rates and suicides. It is an assumption of this paper that improvements in experiences of primary care will lead to improvements in more population-based outcomes of care, although this link needs investigation. The paper shows that there are few measures of generic outcome which are available for use in experiments to assess teenage health care as a baseline now. This has implications for conducting future research projects. Such measures are important and it is a necessary feature of research into teenage health that these measures are devised, tested and validated as a priority.

Adolescent↗
PubMed1997

Adolescents' attitudes to general practice in north London.

A questionnaire-based survey, undertaken in North London state secondary schools, illustrated some stumbling blocks and a lack of knowledge that is likely to inhibit an effective use of general practice among 12-18 year olds. A review of the current arrangements and some adjustment of current services might increase the likelihood of achieving Health of the Nation targets for teenage pregnancies, and may also improve health care for this important and vulnerable section of the population.

Adolescent↗
PubMed1997

Teenagers' views on the general practice consultation and provision of contraception. The Adolescent Working Group.

BACKGROUND: The rate of unwanted pregnancies in adolescents in the United Kingdom (UK) is one of the highest in Europe and is a major reason for the RCGP's concern at the under-use of general practitioners' (GPs') contraceptive services by young people. AIM: To discover the attitudes of 15- to 16-year-olds to the GP consultation and contraceptive services. METHOD: Questionnaires were completed as part of an evaluation of a novel sex education programme in 30 schools in 1994, and provided the data for this study. A total of 4481 teenagers (51.6% male and 48.4% female completed the questionnaires in their classrooms under conditions of complete confidentiality. RESULTS: The median consulting rate per year was two for males and three for females. Over 60% of adolescents attended the consultation with a parent. Of the males, 27.5% 'felt that the discussion with their GP could be relayed to their parents against their wishes', as did 25.1% of the females. Other difficulties with GP appointments were identified as embarrassment (63% of females and 46% of males), difficulty getting a quick appointment (44% of both males and females), and an unsympathetic GP (32% of females and 20.5% of males). CONCLUSIONS: Adolescents identify significant factors blocking them from easy access to consultation with their GP. These included lack of trust in confidentiality, lack of staff friendliness, and delay in appointment. Consideration of how these blocks can be removed will assist in providing improved contraceptive services in primary care. General practices need to consider the above factors when providing contraceptive and other services to their teenage patients.

Adolescent↗
PubMed1996

Inhibition of T cell costimulation abrogates airway hyperresponsiveness in a murine model.

Activation of naive T cells requires at least two signals. In addition to the well characterized interaction of the T cell antigen receptor with the antigen/MHC expressed on an antigen-presenting cell, T cell activation also requires costimulation by a second set of signals. The best characterized costimulatory receptor is CD28, which binds to a family of B7 ligands expressed on antigen-presenting cells. In asthma, although activated T cells play a role in the initiation and maintenance of airway inflammation, the importance of T cell costimulation in bronchial hyperresponsiveness had not been characterized. Therefore, we tested the hypothesis that inhibition of the CD28:B7 costimulatory pathway would abrogate airway hyperresponsiveness. Our results show that blockade of costimulation with CTLA4-Ig, a fusion protein known to prevent costimulation by blocking CD28:B7 interactions, inhibits airway hyperresponsiveness, inflammatory infiltration, expansion of thoracic lymphocytes, and allergen-specific responsiveness of thoracic T cells in this murine model of allergic asthma.

Airway Resistance↗
PubMed1996

Human CD34+ hematopoietic progenitors have low, cytokine-unresponsive O6-alkylguanine-DNA alkyltransferase and are sensitive to O6-benzylguanine plus BCNU.

Human bone marrow (BM) cells contain low levels of the DNA repair protein, O6-alkylguanine-DNA alkyltransferase, which may explain their susceptibility to nitrosourea-induced cytotoxicity and the development of secondary leukemia after nitrosourea treatment. Isolated CD34+ myeloid progenitors were also found to have low levels of alkyltransferase activity. The level of alkyltransferase in CD34+ cells or in mononuclear BM cells did not increase after incubation with granulocyte-macrophage colony-stimulating factor, interleukin-3, stem cell factor, the combination, or 5637 conditioned medium. BCNU sensitivity remained unchanged as well. In addition, O6-benzylguanine depleted alkyltransferase activity in BM cells at concentrations as low as 1.5 mumol/L after a 1-hour exposure. O6-benzylguanine pretreatment markedly sensitized hematopoietic progenitor colony-forming cells to BCNU, resulting in a reduction in the dose of drug (termed the dose-modification factor) required to inhibit 50% of the colony formation (IC50) of threefold to fivefold. Since, unlike many other cell types, proliferating early (CD34+) hematopoietic precursors do not induce alkyltransferase, myelosuppression may be the dose-limiting toxicity of the combination of O6-benzylguanine plus BCNU in clinical trials.

Adult↗