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Biomedical subjects

B Harrison

Publications and source records attributed to B Harrison.

At least 19 recordsLinked to original sources

A pilot study to compare the use of prototypes of multipositional paediatric walking sticks and tripods with conventional sticks and tripods by children with cerebral palsy.

BACKGROUND: The researchers (B.H. and B.T.) designed prototypes of a walking stick and a tripod termed Multipositional Paediatric Walking Aids for children with cerebral palsy (CP). The design won the 'Jenx Award for Innovation in Paediatric Physiotherapy'. The object of this study was to ascertain whether the prototypes had any benefit over conventional designs in children with CP. METHODS: A small case series within-subject comparison design was used. There were four periods, AABA, each 4 weeks in length. Prototypes were used during period B. Eight children with CP between 4 and 11 years were recruited, four used sticks and four used tripods. Following an orthopaedic assessment, each child had assessments at the commencement of the study and every 4 weeks thereafter: (1) Energy used while walking using Physiological Cost Index (PCI). (2) Motor abilities using (a) Gross Motor Function Measure (GMFM-88) and (b) Gross Motor Performance Measure (GMPM). (3) Hand/forearm position recorded on a visual analogue. (4) Parent/child questionnaire. RESULTS: Physiological Cost Index improved overall when the prototypes were used suggesting the amount of energy used when walking with the prototypes was less than with conventional sticks/tripods. GMFM-88 and GMPM results improved for some but not all children. Results for PCI, GMFM and GMPM were not statistically significant. The hand/forearm position of stick users consistently improved at assessment 4. Questionnaire results indicated that stick users preferred the prototypes. CONCLUSION: Multipositional sticks/tripods may have benefits over conventional sticks/tripods. Children using sticks rather than tripods preferred the prototypes. The study demonstrates the need to undertake scientifically controlled trials before marketing new equipment.

Canes↗

Effect of the introduction of a lumbar-puncture sticker and teaching manikin on junior staff documentation and performance of paediatric lumbar punctures.

BACKGROUND: Performing a lumbar puncture in an unwell child can cause anxiety in both the parent and the junior doctor. There is increasing evidence of post-lumbar-puncture complications in this age group. AIMS: To improve the documentation, consent for and technical performance of paediatric lumbar punctures to 100% of the required standard within 3 months. SETTING: The paediatric emergency department of a the Royal North Shore Hospital (University of Sydney, Sydney, Australia). PARTICIPANTS: Paediatric emergency staff, including residents, registrars and consultants. METHODS: Medical records of 40 consecutive children who had undergone a lumbar puncture in the 6 months before the introduction of the lumbar-puncture proforma were reviewed. After introduction of the proforma, the records of 25 consecutive patients were reviewed to assess changes in the outcome measures. Before introduction of the proforma, junior medical staff were instructed in the procedure using specialised lumbar puncture manikins (Baby Stap; Laerdel, USA). RESULTS: Before introduction of the proforma, the median number of documented indicators was 4, out of a maximum of 12. There was almost no documentation of parental consent, patient complications and analgesia. Introduction of the proforma resulted in a highly marked increase to a median of 12 documented indicators per patient (p<0.01, 95% confidence interval 6 to 8). CONCLUSIONS: The introduction of a lumbar-puncture proforma and formal teaching sessions using a paediatric manikin led to a marked improvement in the documentation of paediatric lumbar-punctures. Lumbar-punctures can be performed only by accredited medical officers who have achieved competency on the lumbar-puncture teaching manikin.

Child↗

Consent for genetics studies among clinical trial participants: findings from Action for Health in Diabetes (Look AHEAD).

BACKGROUND: Increasingly, genetic specimens are collected to expand the value of clinical trials through study of genetic effects on disease incidence, progression or response to interventions. PURPOSE: and methods We describe the experience obtaining IRB-approved DNA consent forms across the 19 institutions in the Action for Health in Diabetes (Look AHEAD), a clinical trial examining the effect of a lifestyle intervention for weight loss on the risk of serious cardiovascular events among individuals with type 2 diabetes. We document the rates participants provided consent for DNA research, identify participant characteristics associated with consent, and discuss implications for genetics research. RESULTS: IRB approval to participate was obtained from 17 of 19 institutions. The overall rate of consent was 89.6% among the 15 institutions that had completed consenting at the time of our analysis, which was higher than reported for other types of cohort studies. Consent rates were associated with factors expected to be associated with weight loss and cardiovascular disease and to affect the distribution of candidate genes. Non-consent occurred more frequently among participants grouped as African-American, Hispanic, female, more highly educated or not dyslipidemic. LIMITATIONS: The generalizabilty of results is limited by the inclusion/exclusion criteria of the trial. CONCLUSIONS: Barriers to obtaining consent to participate in genetic studies may differ from other recruitment settings. Because of the potentially complex associations between personal characteristics related to adherence, outcomes and gene distributions, differential rates of consent may introduce biases in estimates of genetic relationships.

Aged↗

The advisory process for anticancer drug regulation: a global perspective.

PURPOSE: This paper summarizes the role of external advisors in oncology drug development and regulation from a global perspective. DESIGN: Recently, representatives from the United States Food and Drug Administration, European Medicines Agency, the Japanese Pharmaceuticals and Medical Devices Agency, the Australian Therapeutic Goods Administration and Health Canada held a meeting in conjunction with the American Society of Clinical Oncology meeting. The role of external advisors in oncology drug development and regulation in each of these jurisdictions was presented and discussed. RESULTS: All regulatory bodies described have experience with two forms of outside expertise: advice from individual experts and advice from a group of experts assembled as an advisory group. Regulatory jurisdictions use individual experts variably. In some regions, individual experts provide advice based on knowledge and experience during the drug development phase or in the planning phase for the submission of a drug registration package. In other regions, these individuals serve as external evaluators with the primary responsibility for the review of a clinical trials package submitted for drug registration. Advisory boards have been formalized in all jurisdictions discussed. Advisory boards have a role in discussing specific applications as well as broad policy issues. A common theme is a composition of a core panel of experts with augmentation by additional expertise as needed for consideration of specific scientific questions. In all jurisdictions, advisory board recommendations are not binding on the regulatory body. CONCLUSIONS: Global oncology drug development and registration involves the use of experts by regulatory authorities. The types of experts needed, the expert's role and the transparency of the advisory process reflect the individual needs in different regions.

Antineoplastic Agents↗

The meaning and experience of being a stroke survivor: an interpretative phenomenological analysis.

PURPOSE: To investigate the meaning and experience of being a stroke survivor. METHOD: Qualitative in-depth semi-structured interviews were conducted with 10 stroke survivors (five face-to-face and five e-mail interviews). The interview data were transcribed verbatim (these were pre-transcribed in e-mail exchange) and analysed using Interpretative Phenomenological Analysis. RESULTS: Four themes emerged from the analysis: Disrupted embodiment and the loss of self; Invisibility of emotional difficulties; Gender, romance and sexuality; and Social interaction. These themes, respectively, revealed that participants often had difficulties with psychological adaptation to the physically disabling aspects of their stroke; they experienced enduring and disabling emotional difficulties; they had a particular concern for the viability and maintenance of romantic and sexual relationships; and they often became socially withdrawn, resulting in an increased pressure on familial caregivers. CONCLUSION: The findings of the present work suggest the need for post-stroke counselling regarding romantic and sexual relationships, as well as promoting acceptance of some of the physical disabilities that come with having a stroke and encouraging positive self-regard. There would also appear to be a need to address the issue of social withdrawal and familial relationships, perhaps when health professionals convey information regarding the person's stroke, and in counselling targeted specifically at family caregivers.

Adaptation, Psychological↗

Fine needle aspiration cytology in the diagnosis of uncommon types of lymphoma.

AIMS: Fine needle aspiration (FNA) cytology is an accepted means of diagnosing and typing common forms of lymphoma, particularly small lymphocytic lymphoma, follicular lymphoma, and large B cell lymphoma. However, its usefulness for diagnosing less common forms of lymphoma is not clearly established and this study was designed to examine this. METHODS: The study reviewed the FNAs of suspected lymphomas collected over a period of approximately five years. RESULTS: FNA samples were available for 138 definite lymphomas; most were common forms of B cell lymphoma. However, there was also one Burkitt lymphoma (BL), two Burkitt-like large B cell lymphomas, 15 classic Hodgkin lymphomas (HLs), two nodular lymphocyte predominant Hodgkin lymphomas, four mantle cell lymphomas, two mediastinal (thymic) large B cell lymphomas (MLBCLs), 11 peripheral T cell lymphomas (PTCLs), and five T cell rich large B cell lymphomas (TCRLBCLs). CONCLUSIONS: FNA diagnosis of BL was possible with immunoflow cytometry (IFC), cell block immunohistochemistry (IHC), and cell block fluorescent in situ hybridisation for c-myc alteration. It was difficult to make a definite diagnosis of HL and MLBCL on FNA alone. Both tend to be sclerotic tumours and FNA tends to yield scanty neoplastic cells. The FNA diagnosis of PTCL depended on cell block IHC; IFC was not usually useful. TCRLBCL did not show light chain restriction on IFC of FNA samples, probably because of frequent reactive B cells in the tumour. Thus, HL, MLBCL, and TCRLBCL are often difficult to diagnose accurately on FNA cytology, even when using IFC and cell block IHC.

Biopsy, Fine-Needle↗

Time to first occurrence of erosions in inflammatory polyarthritis: results from a prospective community-based study.

OBJECTIVE: To examine the time of occurrence of first radiographic erosions in a cohort of patients with inflammatory polyarthritis. METHODS: Patients were recruited through the Norfolk Arthritis Register, which follows up patients annually. Patients with features of rheumatoid arthritis (other than erosions) sufficient, together with erosions, to meet the American College of Rheumatology (formerly, the American Rheumatism Association) 1987 revised criteria were requested to undergo radiographic examinations of the hands and feet at the first and/or second annual followup visits. All patients were requested to undergo radiographic examinations at the fifth annual followup visit. The most recent erosion-free radiograph was identified for 416 eligible patients, and these data were used to derive the duration of disease since the recalled date of onset of first symptoms. The rate of occurrence of first erosions was then determined (as a cumulative prevalence and as an incidence rate using Poisson regression) from analysis of followup films. Patients were assumed to be free of erosions at symptom onset. RESULTS: The cumulative prevalence of erosions in patients whose first film was obtained 12-24 months after disease onset was 36%, equivalent to an incidence rate of 24.5/1,000 patient-months. We identified 3 analysis groups of patients who were free of erosions based on films obtained 12-24 months, 24-36 months, and 36-60 months since the recalled date of onset of first symptoms. New erosions were observed in all 3 groups, with cumulative prevalences of 23%, 28%, and 47%, respectively. These were equivalent to first-erosion incidence rates/1,000 patient-months of 5.4 (95% confidence interval [95% CI] 3.8-83), 6.8 (95% CI 4.7-10.0), and 13.0 (95% CI 8.9-19.2), respectively. CONCLUSION: Many patients with erosive disease first develop their erosions >2 years from disease onset.

Adult↗

The assignment by linkage mapping of four genes from human chromosome 22 to bovine chromosome 5 and 17.

Polymerase chain reaction oligonucleotides were designed to amplify bovine specific sequences for four genes that are located on human chromosome 22 (HSA22): crystallin beta A4 (CRY B A4), parvalbumin (PVALB), tissue inhibitor of metalloproteinase 3 (TIMP3) and matrix metalloproteinase 11 (MMP11). Single strand conformation analysis of these bovine gene fragments defined polymorphisms within a population of three large half-sib families of three F1 Charolais x Brahman sires and a composite herd comprising an equal proportion of Africander, Brahman, Hereford and Shorthorn breeds (CSIRO pedigree). The DNA marker genotypes were used to define linkage associations to other DNA markers already placed on the CSIRO linkage map. The genes TIMP3 and PVALB were assigned to BTA5 and CRYbetaA4 and MMP11 to BTA17.

Animals↗

What is the natural history of rheumatoid arthritis?

Inflammatory polyarthritis can be a self-limiting disease, develop into rheumatoid arthritis (RA) or differentiate into another form of chronic arthritis. It remains a clinical and scientific challenge to understand the relationship between these phenotypes, determine their aetiologies and predict the course and outcome for individual patients. Even patients labelled as having RA show a wide spectrum of clinical phenotypes. Disease definition is a major problem in studying the aetiology of RA as currently used classification criteria were derived using patients with established disease. RA is thought to result from the combination of genetic susceptibility and exposure to an appropriate environmental trigger. The genetic component is probably oligogenic. The association with HLA has been known for over 25 years. RA is now thought to be associated with a conserved sequence of amino acids in a number of HLA-DRB1 alleles, called the RA shared epitope. However, the shared epitope appears to be associated with RA chronicity and severity more than with susceptibility. Other potential RA susceptibility genes include IL-1, aromatase, corticotropin-releasing hormone and a region on the X chromosome. Hormonal and reproductive factors also influence RA susceptibility and severity. RA is more common in women than men, especially before the menopause. Men may be protected by hormonal factors and require a stronger genetic component to develop disease. Although infectious triggers of RA have long been suspected, no definitive evidence has been obtained. Previous blood transfusion, smoking and obesity are also possible risk factors. Chronicity and remission are important aspects of the natural history of early RA. Although we can identify patients at risk of adverse prognosis with some accuracy, we remain unable to predict remission. Functional disability and radiological damage are the most studied outcomes in RA. Radiological damage often occurs early in the course of RA, but patients may show erosion for the first time several years after symptom onset. Many studies have demonstrated a relationship between HLA and features of severe RA in established patients. This appears to be related to gene dosage.

Arthritis↗

An enhanced linkage map of the sheep genome comprising more than 1000 loci.

A medium-density linkage map of the ovine genome has been developed. Marker data for 550 new loci were generated and merged with the previous sheep linkage map. The new map comprises 1093 markers representing 1062 unique loci (941 anonymous loci, 121 genes) and spans 3500 cM (sex-averaged) for the autosomes and 132 cM (female) on the X chromosome. There is an average spacing of 3.4 cM between autosomal loci and 8.3 cM between highly polymorphic [polymorphic information content (PIC) > or = 0.7] autosomal loci. The largest gap between markers is 32.5 cM, and the number of gaps of > 20 cM between loci, or regions where loci are missing from chromosome ends, has been reduced from 40 in the previous map to 6. Five hundred and seventy-three of the loci can be ordered on a framework map with odds of > 1000 : 1. The sheep linkage map contains strong links to both the cattle and goat maps. Five hundred and seventy-two of the loci positioned on the sheep linkage map have also been mapped by linkage analysis in cattle, and 209 of the loci mapped on the sheep linkage map have also been placed on the goat linkage map. Inspection of ruminant linkage maps indicates that the genomic coverage by the current sheep linkage map is comparable to that of the available cattle maps. The sheep map provides a valuable resource to the international sheep, cattle, and goat gene mapping community.

Animals↗

Lessons from an international survey of paper cases of 10 real patients from an early arthritis clinic. CRI (Club Rhumatismes et Inflammation) Group.

OBJECTIVE: To determine how experts would classify 10 early-arthritis cases (7 atypical) and to study discrepancies in diagnoses relative to ACR criteria for rheumatoid arthritis (RA) or ESSG criteria for spondyloarthropathy (SpA). METHODS: Ten real cases (5 met ACR criteria for RA, 6 ESSG criteria for SpA, 3 both and 2 neither) followed for 28.5 +/- 4.8 months were sent as paper cases to 20 international and 12 French experts. Each expert selected a diagnosis among 8 possible choices and rated it on a 0-10 confidence scale. For each case, 3 analog scales (0-100 mm) were used to indicate the probability of RA, SpA or undifferentiated arthritis (UA). RESULTS: Experts often disagreed about diagnoses (up to 5 different diagnoses for a given case, with a mean of 3.9 per case). Similarly, expert opinions on probabilities for RA and SpA differed widely, with great overlap between confidence for RA, SpA and UA. Fulfilment of ACR or ESSG criteria was poorly related to the experts' diagnosis and evaluation of probabilities for RA and SpA. However, UA was a relatively infrequent choice (19%). CONCLUSIONS: There was no general consensus about the nosology of early RA and SpA. Classification of atypical early arthritis was not resolved by currently available criteria for RA and SpA. This may have implications for therapy in early disease.

Adult↗

A placebo-controlled, double-blind cross-over trial of adjunctive one month remacemide hydrochloride treatment in patients with refractory epilepsy.

The efficacy, safety and pharmacokinetics of adjunctive remacemide hydrochloride, a novel, low-affinity non-competitive NMDA receptor channel blocker, were investigated in 28 adult patients with refractory epilepsy. This was a randomized double-blind placebo-controlled cross-over study with five 4-week periods (baseline, treatment 1, washout, treatment 2, washout). Baseline median seizure frequency was reduced by 33% following adjunctive remacemide hydrochloride 150 mg q.i.d. for 4 weeks compared with placebo (P= 0.041). Seizure frequency was reduced by > or =50% in 30% of patients treated with remacemide hydrochloride compared with 9% on placebo. Mean plasma concentration of concomitant carbamazepine increased by approximately 15% following adjunctive remacemide hydrochloride. There was no correlation between increased plasma carbamazepine and reduced seizure frequency. Remacemide hydrochloride was well tolerated and only three patients withdrew due to adverse events (two remacemide hydrochloride, one placebo). Two patients died unexpectedly from their epilepsy during placebo treatment; both deaths were considered by the investigators to be unrelated to earlier remacemide hydrochloride treatment. This first specific efficacy investigation with adjunctive remacemide hydrochloride demonstrated anticonvulsant effects in patients with refractory epilepsy. More extensive clinical investigation is justified.

Acetamides↗