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Biomedical subjects

Suzanne Hill

Publications and source records attributed to Suzanne Hill.

13 recordsLinked to original sources
PubMed2005

Ties that bind: multiple relationships between clinical researchers and the pharmaceutical industry.

BACKGROUND: It is believed that pharmaceutical industry sponsorship of clinical research leads to the development of multiple ties between clinicians and the pharmaceutical industry. To quantify this relationship we conducted a survey of medical specialists listed in the Medical Directory of Australia in 2002 and 2003. METHODS: A questionnaire was mailed that elicited information about all aspects of research relationships between clinicians and pharmaceutical companies. The odds of reporting multiple additional ties (financial and professional) with pharmaceutical companies by clinicians who had an active research relationship were compared with those who did not. All clinicians who returned a completed questionnaire about their research activities were included in the study. RESULTS: A questionnaire was mailed to 2120 medical specialists; 823 (39%) responded. Of these, 338 (41%) reported involvement in industry-sponsored research in the previous year. They were more likely than others to have been offered industry-sponsored items or activities valued at more than 500 AU dollars (>382 US dollars; odds ratio [OR], 3.5; 95% confidence interval [CI], 2.6-4.7) and support for attending international conferences (OR, 5.4; 95% CI, 3.9-7.4). The strongest associations were seen for acting as a paid consultant to industry (OR, 9.0; 95% CI, 3.9-20.4) and for membership on advisory boards (OR, 6.9; 95% CI, 5.1-9.6). There was a strong relationship between research collaboration and accumulation of industry ties. For 1 additional tie the OR was 2.2 (95% CI, 1.2-3.8) and rose to 6.3 (95% CI, 3.5-11.1) with 3 ties and 41.8 (95% CI, 14.5-143.4) with 6 or more ties. CONCLUSIONS: Medical specialists who have research relationships with the pharmaceutical industry are much more likely to have multiple additional ties than those who do not have research relationships. Institutional review should discourage clinical researchers from developing multiple ties.

Australia↗
PubMed2005

Systems for grading the quality of evidence and the strength of recommendations II: pilot study of a new system.

BACKGROUND: Systems that are used by different organisations to grade the quality of evidence and the strength of recommendations vary. They have different strengths and weaknesses. The GRADE Working Group has developed an approach that addresses key shortcomings in these systems. The aim of this study was to pilot test and further develop the GRADE approach to grading evidence and recommendations. METHODS: A GRADE evidence profile consists of two tables: a quality assessment and a summary of findings. Twelve evidence profiles were used in this pilot study. Each evidence profile was made based on information available in a systematic review. Seventeen people were given instructions and independently graded the level of evidence and strength of recommendation for each of the 12 evidence profiles. For each example judgements were collected, summarised and discussed in the group with the aim of improving the proposed grading system. Kappas were calculated as a measure of chance-corrected agreement for the quality of evidence for each outcome for each of the twelve evidence profiles. The seventeen judges were also asked about the ease of understanding and the sensibility of the approach. All of the judgements were recorded and disagreements discussed. RESULTS: There was a varied amount of agreement on the quality of evidence for the outcomes relating to each of the twelve questions (kappa coefficients for agreement beyond chance ranged from 0 to 0.82). However, there was fair agreement about the relative importance of each outcome. There was poor agreement about the balance of benefits and harms and recommendations. Most of the disagreements were easily resolved through discussion. In general we found the GRADE approach to be clear, understandable and sensible. Some modifications were made in the approach and it was agreed that more information was needed in the evidence profiles. CONCLUSION: Judgements about evidence and recommendations are complex. Some subjectivity, especially regarding recommendations, is unavoidable. We believe our system for guiding these complex judgements appropriately balances the need for simplicity with the need for full and transparent consideration of all important issues.

Comprehension↗
PubMed2004

Systems for grading the quality of evidence and the strength of recommendations I: critical appraisal of existing approaches The GRADE Working Group.

BACKGROUND: A number of approaches have been used to grade levels of evidence and the strength of recommendations. The use of many different approaches detracts from one of the main reasons for having explicit approaches: to concisely characterise and communicate this information so that it can easily be understood and thereby help people make well-informed decisions. Our objective was to critically appraise six prominent systems for grading levels of evidence and the strength of recommendations as a basis for agreeing on characteristics of a common, sensible approach to grading levels of evidence and the strength of recommendations. METHODS: Six prominent systems for grading levels of evidence and strength of recommendations were selected and someone familiar with each system prepared a description of each of these. Twelve assessors independently evaluated each system based on twelve criteria to assess the sensibility of the different approaches. Systems used by 51 organisations were compared with these six approaches. RESULTS: There was poor agreement about the sensibility of the six systems. Only one of the systems was suitable for all four types of questions we considered (effectiveness, harm, diagnosis and prognosis). None of the systems was considered usable for all of the target groups we considered (professionals, patients and policy makers). The raters found low reproducibility of judgements made using all six systems. Systems used by 51 organisations that sponsor clinical practice guidelines included a number of minor variations of the six systems that we critically appraised. CONCLUSIONS: All of the currently used approaches to grading levels of evidence and the strength of recommendations have important shortcomings.

Advisory Committees↗
PubMed2004

Grading quality of evidence and strength of recommendations.

Users of clinical practice guidelines and other recommendations need to know how much confidence they can place in the recommendations. Systematic and explicit methods of making judgments can reduce errors and improve communication. We have developed a system for grading the quality of evidence and the strength of recommendations that can be applied across a wide range of interventions and contexts. In this article we present a summary of our approach from the perspective of a guideline user. Judgments about the strength of a recommendation require consideration of the balance between benefits and harms, the quality of the evidence, translation of the evidence into specific circumstances, and the certainty of the baseline risk. It is also important to consider costs (resource utilisation) before making a recommendation. Inconsistencies among systems for grading the quality of evidence and the strength of recommendations reduce their potential to facilitate critical appraisal and improve communication of these judgments. Our system for guiding these complex judgments balances the need for simplicity with the need for full and transparent consideration of all important issues.

Cost-Benefit Analysis↗
PubMed2004

Are economic evaluations of vaccines useful to decision-makers? Case study of Haemophilus influenzae type b vaccines.

BACKGROUND: In concert with efforts to increase global provision, economic evaluations of newer and relatively costly vaccines have proliferated in the medical literature. The extent to which existing vaccine evaluations are useful to decision makers is not clear. We conducted a systematic review of published economic evaluations of conjugate Haemophilus influenzae type b (Hib) vaccine, anticipating that their usefulness to past and present decision makers would be limited by the quality of the analyses and by the extent to which the results were transferable to other settings. METHODS: We systematically identified economic evaluations of conjugate Hib vaccine. We appraised their quality according to a customized checklist and assessed the extent of and reasons for variability of the results. RESULTS: Quality assessment of the available economic evaluations disclosed a number of shortcomings, including the failure across all models to derive systematic estimates of vaccine efficacy as well as a lack of transparency in the costing of Hib disease treatment. Wide variations in results appeared to be caused primarily by epidemiologic and health system differences between settings and secondarily to methodologic differences between models. The generalizability of model results appeared low. CONCLUSIONS: There is scope for improving the overall quality of economic evaluations of Hib vaccination. Relevance to decision makers may also be increased by addressing local budget constraints and vaccine price. There is a need to better understand the decision process, particularly at the national level, to ensure the role of future economic evaluations as important decision tools in the implementation of new vaccines.

Australia↗
PubMed2003

WT1 expression does not disrupt myogenic differentiation in C2C12 murine myoblasts or in human rhabdomyosarcoma.

WT1 encodes a tissue-specific transcription factor important in early mesenchymal differentiation. Altered expression or mutation of WT1 occurs in malignancies derived from such tissues. These include Wilms tumour, a paediatric kidney cancer that may show heterologous differentiation into primitive skeletal muscle, especially in tumours with WT1 mutation. A putative role for WT1 in inhibiting myogenesis has been suggested by transient transfection of C(2)C(12) myoblasts. However, using a more robust model of stable transfectants of C(2)C(12) expressing inducible WT1 isoforms, we found no inhibition of myogenic differentiation. We also investigated a possible role for WT1 in the disrupted myogenesis seen in rhabdomyosarcoma, a paediatric cancer resembling foetal skeletal muscle. WT1 expression levels measured by quantitative real-time reverse transcription polymerase chain reaction were low or absent in those tumours with a PAX-FKHR fusion gene characteristic of the alveolar subtype, and were higher in cases lacking these fusion genes. Overall, there was a weak positive correlation between expression of myogenic differentiation marker genes and WT1 levels. We conclude that expression of WT1 in C(2)C(12) cells and in rhabdomyosarcoma does not inhibit myogenic differentiation.

Animals↗
PubMed2003

A role for two-stage pharmacoeconomic appraisal? Is there a role for interim approval of a drug for reimbursement based on modelling studies with subsequent full approval using phase III data?

Healthcare decision makers and pharmaceutical companies are increasingly using techniques of economic evaluation, particularly modelling, to assist them in their decisions about drug purchasing and drug development. The use of models in other types of policy decisions is also well established. One option, to shorten the time to a purchasing decision, would be for an interim decision for approval for reimbursement to be based on an economic model. Such a system would mainly benefit the drug development process and thus the pharmaceutical industry; however the approach could also lead to poor decision making, unethical marketing and withdrawal of drugs from the consumer. In this article, we consider the option of a two-stage economic appraisal process from the point of view of the seller, the purchaser and the patient and public. Although a two-stage process may offer some advantages in terms of early return on investment and access, there are significant disadvantages in terms of certainty about effects and public policy and expenditure. Until there are better methods of predicting the effectiveness of a new product, it is unlikely that interim decisions can be seen as a reasonable health policy alternative, although it seems likely that industry may continue to lobby for such an approach.

Australia↗
PubMed2002

Transfusion triggers: a systematic review of the literature.

Most clinical practice guidelines recommend restrictive red blood cell (RBC) transfusion practices with the goal of minimizing transmission of blood-borne pathogens. The purpose of this review is to compare clinical outcomes in patients randomized to restrictive versus liberal transfusion thresholds (triggers). We conducted a search of OVID Medline, Current Contents, the Cochrane Library, and bibliographies of published studies. Our search strategies used a combination of key-word terms as text and MeSH headings relating to transfusion triggers. We included trials if the comparison groups were assigned on the basis of a clear transfusion trigger or threshold, and the study was randomized with a concurrent control group. Eligibility of studies was assessed by 2 independent raters, with disagreements resolved by consensus. Disagreements not resolved by consensus were referred to a third party for review. Two raters assessed the methodologic quality of the trials modified from the methods of Schultz. The main study outcomes probability of receiving an RBC transfusion, volume of RBCs transfused, hematocrit levels, mortality, and length of hospital stay. Ten trials, which reported outcomes for a total of 1,780 patients, were included. Five studies were in surgical patients, 3 were in the setting of acute blood loss and trauma, and 2 involved intensive care unit patients. Transfusion triggers varied between 7 and 10 g/dL (most often they were 8 or 9 g/dL). Being randomized to a restrictive transfusion trigger group had the following average effects: the probability of receiving an RBC transfusion was reduced by 42% (relative risk, 0.58; 95% confidence interval [CI] 0.47, 0.71), the volume of RBCs was reduced by 0.93 units (95% CI 0.36, 1.5 units), and hematocrit values were 5.6 % lower (95% CI 3.5, 7.7%). Mortality, rates of cardiac events, morbidity, and length of hospital stay were unaffected. The limited published evidence supports the use of restrictive transfusion triggers in patients who are free of serious cardiac disease. However, most of the data on clinical outcomes were generated by a single trial. The effects of conservative transfusion triggers on functional status, morbidity, and mortality, particularly in patients with cardiac disease, need to be tested in further large clinical trials. In countries with inadequate screening of donor blood, the data may constitute a stronger basis for avoiding transfusion with allogeneic RBCs.

Blood Transfusion↗