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Biomedical subjects

Tom Walley

Publications and source records attributed to Tom Walley.

At least 19 recordsLinked to original sources
PubMed2006

Searching for and use of conference abstracts in health technology assessments: policy and practice.

OBJECTIVES: Current policy and practice regarding identification of and extent of use of data from conference abstracts in health technology assessment reviews (TARs) are examined. METHODS: The methods used were (i) survey of TAR groups to identify general policy and experience related to use of abstract data, and (ii) audit of TARs commissioned by the National Institute for Health and Clinical Excellence (NICE) and published between January 2000 and October 2004. RESULTS: Five of seven TAR groups reported a general policy that included searching for and including studies available as conference abstracts and presentations. A total of sixty-three published HTA reports for NICE were identified. Of these reports, thirty-eight identified at least one randomized controlled trial available as an abstract/presentation. Twenty-six (68 percent) of these thirty-eight TARs included studies available as abstracts. CONCLUSIONS: There are variations in policy and practice across TAR groups regarding the searching for and inclusion of studies available as conference abstracts. There is a need for clarity and transparency for review teams regarding how abstract data are managed. If conference abstracts are to be included, reviewers need to allocate additional time for searching and managing data from these sources. Review teams should also be encouraged to state explicitly their search strategies for identifying conference abstracts, their methods for assessing these abstracts for inclusion and, where appropriate, how the data were used and their effect on the results.

Congresses as Topic↗
PubMed2006

Case study of the comparison of data from conference abstracts and full-text articles in health technology assessment of rapidly evolving technologies: does it make a difference?

OBJECTIVES: The aim of this study was to examine (i) the consistency of reporting research findings presented in conference abstracts and presentations and subsequent full publications, (ii) the ability to judge methodological quality of trials from conference abstracts and presentations, and (iii) the effect of inclusion or exclusion of data from these sources on the pooled effect estimates in a meta-analysis. METHODS: This report is a case study of a selected health technology assessment review (TAR) of a rapidly evolving technology that had identified and included a meta-analysis of trial data from conference abstracts and presentations. RESULTS: The overall quality of reporting in abstracts and presentations was poor, especially in abstracts. There was incomplete or inconsistent reporting of data in the abstract/presentations. Most often inconsistencies were between conference slide presentations and data reported in published full-text articles. Sensitivity analyses indicated that using data only from published papers would not have altered the direction of any of the results when compared with those using published and abstract data. However, the statistical significance of three of ten results would have changed. If conference abstracts and presentations were excluded from the early analysis, the direction of effect and statistical significance would have changed in one result. The overall conclusions of the original analysis would not have been altered. CONCLUSIONS: There are inconsistencies in data presented as conference abstracts/presentations and those reported in subsequent published reports. These inconsistencies could impact the final assessment results. Data discrepancies identified across sources included in TARs should be highlighted and their impact assessed and discussed. Sensitivity analyses should be carried out with and without abstract/presentation data included in the analysis. Incomplete reporting in conference abstracts and presentations limits the ability of reviewers to assess confidently the methodological quality of trials.

Congresses as Topic↗
PubMed2006

Retrospective analysis of opioid prescriptions in cancer patients in a northern Italian region.

We evaluated patterns of use of opioids in palliative care across one region in Italy by cross-referencing a cancer registry with unique patient identifiers, with prescription databases. There were 90 803 patients in the registry, of whom 39 597 died during the study period. Only 8539 (21%) of these were prescribed opioids at the time of their death. Prescribed daily doses of oral morphine used (45 mg) and of buprenorphine (0.71 mg) were low compared with injected morphine (28.6 mg, equivalent to approximately 90 mg of oral morphine) and especially with doses of transdermal fentanyl (1.13 mg, equivalent to approximately 180 mg morphine). The reasons for this acceptance of transdermal fentanyl and reluctance to use oral morphine are unclear, but it seems that more effort in educating healthcare professionals and patients about the use of morphine would be useful. The use of more detailed prescribing data such as prescribed or received daily doses can add to our understanding of headline prescribing data.

Administration, Cutaneous↗
PubMed2005

New drug prescribing by hospital doctors: the nature and meaning of knowledge.

In the UK the high cost of new drugs is partly accountable for the growth in spending on prescription drugs. Most prescribing takes place in general practice and the influence of secondary care prescribing on primary care prescribing is well recognized; yet the factors that influence hospital prescribing have been little researched. Drawing on accounts of actual prescribing events from hospital doctors from a range of specialties, we investigated the processes by which new drugs come into practice, from hospital doctors' awareness of new drugs to the assimilation and interpretation of evidential sources. The determinants of new drug prescribing were interconnected within four forms of knowledge: scientific knowledge, social knowledge, patient knowledge and experiential knowledge. Furthermore, the nature of knowledge could only be understood within its situated context. The revelation of multiple and contingent forms of knowledge highlights the problematic nature of knowledge construction within the approaches of evidence-based medicine.

Diffusion of Innovation↗
PubMed2005

Trends and influences on use of antidiabetic drugs in England, 1992-2003.

OBJECTIVE: To describe trends in prescribing for glycaemic control in diabetes mellitus in England, 1993-2003, and to examine the effects of new clinical evidence or national guidance on these. DESIGN: Observational study of prescribing adjusted for extrapolated changes in epidemiology of insulin and non-insulin treated diabetes. SETTING: Primary care in England, 1992-2003. DATA SOURCES: Three monthly prescribing data from the Prescription Pricing Authority. MAIN OUTCOME MEASURES: Defined daily doses/patient/quarter of oral hypoglycaemics and of insulin. RESULTS: There was an increase in the prevalence of both insulin treated (85%) and non-insulin treated (80%) diabetes. There were increases in all drug use, which were largely explained by this: for example, sulphonylurea use increased by 101% in total but only 11% after correction for change in prevalence and population; insulin use increased by 140% in total, but 33% after correction. Neither guidances from the National Institute of Clinical Excellence nor new clinical evidence had any discernible effect on this. An exception was metformin use, which increased by 495% in total, and by 277% after correction. This increase occurred mainly from early 1998 and seemed to coincide with the publication of evidence of the specific benefits of metformin. CONCLUSIONS: There has been a trend towards more aggressive treatment of diabetes. National guidance may have reinforced this but has not altered the trend. Specific evidence around metformin may have been very influential in increasing its use.

Diabetes Mellitus↗
PubMed2005

A qualitative study of GPs' and PCO stakeholders' views on the importance and influence of cost on prescribing.

With prescribing expenditure rising and evidence of prescribing costs variation, general practitioners (GPs) in the UK are under increasing pressure to contain spending. The introduction of cash-limited, unified budgets and increased monitoring of prescribing within Primary Care Organizations (PCO) are intended to increase efficiency and enhance GPs financial responsibility. Whilst GPs regularly receive data on the costs of their prescribing and also performance against a set prescribing budget, little is known about the extent to which GPs take cost into account in their prescribing decisions. This study undertook a qualitative exploration of the attitudes of various stakeholders on the relative importance and influence of cost on general practice prescribing. In order to explore a plurality of perspectives, data were obtained from focus groups and a series of individual semi-structured interviews with GPs and key PCO stakeholders. The data suggest that although almost all GPs believed costs should be taken into account when prescribing, there was great variation in the extent to which this was applied and to how sensitive GPs were to costs. Cost was secondary to clinical effectiveness and safety, whilst individual patient need was emphasized above other forms of rationality or notions of opportunity costs. Conflict was apparent between a PCO policy of cost-containment and GPs' resistance to cost-cutting. GPs largely applied simple cost-minimization while cost-consideration was undermined by contextual factors. Implications for research and policy are discussed.

Attitude of Health Personnel↗
PubMed2004

Comparative efficacy of newer hypnotic drugs for the short-term management of insomnia: a systematic review and meta-analysis.

OBJECTIVES: To compare the clinical effectiveness of zaleplon, zolpidem or zopiclone (Z-drugs) with either benzodiazepines licensed and approved for use in the UK for the short-term management of insomnia (diazepam, loprazolam, lorazepam, lormetazepam, nitrazepam, temazepam) or with each other. METHODS: MEDLINE, EMBASE, PsycINFO, Science Citation Index/Web of Science were searched from 1966 to March 2003 and The Cochrane Library, reference lists of included studies and a number of psychopharmacology journals. Randomized controlled trials comparing either benzodiazepines with the Z-drugs or any two of the Z-drugs in patients with insomnia were included. Outcome measures included: sleep onset latency, total sleep duration, number of awakenings, quality of sleep, adverse events, tolerance, rebound insomnia and daytime alertness. RESULTS AND CONCLUSIONS: Twenty four eligible studies were identified with a total study population of 3,909 (17 studies comparing a Z-drug with a benzodiazepine and 7 comparing a Z-drug). Insufficient or inappropriately reported data meant that meta-analysis was possible only for a small number of outcomes. There are few clear, consistent differences between the drugs. Some evidence suggests that zaleplon gives shorter sleep latency but shorter duration of sleep than zolpidem, reflecting the pharmacological profiles of the drugs.

Acetamides↗
PubMed2004

Drug-eluting stents: an early systematic review to inform policy.

AIMS: To provide systematic assessment of the clinical effectiveness of drug-eluting stents (DES) versus non-DES to inform national guidance. METHODS AND RESULTS: The review was conducted according to internationally recognised methods. The search strategy identified published (7) and unpublished (7) randomised controlled trials comparing the use of DES to non-DES. Outcomes included death, acute myocardial infarction (AMI), revascularisation, event rate (composite of adverse events), and binary restenosis. Data synthesis included descriptive statistics and meta-analysis. Fourteen randomised clinical trials comparing DES to non-DES and involving 5747 patients were identified. There were reductions in event rates between DES and non-DES; odds ratio (OR) 0.63 (95% confidence interval [95% CI] 0.47, 0.84, n = 1978) for paclitaxel-eluting stents at 12 months, OR 0.30 (95% CI 0.22, 0.42, n = 1296) for sirolimus-eluting stents at 12 months. Combined event rates were inconsistently defined across trials and were primarily composed of revascularisations, possibly driven by protocol-required angiograms. DES reduced binary restenosis rates at angiogram compared to non-DES. No significant differences in rates of death or AMI were identified. CONCLUSION: The early data available indicate that DES reduce adverse cardiac events, mainly revascularisations. However, these data are limited in terms of patient numbers, length of follow-up, and method of outcome assessment. The evaluation of rapidly evolving technologies requires the inclusion of data not routinely considered for inclusion in systematic reviews of effectiveness.

Coronary Restenosis↗
PubMed2004

Angioplasty and stents in coronary artery disease: a systematic review and meta-analysis.

OBJECTIVES: To undertake a systematic review of the clinical effectiveness of routine percutaneous transluminal coronary angioplasty (PTCA) plus stenting vs PTCA alone. DATA SOURCES: MEDLINE; EMBASE; Science Citation Index; The Cochrane Library; cardiovascular journals and conference proceedings; Internet resources (including industry supported web pages); and reference lists of included studies and relevant reviews. REVIEW METHODS: Study selection included published and unpublished randomized controlled trials (RCTs) comparing the use of coronary stents to PTCA. Outcome measures assessed included death, acute myocardial infarction (AMI), event rate (such as major cardiac adverse events (MACE) or other composite measures), and binary restenosis (BR). Data extraction and quality assessment were conducted according to internationally recognized methods. Data synthesis included meta-analysis of assessed outcomes, reported as odds ratios (ORs). RESULTS: Fifty RCTs involving 16,500 patients met the inclusion criteria (39 full articles, 11 abstracts). Of these, 23 studies compared stenting with PTCA in patients with non-specific coronary artery disease (CAD), 11 compared stents with PTCA following AMI, 8 included patients with small coronary arteries and 8 included patients whose vessels had chronic total occlusion. There were no differences in rates of death or AMI. There were reductions in the rates of MACE (death, AMI or revascularization) with stents compared to PTCA (at 6 months, for non-specific group OR: 1.64, 95% CI 1.44-1.87; for AMI group OR: 2.36, 95% CI 1.92-2.89; for small vessel group OR: 1.38, 95% CI 1.10-1.74; at 12 months, for non-specific group OR: 1.31, 95% CI 1.11-1.55; for AMI OR: 2.26, 95% CI 1.47-3.46). Reporting of combined major adverse cardiac events was inconsistent across studies. Most events were revascularizations that may have been partly driven by protocol-required angiograms. Stents reduced BR rates at angiogram at 6 months compared to PTCA in all groups. CONCLUSION: We found no differences in mortality or AMI, but the studies were not powered to identify changes in these endpoints. Coronary stenting is associated with reduced restenosis and combined adverse cardiac events, primarily revascularizations. However, the frequency of revascularization may have been distorted by protocol-dictated angiography.

Age Distribution↗
PubMed2004

Neuropsychotherapeutics in the UK: what has been the impact of NICE on prescribing?

The UK National Institute for Clinical Excellence (NICE) was set up in 1999 to advise the National Health Service (NHS) on the use of new technologies largely, but not exclusively, on the basis of their clinical and cost effectiveness. There have been problems with this, as with any developing system, most of which have arisen from issues not directly under the control of NICE. Despite this, NICE has already achieved a pivotal role in determining the uptake of new therapies into the NHS. In the area of neuropsychiatric therapies, NICE has examined a number of topics and has generally facilitated the increased use of the agents examined, approving the use, within limitations, of such drugs as riluzole, atypical antipsychotics and cholinesterase inhibitors. Although the use of some of these therapies had been growing, it had previously been restricted by funding in the NHS. As a result of NICE guidance, these funding restrictions have generally been lifted. NICE has rejected one area of neurological therapy so far--that of interferon-beta products and glatiramer acetate for multiple sclerosis--on the grounds of clinical uncertainty about long-term benefits and poor cost effectiveness. However, the UK Government has created a novel risk-sharing scheme in collaboration with the sponsoring companies to make these drugs available at a level of cost effectiveness acceptable to the NHS. The feasibility of this scheme is as yet unclear. This might be seen as either a triumph for NICE or as an undermining of it for political ends. One interesting aspect that is more prominent in neuropsychiatric disorders than in other areas of NICE activity has been the power of patient advocacy in encouraging acceptance of therapies where the evidence base was weak or the incremental cost-effectiveness ratio was unfavourable. The principles behind the activities of NICE attract wide support within the NHS, but the details of its decisions have often not been popular within NHS management who have to deliver them. Some of this relates more to the context and political environment within which NICE operates than to a failing within NICE itself. NICE will continue to become increasingly important in determining the use of new drugs within the UK NHS.

Antipsychotic Agents↗