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Biomedical subjects

A Haycox

Publications and source records attributed to A Haycox.

At least 19 recordsLinked to original sources
PubMed2007

Pemetrexed disodium for the treatment of malignant pleural mesothelioma: a systematic review and economic evaluation.

OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of pemetrexed disodium in combination with cisplatin for the treatment of unresectable pleural mesothelioma in chemotherapy-naive patients. DATA SOURCES: Electronic databases were searched up to May 2005. REVIEW METHODS: The systematic review was conducted following accepted guidelines. An assessment of the economic submission received from the manufacturer of pemetrexed was also carried out. This comprised two sections, each employing an economic model. One of these models was then reformulated in order to carry out a separate exploration of economic performance. RESULTS: One randomised controlled trial comparing pemetrexed and cisplatin with cisplatin alone, and involving a total study population of 448 patients, met the inclusion criteria. Pemetrexed in combination with cisplatin in this trial showed a 2.8-month gain in median survival compared with cisplatin alone in an intention-to-treat (ITT) population (12.1 and 9.3 months, respectively, p = 0.020, hazard ratio of 0.77). During the trial, increased reporting of severe toxicity in the pemetrexed arm led to a change in the protocol to add folic acid and vitamin B12 supplementation to therapy. For fully supplemented patients (n = 331) the hazard ratio for median survival in favour of pemetrexed plus cisplatin was also comparable (0.75), but of borderline significance between treatment arms (p = 0.051). The trial inclusion criteria restricted recruitment to those with a Karnofsky performance status of 70 or greater (equivalent to ECOG/WHO 0 or 1 scales more widely used in the UK). Quality of life scores using the Lung Cancer Symptom Scale demonstrated significantly greater improvement for pain and dyspnoea for patients in the combination group compared with those in the cisplatin group. In the ITT population, the incidence of serious toxicities with pemetrexed plus cisplatin was higher compared with cisplatin alone. However, the grade 3/4 toxicities of the combination arm, particularly leucopenia, neutropenia and diarrhoea, were found to be greatly improved by the addition of vitamin B12 and folic acid. The existing published economic literature was very limited. The economic evaluation conducted by the study (and that submitted by the manufacturer) suggested that pemetrexed is unlikely to be considered cost-effective at conventionally accepted thresholds in the UK for all patients, mainly because of the high cost of pemetrexed itself compared with cisplatin. These findings were better for some patient subgroups, e.g. especially for fully supplemented (FS) patients with good performance status (0/1) and advanced disease (AD). These findings seem robust. The estimated cost-effectiveness results were for the FS population, incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY) gained = pound59,600; for the FS with AD population, ICER per QALY = pound47,600; for the FS with performance status 0/1 population, ICER per QALY = pound49,800; and for the FS with performance status 0/1 and AD population, ICER per QALY = pound36,700. CONCLUSIONS: The new therapy examined in this document demonstrates an extension of life expectancy and palliation, as measured by time to progression of disease and other end-points. However, the absolute benefit obtained is small, and it needs to be weighed against the benefits of effective palliative care services. The limited benefit was also at the expense of considerable toxicity to patients. The economic evaluation conducted in this study and that of the manufacturers suggest that pemetrexed is not cost-effective at conventional thresholds for all patients. Cost-effectiveness seems better for some patient subgroups, e.g. especially for patients with good performance status and with advanced diseases, where it is estimated the ICER per QALY would be pound36,700. Given the relatively small number of patients with mesothelioma, albeit increasing, the overall budget impact of pemetrexed would be unlikely to be more than pound5 million per year at present costs. Much more research is needed into the optimum chemotherapy for patients with mesothelioma and a clear definition of what constitutes best supportive care.

Antineoplastic Agents↗
PubMed2006

Recruitment difficulties in a home telecare trial.

We analysed the difficulties encountered in recruiting predominantly older patients, suffering from an acute exacerbation of a chronic illness, to a randomized controlled trial of home telecare. Of 653 patients approached for study participation, after full assessment, 80% (519) met the trial eligibility criteria. Of these, 104 (20%) consented to study participation and 415 (80%) refused. A logistic regression model was constructed to examine independent effects of patient factors on probability of trial participation. Only two independent variables were associated with decreased likelihood of consent: increasing age (1 year older: odds ratio [OR] = 0.96); and being on inhaled steroid medication (OR = 0.60). The most common reason for refusal to participate, accounting for almost one-third of respondents, was a stated preference for a face-to-face nurse visiting service rather than a telecare service. Perhaps home telecare services should continue to be targeted at the more stable chronically ill population and not at those suffering from acute illness.

Aged↗
PubMed2006

A systematic review of the effectiveness and cost-effectiveness of neuroimaging assessments used to visualise the seizure focus in people with refractory epilepsy being considered for surgery.

OBJECTIVE: To review the effectiveness and/or accuracy, cost-effectiveness, and predictive value of neuroimaging of the cerebral cortex to visualise the seizure focus in people with refractory epilepsy being considered for surgery. DATA SOURCES: Electronic databases, Internet searches, hand searching and consultation with experts. METHODS: A systematic review was undertaken according to published guidelines. Results of diagnostic accuracy studies were analysed according to the imaging test evaluated. For each study the proportion of patients who were correctly localised, not localised, partially localised or incorrectly localised by the index test was calculated. Due to the heterogeneity present between studies, statistical pooling was not performed. Instead, a narrative synthesis of results is presented. For studies using multivariate analysis to look at the association of neuroimaging findings and outcome following surgery, all factors considered in the analyses were presented. Studies were grouped according to the neuroimaging technique investigated and the findings discussed with reference to possible sources of heterogeneity between studies. RESULTS: No randomised controlled trials (RCTs) were identified, with the majority of studies evaluating the diagnostic accuracy of various imaging techniques in the localisation of epileptic seizure foci. There was significant heterogeneity (p<0.05) between studies for at least one of the localisation categories (correctly localised, not localised, partially localised and incorrectly localised) for all imaging techniques. Possible explanations for this heterogeneity include differing study designs, index test characteristics, reference standards and population characteristics. Test performance was more promising in studies restricted to patients with temporal lobe epilepsy. Ictal single photon emission computed tomography (SPECT) generally had more correctly localising (70--100%) and fewer non-localising (0--7%) scans than other techniques evaluated in patients with temporal lobe epilepsy. Results for computed tomography and interictal SPECT suggest that these tests are relatively poor at localising the seizure focus. Volumeric magnetic resonance imaging (MRI) and position emission tomography (PET) appear promising, and subtraction ictal single photon emission computed tomography co-registered to magnetic resonance imaging (SISCOM) and magnetic resonance spectrosopy (MRS) less promising than ictal SPECT, but these technologies have been assessed in fewer studies. T2 relaxometry was reported in only one small study with inconclusive results. Seventeen studies (33 evaluations) provided sufficient data on the association of a localised scan with outcome following surgery to calculate a relative risk. The majority of evaluations (24/33) suggested that patients with a correctly or partially localised scan had a better outcome following surgery than those with an incorrectly localised or non-localised scan. However, this association was statistically significant in only three studies, two evaluating routine MRI [(relative risk (RR) 2.74, 95% confidence interval (CI): 1.32 to 5.67; RR 1.28, 95% CI: 1.00 to 1.63] and the other SISCOM (RR 2.12, 95% CI: 1.01, 4.44). Nine studies used multivariate analysis to investigate the association of MRI (7 studies), MRS and volumetric MRI (1 study), PET (3 studies), SPECT (1 study) and SISCOM (3 studies) with the outcome following surgery. There was a trend for localisation of abnormalities to be associated with a beneficial outcome. CONCLUSIONS: Due to the limitations of the included studies, the results of this review do little to inform clinical practice, with insufficient evidence regarding effectiveness and cost-effectiveness of imaging techniques in the work-up for epilepsy surgery. Given the inadequacy of existing data, there is a pressing need for studies investigating the utility of imaging techniques in the work up for epilepsy surgery. The most reliable method to achieve this is the RCT, which could examine the single tests or combinations of tests on patient outcome. The authors suggest that it is important that clinicians, patient groups, policy makers and healthcare/research funders meet and debate the most appropriate way to investigate these technologies.

Cerebral Cortex↗
PubMed2006

Comparison of conference abstracts and presentations with full-text articles in the health technology assessments of rapidly evolving technologies.

OBJECTIVES: To assess the extent of use of data from conference abstracts and presentations in health technology assessments (HTAs) provided as part of the National Institute for Health and Clinical Excellence (NICE) appraisal process. Also to assess the methodological quality of trials from conference abstracts and presentations, the consistency of reporting major outcomes between these sources and subsequent full-length publications, the effect of inclusion or exclusion of data from these sources on the meta-analysis pooled effect estimates, and the timeliness of availability of data from these sources and full articles in relation to the development of technology assessment reviews (TARs). DATA SOURCES: A survey of seven TAR groups. An audit of published TARs: included all NICE TARs published between January 2000 and October 2004. Case studies of selected TARs. REVIEW METHODS: Analyses of the results of the survey and audit were presented as a descriptive summary and in a tabular format. Sensitivity analyses were carried out to compare the effect of inclusion of data from abstracts and presentations on the meta-analysis pooled effect estimates by including data from both abstracts/presentations and full papers, and data from only full publications, included in the original TAR. These analyses were then compared with meta-analysis of data from trials that have subsequently been published in full. RESULTS: All seven TAR groups completed and returned the survey. Five out of seven groups reported a general policy that included searching for and including studies available as conference abstracts/presentations. Five groups responded that if they included data from these sources they would carry out methodological quality assessment of studies from these sources using the same assessment tools as for full publications, and manage the data from these sources in the same way as fully published reports. All groups reported that if relevant outcome data were reported in both an abstract/presentation and a full publication, they would only consider the data in the full publication. Conversely, if data were only available in conference abstract/presentation, all but two groups reported that they would extract and use the data from the abstract/presentation. In total, 63 HTA reports for NICE were identified. In 20 of 63 TARs (32%) explicit statements were made with regards to inclusion and assessment of data from abstracts/presentations. Thirty-eight (60%) identified at least one randomised controlled trial (RCT) available as a conference abstract or presentation. Of these, 26 (68%) included trials available as abstracts/presentations. About 80% (20/26) of the 26 TARs that included RCTs in abstract/presentation form carried out an assessment of the methodological quality of such trials. In 16 TARs full reports of these trials were used for quality assessment where both abstracts/presentations and subsequent full publications were available. Twenty-three of 63 TARs (37%) carried out a quantitative analysis of results. Of these, ten (43%) included trials that were available as abstracts/presentations in the review; however, only 60% (6/10) of these included data from abstracts/presentations in the data analysis of results. Thirteen TARs evaluated rapidly evolving technologies and only three of these identified and included trial data from conference abstracts/presentations and carried out a quantitative analysis where abstract/presentation data were used. These three TARs were used as case studies. In all three case studies the overall quality of reporting in abstracts/presentations was generally poor. In all case studies abstracts and presentations failed to describe the method of randomisation or allocation concealment. Overall, there was no mention of blinding in 66% (25/38) of the abstracts and in 26% (7/27) of the presentations included in case studies, and one presentation (4%) explicitly stated use of intention-to-treat analysis. Results from one case study demonstrated discrepancies in data made available in abstracts or online conference presentations. Not only were discrepancies evident between these sources, but also comparison of conference abstracts/presentations with subsequently published full-length articles demonstrates data discrepancies in reporting of results. Sensitivity analyses based on one case study indicated a change in significance of effect in two outcome measures when only full papers published to date were included. CONCLUSIONS: There are variations in policy and practice across TAR groups regarding searching for and inclusion of studies available as conference abstracts/presentations. There is also variation in the level of detail reported in TARs regarding the use of abstracts/presentations. Therefore, TAR teams should be encouraged to state explicitly their search strategies for identifying conference abstracts and presentations, their methods for assessing these for inclusion, and where appropriate how the data were used and their effect on the results. Comprehensive searching for trials available as conference abstracts/presentations is time consuming and may be of questionable value. However, there may be a case for searching for and including abstract/presentation data if, for example, other sources of data are limited. If conference abstracts/presentations are to be included, the TAR teams need to allocate additional time for searching and managing data from these sources. Incomplete reporting in conference abstracts and presentations limits the ability of reviewers to assess confidently the methodological quality of trials. Where conference abstracts and presentations are considered for inclusion in the review, the TAR teams should increase their efforts to obtain further study details by contacting trialists. Where abstract/presentation data are included, reviewers should discuss the effect of including data from these sources. Any data discrepancies identified across sources in TARs should be highlighted and their impact discussed in the review. In addition, there is a need to carry out, for example, a sensitivity analysis with and without abstract/presentation data in the analysis. There is a need for research into the development of search strategies specific to identification of studies available as conference abstracts and presentations in TARs. Such strategies may include guidance with regard to identification of relevant electronic databases and appropriate conference sites relevant to certain clinical areas. As there are limited case studies included in this report, analyses should be repeated as more TARs accrue, or include the work of other international HTA groups.

Adult↗
PubMed2005

Patient and provider perspectives on home telecare: preliminary results from a randomized controlled trial.

A randomized controlled trial of home telecare for the management of acute exacerbations of chronic obstructive pulmonary disease has been undertaken in the north-west of England. A videophone was used that communicates via the ordinary telephone network. The intervention period for each participant was two weeks. Participants in the telecare arm of the trial were asked to complete logbooks to record their experiences of each telecare encounter. A simple, self-completed, 10-item questionnaire was used that consisted of a Likert scale, ranging from 1 (totally disagree) to 5 (totally agree). Fourteen nurses completed 150 logbooks and 22 patients completed 145 logbooks. These results demonstrate significant differences in perception between patients and their health-care providers with regard to telecare encounters across all the domains addressed. Participating patients consistently demonstrated more positive views of the telecare encounters than their healthcare providers.

Aged↗
PubMed2004

Newer hypnotic drugs for the short-term management of insomnia: a systematic review and economic evaluation.

OBJECTIVES: To assess the clinical and cost-effectiveness of zaleplon, zolpidem and zopiclone (Z-drugs) compared with benzodiazepines. DATA SOURCES: Electronic databases, reference lists of retrieved articles and pharmaceutical company submissions. REVIEW METHODS: Randomised controlled trials (RCTs) that compared either benzodiazepines to the Z-drugs or any two of the non-benzodiazepine drugs in patients with insomnia were included in the review. Data on the following outcome measures were considered: sleep onset latency, total sleep duration, number of awakenings, quality of sleep, adverse effects and rebound insomnia. A search was also undertaken for any study designs that evaluated issues related to adverse events (e.g. dependency and withdrawal symptoms). Full economic evaluations that compared two or more options and considered both costs and consequences including cost-effectiveness, cost-utility analysis or cost-benefit analysis undertaken in the context of high-quality RCTs were considered for inclusion in the review. RESULTS: Twenty-four studies, involving a total study population of 3909 patients, met the inclusion criteria. These included 17 studies comparing a Z-drug with a benzodiazepine and seven comparing a Z-drug with another Z-drug. The diversity of possible comparisons and the range of outcome measures in the review may be confusing. Outcomes were rarely standardised and, even when reported, differed in interpretation. In addition, variations in assessment and variety in the level of information provided make study comparisons difficult. As a result, meta-analysis has been possible on only a small number of outcomes. However, some broad conclusions might be reached based on the limited data provided. The existing published economic literature in this area is very limited. No relevant economic evaluations were identified for inclusion in the review. The industry submissions did not include detailed evidence of cost-effectiveness. Given the lack of robust clinical evidence, no economic model describing the costs and benefits of the newer hypnotic drugs for insomnia was developed. The systematic review provided in this report suggests that an agnostic approach to cost-effectiveness is required at this stage. In the short-term, no systematic evidence is available concerning significant outcome variations between either the different classes of drugs or between individual drugs within each class. Within this short-term horizon, the one element that does vary significantly is the acquisition cost of the individual drugs. CONCLUSIONS: The short-acting drugs seem equally effective and safe with minor differences that may lead a prescriber to favour one over another in different patients. There is no evidence that one is more cost-effective than any other. Analysis of the additional costs to the NHS, depending on the rate of change from benzodiazepine prescriptions to Z-drug prescriptions, at current levels of hypnotic prescribing, range from GBP2 million to GBP17 million per year. There are clear research needs in this area; in particular, none of the existing trials adequately compare these medications. It is suggested that further consideration should be given to a formal trial to allow head-to-head comparison of some of the key drugs in a double-blind RCT lasting at least 2 weeks, and of sufficient size to draw reasonable conclusions. We would also recommend that any such trial should include a placebo arm. It should also collect good-quality data around sleep outcomes and in particular quality of life and daytime drowsiness. We do not believe that any formal study of risk of dependency is feasible at present. Finally, the management of long-term insomnia is suggested for further investigation: considering the frequency of this symptom and its recurring course, the short-term trial of medication and lack of long-term follow-up undermine attempts to develop evidence-based guidelines for the use of hypnotics in this condition, or indeed for its whole management.

Adult↗
PubMed2004

Coronary artery stents: a rapid systematic review and economic evaluation.

OBJECTIVES: To assess the effectiveness and cost-effectiveness of the use of coronary artery stents in patients with coronary heart disease (CHD). DATA SOURCES: Electronic databases. REVIEW METHODS: The review was conducted following accepted guidelines for conducting systematic reviews. Randomised controlled trials that include comparisons of percutaneous transluminal coronary angioplasty (PTCA) versus PTCA with stent, stent versus coronary artery bypass graft (CABG), and drug-eluting stents (DES) versus non-DES in patients with CAD in native or graft vessels and those with stable angina or acute coronary syndrome (ACS) and unstable angina were also included. Data on the following outcome measures were included in the review: combined event rate or event-free survival, death, acute myocardial infarction, target vessel revascularisation, repeat treatment (PTCA, stent or CABG) and binary restenosis. An economic model was developed based on extrapolation of trends in mortality and revascularisation from clinical trials data to a 5-year time horizon. RESULTS: The inclusion criteria were fulfilled by 50 studies comparing the use of stents with PTCA, six comparing stents with CABG and 12 comparing DES eluting stents with non-DES. No studies were identified that compared DES with PTCA or DES with CABG. Existing quality of life data suggest that revascularisation procedures reduce the patient's quality of life for a short period only. Stents were found to be more effective than PTCA in preventing adverse events and revascularisations. In multiple-vessel disease there was no evidence of a difference in mortality (at 1 year) between patients treated surgically and those receiving a stent. Patients treated surgically required fewer revascularisations. There is no evidence of a difference in mortality between patients receiving DES and those treated with bare metal stents at 1 year. A reduction in event rate at 9 and 12 months was found in patients treated with DES. This event rate is primarily made up of increased revascularisation rates in patients treated with bare metal stents. Two-year outcome data from one study indicate that this benefit of DES continues over the longer term. The economic model proved sufficient to indicate long-term trends in cost-effectiveness. CABG was found initially to be more expensive than bare metal stenting in multivessel disease and may have higher immediate risks, but over time the cost differential is reduced and long-term outcomes favour CABG over stenting. A similar situation was found for DES versus CABG in multiple-vessel disease. However, DES may not generally be considered a cost-effective alternative to bare metal stenting in single-vessel disease by policy makers as substantially higher costs are involved with a very small outcome benefit. CONCLUSIONS: DES might be considered cost-effective if the additional cost (compared with ordinary stents) was substantially reduced, the outcome benefits from the use of DES were much improved, and/or its use were targeted on the subgroups of patients with the highest risks of requiring reintervention. Long-term clinical studies are needed that focus on significant outcomes such as mortality. Further research should consider: the differences among plain stents; head-to-head comparisons within DES, CABG compared with DES; and the evaluation of newer non-DES against DES. Evaluation of the effects of revascularisation procedures and especially repeat revascularisation procedures on the patient's quality of life would also be useful, as would the development and testing of risk assessment tools to identify patients likely to need further revascularisations.

Angioplasty, Balloon, Coronary↗
PubMed2003

Lessons from the implementation of a home telecare service.

We conducted a qualitative evaluation of the introduction of a telenursing service. The service used an analogue videophone linked with a physiological monitoring device, which allowed the transmission of data between the patient's home and the hospital. A researcher kept a detailed diary of day-to-day activity for the first year of the project. Computer software for qualitative data analysis was used to code the text and the analysis followed the principles of constant comparison. The diary entries documented how the commercially available equipment was adapted to suit the organization and content of the nurses' work. The nurses made a number of suggestions to improve the user-friendliness of the equipment. The technology, the existing home care service (the comparison arm of the study) and the randomized controlled trial itself all underwent continuous change. The traditional randomized control design of trial has limitations in this situation, and there is a need for more realistic trial designs.

Home Care Services↗
PubMed2003

Cost-benefit evaluation of routine influenza immunisation in people 65-74 years of age.

OBJECTIVES: To determine the cost-effectiveness of influenza vaccination in people aged 65-74 years in the absence of co-morbidity. DESIGN: Primary research: randomised controlled trial. SETTING: Primary care. PARTICIPANTS: People without risk factors for influenza or contraindications to vaccination were identified from 20 general practitioner (GP) practices in Liverpool in September 1999 and invited to participate in the study. There were 5875/9727 (60.4%) people aged 65-74 years identified as potentially eligible and, of these, 729 (12%) were randomised. INTERVENTION: Participants were randomised to receive either influenza vaccine or placebo (ratio 3:1), with all individuals receiving pneumococcal vaccine unless administered in the previous 10 years. Of the 729 people randomised, 552 received vaccine and 177 received placebo; 726 individuals were administered pneumococcal vaccine. MAIN OUTCOME MEASURES AND METHODOLOGY OF ECONOMIC EVALUATION: GP attendance with influenza-like illness (ILI) or pneumonia (primary outcome measure); or any respiratory symptoms; hospitalisation with a respiratory illness; death; participant self-reported ILI; quality of life (QoL) measures at 2, 4 and 6 months post-study vaccination; adverse reactions 3 days after vaccination. A cost-effectiveness analysis was undertaken to identify the incremental cost associated with the avoidance of episodes of influenza in the vaccination population and an impact model was used to extrapolate the cost-effectiveness results obtained from the trial to assess their generalisability throughout the NHS. RESULTS: In England and Wales, weekly consultations for influenza and ILI remained at baseline levels (less than 50 per 100,000 population) until week 50/1999 and then increased rapidly, peaking during week 2/2000 with a rate of 231/100,000. This rate fell within the range of 'higher than expected seasonal activity' of 200-400/100,000. Rates then quickly declined, returning to baseline levels by week 5/2000. The predominant circulating strain during this period was influenza A (H3N2). Five (0.9%) people in the vaccine group were diagnosed by their GP with an ILI compared to two (1.1%) in the placebo group [relative risk (RR), 0.8; 95% confidence interval (CI) = 0.16 to 4.1]. No participants were diagnosed with pneumonia by their GP and there were no hospitalisations for respiratory illness in either group. Significantly fewer vaccinated individuals self-reported a single ILI (4.6% vs 8.9%, RR, 0.51; 95% CI for RR, 0.28 to 0.96). There was no significant difference in any of the QoL measurements over time between the two groups. Reported systemic side-effects showed no significant differences between groups. Local side-effects occurred with a significantly increased incidence in the vaccine group (11.3% vs 5.1%, p = 0.02). Each GP consultation avoided by vaccination was estimated from trial data to generate a net NHS cost of 174 pounds. CONCLUSIONS: No difference was seen between groups for the primary outcome measure, although the trial was underpowered to demonstrate a true difference. Vaccination had no significant effect on any of the QoL measures used, although vaccinated individuals were less likely to self-report ILI. The analysis did not suggest that influenza vaccination in healthy people aged 65-74 years would lead to lower NHS costs. Future research should look at ways to maximise vaccine uptake in people at greatest risk from influenza and also the level of vaccine protection afforded to people from different age and socio-economic populations.

Aged↗
PubMed2003

A randomised controlled trial to evaluate the clinical and cost-effectiveness of Hickman line insertions in adult cancer patients by nurses.

OBJECTIVES: To examine the clinical and cost-effectiveness of image-guided Hickman line insertions versus blind Hickman line insertions undertaken by nurses in adult cancer patients. DESIGN: A cost-effectiveness analysis was carried out alongside a randomised controlled trial. SETTING: A large acute cancer centre in Manchester, UK. PARTICIPANTS: Cancer patients due to have a Hickman line insertion who were over 18 years of age and were clinically and physically compliant with specified protocols. INTERVENTIONS: In order to obtain central venous access for the patient, two interventions were investigated: (i) blind insertion of a Hickman line and (ii) image-guided insertion of a Hickman line. Both interventions involved blind venipuncture of the subclavian vein. In the blind arm, the Hickman line was routinely inserted without the use of image guidance at any point in the procedure. Transfer to the interventional X-ray suite and use of image guidance were options immediately available to the operator during the procedure if required. In the image-guided arm, the position of the guidewire was checked before the Hickman line was introduced and later the Hickman line was positioned with the use of X-ray fluoroscopy. MAIN OUTCOME MEASURES: The primary clinical outcome measure was catheter-tip misplacement and this was expected to be higher in the blind arm. When comparing the skill level of the trainer and the trainees, pneumothorax was the primary clinical outcome measure. Other outcomes measures included arterial puncture, haematoma, infection, failed insertion and assistance from other healthcare professionals. RESULTS: No statistically significant difference was found between the mean cost per patient in the two arms of the trial. The only statistically significant difference in clinical outcomes was the frequency of catheter-tip misplacement, which was higher in the blind arm of the trial. At very low costs, the image-guided approach dominates the blind approach as fewer costs and greater benefits are incurred. It is evident that nurses previously inexperienced in the procedure can be trained to insert Hickman lines successfully both at the bedside and under image guidance within a 3-month period. CONCLUSIONS: This report indicates that nurse insertion of Hickman lines in the majority of adult cancer patients is both safe and effective. However, there are a select group of patients for whom image-guided insertion may be preferred. The results reveal that skills and expertise can be transferred from trainer to trainee through a relatively short, but intensive, training course. It is also evident that patients support nurse insertion. Further research is suggested to compare the safety and efficacy of nurse versus doctor insertions in particular subgroups of patients and also to assess the quantity and quality of current service provision in order to inform NHS decision-making in this area.

Adult↗
PubMed2002

Randomised controlled trial comparing an acute paediatric hospital at home scheme with conventional hospital care.

AIMS: To assess the clinical effectiveness of a paediatric hospital at home service compared to conventional hospital care. METHODS: A total of 399 children suffering from breathing difficulty (n = 202), diarrhoea and vomiting (n = 125), or fever (n = 72) were randomised to Hospital at Home or in-patient paediatric care. Main outcome measures were: comparative clinical effectiveness as measured by readmission rate within three months (used as a proxy for parental coping with illness); and length of stay/care and comparative satisfaction of both patients and carers. RESULTS: Clinical effectiveness of both services was not significantly different. Length of care was one day longer in the Hospital at Home group; however, most parents and children preferred home care. CONCLUSIONS: Hospital at Home is a clinically acceptable form of care for these groups of acute paediatric illness. Readmission rates within three months failed to show any advantage in terms of parental coping. Parents and patients expressed a strong preference for hospital at home.

Acute Disease↗
PubMed2002

Economic evaluation of an acute paediatric hospital at home clinical trial.

AIMS: To compare the privately borne and NHS costs of hospital at home (HAH) and conventional inpatient care for children with selected acute conditions. METHODS: Prospective economic evaluation using cost minimisation analysis within a randomised controlled trial, in paediatric wards of a district general hospital, and private homes in the local catchment area in Wirral, Merseyside. Subjects were children who fulfilled the criteria for admission to HAH, suffering from breathing difficulties (n = 202), diarrhoea and vomiting (n = 125), or fever (n = 72). RESULTS: Direct costs borne by families are reduced by 41% for HAH patients ( pound 23.31 v pound 13.76, p = 0.001). There is no evidence that HAH transfers the burden of care to parents, and there is no difference in absence rates from paid employment. Patients and their careers expressed a strong preference for HAH. Comparison of NHS costs is equivocal, depending on how HAH is implemented alongside the conventional hospital service. CONCLUSION: Paediatric HAH schemes are unlikely to reduce NHS costs and do not increase privately borne costs. They will, however, significantly increase patient and career satisfaction with care provision for sick children with appropriate conditions.

Caregivers↗
PubMed2002

A randomized controlled trial of home telecare.

We have established a randomized controlled trial of home telecare. The intervention aims to address a growing problem in the National Health Service (NHS), that is, high admission rates of patients with exacerbations of chronic obstructive pulmonary disease (COPD). Equipment procurement for the trial has been difficult, as no single supplier was able to meet the project s full requirements. The fact that the service is provided by existing clinical NHS staff has advantages when considering the generalizability of the results within the NHS. However, there are also disadvantages, since existing staff have little research experience. Considerable time has been required to help staff familiarize themselves with the equipment and become comfortable with its use. This has posed a barrier to the implementation of the service.

Home Care Services↗
PubMed2001

The role of team dentistry in improving access to dental care in the UK.

The role of professionals complementary to dentistry (PCDs) in improving access to NHS primary dental care is discussed. The pattern of under-supply of dentists in poor socio-economic areas is highlighted and identified, in drawing a parallel to the workings of primary medical teams, as a possible area where PCDs could be used.

Comprehensive Dental Care↗
PubMed2001

The impact of non-compliance on the cost-effectiveness of pharmaceuticals: a review of the literature.

Non-compliance with drug therapies not only limits their effectiveness, but in some instances, is associated with grave clinical sequelae and substantial economic burden. It is important, therefore, to consider non-compliance in economic evaluations. A review of pharmacoeconomic evaluations, which have applied sensitivity analysis to non-compliance rates, was undertaken to evaluate the impact of non-compliance on the cost-effectiveness of different drug therapies. Although 22 evaluations satisfied the inclusion criteria, additional information was obtained from the authors of most studies, as the published details were inadequate. The majority of evaluations assumed altered effectiveness owing to reduced compliance in the absence of supportive clinical evidence. Because of the disparity in the nature of the outcomes, the measures of non-compliance and the time horizon of the studies evaluated, it was not possible to compare the magnitude of the impact of non-compliance among different drug-disease combinations. However, it was evident that non-compliance always results in a reduction in efficacy, but its impact on costs varied substantially. The importance of incorporating measures of compliance is highlighted, as failing to account for 'real world' compliance rates in pharmacoeconomic evaluations may lead to selection of sub-optimal treatment strategies.

Cost-Benefit Analysis↗
PubMed2001

Accounting for noncompliance in pharmacoeconomic evaluations.

Noncompliance with prescribed drug regimens is a widespread phenomenon which results in decreased efficacy and is often associated with increased medical expenditures. Despite this, economic evaluations based on decision-analytic models rarely incorporate noncompliance to allow for the differences in compliance observed between controlled clinical trials and routine clinical practice. This review examines the issues relating to the measurement of noncompliance, and the clinical and economic consequences of noncompliant drug taking behaviour. In order to fully appreciate the clinical (and therefore the economic) consequences of noncompliance, a detailed understanding of the type of noncompliance, the pharmacokinetic and pharmacodynamic properties of the drug and the pathophysiological processes of the diseases being treated is required. These are described in detail, and a classification of drug-disease combinations according to the potential economic impact of the varying forms of noncompliance is set out. Issues are raised to highlight the need for improved modelling of the impact of noncompliance, and to this end, recommendations are made for future analyses. The main points are that compliance should be defined clearly, distinguishing between the various forms of noncompliance, that the assumptions relating to the health status of noncompliers should be explicit and robust, and that sensitivity analysis should be applied appropriately to ascertain the impact of noncompliance on the cost-effectiveness of drug therapies.

Economics, Pharmaceutical↗