PubMed Health⌕ Search

Biomedical subjects

E Loveman

Publications and source records attributed to E Loveman.

15 recordsLinked to original sources
PubMed2006

A systematic review of the clinical effectiveness of donepezil, rivastigmine and galantamine on cognition, quality of life and adverse events in Alzheimer's disease.

BACKGROUND: The use of cholinesterase inhibitors for Alzheimer's disease (AD) is currently being appraised by the National Institute for Clinical Evidence (NICE). This article provides the latest evidence that NICE will be using as part of this appraisal process. OBJECTIVE: To provide a systematic review of the best quality evidence of the effects of donepezil, rivastigmine and galantamine on cognition, quality of life and adverse events in people with mild to moderately-severe AD. DESIGN: Electronic databases were searched, references of all retrieved articles were checked, and experts were contacted for advice, peer review and to identify additional references. Randomised controlled trials (RCTs) were included if they fulfilled pre-specified criteria. Data were synthesised through a narrative review. RESULTS: Twenty-six RCTs that compared any one of the cholinesterase inhibitors with either a control group or with another cholinesterase inhibitor were included. The quality of reporting and methodology was varied. Treatment with donepezil, rivastigmine or galantamine resulted in significantly better cognitive performance using the ADAS-cog scale when compared with placebo. These findings were generally supported using the MMSE scale. Results from head to head comparisons were limited by the low number of studies and the study quality; generally showing no robust support for any one drug. Few studies evaluated quality of life. Adverse events were generally related to the gastrointestinal system, with a tendency for these to be more common in the treatment arms. CONCLUSIONS: The cholinesterase inhibitors donepezil, rivastigmine, and galantamine can delay cognitive impairment in patients with mild to moderately-severe AD for at least 6 months duration.

Alzheimer Disease↗
PubMed2006

The clinical and cost-effectiveness of donepezil, rivastigmine, galantamine and memantine for Alzheimer's disease.

OBJECTIVES: To provide an update review of the best quality evidence for the clinical effectiveness and cost-effectiveness of donepezil, rivastigmine and galantamine for mild to moderately severe Alzheimer's disease (AD) and of memantine for moderately severe to severe AD. DATA SOURCES: Electronic databases, experts in the field and manufacturer submissions to the National Institute for Health and Clinical Excellence (NICE). REVIEW METHODS: A systematic review of the literature and an economic evaluation were undertaken. The quality of included randomised controlled trials (RCTs) was assessed using criteria developed by the NHS Centre for Reviews and Dissemination. An outline assessment of economic evaluations was undertaken using a standard checklist. The clinical and cost-effectiveness data were synthesised through a narrative review with full tabulation of the results of included studies. Where appropriate, meta-analysis of data was undertaken. RESULTS: For mild to moderately severe AD, the results of the study suggested that all three treatments were beneficial when assessed using cognitive outcome measures. Global outcome measures were positive for donepezil and rivastigmine, but mixed for galantamine. Results for measures of function were mixed for donepezil and rivastigmine, but positive for galantamine. Behaviour and mood measures were mixed for donepezil and galantamine, but showed no benefit for rivastigmine. For memantine, two published RCTs were included; in one of these trials the participants were already being treated with donepezil. The results suggest that memantine is beneficial when assessed using functional and global measurements. The effect of memantine on cognitive and behaviour and mood outcomes is, however, less clear. Literature on the cost-effectiveness of donepezil, rivastigmine and galantamine was dominated by industry-sponsored studies, and studies varied in methods and results. Of the three UK studies, two report donepezil as not cost-effective, whereas a third study reports an additional cost (1996 pounds sterling) of between 1200 pounds sterling and 7000 pounds sterling per year in a non-severe AD health state (concerns over these estimates are raised, suggesting that they may underestimate the true cost-effectiveness of donepezil). Cost-effectiveness analysis undertaken in this review suggests that donepezil treatment has a cost per quality-adjusted life-year (QALY) in excess of 80,000 pounds sterling, with donepezil treatment reducing the mean time spent in full-time care (delays progression of AD) by 1.42-1.59 months (over a 5-year period). From four published cost-effectiveness studies, two UK studies report additional costs associated with rivastigmine treatment. Cost-effectiveness analysis undertaken in the current review suggests that rivastigmine treatment has a cost per QALY in excess of 57,000 pounds sterling, with rivastigmine treatment reducing the mean time spent in full-time care (delays progression) by 1.43-1.63 months (over a 5-year period). From five published cost-effectiveness studies, one UK study reports a cost per QALY of 8693 pounds sterling for 16-mg galantamine treatment and 10,051 pounds sterling for 24-mg galantamine treatment (concerns raised suggest that this may underestimate the true cost-effectiveness of galantamine). Cost-effectiveness analysis undertaken in the present review suggests that galantamine treatment has a cost per QALY in excess of 68,000 pounds sterling, with galantamine reducing the time spent in full-time care (delays progression) by 1.42-1.73 months (over a 5-year period). From two published cost-effectiveness studies, one reports analysis for the UK, finding that memantine treatment results in cost savings and benefits in terms of delaying disease progression (concerns raised suggest that this may underestimate the true cost-effectiveness of memantine). In the current review, the cost-effectiveness of memantine has not been modelled separately, but where alternative parameter inputs on the cost structure and utility values have been used in a reanalysis using the industry model, the cost-effectiveness is reported at between 37,000 pounds sterling and 52,000 pounds sterling per QALY, with this alternative analysis still based on what is regarded as an optimistic or favourable effectiveness profile for memantine. CONCLUSIONS: Although results from the clinical effectiveness review suggest that these treatments may be beneficial, a number of issues need to be considered when assessing the results of the present review, such as the characteristics of the participants included in the individual trials, the outcome measures used, the length of study duration, the effects of attrition and the relationship between statistical significance and clinical significance. Many included trials were sponsored by industry. For donepezil, rivastigmine and galantamine, the cost savings associated with reducing the mean time spent in full-time care do not offset the cost of treatment sufficiently to bring estimated cost-effectiveness to levels generally considered acceptable by NHS policy makers. It is difficult to draw conclusions on the cost-effectiveness of memantine; it is suggested that further amendments to the potentially optimistic industry model (measure of effect) would offer higher cost per QALY estimates. Future research should include: information on the quality of the outcome measures used; development of quality of life instruments for patients and carers; studies assessing the effects of these interventions of durations longer than 12 months; comparisons of benefits between interventions; and research on the prediction of disease progression.

Aged↗
PubMed2005

Surgery for morbid obesity.

BACKGROUND: Obesity is associated with increased morbidity and mortality. Surgery for morbid obesity is considered when other treatments have failed. A number of procedures are available, but the effects of these surgical procedures compared with medical management and with each other are uncertain. OBJECTIVES: To assess the effects of surgery for morbid obesity. SEARCH STRATEGY: Studies were obtained from computerized searches of multiple electronic bibliographic databases, supplemented with hand searches of selected journals and consultation with experts in obesity research. Date of the most recent searches: December 2004. SELECTION CRITERIA: Randomised controlled trials comparing different surgical procedures, and randomised controlled trials and prospective cohort studies comparing surgery with non-surgical management for morbid obesity. DATA COLLECTION AND ANALYSIS: Data were extracted by one reviewer and checked independently by two reviewers. Two reviewers independently assessed trial quality. MAIN RESULTS: Twenty-six trials were included. Two randomised controlled trials and three prospective cohort studies compared surgery with non-surgical management, and 21 randomised controlled trials compared different surgical procedures. The quality of most of the trials was poor; just three trials had adequate allocation concealment. A meta-analysis was not possible due to differences in the surgical procedures performed, measures of weight change and length of follow-up. Compared with conventional management, surgery resulted in greater weight loss (21 kg weight loss at eight years versus weight gain), with improvements in quality of life and comorbidities. Some complications of surgery occurred, such as wound infection. Gastric bypass was associated with greater weight loss, better quality of life and fewer revisions, reoperations and/or conversions than gastroplasty, but had more side-effects. Greater weight loss and fewer side-effects and reoperations occurred with adjustable gastric banding than vertical banded gastroplasty, but laparoscopic vertical banded gastroplasty produced more patients with an excellent or good result and fewer late complications than laparoscopic adjustable silicone gastric banding. Vertical banded gastroplasty was associated with greater weight loss but more vomiting than horizontal gastroplasty. Some postoperative deaths occurred in the studies. Weight loss was similar between open and laparoscopic procedures. Fewer serious complications occurred with laparoscopic surgery, although conversion to open surgery was sometimes required. Most studies found that laparoscopic surgery had a longer operative time. But, it resulted in reduced blood loss and quicker recovery. AUTHORS' CONCLUSIONS: The limited evidence suggests that surgery is more effective than conventional management for weight loss in morbid obesity. The comparative safety and effectiveness of different surgical procedures is unclear.

Gastric Bypass↗
PubMed2005

Clinical effectiveness and cost-effectiveness of immediate angioplasty for acute myocardial infarction: systematic review and economic evaluation.

OBJECTIVES: To review the clinical evidence comparing immediate angioplasty with thrombolysis, and to consider whether it would be cost-effective. DATA SOURCES: Electronic databases. Experts in the field. REVIEW METHODS: For clinical effectiveness, a comprehensive review of randomised control trials (RCTs) was used for efficacy, and a selection of observational studies such as case series or audit data used for effectiveness in routine practice. RCTs of thrombolysis were used to assess the relative value of prehospital and hospital thrombolysis. Observational studies were used to assess the representativeness of patients in the RCTs, and to determine whether different groups have different capacity to benefit. Clinical effectiveness was synthesised through a narrative review with full tabulation of results of all included studies and a meta-analysis to provide a precise estimate of absolute clinical benefit. Consideration was given to the effect of the growing use of stents. The economic modelling adopted an NHS perspective to develop a decision-analytical model of cost-effectiveness focusing on opportunity costs over the short term (6 months). RESULTS: The results were consistent in showing an advantage of immediate angioplasty over hospital thrombolysis. The updated meta-analysis showed that mortality is reduced by about one-third, from 7.6% to 4.9% in the first 6 months, and by about the same in studies of up to 24 months. Reinfarction is reduced by over half, from 7.6% to 3.1%. Stroke is reduced by about two-thirds, from 2.3% with thrombolysis to 0.7% with percutaneous coronary intervention (PCI), with the difference being due to haemorrhagic stroke. The need for coronary artery bypass graft is reduced by about one-third, from 13.2% to 8.4%. Caution is needed in interpreting some of the older trials, as changes such as an increase in stenting and the use of the glycoprotein IIb/IIa inhibitors may improve the results of PCI. There is little evidence comparing prehospital thrombolysis with immediate PCI. Research on thrombolysis followed by PCI, known as 'facilitated PCI', is underway, but results are not yet available. Trials may be done in select centres and results may not be as good in lower volume centres, or out of normal working hours. In addition, much of the marginal mortality benefit of PCI over hospital thrombolysis may be lost if door-to-balloon time were more than an hour longer than door-to-needle time. Conversely, within the initial 6 hours, the later patients present, the greater the relative advantage of PCI. Results suggest that PCI is more cost-effective than thrombolysis, providing additional benefits in health status at some extra cost. In the longer term, the cost difference is expected to be reduced because of higher recurrence and reintervention rates among those who had thrombolysis. CONCLUSIONS: If both interventions were routinely available, the economic analysis favours PCI, given the assumptions of the model. However, very few units in England could offer a routine immediate PCI service at present, and there would be considerable resource implications of setting up such services. Without a detailed survey of existing provision, it is not possible to quantify the implications, but they include both capital and revenue: an increase in catheter laboratory provision and running costs. The greatest problem would be staffing, and that would take some years to resolve. A gradual incrementalist approach based on clinical networks, with transfer to centres able to offer PCI, may be used. In rural areas, one option may be to promote an increase in prehospital thrombolysis, with PCI for thrombolysis failures. There is a need for data on the long-term consequences of treatment, the quality of life of patients after treatment, and the effects of PCI following thrombolysis failure.

Angioplasty↗
PubMed2005

The clinical and cost-effectiveness of implantable cardioverter defibrillators: a systematic review.

OBJECTIVES: To consider the clinical effectiveness and cost-effectiveness of implantable cardioverter defibrillators (ICDs) for arrhythmias. DATA SOURCES: Electronic databases. Manufacturer submissions. REVIEW METHODS: A systematic review of the literature on clinical and cost-effectiveness was undertaken. The quality of selected randomised controlled trials (RCTs) was assessed using the Jadad criteria, and of selected systematic reviews using criteria developed by the NHS Centre for Reviews and Dissemination. Economic evaluations were quality assessed by their internal validity (i.e. the methods used) using a series of relevant questions, and external validity (i.e. generalisability of the economic study to the population of interest) by modified standard criteria. The clinical effectiveness and cost-effectiveness of ICDs for arrhythmias were synthesised through a narrative review with full tabulation of results of all included studies. RESULTS: Eight RCTs, two systematic reviews and a meta-analysis met the inclusion criteria of the review. The RCTs were of variable quality, with most trials having a Jadad quality score of 1/5 or 2/5, owing to the nature of comparing a device with drug therapy and the impossibility of double-blinding. The outcome measure of interest was mortality, which was reported as all-cause mortality in most trials and sudden cardiac death in some trials. Eleven economic evaluations of ICDs for arrhythmias were identified. None were shown to have high internal and external validity. One unpublished study relevant to the UK was identified. The evidence suggests that ICDs reduce mortality in patients with previous ventricular arrest or symptomatic sustained ventricular arrhythmias, in patients who have not had a previous sudden cardiac episode or previous ventricular arrhythmia but have reduced left ventricular function due to coronary artery disease with asymptomatic non-sustained ventricular arrhythmia and sustained tachycardia that could be induced electrophysiologically, and in some patients with severe left ventricular dysfunction (ejection fraction 30%) after myocardial infarction. QoL data are inconsistent but suggest that there is impaired QoL in patients who received numerous shocks from implanted devices. Studies show that ICDs improve survival compared with drug treatment, but with considerably increased cost. Incremental cost per life-year gained ranges from 27,000 US dollars to 213,543 Can dollars and incremental cost per quality-adjusted life-year from 71,700 US dollars to 558,000 US dollars in the published literature. CONCLUSIONS: The use of ICDs in the UK is increasing, but the technology is still under-utilised compared with other developed countries. Extending the current indications to patients with prior myocardial infarction and depressed heart function would impact on costs and service provision. Further research is needed on the risk stratification of patients in whom ICDs are most likely to be clinically and cost-effective. An evaluation of shock frequency on QoL is also required.

Aged↗
PubMed2005

The clinical and cost-effectiveness of left ventricular assist devices for end-stage heart failure: a systematic review and economic evaluation.

OBJECTIVES: To assess the clinical and cost-effectiveness of left ventricular assist devices (LVADs) as a bridge to heart transplantation (BTT), as a bridge to myocardial recovery (BTR) or as a long-term chronic support (LTCS) for people with end-stage heart failure (ESHF). DATA SOURCES: For the systematic review, electronic databases and bibliographies of related publications plus experts and manufacturers. For the economic evaluations, data originated from the systematic review of clinical and cost-effectiveness, UK hospitals, device manufacturers and expert opinion. REVIEW METHODS: For the systematic review, studies were selected and assessed against a set of rigorous criteria; data were then synthesised using a narrative approach through subgroup analysis based on the indication for treatment, type of LVAD and quality of studies. The economic evaluation developed two models to evaluate the use of LVADs, first as a BTT and second as LTCS for patients suffering from ESHF. RESULTS: Sixteen studies assessed the clinical effectiveness of LVADs as a BTT. Despite the poor methodological quality of the evidence, LVADs appeared beneficial compared to other treatment options (i.e. inotropic agents or usual care) or to no care (i.e. the natural history of ESHF) improving the survival of people with ESHF during the period of support and following heart transplantation. Patients supported by an LVAD appeared to have an improved functional status compared with those on usual care and experienced an improvement in their quality of life from before device implantation to the period during support. Serious adverse events are a risk for patients with an LVAD. With a scarcity of evidence directly comparing different devices, it is difficult to identify specific devices as the most clinically effective. The HeartMate LVAD is the only device that has evidence comparing it with the different alternatives, appearing to be more clinically effective than inotropic agents and usual care and as clinically effective as the Novacor device. Second generation devices, such as Jarvik 2000 and MicroMed Debakey LVADs, are early in their development but show considerable promise that should be assessed through long-term studies. Evidence of the clinical effectiveness of LVADs as a BTR was limited to seven non-comparative observational studies that appeared to show that the LVADs were beneficial in providing support until myocardial recovery. It was not possible to assess whether the LVADs are more effective than other alternatives or specific devices. No evidence was found on the quality of life or functional status of patients and limited information on adverse events was reported. Six studies assessed the clinical effectiveness of LVADs as an LTCS and from these it was evident that LVADs provided benefits in terms of improved survival, functional status and quality of life. Nineteen studies assessed the costs and cost-effectiveness of LVADS for people with ESHF, with the majority being simple costing studies and very few studies of the cost-effectiveness of LVADs. With no relevant cost-effectiveness studies available, an economic evaluation for BTT and LTCS was developed. The economic evaluation has shown that neither LVAD indication considered, that is, BTT and LTCS, is a cost-effective use. For the HeartMate LVAD used as a BTT the cost per QALY was pound 65,242. In the less restrictive indication, LTCS, where LVADs are not just given to patients awaiting transplantation, the analysis has shown that LTCS is not cost-effective. The baseline cost per QALY of the first-generation HeartMate LVAD was pound 170,616. One- and multi-way sensitivity analysis had limited effect on the cost per QALY. A hypothetical scenario based on the cost of a second-generation MicroMed DeBakey device illustrated that a 60% improvement in survival over first-generation devices was necessary before the incremental cost-effectiveness approached pound 40,000 per QALY. CONCLUSIONS: Although the review showed that LVADs are clinically effective as a BTT with ESHF, the economic evaluation indicated that they are not cost-effective. With the limited and declining availability of donor hearts for transplantation, it appears that the future of the technology is in its use as an LTCS. Further research is needed to examine the clinical effectiveness of LVADs for people with ESHF, assessing patient survival, functional ability, quality of life and adverse events. Evaluations of the clinical effectiveness of LVADs should include economic evaluations, as well as data on quality of life, utilities, resources and costs. A systematic review of the epidemiology of ESHF should be undertaken to assess its potential impact.

Cost-Benefit Analysis↗
PubMed2003

Specialist nurses in diabetes mellitus.

BACKGROUND: The patient with diabetes has many different learning needs relating to diet, monitoring, and treatments. In many health care systems specialist nurses provide much of these needs, usually aiming to empower patients to self-manage their diabetes. The present review aims to assess the effects of the involvement of specialist nurse care on outcomes for people with diabetes, compared to usual care in hospital clinics or primary care with no input from specialist nurses. OBJECTIVES: To assess the effects of diabetes specialist nurses / nurse case manager in diabetes on the metabolic control of patients with type 1 and type 2 diabetes mellitus. SEARCH STRATEGY: We carried out a comprehensive search of databases including the Cochrane Library, MEDLINE and EMBASE to identify trials. Bibliographies of relevant papers were searched, and hand searching of relevant publications was undertaken to identify additional trials (Date of last search November 2002). SELECTION CRITERIA: Randomised controlled trials and controlled clinical trials of the effects of a specialist nurse practitioner on short and long term diabetic outcomes were included in the review. DATA COLLECTION AND ANALYSIS: Three investigators performed data extraction and quality scoring independently; any discrepancies were resolved by consensus. MAIN RESULTS: Six trials including 1382 participants followed for six to 12 months were included. Two trials were in adolescents. Due to substantial heterogeneity between trials a meta-analysis was not performed. Glycated haemoglobin (HbA1c) in the intervention groups was not found to be significantly different from the control groups over a 12 month follow up period. One study demonstrated a significant reduction in HbA1c in the presence of the diabetes specialist nurse/nurse case manager at 6 months. Significant differences in episodes of hypoglycaemia and hyperglycaemia between intervention and control groups were found in one trial. Where reported, emergency admissions and quality of life were not found to be significantly different between groups. No information was found regarding BMI, mortality, long term diabetic complications, adverse effects, or costs. REVIEWER'S CONCLUSIONS: The presence of a diabetes specialist nurse / nurse case manager may improve patients' diabetic control over short time periods, but from currently available trials the effects over longer periods of time are not evident. There were no significant differences overall in hypoglycaemic episodes, hyperglycaemic incidents, or hospital admissions. Quality of life was not shown to be affected by input from a diabetes specialist nurse/nurse case manager.

Case Management↗
PubMed2003

The clinical and cost-effectiveness of patient education models for diabetes: a systematic review and economic evaluation.

OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of educational interventions for patients with diabetes, compared with usual care or other educational interventions. DATA SOURCES: Electronic databases, reference lists and experts were all consulted in this study. Sponsor submissions to the National Institute of Clinical Excellence were also reviewed. REVIEW METHODS: Electronic databases were searched, references of all retrieved articles were checked for relevant studies, and experts were contacted for advice and peer review and to identify additional published and unpublished references. Randomised clinical trials (RCTs) and controlled clinical trials (CCTs) were included if they fulfilled pre-specified criteria, among which was follow-up from inception for 12 months or longer. Data were synthesised through a narrative review because the diversity of studies prevented a meta-analysis. RESULTS: Twenty-four studies (18 RCTs and six CCTs) that compared education with either a control group or with another educational intervention were included. The quality of reporting and methodology was generally found to be poor by today's standards. As part of treatment intensification, education in Type 1 diabetes (four studies) resulted in significant and long-lasting improvements in metabolic control and reductions in complications. In Type 2 diabetes (16 studies) a diversity of educational programmes did not yield consistent results on measures of metabolic control. Inconsistent results on metabolic control were also found in studies of diabetes of either type (four studies), with studies of lower quality producing significant effects. Few studies evaluated quality of life. Economic evaluations comparing education with usual care or other educational interventions were not identified. CONCLUSIONS: Education as part of intensification of treatment produces improvement in diabetic control in Type 1 diabetes. Mixed results in Type 2 diabetes mean that no clear characterisation is possible as to what features of education may be beneficial. Cost analysis and information from sponsor submissions indicated that where costs associated with patient education were in the region of 500-600 pounds sterling per patients, the benefits over time would have to be very modest to offer an attractive cost-effectiveness profile. Further research should focus on RCTs with clear designs based on explicit hypotheses and with a range of outcomes evaluated after long follow-up intervals.

Cost-Benefit Analysis↗
PubMed2003

The effectiveness of diagnostic tests for the assessment of shoulder pain due to soft tissue disorders: a systematic review.

OBJECTIVES: To evaluate the evidence for the effectiveness and cost-effectiveness of the newer diagnostic imaging tests as an addition to clinical examination and patient history for the diagnosis of soft tissue shoulder disorders. DATA SOURCES: Literature was identified from several sources including general medical databases. REVIEW METHODS: Studies were identified that evaluated clinical examination, ultrasound, magnetic resonance imaging (MRI), or magnetic resonance arthrography (MRA) in patients suspected of having soft tissue shoulder disorders. Outcomes assessed were clinical impingement syndrome or rotator cuff tear (full, partial or any). Only cohort studies were included. The methodological quality of included test accuracy studies was assessed using a formal quality assessment tool for diagnostic studies and the extraction of study findings was conducted in duplicate using a pre-designed and piloted data extraction form to avoid any errors. For each test, sensitivity, specificity and positive and negative likelihood ratios with 95% confidence intervals were calculated for each study. Where possible pooled estimates of sensitivity, specificity and likelihood ratios were calculated using random effects methods. Potential sources of heterogeneity were investigated by conducting subgroup analyses. RESULTS: In the included studies, the prevalence of rotator cuff disorders was generally high, partial verification of patients was common and in many cases patients who were selected retrospectively because they had undergone the reference test. Sample sizes were generally very small. Reference tests were often inappropriate with many studies using arthrography alone, despite problems with its sensitivity. For clinical assessment, 10 cohort studies were found that examined either the accuracy of individual tests or clinical examination as a whole: individual tests were either good at ruling out rotator cuff tears when negative (high sensitivity) or at ruling in such disorders when positive (high specificity), but small sample sizes meant that there was no conclusive evidence. Ultrasound was investigated in 38 cohort studies and found to be most accurate when used for the detection of full-thickness tears; sensitivity was lower for detection of partial-thickness tears. For MRI, 29 cohort studies were included. For full-thickness tears, overall pooled sensitivities and specificities were fairly high and the studies were not statistically heterogeneous; however for the detection of partial-thickness rotator cuff tears, the pooled sensitivity estimate was much lower. The results from six MRA studies suggested that it may be very accurate for detection of full-thickness rotator cuff tears, although its performance for the detection of partial-thickness tears was less consistent. Direct evidence for the performance of one test compared with another is very limited. CONCLUSIONS: The results suggest that clinical examination by specialists can rule out the presence of a rotator cuff tear, and that either MRI or ultrasound could equally be used for detection of full-thickness rotator cuff tears, although ultrasound may be better at picking up partial tears. Ultrasound also may be more cost-effective in a specialist hospital setting for identification of full-thickness tears. Further research suggestions include the need for large, well-designed, prospective studies of the diagnosis of shoulder pain, in particular a follow-up study of patients with shoulder pain in primary care and a prospective cohort study of clinical examination, ultrasound and MRI, alone and/or in combination.

Arthrography↗
PubMed2002

Endocrinology trial design: adverse event reporting in randomised controlled trials of recombinant human GH in GH-deficient adults.

We have evaluated the reporting of withdrawals due to adverse effects and specific adverse effects in randomised controlled trials of recombinant human GH in adults. A systematic review was carried out of randomised controlled trials of the clinical effectiveness of recombinant human GH in adults with GH deficiency in relation to impact on quality of life. Trials were identified from searching electronic databases, bibliographies of related articles and consulting experts. There was reporting of withdrawals due to adverse effects and specific adverse effects. Rates of oedema and arthralgia were reported in included trials. Seventeen randomised controlled trials, published between 1990 and 1999, met the inclusion criteria for the review. Nine trials reported data on the effectiveness of GH on quality of life in adults. Only five trials (29%) reported both withdrawals from the study because of adverse events and specific adverse events with numbers per study arm and per type. Six further trials (35%) reported either withdrawal details or specific adverse event details or partial data on specific adverse events. Six trials (35%), however, did not report information on either withdrawals or specific adverse events. Ten of the 17 studies (59%) reported the number of patients who withdrew from the study due to adverse events per study arm and type of adverse event per study arm. Seven of the 17 trials (41%) reported the number of specific adverse events per study arm and six (35%) reported the type per study arm. The reporting of adverse events in randomised controlled trials of GH is variable and not consistent across trials. It is not possible to assess the impact that adverse events may have had on unblinding patients, and therefore the extent to which the effects of GH may have been overestimated. Therefore those conducting endocrinology trials in the future need to pay attention to the reporting of withdrawals due to adverse events and specific adverse events.

Adult↗
PubMed2001

The auditory evoked response as an awareness monitor during anaesthesia.

We investigated the relationship between the latency of the Nb wave of the auditory evoked response (AER) and periods of awareness during propofol anaesthesia. In the anaesthetic room before cardiac surgery the AER was recorded continuously in 14 patients. Awareness was measured by the ability of the patient to respond to command using the isolated forearm technique (IFT). The Nb latencies were shorter when the patients were able to respond than at loss of response (P<0.001). In six patients who repeated this transition from response to loss of response, there was a high and significant correlation between Nb latencies. None of the patients had any recollection of events after the initial induction of anaesthesia as measured by explicit and implicit memory tests. These results suggest that the Nb latency of the AER may represent an indication of awareness in individual patients, but wide inter-patient variability limits its practical usefulness. In addition, because no evidence of memory was demonstrated, even when patients were known to be awake, the relationship between AER and memory processing remains unclear.

Aged↗
PubMedDate not supplied

Factors influencing nurses' inferences about patient pain.

This study examined the factors that influence nurses' perception of patient pain. Sixteen vignettes were constructed on the basis of interviews with nurses about factors affecting their perception of patient pain and previous published literature. Four variables were systematically varied within a factorial design: diagnosis (surgery vs oncology), level of patient mobility, presence or absence of physical and behavioural signs, and patient gender. Twenty-seven nurses rated each vignette for degree of inferred patient pain and degree of patient psychological distress. Mobility and positive signs of pain had statistically significant effects on nurses' judgments of inferred pain (P < 0.001), but diagnosis had no main effect. Significant interactions showed that: inferred pain in male patients was seen to be greater when immobile while mobility had no effect on the inferred pain of female patients (P < 0.003); oncology patients (compared with surgical patients) had greater inferred pain when displaying positive signs (P < 0.024); and positive signs yielded higher ratings where patients were immobile (P < 0.001). Female patients were perceived to experience higher psychological distress than men (P < 0.037) and oncology patients were perceived to experience higher distress than surgical patients (P < 0.005). Ratings of perceived pain and distress were significantly correlated but did not differ in magnitude. Offered a choice of analgesics to relieve pain for each of the patients depicted, nurses typically chose those with the lowest strength.

Attitude of Health Personnel↗