Acceptability of short term neo-adjuvant androgen deprivation in patients with locally advanced prostate cancer

Purpose: To determine the acceptability of short term neo-adjuvant maximal androgen deprivation (MAD) to patients treated with external beam radiation for locally advanced prostate cancer. Methods: Between 1996 and 2000, 818 patients with locally advanced, but non-metastatic, prostate cancer were entered into a randomised clinical trial (TROG 96.01), which compared radiation treatment alone with the same radiation treatment and 3 or 6 months neo-adjuvant MAD with goserelin and flutamide. Relevant symptoms, and how troublesome they were to the patient, were scored using a self-assessment questionnaire. This was completed by the patient at registration, and at specified times during and after treatment. Patients taking flutamide had liver function tests checked at regular intervals. Results: All patients have completed at least 12 months follow-up after treatment. Nearly all patients completed planned treatment with goserelin, but 27% of patients in the 6-month MAD treatment arm, and 20% in the 3-month arm, had to stop flutamide early. This was mainly due to altered liver function (up to 17% patients) and bowel side effects (up to 8% patients). However, although flutamide resulted in more bowel symptoms for patients on MAD, there was significant reduction in some urinary symptoms on this treatment. Acute bowel and urinary side effects at the end of radiation treatment were similar in all treatment arms. Side effect severity was unrelated to radiation target volume size, which was reduced by MAD, but symptomatology prior to any treatment was a powerful predictor. Of the 36% of patients who were sexually active before any treatment, the majority became inactive whilst on MAD. However, sexual activity at 12 months after radiation treatment was similar in all treatment arms, indicating that the effects of short term MAD on sexual function are reversible. Conclusion: Despite temporary effects on sexual activity, and compliance difficulties with flutamide, short-term neo-adjuvant MAD was not perceived by patients to be a major inconvenience. If neo-adjuvant MAD in the way tested can be demonstrated to lead to improved biochemical control and/or survival, then patients would view these therapeutic gains as worthwhile. Compliance with short-term goserelin was excellent, confirming that LH-RH analogues have a potential role in more long-term adjuvant treatment. However, for more protracted androgen deprivation, survival advantages and deleterious effects need to be assessed in parallel, in order to determine the optimal duration of treatment. (C) 2003 Elsevier Ireland Ltd. All fights reserved.

A prospective multicentre study of pharmacist initiated changes to drug therapy and patient management in acute care government funded hospitals

Aims To determine the cost savings of pharmacist initiated changes to hospitalized patients' drug therapy or management in eight major acute care government funded teaching hospitals in Australia. Methods This was a prospective study performed in eight hospitals examining resource implications of pharmacists' interventions assessed by an independent clinical panel. Pharmacists providing clinical services to inpatients recorded details of interventions, defined as any action that directly resulted in a change to patient management or therapy. An independent clinical review panel, convened at each participating centre, confirmed or rejected the clinical pharmacist's assessment of the impact on length of stay (LOS), readmission probability, medical procedures and laboratory monitoring and quantified the resultant changes, which were then costed. Results A total of 1399 interventions were documented. Eight hundred and thirty-five interventions impacted on drug costs alone. Five hundred and eleven interventions were evaluated by the independent panels with three quarters of these confirmed as having an impact on one or more of: length of stay, readmission probability, medical procedures or laboratory monitoring. There were 96 interventions deemed by the independent panels to have reduced LOS and 156 reduced the potential for readmission. The calculated savings was $263 221 for the eight hospitals during the period of the study. This included $150 307 for length of stay reduction, $111 848 for readmission reduction. Conclusions The annualized cost savings relating to length of stay, readmission, drugs, medical procedures and laboratory monitoring as a result of clinical pharmacist initiated changes to hospitalized patient management or therapy was $4 444 794 for eight major acute care government funded teaching hospitals in Australia.

Do rural consumers expect a prescription from their GP visit? Investigation of patients' expectations for a prescription and doctors' prescribing decisions in rural Australia

Objective: To assess patients’ expectation for receiving a prescription and GPs’ perceptions of patient expectation for a prescription. Design: Matched questionnaire study completed by patients and GPs. Setting: Seven general practices in rural Queensland, Australia. Subjects: The subjects were 481 patients consulting 17 GPs. Main outcome measures: Patients’ expectation for receiving a prescription and GPs’ perceptions of patients’ expectation. Results: Ideal expectation (hope) for a prescription was expressed by 57% (274/481) of patients. Sixty-six per cent (313/481) thought it was likely that the doctor would actually give them a prescription. Doctors accurately predicted hope or lack of hope for a prescription in 65% (314/481) of consultations, but were inaccurate in 19% (93/481). A prescription was written in 55% of consultations. No increase in patients’ expectation, doctors’ perceptions of expectation, or decision to prescribe were detected for patients living a greater distance from the doctors. Conclusions: Rural patients demonstrated similar rates of hope for a prescription to those found in previous urban studies. Rural doctors seem to be similarly ‘accurate’ and ‘inaccurate’ in determining patients’ expectations. Rates of prescribing were comparable to urban rates. Distance was not found to increase the level of patient expectation, affect the doctors’ perception or to influence the decision to prescribe.

Defining worthwhile and desired responses to treatment of chronic low back pain

Objective To describe patients' perceptions of minimum worthwhile and desired reductions in pain and disability upon commencing treatment for chronic low back pain. Design and Setting Descriptive study nested within a community-based randomized controlled trial on prolotherapy injections and exercises. Patients A total of 110 participants with chronic low back pain. Interventions Prior to treatment, participants were asked what minimum percentage reductions in pain and disability would make treatment worthwhile and what percentage reductions in pain and disability they desired with treatment. Outcome Measures. Minimum worthwhile reductions and desired reductions in pain and disability. Results. Median (inter-quartile range) minimum worthwhile reductions were 25% (20%, 50%) for pain and 35% (20%, 50%) for disability. This compared with desired reductions of 80% (60%, 100%) for pain and 80% (50%, 100%) for disability. The internal consistency between pain and disability responses was high (Spearman's coefficient of association of 0.81 and 0.87, respectively). A significant association existed between minimum worthwhile reductions and desired reductions, but no association was found between these two factors and patient age, gender, pain severity or duration, disability, anxiety, depression, response to treatment, or treatment satisfaction. Conclusions. Inquiring directly about patients' expectations of reductions in pain and in disability is important in establishing realistic treatment goals and setting benchmarks for success. There is a wide disparity between the reductions that they regard as minimum worthwhile and reductions that they hope to achieve. However, there is a high internal consistency between reductions in pain and disability that they expect.

Development of a dosage strategy in patients receiving enoxaparin by continuous intravenous infusion using modelling and simulation

Aim To develop an appropriate dosing strategy for continuous intravenous infusions (CII) of enoxaparin by minimizing the percentage of steady-state anti-Xa concentration (C-ss) outside the therapeutic range of 0.5-1.2 IU ml(-1). Methods A nonlinear mixed effects model was developed with NONMEM (R) for 48 adult patients who received CII of enoxaparin with infusion durations that ranged from 8 to 894 h at rates between 100 and 1600 IU h(-1). Three hundred and sixty-three anti-Xa concentration measurements were available from patients who received CII. These were combined with 309 anti-Xa concentrations from 35 patients who received subcutaneous enoxaparin. The effects of age, body size, height, sex, creatinine clearance (CrCL) and patient location [intensive care unit (ICU) or general medical unit] on pharmacokinetic (PK) parameters were evaluated. Monte Carlo simulations were used to (i) evaluate covariate effects on C-ss and (ii) compare the impact of different infusion rates on predicted C-ss. The best dose was selected based on the highest probability that the C-ss achieved would lie within the therapeutic range. Results A two-compartment linear model with additive and proportional residual error for general medical unit patients and only a proportional error for patients in ICU provided the best description of the data. Both CrCL and weight were found to affect significantly clearance and volume of distribution of the central compartment, respectively. Simulations suggested that the best doses for patients in the ICU setting were 50 IU kg(-1) per 12 h (4.2 IU kg(-1) h(-1)) if CrCL < 30 ml min(-1); 60 IU kg(-1) per 12 h (5.0 IU kg(-1) h(-1)) if CrCL was 30-50 ml min(-1); and 70 IU kg(-1) per 12 h (5.8 IU kg(-1) h(-1)) if CrCL > 50 ml min(-1). The best doses for patients in the general medical unit were 60 IU kg(-1) per 12 h (5.0 IU kg(-1) h(-1)) if CrCL < 30 ml min(-1); 70 IU kg(-1) per 12 h (5.8 IU kg(-1) h(-1)) if CrCL was 30-50 ml min(-1); and 100 IU kg(-1) per 12 h (8.3 IU kg(-1) h(-1)) if CrCL > 50 ml min(-1). These best doses were selected based on providing the lowest equal probability of either being above or below the therapeutic range and the highest probability that the C-ss achieved would lie within the therapeutic range. Conclusion The dose of enoxaparin should be individualized to the patients' renal function and weight. There is some evidence to support slightly lower doses of CII enoxaparin in patients in the ICU setting.

Pharmacological treatment and perceived health status during 1-year follow up in patients diagnosed with coronary artery disease, but ineligible for revascularization. Results from the Euro Heart Survey on Coronary Revascularization

Background It has been recognized that a clinically significant portion of patients with coronary artery disease (CAD) continue to experience anginal and other related symptoms that are refractory to the combination of medical therapy and revascularization. The Euro Heart Survey on Revascularization (EHSCR) provided an opportunity to assess pharmacological treatment and outcome in patients with proven CAD who were ineligible for revascularization. Methods We performed a secondary analysis of EHS-CR data. After excluding patients with ST-elevation myocardial infarction and those in whom revascularization was not indicated, 4409 patients remained in the analyses. We selected two groups: (1) patients in whom revascularization was the preferred treatment option (n = 3777, 86%), and (2) patients who were considered ineligible for revascularization (n = 632, 14%). Results Patient ineligible for revascularization had a worse risk profile, more often had a total occlusion (59% vs. 37%, p < 0.001), were treated more often with ACE-inhibitors (65% vs. 55%, p < 0.001) but less likely with aspirin (83% vs. 88%, p < 0.001). Overall, they had higher case-fatality at 1-year (7.0% vs. 3.7%, p < 0.001). Regarding self-perceived health status, measured via the EuroQol 5D (EQ-5D) questionnaire, these same patients reported more problems on all dimensions of the EQ-5D. Furthermore, in the revascularization group we observed an increase between discharge and 1-year follow up (utility score from 0.85 to 1.00) whereas patients ineligible for revascularization did not improve over time (utility score remained 0.80) Conclusion In this large cohort of European patients with CAD, those considered ineligible for revascularization had more co-morbidities and risk factors, and scored worse on self-perceived health status as compared to revascularized patients in the revascularization group. With the exception of ACE-inhibitors and aspirin, there were no major differences regarding drug treatment between the two groups. Given these clinically significant observations, there appears to be a role for nurse-led, multidisciplinary, rehabilitation teams that target clinically vulnerable patients whose symptoms remain refractory to standard medical care.

Evidence about tele-oncology applications and associated benefits for patients and their families

We conducted a systematic review of evidence on the ability of tele-oncology applications to improve access to care closer to home for adult rural patients affected by cancer. From 269 publications identified in the literature search, 54 studies met our inclusion criteria. Forty two were clinical studies (32 quantitative, eight qualitative and two that included both quantitative and qualitative methodology). Strength of evidence from quantitative clinical studies was assessed using an approach that takes account of both study design and study quality. Qualitative studies were appraised by giving scores for six areas of interest. In terms of the continuum of cancer care, the most common study area was psychosocial and supportive care. While there were a number of high quality studies, overall the evidence of benefit from tele-oncology was limited and few investigations had proceeded beyond the stage of establishing feasibility. The literature suggests some useful possibilities for new services to cancer patients in rural areas but it seems likely that these would need validation with suitable local studies.

Attitudes of young people with diabetes to an Internet-based virtual clinic

We assessed the feasibility of developing a virtual diabetes clinic for young people, using the Internet. The proposed content of the site would be based on self-efficacy theory, aiming to develop confidence in self-management of diabetes. A questionnaire about the proposed Website was delivered to 72 patients who attended a young person’s outpatient clinic in a district hospital. Thirty-nine replies were received, a response rate of 54%. The mean age of the respondents was 13 years. A positive attitude to the potential clinic was reported by 95% of respondents. The items rated as most useful were: quick and easy access to up-todate information about diabetes; the opportunity to ask an expert; good graphics; easy navigation; interactivity. Responses to open questions indicated that 24-hour access and anonymity in asking questions were also valued. A virtual clinic appears to be a possible method of health-care delivery to young people with diabetes.

Use of complementary and alternative medicine and self-tests by coronary heart disease patients

Background: Coronary heart disease patients have to learn to manage their condition to maximise quality of life and prevent recurrence or deterioration. They may develop their own informal methods of self-management in addition to the advice they receive as part of formal cardiac rehabilitation programmes. This study aimed to explore the use of complementary and alternative medicines and therapies (CAM), self-test kits and attitudes towards health of UK patients one year after referral to cardiac rehabilitation. Method: Questionnaire given to 463 patients attending an assessment clinic for 12 month follow up in four West Midlands hospitals. Results: 91.1% completed a questionnaire. 29.1% of patients used CAM and/or self-test kits for self-management but few (8.9%) used both methods. CAM was more often used for treating other illnesses than for CHD management. Self-test kit use (77.2%,) was more common than CAM (31.7%,) with BP monitors being the most prevalent (80.0%). Patients obtained self-test kits from a wide range of sources, for the most part (89.5%) purchased entirely on their own initiative. Predictors of self-management were post revascularisation status and higher scores on 'holism', 'rejection of authority' and 'individual responsibility'. Predictors of self-test kit use were higher `holism' and 'individual responsibility' scores. Conclusion: Patients are independently using new technologies to monitor their cardiovascular health, a role formerly carried out only by healthcare practitioners. Post-rehabilitation patients reported using CAM for self-management less frequently than they reported using self-test kits. Reports of CAM use were less frequent than in previous surveys of similar patient groups. Automatic assumptions cannot be made by clinicians about which CHD patients are most likely to self-manage. In order to increase trust and compliance it is important for doctors to encourage all CHD patients to disclose their self-management practices and to continue to address this in follow up consultations.

Medicines management across the primary-hospital healthcare interface: a study of paediatric patients

A comparison of medicines management documents in use by NHS organisations in the West Midlands confirms that there are important differences between the primary care and hospital sectors in respect to medicines management interface issues. Of these, two aspects important to paediatric patients have been studied. These are the transfer of information as a patient is admitted to hospital, and access to long-term medicines for home-patients. National guidance provided by NICE requires medication reconciliation to be undertaken on admission to hospital for adults. A study of paediatric admissions, reported in this thesis, demonstrates that the clinical importance of this process is at least as important for children as for adults, and challenges current UK guidance. The transfer of essential medication information on hospital admission is central to the medication reconciliation process. Two surveys of PCTs in 2007 and again in 2009 demonstrate that very few PCTs provide guidance to GPs to support this process. Provision of guidance is increasing slowly but remains the exception. The provision of long-term medicines for children at home is hindered by this patient population often needing unlicensed drugs. Further studies demonstrate that primary care processes regularly fail to maintain access to essential drugs and patients and their carers frequently turn to hospitals for help. Surveys of hospital medical staff (single site) and hospital nurses (six UK sites) demonstrates the activity these healthcare workers perform to help children get the medicines they need. A similar survey of why carers turn to a hospital pharmacy department for urgent supplies (usually termed rescue-medicines) adds to the understanding of these problems and supports identifying service changes. A large survey of community pharmacies demonstrates the difficulties they have when dispensing hospital prescriptions and identifies practical solutions. This programme concludes by recommending service changes to support medication management for children.

The correlation between tests of visual function and perceived visual ability in central field loss patients

Purpose: To investigate the correlation between tests of visual function and perceived visual ability recorded with a 'quality-of-life' questionnaire for patients with central field loss. Method: 12 females and 7 males (mean age = 53.1 years; Range = 23 - 80 years) with subfoveal neovascular membranes underwent a comprehensive assessment of visual function. Tests included unaided distance vision, high and low contrast distance logMAR visual acuity (VA), Pelli-Robson contrast senstivity (at 1m), near logMAR word VA and text reading speed. All tests were done both monocularly and binocularly. The patients also completed a 28 point questionnaire separated into a 'core' section consisting of general questions about perceived visual function and a 'module' section with specific questions on reading function. Results: Step-wise multiple regression analysis was used to determine which visual function tests were correlated with the patients's perceived visual function and to rank them in order of importance. The visual function test that explains most of the variance in both 'core' score (66%0 and the 'module' score (68%) of the questionnaire is low contrast VA in the better eye (P<0.001 in both cases). Further, the module score also accounts for a significant proportion of the variance (P<0.01) of the distance logMAR VA in both the better and worse eye, and the near logMAR in both the better eye and binocularly. Conclusions: The best predictor of both perceived reading ability and of general perceived visual ability in this study is low contrast logMAR VA. The results highlight that distance VA is not the only relevant measure of visual fucntion in relation to a patients's perceived visual performance and should not be considered a determinant of surgical or management success.

The corporatization of community pharmacy:implications for service provision, the public health function, and pharmacy's claims to professional status in the United Kingdom

Background Pharmacy has experienced both incomplete professionalization and deprofessionalization. Since the late 1970s, a concerted attempt has been made to re-professionalize pharmacy in the United Kingdom (UK) through role extension—a key feature of which has been a drive for greater pharmacy involvement in public health. However, the continual corporatization of the UK community pharmacy sector may reduce the professional autonomy of pharmacists and may threaten to constrain attempts at reprofessionalization. Objectives The objectives of the research: to examine the public health activities of community pharmacists in the UK; to explore the attitudes of community pharmacists toward recent relevant UK policy and barriers to the development of their public health function; and, to investigate associations between activity, attitudes, and the type of community pharmacy worked in (eg, supermarket, chain, independent). Methods A self-completion postal questionnaire was sent to a random sample of practicing community pharmacists, stratified for country and sex, within Great Britain (n = 1998), with a follow-up to nonresponders 4 weeks later. Data were analyzed using SPSS (SPSS Inc., Chicago, IL, USA) (v12.0). A final response rate of 51% (n = 1023/1998) was achieved. Results The level of provision of emergency hormonal contraception on a patient group direction, supervised administration of medicines, and needle-exchange schemes was lower in supermarket pharmacies than in the other types of pharmacy. Respondents believed that supermarkets and the major multiple pharmacy chains held an advantageous position in terms of attracting financing for service development despite suggesting that the premises of such pharmacies may not be the most suitable for the provision of such services. Conclusions A mixed market in community pharmacy may be required to maintain a comprehensive range of pharmacy-based public health services and provide maximum benefit to all patients. Longitudinal monitoring is recommended to ensure that service provision is adequate across the pharmacy network.

How accurate are photographic surrogate markers used to detect macular oedema in the english national Screening Programme?

Introduction: Macular oedema is not directly visible on digital photographs used in screening. Photographic surrogate markers are used to detect patients who may have macular oedema. Evidence suggests that only around 10% of patients with these surrogate markers referred to an ophthalmologist have macular oedema when examined by slit-lamp biomicroscopy. Purpose: The purpose of this audit was to determine how many patients with surrogate markers were truly identified by optical coherence tomography (OCT) as having macular oedema. Method: Data were collected from patients attending digital diabetic retinopathy screening. Patients who presented with surrogate markers for macular oedema also had an OCT scan. The fast macula scan on the Stratus OCT was used and an ophthalmologist reviewed the scans to determine whether macular oedema was present. Results: Out of 66 patients with maculopathy defined as haemorrhages or microaneurysms within one optic disc diameter (DD) of the fovea and visual acuity (VA) worse than 6/9 11 (17%) showed thickening on the OCT, only 4 (6%) had macular oedema. None required laser. Out of 155 patients with maculopathy defined as any exudate within one DD of the fovea or circinate within two DD 45 (29%) showed thickening on the OCT of these 27% required laser. Conclusion: OCT is a useful tool in screening to help identify those who need a true referral to ophthalmology for maculopathy. If exudate is present the chance of having macular oedema and requiring laser treatment is greater than the presence of microaneurysms within one DD and reduced VA.

Patients' perceptions and experiences of taking oral glucose-lowering agents: a longitudinal qualitative study

Aims The aims of this study were to examine Type 2 diabetic patients' expectations, perceptions and experiences of oral glucose-lowering agents (OGLAs), including their reasons for taking/not taking these drugs as prescribed and to provide recommendations for developing interventions to improve OGLA adherence. Methods Longitudinal, qualitative study using repeat in-depth interviews with patients (n = 20) over 4 years following clinical diagnosis. Respondents were recruited from primary and secondary care settings across Lothian, Scotland, UK. Results Despite experiences of side-effects, dislikes and concerns about taking multiple drugs and a belief that OGLAs could themselves cause one's diabetes to progress, most respondents appeared motivated to take these drugs as prescribed. This motivation seemed to arise from respondents' experiences of taking OGLAs and observing them to 'work'. Some respondents described feeling better after taking OGLAs, others, typically those who were asymptomatic, used blood glucose self-monitoring and/or glycated haemoglobin results to observe and evidence the effects of their OGLAs. Most respondents demonstrated a 'passive' expectation that health professionals should be responsible for decisions about medications. Hence, non-adherence typically resulted from forgetfulness rather than ambivalence about either medication or consultation style. Respondent concern about OGLA's largely centred upon lack of knowledge about the medication and what to do when doses were missed. Conclusion The findings call for multifaceted strategies to promote adherence. These could include education to address misconceptions and advise patients how to respond to missed doses; reminders to help patients remember to take their drugs; and structured feedback on the impact of OGLAs on glycaemic control.

Patients' perceptions and experiences of transitions in diabetes care: a longitudinal qualitative study

Objective To examine patients' perceptions and experiences over time of the devolvement of diabetes care/reviews from secondary to primary health-care settings. Design Repeat in-depth interviews with 20 patients over 4 years. Participants and setting Twenty type 2 diabetes patients recruited from primary- and secondary-care settings across Lothian, Scotland. Results Patients' views about their current diabetes care were informed by their previous service contact. The devolvement of diabetes care/reviews to general practice was presented as a 'mixed blessing'. Patients gained reassurance from their perception that receiving practice-based care/reviews signified that their diabetes was well-controlled. However, they also expressed resentment that, by achieving good control, they received what they saw as inferior care and/or less-frequent reviews to others with poorer control. While patients tended to regard GPs as having adequate expertise to conduct their practice-based reviews, they were more ambivalent about nurses taking on this role. Opportunities to receive holistic care in general practice were not always realized due to patients seeing health-care professionals for diabetes management to whom they would not normally present for other health issues. Conclusions It is important to educate patients about their care pathways, and to reassure them that frequency of reviews depends more on clinical need than location of care and that similar care guidelines are followed in hospital clinics and general practice. A patients' history of service contact may need to be taken into account in future studies of service satisfaction.