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Oncology data management in the UK--BODMA's view. British Oncology Data Managers Association.

Over the past 10 years, the original partnership of clinician and statistician for the running of clinical research projects, especially clinical trials, has come to be supplemented by the data manager and trial coordinator. Increasing numbers of such personnel are now being employed, covering a wide diversity of work areas, including clinical research, medical audit and the cancer registries. The British Oncology Data Managers Association (BODMA) was founded in 1987 and is now in a good position to review the current status of data management in the UK. It is proposed that a national network of data managers and trial coordinators within specialist trials centres, oncology departments and district general hospitals, with a good training programme, plus a recognised career structure, is the way to make the best use of this key resource. BODMA is addressing many of these issues and aims to improve and maintain the quality of data management.

Clinical Trials as Topic↗

The management of acid-related dyspepsia in general practice: a comparison of an omeprazole versus an antacid-alginate/ranitidine management strategy. Compete Research Group [corrected].

BACKGROUND: There is need for an evidence-based comparison of clinical management strategies to provide the rationale for selection of a particular therapeutic approach to treatment. Ideal dyspepsia treatment should quickly and conveniently alleviate patient symptoms whilst also minimizing the use of healthcare resources. AIM: To examine dyspepsia symptom relief over 16 weeks and compare an omeprazole clinical management strategy with a commonly used combination of antacid-alginate followed by H2-antagonist. METHODS: Seven hundred and twenty-five patients participated in this randomized, open, parallel group comparison over 16 weeks. Patients were randomized to receive either an omeprazole treatment strategy (363) consisting of omeprazole 10 mg stepping up to 20 mg and 40 mg as required, or an antacid-alginate/ranitidine treatment strategy (362) consisting of antacid-alginate 10 mL q.d.s. stepping up to ranitidine 150 mg b.d. and 150 mg q.d.s. as required. RESULTS: A greater proportion of patients receiving the omeprazole clinical management strategy had achieved the stringent health target of complete symptom relief (61 vs. 40%, P < 0.0001) at 16 weeks. Forty-six per cent of omeprazole-treated patients were symptom free after the first 10 mg step compared to only 17% in the antacid-alginate treated group (P = 0.0001). Total relief of heartburn, the most common symptom at entry, was achieved by more patients in the omeprazole treatment group than the antacid-alginate/ranitidine treatment group, 62 vs. 36%, respectively, at 4 weeks, and 81 vs. 60% at 16 weeks (P = 0.0001). CONCLUSION: Treatment with the omeprazole clinical management strategy was superior to the antacid-alginate/ranitidine management strategy in providing relief of acid-related dyspepsia symptoms after 16 weeks. In addition, the omeprazole treatment strategy involved fewer GP consultations and thus minimized the use of other healthcare resources.

Abdominal Pain↗

Interventions in chronic pain management. 4. Medications in pain management.

UNLABELLED: This self-directed learning module, which highlights pharmacologic approaches in the management of chronic pain, focuses on both traditional and nontraditional medications. It is part of the study guide on interventions in chronic pain management in the Self-Directed Physiatric Education Program for practitioners and trainees in physical medicine and rehabilitation. This article highlights medication concepts, including the cyclooxygenase-2 inhibitors, opiate management of chronic pain, and neuropathic pain management; and it reviews some nontraditional approaches such as homeopathy and herbal remedies. OVERALL ARTICLE OBJECTIVE: To summarize pharmacologic approaches available for the management of chronic pain syndromes.

Analgesics, Opioid↗

Optimizing the efficacy and safety of oral anticoagulant therapy: high-quality dose management, anticoagulation clinics, and patient self-management.

Despite its widespread use, oral anticoagulation therapy suffers from a number of problems that lead to underuse and inadequate treatment. Problems include its narrow therapeutic index, the influence of many concomitant conditions or comorbidities, and the need for high-quality dose management. Poor management of oral anticoagulation is a prime factor influencing the occurrence of adverse events. As a result of these problems, special programs or anticoagulation management services (AMSs) have developed to manage oral anticoagulation. Such programs have demonstrated a significant improvement in outcomes compared with traditional or usual care (UC) by individual physicians. With the introduction of point-of-care prothrombin time monitors, the potential for patient self-testing and self-management has developed. Studies show the possibility of even further improvement in outcomes compared with UC, although the differences from those achieved with an AMS are less impressive.

Administration, Oral↗

Management competencies: intrinsic or acquired? What competencies are required to move into speech pathology management and beyond?

Speech pathology managers frequently move into careers beyond their clinical discipline. As practicing speech pathology managers and students of business leadership, we were curious about the nature of career transitions out of speech pathology management. We conducted an exploratory descriptive study investigating the perceived competencies that facilitate such career transitions and when further education is required to effectively equip one for such transition. The perceived skills related to a speech pathology background are identified along with the gaps in competence for moving into general management positions. Career management practices that facilitate this type of career transition are provided as recommendations for career planning.

Administrative Personnel↗

The impact of initiatives in education, self-management training, and computer-assisted self-care on outcomes in diabetes disease management.

The purpose of this work is to elucidate the advantages and disadvantages arising from three distinct diabetes disease management initiatives in a managed care setting. The initiatives included (1) education alone, (2) education with self-management training, and (3) education with computer-assisted self-care. Outcomes of interest were changes in glycated hemoglobin (HbA1c), body weight, and costs of care in each cohort of care recipients. A total of 978 health plan members with diabetes within a mixed model HMO were included in the initiatives for improving blood glucose control. HbA1c was measured at baseline and at 3 and 12 months, body weight at baseline and 12 months, and costs of care over 1 year. Costs were derived from suppliers and the health plan. The design is a longitudinal observation study. With the edu-cation-alone initiative, costs, HbA1c, and body weight were unchanged. When education is supplemented with ongoing self-management training, HbA1c fell 1.1% (p < 0.01), body weight rose by 11 kg (p < 0.01), and costs for care increased by $18 per member per month. When education is supplemented with ongoing computer-assisted self-care, HbA1c also dropped by 1.1% (p < 0.01), body weight was unchanged (p > 0.4), and costs for care were $1.31 per member per month. All initiatives improved glycated hemoglobin. Other outcomes must therefore be considered. Among the initiatives, this study elucidated significant differences in body weight and costs. Therefore, in choosing a diabetes disease management program, it would appear that costs should be the primary consideration and methodologies that control body weight should be a priority.

Body Weight↗

Complications following management of displaced intra-articular calcaneal fractures: a prospective randomized trial comparing open reduction internal fixation with nonoperative management.

OBJECTIVE: To report on all complications experienced by patients with displaced intra-articular calcaneal fractures (DIACFs) following nonoperative management or open reduction internal fixation (ORIF). DESIGN: Prospective, randomized, multicenter study. SETTING: Four level I trauma centers. PATIENTS: The patient population consisted of consecutive patients, age 17 to 65 at the time of injury, presenting to 1 of the centers with DIACFs between April 1991 and December 1998. INTERVENTIONS: Patients were randomized to the nonoperative treatment group or to operative reduction using a lateral approach to the calcaneus. MAIN OUTCOME MEASUREMENTS: Follow-up for patients was at 2 weeks, 6 weeks, 3 months, 12 months, 24 months, and once greater than 24 months following injury. At each follow-up interval, patients were assessed for the development of major and minor complications. After a minimum of 2-year follow-up, patients were asked to fill out a validated visual analogue scale questionnaire (VAS) and a general health review (SF-36). RESULTS: There were 226 DIACFs (206 patients) in the ORIF group with 57 of 226 (25%) fractures (57 of 206 patients [28%]) having at least 1 major complication. Of 233 fractures (218 patients) nonoperatively managed, 42 (18%) (42 of 218 patients [19%]) developed at least 1 major complication (indirectly resulting in surgery). CONCLUSION: Complications occur regardless of the management strategy chosen for DIACFs and despite management by experienced surgeons. Complications are a cause of significant morbidity for patients. Outcome scores in this study tend to support ORIF for calcaneal fractures. However, ORIF patients are more likely to develop complications. Certain patient populations (WCB and Sanders type IV) developed a high incidence of complications regardless of the management strategy chosen.

Adolescent↗

Project management: a core competency for professional nurses and nurse managers.

Project management is a core competency for nurses and managers. In this article, the project life cycle and project planning and controlling tools are described. Managers can readily see that using project management can be done with minimal training and disruption to the organization. Clearly, the costs of adopting project management are small compared to the benefits in productivity, reduced work stress, and reduced interpersonal conflict.

Humans↗

Energy management: a reemerging concern for the department manager.

The cost of energy in the average health care institution, at one time rarely more than I percent of the total budget, has amounted to 3 percent to 5 percent or more of the budget since the mid-1970s. As society gradually adjusted to these higher energy costs, the urgency for energy conservation faded, and true energy management, briefly a high priority, fell by the wayside. It is now evident that higher energy costs are here to stay, and energy supplies are becoming more limited, in some areas alarmingly so, at the same time other financial concerns are making themselves felt. Therefore, energy management is resurfacing as an active management concern. Much of energy management at the department level is a matter of awareness and attitude, and an energy-conscious manager can influence the staff toward energy consciousness.

Attitude of Health Personnel↗

Clinical management as boundary management. A comparative analysis of Canadian and UK health-care institutions.

Focuses on the critical role played by professionals in the management of healthcare institutions in the UK and Canada. Using empirical data, examines the structural models of clinical management, the roles of clinical managers and their relationships with colleague professionals. Compares the approaches taken in the UK and Canada, and explores issues of context, history and relative power. Questions the extent to which professionals are losing autonomy to other professions and management. In particular examines whether the sharing of power inter-professionally may lead to greater, overall collective professional autonomy. Develops themes of the contextual influences on the process of change, and whether professionals are more effectively managed by internal or external processes of control.

Administrative Personnel↗

The conflict management style of staff nurses and nurse managers.

Conflict is recognized as being a common occurrence in both everyday personal and professional nursing life, and it is now generally agreed that conflict can be both problematic and potentially beneficial to both individuals and organizations. There is a large amount of anecdotal and narrative literature about the nature and sources of conflict which fails to reflect upon the complexities and theoretical perspectives that exist. There are also few research studies which examine the nature of nursing conflict and how conflict is managed by nurses in the workplace. This study presents a review of some aspects of conflict and its management and specifically investigates the conflict management style of staff nurses and nurse managers in the hospital setting. The results suggest that avoidance is the most commonly used conflict management strategy, with competition being the least favoured.

Adaptation, Psychological↗

A randomized controlled trial comparing midwife-managed care and obstetrician-managed care for women assessed to be at low risk in the initial intrapartum period.

OBJECTIVE: To compare the efficacy of midwife-managed care and obstetrician-managed care for women assessed to be at low risk in the initial intrapartum period. METHODS: 1,050 women assessed to be at low risk on admission to labour ward in the Prince of Wales Hospital participated in this study. By computer-generated random allocation, 563 (54%) women were assigned to Group A (experimental) under midwifery care, and 487 (46%) women to Group B (control) under obstetrician care. The outcomes and complications between the 2 groups were compared. Data were analyzed by 2 x 2 contingency tables and Chi-square. RESULTS: 150 (26.6%) women in the experimental group were taken over by the obstetricians. 46 (30.7%) women were transferred to obstetrician-management for the preference of epidural analgesia. The other reasons for taken over the remaining 104 (69.3%) women were fetal distress, poor progress of labour, complications in first or second stage of labour. The experimental group had less oxytocic augmentation (Chi-square = 7.49, p = 0.006) and the insertion of intravenous infusion (Chi-square = 5.34, p = 0.02). Both groups had similar outcomes on normal delivery, operative vaginal delivery, caesarean section and complications. CONCLUSIONS: Midwife-managed care is as safe as obstetrician-managed care for women who were assessed to be at low risk in the intrapartum period. Routine visit by obstetrician is not necessary and the midwives are able to detect complications in the course of labour and alert the obstetrician for taking the necessary action.

Cesarean Section↗

The diagnosis and management of renovascular disease: a primary care perspective. Part II. Issues in management.

Renovascular disease is a complex disorder, most commonly caused by fibromuscular dysplasia and atherosclerotic disease. It usually presents in one of three forms: asymptomatic renal artery stenosis, renovascular hypertension, or ischemic nephropathy. This complexity may make diagnostic and management decisions difficult for the primary care physician. In Part I of this review (presented in the May/June 2003 issue of The JCH), the authors discussed when to consider and how to go about making a diagnosis of renovascular disease. In Part II, the authors review the management of this complex condition. There is a debate concerning the optimal treatment of patients with renovascular disease. Management options include medical, surgical, or percutaneous approaches (angioplasty and stenting). Generally in patients with fibromuscular disease, the results of surgery and percutaneous approaches appear superior. In patients with atherosclerotic disease, the data are less consistent, and there does appear to be a group of patients who will respond well to medical management. A potential management algorithm is presented.

Humans↗

Current evidence for the management of ankylosing spondylitis: a systematic literature review for the ASAS/EULAR management recommendations in ankylosing spondylitis.

OBJECTIVE: To assess available management strategies in ankylosing spondylitis (AS) using a systematic approach, as a part of the development of evidence based recommendations for the management of AS. METHODS: A systematic search of Medline, Embase, CINAHL, PEDro, and the Cochrane Library was performed to identify relevant interventions for the management of AS. Evidence for each intervention was categorised by study type, and outcome data for efficacy, adverse effects, and cost effectiveness were abstracted. The effect size, rate ratio, number needed to treat, and incremental cost effectiveness ratio were calculated for each intervention where possible. Results from randomised controlled trials were pooled where appropriate. RESULTS: Both pharmacological and non-pharmacological interventions considered to be of interest to clinicians involved in the management of AS were identified. Good evidence (level Ib) exists supporting the use of non-steroidal anti-inflammatory drugs (NSAIDs) and coxibs for symptomatic treatment. Non-pharmacological treatments are also supported for maintaining function in AS. The use of conventional antirheumatoid arthritis drugs is not well supported by high level research evidence. Tumour necrosis factor inhibitors (infliximab and etanercept) have level Ib evidence supporting large treatment effects for spinal pain and function in AS over at least 6 months. Level IV evidence supports surgical interventions in specific patients. CONCLUSION: This extensive literature review forms the evidence base considered in the development of the new ASAS/EULAR recommendations for the management of AS.

Anti-Inflammatory Agents, Non-Steroidal↗

The compatibility of general managers' activities and intentions in managing change in the NHS.

As Hales (1986) has observed, the problem of much of the managerial research to date has been the reluctance to ask why managers behave in the way they do. The behaviour of general managers in tackling organisational change in the NHS needs to be viewed not only with respect to what is done but also with respect to how personal and organisational objectives are construed. In other words, the implementation of organisational change ultimately rests on how general managers perceive the nature of this change and their role in structuring their own personal and organisational objectives into appropriate activities. Examining the compatibility of managerial activities and the underlying values and intentions which support them is of critical importance in any cognitively-based approach. These intentions provide an important link between perceptions (i.e. how the organisation is construed) and behaviour (i.e. what activities managers choose to perform). Understanding the conceptual frameworks which underpin managerial activities could have profound implications for assessing the performance of general managers.

Administrative Personnel↗

Managers, myths and misses: target efficiency and health care management education in Australia.

The Australian penchant for monitoring overseas developments in general and health matters is noted. The face validity of the findings of the International Project on Culture and Management (IPCM) is assessed positively and certain structural commonalities of the health systems of the USA and Australia are identified, without attributing causality in the development of managers' attributes. Linkages between Australia, Malaysia and Hong Kong are also explored briefly. In addition, key attributes of the sample of Australian managers are discussed together with the limitations related to emerging forms of provision and organization in health services and to their distribution in the study sample. The IPCM findings may be used in course design but are unlikely to cause any major change, although one may debate on the values of applicants towards health service management education courses. The findings may help to stimulate the establishment of performance measures for management education in Australia.

Administrative Personnel↗

Interdisciplinary approach to the management of intestinal transplant recipients: evaluation, discharge, and lifetime management.

Patients suffering from intestinal failure present unique and difficult challenges to the transplant team. Augmenting the need for interdisciplinary teamwork is the higher incidence of death on the intestinal transplant waiting list. Successful management of this population requires an interdisciplinary approach at each stage of care, beginning with evaluation and continuing through discharge and lifetime management. A close relationship between patients, their caregivers, and all members of the transplant team is an essential component to successful lifetime management. Open communication between team members and unlimited accessibility to each other enables work flow to be managed efficiently, and enables the provision of optimal care. In this article, we describe the functions of the nonphysician clinical personnel needed to manage the intestinal transplant patient--beginning at the evaluation through lifetime follow-up care. The goal of each professional is the same: to restore the patient to the best quality of life possible.

Humans↗

Cost-effectiveness of intensive v. standard case management for severe psychotic illness. UK700 case management trial. UK700 Group.

BACKGROUND: Intensive case management is commonly advocated for the care of the severely mentally ill, but evidence of its cost-effectiveness is lacking. AIMS: To investigate the cost-effectiveness of intensive compared with standard case management for patients with severe psychosis. METHOD: 708 patients with psychosis and a history of repeated hospital admissions were randomly allocated to standard (case-loads 30-35) or intensive (case-loads 10-15) case management. Clinical and resource use data were assessed over two years. RESULTS: No statistically significant difference was found between intensive and standard case management in the total two-year costs of care per patient (means 24,550 Pounds and 22,700 Pounds, respectively, difference 1850 Pounds, 95% CI--1600 Pounds to 5300 Pounds). There was no evidence of differential effects in African-Caribbean patients or in the most disabled. Psychiatric in-patient hospital stay accounted for 47% of the total costs, but neither such hospitalisation nor other clinical outcomes differed between the randomised groups. CONCLUSION: Reduced case-loads have no clear beneficial effect on costs, clinical outcome or cost-effectiveness. The policy of advocating intensive case management for patients with severe psychosis is not supported by these results.

Adolescent↗