Evaluation of a training programme for Pharmacist Independent Prescribers in a care home medicine management intervention.

BACKGROUND: The provision of independent prescribing rights for United Kingdom (UK) pharmacists has enabled them to prescribe within their area of competence. The aim of this study was to evaluate an evidence-based training programme designed to prepare Pharmacist Independent Prescribers (PIPs) to safely and effectively assume responsibility for pharmaceutical care of older people in care homes in the UK, within a randomised controlled trial. METHODS: The training and competency assessment process included two training days, professional development planning against a bespoke competency framework, mentor support, and a viva with an independent General Practitioner (GP). Data on the PIPs' perceptions of the training were collected through evaluation forms immediately after the training days and through online questionnaires and interviews after delivery of the 6-month intervention. Using a mixed method approach each data set was analysed separately then triangulated providing a detailed evaluation of the process. Kaufman's Model of Learning Evaluation guided interpretations. RESULTS: All 25 PIPs who received the training completed an evaluation form (N = 25). Post-intervention questionnaires were completed by 16 PIPs and 14 PIPs took part in interviews. PIPs reported the training days and mentorship enabled them to develop a personalised portfolio of competence in preparation for discussion during a viva with an independent GP. Contact with the mentor reduced as PIPs gained confidence in their role. PIPs applied their new learning throughout the delivery of the intervention leading to perceived improvements in residents' quality of life and medicines management. A few PIPs reported that developing a portfolio of competence was time intensive, and that further training on leadership skills would have been beneficial. CONCLUSIONS: The bespoke training programme was fit for purpose. Mentorship and competency assessment were resource intensive but appropriate. An additional benefit was that many PIPs reported professional growth beyond the requirement of the study. TRIAL REGISTRATION: The definitive RCT was registered with the ISRCTN registry (registration number ISRCTN 17,847,169 ).

A cohort study of influences, health outcomes and costs of patients' health-seeking behaviour for minor ailments from primary and emergency care settings.

OBJECTIVES: To compare health-related and cost-related outcomes of consultations for symptoms suggestive of minor ailments in emergency departments (EDs), general practices and community pharmacies. DESIGN: Observational study; prospective cohort design. SETTING: EDs (n=2), general practices (n=6) and community pharmacies (n=10) in a mix of rural/urban and deprived/affluent areas across North East Scotland and East Anglia. Participants Adults (≥18 years) presenting between 09:00 and 18:00 (Monday-Friday) in general practices and 09:00-18:00 (Monday-Saturday) in pharmacies and EDs with ≥1 of the following: musculoskeletal pain; eye discomfort; gastrointestinal disturbance; or upper respiratory tract-related symptoms. INTERVENTIONS: Participants completed three questionnaires: baseline (prior to index consultation); satisfaction with index consultation and follow-up (2 weeks after index consultation). MAIN OUTCOME MEASURES: Symptom resolution, quality of life, costs, satisfaction and influences on care-seeking behaviour. RESULTS: 377 patients participated, recruited from EDs (81), general practices (162) and community pharmacies (134). The 2-week response rate was 70% (264/377). Symptom resolution was similar across all three settings: ED (37.3%), general practice (35.7%) and pharmacy (44.3%). Mean overall costs per consultation were significantly lower for pharmacy (£29.30 (95% CI £21.60 to £37.00)) compared with general practice (£82.34 (95% CI £63.10 to £101.58)) and ED (£147.09 (95% CI £125.32 to £168.85)). Satisfaction varied across settings and by measure used. Compared with pharmacy and general practice use, ED use was significantly (p<0.001) associated with first episode and short duration of symptom(s), as well as higher levels of perceived seriousness and urgency for seeking care. Convenience of location was the most common reason for choice of consultation setting. CONCLUSIONS: These results suggest similar health-related outcomes and substantially lower costs with pharmacy consultations for minor ailments. Effective strategies are now needed to shift demand for minor ailment management away from EDs and general practices to the community pharmacy setting.

A randomised controlled equivalence trial to determine the effectiveness and cost-utility of manual chest physiotherapy techniques in the management of exacerbations of chronic obstructive pulmonary disease (MATREX).

OBJECTIVES: To estimate the effect, if any, of manual chest physiotherapy (MCP) administered to patients hospitalised with chronic obstructive pulmonary disease (COPD) exacerbation on both disease-specific and generic health-related quality of life. To compare the health service costs for those receiving and not receiving MCP. DESIGN: A pragmatic, randomised controlled trial powered for equivalence. It was not possible to blind participants, clinicians or research staff to study arm allocation during the intervention. SETTING: Four UK hospitals in Norwich, Great Yarmouth, King's Lynn and Liverpool. PARTICIPANTS: 526 participants aged 34-91 years were recruited between November 2005 and April 2008; of these, 372 provided evaluable data for the primary outcome. All persons hospitalised with COPD exacerbation and evidence of sputum production on examination were eligible for the trial providing there were no contraindications to performing MCP. INTERVENTIONS: Participants were allocated to either MCP or no MCP on an intention-to-treat (ITT) basis. However, active cycle of breathing techniques (ACBT) was used in both arms. Participants allocated to the intervention were guided to perform ACBT while the physiotherapist delivered MCP. Participants allocated to the control arm received instruction on ACBT only. MAIN OUTCOME MEASURES: The primary outcome was COPD-specific quality of life, measured using the St George's Respiratory Questionnaire (SGRQ) at 6 months post randomisation. The European Quality of Life-5 Dimensions (EQ-5D) questionnaire was used to calculate the quality-adjusted life-year (QALY) gain associated with MCP compared with no MCP. Secondary physiological outcome measures were also used. RESULTS: Of the 526 participants, 261 were allocated to MCP and 264 to control, with 186 participants evaluable in each arm. ITT analyses indicated no significant difference at 6 months post randomisation in total SGRQ score [adjusted effect size (no MCP - MCP) 0.03 (95% confidence interval, CI -0.14 to 0.19)], SGRQ symptom score [adjusted effect size 0.04 (95% CI -0.15 to 0.23)], SGRQ activity score [adjusted effect size -0.02 (95% CI -0.20 to 0.16)] or SGRQ impact score [adjusted effect size 0.02 (95% CI -0.15 to 0.18)]. The imputed ITT and per-protocol results were similar. No significant differences were observed in any of the outcome measures or subgroup analyses. Compared with no MCP, employing MCP was associated with a slight loss in quality of life (0.001 QALY loss) but lower health service costs (cost saving of 410.79 pounds). Based on these estimates, at a cost-effectiveness threshold of lambda = 20,000 pounds per QALY, MCP would constitute a cost-effective use of resources (net benefit = 376.14 pounds). There was, however, a high level of uncertainty associated with these results and it is possible that the lower health service costs could have been due to other factors. CONCLUSIONS: In terms of longer-term quality of life the use of MCP did not appear to affect outcome. However, this does not mean that MCP is of no therapeutic value to patients with COPD in specific circumstances. Although the cost-effectiveness analysis suggested that its use was cost-effective, much uncertainty was associated with this finding and it would be difficult to justify providing MCP therapy on the basis of cost-effectiveness alone. Future research should include evaluation of MCP for patients with COPD producing high volumes of sputum, and an evaluation of the effectiveness of ACBT in COPD exacerbation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN13825248.

Use of 2-[18F]fluoro-2-deoxyglucose as a potential agent in the prediction of graft rejection by positron emission tomography.

BACKGROUND: We investigated the potential of predicting allograft rejection by measuring the ability of graft-infiltrating cells to take up 2-[18F]fluoro-2-deoxyglucose ([18F]FDG). This molecule is a positron emitting glucose analogue that is taken up by metabolically active cells and can be detected using positron emission tomography. METHODS: Uptake of [18F]FDG during an alloresponse was measured both in vitro in mixed lymphocyte cultures and in vivo using allogeneic and syngeneic skin grafts. RESULTS: Uptake of [18F]FDG was seen in a mixed lymphocyte reaction. Using a mouse skin graft model, we found that mean [18F]FDG uptake was 1.5-2 times higher in allografts than in syngeneic grafts; the increase in uptake correlated with the level of T-cell infiltrate seen histologically. CONCLUSION: Assessing the metabolic activity of graft-infiltrating cells with [18F]FDG may be useful in the prediction of graft rejection episodes.

People and organizational aspects of medical informatics.

Positive outcomes come to health care organizations that are doing the right things well, that is, their organizational strategies are aligned with their environments and they are executing those strategies well. Likewise, the informatics strategies must also be aligned with the organization's strategies. Without this congruence, informatics does not have the potential to have a substantial positive impact on the overall organizational outcomes. The execution of the informatics strategies must also be exemplary; however, the change processes required for achieving the desired informatics and organizational outcome goals are demanding and complicated. Implementing them in extremely complex organizations that operate on a 7-day by 24 hour basis is not easy. However, we are constantly learning more about complex change processes and the ways we can better manage them to improve our needed informatics outcomes. The challenge is to build upon the existing research base to more us even further ahead.

Antecedents of the people and organizational aspects of medical informatics: review of the literature.

People and organizational issues are critical in both implementing medical informatics systems and in dealing with the altered organizations that new systems often create. The people and organizational issues area--like medical informatics itself--is a blend of many disciplines. The academic disciplines of psychology, sociology, social psychology, social anthropology, organizational behavior and organizational development, management, and cognitive sciences are rich with research with significant potential to ease the introduction and on-going use of information technology in today's complex health systems. These academic areas contribute research data and core information for better understanding of such issues as the importance of and processes for creating future direction; managing a complex change process; effective strategies for involving individuals and groups in the informatics effort; and effectively managing the altered organization. This article reviews the behavioral and business referent disciplines that can potentially contribute to improved implementations and on-going management of change in the medical informatics arena.

Responsibility modelling: a new approach to the process of re-engineering the health-care organisation.

Technology changes our world. It is an accepted fact that the adoption and utilization of information technology by an organization will change the work patterns and power structures of that organization. Health-Care organizations realize that the process of re-alignment and re-engineering is a critical one, as it exposes consumers of health-care to the possible risk of death, or at least the loss of personal information. In this paper I will present the idea of modeling responsibilities as a vehicle for the re-engineering of the processes by which social values are mediated and health-care is delivered.

Natural cytokine antagonists and endogenous antiendotoxin core antibodies in sepsis syndrome. The Sepsis Intervention Group.

OBJECTIVE: To assess the value of measuring circulating concentrations of mediators (endotoxin, tumor necrosis factor-alpha [TNF-alpha], interleukin-1 beta [IL-1 beta], and interleukin-6[IL-6]) and their endogenous antagonists (antiendotoxin core antibody [EndoCAb], interleukin-1 receptor antagonist [IL-1ra], and soluble TNF receptors [sTNF-R]) in predicting mortality and organ failure in sepsis syndrome. DESIGN: Cohort study with a follow-up period of 30 days. SETTING: Intensive therapy units of five tertiary referral centers in Scotland. SUBJECTS: A total of 146 intensive therapy unit patients with sepsis syndrome underwent repeated sampling during a 10-day period following admission to an intensive therapy unit. MAIN OUTCOME MEASURES: Circulating concentrations of mediators and antagonists were compared in survivors and nonsurvivors. RESULTS: Median Acute Physiology and Chronic Health Evaluation II score was 23 (range, 8 to 40). Mortality at 30 days was 49%. On entry to the study, circulating endotoxin was detected in 66% of patients, TNF-alpha in 14%, and IL-1 beta in 29%. Levels did not predict mortality or organ failure. Patients with IL-6 concentrations in excess of 3000 pg/mL had an increased mortality rate (64% vs 40%, P = .02). The incidence of IgG EndoCAb depletion on entry to the study was 26% in nonsurvivors and 10% in survivors (P = .02). Initial concentrations of both type I and type II sTNF-R were significantly higher in nonsurvivors (P < .01). Initial circulating IL-1ra concentrations were not of value in predicting mortality. Cytokine antagonists were present in concentrations 30- to 100,000-fold greater than their corresponding cytokine. CONCLUSION: The observed high circulating levels of the cytokine antagonists IL-1ra and sTNF-R and the relatively small proportion of patients developing EndoCAb depletion may contribute to the limitations of therapies that aim to augment natural defenses against endotoxin or the proinflammatory cytokines.

Modeling and eliciting organizational and information system requirements.

Two things have influenced organizational development more than any other: the coffee machine and the computer. The reason for this is that they mediate social relationships. Computers are also being used more and more within every type of organization in an attempt to make the organization faster, more cost efficient, and more competitive. With the adoption of such technology we need to recognize that computers encapsulate social values and can consequently be seen as instruments of power. Within the area of safety critical systems, such as a medical information system, it is vital that, when specifying and capturing requirements about the system, the technical and social values are identified and made explicit. In this paper an outline of a modeling framework will be presented that allows for the encapsulation and analysis of the social and technical aspects of an organizational information system. A modeling language and notation will be constructed and used to construct and analyze both the static and dynamic models of organizations and organizational behavior. The construction and analysis is achieved through the use of concepts such as role and responsibility. The conceptual modeling framework is then applied to a case study. This case study is based upon an accident and emergency department of an inner-city hospital situated within the center of Dublin, Ireland.

Modelling and eliciting organisational and information system requirements for medical information systems.

In this paper an outline of a modelling technique will be presented that allows for the encapsulation and analysis of the social and technical aspects of an organisational information system. This notation is used to construct and analyse both the static and dynamic models of organisations and organisational behaviour. The construction and analysis is achieved through the use of concepts such as role and responsibility. The conceptual modelling framework is then applied to a case study. This case study is based upon an accident and emergency department of an inner city hospital situated within the centre of Dublin, Ireland.

Drug-induced hyperthermia.

Drugs with antidopaminergic properties and those capable of stimulating serotonin release can be responsible for hyperthermia syndromes such as neuroleptic malignant syndrome and serotonin syndrome. Dopamine and serotonin are important neurotransmitters in temperature regulation and it is likely that these reactions result from drug-induced changes in neurotransmitter levels. We describe three cases of drug-induced hyperthermia, discuss their aetiology and management, with both general measures and therapies designed to redress neurotransmitter imbalance.

Comparison of enflurane and halothane in hypotensive eye surgery.

Thirty patients undergoing elective eye surgery had anaesthesia induced with sodium thiopentone, suxamethonium and d-tubocurarine chloride. Patients were ventilated with nitrous oxide, oxygen and either halothane or enflurane. The volatile agents were used to decrease the systolic blood pressure to 80 mmHg. The volatile agent concentration in the blood was measured at 30 min intervals. Both agents were effective in producing hypotension, but enflurane was the more potent hypotensive agent in terms of MAC equivalents. There was no significant differences between the agents with respect to speed of recovery.

Audit of terminal care in a general practice.

OBJECTIVE: To determine satisfaction of relatives and general practitioners with care of patients during terminal illness and make recommendations on improving terminal care in general practice. DESIGN: Interviews with available relatives of patients who had had terminal illnesses and died in 1987, supplemented by questionnaires; questionnaire survey of general practitioners after review of case notes of all their patients who had died of terminal illnesses in 1987. SETTING: One urban general practice. SUBJECTS: 34 Relatives of patients with terminal illnesses who died in 1987; five general practitioners from one practice. RESULTS: In six cases relatives were dissatisfied, mainly because of lack of communication; in eight cases doctors were dissatisfied because of communication, poor symptom control, and inadequate care. IMPLICATIONS: There is a need for improved communication between relatives and the health professionals involved in terminal care as well as better advice on services and benefits available to both patients and relatives. Bereavement counselling should be better organised.

The morphine sparing effects of diclofenac sodium following abdominal surgery.

A randomised, double-blind placebo controlled study was undertaken to assess the analgesic efficacy of diclofenac. Following major abdominal surgery and 12 hours later, patients received either placebo or diclofenac 75 mg intramuscularly and their cumulative morphine requirements administered by a patient-controlled system over 24 hours were compared. Pain scores were also measured. Arterial blood gases and coagulation studies were assessed pre- and postoperatively. Morphine consumption was significantly greater in the placebo group (59.5 compared to 38.5 mg, p less than 0.01). Pain scores were significantly lower in the diclofenac group at 4 hours, but not thereafter. Arterial carbon dioxide was significantly increased in the control groups. There was no significant change in platelet count within each group, but a significant difference between the groups (p less than 0.05).

Serum magnesium levles in patients treated with phenytoin.

Phenytoin and magnesium levels were measured in eighty epileptics and seventy-one control subjects in an investigation into possible effects of phenytoin on serum magnesium levels. Phenytoin levels were measured using GLC and magnesium levels by atomic absorption spectrophotometry. The study showed no significant effect of phenytoin on serum mangesium concentration.