Health checks on patients 75 years and over in Nottinghamshire after the new GP contract.

OBJECTIVE--To investigate annual health checks for patients of 75 years and over required by the 1990 contract for general practitioners. DESIGN--Visits to practices to collect information on how assessments were organised and carried out; completion of questionnaires for every patient who had been assessed in a sample month, using information provided by the practice records. SETTING--20 general practices in one family health services authority. SUBJECTS--Patients of 75 years and over in 20 general practices. RESULTS--Three practices (15%) had not performed checks. Thirteen practices sent a letter to invite patients to undergo a check. Of these practices, seven followed up non-responders. Two practices visited patients'' homes unannounced, and two did checks on an opportunistic basis only. Sixteen practices used a checklist. Sixteen practices involved their practice nurses; at eight of these, doctors also performed checks; in six practices the nurses undertaking the checks had no training in assessing old people. Ten practices assessed more than 75% of their old people in the first year of the new contract. Practices that did not follow up patients who had not responded to the invitation for assessment completed significantly fewer checks. During the sample month, 331 patients were assessed in the 17 practices. 204 new problems were discovered in 143 patients. Significantly more problems per patient were found in inner city areas. CONCLUSIONS--The way health checks were performed varied greatly, both in their organisation and the practices'' attitudes. Many old people did not respond to letters asking if they wanted an assessment but very few refused one if followed up. Forty three per cent of those assessed had some unmet need. The number of new problems found per patient may reduce over the next few years if the assessments are successful. The need for annual assessment should be kept under review and adequate resources made available for the needs uncovered. Improved training for practice nurses in assessment is needed. Effectiveness of the checks must be monitored. If most unmet need falls in particular high risk groups it would seem sensible to modify the annual check to target these groups.     

Early and long-term outcome of elective stenting of the infarct-related artery in patients with viability in the infarct-area: Rationale and design of the Viability-guided Angioplasty after acute Myocardial Infarction-trial (The VIAMI-trial)

BACKGROUND: Although percutaneous coronary intervention (PCI) is becoming the standard therapy in ST-segment elevation myocardial infarction (STEMI), to date most patients, even in developed countries, are reperfused with intravenous thrombolysis or do not receive a reperfusion therapy at all. In the post-lysis period these patients are at high risk for recurrent ischemic events. Early identification of these patients is mandatory as this subgroup could possibly benefit from an angioplasty of the infarct-related artery.Since viability seems to be related to ischemic adverse events, we initiated a clinical trial to investigate the benefits of PCI with stenting of the infarct-related artery in patients with viability detected early after acute myocardial infarction. METHODS: The VIAMI-study is designed as a prospective, multicenter, randomized, controlled clinical trial. Patients who are hospitalized with an acute myocardial infarction and who did not have primary or rescue PCI, undergo viability testing by low-dose dobutamine echocardiography (LDDE) within 3 days of admission. Consequently, patients with demonstrated viability are randomized to an invasive or conservative strategy. In the invasive strategy patients undergo coronary angiography with the intention to perform PCI with stenting of the infarct-related coronary artery and concomitant use of abciximab. In the conservative group an ischemia-guided approach is adopted (standard optimal care).The primary end point is the composite of death from any cause, reinfarction and unstable angina during a follow-up period of three years. CONCLUSION: The primary objective of the VIAMI-trial is to demonstrate that angioplasty of the infarct-related coronary artery with stenting and concomitant use of abciximab results in a clinically important risk reduction of future cardiac events in patients with viability in the infarct-area, detected early after myocardial infarction.     

Alzheimer's disease multiple intervention trial (ADMIT): study protocol for a randomized controlled clinical trial

ABSTRACT: BACKGROUND: Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer's disease reduces patients' neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects' functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged [greater than or equal to]45 years who are diagnosed with possible or probable Alzheimer's disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study.Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer's disease compared to subjects treated in the control group. Outcomes The primary outcome is the Alzheimer's Disease Cooperative Studies Group Activities of Daily Living Scale; secondary outcome measures are two performance-based measures including the Short Physical Performance Battery and Short Portable Sarcopenia Measure. Outcome assessments for both the caregiver-reported scale and subjects' physical performance scales are completed in the subject's home. Randomization Eligible patient-care giver dyads will be stratified by clinic type and block randomized with a computer developed randomization scheme using a 1:1 allocation ratio. Blinding Single blinded. Research assistants completing the outcome assessments were blinded to the subjects' treatment group. Trial status Ongoing ClinicalTrial.Gov identifier NCT01314950; date of completed registration 10 March 2011; date first patient randomized 9 March 2011.     

AACE/ACE Disease State Clinical Review: Medical Management of Cushing Disease

ObjectiveTo review available medical therapies for patients with Cushing disease and to provide a roadmap for their use in clinical practice.MethodsPubMed searches were performed to identify all of the available published data on medical management of Cushing disease.ResultsMedical therapy is usually not the firstline treatment for patients with Cushing disease but may be used to improve clinical manifestations of Cushing disease in patients who are not suitable candidates for surgery, following unsuccessful surgery or recurrence, or as a “bridge therapy” in those who have undergone radiotherapy. Medical therapy may also be used in preoperative preparation of patients with severe disease. Current available medical options for patients with Cushing disease include centrally acting agents, steroidogenesis inhibitors, and a glucocorticoid receptor antagonists. At present, there are no head-to-head studies comparing the efficacy, tolerability, and safety of different U.S. Food and Drug Administration (FDA)- and non-FDA-approved drugs in patients with Cushing disease. With the initiation of new studies and the completion of ongoing clinical trials, the number of FDA-approved drugs for medical treatment of Cushing disease is expected to increase.ConclusionMedical therapy has an important adjunctive role in the management of patients with Cushing disease. The decision to initiate medical treatment depends on many factors, including patient characteristics and preference. Long-term studies are needed to better define the clinical efficacy, safety, and tolerability of medical treatment of Cushing disease, including the role of combination therapies. (Endocr Pract. 2014;20:746-757)     

Costs and cost effectiveness of health checks conducted by nurses in primary care: the Oxcheck study.

OBJECTIVE--To measure the costs and cost effectiveness of the Oxcheck cardiovascular risk factor screening and intervention programme. DESIGN--Cost effectiveness analysis of a randomised controlled trial using clinical and economic data taken from the trial. SETTING--Five general practices in Luton and Dunstable, England. SUBJECTS--2205 patients who attended a health check in 1989-90 and were scheduled for re-examination in 1992-3 (intervention group); 1916 patients who attended their initial health check in 1992-3 (control group). Participants were men and women aged 35-64 years. INTERVENTION--Health check conducted by nurse, with health education and follow up according to degree of risk. MAIN OUTCOME MEASURES--Cost of health check programme; cost per 1% reduction in coronary risk. RESULTS--Health check and follow up cost 29.27 pounds per patient. Estimated programme cost per 1% reduction in coronary risk per participant was between 1.46 pounds and 2.25 pounds; it was nearly twice as much for men as women. CONCLUSIONS--The cost to the practice of implementing Oxcheck-style health checks in an average sized practice of 7500 patients would be 47,000 pounds, a proportion of which could be paid for through staff pay reimbursements and Band Three health promotion target payments. This study highlights the considerable difficulties faced when calculating the costs and benefits of a health promotion programme. Economic evaluations should be integrated into the protocols of randomised controlled trials to enable judgments to be made on the relative cost effectiveness of different prevention strategies.     

Nurse practitioners in primary care III. The southern Ontario randomized trial

A group of nurses who formerly had performed office functions received a special university-based educational program designed to prepare them to assume much of primary care management as nurse practitioners. The associated family physicians would shift their role to general supervision and attention to difficult clinical problems. To test this new form of practice, two complementary randomized trials have been conducted in south-central Ontario. The particular trial reported here was intended to assess the influence of the educational program on the changing roles of the professional personnel. The nurses of 14 family medical practices, with the physicians'' support and commitment to participation, applied for the new training. Seven applicants were randomly selected to receive the training and their corresponding practices became the experimental group, while the remaining nurses and practices were retained as controls. During the subsequent year of investigation important changes occurred in professional roles of the experimental group. Nurse practitioners spent more time in clinical activities than conventional office nurses. The shift was not at the expense of time devoted to clinical work by physicians. Doctors delegated more professional activities to nurse practitioners than to conventional nurses. Except for remuneration (affected by legal constraints) job satisfaction among experimental physicians and nurses remained high after one year of experience with the new method.     

Cognitive behaviour therapy for the chronic fatigue syndrome: a randomized controlled trial.

OBJECTIVE--To evaluate the acceptability and efficacy of adding cognitive behaviour therapy to the medical care of patients presenting with the chronic fatigue syndrome. DESIGN--Randomised controlled trial with final assessment at 12 months. SETTING--An infectious diseases outpatient clinic. SUBJECTS--60 consecutively referred patients meeting consensus criteria for the chronic fatigue syndrome. INTERVENTIONS--Medical care comprised assessment, advice, and follow up in general practice. Patients who received cognitive behaviour therapy were offered 16 individual weekly sessions in addition to their medical care. MAIN OUTCOME MEASURES--The proportions of patients (a) who achieved normal daily functioning (Karnofsky score 80 or more) and (b) who achieved a clinically significant improvement in functioning (change in Karnofsky score 10 points or more) by 12 months after randomisation. RESULTS--Only two eligible patients refused to participate. All randomised patients completed treatment. An intention to treat analysis showed that 73% (22/30) of recipients of cognitive behaviour therapy achieved a satisfactory outcome as compared with 27% (8/30) of patients who were given only medical care (difference 47 percentage points; 95% confidence interval 24 to 69). Similar differences were observed in subsidiary outcome measures. The improvement in disability among patients given cognitive behaviour therapy continued after completion of therapy. Illness beliefs and coping behaviour previously associated with a poor outcome changed more with cognitive behaviour therapy than with medical care alone. CONCLUSION--Adding cognitive behaviour therapy to the medical care of patients with the chronic fatigue syndrome is acceptable to patients and leads to a sustained reduction in functional impairment.     

Current indications for prevention and therapy of steroid-induced osteoporosis in men and women

Steroid-induced osteoporosis is a textbook example of the secondary type of this medical condition. Glucocorticosteroids suppress bone formation by their direct and indirect effect on osteoblasts, osteoclasts and osteocytes, increasing their resorption and, eventually, leading to negative bone balance. A clinical problem arises regarding the fact that approximately 50% of patients on chronic steroid therapy undergo asymptomatic bone fractures. The treatment mode includes minimising the dose of administered steroids, encouraging an improved lifestyle and supplementation with adequate calcium and vitamin D(3) doses. Bisphosphonates are a group of medical agents used both to prevent and treat steroid-induced osteoporosis, although new therapies have also become available in recent years.     

Current indications for prevention and therapy of steroid-iduced osteoporosis in men and women

Steroid-induced osteoporosis is a textbook example of the secondary type of this medical condition. Glucocorticosteroids suppress bone formation by their direct and indirect effect on osteoblasts, osteoclasts and osteocytes, increasing their resorption and, eventually, leading to negative bone balance. A clinical problem arises regarding the fact that approximately 50% of patients on chronic steroid therapy undergo asymptomatic bone fractures. The treatment mode includes minimising the dose of administered steroids, encouraging an improved lifestyle and supplementation with adequate calcium and vitamin D3 doses. Bisphosphonates are a group of medical agents used both to prevent and treat steroid-induced osteoporosis, although new therapies have also become available in recent years.     

Practical perspectives of personalized healthcare in oncology

There is an increasing prevalence of drug-diagnostic combinations in oncology. This has placed diagnostic stakeholders directly into the complex benefit-risk, cost, value and uncertainty-driven development paradigm traditionally the preserve of the drug development community. In this review we focus on the delivery of the clinical data required to advance such drug-diagnostic combination development programmes and ultimately satisfy regulators and payors of the value of contemporaneous changes in diagnostic and treatment practice. Ideally all stakeholders would like to initially estimate, and ultimately specify, the comparative benefit-risk for a new treatment option with and without changing diagnostic practice. Hence, in an ideal world clinical trial design is focused on acquiring biomarker treatment interaction data. In this review we describe the key scientific and feasibility inputs required to design and deliver such trials and the drivers, advantages and disadvantages associated with departing from this model. We do not discuss the discovery of new biomarkers nor the analytical validation and marketing of diagnostic products. Following on from trial design we describe how subsequent success then depends upon the concepts that guide trial design being driven into the complex world of large, multinational clinical trial delivery. For every aspect of a traditional clinical drug trial such as supply, recruitment and adherence, there is a corresponding concept for the diagnostic element. In practice, this means that each patient's contribution to the decision making data-set is subject to double jeopardy (attrition on clinical outcome and biomarker status). Historically, this has led to significantly reduced power for detecting biomarker-treatment interactions, reduced decision making confidence and a waste of valuable human and financial resources. We describe recent practice changes and experience that have led to the successful delivery of such trials focusing on both pre- and on trial aspects. The former includes the pivotal role of tissue banks in accurate estimation of evaluability and prevalence for biomarker assays and the latter several practices designed to engage and incentivize key stakeholders particularly CRAs and pathologists. The result is that in the new world of developing personalized treatments for cancer patients the real-time acquisition and monitoring of biomarker data receives similar support to that traditionally reserved for clinical outcome data and far more patients contribute to the testing of personalized medicine hypotheses.     

Use of vitamin B12 injections among elderly patients by primary care practitioners in Ontario

BACKGROUND: Excess use of parenteral vitamin B12 has been reported from audits of clinical practices. The authors assessed the use of vitamin B12 injections in patients aged 65 years and over in Ontario. METHODS: A cross-sectional analysis was conducted that included all elderly people covered by the Ontario Health Insurance Plan who received insured services from general practitioners or family physicians (GP/FPs). For each practice the proportion of elderly patients who received regular vitamin B12 injections between July 1996 and June 1997 was calculated. The frequency of injections was determined for each patient receiving regular B12 replacement. RESULTS: Of the 1,196,748 elderly patients (mean age 74.8 [standard deviation 6.8], 58.0% female) treated by 14,177 GP/FPs, 23,651 (2.0%) received regular B12 injections. The rate of B12 injections per patient, standardized for age and sex, varied between practices (range 0%-48.6%). Although no authoritative sources support the practice, 3303 (19.8%) of the 16,707 patients receiving long-term parenteral therapy had, on average, overly frequent injections (more than 1 injection every 4 weeks). For 76 (12.3%) of the 617 practices with 10 or more patients receiving regular vitamin B12 injections, the mean injection frequency was greater than once every 4 weeks. The proportion of patients in these 617 practices who received overly frequent injections varied extensively (0%-100%). INTERPRETATION: Our findings indicate that some primary care physicians in Ontario administer unnecessary vitamin B12 injections to elderly patients.     

Predictive and therapeutic biomarkers in chimeric antigen receptor T-cell therapy: A clinical perspective

The adoptive transfer of genetically engineered T cells modified to express a chimeric antigen receptor (CAR) has shown remarkable activity and induces long-term remissions in patients with advanced hematologic malignancies. To date, little is known about predictive indicators of therapeutic efficacy or serious toxicity after CAR T-cell therapy in clinical practice. Biomarkers are not only potentially able to inform physicians and researchers of immunotherapy targets in particular but could also be used to monitor the effectiveness of treatments and to predict incidence of side effects in some circumstances. Identification of new biomarkers can therefore not only contribute to the development of new therapeutic and prognostic strategies for CAR T-cell therapy for cancer but also help to generate improved clinical practices for early recognition and minimization of adverse effects while preserving the antitumor activity of the CAR T cells. Herein, we will consider a variety of predictive and therapeutic biomarkers in CAR T-cell therapy and the state of current understanding of their clinical utility. The incorporation of biomarker studies in CAR T-cell clinical trials and practice will help to realize the potential clinical benefit of biomarker-guided therapy.     

Adherence to Antiretroviral Therapy in Jinja,Uganda: A Six-Year Follow-Up Study

Introduction

We report on the adherence experience of a group of people living with HIV on ART over six years in Uganda.

Methods

Between 2005 and 2009, we followed up 41 participants who were also part of a clinical trial comparing home and facility based delivery of ART in Jinja, eastern Uganda. We conducted qualitative in-depth interviews at enrolment, 3, 6, 18 and 30 months to capture experiences with adherence over time. In 2011 we returned to these participants to find out how they were fairing with long term adherence. We managed to retrace 24 participants and interviewed them about their experience. We thematically analysed the data and compared findings over time.

Results

Initially there were few barriers to adherence and many followed the adherence guidance closely. By year six, relaxation of these rules was noticeable although self-reported adherence continued to be high. Alcohol consumption was more common than before. Some relatives of the participants who had died claimed that some deaths were a result of alcohol. While participants reported that ART had allowed them to reclaim independence and return to work the changes in work and social routines created new challenges for adherence. Side effects like lipodystrophy were not only causing some stigma but for some tested their faith in the drugs. Many participants reported resumption of sexual lives but apart from those who selected same status partners, disclosure to new partners was minimal.

Conclusion

Good adherence practice to ART wanes over the long-term, and people who may have disclosed at initiation find it difficult to do so to new partners once they are healthy. Further adherence interventions and support with disclosure over the course of therapy may need to be considered. (Words: 283)     

Estimating incremental cost-effectiveness ratios and their confidence intervals with differentially censored data

With medical costs escalating over recent years, cost analysis is being conducted more and more to assess economic impact of new treatment options. An incremental cost-effectiveness ratio (ICER) is a measure that assesses the additional cost for a new treatment for each additional unit of effectiveness, such as saving 1 year of life. In this article, we consider cost-effectiveness analysis for new treatments evaluated in a randomized clinical trial setting with staggered entries. In particular, the censoring times are different for cost and survival data. We propose a method for estimating the ICER and obtaining its confidence interval when differential censoring exists. Simulation experiments are conducted to evaluate our proposed method. We also apply our methods to a clinical trial example comparing the cost-effectiveness of implanted defibrillators with conventional therapy for individuals with reduced left ventricular function after myocardial infarction.     

Influences on control in diabetes mellitus: patient,doctor, practice,or delivery of care?

OBJECTIVE--To assess patient, doctor, practice, and process of care variables for their effect on glycaemic control in diabetes mellitus, and to quantify their relative effects. DESIGN--Search of general practice medical records, patient questionnaires and examination, doctor questionnaire, videotaping and analysis of consultations, and practice questionnaire. SETTING--12 practices with 32 participating general practitioners in Nottinghamshire. SUBJECTS--318 patients randomly selected from those with diabetes in each practice, 10 for each participating doctor. MAIN OUTCOME MEASURE--Glycaemic control as measured by random glycated haemoglobin A1c estimation (random haemoglobin A1 measurement). RESULTS--Glycaemic control was significantly related to the disease process as measured by years since diagnosis, treatment group, and number of diabetes related clinical events. Females had significantly worse control than males. Other patient factors, such as age, social class, lifestyle, attitudes, satisfaction, and knowledge, had no association with glycaemic control. Of all the doctor factors examined, only doctors who professed a special interest in diabetes achieved significantly better glycaemic control. Bigger and better equipped practices and those with a diabetic miniclinic had patients with significantly better glycaemic control, as did those with access to dietetic advice. Patients attending hospital clinics had worse glycaemic control, but this seemed to be attributable to the case mix and practice characteristics. Shared care did not contribute to the multiple linear regression model. CONCLUSION--Glycaemic control among diabetic patients in the community is related to such factors as treatment group, sex, and years since diagnosis; it is also related to the organisation and process of care. The findings support concentrating diabetic care on partners with special interests in diabetes in well equipped practices with adequate dietetic support.     

Is cystic fibrosis genetic medicine's canary?

In 1989 the gene that causes cystic fibrosis (CF) was identified in a search accompanied by intense anticipation that the gene, once discovered, would lead rapidly to gene therapy. Many hoped that the disease would effectively disappear. Those affected were going to inhale vectors packed with functioning genes, which would go immediately to work in the lungs. It was a bewitching image, repeatedly invoked in both scientific and popular texts. Gene therapy clinical trials were carried out with a range of strategies and occasionally success seemed close, but by 1996 the idea that gene therapy for CF would quickly provide a cure was being abandoned by the communities engaged with treatment and research. While conventional wisdom holds that the death of Jesse Gelsinger in an unrelated gene therapy trial in 1999 produced new skepticism about gene therapy, the CF story suggests a different trajectory, and some different lessons. This article considers the rise and fall of gene therapy for CF and suggests that CF may provide a particularly compelling case study of a failed genomic technology, perhaps even of a medical "canary." The story of CF might be a kind of warning to us that genetic medicine may create as many problems as it solves, and that moving forward constructively with these techniques and practices requires many kinds of right information, not just about biology, but also about values, priorities, market forces, uncertainty, and consumer choice.     

INTER‐ETHICS: TOWARDS AN INTERACTIVE AND INTERDEPENDENT BIOETHICS

Since its origin bioethics has been a specialized, academic discipline, focussing on moral issues, using a vast set of globalized principles and rational techniques to evaluate and guide healthcare practices. With the emergence of a plural society, the loss of faith in experts and authorities and the decline of overarching grand narratives and shared moralities, a new approach to bioethics is needed. This approach implies a shift from an external critique of practices towards embedded ethics and interactive practice improvement, and from a legal defence of rights towards fostering interdependent practices of responsibility. This article describes these transitions within bioethics in relation to the broader societal and cultural dynamics within Western societies, and traces the implications for the methodologies and changing roles of the bioethicist. The bioethicist we foresee is not just a clever expert but also a relationally sensitive person who engages stakeholders in reciprocal dialogues about their practice of responsibility and helps to integrate various sorts of knowledge (embodied, experiential, visual, and cognitive‐scientific). In order to illustrate this new approach, we present a case study. It concerns a project focusing on an innovation in elderly care, based on the participation of various stakeholders, especially older people themselves.     

Acceptability of opportunistic screening for occult gastrointestinal blood loss.

OBJECTIVE--To test patient compliance for faecal occult blood testing in suburban and inner city general practice. DESIGN--Prospective opportunistic trial using the Haemoccult test kit. Tests were offered during routine surgery attendance. SETTING--Three group general practices in Birmingham. SUBJECTS--All patients aged 40 years or older on the start date who routinely attended surgery during two years. MAIN OUTCOME MEASURES--Numbers of patients approached for testing and the numbers refusing, accepting, and returning the test kits. RESULTS--Only 26.3% (1230/4677) of the potential target population had been screened within the two years, although 988 (39.3%) of the suburban practice target were screened. However, 55.7% (1230/2207) of patients actually offered a test returned completed kits, with only 6% (133) refusing the kit. 683 (61.6%) patients aged 50-69 returned kits, compared with 343 (54.3%) aged 70 or over and 204 (43.8%) aged 40-49. These differences were significant (p less than 0.001). Patients from the inner city practice were significantly less likely to be offered the test than those in suburban practice (242 (11.2%) v 988 (39.9%), p less than 0.001) and return the samples (242 (38.8%) v 988 (62.4%), p less than 0.001). Patients from the inner city practice were also more likely to refuse the test (78 (12.5%) v 55 (3.5%), p less than 0.001). CONCLUSIONS--Opportunistic testing for occult faecal blood in asymptomatic patients was reasonably acceptable to patients, especially those in a suburban practice. If the test is shown to reduce mortality from colorectal cancer then formal screening would probably achieve acceptable target rates, especially among patients aged 50-69, who represent the prime risk group.     

Can general practitioners use training in relaxation and management of stress to reduce mild hypertension?

To see whether general practitioners could effectively carry out training in relaxation and management of stress to reduce mild hypertension a study was carried out with a subsample of phase 2 of the Medical Research Council''s treatment of mild hypertension trial.¹ In the main mild hypertension trial patients had been receiving either an active drug or placebo for six years. In phase 2 a subsample of these patients were randomly allocated either to continue or to stop receiving the active drug or placebo. In a further subsample patients were again randomised to receive or not to receive relaxation therapy. This factorial design presented an additional opportunity to assess whether patients controlled with active drugs might have their blood pressure maintained by this behavioural therapy once drug treatment was stopped and to assess whether blood pressure might be further reduced by this therapy in patients who had been under regular medical supervision for as long as six years and who had already received non-pharmacological advice. The therapy was conducted by general practitioners in group sessions once a week for eight weeks. The training in relaxation was accompanied by galvanic skin resistance biofeedback. At one year follow up blood pressure in the relaxation subgroups was either maintained (in the group who had stopped receiving drugs) or reduced further (in the group who had continued receiving drugs and in both placebo groups), while in the control group it had increased in all the subgroups, but particularly in those who had stopped receiving drugs. Differences in changes in blood pressure between the relaxation and control groups were significant. There were five new cardiovascular events, including evidence of myocardial ischaemia in blindly coded electrocardiograms in the control group, compared with one in the treatment group.General practitioners, if motivated, can successfully apply this technique of training those with mild hypertension in relaxation and management of stress.