Neil C Campbell

Designing and evaluating complex interventions to improve health care

Determining the effectiveness of complex interventions can be difficult and time consuming. Neil C Campbell and colleagues explain the importance of ground work in getting usable results

Secondary prevention clinics for coronary heart disease: four year follow up of a randomised controlled trial in primary care

Abstract Objectives: To evaluate the effects of nurse led clinics in primary care on secondary prevention, total mortality, and coronary event rates after four years. Design: Follow up of a randomised controlled trial by postal questionnaires and review of case notes and national datasets. Setting: Stratified, random sample of 19 general practices in north east Scotland. Participants: 1343 patients (673 intervention and 670 control) under 80 years with a working diagnosis of coronary heart disease but without terminal illness or dementia and not housebound. Intervention: Nurse led secondary prevention clinics promoted medical and lifestyle components of secondary prevention and offered regular follow up for one year. Main outcome measures: Components of secondary prevention (aspirin, blood pressure management, lipid management, healthy diet, exercise, non-smoking), total mortality, and coronary events (non-fatal myocardial infarctions and coronary deaths). Results: Mean follow up was at 4.7 years. Significant improvements were shown in the intervention group in all components of secondary prevention except smoking at one year, and these were sustained after four years except for exercise. The control group, most of whom attended clinics after the initial year, caught up before final follow up, and differences between groups were no longer significant. At 4.7 years, 100 patients in the intervention group and 128 in the control group had died: cumulative death rates were 14.5% and 18.9%, respectively (P=0.038). 100 coronary events occurred in the intervention group and 125 in the control group: cumulative event rates were 14.2% and 18.2%, respectively (P=0.052). Adjusting for age, sex, general practice, and baseline secondary prevention, proportional hazard ratios were 0.75 for all deaths (95% confidence intervals 0.58 to 0.98; P=0.036) and 0.76 for coronary events (0.58 to 1.00; P=0.049) Conclusions: Nurse led secondary prevention improved medical and lifestyle components of secondary prevention and this seemed to lead to significantly fewer total deaths and probably fewer coronary events. Secondary prevention clinics should be started sooner rather than later. What is already known on this topic Several effective interventions exist for the secondary prevention of coronary heart disease, but implementing them in practice has proved difficult Secondary prevention programmes for coronary heart disease have improved short term outcomes such as processes of care and quality of life What this study adds Short term improvements in uptake of secondary prevention produced by nurse led clinics are maintained in the longer term Improved medical and lifestyle components of secondary prevention produced by nurse led clinics seem to lead to fewer total deaths and coronary events

Secondary prevention in coronary heart disease: a randomised trial of nurse led clinics in primary care

Objective To evaluate whether nurse run clinics in general practice improve secondary prevention in patients with coronary heart disease. Design Randomised controlled trial. Setting A random sample of 19 general practices in northeast Scotland. Patients 1173 patients (685 men and 488 women) under 80 years with working diagnoses of coronary heart disease, but without terminal illness or dementia and not housebound. Intervention Nurse run clinics promoted medical and lifestyle aspects of secondary prevention and offered regular follow up. Main outcome measures Components of secondary prevention assessed at baseline and one year were: aspirin use; blood pressure management; lipid management; physical activity; dietary fat; and smoking status. A cumulative score was generated by counting the number of appropriate components of secondary prevention for each patient. Results There were significant improvements in aspirin management (odds ratio 3.22, 95% confidence interval 2.15 to 4.80), blood pressure management (5.32, 3.01 to 9.41), lipid management (3.19, 2.39 to 4.26), physical activity (1.67, 1.23 to 2.26) and diet (1.47, 1.10 to 1.96). There was no effect on smoking cessation (0.78, 0.47 to 1.28). Of six possible components of secondary prevention, the baseline mean was 3.27. The adjusted mean improvement attributable to intervention was 0.55 of a component (0.44 to 0.67). Improvement was found regardless of practice baseline performance. Conclusions Nurse run clinics proved practical to implement in general practice and effectively increased secondary prevention in coronary heart disease. Most patients gained at least one effective component of secondary prevention and, for them, future cardiovascular events and mortality could be reduced by up to a third.

Secondary prevention in coronary heart disease: baseline survey of provision in general practice

Abstract Objective: To determine secondary preventive treatment and habits among patients with coronary heart disease in general practice. Design: Process of care data on a random sample of patients were collected from medical records. Health and lifestyle data were collected by postal questionnaire (response rate 71%). Setting: Stratified, random sample of general practices in Grampian. Subjects: 1921 patients aged under 80 years with coronary heart disease identified from pre-existing registers of coronary heart disease and nitrate prescriptions. Main outcome measures: Treatment with aspirin, β blockers, and angiotensin converting enzyme inhibitors. Management of lipid concentrations and hypertension according to local guidelines. Dietary habits (dietary instrument for nutritional evaluation score), physical activity (health practice indices), smoking, and body mass index. Results: 825/1319 (63%) patients took aspirin. Of 414 patients with recent myocardial infarction, 131 (32%) took β blockers, and of 257 with heart failure, 102 (40%) took angiotensin converting enzyme inhibitors. Blood pressure was managed according to current guidelines for 1566 (82%) patients but lipid concentrations for only 133 (17%). 673 of 1327 patients (51%) took little or no exercise, 245 of 1333 (18%) were current smokers, 808 of 1264 (64%) were overweight, and 627 of 1213 (52%) ate more fat than recommended. Conclusion: In terms of secondary prevention, half of patients had at least two aspects of their medical management that were suboptimal and nearly two thirds had at least two aspects of their health behaviour that would benefit from change. There seems to be considerable potential to increase secondary prevention of coronary heart disease in general practice. Key messages Patients with coronary heart disease can benefit from both medical and lifestyle secondary prevention measures This study found that half of patients with coronary heart disease in general practice had at least two missed opportunities for effective medical interventions Nearly two thirds of patients with coronary heart disease in general practice had two or more high risk lifestyle factors that would benefit from change There seems to be plenty of opportunity for improving secondary prevention of coronary heart disease in general practice

Rural and urban differences in stage at diagnosis of colorectal and lung cancers

There is evidence that patients living in outlying areas have poorer survival from cancer. This study set out to investigate whether they have more advanced disease at diagnosis. Case notes of 1323 patients in north and northeast Scotland who were diagnosed with lung or colorectal cancer in 1995 or 1996 were reviewed. Of patients with lung cancer, 42% (69/164) living 58 km or more from a cancer centre had disseminated disease at diagnosis compared to 33% (71/215) living within 5 km. For colorectal cancer the respective figures were 24% (38/161) and 16% (31/193). For both cancers combined, the adjusted odds ratio for disseminated disease at diagnosis in furthest group compared to the closest group was 1.59 (P = 0.037). Of 198 patients with non-small-cell lung cancer in the closest group, 56 (28%) had limited disease (stage I or II) at diagnosis compared to 23 of 165 (14%) of the furthest group (P = 0.002). The respective figures for Dukes A and B colorectal cancer were 101 of 196 (52%) and 67 of 172 (39%) (P = 0.025). These findings suggest that patients who live remote from cities and the associated cancer centres have poorer chances of survival from lung or colorectal cancer because of more advanced disease at diagnosis. This needs to be taken into account when planning investigation and treatment services.

Rural factors and survival from cancer: analysis of Scottish cancer registrations.

In this survival study 63 976 patients diagnosed with one of six common cancers in Scotland were followed up. Increasing distance from a cancer centre was associated with less chance of diagnosis before death for stomach, breast and colorectal cancers and poorer survival after diagnosis for prostate and lung cancers.

Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy

Successful advances in the treatment of advanced malignant diseases rely on recruitment of patients into clinical trials of novel agents. However, there is a genuine concern for the welfare of individual patients. The aim of this study was to examine motives of patients entering early clinical trials of novel cancer therapies. Questionnaire survey with both open- and close-ended questions. The patients were surveyed after they had given informed consent and before or during the first cycle of treatment. In all, 38 phase I/II trial patients participated and completed the survey. Obtaining possible health benefit was listed by 89% as being a ‘very important’ factor in their decision to participate, with only 17% giving reasons of helping future cancer patients and treatment. Other items cited as a ‘very important’ motivating factor were ‘trust in the doctor’ (66%), ‘being treated by the latest treatment available’ (66%), ‘better standard of care and closer follow-up’ (61%), and ‘closer monitoring of patients in trials’ (58%). Only 47% patients indicated that someone had explained to them about any ‘reasonable’ alternatives to the trial. In total, 71% strongly agreed that ‘surviving for as long time as possible was the most important thing (for them)’. Nearly all (97%) indicated that they knew the purpose of the trial and had enough time to consider participation in the trial (100%). In this survey, most patients entering phase I and II clinical trials felt they understood the purpose of the research and had given truly informed consent. Despite this, most patients participated in the hope of therapeutic benefit, although this is known to be a rare outcome in this patient subset. Trialists should be aware, and take account of the expectations that participants place in trial drugs.

Systematic review of factors influencing patient and practitioner delay in diagnosis of upper gastrointestinal cancer

As knowledge on the causation of cancers advances and new treatments are developed, early recognition and accurate diagnosis becomes increasingly important. This review focused on identifying factors influencing patient and primary care practitioner delay for upper gastrointestinal cancer. A systematic methodology was applied, including extensive searches of the literature published from 1970 to 2003, systematic data extraction, quality assessment and narrative data synthesis. Included studies were those evaluating factors associated with the time interval between a patient first noticing a cancer symptom and presenting to primary care, between a patient first presenting to primary care and being referred to secondary care, or describing an intervention designed to reduce those intervals. Twenty-five studies were included in the review. Studies reporting delay intervals demonstrated that the patient phase of delay was greater than the practitioner phase, whilst patient-related research suggests that recognition of symptom seriousness is more important than recognition of the presence of the symptom. The main factors related to practitioner delay were misdiagnosis, application and interpretation of tests, and the confounding effect of existing disease. Greater understanding of patient factors is required, along with evaluation of interventions to ensure appropriate diagnosis, examination and investigation.

Impact of deprivation and rural residence on treatment of colorectal and lung cancer.

For common cancers, survival is poorer for deprived and outlying, rural patients. This study investigated whether there were differences in treatment of colorectal and lung cancer in these groups. Case notes of 1314 patients in north and northeast Scotland who were diagnosed with lung or colorectal cancer in 1995 or 1996 were reviewed. On univariate analysis, the proportions of patients receiving surgery, chemotherapy and radiotherapy appeared similar in all socio-economic and rural categories. Adjusting for disease stage, age and other factors, there was less chemotherapy among deprived patients with lung cancer (odds ratio 0.39; 95% confidence intervals 0.16 to 0.96) and less radiotherapy among outlying patients with colorectal cancer (0.39; 0.19 to 0.82). The time between first referral and treatment also appeared similar in all socio-economic and rural groups. Adjusting for disease stage and other variables, times to lung cancer treatment remained similar, but colorectal cancer treatment was quicker for outlying patients (adjusted hazard ratio 1.30; 95% confidence intervals 1.03 to 1.64). These findings suggest that socio-economic status and rurality may have a minor impact on modalities of treatment for colorectal and lung cancer, but do not lead to delays between referral and treatment.

Factors influencing time from presentation to treatment of colorectal and breast cancer in urban and rural areas

Stage at diagnosis and survival from cancer vary according to where people live, suggesting some may have delays in diagnosis. The aim of this study was to determine if time from presentation to treatment was longer for colorectal and breast cancer patients living further from cancer centres, and identify other important factors in delay. Data were collected on 1097 patients with breast and 1223 with colorectal cancer in north and northeast Scotland. Women with breast cancer who lived further from cancer centres were treated more quickly than those living closer to cancer centres (P=0.011). Multilevel modelling found that this was largely due to them receiving earlier treatment at hospitals other than cancer centres. Breast lump, change in skin contour, lymphadenopathy, more symptoms and signs, and increasing age predicted faster treatment. Screen detected cancers and private referrals were treated more quickly. For colorectal cancer, time to treatment was similar for people in rural and urban areas. Quicker treatment was associated with palpable rectal or abdominal masses, tenesmus, abdominal pain, frequent GP consultations, age between 50 and 74 years, tumours of the transverse colon, and iron medication at presentation. Delay was associated with past anxiety or depression. There was variation between general practices and treatment appeared quicker at practices with more female general practitioners.