Alan A Montgomery

Epidemiology and impact of multimorbidity in primary care: a retrospective cohort study

BACKGROUND In developed countries, primary health care increasingly involves the care of patients with multiple chronic conditions, referred to as multimorbidity. AIM To describe the epidemiology of multimorbidity and relationships between multimorbidity and primary care consultation rates and continuity of care. DESIGN OF STUDY Retrospective cohort study. SETTING Random sample of 99 997 people aged 18 years or over registered with 182 general practices in England contributing data to the General Practice Research Database. METHOD Multimorbidity was defined using two approaches: people with multiple chronic conditions included in the Quality and Outcomes Framework, and people identified using the Johns Hopkins University Adjusted Clinical Groups (ACG®) Case-Mix System. The determinants of multimorbidity (age, sex, area deprivation) and relationships with consultation rate and continuity of care were examined using regression models. RESULTS Sixteen per cent of patients had more than one chronic condition included in the Quality and Outcomes Framework, but these people accounted for 32% of all consultations. Using the wider ACG list of conditions, 58% of people had multimorbidity and they accounted for 78% of consultations. Multimorbidity was strongly related to age and deprivation. People with multimorbidity had higher consultation rates and less continuity of care compared with people without multimorbidity. CONCLUSION Multimorbidity is common in the population and most consultations in primary care involve people with multimorbidity. These people are less likely to receive continuity of care, although they may be more likely to gain from it.

Evaluation of computer based clinical decision support system and risk chart for management of hypertension in primary care: randomised controlled trial

Abstract Objectives: To investigate the effect of a computer based clinical decision support system and a risk chart on absolute cardiovascular risk, blood pressure, and prescribing of cardiovascular drugs in hypertensive patients. Design: Cluster randomised controlled trial. Setting: 27 general practices in Avon. Participants: 614 patients aged between 60 and 79 years with high blood pressure. Interventions: Patients were randomised to computer based clinical decision support system plus cardiovascular risk chart; cardiovascular risk chart alone; or usual care. Main outcome measures: Percentage of patients in each group with a five year cardiovascular risk≥10%, systolic blood pressure, diastolic blood pressure, prescribing of cardiovascular drugs. Results: Patients in the computer based clinical decision support system and chart only groups were no more likely to have cardiovascular risk reduced to below 10% than patients receiving usual care. Patients in the computer based clinical decision support group were more likely to have a cardiovascular risk≥10% than chart only patients, odds ratio 2.3 (95% confidence interval 1.1 to 4.8). The chart only group had significantly lower systolic blood pressure compared with the usual care group (difference in means−4.6 mm Hg (95% confidence interval−8.4 to−0.8). Reduction of diastolic blood pressure did not differ between the three groups. The chart only group were twice as likely to be prescribed two classes of cardiovascular drugs and over three times as likely to be prescribed three or more classes of drugs compared with the other groups. Conclusions: The computer based clinical decision support system did not confer any benefit in absolute risk reduction or blood pressure control and requires further development and evaluation before use in clinical care can be recommended. Use of chart guidelines are associated with a potentially important reduction in systolic blood pressure.

Quality of care for elderly residents in nursing homes and elderly people living at home: controlled observational study

Abstract Objectives: To assess the quality of care given to elderly people and compare the care given to residents in nursing homes with those living in their own homes. Design: Controlled observational study. Setting: Primary care, Bristol. Subjects: Elderly individuals (aged 65 years) registered with three general practices, of whom 172 were residents in nursing homes (cases) and 526 lived at home (matched controls). Main outcome measures: The quality of clinical care given to patients was measured against explicit standards. Quality indicators were derived from national sources and agreed with participating general practitioners. Results: The overall standard of care was inadequate when judged against the quality indicators, irrespective of where patients lived. The overall prescribing of beneficial drugs for some conditions was deficient—for example, only 38% (11/29) (95% confidence interval 20% to 58%) of patients were prescribed β blockers after myocardial infarction. The proportion of patients with heart disease or diabetes who had had their blood pressure measured in the past two years (heart disease) or past year (diabetes) was lower among those living in nursing homes: for heart disease, 74% (17/23) v 96% (122/127) (adjusted odds ratio 0.18, 0.04 to 0.75); for diabetes, 62% (8/13) v 96% (50/52) (adjusted odds ratio 0.05, 0.01 to 0.38). In terms of potentially harmful prescribing, significantly more patients in nursing homes were prescribed neuroleptic medication (28% (49/172) v 11% (56/526) (3.82, 2.37 to 6.17)) and laxatives (39% (67/172) v 16% (85/526) (2.79, 1.79 to 4.36)). Nursing home residents were less likely to have the appropriate diagnostic Read code linked to their prescribed neuroleptic drug (0.22, 0.07 to 0.71). Conclusions: The quality of medical care that elderly patients receive in one UK city, particularly those in nursing homes, is inadequate. We suggest that better coordinated care for these patients would avoid the problems of overuse of unnecessary or harmful drugs, underuse of beneficial drugs, and poor monitoring of chronic disease. What is already known on this topic Doctors too often prescribe harmful drugs and too seldom prescribe beneficial drugs for elderly people The quality of medical care for those living in nursing and residential homes has also been questioned What this study adds Elderly people in one UK city receive inadequate care when judged against explicit quality indicators Those living in nursing homes receive poorer care than those living at home in terms of underuse of beneficial drugs, poor monitoring of chronic disease, and overuse of inappropriate or unnecessary drugs

Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes: the Early ACTID randomised controlled trial

BACKGROUND Lifestyle changes soon after diagnosis might improve outcomes in patients with type 2 diabetes mellitus, but no large trials have compared interventions. We investigated the effects of diet and physical activity on blood pressure and glucose concentrations. METHODS We did a randomised, controlled trial in southwest England in adults aged 30-80 years in whom type 2 diabetes had been diagnosed 5-8 months previously. Participants were assigned usual care (initial dietary consultation and follow-up every 6 months; control group), an intensive diet intervention (dietary consultation every 3 months with monthly nurse support), or the latter plus a pedometer-based activity programme, in a 2:5:5 ratio. The primary endpoint was improvement in glycated haemoglobin A(1c)(HbA(1c)) concentration and blood pressure at 6 months. Analysis was done by intention to treat. This study is registered, number ISRCTN92162869. FINDINGS Of 593 eligible individuals, 99 were assigned usual care, 248 the diet regimen, and 246 diet plus activity. Outcome data were available for 587 (99%) and 579 (98%) participants at 6 and 12 months, respectively. At 6 months, glycaemic control had worsened in the control group (mean baseline HbA(1c) percentage 6·72, SD 1·02, and at 6 months 6·86, 1·02) but improved in the diet group (baseline-adjusted difference in percentage of HbA(1c) -0·28%, 95% CI -0·46 to -0·10; p=0·005) and diet plus activity group (-0·33%, -0·51 to -0·14; p<0·001). These differences persisted to 12 months, despite less use of diabetes drugs. Improvements were also seen in bodyweight and insulin resistance between the intervention and control groups. Blood pressure was similar in all groups. INTERPRETATION An intensive diet intervention soon after diagnosis can improve glycaemic control. The addition of an activity intervention conferred no additional benefit. FUNDING Diabetes UK and the UK Department of Health.

Design, analysis and presentation of factorial randomised controlled trials

BackgroundThe evaluation of more than one intervention in the same randomised controlled trial can be achieved using a parallel group design. However this requires increased sample size and can be inefficient, especially if there is also interest in considering combinations of the interventions. An alternative may be a factorial trial, where for two interventions participants are allocated to receive neither intervention, one or the other, or both. Factorial trials require special considerations, however, particularly at the design and analysis stages.DiscussionUsing a 2 × 2 factorial trial as an example, we present a number of issues that should be considered when planning a factorial trial. The main design issue is that of sample size. Factorial trials are most often powered to detect the main effects of interventions, since adequate power to detect plausible interactions requires greatly increased sample sizes. The main analytical issues relate to the investigation of main effects and the interaction between the interventions in appropriate regression models. Presentation of results should reflect the analytical strategy with an emphasis on the principal research questions. We also give an example of how baseline and follow-up data should be presented. Lastly, we discuss the implications of the design, analytical and presentational issues covered.SummaryDifficulties in interpreting the results of factorial trials if an influential interaction is observed is the cost of the potential for efficient, simultaneous consideration of two or more interventions. Factorial trials can in principle be designed to have adequate power to detect realistic interactions, and in any case they are the only design that allows such effects to be investigated.

Facilitated physical activity as a treatment for depressed adults: randomised controlled trial

Objective To investigate the effectiveness of facilitated physical activity as an adjunctive treatment for adults with depression presenting in primary care. Design Pragmatic, multicentre, two arm parallel randomised controlled trial. Setting General practices in Bristol and Exeter. Participants 361 adults aged 18-69 who had recently consulted their general practitioner with symptoms of depression. All those randomised had a diagnosis of an episode of depression as assessed by the clinical interview schedule-revised and a Beck depression inventory score of 14 or more. Interventions In addition to usual care, intervention participants were offered up to three face to face sessions and 10 telephone calls with a trained physical activity facilitator over eight months. The intervention was based on theory and aimed to provide individually tailored support and encouragement to engage in physical activity. Main outcome measures The primary outcome was self reported symptoms of depression, assessed with the Beck depression inventory at four months post-randomisation. Secondary outcomes included use of antidepressants and physical activity at the four, eight, and 12 month follow-up points, and symptoms of depression at eight and 12 month follow-up. Results There was no evidence that participants offered the physical activity intervention reported improvement in mood by the four month follow-up point compared with those in the usual care group; adjusted between group difference in mean Beck depression inventory score −0.54 (95% confidence interval −3.06 to 1.99; P=0.68). Similarly, there was no evidence that the intervention group reported a change in mood by the eight and 12 month follow-up points. Nor was there evidence that the intervention reduced antidepressant use compared with usual care (adjusted odds ratio 0.63, 95% confidence interval 0.19 to 2.06; P=0.44) over the duration of the trial. However, participants allocated to the intervention group reported more physical activity during the follow-up period than those allocated to the usual care group (adjusted odds ratio 2.27, 95% confidence interval 1.32 to 3.89; P=0.003). Conclusions The addition of a facilitated physical activity intervention to usual care did not improve depression outcome or reduce use of antidepressants compared with usual care alone. Trial registration Current Controlled Trials ISRCTN16900744.

Two decision aids for mode of delivery among women with previous caesarean section: randomised controlled trial

Objectives To determine the effects of two computer based decision aids on decisional conflict and mode of delivery among pregnant women with a previous caesarean section. Design Randomised trial, conducted from May 2004 to August 2006. Setting Four maternity units in south west England, and Scotland. Participants 742 pregnant women with one previous lower segment caesarean section and delivery expected at ≥37 weeks. Non-English speakers were excluded. Interventions Usual care: standard care given by obstetric and midwifery staff. Information programme: women navigated through descriptions and probabilities of clinical outcomes for mother and baby associated with planned vaginal birth, elective caesarean section, and emergency caesarean section. Decision analysis: mode of delivery was recommended based on utility assessments performed by the woman combined with probabilities of clinical outcomes within a concealed decision tree. Both interventions were delivered via a laptop computer after brief instructions from a researcher. Main outcome measures Total score on decisional conflict scale, and mode of delivery. Results Women in the information programme (adjusted difference −6.2, 95% confidence interval −8.7 to −3.7) and the decision analysis (−4.0, −6.5 to −1.5) groups had reduced decisional conflict compared with women in the usual care group. The rate of vaginal birth was higher for women in the decision analysis group compared with the usual care group (37% v 30%, adjusted odds ratio 1.42, 0.94 to 2.14), but the rates were similar in the information programme and usual care groups. Conclusions Decision aids can help women who have had a previous caesarean section to decide on mode of delivery in a subsequent pregnancy. The decision analysis approach might substantially affect national rates of caesarean section. Trial Registration Current Controlled Trials ISRCTN84367722.

Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised controlled trial

Objective To investigate whether paracetamol (acetaminophen) plus ibuprofen are superior to either drug alone for increasing time without fever and the relief of fever associated discomfort in febrile children managed at home. Design Individually randomised, blinded, three arm trial. Setting Primary care and households in England. Participants Children aged between 6 months and 6 years with axillary temperatures of at least 37.8°C and up to 41.0°C. Intervention Advice on physical measures to reduce temperature and the provision of, and advice to give, paracetamol plus ibuprofen, paracetamol alone, or ibuprofen alone. Main outcome measures Primary outcomes were the time without fever (<37.2°C) in the first four hours after the first dose was given and the proportion of children reported as being normal on the discomfort scale at 48 hours. Secondary outcomes were time to first occurrence of normal temperature (fever clearance), time without fever over 24 hours, fever associated symptoms, and adverse effects. Results On an intention to treat basis, paracetamol plus ibuprofen were superior to paracetamol for less time with fever in the first four hours (adjusted difference 55 minutes, 95% confidence interval 33 to 77; P<0.001) and may have been as good as ibuprofen (16 minutes, −7 to 39; P=0.2). For less time with fever over 24 hours, paracetamol plus ibuprofen were superior to paracetamol (4.4 hours, 2.4 to 6.3; P<0.001) and to ibuprofen (2.5 hours, 0.6 to 4.4; P=0.008). Combined therapy cleared fever 23 minutes (2 to 45; P=0.025) faster than paracetamol alone but no faster than ibuprofen alone (−3 minutes, 18 to −24; P=0.8). No benefit was found for discomfort or other symptoms, although power was low for these outcomes. Adverse effects did not differ between groups. Conclusion Parents, nurses, pharmacists, and doctors wanting to use medicines to supplement physical measures to maximise the time that children spend without fever should use ibuprofen first and consider the relative benefits and risks of using paracetamol plus ibuprofen over 24 hours. Trial registration Current Controlled Trials ISRCTN26362730.

Patients’ experience and satisfaction in primary care: secondary analysis using multilevel modelling

Objective To explore whether responses to questions in surveys of patients that purport to assess the performance of general practices or doctors reflect differences between practices, doctors, or the patients themselves. Design Secondary analysis of data from a study of access to general practice, combining data from a survey of patients with information about practice organisation and doctors consulted, and using multilevel modelling at practice, doctor, and patient level. Setting Nine primary care trusts in England. Participants 4573 patients who consulted 150 different doctors in 27 practices. Main outcome measures Overall satisfaction; experience of wait for an appointment; reported access to care; satisfaction with communication skills. Results The experience based measure of wait for an appointment was more discriminating between practices (practice level accounted for 20.2% (95% confidence interval 9.1% to 31.3%) of variance) than was the overall satisfaction measure (practice level accounted for 4.6% (1.6% to 7.6%) of variance). Only 6.3% (3.8% to 8.9%) of the variance in the doctors’ communication skills measure was due to differences between doctors; 92.4% (88.5% to 96.4%) of the variance occurred at the level of the patient (including differences between patients’ perceptions and random variation). At least 79% of the variance on all measures occurred at the level of the patient, and patients’ age, sex, ethnicity, and housing and employment status explained some of this variation. However, adjustment for patients’ characteristics made very little difference to practices’ scores or the ranking of individual practices. Conclusions Analyses of surveys of patients should take account of the hierarchical nature of the data by using multilevel models. Measures related to patients’ experience discriminate more effectively between practices than do measures of general satisfaction. Surveys of patients’ satisfaction fail to distinguish effectively between individual doctors because most of the variation in doctors’ reported performance is due to differences between patients and random error rather than differences between doctors. Although patients’ reports of satisfaction and experience are systematically related to patients’ characteristics such as age and sex, the effect of adjusting practices’ scores for the characteristics of their patients is small.

Women’s experience of decision making about mode of delivery after a previous caesarean section: the role of health professionals and information about health risks

Objective  To explore women’s experiences of decision making about mode of delivery after previous caesarean section.