Healthcare utilization and monetary costs associated with agitation in UK care home residents with advanced dementia: a prospective cohort study.

OBJECTIVE: Nearly half of care home residents with advanced dementia have clinically significant agitation. Little is known about costs associated with these symptoms toward the end of life. We calculated monetary costs associated with agitation from UK National Health Service, personal social services, and societal perspectives. DESIGN: Prospective cohort study. SETTING: Thirteen nursing homes in London and the southeast of England. PARTICIPANTS: Seventy-nine people with advanced dementia (Functional Assessment Staging Tool grade 6e and above) residing in nursing homes, and thirty-five of their informal carers. MEASUREMENTS: Data collected at study entry and monthly for up to 9 months, extrapolated for expression per annum. Agitation was assessed using the Cohen-Mansfield Agitation Inventory (CMAI). Health and social care costs of residing in care homes, and costs of contacts with health and social care services were calculated from national unit costs; for a societal perspective, costs of providing informal care were estimated using the resource utilization in dementia (RUD)-Lite scale. RESULTS: After adjustment, health and social care costs, and costs of providing informal care varied significantly by level of agitation as death approached, from £23,000 over a 1-year period with no agitation symptoms (CMAI agitation score 0-10) to £45,000 at the most severe level (CMAI agitation score >100). On average, agitation accounted for 30% of health and social care costs. Informal care costs were substantial, constituting 29% of total costs. CONCLUSIONS: With the increasing prevalence of dementia, costs of care will impact on healthcare and social services systems, as well as informal carers. Agitation is a key driver of these costs in people with advanced dementia presenting complex challenges for symptom management, service planners, and providers.

A brief intervention for weight control based on habit-formation theory delivered through primary care: results from a randomised controlled trial.

BACKGROUND: Primary care is the 'first port of call' for weight control advice, creating a need for simple, effective interventions that can be delivered without specialist skills. Ten Top Tips (10TT) is a leaflet based on habit-formation theory that could fill this gap. The aim of the current study was to test the hypothesis that 10TT can achieve significantly greater weight loss over 3 months than 'usual care'. METHODS: A two-arm, individually randomised, controlled trial in primary care. Adults with obesity were identified from 14 primary care providers across England. Patients were randomised to either 10TT or 'usual care' and followed up at 3, 6, 12, 18 and 24 months. The primary outcome was weight loss at 3 months, assessed by a health professional blinded to group allocation. Difference between arms was assessed using a mixed-effect linear model taking into account the health professionals delivering 10TT, and adjusted for baseline weight. Secondary outcomes included body mass index, waist circumference, the number achieving a 5% weight reduction, clinical markers for potential comorbidities, weight loss over 24 months and basic costs. RESULTS: Five-hundred and thirty-seven participants were randomised to 10TT (n=267) or to 'usual care' (n=270). Data were available for 389 (72%) participants at 3 months and for 312 (58%) at 24 months. Participants receiving 10TT lost significantly more weight over 3 months than those receiving usual care (mean difference =-0.87kg; 95% confidence interval: -1.47 to -0.27; P=0.004). At 24 months, the 10TT group had maintained their weight loss, but the 'usual care' group had lost a similar amount. The basic cost of 10TT was low, that is, around £23 ($32) per participant. CONCLUSIONS: The 10TT leaflet delivered through primary care is effective in the short-term and a low-cost option over the longer term. It is the first habit-based intervention to be used in a health service setting and offers a low-intensity alternative to 'usual care'.

Predicting dementia risk in primary care: development and validation of the Dementia Risk Score using routinely collected data.

BACKGROUND: Existing dementia risk scores require collection of additional data from patients, limiting their use in practice. Routinely collected healthcare data have the potential to assess dementia risk without the need to collect further information. Our objective was to develop and validate a 5-year dementia risk score derived from primary healthcare data. METHODS: We used data from general practices in The Health Improvement Network (THIN) database from across the UK, randomly selecting 377 practices for a development cohort and identifying 930,395 patients aged 60-95 years without a recording of dementia, cognitive impairment or memory symptoms at baseline. We developed risk algorithm models for two age groups (60-79 and 80-95 years). An external validation was conducted by validating the model on a separate cohort of 264,224 patients from 95 randomly chosen THIN practices that did not contribute to the development cohort. Our main outcome was 5-year risk of first recorded dementia diagnosis. Potential predictors included sociodemographic, cardiovascular, lifestyle and mental health variables. RESULTS: Dementia incidence was 1.88 (95% CI, 1.83-1.93) and 16.53 (95% CI, 16.15-16.92) per 1000 PYAR for those aged 60-79 (n = 6017) and 80-95 years (n = 7104), respectively. Predictors for those aged 60-79 included age, sex, social deprivation, smoking, BMI, heavy alcohol use, anti-hypertensive drugs, diabetes, stroke/TIA, atrial fibrillation, aspirin, depression. The discrimination and calibration of the risk algorithm were good for the 60-79 years model; D statistic 2.03 (95% CI, 1.95-2.11), C index 0.84 (95% CI, 0.81-0.87), and calibration slope 0.98 (95% CI, 0.93-1.02). The algorithm had a high negative predictive value, but lower positive predictive value at most risk thresholds. Discrimination and calibration were poor for the 80-95 years model. CONCLUSIONS: Routinely collected data predicts 5-year risk of recorded diagnosis of dementia for those aged 60-79, but not those aged 80+. This algorithm can identify higher risk populations for dementia in primary care. The risk score has a high negative predictive value and may be most helpful in 'ruling out' those at very low risk from further testing or intensive preventative activities.

Modelling the cost-effectiveness of preventing major depression in general practice patients.

BACKGROUND: The prevention of depression is a key public health policy priority. PredictD is the first risk algorithm for the prediction of the onset of major depression. Our aim in this study was to model the cost-effectiveness of PredictD in depression prevention in general practice (GP). METHOD: A decision analytical model was developed to determine the cost-effectiveness of two approaches, each of which was compared to treatment as usual (TAU) over 12 months: (1) the PredictD risk algorithm plus a low-intensity depression prevention programme; and (2) a universal prevention programme in which there was no initial identification of those at risk. The model simulates the incidence of depression and disease progression over 12 months and calculates the net monetary benefit (NMB) from the National Health Service (NHS) perspective. RESULTS: Providing patients with PredictD and a depression prevention programme prevented 15 (17%) cases of depression in a cohort of 1000 patients over 12 months and had the highest probability of being the optimal choice at a willingness to pay (WTP) of £20,000 for a quality-adjusted life year (QALY). Universal prevention was strongly dominated by PredictD plus a depression prevention programme in that universal prevention resulted in less QALYs than PredictD plus prevention for a greater cost. CONCLUSIONS: Using PredictD to identify primary-care patients at high risk of depression and providing them with a low-intensity prevention programme is potentially cost-effective at a WTP of £20,000 per QALY.

Predicting onset of major depression in general practice attendees in Europe: extending the application of the predictD risk algorithm from 12 to 24 months.

BACKGROUND: PredictD is a risk algorithm that was developed to predict risk of onset of major depression over 12 months in general practice attendees in Europe and validated in a similar population in Chile. It was the first risk algorithm to be developed in the field of mental disorders. Our objective was to extend predictD as an algorithm to detect people at risk of major depression over 24 months. Method Participants were 4190 adult attendees to general practices in the UK, Spain, Slovenia and Portugal, who were not depressed at baseline and were followed up for 24 months. The original predictD risk algorithm for onset of DSM-IV major depression had already been developed in data arising from the first 12 months of follow-up. In this analysis we fitted predictD to the longer period of follow-up, first by examining only the second year (12-24 months) and then the whole period of follow-up (0-24 months). RESULTS: The instrument performed well for prediction of major depression from 12 to 24 months [c-index 0.728, 95% confidence interval (CI) 0.675-0.781], or over the whole 24 months (c-index 0.783, 95% CI 0.757-0.809). CONCLUSIONS: The predictD risk algorithm for major depression is accurate over 24 months, extending it current use of prediction over 12 months. This strengthens its use in prevention efforts in general medical settings.

Spiritual and religious beliefs as risk factors for the onset of major depression: an international cohort study.

BACKGROUND: Several studies have reported weak associations between religious or spiritual belief and psychological health. However, most have been cross-sectional surveys in the U.S.A., limiting inference about generalizability. An international longitudinal study of incidence of major depression gave us the opportunity to investigate this relationship further. METHOD: Data were collected in a prospective cohort study of adult general practice attendees across seven countries. Participants were followed at 6 and 12 months. Spiritual and religious beliefs were assessed using a standardized questionnaire, and DSM-IV diagnosis of major depression was made using the Composite International Diagnostic Interview (CIDI). Logistic regression was used to estimate incidence rates and odds ratios (ORs), after multiple imputation of missing data. RESULTS: The analyses included 8318 attendees. Of participants reporting a spiritual understanding of life at baseline, 10.5% had an episode of depression in the following year compared to 10.3% of religious participants and 7.0% of the secular group (p<0.001). However, the findings varied significantly across countries, with the difference being significant only in the U.K., where spiritual participants were nearly three times more likely to experience an episode of depression than the secular group [OR 2.73, 95% confidence interval (CI) 1.59­4.68]. The strength of belief also had an effect, with participants with strong belief having twice the risk of participants with weak belief. There was no evidence of religion acting as a buffer to prevent depression after a serious life event. CONCLUSIONS: These results do not support the notion that religious and spiritual life views enhance psychological well-being.

Two-stage method to remove population- and individual-level outliers from longitudinal data in a primary care database.

PURPOSE: In the UK, primary care databases include repeated measurements of health indicators at the individual level. As these databases encompass a large population, some individuals have extreme values, but some values may also be recorded incorrectly. The challenge for researchers is to distinguish between records that are due to incorrect recording and those which represent true but extreme values. This study evaluated different methods to identify outliers. METHODS: Ten percent of practices were selected at random to evaluate the recording of 513,367 height measurements. Population-level outliers were identified using boundaries defined using Health Survey for England data. Individual-level outliers were identified by fitting a random-effects model with subject-specific slopes for height measurements adjusted for age and sex. Any height measurements with a patient-level standardised residual more extreme than ±10 were identified as an outlier and excluded. The model was subsequently refitted twice after removing outliers at each stage. This method was compared with existing methods of removing outliers. RESULTS: Most outliers were identified at the population level using the boundaries defined using Health Survey for England (1550 of 1643). Once these were removed from the database, fitting the random-effects model to the remaining data successfully identified only 75 further outliers. This method was more efficient at identifying true outliers compared with existing methods. CONCLUSIONS: We propose a new, two-stage approach in identifying outliers in longitudinal data and show that it can successfully identify outliers at both population and individual level. Copyright © 2011 John Wiley & Sons, Ltd.

Characteristics of a population-wide sample of smokers recruited proactively for the ESCAPE trial.

OBJECTIVES: To describe the characteristics of a sample of smokers recruited proactively into a smoking cessation trial, and to compare these characteristics with the wider population using data from the General Household Survey (GHS) and National Statistics Omnibus Survey. STUDY DESIGN: Sample recruited for a randomized controlled trial. METHODS: Between August 2007 and October 2008, 123 general practices mailed questionnaires to smokers in the U.K. identified from computer records. Smokers willing to participate in a trial of personalized computer-tailored feedback returned the questionnaires to the research team. The characteristics of the sample were compared with the wider population using data from the GHS and National Statistics Omnibus Survey, and Index of Material Deprivation scores. RESULTS: A response rate of 11.4% (n = 6697) was achieved. The sample was demographically similar to the population sample, with an even distribution of participants from areas of both high and low deprivation. The sample was more dependent than the GHS sample, but less dependent than clinic samples. Distribution by motivation and readiness to quit was similar to population estimates. CONCLUSIONS: Public health strategies targeting the entire population of smokers are needed to counter the low recruitment rates resulting from the traditional reactive methods of recruitment to smoking cessation studies. Using computerized records to identify and contact patients who are smokers is a simple method of recruiting a larger, more representative sample of smokers.

An international risk prediction algorithm for the onset of generalized anxiety and panic syndromes in general practice attendees: predictA.

BACKGROUND: There are no risk models for the prediction of anxiety that may help in prevention. We aimed to develop a risk algorithm for the onset of generalized anxiety and panic syndromes. METHOD: Family practice attendees were recruited between April 2003 and February 2005 and followed over 24 months in the UK, Spain, Portugal and Slovenia (Europe4 countries) and over 6 months in The Netherlands, Estonia and Chile. Our main outcome was generalized anxiety and panic syndromes as measured by the Patient Health Questionnaire. We entered 38 variables into a risk model using stepwise logistic regression in Europe4 data, corrected for over-fitting and tested it in The Netherlands, Estonia and Chile. RESULTS: There were 4905 attendees in Europe4, 1094 in Estonia, 1221 in The Netherlands and 2825 in Chile. In the algorithm four variables were fixed characteristics (sex, age, lifetime depression screen, family history of psychological difficulties); three current status (Short Form 12 physical health subscale and mental health subscale scores, and unsupported difficulties in paid and/or unpaid work); one concerned country; and one time of follow-up. The overall C-index in Europe4 was 0.752 [95% confidence interval (CI) 0.724-0.780]. The effect size for difference in predicted log odds between developing and not developing anxiety was 0.972 (95% CI 0.837-1.107). The validation of predictA resulted in C-indices of 0.731 (95% CI 0.654-0.809) in Estonia, 0.811 (95% CI 0.736-0.886) in The Netherlands and 0.707 (95% CI 0.671-0.742) in Chile. CONCLUSIONS: PredictA accurately predicts the risk of anxiety syndromes. The algorithm is strikingly similar to the predictD algorithm for major depression, suggesting considerable overlap in the concepts of anxiety and depression.

Predicting the onset of major depression in primary care: international validation of a risk prediction algorithm from Spain.

BACKGROUND: The different incidence rates of, and risk factors for, depression in different countries argue for the need to have a specific risk algorithm for each country or a supranational risk algorithm. We aimed to develop and validate a predictD-Spain risk algorithm (PSRA) for the onset of major depression and to compare the performance of the PSRA with the predictD-Europe risk algorithm (PERA) in Spanish primary care. METHOD: A prospective cohort study with evaluations at baseline, 6 and 12 months. We measured 39 known risk factors and used multi-level logistic regression and inverse probability weighting to build the PSRA. In Spain (4574), Chile (2133) and another five European countries (5184), 11 891 non-depressed adult primary care attendees formed our at-risk population. The main outcome was DSM-IV major depression (CIDI). RESULTS: Six variables were patient characteristics or past events (sex, age, sex×age interaction, education, physical child abuse, and lifetime depression) and six were current status [Short Form 12 (SF-12) physical score, SF-12 mental score, dissatisfaction with unpaid work, number of serious problems in very close persons, dissatisfaction with living together at home, and taking medication for stress, anxiety or depression]. The C-index of the PSRA was 0.82 [95% confidence interval (CI) 0.79-0.84]. The Integrated Discrimination Improvement (IDI) was 0.0558 [standard error (s.e.)=0.0071, Zexp=7.88, p<0.0001] mainly due to the increase in sensitivity. Both the IDI and calibration plots showed that the PSRA functioned better than the PERA in Spain. CONCLUSIONS: The PSRA included new variables and afforded an improved performance over the PERA for predicting the onset of major depression in Spain. However, the PERA is still the best option in other European countries.

Development and pilot evaluation of a complex intervention to improve experienced continuity of care in patients with cancer.

High experienced continuity of care in patients with cancer is associated with lower needs for care, better quality of life and better psychological outcomes. We developed and evaluated an intervention to improve experienced continuity. The intervention, consisted of (1) a 17-item patient-completed continuity assessment; (2) feedback to clinical nurse specialists and action to address the needs identified. Multidisciplinary team meetings and oncology outpatient clinics were observed, and patients and staff were interviewed. After qualitative work and reliability testing, the intervention was evaluated in a feasibility trial. Sixty-one patients provided data for analysis. No statistically significant differences were found in patients' experienced continuity between the trial arms, but important trends were seen in measures of needs for care in favour of those receiving the intervention. Feeding back findings from the continuity assessment to clinicians reduced patients' needs for care. Our results indicate that an intervention to target patients' experiences of continuity can reduce their subsequent needs for care. However, overcoming barriers to organisational change and addressing some patients' hesitation to report their continuity difficulties must be considered when implementing such an intervention. A phase III trial targeting patients with inadequate experienced continuity of care is recommended.

Perceived concepts of continuity of care in people with colorectal and breast cancer--a qualitative case study analysis.

We aimed to develop ideas on continuity of cancer care. In-depth qualitative interviews were conducted with 28 people. Seven had cancer. Each person with cancer nominated a close person and a primary and secondary health care professional. We examined from four perspectives: experiences of the initial diagnosis; subsequent treatment; views on continuity of care; information given about the illness; psychological/physical impact of cancer and communication with professionals, family and friends. Perceived continuity of care was influenced by the actions of patients', involvement of close contacts and engagement in shared decision making. Additionally communication between primary and secondary care, the role of various health professionals and hospital administrative systems strongly influenced continuity of care. Informational, management and relational continuity have been previously described. Our data uncovered the effect of patients' actions and the involvement of close friends and families on continuity of cancer care. People with cancer should be enabled to influence continuity of their care. Full recognition of the role of health professionals, different approaches to sharing information with patients and tightening of hospital administrative systems should also be considered.

Statin prescribing for prevention of cardiovascular disease amongst people with severe mental illness: Cohort study in UK primary care.

BACKGROUND: Severe mental illness (SMI) is associated with excess cardiovascular disease (CVD) morbidity, but little is known on provision of preventative interventions. We investigated statin initiation for primary CVD prevention in individuals with and without SMI. METHODS: We used primary care data from The Health Improvement Network from 2006 to 2015 for UK patients aged 30-99years with no pre-existing CVD conditions and selected individuals with schizophrenia (n=13,252) or bipolar disorder (n=11,994). In addition, we identified samples of individuals without schizophrenia (n=66,060) and bipolar disorder (n=59,765), but with similar age and gender distribution. Missing data on CVD covariates were estimated using multiple imputation. Statin prescribing differences between individuals with and without SMI were investigated using multivariable Poisson regression models. RESULTS: Initiation of statin prescribing was between 2 and 3 fold higher in people aged 30-59years with SMI than in those without after adjusting for CVD covariates. The rates in those aged 60-74years with SMI were similar or slightly higher relative to those without SMI. The incidence rate ratio (IRR) was 1.15 (95% CI 1.03-1.28) for bipolar disorder and 1.00 (0.91-1.11) for schizophrenia. The rate of statin prescribing was lower (IRR 0.81 (0.66-0.98)) amongst the oldest (aged 75+years) with schizophrenia relative to those without schizophrenia. CONCLUSIONS: Despite higher rates of new statin prescriptions to younger individuals with SMI relative to individuals without SMI, there was evidence of lower rates of statin initiation for older individuals with schizophrenia, and this group may benefit from additional measures to prevent CVD.

Effects of chronic exposure of hydroxychloroquine/chloroquine on the risk of cancer, metastasis, and death: a population-based cohort study on patients with connective tissue diseases.

BACKGROUND: Hydroxychloroquine and chloroquine may reduce the risk of cancer as they inhibit autophagy, in particular, in people with connective tissue diseases. METHODS: The hazard ratios of cancers, metastases, and death were assessed in adults with connective tissue diseases prescribed hydroxychloroquine/chloroquine for at least 1 year in comparison with unexposed individuals with the same underlying conditions. A competing risk survival regression analysis was performed. Data were extracted from the Health Improvement Network UK primary care database. RESULTS: Eight thousand nine hundred and ninety-nine individuals exposed to hydroxychloroquine (98.6%) or chloroquine (1.4%) and 24,118 unexposed individuals were included in the study (median age: 56 [45-66] years, women: 76.8%). When compared to the unexposed group, individuals exposed to hydroxychloroquine/chloroquine were not at lower risk of non-skin cancers (adjusted sub-distribution hazard ratio [sHR]: 1.04 [0.92-1.18], p=0.54), hematological malignancies (adjusted sHR: 1.00 [0.73-1.38], p=0.99), or skin cancers (adjusted sHR: 0.92 [0.78-1.07], p=0.26). The risk of metastasis was not significantly different between the two groups. However, it was significantly lower during the exposure period when compared with the unexposed (adjusted sHR: 0.64 [0.44-0.95] for the overall population and 0.61 [0.38-1.00] for those diagnosed with incident cancers). The risk of death was also significantly lower in those exposed to hydroxychloroquine/chloroquine (adjusted HR: 0.90 [0.81-1.00] in the overall population and 0.78 [0.64-0.96] in those diagnosed with incident cancer). CONCLUSION: Individuals on long-term exposure to hydroxychloroquine/chloroquine are not at lower risk of cancer. However, hydroxychloroquine/chloroquine may lower the risk of metastatic cancer and death.

Statin prescribing for people with severe mental illnesses: a staggered cohort study of 'real-world' impacts.

OBJECTIVES: To estimate the 'real-world effectiveness of statins for primary prevention of cardiovascular disease (CVD) and for lipid modification in people with severe mental illnesses (SMI), including schizophrenia and bipolar disorder. DESIGN: Series of staggered cohorts. We estimated the effect of statin prescribing on CVD outcomes using a multivariable Poisson regression model or linear regression for cholesterol outcomes. SETTING: 587 general practice (GP) surgeries across the UK reporting data to The Health Improvement Network. PARTICIPANTS: All permanently registered GP patients aged 40-84 years between 2002 and 2012 who had a diagnosis of SMI. Exclusion criteria were pre-existing CVD, statin-contraindicating conditions or a statin prescription within the 24 months prior to the study start. EXPOSURE: One or more statin prescriptions during a 24-month 'baseline' period (vs no statin prescription during the same period). MAIN OUTCOME MEASURES: The primary outcome was combined first myocardial infarction and stroke. All-cause mortality and total cholesterol concentration were secondary outcomes. RESULTS: We identified 2944 statin users and 42 886 statin non-users across the staggered cohorts. Statin prescribing was not associated with significant reduction in CVD events (incident rate ratio 0.89; 95% CI 0.68 to 1.15) or all-cause mortality (0.89; 95% CI 0.78 to 1.02). Statin prescribing was, however, associated with statistically significant reductions in total cholesterol of 1.2 mmol/L (95% CI 1.1 to 1.3) for up to 2 years after adjusting for differences in baseline characteristics. On average, total cholesterol decreased from 6.3 to 4.6 in statin users and 5.4 to 5.3 mmol/L in non-users. CONCLUSIONS: We found that statin prescribing to people with SMI in UK primary care was effective for lipid modification but not CVD events. The latter finding may reflect insufficient power to detect a smaller effect size than that observed in randomised controlled trials of statins in people without SMI.

Relative risks of cardiovascular disease in people prescribed olanzapine, risperidone and quetiapine.

Antipsychotics may confer long term benefits and risks, including cardiovascular disease (CVD) risk. Several studies using routine clinical data have reported associations between antipsychotics and CVD but potential confounding factors and unclear classification of drug exposure limits their interpretation. METHOD: We used data from The Health Improvement Network, a large UK primary care database to determine relative risks of (CVD) comparing similar groups of people only prescribed olanzapine versus either risperidone or quetiapine. We included participants over 18 between 1995 and 2011. To assess confounding factors we created propensity scores for being prescribed each antipsychotic. We used propensity score matching and Poisson regression to calculate the CVD incidence rate ratios for olanzapine versus the other two drugs. RESULTS: We identified 18,319 people who received a single antipsychotic during follow-up (n=5090 risperidone, 7797 olanzapine and 4613 quetiapine). In unmatched analyses, the CVD incidence rate ratio (IRR) for olanzapine versus risperidone was 0.63 (0.51-0.77) but the propensity score matched IRR was 0.78 (0.61-1.02). In the unmatched olanzapine versus quetiapine analysis the IRR adjusted for age and sex for olanzapine was 1.52 (1.16-1.98) but the propensity score matched analysis gave an IRR of 1.08 (0.79-1.46). CONCLUSIONS: After propensity score matching, we found no statistical differences in CVD incidence between olanzapine and either risperidone or quetiapine. Analyses which did not account for confounding factors produced very different results. Researchers must address confounding factors when designing observational studies to assess adverse outcomes of drugs, including antipsychotics.

Conceptual framework and systematic review of the effects of participants' and professionals' preferences in randomised controlled trials.

OBJECTIVES: To develop a conceptual framework of preferences for interventions in the context of randomised controlled trials (RCTs), as well as to examine the extent to which preferences affect recruitment to RCTs and modify the measured outcome in RCTs through a systematic review of RCTs that incorporated participants' and professionals' preferences. Also to make recommendations on the role of participants' and professionals' preferences in the evaluation of health technologies. DATA SOURCES: Electronic databases. REVIEW METHODS: The conceptual review was carried out on published papers in the psychology and economics literature concerning concepts of relevance to patient decision-making and preferences, and their measurement. For the systematic review, studies across all medical specialities meeting strict criteria were selected. Data were then extracted, synthesised and analysed. RESULTS: Key elements for a conceptual framework were found to be that preferences are evaluations of an intervention in terms of its desirability and these preferences relate to expectancies and perceived value of the process and outcome of interventions. RCTs differed in the information provided to patients, the complexity of techniques used to provide that information and the degree to which preference elicitation may simply produce pre-existing preferences or actively construct them. Most current RCTs used written information alone. Preference can be measured in many different ways and most RCTs did not provide quantitative measures of preferences, and those that did tended to use very simple measures. The second part of the study, the systematic review included 34 RCTs. The findings gave support to the hypothesis that preferences affect trial recruitment. However, there was less evidence that external validity was seriously compromised. There was some evidence that preferences influenced outcome in a proportion of trials. However, evidence for preference effects was weaker in large trials and after accounting for baseline differences. Preference effects were also inconsistent in direction. There was no evidence that preferences influenced attrition. Therefore, the available evidence does not support the operation of a consistent and important 'preference effect'. Interventions cannot be categorised consistently on degree of participation. Examining differential preference effects based on unreliable categories ran the risk of drawing incorrect conclusions, so this was not carried out. CONCLUSIONS: Although patients and physicians often have intervention preferences, our review gives less support to the hypothesis that preferences significantly compromise the internal and external validity of trials. This review adds to the growing evidence that when preferences based on informed expectations or strong ethical objections to an RCT exist, observational methods are a valuable alternative. All RCTs in which participants and/or professionals cannot be masked to treatment arms should attempt to estimate participants' preferences. In this way, the amount of evidence available to answer questions about the effect of treatment preferences within and outwith RCTs could be increased. Furthermore, RCTs should routinely attempt to report the proportion of eligible patients who refused to take part because of their preferences for treatment. The findings also indicate a number of approaches to the design, conduct and analysis of RCTs that take account of participants' and/or professionals' preferences. This is referred to as a methodological tool kit for undertaking RCTs that incorporate some consideration of patients' or professionals' preferences. Future research into the amount and source of information available to patients about interventions in RCTs could be considered, with special emphasis on the relationship between sources inside and outside the RCT context. Qualitative research undertaken as part of ongoing RCTs might be especially useful. The processes by which this information leads to preferences in order to develop or extend the proposed expectancy--value framework could also be examined. Other areas for consideration include: how information about interventions changes participants' preferences; a comparison of the feasibility and effectiveness of different informed consent procedures; how strength of preference varies for different interventions within the same RCT and how these differences can be taken account of in the analysis; the differential effects of patients' and professionals' preferences on evidence arising from RCTs; and whether the standardised measurement of preferences within all RCTs (and analysis of the effect on outcome) would allow the rapid development of a significant evidence base concerning patient preferences, albeit in relation to a single preference design.

Interactive Health Communication Applications for people with chronic disease.

BACKGROUND: Interactive Health Communication Applications (IHCAs) are computer-based, usually web-based, information packages for patients that combine health information with at least one of social support, decision support, or behaviour change support. These are innovations in health care and their effects on health are uncertain. OBJECTIVES: To assess the effects of IHCAs for people with chronic disease. SEARCH STRATEGY: We designed a four-part search strategy. First, we searched electronic bibliographic databases for published work; second, we searched the grey literature; and third, we searched for ongoing and recently completed clinical trials in the appropriate databases. Finally, researchers of included studies were contacted, and reference lists from relevant primary and review articles were followed up. As IHCAs require relatively new technology, the search time period commenced at 1990, where possible, and ran until 31 December 2003. SELECTION CRITERIA: Randomised controlled trials (RCTs) of IHCAs for adults and children with chronic disease. DATA COLLECTION AND ANALYSIS: One reviewer screened abstracts for relevance. Two reviewers screened all candidate studies to determine eligibility, apply quality criteria, and extract data from included studies. Authors of included RCTs were contacted for missing data. Results of RCTs were pooled using random-effects model with standardised mean differences (SMDs) for continuous outcomes and odds ratios for binary outcomes; heterogeneity was assessed using the I(2 )statistic. MAIN RESULTS: We identified 24 RCTs involving 3739 participants which were included in the review.IHCAs had a significant positive effect on knowledge (SMD 0.46; 95% confidence interval (CI) 0.22 to 0.69), social support (SMD 0.35; 95% CI 0.18 to 0.52) and clinical outcomes (SMD 0.18; 95% CI 0.01 to 0.35). Results suggest it is more likely than not that IHCAs have a positive effect on self-efficacy (a person's belief in their capacity to carry out a specific action) (SMD 0.24; 95% CI 0.00 to 0.48). IHCAs had a significant positive effect on continuous behavioural outcomes (SMD 0.20; 95% CI 0.01 to 0.40). Binary behavioural outcomes also showed a positive effect for IHCAs, although this result was not statistically significant (OR 1.66; 95% CI 0.71 to 3.87). It was not possible to determine the effects of IHCAs on emotional or economic outcomes. AUTHORS' CONCLUSIONS: IHCAs appear to have largely positive effects on users, in that users tend to become more knowledgeable, feel better socially supported, and may have improved behavioural and clinical outcomes compared to non-users. There is a need for more high quality studies with large sample sizes to confirm these preliminary findings, to determine the best type and best way to deliver IHCAs, and to establish how IHCAs have their effects for different groups of people with chronic illness.

Interactive health communication applications for chronic disease: patient and carer perspectives.

Interactive health communication applications (IHCAs) may be particularly useful to patients and carers managing chronic disease. We have run eight focus groups with patients and two with carers involving a total of 40 participants. The focus groups were designed to seek patients' and carers' requirements of IHCAs and to identify the criteria they would use to assess them. Analysis revealed that many participants saw the value and potential of IHCAs. Even those with modest previous computer experience could use them with little tuition. The findings from this study have policy implications for the development of applications to maximize the potential benefit of IHCAs to patients and carers.