Dennis Petrie

Effective feedback to improve primary care prescribing safety (EFIPPS) a pragmatic three-arm cluster randomised trial: Designing the intervention

BackgroundHigh-risk prescribing in primary care is common and causes considerable harm. Feedback interventions have small/moderate effects on clinical practice, but few trials explicitly compare different forms of feedback. There is growing recognition that intervention development should be theory-informed, and that comprehensive reporting of intervention design is required by potential users of trial findings. The paper describes intervention development for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study, a pragmatic three-arm cluster randomised trial in 262 Scottish general practices.MethodsThe NHS chose to implement a feedback intervention to utilise a new resource, new Prescribing Information System (newPIS). The development phase required selection of high-risk prescribing outcome measures and design of intervention components: (1) educational material (the usual care comparison), (2) feedback of practice rates of high-risk prescribing received by both intervention arms and (3) a theory-informed behaviour change component to be received by one intervention arm. Outcome measures, educational material and feedback design, were developed with a National Health Service Advisory Group. The behaviour change component was informed by the Theory of Planned Behaviour and the Health Action Process Approach. A focus group elicitation study and an email Delphi study with general practitioners (GPs) identified key attitudes and barriers of responding to the prescribing feedback. Behaviour change techniques were mapped to the psychological constructs, and the content was informed by the results of the elicitation and Delphi study.ResultsSix high-risk prescribing measures were selected in a consensus process based on importance and feasibility. Educational material and feedback design were based on current NHS Scotland practice and Advisory Group recommendations. The behaviour change component was resource constrained in development, mirroring what is feasible in an NHS context. Four behaviour change interventions were developed and embedded in five quarterly rounds of feedback targeting attitudes, subjective norms, perceived behavioural control and action planning (2×).ConclusionsThe paper describes a process which is feasible to use in the resource-constrained environment of NHS-led intervention development and documents the intervention to make its design and implementation explicit to potential users of the trial findings.Trial registrationClinicalTrials.gov: NCT01602705

The value of high adherence to tamoxifen in women with breast cancer: a community-based cohort study

Background:Low adherence to adjuvant tamoxifen is associated with worse health outcomes but little is known about the cost-effectiveness of high adherence.Methods:We conducted an economic evaluation using data for all women with incident breast cancer between 1993 and 2000 who were subsequently prescribed tamoxifen in the Tayside region of Scotland. Patient-level, lifetime Markov models evaluated the impact of high vs low adherence to tamoxifen using linked prescribing, cancer registry, clinical cancer audit, hospital discharge and death records. Direct medical costs were estimated for each patient and quality-of-life weights were assigned. Recurrence information was collected by case note review and adherence calculated from prescribing records with low adherence classed below 80%.Results:A total of 354 (28%) patients had a recorded recurrence and 504 (39%) died. Four hundred and seventy-five (38%) patients had low adherence over the treatment period, which was associated with reduced time to recurrence of 52% (P<0.001). Time to other cause mortality was also reduced by 23% (P=0.055) but this was not statistically significant. For an average patient over her lifetime, low adherence was associated with a loss of 1.43 (95% CI: 1.15–1.71) discounted life years or 1.12 (95% CI: 0.91–1.34) discounted quality-adjusted life years (QALYs) and increased discounted medical costs of £5970 (95% CI: £4644–£7372). Assuming a willingness to pay threshold of £25 000 per QALY, the expected value of changing a patient from low to high adherence is £33 897 (95% CI: £28 322–£39 652).Conclusion:Patients with low adherence have shorter time to recurrence, increased medical costs and worse quality of life. Interventions that encourage patients to continue taking their treatment on a daily basis for the recommended 5-year period may be highly cost-effective.

The relationship between alcohol consumption and self-reported health status using the EQ5D: Evidence from rural Australia☆

Alcohol misuse represents one of the leading causes of preventable death, illness and injury in Australia. Extensive research exists estimating the effect of risky alcohol use on mortality, but little research quantifies the impact of risky alcohol consumption on morbidity. Such estimates are required to more precisely measure the benefit of interventions aimed at reducing risky alcohol use. Ordered probit and tobit models are used in this research to analyse the impact of risky drinking on self-reported health status using questionnaire data from an age and gender stratified sample drawn from 20 rural communities in New South Wales which are part of a large randomised controlled trial of community based alcohol interventions. It is found that risky alcohol use is associated with lower self-reported health; however, the average effect is small apart for those drinking at very-high risk. The effect of alcohol on morbidity, derived from the current analyses, is lower than that commonly used in current economics analyses. If this is accurate for geographical regions other than rural Australia, then from a policy viewpoint, these economic analyses may tend to overemphasise interventions which are morbidity reducing, such as taxation, and place undue focus on alcohol as a risk factor and consequently adversely impact resource allocation decisions.

Tackling Alcohol Misuse Purchasing Patterns Affected by Minimum Pricing for Alcohol

BackgroundAlcohol consumption is associated with a range of health and social harms that increase with the level of consumption. Policy makers are interested in effective and cost-effective interventions to reduce alcohol consumption and associated harms. Economic theory and research evidence demonstrate that increasing price is effective at the population level. Price interventions that target heavier consumers of alcohol may be more effective at reducing alcohol-related harms with less impact on moderate consumers. Minimum pricing per unit of alcohol has been proposed on this basis but concerns have been expressed that ‘moderate drinkers of modest means’ will be unfairly penalized. If those on low incomes are disproportionately affected by a policy that removes very cheap alcohol from the market, the policy could be regressive. The effect on households’ budgets will depend on who currently purchases cheaper products and the extent to which the resulting changes in prices will impact on their demand for alcohol. This paper focuses on the first of these points.ObjectiveThis paper aims to identify patterns of purchasing of cheap off-trade alcohol products, focusing on income and the level of all alcohol purchased.MethodThree years (2006–08) of UK household survey data were used. The Expenditure and Food Survey provides comprehensive 2-week data on household expenditure. Regression analyses were used to investigate the relationships between the purchase of cheap off-trade alcohol, household income levels and whether the household level of alcohol purchasing is categorized as moderate, hazardous or harmful, while controlling for other household and non-household characteristics. Predicted probabilities and quantities for cheap alcohol purchasing patterns were generated for all households.ResultsThe descriptive statistics and regression analyses indicate that low-income households are not the predominant purchasers of any alcohol or even of cheap alcohol. Of those who do purchase off-trade alcohol, the lowest income households are the most likely to purchase cheap alcohol. However, when combined with the fact that the lowest income households are the least likely to purchase any off-trade alcohol, they have the lowest probability of purchasing cheap off-trade alcohol at the population level. Moderate purchasing households in all income quintiles are the group predicted as least likely to purchase cheap alcohol. The predicted average quantity of low-cost off-trade alcohol reveals similar patterns.ConclusionThe results suggest that heavier household purchasers of alcohol are most likely to be affected by the introduction of a ‘minimum price per unit of alcohol’ policy. When we focus only on those households that purchase off-trade alcohol, lower income households are the most likely to be affected. However, minimum pricing in the UK is unlikely to be significantly regressive when the effects are considered for the whole population, including those households that do not purchase any off-trade alcohol. Minimum pricing will affect the minority of low-income households that purchase off-trade alcohol and, within this group, those most likely to be affected are households purchasing at a harmful level.

A cluster randomised stepped wedge trial to evaluate the effectiveness of a multifaceted information technology-based intervention in reducing high-risk prescribing of non-steroidal anti-inflammatory drugs and antiplatelets in primary medical care: The DQIP study protocol

BackgroundHigh-risk prescribing of non-steroidal anti-inflammatory drugs (NSAIDs) and antiplatelet agents accounts for a significant proportion of hospital admissions due to preventable adverse drug events. The recently completed PINCER trial has demonstrated that a one-off pharmacist-led information technology (IT)-based intervention can significantly reduce high-risk prescribing in primary care, but there is evidence that effects decrease over time and employing additional pharmacists to facilitate change may not be sustainable.Methods/designWe will conduct a cluster randomised controlled with a stepped wedge design in 40 volunteer general practices in two Scottish health boards. Eligible practices are those that are using the INPS Vision clinical IT system, and have agreed to have relevant medication-related data to be automatically extracted from their electronic medical records. All practices (clusters) that agree to take part will receive the data-driven quality improvement in primary care (DQIP) intervention, but will be randomised to one of 10 start dates. The DQIP intervention has three components: a web-based informatics tool that provides weekly updated feedback of targeted prescribing at practice level, prompts the review of individual patients affected, and summarises each patients relevant risk factors and prescribing; an outreach visit providing education on targeted prescribing and training in the use of the informatics tool; and a fixed payment of 350 GBP (560 USD; 403 EUR) up front and a small payment of 15 GBP (24 USD; 17 EUR) for each patient reviewed in the 12 months of the intervention. We hypothesise that the DQIP intervention will reduce a composite of nine previously validated measures of high-risk prescribing. Due to the nature of the intervention, it is not possible to blind practices, the core research team, or the data analyst. However, outcome assessment is entirely objective and automated. There will additionally be a process and economic evaluation alongside the main trial.DiscussionThe DQIP intervention is an example of a potentially sustainable safety improvement intervention that builds on the existing National Health Service IT-infrastructure to facilitate systematic management of high-risk prescribing by existing practice staff. Although the focus in this trial is on Non-steroidal anti-inflammatory drugs and antiplatelets, we anticipate that the tested intervention would be generalisable to other types of prescribing if shown to be effective.Trial registrationClinicalTrials.gov, dossier number: NCT01425502

Lies, Damned Lies, and Health Inequality Measurements: Understanding the Value Judgments

Supplemental Digital Content is available in the text.

The effectiveness of community-action in reducing risky alcohol consumption and harm: a cluster randomised controlled trial

In a cluster randomized controlled trial, Anthony Shakeshaft and colleagues measure the effectiveness of a multi-component community-based intervention for reducing alcohol-related harm.

Severe Hypoglycemia and Mortality After Cardiovascular Events for Type 1 Diabetic Patients in Sweden

OBJECTIVE To examine whether previous severe hypoglycemic events were associated with the risk of all-cause mortality after major cardiovascular events (myocardial infarction [MI] or stroke) in patients with type 1 diabetes. RESEARCH DESIGN AND METHODS This study is based on data from the Swedish National Diabetes Register linked to patient-level hospital records, prescription data, and death records. We selected patients with type 1 diabetes who visited a clinic during 2002–2010 and experienced a major cardiovascular complication after their clinic visit. We estimated a two-part model for all-cause mortality after a major cardiovascular event: logistic regression for death within the first month and a Cox proportional hazards model conditional on 1-month survival. At age 60 years, 5-year cumulative mortality risk was estimated from the models for patients with and without prior diabetes complications. RESULTS A total of 1,839 patients experienced major cardiovascular events, of whom 403 had previously experienced severe hypoglycemic events and 703 died within our study period. A prior hypoglycemic event was associated with a significant increase in mortality after a cardiovascular event, with hazard ratios estimated at 1.79 (95% CI 1.37–2.35) within the first month and 1.25 (95% CI 1.02–1.53) after 1 month. Patients with prior hypoglycemia had an estimated 5-year cumulative mortality risk of 52.4% (95% CI 45.3–59.5) and 39.8% (95% CI 33.4–46.3) for MI and stroke, respectively. CONCLUSIONS We have found evidence that patients with type 1 diabetes in Sweden with prior severe hypoglycemic events have increased risk of mortality after a cardiovascular event.

Accounting for the dead in the longitudinal analysis of income-related health inequalities

This paper develops an accounting framework to consider the effect of deaths on the longitudinal analysis of income-related health inequalities. Ignoring deaths or using Inverse Probability Weights (IPWs) to re-weight the sample for mortality-related attrition can produce misleading results. Incorporating deaths into the longitudinal analysis of income-related health inequalities provides a more complete picture in terms of the evaluation of health changes in respect to socioeconomic status. We illustrate our work by investigating health mobility from 1999 till 2004 using the British Household Panel Survey (BHPS). We show that for Scottish males explicitly accounting for the dead rather than using IPWs to account for mortality-related attrition changes the direction of the relationship between relative health changes and initial income position, from negative to positive, while for other groups it significantly increases the strength of the positive relationship. Incorporating the dead may be vital in the longitudinal analysis of health inequalities.

The income-climate trap of health development: A comparative analysis of African and non-African countries

This article conducts a comparative analysis of the interrelationship between climate, life expectancy and income between African and non-African countries. To put the analysis in a broader context of development, the paper develops an income-climate trap model that explains the multi-directional interaction between income, climate and life expectancy. It is suggested that the interaction can give rise to either a virtuous cycle of prosperity or a vicious cycle of poverty. Applying the model to a data set of 158 countries, we find that climate is a more important determinant of life expectancy in African countries than in non-African countries. We provide further empirical evidence that while climate is important in determining both life expectancy and income, income can in turn moderate the adverse effects of climate on life expectancy. In the past two decades, the income level of non-African countries has grown significantly while that of African countries has largely been stagnant, implying that the future development of African countries remains highly vulnerable to adverse climatic conditions. These findings have important implications in the context of climate change, as global warming is likely to create worsening climatic conditions that could see many less developed countries sinking deeper into an income-climate trap of underdevelopment in health.