Rational Prescribing in Primary care (RaPP): process evaluation of an intervention to improve prescribing of antihypertensive and cholesterol-lowering drugs

BACKGROUND: A randomised trial of a multifaceted intervention for improving adherence to clinical practice guidelines for the pharmacological management of hypertension and hypercholesterolemia increased prescribing of thiazides, butdetected no impact onthe use of cardiovascular risk assessment toolsor achievement of treatment targets. We carried out a predominantly quantitative process evaluation to help explain and interpret the trial-findings. METHODS: Several data-sources were used including: questionnaires completed by pharmacists immediately after educational outreach visits, semi-structured interviews with physicians subjected to the intervention, and data extracted from their electronic medical records. Multivariate regression analyses were conducted to explore the association between possible explanatory variables and the observed variation across practices for the three main outcomes. RESULTS: The attendance rate during the educational sessions in each practice was high; few problems were reported, and the physicians were perceived as being largely supportive of the recommendations we promoted, except for some scepticism regarding the use of thiazides as first-line antihypertensive medication. Multivariate regression models could explain only a small part of the observed variation across practices and across trial-outcomes, and key factors that might explain the observed variation in adherence to the recommendations across practices were not identified. CONCLUSION: This study did not provide compelling explanations for the trial results. Possible reasons for this include a lack of statistical power and failure to include potential explanatory variables in our analyses, particularly organisational factors. More use of qualitative research methods in the course of the trial could have improved our understanding

Improving the use of research evidence in guideline development: 2. Priority setting

BACKGROUND: The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the second of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this. OBJECTIVES: We reviewed the literature on priority setting for health care guidelines, recommendations and technology assessments. METHODS: We searched PubMed and three databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct systematic reviews ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments. KEY QUESTIONS AND ANSWERS: There is little empirical evidence to guide the choice of criteria and processes for establishing priorities, but there are broad similarities in the criteria that are used by various organisations and practical arguments for setting priorities explicitly rather than implicitly, WHAT CRITERIA SHOULD BE USED TO ESTABLISH PRIORITIES? • WHO has limited resources and capacity to develop recommendations. It should use these resources where it has the greatest chance of improving health, equity, and efficient use of healthcare resources. • We suggest the following criteria for establishing priorities for developing recommendations based on WHO's aims and strategic advantages: • Problems associated with a high burden of illness in low and middle-income countries, or new and emerging diseases. • No existing recommendations of good quality. • The feasibility of developing recommendations that will improve health outcomes, reduce inequities or reduce unnecessary costs if they are implemented. • Implementation is feasible, will not exhaustively use available resources, and barriers to change are not likely to be so high that they cannot be overcome. • Additional priorities for WHO include interventions that will likely require system changes and interventions where there might be a conflict in choices between individual and societal perspectives. WHAT PROCESSES SHOULD BE USED TO AGREE ON PRIORITIES? • The allocation of resources to the development of recommendations should be part of the routine budgeting process rather than a separate exercise. • Criteria for establishing priorities should be applied using a systematic and transparent process. • Because data to inform judgements are often lacking, unmeasured factors should also be considered – explicitly and transparently. • The process should include consultation with potential end users and other stakeholders, including the public, using well-constructed questions, and possibly using Delphi-like procedures. • Groups that include stakeholders and people with relevant types of expertise should make decisions. Group processes should ensure full participation by all members of the group. • The process used to select topics should be documented and open to inspection. SHOULD WHO HAVE A CENTRALISED OR DECENTRALISED PROCESS? • Both centralised and decentralised processes should be used. Decentralised processes can be considered as separate "tracks". • Separate tracks should be used for considering issues for specific areas, populations, conditions or concerns. The rationales for designating special tracks should be defined clearly; i.e. why they warrant special consideration. • Updating of guidelines could also be considered as a separate "track", taking account of issues such as the need for corrections and the availability of new evidence

Improving the use of research evidence in guideline development: 6. Determining which outcomes are important

BACKGROUND: The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the sixth of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this. OBJECTIVES: We reviewed the literature on determining which outcomes are important for the development of guidelines. METHODS: We searched five databases of methodological studies for existing systematic reviews and relevant methodological research. We did not conduct a complete systematic review ourselves. Our conclusions are based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments. KEY QUESTIONS AND ANSWERS: We did not find a systematic review that addresses any of the following key questions and we found limited relevant research evidence. What methods should WHO use to identify important outcomes? • Methods of outcome identification should be transparent and explicit. • The consultation process should start with identification of all relevant outcomes associated with an intervention. • Those affected, including consumers, should be involved in the selection of outcomes. • A question driven approach (what is important?) is preferable to a data driven approach (what data are at hand?) to identify important outcomes. What type of outcomes should WHO consider and how should cultural diversity be taken account of in the selection of outcomes? • Desirable (benefits, less burden and savings) and undesirable effects should be considered in all guidelines. • Undesirable effects include harms (including the possibility of unanticipated adverse effects), greater burden (e.g. having to go to the doctor) and costs (including opportunity costs). • Important outcomes (e.g. mortality, morbidity, quality of life) should be preferred over surrogate, indirect outcomes (e.g. cholesterol levels, lung function) that may or may not correlate with patient important outcomes. • Ethical considerations should be part of the evaluation of important outcomes (e.g. impacts on autonomy). • If the importance of outcomes is likely to vary across cultures, stakeholders from diverse cultures should be consulted and involved in the selection of outcomes. How should the importance of outcomes be ranked? • Outcomes should be ranked by relative importance, separated into benefits and downsides. • Information from research on values and preferences should inform the ranking of outcomes whenever possible. • If the importance of outcomes is likely to vary across cultures, ranking of outcomes should be done in specific settings. • If evidence is lacking for an important outcome, this should be acknowledged, rather than ignoring the outcome

Rational Prescribing in Primary Care (RaPP-trial). A randomised trial of a tailored intervention to improve prescribing of antihypertensive and cholesterol-lowering drugs in general practice [ISRCTN48751230]

BACKGROUND: The underlying reasons for differences between clinical practice and systematically developed guidelines vary from one clinical problem to another. It is therefore logical to tailor strategies to support the implementation of guidelines to address identified barriers to change. The objective of this trial is to evaluate the effects of a tailored intervention to support the implementation of systematically developed guidelines for the use of antihypertensive and cholesterol-lowering drugs for the primary prevention of cardiovascular disease. METHODS/DESIGN: Unblinded, cluster-randomised trial. 150 general practices will be recruited from two geographical areas in Norway, and randomised to the intervention or control group (passive dissemination of guidelines). Outcomes will be measured for all eligible patients seen in the participating practices during one year after the intervention. A multifaceted intervention has been tailored to address identified barriers to change. Key components are an educational outreach visit with audit and feedback, and computerised reminders. Pharmacists will conduct the visits. During the outreach visit the main recommendations will be presented and software will be installed that links to the electronic medical record systems used in the participating practices. The software will perform an audit that will be fed back during the visit, present pop-up reminders for patients with high blood pressure or cholesterol, and provide a cardiovascular risk calculator and patient education material. The main outcomes are the proportions of 1) first time prescriptions for hypertension where thiazides are not prescribed, 2) patients not assessed for cardiovascular risk before prescribing antihypertensive or cholesterol-lowering drugs, and 3) patients treated for hypertension or high cholesterol for three months or more who have not achieved recommended treatment goals

Association between Face mask use and Risk of SARS-CoV-2 Infection: Cross-sectional study

We examined the association between face masks and risk of infection with SARS-CoV-2 using cross-sectional data from 3,209 participants in a randomized trial exploring the effectiveness of glasses in reducing the risk of SARS-CoV-2 infection. Face mask use was based on participants’ response to the end-of-follow-up survey. We found that the incidence of self-reported COVID-19 was 33% (aRR 1.33; 95% CI 1.03–1.72) higher in those wearing face masks often or sometimes, and 40% (aRR 1.40; 95% CI 1.08–1.82) higher in those wearing face masks almost always or always, compared to participants who reported wearing face masks never or almost never. We believe the observed increase in the incidence of infection associated with wearing a face mask is likely due to unobservable and hence nonadjustable differences between those wearing and not wearing a mask. Observational studies reporting on the relationship between face mask use and risk of respiratory infections should be interpreted cautiously, and more randomized trials are needed.publishedVersio

The “Child Health Evidence Week” and GRADE grid may aid transparency in the deliberative process of guideline development

AbstractObjectiveTo explore the evidence translation process during a 1-week national guideline development workshop (“Child Health Evidence Week”) in Kenya.Study Design and SettingNonparticipant observational study of the discussions of a multidisciplinary guideline development panel in Kenya. Discussions were aided by GRADE (Grading of Recommendations Assessment, Development, and Evaluation) grid.ResultsThree key thematic categories emerged: 1) “referral to other evidence to support or refute the proposed recommendations;” 2) “assessment of the presented research evidence;” and 3) “assessment of the local applicability of evidence.” The types of evidence cited included research evidence and anecdotal evidence based on clinician experiences. Assessment of the research evidence revealed important challenges in the translation of evidence into recommendations, including absence of evidence, low quality or inconclusive evidence, inadequate reporting of key features of the management under consideration, and differences in panelists’ interpretation of the research literature. A broad range of factors with potential to affect local applicability of evidence were discussed.ConclusionThe process of the “Child Health Evidence Week” combined with the GRADE grid may aid transparency in the deliberative process of guideline development, and provide a mechanism for comprehensive assessment, documentation, and reporting of multiple factors that influence the quality and applicability of guideline recommendations

The Effects of Mandatory Prescribing of Thiazides for Newly Treated, Uncomplicated Hypertension: Interrupted Time-Series Analysis

Atle Fretheim and colleagues found that the prescribing of thiazides in Norway for uncomplicated hypertension more than doubled after a rule requiring their use as first-choice therapy was put into effect

Quasi-experimental study designs series – Paper 10: Synthesizing evidence for effects collected from quasi-experimental studies presents surmountable challenges

Objective: To outline issues of importance to analytic approaches to the synthesis of quasi-experiments (QEs), and to provide a statistical model for use in analysis. Study Design and Setting: We drew on the literatures of statistics, epidemiology, and social-science methodology to outline methods for synthesis of QE studies. The design and conduct of quasi-experiments, effect sizes from QEs, and moderator variables for the analysis of those effect sizes were discussed. Results: Biases, confounding, design complexities and comparisons across designs offer serious challenges to syntheses of QEs. Key components of meta-analyses of QEs were identified, including the aspects of QE study design to be coded and analyzed. Of utmost importance are the design and statistical controls implemented in the QEs. Such controls and any potential sources of bias and confounding must be modeled in analyses, along with aspects of the interventions and populations studied. Because of such controls, effect sizes from QEs are more complex than those from randomized experiments. A statistical meta-regression model that incorporates important features of the QEs under review was presented. Conclusion: Meta-analyses of quasi-experiments provide particular challenges, but thorough coding of intervention characteristics and study methods, along with careful analysis, should allow for sound inferences