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

Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study

Objective To examine the use of qualitative approaches alongside randomised trials of complex healthcare interventions

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

Portals to Wonderland: Health portals lead to confusing information about the effects of health care

BACKGROUND: The Internet offers a seemingly endless amount of health information of varying quality. Health portals, which provide entry points to quality-controlled collections of websites, have been hailed as a solution to this problem. The objective of this study is to assess the extent to which government-run health portals provide access to relevant, valid and understandable information about the effects of health care. METHODS: We selected eight clinically relevant questions for which there was a systematic review, searched four portals for answers, and compared the answers we found to the results of the systematic reviews. RESULTS: Our searches resulted in 3400 hits, 155 of which mentioned both the condition and the intervention in one of the eight questions. Sixty-three of the 155 web pages did not give any information about the effect of the intervention. Seventy-seven qualitatively described the effects of the intervention. Twenty-six of these had information that was too unclear to be categorised; 15 were not consistent with the systematic review; and 36 were consistent with the review, but usually did not mention what happens without the intervention, what outcomes have been measured or when they were measured. Fifteen web pages quantitatively described effects. Four of these were abstracts from the systematic review, nine had information that was incomplete and potentially misleading because of a lack of information about people not receiving the intervention and the length of follow-up; one had information that was consistent with the review, but only referred to three trials whereas the review included six; and one was consistent with the review. CONCLUSION: Information accessible through health portals is unlikely to be based on systematic reviews and is often unclear, incomplete and misleading. Portals are only as good as the websites they lead to. Investments in national health portals are unlikely to benefit consumers without investments in the production and maintenance of relevant, valid and understandable information to which the portals lead

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

SUPPORT Tools for evidence-informed health Policymaking (STP)

This article is the Introduction to a series written for people responsible for making decisions about health policies and programmes and for those who support these decision makers

Publication bias in clinical trials

This is the protocol for a review and there is no abstract. The objectives are as follows: To summarise evidence of publication bias for trials of health care interventions.Output Type: Protoco

Key concepts for informed health choices: Where’s the evidence? [version 2; peer review: 2 approved, 1 approved with reservations]

Background The Informed Health Choices (IHC) Key Concepts is a framework that provides a basis for developing educational resources and evaluating people’s ability to think critically about health actions. We developed the original Key Concepts framework by reviewing texts and checklists for the public, journalists, and health professionals and collecting structured feedback from an international advisory group. We revised the original 2015 framework yearly from 2016 to 2018 based on feedback and experience using the framework. The objectives of this paper are to describe the development of the framework since 2018 and summarise their basis. Methods For the 2019 version, we responded to feedback on the 2018 version. For the current 2022 version, in addition to responding to feedback on the 2019 version, we reviewed the evidence base for each of the concepts. Whenever possible, we referenced systematic reviews that provide a basis for a concept. We screened all Cochrane methodology reviews and searched Epistemonikos, PubMed, and Google Scholar for methodology reviews and meta-epidemiological studies. Results The original framework included 32 concepts in six groups. The 2019 version and the current 2022 version include 49 concepts in the same three main groups that we have used since 2016. There are now 10 subgroups or higher-level concepts. For each concept, there is an explanation including one or more examples, the basis for the concept, and implications. Over 600 references are cited that support the concepts, and over half of the references are systematic reviews. Conclusions There is a large body of evidence that supports the IHC key concepts and we have received few suggestions for changes since 2019