Search

Abstract Background Few randomized trials of public health and social measures were carried out during the COVID-19 pandemic. We report on the major barriers we faced when we tried to run such trials. Methods We reviewed all randomized trials proposed and initiated by the Centre for Epidemic Interventions Research in Norway during the COVID-19 pandemic. Results Of the 18 proposed trials, 11 trials were not implemented. One of the key legal and ethical barriers to conducting the trials was the Norwegian Health Research Act, which demands informed consent from all participants who are exposed to an intervention. A lack of sufficient political support was also a challenge, as was unpredictability, due to shifting disease incidence and changing recommendations from the authorities. Conclusion Strengthening the evidence base for public health and social measures in pandemics will require political and public understanding and support and a legal framework that allows for the conduct of such trials.

Objectives To systematically review and meta-analyse the evidence for effect modification by refractory status and number of treatment lines in relapsed/refractory multiple myeloma (RRMM); and to assess whether effect modification is likely to invalidate network meta-analyses (NMA) that assume negligible modification.Design Systematic review, meta-analysis and simulation.Data sources We systematically searched the literature (e.g., OVID Medline) to identify eligible publications in February 2020 and regularly updated the search until January 2022. We also contacted project stakeholders (including industry)Eligibility criteria Phase 2 and 3 randomised controlled trials reporting stratified estimates for comparisons with at least one of a prespecified set of treatments relevant for use in Norwegian RRMM patients.Outcomes We used meta-analysis to estimate relative HRs (RHRs) for overall survival (OS) and progression-free survival (PFS) with respect to refractory status and number of treatment lines. We used the estimated RHRs in simulations to estimate the percentage of NMA results expected to differ significantly in the presence versus absence of effect modification.Results Among the 42 included publications, stratified estimates were published by and extracted from up to 18 (43%) publications and on as many as 8364 patients. Within-study evidence for effect modification is very weak (p>0.05 for 47 of 49 sets of stratified estimates). The largest RHR estimated was 1.32 (95% CI 1.18 to 1.49) for the modifying effect of refractory status on HR for PFS. Simulations suggest that, in the worst case, this would result in only 4.48% (95% CI 4.42% to 4.54%) of NMA estimates differing statistically significantly in the presence versus absence of effect modification.Conclusions Based on the available evidence, effect modification appears to be sufficiently small that it can be neglected in adequately performed NMAs. NMAs can probably be relied on to provide estimates of HRs for OS and PFS in RRMM, subject to caveats discussed herein.

Background: English media have reported that many unvaccinated individuals took the COVID-19 vaccine after receiving a phone call from their GP. Aim: To determine whether phone calls from GPs to unvaccinated patients at increased risk of severe COVID-19 improves uptake of the COVID-19 vaccine. Design & setting: Randomised trial where 202 participants were allocated to receive a phone call from their GP, and 452 participants were allocated to not get the call. Twenty-five GPs at 11 medical centres in Norway took part. The post-trial focus group discussion was with five GPs. Method: Participants were sourced from the GP electronic medical record system, which communicates with the Norwegian Immunisation Registry and can generate a list of the GPs’ unvaccinated patients at increased risk of severe COVID-19. Results: The GPs managed to speak over the phone with 154 (76%) patients allocated to receiving a phone call. At follow-up (average 7.5 weeks), 8.9% in the intervention group and 5.3% in the control group had been vaccinated (odds ratio [OR] 1.72; 95% confidence interval [CI] = 0.90 to 3.28). Findings from the focus group discussion suggested the timing of the intervention as a likely key reason for its limited success. Conclusion: An increase in the proportion of patients who took the COVID-19 vaccine in the intervention group was observed, but the difference was smaller than anticipated, and may be a chance finding. The effect of this type of intervention will likely vary across contexts and may have proved more effective if a larger proportion of the population were unvaccinated.

Abstract Much health communication during the COVID-19 pandemic has been designed to persuade people more than to inform them. For example, messages like “masks save lives” are intended to compel people to wear face masks, not to enable them to make an informed decision about whether to wear a face mask or to understand the justification for a mask mandate. Both persuading people and informing them are reasonable goals for health communication. However, those goals can sometimes be in conflict. In this article, we discuss potential conflicts between seeking to persuade or to inform people, the use of spin to persuade people, the ethics of persuasion, and implications for health communication in the context of the pandemic and generally. Decisions to persuade people rather than enable them to make an informed choice may be justified, but the basis for those decisions should be transparent and the evidence should not be distorted. We suggest nine principles to guide decisions by health authorities about whether to try to persuade people.

Abstract Background Closed fitness centers during the Covid-19 pandemic may negatively impact health and wellbeing. We assessed whether training at fitness centers increases the risk of SARS-CoV-2 virus infection. Methods In a two-group parallel randomized controlled trial, fitness center members aged 18 to 64 without Covid-19-relevant comorbidities, were randomized to access to training at a fitness center or no-access. Fitness centers applied physical distancing (1 m for floor exercise, 2 m for high-intensity classes) and enhanced hand and surface hygiene. Primary outcomes were SARS-CoV-2 RNA status by polymerase chain reaction (PCR) after 14 days, hospital admission after 21 days. The secondary endpoint was SARS-CoV-2 antibody status after 1 month. Results 3764 individuals were randomized; 1896 to the training arm and 1868 to the no-training arm. In the training arm, 81.8% trained at least once, and 38.5% trained ≥six times. Of 3016 individuals who returned the SARS-CoV-2 RNA tests (80.5%), there was one positive test in the training arm, and none in the no-training arm (risk difference 0.053%; 95% CI − 0.050 to 0.156%; p = 0.32). Eleven individuals in the training arm (0.8% of tested) and 27 in the no-training arm (2.4% of tested) tested positive for SARS-CoV-2 antibodies (risk difference − 0.87%; 95%CI − 1.52% to − 0.23%; p = 0.001). No outpatient visits or hospital admissions due to Covid-19 occurred in either arm. Conclusion Provided good hygiene and physical distancing measures and low population prevalence of SARS-CoV-2 infection, there was no increased infection risk of SARS-CoV-2 in fitness centers in Oslo, Norway for individuals without Covid-19-relevant comorbidities. Trial registration The trial was prospectively registered in ClinicalTrials.gov on May 13, 2020. Due to administrative issues it was first posted on the register website on May 29, 2020: NCT04406909 .

BackgroundA low test positivity rate is key to keeping the COVID-19 pandemic under control. Throughout the pandemic, several migrant groups in Norway have seen higher rates of confirmed COVID-19 and related hospitalizations, while test positivity has remained high in the same groups. The Norwegian government has used several platforms for communication, and targeted social media advertisements have in particular been an important part of the communication strategy to reach these groups. ObjectiveIn this study, we aimed to investigate whether such a targeted Facebook campaign increased the rate of COVID-19 tests performed in certain migrant groups. MethodsWe randomly assigned 386 Norwegian municipalities and city districts to intervention or control groups. Individuals born in Eritrea, Iraq, Pakistan, Poland, Russia, Somalia, Syria, and Turkey residing in intervention areas were targeted with a social media campaign aiming at increasing the COVID-19 test rate. The campaign message was in a simple language and conveyed in the users’ main language or in English. ResultsDuring the 2-week follow-up period, the predicted probability of having a COVID-19 test taken was 4.82% (95% CI 4.47%-5.18%) in the control group, and 5.58% (95% CI 5.20%-5.99%) in the intervention group (P=.004). ConclusionsOur targeted social media intervention led to a modest increase in test rates among certain migrant groups in Norway. Trial RegistrationClinicalTrials.gov NCT04866589; https://clinicaltrials.gov/ct2/show/NCT04866589

Abstract Background Validated instruments to assess breastfeeding knowledge and attitude are non-existent in Africa including Ethiopia. We aimed to adapt and validate the Breastfeeding Knowledge Questionnaire (BFKQ) and the Iowa Infant Feeding Attitude Scale (IIFAS) for use in Afan Oromo (AO), the most widely spoken language in Ethiopia. Methods After forward-backward translation into Afan Oromo, the instruments were reviewed for content validity by a panel of a nutritionist and pediatricians, and pretested on a sample of 30 mothers. Then, a cross-sectional study involving 468 pregnant women in their second and third trimester was conducted between May and August 2017 in the Manna district, Southwest Ethiopia, using the final versions of the adapted questionnaires. We used exploratory and confirmatory factor analysis to assess the construct validity, receiver operating characteristic (ROC) curves to determine the predictive validity and Cronbach’s alpha coefficients to assess internal consistency. Results Using exploratory factor analysis (EFA), nine domains containing 34 items were extracted from the BFKQ-AO. A confirmatory factor analysis of the constructs from EFA confirmed construct validity of the instrument (χ2/df = 2.11, RMSEA = 0.049, CFI = 0.845, TLI = 0.823). In factor analysis of the IIFAS, the first factor explained 19.7% of the total variance and the factor loadings and scree plot test suggested unidimensionality of the tool. Cronbach’s alpha was 0.79 for the BFKQ-AO and 0.72 for IIFAS-AO suggesting an acceptable internal consistency of both instruments. For the sensitivity and specificity in predicting intention of breastfeeding for ≥24 months, the area under the curve (AUC) was 82% for IIFAS score and 79% for BFKQ score. Conclusions Here we present the first study that reported the use of the BFKQ and the IIFAS in Ethiopia. Our results showed that both BFKQ-AO and IIFAS-AO can be reliable and valid tools for measuring maternal breastfeeding knowledge and attitude in the study population, showing the potential for adapting these tools for application in a wider Ethiopian context.

Abstract Background People of all ages are flooded with health claims about treatment effects (benefits and harms of treatments). Many of these are not reliable, and many people lack skills to assess their reliability. Primary school is the ideal time to begin to teach these skills, to lay a foundation for continued learning and enable children to make well-informed health choices, as they grow older. However, these skills are rarely being taught and yet there are no rigorously developed and evaluated resources for teaching these skills. Objectives To develop the Informed Health Choices (IHC) resources (for learning and teaching people to assess claims about the effects of treatments) for primary school children and teachers. Methods We prototyped, piloted, and user-tested resources in four settings that included Uganda, Kenya, Rwanda, and Norway. We employed a user-centred approach to designing IHC resources which entailed multiple iterative cycles of development (determining content scope, generating ideas, prototyping, testing, analysing and refining) based on continuous close collaboration with teachers and children. Results We identified 24 Key Concepts that are important for children to learn. We developed a comic book and a separate exercise book to introduce and explain the Key Concepts to the children, combining lessons with exercises and classroom activities. We developed a teachers’ guide to supplement the resources for children. Conclusion By employing a user-centred approach to designing resources to teach primary children to think critically about treatment claims and choices, we developed learning resources that end users experienced as useful, easy to use and well-suited to use in diverse classroom settings.

Abstract Introduction Earlier, we designed and evaluated an educational mass media intervention for improving people’s ability to think more critically and to assess the trustworthiness of claims (assertions) about the benefits and harms (effects) of treatments. The overall aims of this follow-up study were to evaluate the impact of our intervention 1 year after it was administered, and to assess retention of learning and behaviour regarding claims about treatments. Methods We randomly allocated consenting parents to listen to either the Informed Health Choices podcast (intervention) or typical public service announcements about health issues (control) over 7–10 weeks. Each intervention episode explained how the trustworthiness of treatment claims can be assessed by using relevant key concepts of evidence-informed decision-making. Participants listened to two episodes per week, delivered by research assistants. We evaluated outcomes immediately, and a year after the intervention. Primary outcomes were mean score and the proportion with a score indicating a basic ability to apply the key concepts (> 11 out of 18 correct answers) on a tool measuring people’s ability to critically appraise the trustworthiness of treatment claims. Skills decay/retention was estimated by calculating the relative difference between the follow-up and initial results in the intervention group, adjusting for chance. Statistical analyses were performed using R (R Core Team, Vienna, Austria; version 3.4.3). Results After 1 year, the mean score for parents in the intervention group was 58.9% correct answers, compared to 52.6% in the control (adjusted mean difference of 6.7% (95% CI 3.3% to 10.1%)). In the intervention group, 47.2% of 267 parents had a score indicating a basic ability to assess treatment claims compared to 39.5% of 256 parents in the control (adjusted difference of 9.8% more parents (95% CI 0.9% to 18.9%). These represent relative reductions of 29% in the mean scores and 33% in the proportion of parents with a score indicating a basic ability to assess the trustworthiness of claims about treatment effects. Conclusions Although listening to the Informed Health Choices podcast initially led to a large improvement in the ability of parents to assess claims about the effects of treatments, our findings show that these skills decreased substantially over 1 year. More active practice could address the substantial skills decay observed over 1 year. Trial registration Pan African Clinical Trial Registry (www.pactr.org), PACTR201606001676150. Registered on 12 June 2016.

Abstract Introduction We evaluated an intervention designed to teach 10- to 12-year-old primary school children to assess claims about the effects of treatments (any action intended to maintain or improve health). We report outcomes measured 1 year after the intervention. Methods In this cluster-randomised trial, we included primary schools in the central region of Uganda that taught year 5 children (aged 10 to 12 years). We randomly allocated a representative sample of eligible schools to either an intervention or control group. Intervention schools received the Informed Health Choices primary school resources (textbooks, exercise books and a teachers’ guide). The primary outcomes, measured at the end of the school term and again after 1 year, were the mean score on a test with two multiple-choice questions for each of the 12 concepts and the proportion of children with passing scores. Results We assessed 2960 schools for eligibility; 2029 were eligible, and a random sample of 170 were invited to recruitment meetings. After recruitment meetings, 120 eligible schools consented and were randomly assigned to either the intervention group (n = 60 schools; 76 teachers and 6383 children) or the control group (n = 60 schools; 67 teachers and 4430 children). After 1 year, the mean score in the multiple-choice test for the intervention schools was 68.7% compared with 53.0% for the control schools (adjusted mean difference 16.7%; 95% CI, 13.9 to 19.5; P

Abstract Background Claims about what we need to do to improve our health are everywhere. Most interventions simply tell people what to do, and do not empower them to critically assess health information. Our objective was to design mass media resources to enable the public to critically appraise the trustworthiness of claims about the benefits and harms of treatments and make informed health choices. Methods Research was conducted between 2013 and 2016 across multiple iterative phases. Participants included researchers, journalists, parents, other members of the public. First, we developed a list of 32 key concepts that people need to understand to be able to assess the trustworthiness of claims about treatment effects. Next, we used a human-centred design approach, to generate ideas for resources for teaching the key concepts, and developed and user-tested prototypes through qualitative interviews. We addressed identified problems and repeated this process until we had a product that was deemed relevant and desirable by our target audience, and feasible to implement. Results We generated over 160 ideas, mostly radio-based. After prototyping some of these, we found that a podcast produced collaboratively by health researchers and journalists was the most promising approach. We developed eight episodes of the Informed Health Choices podcast, a song on critical thinking about treatments and a reminder checklist. Early versions of the podcast were reportedly too long, boring and confusing. We shortened the episodes, included one key concept per episode, and changed to story-telling with skits. The final version of the podcast was found to be useful, understandable, credible and desirable. Conclusion We found many problems with various prototypes of mass media resources. Using a human-centred design approach, we overcame those problems. We have developed a guide to help others prepare similar podcasts.

Objectives: Higher education institutions all over the world struggled to balance the need for infection control and educational requirements, as they prepared to reopen after the first wave of the COVID-19 pandemic. A particularly difficult choice was whether to offer for in-person or online teaching. Norwegian universities and university colleges opted for a hybrid model when they reopened for the autumn semester, with some students being offered more in-person teaching than others. We seized this opportunity to study the association between different teaching modalities and COVID-19 risk, quality of life (subjective well-being), and teaching satisfaction. Study design: Prospective, observational cohort study. Methods: We recruited students in higher education institutions in Norway who we surveyed biweekly from September to December in 2020. Results: 26 754 students from 14 higher education institutions provided data to our analyses. We found that two weeks of in-person teaching was negatively associated with COVID-19 risk compared to online teaching, but the difference was very uncertain (−22% relative difference; 95% CI -77%–33%). Quality of life was positively associated with in-person teaching (3%; 95% CI 2%–4%), as was teaching satisfaction (10%; 95% CI 8%–11%). Conclusion: The association between COVID-19 infection and teaching modality was highly uncertain. Shifting from in-person to online teaching seems to have a negative impact on the well-being of students in higher education.

Abstract Background Uganda, a low resource country, implemented the skilled attendance at birth strategy, to meet a key target of the 5th Millenium Development Goal (MDG), 75% reduction in maternal mortality ratio. Maternal mortality rates remained high, despite the improvement in facility delivery rates. In this paper, we analyse the strategies implemented and bottlenecks experienced as Uganda’s skilled birth attendance policy was rolled out. These experiences provide important lessons for decision makers as they implement policies to further improve maternity care. Methods This is a case study of the implementation process, involving a document review and in-depth interviews among key informants selected from the Ministry of Health, Professional Organisations, Ugandan Parliament, the Health Service Commission, the private not-for-profit sector, non-government organisations, and District Health Officers. The Walt and Gilson health policy triangle guided data collection and analysis. Results The skilled birth attendance policy was an important priority on Uganda’s maternal health agenda and received strong political commitment, and support from development partners and national stakeholders. Considerable effort was devoted to implementation of this policy through strategies to increase the availability of skilled health workers for instance through expanded midwifery training, and creation of the comprehensive nurse midwife cadre. In addition, access to emergency obstetric care improved to some extent as the physical infrastructure expanded, and distribution of medicines and supplies improved. However, health worker recruitment was slow in part due to the restrictive staff norms that were remnants of previous policies. Despite considerable resources allocated to creating the comprehensive nurse midwife cadre, this resulted in nurses that lacked midwifery skills, while the training of specialised midwives reduced. The rate of expansion of the physical infrastructure outpaced the available human resources, equipment, blood infrastructure, and several health facilities were not fully functional. Conclusion Uganda’s skilled birth attendance policy aimed to increase access to obstetric care, but recruitment of human resources, and infrastructural capacity to provide good quality care remain a challenge. This study highlights the complex issues and unexpected consequences of policy implementation. Further evaluation of this policy is needed as decision-makers develop strategies to improve access to skilled care at birth.

Abstract Background Human papillomavirus (HPV) infection causes cervical cancer. More than 80% of those diagnosed with cervical cancer live in low- and middle-income countries (LMICs). The World Health Organization recommends vaccination as a public health measure against cervical cancer. Communication interventions are able to change how people think about vaccination and are thus instrumental in addressing vaccine hesitancy. Our aim was to provide a broad scoping overview of the available evidence on communication with adolescents, parents, and other stakeholders around HPV vaccination for adolescents, with a specific focus on LMICs. Methods We conducted a systematic scoping overview of systematic reviews addressing a range of questions regarding communication around HPV vaccination. We considered reviews published between 2007 and 2018 focusing on communication around HPV vaccination and that searched for qualitative or quantitative studies for inclusion. We searched the Epistemonikos database which includes reviews from multiple electronic databases. Two overview authors screened titles and abstracts and examined potentially eligible reviews in full text. Data extraction was performed by one overview author and verified by a second. We assessed the reliability of the included reviews using an adapted version of AMSTAR 2. Results We included twelve reviews in our overview. Four reviews assessed the effectiveness of communication interventions. These interventions intended to inform or educate about HPV and HPV vaccination, such as videos and fact sheets, or to remind or recall, such as text message reminders. Eight reviews assessed factors associated with HPV vaccination uptake, including communication-related factors such as whether the vaccine was recommended by a physician and people’s knowledge regarding the vaccine. Nine reviews searched for studies from LMICs, but most found only a small number of studies from these countries. Conclusions The small number of studies identified from LMICs is of concern as these countries face the largest burden of disease related to HPV. This scoping overview also found and excluded a number of reviews because of important methodological limitations, highlighting the need for future reviews to use appropriate methods. The overview indicates areas in which further primary studies are needed on HPV vaccination communication in LMICs. Systematic review registration Open Science Framework https://osf.io/agzb4/

Objectives To make informed decisions about healthcare, patients and the public, health professionals and policymakers need information about the effects of interventions. People need information that is based on the best available evidence; that is presented in a complete and unbiased way; and that is relevant, trustworthy and easy to use and to understand. The aim of this paper is to provide guidance and a checklist to those producing and communicating evidence-based information about the effects of interventions intended to inform decisions about healthcare.Design To inform the development of this checklist, we identified research relevant to communicating evidence-based information about the effects of interventions. We used an iterative, informal consensus process to synthesise our recommendations. We began by discussing and agreeing on some initial recommendations, based on our own experience and research over the past 20–30 years. Subsequent revisions were informed by the literature we examined and feedback. We also compared our recommendations to those made by others. We sought structured feedback from people with relevant expertise, including people who prepare and use information about the effects of interventions for the public, health professionals or policymakers.Results We produced a checklist with 10 recommendations. Three recommendations focus on making it easy to quickly determine the relevance of the information and find the key messages. Five recommendations are about helping the reader understand the size of effects and how sure we are about those estimates. Two recommendations are about helping the reader put information about intervention effects in context and understand if and why the information is trustworthy.Conclusions These 10 recommendations summarise lessons we have learnt developing and evaluating ways of helping people to make well-informed decisions by making research evidence more understandable and useful for them. We welcome feedback for how to improve our advice.

Abstract Background Infant mortality rates are still high in Ethiopia. Breastfeeding is regarded as the simplest and least expensive strategy for reduction of infant mortality rates. Community-based educational and support interventions provided prenatally and postnatally are effective in increasing breastfeeding rates. However, such interventions are not widely implemented in Ethiopia. This study aims to assess the effect of breastfeeding education and support on timely initiation and duration of exclusive breastfeeding. Methods A cluster-randomized controlled trial at the community level will be conducted to compare the effect of breastfeeding education and support versus routine care. The intervention will be provided by Women Development Army leaders who are already in the country’s health system using a 40-h WHO breastfeeding counseling course, “Infant and Young Child Feeding Counseling: an integrated course” and the “Training of Trainers Manual for Counseling on Maternal, Infant and Young Child Nutrition” in the local language. Culturally appropriate operational packages of information will be developed for them. Using preset criteria at least 432 pregnant women in their third trimester will be recruited from 36 zones. Visits in the intervention arm include two prenatal visits and 8 postnatal visits. Supervisory visits will be conducted monthly to each intervention zone. Data will be entered into Epi-data version 3.1 and analyzed using STATA version 13.0. All analysis will be done by intention to treat analysis. We will fit mixed-effects linear regression models for the continuous outcomes and mixed-effects linear probability models for the binary outcomes with study zone as random intercept to estimate study arm difference (intervention vs. routine education) adjusted for baseline value of the outcome and additional relevant covariates. The protocol was developed in collaboration with the Jimma Zone and Mana district Health office. Ethical clearance was obtained from the Institutional Review Board of University of Oslo and Jimma University. This study is partly funded by NORAD’s NORHED programme. Discussion We expect that the trial will generate findings that can inform breastfeeding policies and practices in Ethiopia. Trial registration ClinicalTrials.gov NCT 03030651 January 25, 2017 version 3 dated 16 July 2018.

Abstract A recently published trial of face mask use to protect against COVID-19 demonstrated a key barrier to carrying out randomised trials in public health: the need for unattainably large sample sizes. For many public health interventions, the choice is not between sufficiently powered trials and underpowered trials, but between underpowered trials and no trials at all. Underpowered trials should be viewed as contributions to the larger body of evidence, alongside other studies of various sizes and designs, collectively assessed and synthesized in systematic reviews. Overemphasis on sample size calculation is probably more of a hindrance than a help to scientific progress.

Abstract Background The ability to appraise claims about the benefits and harms of treatments is crucial for informed health care decision-making. This research aims to enable children in East African primary schools (the clusters) to acquire and retain skills that can help them make informed health care choices by improving their ability to obtain, process and understand health information. The trial will evaluate (at the individual participant level) whether specially designed learning resources can teach children some of the key concepts relevant to appraising claims about the benefits and harms of health care interventions (treatments). Methods This is a two-arm, cluster-randomised trial with stratified random allocation. We will recruit 120 primary schools (the clusters) between April and May 2016 in the central region of Uganda. We will stratify participating schools by geographical setting (rural, semi-urban, or urban) and ownership (public or private). The Informed Healthcare Choices (IHC) primary school resources consist of a textbook and a teachers’ guide. Each of the students in the intervention arm will receive a textbook and attend nine lessons delivered by their teachers during a school term, with each lesson lasting 80 min. The lessons cover 12 key concepts that are relevant to assessing claims about treatments and making informed health care choices. The second arm will carry on with the current primary school curriculum. We have designed the Claim Evaluation Tools to measure people’s ability to apply key concepts related to assessing claims about the effects of treatments and making informed health care choices. The Claim Evaluation Tools use multiple choice questions addressing each of the 12 concepts covered by the IHC school resources. Using the Claim Evaluation Tools we will measure two primary outcomes: (1) the proportion of children who ‘pass’, based on an absolute standard and (2) their average scores. Discussion As far as we are aware this is the first randomised trial to assess whether key concepts needed to judge claims about the effects of treatment can be taught to primary school children. Whatever the results, they will be relevant to learning how to promote critical thinking about treatment claims. Trial status: the recruitment of study participants was ongoing at the time of manuscript submission. Trial registration Pan African Clinical Trial Registry, trial identifier: PACTR201606001679337 . Registered on 13 June 2016.

Abstract Background The role of health communication in vaccination programmes cannot be overemphasized: it has contributed significantly to creating and sustaining demand for vaccination services and improving vaccination coverage. In Nigeria, numerous communication approaches have been deployed but these interventions are not without challenges. We therefore aimed to explore factors affecting the delivery of vaccination communication in Nigeria. Methods We used a qualitative approach and conducted the study in two states: Bauchi and Cross River States in northern and southern Nigeria respectively. We identified factors affecting the implementation of communication interventions through interviews with relevant stakeholders involved in vaccination communication in the health services. We also reviewed relevant documents. Data generated were transcribed verbatim and analysed using thematic analysis. Results We used the SURE framework to organise the identified factors (barriers and facilitators) affecting vaccination communication delivery. We then grouped these into health systems and community level factors. Some of the commonly reported health system barriers amongst stakeholders interviewed included: funding constraints, human resource factors (health worker shortages, training deficiencies, poor attitude of health workers and vaccination teams), inadequate infrastructure and equipment and weak political will. Community level factors included the attitudes of community stakeholders and of parents and caregivers. We also identified factors that appeared to facilitate communication activities. These included political support, engagement of traditional and religious institutions and the use of organised communication committees. Conclusions Communication activities are a crucial element of immunization programmes. It is therefore important for policy makers and programme managers to understand the barriers and facilitators affecting the delivery of vaccination communication so as to be able to implement communication interventions more effectively.

Although peer-led education and support may improve breastfeeding practices, there is a paucity of evidence on the effectiveness of such interventions in the Ethiopian context. We designed a cluster-randomized trial to evaluate the efficacy of a breastfeeding education and support intervention (BFESI) on infant growth, early initiation (EI), and exclusive breastfeeding (EBF) practices. We randomly assigned 36 clusters into either an intervention group (n = 249) receiving BFESI by trained Women’s Development Army (WDA) leaders or a control group (n = 219) receiving routine care. The intervention was provided from the third trimester of pregnancy until five months postpartum. Primary study outcomes were EI, EBF, and infant growth; secondary outcomes included maternal breastfeeding knowledge and attitude, and child morbidity. The intervention effect was analysed using linear regression models for the continuous outcomes, and linear probability or logistic regression models for the categorical outcomes. Compared to the control, BFESI significantly increased EI by 25.9% (95% CI: 14.5, 37.3%; p = 0.001) and EBF by 14.6% (95% CI: 3.77, 25.5%; p = 0.010). Similarly, the intervention gave higher breastfeeding attitude scores (Effect size (ES): 0.85SD; 95% CI: 0.70, 0.99SD; p < 0.001), but not higher knowledge scores (ES: 0.15SD; 95% CI: −0.10, 0.41SD; p = 0.173). From the several growth and morbidity outcomes evaluated, the only outcomes with significant intervention effect were a higher mid-upper arm circumference (ES: 0.25cm; 95% CI: 0.01, 0.49cm; p = 0.041) and a lower prevalence of respiratory infection (ES: −6.90%; 95% CI: −13.3, −0.61%; p = 0.033). Training WDA leaders to provide BFESI substantially improves EI and EBF practices and attitude towards breastfeeding.

Background: Effective communication is a critical component in ensuring that children are fully vaccinated. Although numerous communication interventions have been proposed and implemented in various parts of Nigeria, the range of communication strategies used has not yet been mapped systematically. This study forms part of the ‘Communicate to vaccinate’ (COMMVAC) project, an initiative aimed at building research evidence for improving communication with parents and communities about childhood vaccinations in low- and middle-income countries. Objective: This study aims to: 1) identify the communication strategies used in two states in Nigeria; 2) map these strategies against the existing COMMVAC taxonomy, a global taxonomy of vaccination communication interventions; 3) create a specific Nigerian country map of interventions organised by purpose and target; and 4) analyse gaps between the COMMVAC taxonomy and the Nigerian map. Design: We conducted the study in two Nigerian states: Bauchi State in Northern Nigeria and Cross River State in Southern Nigeria. We identified vaccination communication interventions through interviews carried out among purposively selected stakeholders in the health services and relevant agencies involved in vaccination information delivery; through observations and through relevant documents. We used the COMMVAC taxonomy to organise the interventions we identified based on the intended purpose of the communication and the group to which the intervention was targeted. Results: The Nigerian map revealed that most of the communication strategies identified aimed to inform and educate and remind or recall. Few aimed to teach skills, enhance community ownership, and enable communication. We did not identify any intervention that aimed to provide support or facilitate decision-making. Many interventions had more than one purpose. The main targets for most interventions were caregivers and community members, with few interventions directed at health workers. Most interventions identified were used in the context of campaigns rather than routine immunisation programmes. Conclusions: The identification and development of the Nigerian vaccination communication interventions map could assist programme managers to identify gaps in vaccination communication. The map may be a useful tool as part of efforts to address vaccine hesitancy and improve vaccination coverage in Nigeria and similar settings.

Understanding stakeholders' (parents', communities' and health workers') perspectives of communication about childhood vaccination, including their preferences for its format, delivery and content, is an important step towards designing better communication strategies and ensuring more informed parents. Our objectives were to explore stakeholders' views, experiences and preferences for childhood vaccination communication in Cameroon.In 2014, in the Central and North West Regions of Cameron, we gathered qualitative data for our case study using the following methods: semi structured interviews; observations and informal conversations during routine immunization clinics and three rounds of the National Polio Immunization Campaign; document analysis of reports and mass media communications about vaccination; and a survey of parents. We conducted a thematic analysis of the qualitative data to identify themes relating to views, experiences and perceptions of vaccination information and its delivery. Survey data were analysed using simple descriptive statistics.All of the parents interviewed felt that vaccinating their child was important, and trusted the information provided by health workers. However, many parents wanted more information. Parents did not always feel that they could ask questions during vaccination appointments. All participants felt that health workers and vaccination clinics were important sources of information. Social mobilisation activities such as door-to-door visits and announcements during religious services were important and accepted ways of communicating information, especially during vaccination campaigns. Information communicated through mass media and text messages was also seen as important. In general, stakeholders believed that more consistent messaging about routine vaccination through community channels would be helpful to remind parents of the importance of routine vaccination during ongoing rounds of vaccination campaigns against polio.This study confirms that parents regard information about childhood vaccination as important, but that health services need to be organized in ways that prioritize and facilitate communication, particularly about routine vaccination.

Effective vaccination communication with parents is critical in efforts to overcome barriers to childhood vaccination, tackle vaccine hesitancy and improve vaccination coverage. Health workers should be able to provide information to parents and other caregivers and support them in reaching decisions about vaccinating their children. Limited information exists regarding the perceptions of caregivers and health workers on the vaccination communication strategies employed in Nigeria. This study, which forms part of the 'Communicate to vaccinate' (COMMVAC) project, aims to explore the perceptions and experiences of caregivers and health workers in Nigeria on vaccination communication strategies implemented in their settings.We conducted the study in two States: Bauchi in Northern Nigeria and Cross River in the south. We carried out observations (n = 40), in-depth interviews (n = 14) and focus group discussions (FGDs) (n = 12) amongst 14 purposively selected health workers, two community leaders and 84 caregivers in the two states. We transcribed data verbatim and analysed the data using a framework analysis approach.Caregivers were informed about vaccination activities through three main sources: health facilities (during health education sessions conducted at antenatal or immunization clinics); media outlets; and announcements (in churches/mosques, communities and markets). Caregivers reported that the information received was very useful. Their preferred sources of information included phone text messages, town announcers, media and church/mosque announcements. Some caregivers perceived the clinic environment, long waiting times and health worker attitudes as barriers to receiving vaccination information.When delivering communication interventions, health workers described issues tied to poor communication skills; poor motivation; and attitudes of community members, including vaccine resistance.Communication about vaccination involves more than the message but is also influenced by the environment and the attitudes of the deliverer and receiver. It is pertinent for health policy makers and programme managers to understand these factors so as to effectively implement communication approaches.

Abstract In 2016, three researchers published a report where they concluded that systematic reviews from my institution, the Norwegian Knowledge Centre for the Health Services, are of little use for health policy decision-making. Based on their reading of the conclusion section in 14 reports, they argue that our systematic reviews are not useful due to their lack of clear and conclusive findings. I have reviewed the same documents and I beg to differ. Unfortunately, the description of their methodological approach is both sparse and difficult to grasp, making it very hard to understand how they arrived at their conclusions.

Background People need critical thinking skills to make well-informed health choices and avoid waste and unnecessary suffering. However, educational interventions can have adverse effects, which is often overlooked. We created a framework of potential harms of interventions to improve critical thinking about health choices. The objective was to identify potential effects and articulate potential mechanisms. We intended to use the framework to inform the development and evaluation of an intervention in Kenya, Rwanda, and Uganda. Methods We created an initial framework drawing on two earlier frameworks. We surveyed external experts using Likert-scale and open-ended items, including researchers, educators, and others, in a variety of relevant fields. We emailed the survey to an international advisory network, and all other experts recommended by respondents. We analyzed the quantitative data using descriptive statistics. We conducted a thematic analysis of the qualitative data. We revised the framework based on those results. To identify any effects missing from the revised framework, we individually interviewed a convenience sample of one teacher from each of Kenya, Rwanda, and Uganda. Results We received responses from 38 of 70 external experts (54%). The quantitative survey data suggested respondents agreed with the initial framework overall. However, the qualitative data led to substantial revisions. The revised framework consists of categories of adverse outcomes; outcomes within each category; sub-outcomes; individuals, groups, and populations that might experience each adverse outcome; beneficial outcomes corresponding with adverse outcomes; and potential mechanisms of adverse effects. There are six categories: decision-making harms, psychological harms, equity harms, group and social harms, waste, and other harms. In the interviews with teachers, we did not identify any effects missing from the revised framework. Conclusions As far as we know, the framework is the first tool of its kind for education research. It can be improved upon and adapted.

Patients' adherence to antiretroviral therapy (ART) is important for effective medical treatment of HIV/AIDS. We conducted a qualitative interview study in the Copperbelt Province of Zambia in 2006. The aim of the study was to explore patients' and health care professionals' perceived barriers and facilitators to patients' adherence to ART. Based on data from individual interviews and focus group interviews with a total of 60 patients and 12 health care professionals, we identified barriers and facilitators related to patients' beliefs and behaviours, the health service, and socio-economic and cultural factors. Among the barriers we identified were lack of communication and information about ART, inadequate time during consultations, lack of follow-up and counselling, forgetfulness, stigma, discrimination and disclosure of HIV status, lack of confidentiality in the treatment centres, and lack of nutritional support. Feeling better, prospects of living longer, family support, information about ART, support for income-generating activities, disclosure of HIV status, prayers and transport support were among the facilitators. Our study suggests that several issues need to be considered when providing ART. Further research is needed to study interactions between patients and their health care providers. Our findings can inform interventions to improve adherence to ART.

BackgroundBest formats for summarising and presenting evidence for use in clinical guideline development remain less well defined. We aimed to assess the effectiveness of different evidence summary formats to address this gap.MethodsHealthcare professionals attending a one-week Kenyan, national guideline development workshop were randomly allocated to receive evidence packaged in three different formats: systematic reviews (SRs) alone, systematic reviews with summary-of-findings tables, and 'graded-entry' formats (a 'front-end' summary and a contextually framed narrative report plus the SR). The influence of format on the proportion of correct responses to key clinical questions, the primary outcome, was assessed using a written test. The secondary outcome was a composite endpoint, measured on a 5-point scale, of the clarity of presentation and ease of locating the quality of evidence for critical neonatal outcomes. Interviews conducted within two months following completion of trial data collection explored panel members' views on the evidence summary formats and experiences with appraisal and use of research information.Results65 (93%) of 70 participants completed questions on the prespecified outcome measures. There were no differences between groups in the odds of correct responses to key clinical questions. 'Graded-entry' formats were associated with a higher mean composite score for clarity and accessibility of information about the quality of evidence for critical neonatal outcomes compared to systematic reviews alone (adjusted mean difference 0.52, 95% CI 0.06 to 0.99). There was no difference in the mean composite score between SR with SoF tables and SR alone. Findings from interviews with 16 panelists indicated that short narrative evidence reports were preferred for the improved clarity of information presentation and ease of use.ConclusionsOur findings suggest that 'graded-entry' evidence summary formats may improve clarity and accessibility of research evidence in clinical guideline development.Trial registrationControlled-Trials.com ISRCTN05154264.

BACKGROUND: We conducted an Internet-based randomized trial comparing three valence framing presentations of the benefits of antihypertensive medication in preventing cardiovascular disease (CVD) for people with newly diagnosed hypertension to determine which framing presentation resulted in choices most consistent with participants' values. METHODS AND FINDINGS: In this second in a series of televised trials in cooperation with the Norwegian Broadcasting Company, adult volunteers rated the relative importance of the consequences of taking antihypertensive medication using visual analogue scales (VAS). Participants viewed information (or no information) to which they were randomized and decided whether or not to take medication. We compared positive framing over 10 years (the number escaping CVD per 1000); negative framing over 10 years (the number that will have CVD) and negative framing per year over 10 years of the effects of antihypertensive medication on the 10-year risk for CVD for a 40 year-old man with newly diagnosed hypertension without other risk factors. Finally, all participants were shown all presentations and detailed patient information about hypertension and were asked to decide again. We calculated a relative importance score (RIS) by subtracting the VAS-scores for the undesirable consequences of antihypertensive medication from the VAS-score for the benefit of CVD risk reduction. We used logistic regression to determine the association between participants' RIS and their choice. 1,528 participants completed the study. The statistically significant differences between the groups in the likelihood of choosing to take antihypertensive medication in relation to different values (RIS) increased as the RIS increased. Positively framed information lead to decisions most consistent with those made by everyone for the second, more fully informed decision. There was a statistically significant decrease in deciding to take antihypertensives on the second decision, both within groups and overall. CONCLUSIONS: For decisions about taking antihypertensive medication for people with a relatively low baseline risk of CVD (70 per 1000 over 10 years), both positive and negative framing resulted in significantly more people deciding to take medication compared to what participants decided after being shown all three of the presentations. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number Register ISRCTN 33771631.

BACKGROUND: We conducted an Internet-based randomized trial comparing four graphical displays of the benefits of antibiotics for people with sore throat who must decide whether to go to the doctor to seek treatment. Our objective was to determine which display resulted in choices most consistent with participants' values. METHODS AND FINDINGS: This was the first of a series of televised trials undertaken in cooperation with the Norwegian Broadcasting Company. We recruited adult volunteers in Norway through a nationally televised weekly health program. Participants went to our Web site and rated the relative importance of the consequences of treatment using visual analogue scales (VAS). They viewed the graphical display (or no information) to which they were randomized and were asked to decide whether to go to the doctor for an antibiotic prescription. We compared four presentations: face icons (happy/sad) or a bar graph showing the proportion of people with symptoms on day three with and without treatment, a bar graph of the average duration of symptoms, and a bar graph of proportion with symptoms on both days three and seven. Before completing the study, all participants were shown all the displays and detailed patient information about the treatment of sore throat and were asked to decide again. We calculated a relative importance score (RIS) by subtracting the VAS scores for the undesirable consequences of antibiotics from the VAS score for the benefit of symptom relief. We used logistic regression to determine the association between participants' RIS and their choice. 1,760 participants completed the study. There were statistically significant differences in the likelihood of choosing to go to the doctor in relation to different values (RIS). Of the four presentations, the bar graph of duration of symptoms resulted in decisions that were most consistent with the more fully informed second decision. Most participants also preferred this presentation (38%) and found it easiest to understand (37%). Participants shown the other three presentations were more likely to decide to go to the doctor based on their first decision than everyone based on the second decision. Participants preferred the graph using faces the least (14.4%). CONCLUSIONS: For decisions about going to the doctor to get antibiotics for sore throat, treatment effects presented by a bar graph showing the duration of symptoms helped people make decisions more consistent with their values than treatment effects presented as graphical displays of proportions of people with sore throat following treatment. CLINICAL TRIALS REGISTRATION: ISRCTN58507086.

BACKGROUND: Tuberculosis (TB) is a major contributor to the global burden of disease and has received considerable attention in recent years, particularly in low- and middle-income countries where it is closely associated with HIV/AIDS. Poor adherence to treatment is common despite various interventions aimed at improving treatment completion. Lack of a comprehensive and holistic understanding of barriers to and facilitators of, treatment adherence is currently a major obstacle to finding effective solutions. The aim of this systematic review of qualitative studies was to understand the factors considered important by patients, caregivers and health care providers in contributing to TB medication adherence. METHODS AND FINDINGS: We searched 19 electronic databases (1966-February 2005) for qualitative studies on patients', caregivers', or health care providers' perceptions of adherence to preventive or curative TB treatment with the free text terms "Tuberculosis AND (adherence OR compliance OR concordance)". We supplemented our search with citation searches and by consulting experts. For included studies, study quality was assessed using a predetermined checklist and data were extracted independently onto a standard form. We then followed Noblit and Hare's method of meta-ethnography to synthesize the findings, using both reciprocal translation and line-of-argument synthesis. We screened 7,814 citations and selected 44 articles that met the prespecified inclusion criteria. The synthesis offers an overview of qualitative evidence derived from these multiple international studies. We identified eight major themes across the studies: organisation of treatment and care; interpretations of illness and wellness; the financial burden of treatment; knowledge, attitudes, and beliefs about treatment; law and immigration; personal characteristics and adherence behaviour; side effects; and family, community, and household support. Our interpretation of the themes across all studies produced a line-of-argument synthesis describing how four major factors interact to affect adherence to TB treatment: structural factors, including poverty and gender discrimination; the social context; health service factors; and personal factors. The findings of this study are limited by the quality and foci of the included studies. CONCLUSIONS: Adherence to the long course of TB treatment is a complex, dynamic phenomenon with a wide range of factors impacting on treatment-taking behaviour. Patients' adherence to their medication regimens was influenced by the interaction of a number of these factors. The findings of our review could help inform the development of patient-centred interventions and of interventions to address structural barriers to treatment adherence.

BACKGROUND: The purpose of our study was to evaluate the effects of a new reimbursement rule for antihypertensive medication that made thiazides mandatory first-line drugs for newly treated, uncomplicated hypertension. The objective of the new regulation was to reduce drug expenditures. METHODS AND FINDINGS: We conducted an interrupted time-series analysis on prescribing data before and after the new reimbursement rule for antihypertensive medication was put into effect. All patients started on antihypertensive medication in 61 general practices in Norway were included in the analysis. The new rule was put forward by the Ministry of Health and was approved by parliament. Adherence to the rule was monitored only minimally, and there were no penalties for non-adherence. Our primary outcome was the proportion of thiazide prescriptions among all prescriptions made for persons started on antihypertensive medication. Secondary outcomes included the proportion of patients who, within 4 mo, reached recommended blood-pressure goals and the proportion of patients who, within 4 mo, were not started on a second antihypertensive drug. We also compared drug costs before and after the intervention. During the baseline period, 10% of patients started on antihypertensive medication were given a thiazide prescription. This proportion rose steadily during the transition period, after which it remained stable at 25%. For other outcomes, no statistically significant differences were demonstrated. Achievement of treatment goals was slightly higher (56.6% versus 58.4%) after the new rule was introduced, and the prescribing of a second drug was slightly lower (24.0% versus 21.8%). Drug costs were reduced by an estimated Norwegian kroner 4.8 million (0.58 million Euros, US$0.72 million) in the first year, which is equivalent to Norwegian kroner 1.06 per inhabitant (0.13 Euros, US$0.16). CONCLUSIONS: Prescribing of thiazides in Norway for uncomplicated hypertension more than doubled after a reimbursement rule requiring the use of thiazides as the first-choice therapy was put into effect. However, the resulting savings on drug expenditures were modest. There were no significant changes in the achievement of treatment goals or in the prescribing of a second antihypertensive drug.

BACKGROUND: This trial was conducted as part of a project that aims to enhance public understanding and use of research in decisions about healthcare by enabling viewers to participate in research and to follow the process, through television reports and on the web. Valerian is an herbal over-the-counter drug that is widely used for insomnia. Systematic reviews have found inconsistent and inconclusive results about its effects. METHODS: Participants were recruited through a weekly nationally televised health program in Norway. Enrolment and data collection were over the Internet. 405 participants who were 18 to 75 years old and had insomnia completed a two week diary-keeping run-in period without treatment and were randomised and mailed valerian or placebo tablets for two weeks. All participants and investigators were blind to treatment until after the analysis was completed. FINDINGS: For the primary outcome of a minimally important improvement in self-reported sleep quality (> or = 0.5 units on a 7 point scale), the difference between the valerian group (29%) and the placebo group (21%) was not statistically significant (difference 7.5%; 95% CI-0.9 to 15.9; p = 0.08). On the global self-assessment question at the end of the treatment period 5.5% (95% CI 0.2 to 10.8) more participants in the valerian group perceived their sleep as better or much better (p = 0.04). There were similar trends favouring the valerian group for night awakenings (difference = 6.0%, 95% CI-0.5 to 12.5) and sleep duration (difference = 7.5%, 95% CI-1.0 to 16.1). There were no serious adverse events and no important or statistically significant differences in minor adverse events. INTERPRETATION: Based on this and previous studies, valerian appears to be safe, but with modest beneficial effects at most on insomnia compared to placebo. The combined use of television and the Internet in randomised trials offers opportunities to answer questions about the effects of health care interventions and to improve public understanding and use of randomised trials. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN72748991.

BackgroundA gap exists between evidence and practice regarding the management of cardiovascular risk factors. This gap could be narrowed if systematically developed clinical practice guidelines were effectively implemented in clinical practice. We evaluated 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 and findingsWe conducted a cluster-randomized trial comparing a tailored intervention to passive dissemination of guidelines in 146 general practices in two geographical areas in Norway. Each practice was randomized to either the tailored intervention (70 practices; 257 physicians) or control group (69 practices; 244 physicians). Patients started on medication for hypertension or hypercholesterolemia during the study period and all patients already on treatment that consulted their physician during the trial were included. A multifaceted intervention was tailored to address identified barriers to change. Key components were an educational outreach visit with audit and feedback, and computerized reminders linked to the medical record system. Pharmacists conducted the visits. Outcomes were measured for all eligible patients seen in the participating practices during 1 y before and after the intervention. The main outcomes were the proportions of (1) first-time prescriptions for hypertension where thiazides were prescribed, (2) patients assessed for cardiovascular risk before prescribing antihypertensive or cholesterol-lowering drugs, and (3) patients treated for hypertension or hypercholesterolemia for 3 mo or more who had achieved recommended treatment goals. The intervention led to an increase in adherence to guideline recommendations on choice of antihypertensive drug. Thiazides were prescribed to 17% of patients in the intervention group versus 11% in the control group (relative risk 1.94; 95% confidence interval 1.49-2.49, adjusted for baseline differences and clustering effect). Little or no differences were found for risk assessment prior to prescribing and for achievement of treatment goals.ConclusionsOur tailored intervention had a significant impact on prescribing of antihypertensive drugs, but was ineffective in improving the quality of other aspects of managing hypertension and hypercholesterolemia in primary care.

BACKGROUND: Interventions designed to narrow the gap between research findings and clinical practice may be effective, but also costly. Economic evaluations are necessary to judge whether such interventions are worth the effort. We have evaluated the economic effects of a tailored intervention to support the implementation of guidelines for the use of antihypertensive and cholesterol-lowering drugs. The tailored intervention was evaluated in a randomized trial, and was shown to significantly increase the use of thiazides for patients started on antihypertensive medication, but had little or no impact on other outcomes. The increased use of thiazides was not expected to have an impact on health outcomes. METHODS AND FINDINGS: We performed cost-minimization and cost-effectiveness analyses on data from a randomized trial involving 146 general practices from two geographical areas in Norway. Each practice was randomized to either the tailored intervention (70 practices; 257 physicians) or control group (69 practices; 244 physicians). Only patients that were being started on antihypertensive medication were included in the analyses. A multifaceted intervention was tailored to address identified barriers to change. Key components were an educational outreach visit with audit and feedback, and computerized reminders. Pharmacists conducted the visits. A cost-minimization framework was adopted, where the costs of intervention were set against the reduced treatment costs (principally due to increased use of thiazides rather than more expensive medication). The cost-effectiveness of the intervention was estimated as the cost per additional patient being started on thiazides. The net annual cost (cost minimization) in our study population was 53,395 US dollars, corresponding to 763 US dollars per practice. The cost per additional patient started on thiazides (cost-effectiveness) was 454 US dollars. The net annual savings in a national program was modeled to be 761,998 US dollars, or 540 US dollars per practice after 2 y. In this scenario the savings exceeded the costs in all but two of the sensitivity analyses we conducted, and the cost-effectiveness was estimated to be 183 US dollars. CONCLUSIONS: We found a significant shift in prescribing of antihypertensive drugs towards the use of thiazides in our trial. A major reason to promote the use of thiazides is their lower price compared to other drugs. The cost of the intervention was more than twice the savings within the time frame of our study. However, we predict modest savings over a 2-y period.