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Abstract 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.

Objective: To determine the effects of stretching before and after physical activity on risks of injury and soreness in a community population., Design: Internet-based pragmatic randomised trial conducted between January 2008 and January 2009., Setting: International., Participants: A total of 2377 adults who regularly participated in physical activity., Interventions: Participants in the stretch group were asked to perform 30 s static stretches of seven lower limb and trunk muscle groups before and after physical activity for 12 weeks. Participants in the control group were asked not to stretch., Main Outcome Measurements: Participants provided weekly on-line reports of outcomes over 12 weeks. Primary outcomes were any injury to the lower limb or back, and bothersome soreness of the legs, buttocks or back. Injury to muscles, ligaments and tendons was a secondary outcome., Results: Stretching did not produce clinically important or statistically significant reductions in all-injury risk (HR=0.97, 95% CI 0.84 to 1.13), but did reduce the risk of experiencing bothersome soreness (mean risk of bothersome soreness in a week was 24.6% in the stretch group and 32.3% in the control group; OR=0.69, 95% CI 0.59 to 0.82). Stretching reduced the risk of injuries to muscles, ligaments and tendons (incidence rate of 0.66 injuries per person-year in the stretch group and 0.88 injuries per person-year in the control group; HR=0.75, 95% CI 0.59 to 0.96)., Conclusion: Stretching before and after physical activity does not appreciably reduce all-injury risk but probably reduces the risk of some injuries, and does reduce the risk of bothersome soreness., Trial Registration: anzctr.org.au 12608000044325.

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.

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: A 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 Findings: We 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., Conclusions: Our 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: The opportunities for continuing education among general practice (GP) assistants vary because of their dependence on their employers' attitudes and interests. Not all available continuing education activities are equally effective. The purpose of this study was to describe GP assistants' use of a range of quality improvement and continuing education activities, especially with regard to how much time was spent on each activity and how often the activities were used., Material and Methods: A questionnaire was sent to GP assistants in 1321 general practices., Results: 948 GP assistants returned the questionnaires. They spent on average one hour per week on continuing education. The primary activities were discussions with colleagues (daily), and meetings with pharmaceutical industry representatives (weekly). The use of courses was relatively modest; more than half of them were organised by pharmaceutical companies. Learning something new, improving practice and personal development were the most important motives for participating in continuing education., Interpretation: The opportunities for continuing education available to GP assistants vary a great deal and are to a large extent left to the pharmaceutical industry. Many if not most of the opportunities available cannot be expected to lead to changes in practice. Those responsible for general practice - GPs as well as the health authorities--should ensure that GP assistants have a wider and better range of options for continuing education.

Background: Many guidelines are not developed from systematic models and are not based on high-quality evidence. The existence of a guideline does not in itself lead to changes in practice and many guidelines are not used once they have been issued., Material and Methods: A questionnaire on continuing education and the use of guidelines was sent to 1500 general practitioners (GP) and GP assistants in 1321 general practices in Norway. 857 GPs and 948 GP assistants returned the questionnaire., Results: There was a large variation in the extent to which guidelines were known and used. Many GPs and GP assistants had little knowledge of guidelines published in the Journal of the Norwegian Medical Association or by the Norwegian Medicines Agency, the Norwegian Board of Health or the Norwegian Centre for Health Technology Assessment. There were exceptions: 52% of GPs used the Norwegian College of General Practitioners' treatment programme for diabetes and 77% of GP assistants used the Norwegian quality assurance programme for laboratory services in primary care., Interpretation: Guidelines should be based on the best available evidence but this in itself is not enough to ensure that they are adhered to. Effective strategies for implementation are also important.

Background: Continuing education should ensure that a doctor provides effective care based on the best available evidence. But not all continuing education is equally effective., Material and Methods: A questionnaire on continuing education was sent to 1500 general practitioners (GPs) in Norway. The response rate was 58%., Results: GPs spent on average 2.3 hours per week on continuing education. Discharge reports were used daily for continuing education by 75% of GPs and represented 10% of the total time spent on continuing education in a 30-day period. Courses were not used so often but took up a lot of time when attended. Traditional lectures accounted for 80% of course instruction. Learning something new and improving practice were the two most important objectives for participating in continuing education. Around every second GP participated in a small group of colleagues., Interpretation: GPs spend a lot of time on continuing education activities that research has shown to have little or no effect on practice. It is essential that the activities used are evaluated to a much greater extent than what they are now.

Background: A cluster randomized trial of tailored interventions to support the implementation of guidelines for sore throat and urinary tract infection found little or no change in the main outcomes, which were antibiotic prescriptions, use of laboratory tests and use of telephone consultations. There was great variation between the practices in the change in these outcomes., Objectives: Our aim was to evaluate how the interventions were received and to understand why practices did or did not change., Methods: The trial was conducted in general practices in Norway. Data for this process evaluation were collected from the 120 practices that completed the trial. Multiple methods were used: observations, semi-structured telephone interviews, a postal survey and data extracted from electronic medical records. We investigated factors that might explain a lack of change, including: agreement with the guidelines; communication within each practice; degree of participation in the project; taking time to discuss the guidelines and their implementation; use of the components of the interventions; and routines for telephone consultations. Possible explanatory factors were explored in relation to variation in change and the overall extent of change in rates of use of antibiotics, laboratory tests and telephone consultations., Results: Sixty-three per cent of practices agreed with the guidelines. Only 35% reported having regular meetings, and 33% discussed the project before its start, although 75% reported agreement about participating within the practice. Only 33% reported meeting to discuss the guidelines. Use of the components of the interventions ranged from 11% for the increased fee for telephone consultations to 48% for the computerized decision support. Forty-four per cent reported problems with telephone routines. No single factor explained the observed variation in the extent of change across practices., Conclusions: Inadequate time, resources and support were the most salient factors that might explain a lack of change. Problems with internal communication and telephone routines were important contributing factors in many practices.

Objective: To assess the effectiveness of tailored interventions to implement guidelines for urinary tract infections in women and sore throat., Design: Unblinded, cluster randomised pretest-post-test trial., Setting: 142 general practices in Norway., Participants: 72 practices received interventions to implement guidelines for urinary tract infection and 70 practices received interventions to implement guidelines for sore throat, serving as controls for each other. 59 practices in the urinary tract infection group and 61 practices in the sore throat group completed the study. Outcomes were measured in 16 939 consultations for sore throat and 9887 consultations for urinary tract infection., Interventions: Interventions were developed to overcome identified barriers to implementing the guidelines. The main components of the tailored interventions were patient educational material, computer based decision support and reminders, an increase in the fee for telephone consultations, and interactive courses for general practitioners and practice assistants., Main Outcome Measures: Changes in rates of use of antibiotics, laboratory tests, and telephone consultations., Results: Patients in the sore throat group were 3% less likely to receive antibiotics after the intervention. Women with symptoms of urinary tract infection in the intervention group were 5.1% less likely to have a laboratory test ordered. No significant differences were found between the groups for the other outcomes. Large variation was found across the included practices in the rates of antibiotic prescription, use of laboratory tests and telephone consultations, and in the extent of change for all three outcome measures., Conclusions: Passively delivered, complex interventions targeted at identified barriers to change had little effect in changing practice.