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1.  Does the primary screening test influence women’s anxiety and intention to screen for cervical cancer? A randomized survey of Norwegian women 
BMC Public Health  2014;14:360.
Background
Countries must decide whether or not to replace primary cytology-based screening with primary human papillomavirus (HPV)-based screening. We aimed to assess how primary screening for an HPV infection, a sexually transmitted infection (STI), and the type of information included in the invitation letter, will affect screening intention.
Methods
We randomized a representative sample of Norwegian women to one of three invitation letters: 1) Pap smear, 2) HPV testing or 3) HPV testing with additional information about the nature of the infection. Intention to participate, anxiety level and whether women intend to follow-up abnormal results were measured between groups using chi-squared and nonparametric Kruskal-Wallis tests. Determinants of intention were explored using logistic regression.
Results
Responses from 3540 women were representative of the Norwegian population with respect to age, civil status and geographic location. No significant difference across invitation letters was found in women’s stated intention to participate (range: 91.8-92.3%), anxiety (39-42% were either quite or very worried) or to follow-up after an abnormal result (range: 97.1-97.6%). Strength of intention to participate was only marginally lower for HPV-based invitation letters, albeit significant (p-value = 0.008), when measured on a scale. Only 36–40% of respondents given the HPV invitations correctly understood that they likely had an STI.
Conclusions
We found that switching to primary HPV screening, independent of additional information about HPV infections, is not likely to reduce screening participation rates or increase anxiety; however, women lacked the ability to interpret the meaning of an HPV-test result.
doi:10.1186/1471-2458-14-360
PMCID: PMC4021156  PMID: 24735469
Mass screening; Human papillomavirus; Pap smear; Health policy
2.  Trends in time to invasive examination and treatment from 2001 to 2009 in patients admitted first time with non-ST elevation myocardial infarction or unstable angina in Denmark 
BMJ Open  2014;4(1):e004052.
Objective
To investigate trends in time to invasive examination and treatment for patient with first time diagnosis of non-ST elevation myocardial infarction (NSTEMI) and unstable angina during the period from 2001 to 2009 in Denmark.
Design
From 1 January 2001 to 31 December 2009 all first time hospitalisations with NSTEMI and unstable angina were identified in the National Patient Registry (n=65 909). Time from admission to initiation of coronary angiography (CAG), percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) was calculated. We described the development in invasive examination and treatment probability (CAG, PCI and CABG at 3, 7, 10, 30 and 60 days) for the years 2001–2009, taking the competing risk of death into account using Aalen–Johansen estimators and a Fine-Gray model.
Setting
Nationwide Danish cohort.
Results
The proportion of patients receiving a CAG and PCI increased substantially over time while the proportion receiving a CABG decreased for both NSTEMI and unstable angina. For both NSTEMI and unstable angina, a significant increase in invasive examination and treatment probability at 3 days for CAG and PCI were seen especially from 2007 through to 2009. For NSTEMI, the CAG examination probability at 3 days leaped from 20% in 2007 to 32% in 2008 and 39% in 2009, and for PCI the same was true with a leap in treatment probability from 19% to 28% from 2008 to 2009.
Conclusions
In Denmark the use of CAG and PCI in treatment of NSTEMI and unstable angina has increased from 2001 to 2009, while the use of CABG has decreased. During the same period, there was a marked increase in invasive examination and treatment probability at 3 days, that is, more patients were treated faster which is in line with the political aim of reducing time to treatment.
doi:10.1136/bmjopen-2013-004052
PMCID: PMC3902505  PMID: 24413349
EPIDEMIOLOGY
3.  Impact of effectiveness information format on patient choice of therapy and satisfaction with decisions about chronic disease medication: the "Influence of intervention Methodologies on Patient Choice of Therapy (IMPACT)" cluster-randomised trial in general practice 
Background
Risk communication is an integral part of shared decision-making in health care. In the context of interventions for chronic diseases it represents a particular challenge for all health practitioners. By using two different quantitative formats to communicate risk level and effectiveness of a cholesterol-lowering drug, we posed the research question: how does the format of risk information influence patients’ decisions concerning therapy, patients’ satisfaction with the communication as well as confidence in the decision. We hypothesise that patients are less prone to accept therapy when the benefits of long-term intervention are presented in terms of prolongation of life (POL) in months compared to the absolute risk reduction (ARR). We hypothesise that patients presented with POL will be more satisfied with the communication and confident in their decision, suggesting understanding of the time-related term.
Methods/Design
In 2009 a sample of 328 general practitioners (GPs) in the Region of Southern Denmark was invited to participate in a primary care-based clinical trial among patients making real-life clinical decisions together with their GP. Interested GPs were cluster-randomised to inform patients about cardiovascular disease (CVD) risk and the effectiveness of statin therapy using either POL or ARR. The GPs attended a training session before informing their patients. Before training and after the trial period they received a questionnaire about their attitudes to risk communication and the use of numerical information. Patients’ redemptions of statin prescriptions will be registered in a regional prescription database to evaluate a possible association between redemption rates and effectiveness format. The Combined Outcome Measure for Risk Communication And Treatment Decision Making Effectiveness (COMRADE) questionnaire will be used to measure patients’ confidence and satisfaction with the risk communication immediately after the conversation with their GPs.
Discussion
This randomised clinical trial compares the impact of two effectiveness formats on real-life risk communication between patients and GPs, including affective patient outcomes and actual choices about acceptance of therapy. Though we found difficulties in recruiting GPs, according to the study protocol we have succeeded in engaging sufficient GPs for the trial, enabling us to perform the planned analyses.
Trial registration
ClinicalTrials.gov Protocol Registration System http://ww.clinicaltrials.gov/NCT01414751
doi:10.1186/1472-6963-13-76
PMCID: PMC3599428  PMID: 23442351
RCT; Shared decision making; Risk communication; Prognosis; Absolute risk reduction; Prolongation of life; Cardiovascular disease; Primary prevention; Health behaviour; General practice
4.  Patient related outcomes in a real life prospective follow up study: Allergen immunotherapy increase quality of life and reduce sick days 
Background
One fourth of the adult population in Europe suffer from respiratory allergy. Subcutaneous-allergen-specific-immunotherapy (SCIT) has long-term disease modifying effect on disease specific Health-Related Quality of Life (HRQoL). The purpose of this study was to assess the effect of SCIT on alternative disease outcomes in patients with grass-pollen and/or house dust mite induced allergic rhino-conjunctivitis and/or an asthma diagnosis. Focus was on expressing outcomes in terms of generic quality of life (Quality-Adjusted-Life-Years (QALY)) and reductions in sick days.
Methods
The study was a multi-centre study with prospective follow-up. 248 patients were initiated on SCIT. The disease specific Rhino-conjunctivitis Quality of Life Questionnaire (RQLQ) and two generic (HRQoL) instruments 15D and EQ-5D were used at baseline and at follow-up. The outcome measures included change in; disease severity, RQLQ-scores, number of days with symptoms- and number of sick days per year and finally changes in generic HRQoL and thus, QALY. Disease severity was assessed by specialist doctors; severity of rhino-conjunctivitis was classified according to the Allergic Rhinitis and its Impact on Asthma (ARIA) and asthma severity according to the Global Initiative for Asthma (GINA guideline). The remaining outcome measures were assessed by the patients in questionnaires at baseline and at follow-up. An intension to treat approach was applied. For missing items imputation of sample mean base-line values or follow-up values were used after specified criteria. The effect of SCIT on rhino-conjunctivitis and/or asthma diagnoses was analysed at follow-up using three logistic regression models.
Results
The disease severity showed significantly improved disease control. Mean RQLQ-score was reduced from 3.02 at baseline to 2.00 at follow-up. Average annual days with symptoms were reduced from 189 to 145 days whilst annual sick days were reduced from 3.7 to 1.2 days. The 15D-score increased from 0.83 to 0.86 and the EQ-5D-score from 0.70 to 0.77, which indicated an annual gain per patient of 0.03-0.06 QALY.
Conclusions
Allergic patients suffering from rhino-conjunctivitis alone or rhino-conjunctivitis and asthma experience significantly increased HRQoL and they gain 0.03-0.06 QALY, when treated with SCIT for one year.
Trial registration
The study was registered at ClinicalTrials.gov with the identifier: NCT01486498.
doi:10.1186/1939-4551-6-15
PMCID: PMC3846409  PMID: 24229439
Allergic; Rhinitis; Asthma; Health Related Quality of Life; Sick leave; Absenteeism; House dust mite allergy; Immunotherapy; Pollen allergy; Quality adjusted; Life years; Rhino-conjunctivitis; 15D; EQ-5D
5.  Medication effectiveness may not be the major reason for accepting cardiovascular preventive medication: A population-based survey 
Background
Shared decision-making and patients’ choice of interventions are areas of increasing importance, not least seen in the light of the fact that chronic conditions are increasing, interventions considered important for public health, and still non-acceptance of especially risk-reducing treatments of cardiovascular diseases (CVD) is prevalent. A better understanding of patients’ medication-taking behavior is needed and may be reached by studying the reasons why people accept or decline medication recommendations. The aim of this paper was to identify factors that may influence people’s decisions and reasoning for accepting or declining a cardiovascular preventive medication offer.
Methods
From a random sample of 4,000 people aged 40–59 years in a Danish population, 1,169 participants were asked to imagine being at increased risk of cardiovascular disease and being offered a preventive medication. After receiving ‘complete’ information about effectiveness of the medication they were asked whether they would accept medication. Finally, they were asked about reasons for the decision.
Results
A total of 725 (67%) of 1,082 participants accepted the medication offer. Even quite large effects of medication (up to 8 percentage points absolute risk reduction) had a smaller impact on acceptance to medication than personal experience with cardiovascular disease. Furthermore, increasing age of the participant and living with a partner were significantly associated with acceptance. Some 45% of the respondents accepting justified their choice as being for health reasons, and they were more likely to be women, live alone, have higher income and higher education levels. Among those who did not accept the medication offer, 56% indicated that they would rather prefer to change lifestyle.
Conclusions
Medication effectiveness seems to have a moderate influence on people’s decisions to accept preventive medication, while factors such as personal experience with cardiovascular disease may have an equally strong or stronger influence, indicating that practitioners could do well to carefully identify the reasons for their patients’ treatment decisions.
doi:10.1186/1472-6947-12-89
PMCID: PMC3465182  PMID: 22873796
Decision-making; Risk assessment; Risk communication; Preventive health services; Primary prevention; Cardiovascular disease; Health behavior
6.  Future costs in cost-effectiveness analysis: an empirical assessment 
Aim
The aim of this study was to assess the impact on the cost-effectiveness ratio of including measures of production and consumption following a health care or health promotion intervention that improves survival.
Data and methods
We defined the net incremental consumption, or future costs, as the change in consumption minus change in production, while differentiating between health care and non-health care consumption. Based on 2005 register-based data for the entire Danish population, we estimated the average value of annual production and consumption for 1-year age groups. We computed the net consumption in the remaining expected lifetime and the net consumption per life year gained for different age groups.
Results
Age has a profound effect on the magnitude of net consumption. When including net incremental consumption in the cost-effectiveness ratio of a health care or health promotion intervention, the relative cost-effectiveness changed up to €21,000 across age groups. The largest difference in the cost-effectiveness ratio was observed among the 30-year-olds where costs were reduced significantly due to significant future net contributions to society.
Conclusion
This paper contains cost figures for use in cost-effectiveness analyses, when the societal perspective is adopted and future consumption and production effects are taken into account. The net consumption varies considerably with age. Inclusion of net incremental consumption in the cost-effectiveness analysis will markedly affect the relative cost-effectiveness of interventions targeted at different age groups. Omitting future cost from cost-effectiveness analysis may bias the ranking of health care interventions and favour interventions aimed at older age groups. We used Danish data for this assessment, and our results will therefore not represent true figures for other countries. We do, however, believe that the overall impact of including net production value in CEA will be similar in other countries that have similar transfers of income from the younger age groups to older age groups as well as publicly financed social and health care services.
doi:10.1007/s10198-010-0280-0
PMCID: PMC3249583  PMID: 20878202
Future costs; Cost-effectiveness analysis; Life years saved; C31; D61; I10
7.  Societal views on orphan drugs: cross sectional survey of Norwegians aged 40 to 67 
Objective To determine whether a general societal preference for prioritising treatment of rare diseases over common ones exists and could provide a justification for accepting higher cost effectiveness thresholds for orphan drugs.
Design Cross sectional survey using a web based questionnaire.
Setting Norway.
Participants Random sample of 1547 Norwegians aged 40-67.
Main outcome measure Choice between funding treatment for a rare disease versus a common disease and how funds should be allocated if it were not possible to treat all patients, for each of two scenarios: identical treatment costs per patient and higher costs for the rare disease. Respondents rated five statements concerning attitudes to equity on a five point Likert scale (5=completely agree).
Results For the equal cost scenario, 11.2% (9.6% to 12.8%) of respondents favoured treating the rare disease, 24.9% (21.7% to 26.0%) the common disease, and 64.9% (62.6% to 67.3%) were indifferent. When the rare disease was four times more costly to treat, the results were, respectively, 7.4% (6.1% to 8.7%), 45.3% (42.8% to 47.8%), and 47.3% (44.8% to 49.8%). Rankings for attitude on a Likert scale indicated strong support for the statements “rare disease patients should have the right to treatment even if more expensive” (mean score 4.5, SD 0.86) and “resources should be used to provide the greatest possible health benefits” (3.9, 1.23).
Conclusions Despite strong general support for statements expressing a desire for equal treatment rights for patients with rare diseases, there was little evidence that a societal preference for rarity exists if treatment of patients with rare diseases is at the expense of treatment of those with common diseases.
doi:10.1136/bmj.c4715
PMCID: PMC2944922  PMID: 20861122
8.  Characteristics of patients receiving allergy vaccination: to which extent do socio-economic factors play a role? 
Background: Little is known about characteristics of patients receiving allergen-specific immunotherapy. Identifying obstacles to appropriate treatment according to guidelines may facilitate the development of strategies aiming at improved treatment of patients with allergic respiratory diseases. The objective of this study was to investigate differences in disease severity, demographic and socioeconomic status between allergic rhinitis patients receiving allergen-specific immunotherapy and allergic rhinitis patients not receiving allergen-specific immunotherapy. Methods: A total of 366 patients were studied of whom 210 were going to receive subcutaneously administrated immunotherapy (SIT) against grass pollen and/or house dust mite allergy. The severity of rhino-conjunctivitis (hay fever) and/or asthma was classified according to international guidelines. The questionnaires included an EQ-5D visual analogue scale instrument and some socio-economic questions. Results: Severity of disease, young age, high level of education as well as greater perceived impairment of health-related quality of life due to allergic symptoms were significantly associated with use of SIT. Somewhat unexpectedly, household income was not associated with use of SIT. Conclusion: Use of SIT was associated with both disease severity measures and educational level, but not income level. These results suggest social inequality as reflected by lower use of SIT among patients with lower educational level may represent an obstacle to treatment with SIT.
doi:10.1093/eurpub/ckq063
PMCID: PMC3098894  PMID: 20484343
asthma; hay fever; health services needs and demand; immunological desensitization; quality of life
9.  Laypersons' understanding of relative risk reductions: Randomised cross-sectional study 
Background
Despite increasing recognition of the importance of involving patients in decisions on preventive healthcare interventions, little is known about how well patients understand and utilise information provided on the relative benefits from these interventions. The aim of this study was to explore whether lay people can discriminate between preventive interventions when effectiveness is presented in terms of relative risk reduction (RRR), and whether such discrimination is influenced by presentation of baseline risk.
Methods
The study was a randomised cross-sectional interview survey of a representative sample (n = 1,519) of lay people with mean age 59 (range 40–98) years in Denmark. In addition to demographic information, respondents were asked to consider a hypothetical drug treatment to prevent heart attack. Its effectiveness was randomly presented as RRR of 10, 20, 30, 40, 50 or 60 percent, and half of the respondents were presented with quantitative information on the baseline risk of heart attack. The respondents had also been asked whether they were diagnosed with hypercholesterolemia or had experienced a heart attack.
Results
In total, 873 (58%) of the respondents consented to the hypothetical treatment. While 49% accepted the treatment when RRR = 10%, the acceptance rate was 58–60% for RRR>10. There was no significant difference in acceptance rates across respondents irrespective of whether they had been presented with quantitative information on baseline risk or not.
Conclusion
In this study, lay people's decisions about therapy were only slightly influenced by the magnitude of the effect when it was presented in terms of RRR. The results may indicate that lay people have difficulties in discriminating between levels of effectiveness when they are presented in terms of RRR.
doi:10.1186/1472-6947-8-31
PMCID: PMC2494548  PMID: 18631406
10.  Waist Circumference and Body Mass Index as Predictors of Health Care Costs 
PLoS ONE  2008;3(7):e2619.
Background
In the present study we analyze the relationship between body mass index (BMI) and waist circumference (WC) and future health care costs. On the basis of the relation between these anthropometric measures and mortality, we hypothesized that for all levels of BMI increased WC implies added future health care costs (Hypothesis 1) and for given levels of WC increased BMI entails reduced future health care costs (Hypothesis 2). We furthermore assessed whether a combination of the two measures predicts health care costs better than either individual measure.
Research Methodology/Principal Findings
Data were obtained from the Danish prospective cohort study Diet, Cancer and Health. The population includes 15,334 men and 16,506 women 50 to 64 years old recruited in 1996 to 1997. The relationship between future health care costs and BMI and WC in combination was analyzed by use of categorized and continuous analyses. The analysis confirms Hypothesis 1, reflecting that an increased level of abdominal fat for a given BMI gives higher health care costs. Hypothesis 2, that BMI had a protective effect for a given WC, was only confirmed in the continuous analysis and for a subgroup of women (BMI<30 kg/m2 and WC <88 cm). The relative magnitude of the estimates supports that the regressions including WC as an explanatory factor provide the best fit to the data.
Conclusion
The study showed that WC for given levels of BMI predicts increased health costs, whereas BMI for given WC did not predict health costs except for a lower cost in non-obese women with normal WC. Combining WC and BMI does not give a better prediction of costs than WC alone.
doi:10.1371/journal.pone.0002619
PMCID: PMC2440800  PMID: 18612430
11.  Communicating effectiveness of intervention for chronic diseases: what single format can replace comprehensive information? 
Background
There is uncertainty about how GPs should convey information about treatment effectiveness to their patients in the context of cardiovascular disease. Hence we study the concordance of decisions based on one of four single information formats for treatment effectiveness with subsequent decisions based on all four formats combined with a pictorial representation.
Methods
A randomized study comprising 1,169 subjects aged 40–59 in Odense, Denmark. Subjects were randomized to receive information in terms of absolute risk reduction (ARR), relative risk reduction (RRR), number needed to treat (NNT), or prolongation of life (POL) without heart attack, and were asked whether they would consent to treatment. Subsequently the same information was conveyed with all four formats jointly accompanied by a pictorial presentation of treatment effectiveness. Again, subjects should consider consent to treatment.
Results
After being informed about all four formats, 52%–79% of the respondents consented to treatment, depending on level of effectiveness and initial information format. Overall, ARR gave highest concordance, 94% (95% confidence interval (91%; 97%)) between initial and final decision, but ARR was not statistically superior to the other formats.
Conclusion
Decisions based on ARR had the best concordance with decisions based on all four formats and pictorial representation, but the difference in concordance between the four formats was small, and it is unclear whether respondents fully understood the information they received.
doi:10.1186/1472-6947-8-25
PMCID: PMC2467410  PMID: 18565218
12.  Influenza pandemic: perception of risk and individual precautions in a general population. Cross sectional study 
BMC Public Health  2007;7:48.
Background
An influenza pandemic may have considerable impact on health and societal functioning. The aim of this study was to explore people's reflections on the consequences of a pandemic.
Methods
Cross-sectional web-based survey of 1,168 Norwegians aged 16–82 years. The main outcome measures were answers to questions about a potential pandemic ("serious influenza epidemic"): statements about personal precautions including stockpiling Tamiflu®, the perceived number of fatalities, the perceived effects of Tamiflu®, the sources of information about influenza and trust in public information.
Results
While 80% of the respondents stated that they would be "careful about personal hygiene", only a few would stay away from work (2%), or move to an isolated place (4%). While 27% of respondents were uncertain about the number of fatalities during an influenza pandemic, 48% thought it would be lower than the estimate of Norwegian health authorities (0.05%–1%) and only 3% higher. At least half of the respondents thought that Tamiflu® might reduce the mortality risk, but less than 1% had personally purchased the drug. The great majority had received their information from the mass media, and only 9% directly from health authorities. Still the majority (65%) trusted information from the authorities, and only 9% reported overt distrust.
Conclusion
In Norway, considerable proportions of people seem to consider the mortality risk during a pandemic less than health authorities do. Most people seem to be prepared to take some, but not especially disruptive, precautions.
doi:10.1186/1471-2458-7-48
PMCID: PMC1852795  PMID: 17407563
13.  Can postponement of an adverse outcome be used to present risk reductions to a lay audience? A population survey 
Background
For shared decision making doctors need to communicate the effectiveness of therapies such that patients can understand it and discriminate between small and large effects. Previous research indicates that patients have difficulties in understanding risk measures. This study aimed to test the hypothesis that lay people may be able to discriminate between therapies when their effectiveness is expressed in terms of postponement of an adverse disease event.
Methods
In 2004 a random sample of 1,367 non-institutionalized Danes aged 40+ was interviewed in person. The participants were asked for demographic information and asked to consider a hypothetical preventive drug treatment. The respondents were randomized to the magnitude of treatment effectiveness (heart attack postponement of 1 month, 6 months, 12 months, 2 years, 4 years and 8 years) and subsequently asked whether they would take such a therapy. They were also asked whether they had hypercholesterolemia or had experienced a heart attack.
Results
In total 58% of the respondents consented to the hypothetical treatment. The proportions accepting treatment were 39%, 52%, 56%, 64%, 67% and 73% when postponement was 1 month, 6 months, 12 months, 2 years, 4 years and 8 years respectively. Participants who thought that the effectiveness information was difficult to understand, were less likely to consent to therapy (p = 0.004).
Conclusion
Lay people can discriminate between levels of treatment effectiveness when they are presented in terms of postponement of an adverse event. The results indicate that such postponement is a comprehensible measure of effectiveness.
doi:10.1186/1472-6947-7-8
PMCID: PMC1851704  PMID: 17394656

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