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1.  Clinical drug trials in general practice: a 10-year overview of protocols 
Trials  2013;14:162.
Background
Drugs predominantly prescribed in general practice should ideally be tested in that setting; however, little is known about drug trials in general practice. Our aim was to describe drug trials in Norwegian general practice over the period of a decade.
Methods
The present work concerns a 10-year retrospective study of protocols submitted to the Norwegian national medicines agency (1998 to 2007) identifying all studies involving general practitioners (GPs) as clinical investigator(s). We analyzed the number of trials, drug company involvement, patients, participating doctors, payment, medications tested and main diagnostic criteria for inclusion. We also analyzed one trial in greater detail.
Results
Out of 2,054 clinical drug trials, 196 (9.5%) were undertaken in general practice; 93% were multinational, 96% were industry funded and 77% included patients both from general practice and specialist care. The trials were planned to be completed in the period 1998 to 2012. A total of 23,000 patients in Norway and 340,000 patients internationally were planned to be included in the 196 trials. A median of 5 GPs participated in each trial (range 1 to 402). Only 0.7% of 831 GP investigators had general practice university affiliations. Median payment for participating investigators was €1,900 (range €0 to 13,500) per patient completing the trial. A total of 30 pharmaceutical companies were involved. The drugs most commonly studied were antidiabetics (21%), obstructive airway disease medications (12%), agents acting on the renin-angiotensin system (10%), and lipid modifying agents (10%). One trial, presented in more detail, had several characteristics of a seeding or marketing trial.
Conclusions
Only one in four drug trials involving general practice were solely general practice trials and almost all were industry initiated without input from academic general practice. There was a large variation in the number of patients, participating doctors, and economic compensation for trial investigators, with some investigators receiving substantial payments.
doi:10.1186/1745-6215-14-162
PMCID: PMC3672091  PMID: 23725228
Clinical trial; Drug industry; General practice; Patient selection; Randomized controlled trials
2.  Pharmacological primary and secondary cardiovascular prevention among diabetic patients in a multiethnic general practice population: still room for improvements 
Background
Ethnic minority groups have higher prevalence of cardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM). We assessed general practitioners’ (GPs’) performance with respect to the pharmacological prevention of CVD in patients with T2DM from different ethnic backgrounds in Oslo.
Methods
Of 1653 T2DM patients cared for by 49 GPs in 2005, 380 had a diagnosis of CVD. Ethnicity was categorized as Norwegian, South Asian and other. Risk factor levels, medication use, achievement of treatment targets (HbA1c ≤ 7.5%, systolic blood pressure (SBP) ≤ 140 mmHg, total cholesterol/HDL-cholesterol < 4) and therapeutic intensity (number of drugs targeting each risk factor) were recorded. Chi-square, Wald tests and multiple linear regression analyses were used.
Results
Of the 1273 patients receiving primary prevention, 1.5% had their Hb1Ac, 4.8% SBP and 12.7% lipids levels above treatment thresholds without relevant prescriptions. Among patients on pharmacological therapy, 66% reached the HbA1c, 62% SBP and 62% lipid target. Proportions not achieving the HbA1c target were 26% in Norwegians, 38% in South Asians and 29% in others (p = 0.008). Proportions not achieving the SBP target were 42% in Norwegians, 22% in South Asians and 25% in others (p ≤ 0.001). Of those not achieving the HbA1c and SBP targets, 43% and 35% respectively, used only one agent.
In secondary prevention, 0.8% of the patients had their HbA1c, 0.5% SBP and 7.4% lipid levels above treatment thresholds without relevant prescriptions. Among patients on pharmacological therapy, 65% reached the HbA1c, 64% SBP and 66% lipid target. Proportions not achieving the HbA1c target were 26% in Norwegians, 47% in South Asians and 40% in others (p = 0.03). Proportions not achieving the SBP target were 36% in Norwegians, 22% in South Asians and 56% in others (p = 0.050). Of those not achieving HbA1c and SBP targets, 49% and 21% respectively, were on mono-therapy.
Conclusions
Norwegian GPs comply reasonably well with guidelines for pharmacological prevention of CVD in T2DM patients across ethnic groups. However, lipid-lowering therapy was generally underused, and the achievement of treatment targets for HbA1c in ethnic minorities and for BP in Norwegians could be improved.
doi:10.1186/1472-6963-13-182
PMCID: PMC3664587  PMID: 23688317
Type 2 diabetes; CVD prevention; Ethnicity; General practice
3.  Symptom reporting in a general population in Norway: Results from the Ullensaker study 
Abstract
Objective. To determine the number of symptoms experienced in an adult population and their relationship with self- reported health, demographic, and lifestyle factors. Design. A postal questionnaire addressing 23 different symptoms, health, demographic, and lifestyle factors. Setting. The community of Ullensaker, Norway, in 2004. Subjects. 3325 subjects (participation rate = 54.4%). Main outcome measure. Number of self-reported symptoms. Results. At least one symptom was reported by 91.9% of the participants, 46.7% reported six or more, and 17.3% reported 10 or more symptoms. Symptom reporting was frequent in all age groups, also among young people. Women reported a greater mean number of symptoms than men (6.7 vs. 5.1). Those reporting poor health, receipt of social security benefit, unemployment, low education, or obesity had most symptoms. The proportion of respondents with these characteristics increased almost linearly with increasing number of symptoms. According to an adjusted multivariate model, self-reported overall health explained 28.2 % of the variance in the number of symptoms. Conclusion. A large proportion of the responders reported a high number of symptoms. A simple method of counting symptoms may be useful in approaching patients in general and multi-symptom patients in particular, because the total burden of symptoms is strongly associated with the patient's self-reported health and may even be a predictor of future disability.
doi:10.3109/02813432.2012.751697
PMCID: PMC3587302  PMID: 23293843
General practice; lifestyle; medically unexplained symptoms (MUS); Norway; number of symptoms; overall health; population survey; self-reported symptoms
4.  Sensitivity and specificity of Norwegian optometrists’ evaluation of diabetic retinopathy in single-field retinal images – a cross-sectional experimental study 
Background
In the working age group, diabetic retinopathy is a leading cause of visual impairment. Regular eye examinations and early treatment of retinopathy can prevent visual loss, so screening for diabetic retinopathy is cost-effective. Dilated retinal digital photography with the additional use of ophthalmoscopy is the most effective and robust method of diabetic retinopathy screening. The aim of this study was to estimate the sensitivity and specificity of diabetic retinopathy screening when performed by Norwegian optometrists.
Methods
This study employed a cross-sectional experimental design. Seventy-four optometrists working in private optometric practice were asked to screen 14 single-field retinal images for possible diabetic retinopathy. The screening was undertaken using a web-based visual identification and management of ophthalmological conditions (VIMOC) examination. The images used in the VIMOC examination were selected from a population survey and had been previously examined by two independent ophthalmologists. In order to establish a “gold standard”, images were only chosen for use in the VIMOC examination if they had elicited diagnostic agreement between the two independent ophthalmologists. To reduce the possibility of falsely high specificity occurring by chance, half the presented images were of retinas that were not affected by diabetic retinopathy. Sensitivity and specificity for diabetic retinopathy was calculated with 95% confidence intervals (CIs).
Results
The mean (95%CI) sensitivity for identifying eyes with any diabetic retinopathy was 67% (62% to 72%). The mean (95%CI) specificity for identifying eyes without diabetic retinopathy was 84% (80% to 89%). The mean (95%CI) sensitivity for identifying eyes with mild non-proliferative diabetic retinopathy or moderate non-proliferative diabetes was 54% (47% to 61%) and 100%, respectively. Only four optometrists (5%) met the required standard of at least 80% sensitivity and 95% specificity that has been previously set for diabetic retinopathy screening programmes.
Conclusions
The evaluation of retinal images for diabetic retinopathy by Norwegian optometrists does not meet the required screening standard of at least 80% sensitivity and 95% specificity. The introduction of measures to improve this situation could have implications for both formal optometric training and continuing optometric professional education.
doi:10.1186/1472-6963-13-17
PMCID: PMC3562149  PMID: 23305337
Diabetic retinopathy; Optometrist; Sensitivity; Specificity; Retinal images; Case finding; Screening
5.  Study protocol: Brief intervention for medication overuse headache - A double-blinded cluster randomised parallel controlled trial in primary care 
BMC Neurology  2012;12:70.
Background
Chronic headache (headache ≥ 15 days/month for at least 3 months) affects 2–5% of the general population. Medication overuse contributes to the problem. Medication-overuse headache (MOH) can be identified by using the Severity of Dependence Scale (SDS). A “brief intervention” scheme (BI) has previously been used for detoxification from drug and alcohol overuse in other settings. Short, unstructured, individualised simple information may also be enough to detoxify a large portion of those with MOH. We have adapted the structured (BI) scheme to be used for MOH in primary care.
Methods/Design
A double-blinded cluster randomised parallel controlled trial (RCT) of BI vs. business as usual. Intervention will be performed in primary care by GPs trained in BI. Patients with MOH will be identified through a simple screening questionnaire sent to patients on the GPs lists. The BI method involves an approach for identifying patients with high likelihood of MOH using simple questions about headache frequency and the SDS score. Feedback is given to the individual patient on his/her score and consequences this might have regarding the individual risk of medication overuse contributing to their headache. Finally, advice is given regarding measures to be taken, how the patient should proceed and the possible gains for the patient. The participating patients complete a headache diary and receive a clinical interview and neurological examination by a GP experienced in headache diagnostics three months after the intervention. Primary outcomes are number of headache days and number of medication days per month at 3 months. Secondary outcomes include proportions with 25 and 50% improvement at 3 months and maintenance of improvement and quality of life after 12 months.
Discussion
There is a need for evidence-based and cost-effective strategies for treatment of MOH but so far no consensus has been reached regarding an optimal medication withdrawal method. To our knowledge this is the first RCT of structured non-pharmacological MOH treatment in primary care. Results may hold the potential of offering an instrument for treating MOH patients in the general population by GPs.
Trial registration
ClinicalTrials.gov identifier: NCT01314768
doi:10.1186/1471-2377-12-70
PMCID: PMC3488483  PMID: 22883540
Medication-overuse headache; Chronic headache; Chronic tension-type headache; Migraine; Brief intervention; General practice; Primary care; Cluster randomised controlled trial
6.  A strong association between non-musculoskeletal symptoms and musculoskeletal pain symptoms: results from a population study 
Background
There is a lack of knowledge about the pattern of symptom reporting in the general population as most research focuses on specific diseases or symptoms. The number of musculoskeletal pain sites is a strong predictor for disability pensioning and, hence, is considered to be an important dimension in symptom reporting. The simple method of counting symptoms might also be applicable to non-musculoskeletal symptoms, rendering further dimensions in describing individual and public health. In a general population, we aimed to explore the association between self-reported non-musculoskeletal symptoms and the number of pain sites.
Methods
With a cross-sectional design, the Standardised Nordic Questionnaire and the Subjective Health Complaints Inventory were used to record pain at ten different body sites and 13 non-musculoskeletal symptoms, respectively, among seven age groups in Ullensaker, Norway (n = 3,227).
Results
Results showed a strong, almost linear relationship between the number of non-musculoskeletal symptoms and the number of pain sites (r = 0.55). The number and type of non-musculoskeletal symptoms had an almost equal explanatory power in the number of pain sites reported (27.1% vs. 28.2%).
Conclusion
The linear association between the number of non-musculoskeletal and musculoskeletal symptoms might indicate that the symptoms share common characteristics and even common underlying causal factors. The total burden of symptoms as determined by the number of symptoms reported might be an interesting generic indicator of health and well-being, as well as present and future functioning. Research on symptom reporting might also be an alternative pathway to describe and, possibly, understand the medically unexplained multisymptom conditions.
doi:10.1186/1471-2474-12-285
PMCID: PMC3310803  PMID: 22176611
Epidemiology; Cross-sectional; General population; Musculoskeletal pain; Medically unexplained symptoms
7.  Cardiovascular disease by diabetes status in five ethnic minority groups compared to ethnic Norwegians 
BMC Public Health  2011;11:554.
Background
The population in Norway has become multi-ethnic due to migration from Asia and Africa over the recent decades. The aim of the present study was to explore differences in the self-reported prevalence of cardiovascular disease (CVD) and associated risk factors by diabetes status in five ethnic minority groups compared to ethnic Norwegians.
Methods
Pooled data from three population-based cross-sectional studies conducted in Oslo between 2000 and 2002 was used. Of 54,473 invited individuals 24,749 (45.4%) participated. The participants self-reported health status, underwent a clinical examination and blood samples were drawn. A total of 17,854 individuals aged 30 to 61 years born in Norway, Sri-Lanka, Pakistan, Iran, Vietnam or Turkey were included in the study. Chi-square tests, one-way ANOVAs, ANCOVAs, multiple and logistic regression were used.
Results
Age- and gender-standardized prevalence of self-reported CVD varied between 5.8% and 8.2% for the ethnic minority groups, compared to 2.9% among ethnic Norwegians (p < 0.001). Prevalence of self-reported diabetes varied from 3.0% to 15.0% for the ethnic minority groups versus 1.8% for ethnic Norwegians (p < 0.001). Among individuals without diabetes, the CVD prevalence was 6.0% versus 2.6% for ethnic minorities and Norwegians, respectively (p < 0.001). Corresponding CVD prevalence rates among individuals with diabetes were 15.3% vs. 12.6% (p = 0.364). For individuals without diabetes, the odds ratio (OR) for CVD in the ethnic minority groups remained significantly higher (range 1.5-2.6) than ethnic Norwegians (p < 0.05), after adjustment for age, gender, education, employment, and body height, except for Turkish individuals. Regardless of diabetes status, obesity and physical inactivity were prevalent in the majority of ethnic minority groups, whereas systolic- and diastolic- blood pressures were higher in Norwegians. In nearly all ethnic groups, individuals with diabetes had higher triglycerides, waist-to-hip ratio (WHR), and body mass index compared to individuals without diabetes. Age, diabetes, hypertension, hypercholesterolemia, and WHR were significant predictors of CVD in both ethnic Norwegians and ethnic minorities, but significant ethnic differences were found for age, diabetes, and hypercholesterolemia.
Conclusions
Ethnic differences in the prevalence of CVD were prominent for individuals without diabetes. Primary CVD prevention including identification of undiagnosed diabetes should be prioritized for ethnic minorities without known diabetes.
doi:10.1186/1471-2458-11-554
PMCID: PMC3199594  PMID: 21752237
Cardiovascular disease; diabetes; ethnicity; socioeconomic position; risk factors.
8.  Does present use of cardiovascular medication reflect elevated cardiovascular risk scores estimated ten years ago? A population based longitudinal observational study 
BMC Public Health  2011;11:144.
Background
It is desirable that those at highest risk of cardiovascular disease should have priority for preventive measures, eg. treatment with prescription drugs to modify their risk. We wanted to investigate to what extent present use of cardiovascular medication (CVM) correlates with cardiovascular risk estimated by three different risk scores (Framingham, SCORE and NORRISK) ten years ago.
Methods
Prospective logitudinal observational study of 20 252 participants in The Hordaland Health Study born 1950-57, not using CVM in 1997-99. Prescription data obtained from The Norwegian Prescription Database in 2008.
Results
26% of men and 22% of women aged 51-58 years had started to use some CVM during the previous decade. As a group, persons using CVM scored significantly higher on the risk algorithms Framingham, SCORE and NORRISK compared to those not treated. 16-20% of men and 20-22% of women with risk scores below the high-risk thresholds for the three risk scores were treated with CVM, while 60-65% of men and 25-45% of women with scores above the high-risk thresholds received no treatment. Among women using CVM, only 2.2% (NORRISK), 4.4% (SCORE) and 14.5% (Framingham) had risk scores above the high-risk values. Low education, poor self-reported general health, muscular pains, mental distress (in females only) and a family history of premature cardiovascular disease correlated with use of CVM. Elevated blood pressure was the single factor most strongly predictive of CVM treatment.
Conclusion
Prescription of CVM to middle-aged individuals by large seems to occur independently of estimated total cardiovascular risk, and this applies especially to females.
doi:10.1186/1471-2458-11-144
PMCID: PMC3056749  PMID: 21366925
9.  Quality of care for patients with type 2 diabetes in general practice according to patients' ethnic background: a cross-sectional study from Oslo, Norway 
Background
In recent decades immigration to Norway from Asia, Africa and Eastern Europe has increased rapidly. The aim of this study was to assess the quality of care for type 2 diabetes mellitus (T2DM) patients from these ethnic minority groups compared with the care received by Norwegians.
Methods
In 2006, electronic medical record data were screened at 11 practices (49 GPs; 58857 patients). 1653 T2DM patients cared for in general practice were identified. Ethnicity was defined as self-reported country of birth. Chi-squared tests, one-way ANOVAs, multiple regression, linear mixed effect models and generalized linear mixed models were used.
Results
Diabetes was diagnosed at a younger age in patients from the ethnic minority groups (South Asians (SA): mean age 44.9 years, Middle East/North Africa (MENA): 47.2 years, East Asians (EA): 52.0 years, others: 49.0 years) compared with Norwegians (59.7 years, p < 0.001). HbA1c, systolic blood pressure (SBP) and s-cholesterol were measured in >85% of patients in all groups with minor differences between minority groups and Norwegians. A greater proportion of the minority groups were prescribed hypoglycaemic medications compared with Norwegians (≥79% vs. 72%, p < 0.001). After adjusting for age, gender, diabetes duration, practice and physician unit, HbA1c (geometric mean) for Norwegians was 6.9% compared to 7.3-7.5% in the minority groups (p < 0.05). The proportion with poor glycaemic control (HbA1c > 9%) was higher in minority groups (SA: 19.6%, MENA: 18.9% vs. Norwegians: 5.6%, p < 0.001. No significant ethnic differences were found in the proportions reaching the combined target: HbA1c ≤ 7.5%, SBP ≤ 140 mmHg, diastolic blood pressure (DBP) ≤ 85 mmHg and total s-cholesterol ≤5.0 mmol/L (Norwegians: 25.5%, SA: 24.9%, MENA: 26.9%, EA: 26.1%, others:17.5%).
Conclusions
Mean age at the time of diagnosis of T2DM was 8-15 years younger in minority groups compared with Norwegians. Recording of important processes of care measures is high in all groups. Only one in four of most patient groups achieved all four treatment targets and prescribing habits may be sub-optimal. Patients from minority groups have worse glycaemic control than Norwegians which implies that it might be necessary to improve the guidelines to meet the needs of specific ethnic groups.
doi:10.1186/1472-6963-10-145
PMCID: PMC2887836  PMID: 20507647
10.  General practitioners and tutors' experiences with peer group academic detailing: a qualitative study 
BMC Family Practice  2010;11:12.
Background
The Prescription Peer Academic Detailing (Rx-PAD) project is an educational intervention study aiming at improving GPs' competence in pharmacotherapy. GPs in CME peer groups were randomised to receive a tailored intervention, either to support a safer prescription practice for elderly patients or to improve prescribing of antibiotics to patients with respiratory tract infections. The project was based on the principles of peer group academic detailing, incorporating individual feedback on GPs' prescription patterns. We did a study to explore GPs and tutors' experiences with peer group academic detailing, and to explore GPs' reasons for deviating from recommended prescribing practice.
Methods
Data was collected through nine focus group interviews with a total of 39 GPs and 20 tutors. Transcripts from the interviews were analyzed by two researchers according to a procedure for thematic content analysis.
Results
A shared understanding of the complex decision-making involved in prescribing in general practice was reported by both GPs and tutors as essential for an open discussion in the CME groups. Tutors experienced that CME groups differed regarding structure and atmosphere, and in some groups it was a challenge to run the scheme as planned. Individual feedback motivated GPs to reflect on and to improve their prescribing practice, though feedback reports could cause distress if the prescribing practice was unfavourable. Explanations for inappropriate prescriptions were lack of knowledge, factors associated with patients, the GP's background, the practice, and other health professionals or health care facilities.
Conclusions
GPs and tutors experienced peer group academic detailing as a suitable method to discuss and learn more about pharmacotherapy. An important outcome for GPs was being more reflective about their prescriptions. Disclosure of inappropriate prescribing can cause distress in some doctors, and tutors must be prepared to recognise and manage such reactions.
doi:10.1186/1471-2296-11-12
PMCID: PMC2828999  PMID: 20152015
11.  The Norwegian General Practice (NORGEP) criteria for assessing potentially inappropriate prescriptions to elderly patients 
Objective
To establish a clinically relevant list with explicit criteria for pharmacologically inappropriate prescriptions in general practice for elderly people ≥70 years.
Design
A three-round Delphi process for validating the clinical relevance of suggested criteria (n = 37) for inappropriate prescriptions to elderly patients.
Setting
A postal consensus process undertaken by a panel of specialists in general practice, clinical pharmacology, and geriatrics.
Main outcome measures
The Norwegian General Practice (NORGEP) criteria, a relevance-validated list of drugs, drug dosages, and drug combinations to be avoided in the elderly (≤70 years) patients.
Results
Of the 140 invited panellists, 57 accepted to participate and 47 completed all three rounds of the Delphi process. The panellists reached consensus that 36 of the 37 suggested criteria were clinically relevant for general practice. Relevance of three of the criteria was rated significantly higher in Round 3 than in Round 1. At the end of the Delphi process, a significant difference between the different specialist groups’ scores was seen for only one of the 36 criteria.
Conclusion
The NORGEP criteria may serve as rules of thumb for general practitioners (GPs) related to their prescribing practice for elderly patients, and as a tool for evaluating the quality of GPs’ prescribing in settings where access to clinical information for individual patients is limited, e.g. in prescription databases and quality improvement interventions.
doi:10.1080/02813430902992215
PMCID: PMC3413187  PMID: 19462339
Drug safety; Delphi technique; explicit criteria; elderly; family practice; general practice; prescribing
12.  Care of vision and ocular health in diabetic members of a national diabetes organization: A cross-sectional study 
Background
Regular examination and early treatment of diabetic retinopathy can prevent visual loss. The aim of the study was to describe the care of vision and ocular health in people with diabetes in Norway.
Methods
A cross-sectional questionnaire survey of a random sample (n = 1,887) of the Norwegian Diabetic Associations' (NDA) members was carried out in 2005. Questions were asked about care of vision and ocular health, history of ocular disease and visual symptoms, general medical history and diabetes management. The study was approved by the Regional Committee for Medical Research Ethics.
Results
The response rate was 74%. Forty-four questionnaires with incomplete data regarding gender, age or type of diabetes were excluded, leaving 1352 cases (52% females) for analysis. 451 (33%) had type 1 and 901 (67%) had type 2 diabetes, the mean duration of diabetes was respectively, 22 (sd ± 14) and 10 (sd ± 9) years. In all 1,052 (78%) had their eyes examined according to guidelines and 1,169 (87%) confirmed to have received information about regular eye examinations. One in two recalled to have received such information from their general practitioner. To have received information about the importance of eye examinations (PR 3.1, 95% CI 2.4 to 4.0), and diabetes duration > 10 years (PR 1.2, 95% CI 1.2 to 1.3), were independently associated with reporting regular eye examinations. A history of diabetic retinopathy was reported by 178 (13%) responders, of which 101 (57%) reported a history of laser treatment. Responders who had regular eye examinations reported more frequently a history of diabetic retinopathy (19% vs. 5%, p < 0.001). The frequency of retinopathy was significantly higher in responders with reported HbA1c values above treatment target (23% vs. 13%, p = 0.001). However, in responders who were not regularly examined, there was no difference in reported frequency of retinopathy with regard to HbA1c level.
Conclusion
Eight out of ten diabetic members of the NDA had their eyes examined according to current guidelines and the majority was well informed about the risk of vision loss due to diabetes. The results indicate that the reported history of diabetic retinopathy likely underestimates the prevalence of retinopathy.
doi:10.1186/1472-6963-8-159
PMCID: PMC2525638  PMID: 18655733
13.  Sleep disturbances in an arctic population: The Tromsø Study 
Background
Prevalence estimates for insomnia range from 10 to 50% in the adult general population. Sleep disturbances cause great impairment in quality of life, which might even rival or exceed the impairment in other chronic medical disorders. The economic implications and use of health-care services related to chronic insomnia represent a clinical concern as well as a pronounced public health problem. Hypnotics are frequently prescribed for insomnia, but alcohol and over-the-counter sleep aids seem to be more widely used by insomniacs than prescription medications. Despite the complex relationship between insomnia and physical and mental health factors, the condition appears to be underrecognized and undertreated by health care providers, probably due to the generally limited knowledge of the causes and natural development of insomnia.
Methods/Design
The Tromsø Study is an ongoing population-based cohort study with five previous health studies undertaken between 1974 and 2001. This protocol outlines a planned study within the sixth Tromsø Study (Tromsø VI), aiming at; 1) describing sleep patterns in a community-based sample representative of the general population of northern Norway, and 2) examining outcome variables of sleep disturbances against possible explanatory and confounding variables, both within a cross-sectional approach, as well as retrospectively in a longitudinal study – exploring sleep patterns in subjects who have attended two or more of the previous Tromsø studies between 1974 and 2009. First, we plan to perform a simple screening in order to identify those participants with probable sleep disturbances, and secondly to investigate these sleep disturbances further, using an extensive sleep-questionnaire. We will also collect biological explanatory variables, i.e. blood samples, weight, height and blood pressure. We plan to merge data on an individual level from the Tromsø VI Study with data from the Norwegian Prescription Database (NorPD), which is a national registry including data for all prescription drugs issued at Norwegian pharmacies. Participants with sleep disturbances will be compared with pair-matched controls without sleep disturbances.
Discussion
Despite ongoing research, many challenges remain in the characterization of sleep disturbances and its correlates. Future mapping of the biological dimensions, natural history, as well as the behavioral and drug-related aspects of sleep disturbances in a representative population samples is clearly needed.
doi:10.1186/1472-6963-8-117
PMCID: PMC2424044  PMID: 18510767
14.  Suspected retinopathies in Norwegian optometric practice with emphasis on patients with diabetes: a cross-sectional study 
Background
The scope of optometry differs worldwide. In Norway the vast majority of optometrists perform ophthalmoscopy as part of their routine examinations. The aim of this study was to describe the frequency of suspected retinopathies in patients seen for routine optometric examination and to determine how optometrists deal with these patients.
Methods
212 optometrists participated in a questionnaire survey and a practice registration during November 2004 – May 2005. In the practice registration, details for 20 consecutive patient encounters were recorded. Data were analysed by chi-square tests and multiple logistic regression.
Results
All optometrist stated that ocular history taking was an integrated part of their routine examination, while general health and diabetes history were routinely addressed by 59% and 42% of the optometrists, respectively. During the practice registration 4,052 patient encounters were recorded. Ophthalmoscopy was performed in 88% of the patients, of which 2% were dilated fundus examinations. Retinopathy was suspected in 106 patients, of whom 31 did not report a previous history of ocular or systemic disease. Old age (75+), hypertension and diabetes strongly predicted retinopathy with odds ratio (95% CI) of 6.4 (4.2 to 9.9), 3.8 (2.4 to 6.0) and 2.5 (1.4 to 4.7), respectively. Diabetic retinopathy was seen in 10% of diabetic patients and suspected in 0.2% of patients with no established history of diabetes. Retinopathy was not confirmed in 9 out 18 patients with a history of diabetic retinopathy; seven of these had undergone laser treatment. Out of the 106 patients with findings of retinopathy, 28 were referred to an ophthalmologist or a general practitioner (GP), written reports were sent to a GP in 16 cases, ten patients were urged to contact their GP for further follow up, while 52 were considered in need of routine optometric follow up only.
Conclusion
Optometric practice provides a low threshold setting for detecting cases of ocular disease and retinal manifestations of systemic disease in the population. At present diagnosis of retinopathy in Norwegian optometric practice is unreliable. There are potentials for improving the optometrists' routine examination, their patient management patterns and collaboration routines with medical doctors.
doi:10.1186/1472-6963-8-38
PMCID: PMC2262885  PMID: 18261204
15.  Pharmacologically inappropriate prescriptions for elderly patients in general practice: How common? 
Objective
To assess Norwegian general practitioners’ (GPs’) level of potentially harmful drug prescribing for elderly patients.
Design
Prescription data for 12 months were retrospectively retrieved from the Norwegian Prescription Database (NorPD). Data were assessed in relation to 13 prescription quality indicators.
Setting
General practice.
Subjects
A total of 454 GPs attending continuous medical education (CME) groups in Southern Norway, 85 836 patients ≥70 years who received any prescription from the GPs during the study period.
Main outcome measures
Number of prescriptions assessed in relation to pharmacological inappropriateness based on a list of 13 explicit prescription quality indicators.
Results
Some 18.4% of the patients (66% females with mean age 79.8 years, 34% males with mean age 78.7 years) received one or more inappropriate prescriptions from their GP. An NSAID in a potentially harmful combination with another drug (7%) and a long-acting benzodiazepine (4.6%) were the most frequent inappropriate prescriptions made. Doctor characteristics associated with more inappropriate prescribing practice were old age and working single-handed with many elderly patients.
Conclusion
The study reveals areas where GPs’ prescribing practice for elderly patients can be improved and which can be targeted in educational interventions.
doi:10.1080/02813430802002875
PMCID: PMC3406653  PMID: 18570005
Drug safety; elderly; family practice; general practitioner; prescribing
16.  Which population groups should be targeted for cardiovascular prevention? A modelling study based on the Norwegian Hordaland Health Study (HUSK) 
Objective
To assess level of cardiovascular risk factors in a non-selected, middle-aged population. To estimate the proportion target for risk intervention according to present guidelines and according to different cut-off levels for two risk algorithms.
Design
Population survey, modelling study.
Setting
The Norwegian Hordaland Health Study (HUSK) 1997–99.
Subjects
A total of 22 289 persons born in 1950–57.
Main outcome measures
Own and relatives’ cardiovascular morbidity, antihypertensive and lipid-lowering treatment, smoking, blood pressure, cholesterol. Framingham and Systematic Coronary Risk Evaluation (SCORE) algorithms. The European guidelines on CVD prevention in clinical practice were applied to estimate size of risk groups.
Results
Some 9.7% of men and 7.6% of women had CVD, diabetes mellitus, a high level of one specific risk factor, or received lipid-lowering or antihypertensive treatment. Applying a SCORE (60 years) cut-off level at 5% to the rest of the population selected 52.4% of men and 0.8% of women into a primary prevention group, while a cut-off level at 8% included 22.0% and 0.06% respectively. A cut-off level for the Framingham score (60 years) of 20% selected 43.6% of men and 4.7% of women, while a cut-off level of 25% selected 25.6% of men and 1.8% of women.
Conclusion
The findings illustrate how choices regarding risk estimation highly affect the size of the target population. Modelling studies are important when preparing guidelines, to address implications for resource allocation and risk of medicalization. The population share to be targeted for primary prevention ought to be estimated, including the impact of various cut-off points for risk algorithms on the size of the risk population.
doi:10.1080/02813430701241087
PMCID: PMC3379744  PMID: 17497488
Cardiovascular disease; family practice; guidelines; modelling study; risk
17.  Antihypertensive and lipid lowering treatment in 70–74 year old individuals – predictors for treatment and blood-pressure control: a population based survey. The Hordaland Health Study (HUSK) 
BMC Geriatrics  2006;6:16.
Background
In an elderly, community based population we aimed at investigating antihypertensive and lipid lowering medication use in relation to own and familiar cardiovascular morbidity and diabetes mellitus, as well as to lifestyle factors and general health. We also examined levels of blood pressure in untreated and treated residents, to investigate factors correlating with blood pressure control.
Methods
A health survey carried out in 1997-9 in the county of Hordaland, Norway included a self-administered questionnaire mailed to 4 338 persons born in 1925-7. Drug use the day prior to filling in the questionnaire was reported. A health check-up was carried out, where their systolic and diastolic blood pressure (SBP and DBP), body mass index (BMI), and serum-cholesterol level were recorded.
Results
One third of respondents used one or more antihypertensive drugs, while 13% of men and women were treated with a statin. Diabetes mellitus, own or relatives'cardiovascular disease, having quit smoking, physical inactivity, and overweight correlated with antihypertensive treatment. Mean blood pressure was lower in respondents not on treatment. Among those on treatment, 38% of men and 29% of women had reached a target BP-level of lower than 140/90 mm Hg. Own cardiovascular disease and a low BMI correlated with good BP-control.
Conclusion
One third of 70–74 year old individuals living in the community used one or more antihypertensive drugs. Only around one third of those treated had reached a target BP-level of less than 140/90 mm Hg. Own cardiovascular disease and a low BMI correlated with good BP-control.
doi:10.1186/1471-2318-6-16
PMCID: PMC1624832  PMID: 17052334
18.  Can antibiotic prescriptions in respiratory tract infections be improved? A cluster-randomized educational intervention in general practice – The Prescription Peer Academic Detailing (Rx-PAD) Study [NCT00272155] 
Background
More than half of all antibiotic prescriptions in general practice are issued for respiratory tract infections (RTIs), despite convincing evidence that many of these infections are caused by viruses. Frequent misuse of antimicrobial agents is of great global health concern, as we face an emerging worldwide threat of bacterial antibiotic resistance. There is an increasing need to identify determinants and patterns of antibiotic prescribing, in order to identify where clinical practice can be improved.
Methods/Design
Approximately 80 peer continuing medical education (CME) groups in southern Norway will be recruited to a cluster randomized trial. Participating groups will be randomized either to an intervention- or a control group. A multifaceted intervention has been tailored, where key components are educational outreach visits to the CME-groups, work-shops, audit and feedback. Prescription Peer Academic Detailers (Rx-PADs), who are trained GPs, will conduct the educational outreach visits. During these visits, evidence-based recommendations of antibiotic prescriptions for RTIs will be presented and software will be handed out for installation in participants PCs, enabling collection of prescription data. These data will subsequently be linked to corresponding data from the Norwegian Prescription Database (NorPD). Individual feedback reports will be sent all participating GPs during and one year after the intervention. Main outcomes are baseline proportion of inappropriate antibiotic prescriptions for RTIs and change in prescription patterns compared to baseline one year after the initiation of the tailored pedagogic intervention.
Discussion
Improvement of prescription patterns in medical practice is a challenging task. A thorough evaluation of guidelines for antibiotic treatment in RTIs may impose important benefits, whereas inappropriate prescribing entails substantial costs, as well as undesirable consequences like development of antibiotic resistance. Our hypothesis is that an educational intervention program will be effective in improving prescription patterns by reducing the total number of antibiotic prescriptions, as well as reducing the amount of broad-spectrum antibiotics, with special emphasis on macrolides.
doi:10.1186/1472-6963-6-75
PMCID: PMC1569835  PMID: 16776824
19.  A cluster-randomized educational intervention to reduce inappropriate prescription patterns for elderly patients in general practice – The Prescription Peer Academic Detailing (Rx-PAD) study [NCT00281450] 
Background
Age-related alterations in metabolism and excretion of medications increase the risk of adverse drug events in the elderly. Inappropriate polypharmacy and prescription practice entails increased burdens of impaired quality of life and drug related morbidity and mortality. The main objective of this trial is to evaluate effects of a tailored educational intervention towards general practitioners (GPs) aimed at supporting the implementation of a safer drug prescribing practice for elderly patients ≥ 70 years.
Methods/design
Approximately 80 peer continuing medical education (CME) groups (about 600 GPs) in southern Norway will be recruited to a cluster randomized trial. Participating groups will be randomized either to an intervention- or a control group. The control group will not receive any intervention towards prescription patterns in elderly, but will be the target of an educational intervention for prescription of antibiotics for respiratory tract infections. A multifaceted intervention has been tailored, where key components are educational outreach visits to the CME-groups, work-shops, audit and feedback. Prescription Peer Academic Detailers (Rx-PADs), who are trained GPs, will conduct the educational outreach visits. During these visits, a set of quality indicators (QIs), i.e. explicit recommendations for safer prescribing for elderly patients, will be presented and discussed. Software will be handed out for installation in participants' practice computers to enable extraction of pre-defined prescription data. These data will subsequently be linked to corresponding data from the Norwegian Prescription Database (NorPD). Individual feedback reports will be sent all participating GPs during and one year after the intervention. Feedback reports will include QI-scores on individual- and group levels, before and after the intervention. The main outcome of this trial is the change in proportions of inappropriate prescriptions (QIs) for elderly patients ≥ 70 years following intervention, compared to baseline levels.
Discussion
Improvement of prescription patterns in medical practice is a challenging task. Evidence suggests that a thorough evaluation of diagnostic indications for drug treatment in the elderly and/or a reduction of potentially inappropriate drugs may impose significant clinical benefits. Our hypothesis is that an educational intervention program will be effective in improving prescribing patterns for elderly patients in GP settings.
doi:10.1186/1472-6963-6-72
PMCID: PMC1525163  PMID: 16764734
20.  Self-reported drug utilization, health, and lifestyle factors among 70–74 year old community dwelling individuals in Western Norway. The Hordaland Health Study (HUSK) 
BMC Public Health  2006;6:121.
Background
To examine the level and patterns of self-reported medication use (prescription and non-prescription drugs) among 70–74 year old individuals living in the community, and to explore self-reported indications for use, and factors possibly predictive of drug use.
Methods
A health survey carried out in 1997–99 in the county of Hordaland (Western Norway) in the setting of a population study. A self-administered questionnaire was mailed to 4338 persons born in 1925–27, and a health check-up was offered. Drug use the previous day was reported (point prevalence). 3341 (77.0%) persons who responded, comprise the material for the analyses.
Results
Between one third (males) and one quarter (females) did not take any drug the previous day. Mean number of drugs among users was 2.8 (men and women). 32% used three or more drugs and 11.5% five or more. Hypertension and other cardiovascular problems were by far the most common reasons for drug use, followed by respiratory, musculoskeletal and mental health problems. Self-reported poor health, a high Body Mass Index (BMI), and being an ex-smoker (but not currently a smoker) correlated with increasing number of drugs taken.
Conclusion
Among 70–74-year old individuals living in the community no use of medication was more common than major polypharmacy (5+ drugs). Persons who had fallen ill and were put on regular medication, probably tended to quit smoking, while those who remained healthy, continued to smoke.
doi:10.1186/1471-2458-6-121
PMCID: PMC1501015  PMID: 16672058
21.  Changed terms for drug payment influenced GPs’ diagnoses and prescribing practice for inhaled corticosteroids 
Background:
Inhaled glucocorticosteroids (ICS) are first-line anti-inflammatory treatment in asthma, but not in chronic obstructive pulmonary disease (COPD). To restrict ICS use in COPD to cases of severe disease, new terms for reimbursement of drug costs were introduced in Norway in 2006, requiring a diagnosis of COPD to be verified by spirometry.
Objectives:
To describe how GPs’ diagnoses and treatment of patients who used ICS before 2006 changed after a reassessment of the patients that included spirometry.
Methods:
From the shared electronic patient record system in one group practice, patients ≥ 50 years prescribed ICS (including in combination with long-acting beta2-agonists) during the previous year were identified and invited to a tailored consultation including spirometry to assure the quality of diagnosis and treatment. GPs’ diagnoses and ICS prescribing patterns after this reassessment were recorded, retrospectively.
Results:
Of 164 patients identified, 112 were included. Post-bronchodilator spirometry showed airflow limitation indicating COPD in 55 patients. Of the 57 remaining patients, five had a positive reversibility test. The number of patients diagnosed with asthma increased (from 25 to 62) after the reassessment. A diagnosis of COPD was also more frequently used, whereas fewer patients had other pulmonary diagnoses. ICS was discontinued in 31 patients; 20 with mild to moderate COPD and 11 with normal spirometry.
Conclusion:
Altered reimbursement terms for ICS changed GPs’ diagnostic practice in a way that made the diagnoses better fit with the treatment given, but over-diagnosis of asthma could not be excluded. Spirometry was useful for identifying ICS overuse.
doi:10.3109/13814788.2013.766713
PMCID: PMC3696339  PMID: 23560809
Diagnosis; COPD; asthma; treatment; general practice
22.  Improving antibiotic prescribing in acute respiratory tract infections: cluster randomised trial from Norwegian general practice (prescription peer academic detailing (Rx-PAD) study) 
Objective To assess the effects of a multifaceted educational intervention in Norwegian general practice aiming to reduce antibiotic prescription rates for acute respiratory tract infections and to reduce the use of broad spectrum antibiotics.
Design Cluster randomised controlled study.
Setting Existing continuing medical education groups were recruited and randomised to intervention or control.
Participants 79 groups, comprising 382 general practitioners, completed the interventions and data extractions.
Interventions The intervention groups had two visits by peer academic detailers, the first presenting the national clinical guidelines for antibiotic use and recent research evidence on acute respiratory tract infections, the second based on feedback reports on each general practitioner’s antibiotic prescribing profile from the preceding year. Regional one day seminars were arranged as a supplement. The control arm received a different intervention targeting prescribing practice for older patients.
Main outcome measures Prescription rates and proportion of non-penicillin V antibiotics prescribed at the group level before and after the intervention, compared with corresponding data from the controls.
Results In an adjusted, multilevel model, the effect of the intervention on the 39 intervention groups (183 general practitioners) was a reduction (odds ratio 0.72, 95% confidence interval 0.61 to 0.84) in prescribing of antibiotics for acute respiratory tract infections compared with the controls (40 continuing medical education groups with 199 general practitioners). A corresponding reduction was seen in the odds (0.64, 0.49 to 0.82) for prescribing a non-penicillin V antibiotic when an antibiotic was issued. Prescriptions per 1000 listed patients increased from 80.3 to 84.6 in the intervention arm and from 80.9 to 89.0 in the control arm, but this reflects a greater incidence of infections (particularly pneumonia) that needed treating in the intervention arm.
Conclusions The intervention led to improved antibiotic prescribing for respiratory tract infections in a representative sample of Norwegian general practitioners, and the courses were feasible to the general practitioners.
Trial registration Clinical trials NCT00272155.
doi:10.1136/bmj.f4403
PMCID: PMC3724398  PMID: 23894178

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