Evaluation of sex inequity in lung-cancer-specific survival.

BACKGROUND: Whether sex is an independent prognostic factor in lung cancer survival is the subject of ongoing debate. Both large national registries and single hospital studies have shown conflicting findings. In this study, we explore the impact of sex on lung-cancer-specific survival in an unselected population that is well-characterized with respect to stage and other covariates. MATERIAL AND METHODS: All patients diagnosed with lung cancer at a single hospital serving a whole and defined region in Southern Norway during the 10 years 2007-2016 were included. Follow-up data were available for at least 56 months for all patients. Analyses were adjusted for stage, treatment, performance status, smoking, age, histology, epidermal growth factor receptor/anaplastic lymphoma kinase/immunotherapy treatment and period. Differences in lung-cancer-specific survival by sex were explored using restricted mean survival times (RMST). RESULTS: Of the 1,261 patients diagnosed with lung cancer, 596 (47%) were females and 665 (53%) males, with mean ages of 68.5 and 69.5 years, respectively. The observed 5-year lung-cancer-specific survival rate was 27.4% (95% CI 23.7, 31.2) in females and 21.4% (95% CI 18.2, 24.8) in males. However, after adjustment for covariates, no significant differences by sex were observed. The 5-year RMST was 0.9 months shorter (95% CI -2.1, 0.31, p = 0.26) in males compared to females. INTERPRETATION: In this cohort, sex was not associated with a difference in lung-cancer-specific survival after adjusting for clinical and biological factors. Imbalance in stage at diagnosis was the main contributor to the observed difference in lung-cancer-specific survival by sex.

Intervention for reducing the overuse of upper endoscopy in patients <45 years: a protocol for a stepwise intervention programme.

Utilisation rates for healthcare services vary widely both within and between nations. Moreover, healthcare providers with insurance-based reimbursement systems observe an effect of social determinants of health on healthcare utilisation rates and outcomes. Even in countries with publicly funded universal healthcare such as Norway, utilisation rates for medical and surgical interventions vary between and within health regions and hospitals.Most interventions targeting overuse and high utilisation rates are based on the assumption that knowledge of areas of unwarranted variation in healthcare automatically will lead to a reduction in unwarranted variation. Recommendations regarding how to reduce this variation are often not very detailed or prominent.This paper describes a protocol for reducing the overuse of upper endoscopy in a Norwegian health region. The protocol uses a combination of digital tools and psychological methods targeting behavioural change in order to alter healthcare workers' approach to patient care.The aim of the planned intervention is to evaluate the effectiveness of a multifaceted set of interventions to reduce the overuse of upper endoscopy in patients under 45 years. A secondary aim is to evaluate the specific effect of the various parts of the intervention.

Patients with depression symptoms are more likely to experience improvements of internet-based cognitive behavioral therapy: a secondary analysis of effect modifiers in patients with non-cardiac chest pain in a randomized controlled trial.

BACKGROUND: Non-cardiac chest pain is common and associated with increased anxiety and reduced health-related quality of life. Randomized controlled trials on psychological interventions for patients with non-cardiac chest pain have reported mixed results. Patients with non-cardiac chest pain are a heterogeneous group. Identifying sub-groups that could potentially benefit more (or less) from an intervention would be valuable knowledge. We have conducted a randomized controlled trial where internet-based cognitive behavioural therapy (iCBT) had effect on reducing cardiac anxiety and increasing health-related quality of life at 12-month follow-up. The aim of the present study was to explore potential effect modifiers of iCBT in patients with non-cardiac chest pain on cardiac anxiety and/or health related quality of life at 12-month follow-up. METHODS: We analysed data from our randomized, controlled trial where 161 patients with non-cardiac chest pain were included and randomized to either iCBT or a treatment as usual (control). Cardiac anxiety measured by the Cardiac Anxiety Questionnaire and health-related quality of life measured by the EuroQol Visual Analog Scale at 12 month follow-up were the primary outcomes. Four potential baseline characteristics where identified as potential effect modifiers by a theory-based approach: (1) depression measured by the Patient Health Questionnaire; (2) anxiety measured by the Body Sensations Questionnaire; (3) prior healthcare contacts measured by a self-developed question; and (4) chest pain frequency measured by a self-developed question. Each potential effect modifier was analysed in a linear regression model where cardiac anxiety and EQ-VAS scores at 12-month follow-up, separately, were used as dependent variables. The potential differential treatment effect for each effect modifier was assessed by the interaction term: effect modifier x treatment group. RESULTS: Depression symptoms at baseline predicted a differential treatment effect at 12-month follow-up on health-related quality of life in favor of the iCBT group (regression coefficient of the interaction term: -1.85 (CI -3.28 to -0.41), p = 0.01), but not on cardiac anxiety at 12-month follow-up. Fear of bodily symptoms, chest pain frequency and prior health care contacts at baseline did not predict a treatment effect on either health-related quality of life or cardiac anxiety. CONCLUSIONS: Depression symptoms at baseline predicted a positive treatment effect of iCBT on health-related quality of life in patients suffering from non-cardiac chest pain. This indicates that it is important to identify patients with non-cardiac chest pain and co-occurring depression symptoms given that they are particularly likely to benefit from iCBT. TRIAL REGISTRATION: ClinicalTrials.gov NCT03096925 .

Effectiveness of Internet-Based Cognitive Behavioral Therapy With Telephone Support for Noncardiac Chest Pain: Randomized Controlled Trial.

BACKGROUND: Noncardiac chest pain has a high prevalence and is associated with reduced quality of life, anxiety, avoidance of physical activity, and high societal costs. There is a lack of an effective, low-cost, easy to distribute intervention to assist patients with noncardiac chest pain. OBJECTIVE: In this study, we aimed to investigate the effectiveness of internet-based cognitive behavioral therapy with telephone support for noncardiac chest pain. METHODS: We conducted a randomized controlled trial, with a 12-month follow-up period, to compare internet-based cognitive behavioral therapy to a control condition (treatment as usual). A total of 162 participants aged 18 to 70 years with a diagnosis of noncardiac chest pain were randomized to either internet-based cognitive behavioral therapy (n=81) or treatment as usual (n=81). The participants in the experimental condition received 6 weekly sessions of internet-based cognitive behavioral therapy. The sessions covered different topics related to coping with noncardiac chest pain (education about the heart, physical activity, interpretations/attention, physical reactions to stress, optional panic treatment, and maintaining change). Between sessions, the participants also engaged in individually tailored physical exercises with increasing intensity. In addition to internet-based cognitive behavioral therapy sessions, participants received a brief weekly call from a clinician to provide support, encourage adherence, and provide access to the next session. Participants in the treatment-as-usual group received standard care for their noncardiac chest pain without any restrictions. Primary outcomes were cardiac anxiety, measured with the Cardiac Anxiety Questionnaire, and fear of bodily sensations, measured with the Body Sensations Questionnaire. Secondary outcomes were depression, measured using the Patient Health Questionnaire; health-related quality of life, measured using the EuroQol visual analog scale; and level of physical activity, assessed with self-report question. Additionally, a subgroup analysis of participants with depressive symptoms at baseline (PHQ-9 score ≥5) was conducted. Assessments were conducted at baseline, posttreatment, and at 3- and 12-month follow-ups. Linear mixed models were used to evaluate treatment effects. Cohen d was used to calculate effect sizes. RESULTS: In the main intention-to-treat analysis at the 12-month follow-up time point, participants in the internet-based cognitive behavioral therapy group had significant improvements in cardiac anxiety (-3.4 points, 95% CI -5.7 to -1.1; P=.004, d=0.38) and a nonsignificant improvement in fear of bodily sensations (-2.7 points, 95% CI -5.6 to 0.3; P=.07) compared with the treatment-as-usual group. Health-related quality of life at the 12-month follow-up improved with statistical and clinical significance in the internet-based cognitive behavioral therapy group (8.8 points, 95% CI 2.8 to 14.8; P=.004, d=0.48) compared with the treatment-as-usual group. Physical activity had significantly (P<.001) increased during the 6-week intervention period for the internet-based cognitive behavioral therapy group. Depression significantly improved posttreatment (P=.003) and at the 3-month follow-up (P=.03), but not at the 12-month follow-up (P=.35). Participants with depressive symptoms at baseline seemed to have increased effect of the intervention on cardiac anxiety (d=0.55) and health-related quality of life (d=0.71) at the 12-month follow-up. In the internet-based cognitive behavioral therapy group, 84% of the participants (68/81) completed at least 5 of the 6 sessions. CONCLUSIONS: This study provides evidence that internet-based cognitive behavioral therapy with minimal therapist contact and a focus on physical activity is effective in reducing cardiac anxiety and increasing health related quality of life in patients with noncardiac chest pain. TRIAL REGISTRATION: ClinicalTrials.gov NCT03096925; http://clinicaltrials.gov/ct2/show/NCT03096925.

Factors associated with delayed treatment initiation in an unselected cohort of patients with small-cell lung cancer.

BACKGROUND: Small-cell lung cancer (SCLC) is an aggressive, rapidly progressive malignancy. Thus, expedient diagnosis and treatment initiation is important. This study identifies and quantifies factors associated with delayed diagnosis and treatment initiation in patients with SCLC and compares time to treatment in SCLC with a cohort of patients with non-small cell lung cancer (NSCLC). MATERIALS AND METHODS: The study included all patients diagnosed with SCLC at a hospital in southern Norway in a ten-year period (2007-2016), and all NSCLC patients during the period 2013-2016. Total time to treatment (TTT), was defined as the number of days from date of referral due to suspicion of lung cancer to first day of treatment. Factors associated with prolonged TTT were estimated using multivariate median regression analysis. RESULTS: The median TTT and interquartile range (IQR) for the 183 patients with SCLC was 16 (10-23) days. Factors associated with delayed TTT included outpatient versus inpatient evaluation (+8.4 days), number of diagnostic procedures (+4.3 days per procedure), stage I-III versus stage IV (+3.6 days) and age (+2.1 days per 10 years). In 2013-16, TTT in SCLC was 3.5 days shorter than in the period before and less than half that of NSCLC in the same period, 15 (9-22) versus 33 (22-50) days (p = 0.001). CONCLUSION: Shorter TTT is seen in higher stage, while longer TTT is a result of increasing complexity of the diagnostic process and treatment decisions of patients with curative intent treatment. Knowledge on delaying factors can shorten TTT and improve clinical practice.

Reduced delays in diagnostic pathways for non-small cell lung cancer after local and National initiatives.

OBJECTIVES: Patients with non-small cell lung cancer (NSCLC) may experience progression and stage shift due to delays in a complex and time-consuming diagnostic work-up. We have analyzed the impact of both a local and national intervention on total time to treatment (TTT). MATERIAL AND METHODS: All patients diagnosed with NSCLC at a Norwegian county hospital from 2007 to 2016 were reviewed. Logistic bottlenecks and delays were identified (2007-12) resulting in implementation of a local initiative with new diagnostic algorithm introduced by the beginning of 2013. In 2015, national diagnostic cancer pathways were implemented. TTT defined as time from received referral from the primary physician to start of treatment was compared in the three diagnostic time periods; baseline (2007-12), local (2013-14) and national (2015-16). RESULTS: A total of 780 patients were included. Among patients treated with curative intent the median TTT decreased by 21 days, from 64 to 43 days (p < 0.001) while the mean number of diagnostic procedures increased from 3.5 to 3.9. In median regression analysis, the local initiative was associated with a reduction of estimated 7.8 days (95% CI 3.2, 12.3) in TTT, while the national initiative correlated with a reduction of estimated 14.9 days (95% CI 10.2, 19.6) compared to time at baseline. Covariates associated with longer TTT were stage I, use of PET-CT, diagnostic procedure at external hospital, and number of diagnostic procedures. CONCLUSION: Local and national initiatives significantly reduced TTT in NSCLC. The effect was most pronounced among patients with disease available for curative treatment.

Trends in maternal use of snus and smoking tobacco in pregnancy. A register study in southern Norway.

BACKGROUND: The use of tobacco products including Swedish snus (moist snuff) in pregnancy may cause adverse health outcomes. While smoking prevalence has decreased among fertile women in Norway, snus use has increased during the last years. We investigated whether these trends were reflected also during pregnancy in a population of women in Southern Norway. METHODS: Data on smoking tobacco and snus use at three time points before and during pregnancy for 20,844 women were retrieved from the electronic birth record for the years 2012-2017. The results for the three-year period 2015-2017 were compared with a previously studied period 2012-2014. Prevalence and quit rates of tobacco use within groups of age, parity and education were reported. Within the same groups adjusted quit rates were analyzed using logistic regression. Mean birthweight and Apgar score of offspring were calculated for tobacco-users and non-users. RESULTS: There was an increase of snus use before pregnancy from the period 2012-2014 to the period 2015-2017 from 5.1% (CI; 4.6 to 5.5) to 8.4% (CI; 7.8 to 8.9). Despite this, the use of snus during pregnancy did not increase from the first to the second period, but stabilized at 2.8% (CI; 2.5 to 3.2) in first trimester and 2.0% (CI; 1.7 to 2.2) in third trimester. Cigarette smoking decreased significantly both before and during pregnancy. Snus use and smoking during pregnancy were associated with a reduction in average birthweight, but no significant effects on Apgar scores. Odds ratios for quitting both snus and smoking tobacco during pregnancy were higher for women aged 25-34 years, for the primiparas and for those with a high level of education. Pregnant women were more likely to have quit tobacco use in the last time period compared to the first. CONCLUSIONS: While smoking during pregnancy was decreasing, the use of snus remained constant, levelling off to around 3% in first trimester and 2% in third trimester. Approximately 25% of those that used snus, and 40% that smoked before pregnancy, continued use to the third trimester. This calls for a continuous watch on the use of snus and other nicotine products during pregnancy.

The EU project "United4Health": Results and experiences from automatic health status assessment in a Norwegian telemedicine trial system.

INTRODUCTION: Patients with chronic obstructive pulmonary disease require help in daily life situations to increase their individual perception of security, especially under worsened medical conditions. Unnecessary hospital (re-)admissions and home visits by doctors or nurses shall be avoided. This study evaluates the results from a two-year telemedicine field trial for automatic health status assessment based on remote monitoring and analysis of a long time series of vital signs data from patients at home over periods of weeks or months. METHODS: After discharge from hospital treatment for acute exacerbations, 94 patients were recruited for follow-up by the trial system. The system supported daily measurements of pulse and transdermal peripheral capillary oxygen saturation at patients' homes, a symptom-specific questionnaire, and provided nurses trained to use telemedicine ("telenurses") with an automatically generated health status overview of all monitored patients. A colour code (green/yellow/red) indicated whether the patient was stable or had a notable deterioration, while red alerts highlighted those in most urgent need of follow-up. The telenurses could manually overwrite the status level based on the patients' conditions observed through video consultation. RESULTS: Health status evaluation in 4970 telemonitor datasets were assessed retrospectively. The automatic health status determination (subgroup of 33 patients) showed green status at 46% of the days during a one-month monitoring period, 28% yellow status, and 19% red status (no data reported at 7% of the days). The telenurses manually downrated approximately 10% of the red or yellow alerts. DISCUSSION: The evaluation of the defined real-time health status assessment algorithms, which involve static rules with personally adapted elements, shows limitations to adapt long-term home monitoring with adequate interpretation of day-to-day changes in the patient's condition. Thus, due to the given sensitivity and specificity of such algorithms, it seems challenging to avoid false high alerts.

Health economic evaluations of patient education interventions a scoping review of the literature.

OBJECTIVES: To provide a comprehensive overview of health economic evaluations of patient education interventions for people living with chronic illness. METHODS: Relevant literature published between 2000 and 2016 has been comprehensively reviewed, with attention paid to variations in study, intervention, and patient characteristics. RESULTS: Of the 4693 titles identified, 56 articles met the inclusion criteria and were included in this scoping review. Of the studies reviewed, 46 concluded that patient education interventions were beneficial in terms of decreased hospitalization, visits to Emergency Departments or General Practitioners, provide benefits in terms of quality-adjusted life years, and reduce loss of production. Eight studies found no health economic impact of the interventions. CONCLUSIONS: The results of this review strongly suggest that patient education interventions, regardless of study design and time horizon, are an effective tool to cut costs. This is a relatively new area of research, and there is a great need of more research within this field. PRACTICE IMPLICATIONS: In bringing this evidence together, our hope is that healthcare providers and managers can use this information within a broad decision-making process, as guidance in discussions of care quality and of how to provide appropriate, cost-effective patient education interventions.

Incidence of non-pulmonary cancer and lung cancer by amount of emphysema and airway wall thickness: a community-based cohort.

There is limited knowledge about the prognostic value of quantitative computed tomography (CT) measures of emphysema and airway wall thickness in cancer.The aim of this study was to investigate if using CT to quantitatively assess the amount of emphysema and airway wall thickness independently predicts the subsequent incidence of non-pulmonary cancer and lung cancer.In the GenKOLS study of 2003-2005, 947 ever-smokers performed spirometry and underwent CT examination. The main predictors were the amount of emphysema measured by the percentage of low attenuation areas (%LAA) on CT and standardised measures of airway wall thickness (AWT-PI10). Cancer data from 2003-2013 were obtained from the Norwegian Cancer Register. The hazard ratio associated with emphysema and airway wall thickness was assessed using Cox proportional hazards regression for cancer diagnoses.During 10 years of follow-up, non-pulmonary cancer was diagnosed in 11% of the subjects with LAA <3%, in 19% of subjects with LAA 3-10%, and in 17% of subjects with LAA ≥10%. Corresponding numbers for lung cancer were 2%, 3% and 11%, respectively. After adjustment, the baseline amount of emphysema remained a significant predictor of the incidence of non-pulmonary cancer and lung cancer. Airway wall thickness did not predict cancer independently.This study offers a strong argument that emphysema is an independent risk factor for both non-pulmonary cancer and lung cancer.

Do self-management interventions in COPD patients work and which patients benefit most? An individual patient data meta-analysis.

BACKGROUND: Self-management interventions are considered effective in patients with COPD, but trials have shown inconsistent results and it is unknown which patients benefit most. This study aimed to summarize the evidence on effectiveness of self-management interventions and identify subgroups of COPD patients who benefit most. METHODS: Randomized trials of self-management interventions between 1985 and 2013 were identified through a systematic literature search. Individual patient data of selected studies were requested from principal investigators and analyzed in an individual patient data meta-analysis using generalized mixed effects models. RESULTS: Fourteen trials representing 3,282 patients were included. Self-management interventions improved health-related quality of life at 12 months (standardized mean difference 0.08, 95% confidence interval [CI] 0.00-0.16) and time to first respiratory-related hospitalization (hazard ratio 0.79, 95% CI 0.66-0.94) and all-cause hospitalization (hazard ratio 0.80, 95% CI 0.69-0.90), but had no effect on mortality. Prespecified subgroup analyses showed that interventions were more effective in males (6-month COPD-related hospitalization: interaction P=0.006), patients with severe lung function (6-month all-cause hospitalization: interaction P=0.016), moderate self-efficacy (12-month COPD-related hospitalization: interaction P=0.036), and high body mass index (6-month COPD-related hospitalization: interaction P=0.028 and 6-month mortality: interaction P=0.026). In none of these subgroups, a consistent effect was shown on all relevant outcomes. CONCLUSION: Self-management interventions exert positive effects in patients with COPD on respiratory-related and all-cause hospitalizations and modest effects on 12-month health-related quality of life, supporting the implementation of self-management strategies in clinical practice. Benefits seem similar across the subgroups studied and limiting self-management interventions to specific patient subgroups cannot be recommended.

Use of snus and smoking tobacco among pregnant women in the Agder counties. / Bruk av snus og røyketobakk hos gravide i Agder.

BACKGROUND: The use of snus during pregnancy increases the risk of stillbirths, premature delivery and reduced birthweight. People have been warned against smoking during pregnancy, but less so against the use of snus. We have investigated the use of snus and smoking tobacco among pregnant women in the Agder counties. MATERIAL AND METHOD: Data on pregnant women and 10 583 births for the years 2012, 2013 and 2014 were retrieved from the electronic birth records of Sørlandet Hospital. RESULTS: In the three-year period 2012 ­ 2014, altogether 5 % used snus and 19 % used smoking tobacco before pregnancy and 2 % and 8 % respectively at the end of pregnancy. The use of snus before pregnancy increased from 3.6 % in 2012 to 6.8 % in 2014. The equivalent figures for the first trimester were 1.7 % and 3.4 %, and for the last trimester 1.2 % and 2.1 %. The use of smoking tobacco declined by 2 % over the three-year period. In the age group 16 ­ 24 years, a total of 12 % used snus before pregnancy and 5 % at the end. Of 522 women who used snus before their pregnancy, altogether 57.5 % had quit during the first trimester and 71.4 % during the third trimester. The corresponding figures for those 2 015 women who used smoking tobacco before their pregnancy were 45.2 % and 58.0 % (p < 0.001). INTERPRETATION: The use of snus before and during pregnancy doubled over the three-year period 2012 ­ 2014. The use was especially widespread in the youngest age groups. The proportion of women who quit using snus during their pregnancy was significantly higher than the proportion that quit smoking.

Characteristics of effective self-management interventions in patients with COPD: individual patient data meta-analysis.

It is unknown whether heterogeneity in effects of self-management interventions in patients with chronic obstructive pulmonary disease (COPD) can be explained by differences in programme characteristics. This study aimed to identify which characteristics of COPD self-management interventions are most effective.Systematic search in electronic databases identified randomised trials on self-management interventions conducted between 1985 and 2013. Individual patient data were requested for meta-analysis by generalised mixed effects models.14 randomised trials were included (67% of eligible), representing 3282 patients (75% of eligible). Univariable analyses showed favourable effects on some outcomes for more planned contacts and longer duration of interventions, interventions with peer contact, without log keeping, without problem solving, and without support allocation. After adjusting for other programme characteristics in multivariable analyses, only the effects of duration on all-cause hospitalisation remained. Each month increase in intervention duration reduced risk of all-cause hospitalisation (time to event hazard ratios 0.98, 95% CI 0.97-0.99; risk ratio (RR) after 6 months follow-up 0.96, 95% CI 0.92-0.99; RR after 12 months follow-up 0.98, 95% CI 0.96-1.00).Our results showed that longer duration of self-management interventions conferred a reduction in all-cause hospitalisations in COPD patients. Other characteristics are not consistently associated with differential effects of self-management interventions across clinically relevant outcomes.

Assessing alcohol use and smoking among patients admitted to the medical ward.

BACKGROUND: The objective of the study was to investigate the incidence of risky alcohol consumption in patients admitted to medical wards, and to examine possible differences in how smoking habits and alcohol consumption are assessed and monitored by health personnel. MATERIAL AND METHOD: The study was conducted on medical wards at Southern Norway Hospital Trust in autumn 2013. Out of 998 patients who were successively admitted, 536 were included in the analysis. A questionnaire was used to survey smoking and risky alcohol consumption, and to determine whether patients could remember being asked and advised about these during their hospitalisation period. RESULTS: Fifty patients (9.3%) fulfilled the criteria for risky alcohol consumption. A lower percentage reported having been asked about their drinking habits than about their smoking habits (44% versus 62%, p < 0.001). Compared to those who smoked, a lower percentage of those with risky alcohol consumption reported that they had been recommended to reduce their consumption or quit; 10% vs. 29% (p = 0.009). INTERPRETATION: The patients' experience was that they were asked less about their alcohol consumption than about smoking. They also reported receiving less health-promoting advice in relation to alcohol. Doctors should be more conscious of including alcohol consumption when taking regular case histories.

Predictors of health-related quality of life changes after lifestyle intervention in persons at risk of type 2 diabetes mellitus.

PURPOSE: To assess health-related quality of life (HRQOL) of subjects at risk of type 2 diabetes undergoing lifestyle intervention, and predictors for improved HRQOL. METHODS: The Finnish Diabetes Risk Score was used by general practitioners to identify individuals at risk. Low-intensity interventions with an 18-month follow-up were employed. HRQOL was assessed using the SF-36 at baseline and compared with results from a general Norwegian population survey and further at 6 and 18 months. Simple and multiple linear regression analyses were applied to identify predictors of changes in HRQOL of clinical importance. RESULTS: Two hundred and thirteen participants (50 % women; mean age: 46 years, mean body mass index: 37) were included: 182 returned for 18-month follow-up, of whom 172 completed the HRQOL questionnaire. HRQOL was reduced with clinical significance compared with general Norwegians. The mean changes in HRQOL from the baseline to the follow-up were not of clinical importance. However, one out of three individuals achieved a moderate or large clinical improvement in HRQOL. The best determinant for improved HRQOL was obtained for a composite, clinically significant lifestyle change, i.e. both a weight reduction of at least 5 % and an improvement in exercise capacity of at least 10 %, which was associated with an improvement in five out of the eight SF-36 domains. CONCLUSION: Subjects at risk of type 2 diabetes report a clinically important reduction in HRQOL compared with general Norwegians. The best predictor of improved HRQOL was a small weight loss combined with a small improvement in aerobic capacity.

Effects of lifestyle intervention in persons at risk for type 2 diabetes mellitus - results from a randomised, controlled trial.

BACKGROUND: Lifestyle change is probably the most important single action to prevent type 2 diabetes mellitus. The purpose of this study was to assess the effects of a low-intensity individual lifestyle intervention by a physician and compare this to the same physician intervention combined with an interdisciplinary, group-based approach in a real-life setting. METHODS: The "Finnish Diabetes Risk score" (FINDRISC) was used by GPs to identify individuals at high risk. A randomised, controlled design and an 18 month follow-up was used to assess the effect of individual lifestyle counselling by a physician (individual physician group, (IG)) every six months, with emphasis on diet and exercise, and compare this to the same individual lifestyle counselling combined with a group-based interdisciplinary program (individual and interdisciplinary group, (IIG)) provided over 16 weeks. Primary outcomes were changes in lifestyle indicated by weight reduction ≥ 5%, improvement in exercise capacity as assessed by VO2 max and diet improvements according to the Smart Diet Score (SDS). RESULTS: 213 participants (104 in the IG and 109 in the IIG group, 50% women), with a mean age of 46 and mean body mass index 37, were included (inclusion rate > 91%) of whom 182 returned at follow-up (drop-out rate 15%). There were no significant differences in changes in lifestyle behaviours between the two groups. At baseline 57% (IG) and 53% (IIG) of participants had poor aerobic capacity and after intervention 35% and 33%, respectively, improved their aerobic capacity at least one metabolic equivalent. Unhealthy diets according to SDS were common in both groups at baseline, 61% (IG) and 60% (IIG), but uncommon at follow-up, 17% and 10%, respectively. At least 5% weight loss was achieved by 35% (IG) and 28% (IIG). In the combined IG and IIG group, at least one primary outcome was achieved by 93% while all primary outcomes were achieved by 6%. Most successful was the 78% reduction in the proportion of participants with unhealthy diet (almost 50% absolute reduction). CONCLUSION: It is possible to achieve important lifestyle changes in persons at risk for type 2 diabetes with modest clinical efforts. Group intervention yields no additional effects. The design of the study, with high inclusion and low dropout rates, should make the results applicable to ordinary clinical settings. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00202748.