Improvement of the performance of survival prediction in the ageing blunt trauma population: A cohort study.

INTRODUCTION: The overestimation of survival predictions in the ageing trauma population results in negative benchmark numbers in hospitals that mainly treat elderly patients. The aim of this study was to develop and validate a modified Trauma and Injury Severity Score (TRISS) for accurate survival prediction in the ageing blunt trauma population. METHODS: This retrospective study was conducted with data from two Dutch Trauma regions. Missing values were imputed. New prediction models were created in the development set, including age (continuous or categorical) and Anesthesiologists Physical Status (ASA). The models were externally validated. Subsets were created based on age (≥75 years) and the presence of hip fracture. Model performance was assessed by proportion explained variance (Nagelkerke R2), discrimination (Area Under the curve of the Receiver Operating Characteristic, AUROC) and visually with calibration plots. A final model was created based on both datasets. RESULTS: No differences were found between the baseline characteristics of the development dataset (n = 15,530) and the validation set (n = 15,504). The inclusion of ASA in the prediction models showed significant improved discriminative abilities in the two subsets (e.g. AUROC of 0.52 [95% CI: 0.46, 0.58] vs. 0.74 [95% CI: 0.69, 0.78] for elderly patients with hip fracture) and an increase in the proportion explained variance (R2 = 0.32 to R2 = 0.35 in the total cohort). The final model showed high agreement between observed and predicted survival in the calibration plot, also in the subsets. CONCLUSIONS: Including ASA and age (continuous) in survival prediction is a simple adjustment of the TRISS methodology to improve survival predictions in the ageing blunt trauma population. A new model is presented, through which even patients with isolated hip fractures could be included in the evaluation of trauma care.

Imputation strategies in the trauma registration.

BACKGROUND: Trauma databases often contain relatively high proportions of missing physiologic values. Multiple imputation (MI) could be a possible adequate solution for the missing values. This study aimed to demonstrate the influence of more simplified imputation models on standardized W statistic (Ws) (number of excess survivors per hundred patients that would be achieved if the study center treated identically the same case mix as the reference population). METHODS: Data from three trauma care networks in the Netherlands were used to investigate local differences in missing data. Five different imputation models (MI 1 to 5) were created based on literature and expert opinion. A sixth database was created using maximal single imputation and a seventh database with only complete case analysis (CCA). The Ws values were calculated for the three regions separately. RESULTS: A total of 8,853, 24,487, and 8,599 observations were examined in region 1, region 2, and region 3, respectively. The Ws in region 1 ranged from -0.48 (95% confidence interval [CI], -1.71 to 0.80) for CCA to 0.53 (95% CI, -0.19 to 1.26) for MI 4 and a range of 0.40 (95% CI, -0.91 to 0.10) for CCA to -0.32 (-0.69, 0.04) for MI 1 and MI 4 was found in region 2. The Ws for region 3 ranged from -0.19 (-0.83 to 0.45) in all MI data sets to -0.12 (-0.76 to 0.52) in the CCA data set. Although there were no significant differences between the Ws of the imputation data sets and the CCA analysis, large differences were found in the region with the most missing values. CONCLUSION: Different imputation strategies did influence Ws values. Supplementary variables showed no additional value for the imputation process and a more simplified imputation model could be used to adequately impute missing data. LEVEL OF EVIDENCE: Prognostic, level II.

Randomized Trial of a Lifestyle Program in Obese Infertile Women.

BACKGROUND: Small lifestyle-intervention studies suggest that modest weight loss increases the chance of conception and may improve perinatal outcomes, but large randomized, controlled trials are lacking. METHODS: We randomly assigned infertile women with a body-mass index (the weight in kilograms divided by the square of the height in meters) of 29 or higher to a 6-month lifestyle intervention preceding treatment for infertility or to prompt treatment for infertility. The primary outcome was the vaginal birth of a healthy singleton at term within 24 months after randomization. RESULTS: We assigned women who did not conceive naturally to one of two treatment strategies: 290 women were assigned to a 6-month lifestyle-intervention program preceding 18 months of infertility treatment (intervention group) and 287 were assigned to prompt infertility treatment for 24 months (control group). A total of 3 women withdrew consent, so 289 women in the intervention group and 285 women in the control group were included in the analysis. The discontinuation rate in the intervention group was 21.8%. In intention-to-treat analyses, the mean weight loss was 4.4 kg in the intervention group and 1.1 kg in the control group (P<0.001). The primary outcome occurred in 27.1% of the women in the intervention group and 35.2% of those in the control group (rate ratio in the intervention group, 0.77; 95% confidence interval, 0.60 to 0.99). CONCLUSIONS: In obese infertile women, a lifestyle intervention preceding infertility treatment, as compared with prompt infertility treatment, did not result in higher rates of a vaginal birth of a healthy singleton at term within 24 months after randomization. (Funded by the Netherlands Organization for Health Research and Development; Netherlands Trial Register number, NTR1530.).

Skin autofluorescence as proxy of tissue AGE accumulation is dissociated from SCORE cardiovascular risk score, and remains so after 3 years.

BACKGROUND: Skin autofluorescence (SAF), as a proxy of AGE accumulation, is predictive of cardiovascular (CVD) complications in i.a. type 2 diabetes mellitus and renal failure, independently of most conventional CVD risk factors. The present exploratory substudy of the Groningen Overweight and Lifestyle (GOAL)-project addresses whether SAF is related to Systematic COronary Risk Evaluation (SCORE) risk estimation (% 10-year CVD-mortality risk) in overweight/obese persons in primary care, without diabetes/renal disease, and if after 3-year treatment of risk factors (change in, Δ) SAF is related to ΔSCORE. METHODS: In a sample of 65 participants from the GOAL study, with a body mass index (BMI) >25-40 kg/m2, hypertension and/or dyslipidemia, but without diabetes/renal disease, SAF and CVD risk factors were measured at baseline, and after 3 years of lifestyle and pharmaceutical treatment. RESULTS: At baseline, the mean SCORE risk estimation was 3.1±2.6%, mean SAF 2.04±0.5AU. In multivariate analysis SAF was strongly related to age, but not to other risk factors/SCORE. After 3 years ΔSAF was 0.34±0.45 AU (p<0.001). ΔSAF was negatively related to Δbodyweight but not to ΔSCORE%, or its components. At follow-up, SAF was higher in 11 patients with a history of CVD compared to 54 persons without CVD (p=0.002). CONCLUSIONS: Baseline and 3-year-Δ SAF are not related to (Δ)SCORE, or its components, except age, in the studied population. ΔSAF was negatively related to Δweight. As 3-year SAF was higher in persons with CVD, these results support a larger study on SAF to assess its contribution to conventional risk factors/SCORE in predicting CVD in overweight persons with low-intermediate cardiovascular risk.

Maintenance of lifestyle changes: 3-year results of the Groningen Overweight and Lifestyle study.

OBJECTIVE: This study aims to evaluate the three-year effect of lifestyle counseling by a nurse practitioner (NP) on physical activity (PA) and dietary intake compared with usual care by a general practitioner (GP). METHODS: At baseline, subjects were randomly allocated to the NP group (n = 225) or to the GP group (n = 232). The NP group received a low-intensive lifestyle intervention for three years by the NP and the GP group received one consultation by the GP and thereafter usual care. PA and dietary intake were assessed with questionnaires at baseline, 1 year follow-up and 3 year follow-up. RESULTS: After three years, leisure-time activity increased and favorable improvements towards a healthy diet were made for both groups. These three-year changes in PA and diet did not differ significantly between groups. Changes in PA and dietary habits after one year were practically maintained after 3 years, because only small relapses were found. CONCLUSION: After three years, subjects were more physically active and had a healthier diet compared to baseline. Lifestyle counseling by NP resulted in similar lifestyle changes compared to GP consultation. PRACTICE IMPLICATIONS: NPs could also advice patients at cardiovascular risk by lifestyle counseling, to possibly reduce GP barriers.

Process evaluation of a lifestyle intervention in primary care: implementation issues and the participants' satisfaction of the GOAL study.

The Groningen Overweight and Lifestyle (GOAL) intervention effectively prevents weight gain. The present study describes a process evaluation in which 214 participants in the intervention group received a structured questionnaire within 7 months (a median of 5 months) after the end of the intervention. The authors investigated the content of the intervention (on basis of the participants' recall), the participants' satisfaction of the intervention, the participants' satisfaction with the nurse practitioners (NPs), and the determinants of the participants' satisfaction. In general, the results show that the content corresponded well with the protocol for the intervention, except for the number of telephone calls and the percentage of participants with individualized goals for a healthy lifestyle. The overall satisfaction of the participants was high, and success and perceived success and a low educational level were important determinants for a higher overall satisfaction grade. Furthermore, the NP was considered to be an expert and motivational to learning and keeping up a healthy lifestyle. The authors therefore conclude that the GOAL study is feasible and indicates that the NP is well equipped to treat these patients. However, it is recommended to reinforce the advice given and the lifestyle goals after the first contact sessions.

Preventing weight gain by lifestyle intervention in a general practice setting: three-year results of a randomized controlled trial.

BACKGROUND: Weight regain after initial loss of weight is common, which indicates a need for lifestyle counseling aimed at preventing weight gain instead of weight loss. This study was conducted to determine whether structured lifestyle counseling by nurse practitioners (NPs) group compared with usual care by general practitioners (GP-UC) in overweight and obese patients can prevent (further) weight gain. METHODS: A randomized controlled trial in 11 general practice locations in the Netherlands of 457 patients (body mass index, 25-40 [calculated as weight in kilograms divided by height in meters squared]; mean age, 56 years; 52% female) with either hypertension or dyslipidemia or both. The NP group received lifestyle counseling with guidance of the NP using a standardized software program. The GP-UC group received usual care from their GP. Main outcome measures were changes in body weight, waist circumference, blood pressure, and fasting glucose and blood lipid levels after 3 years. RESULTS: In both groups, approximately 60% of the participants achieved weight maintenance after 3 years. There was no significant difference in mean (SD) weight change and change of waist circumference between the NP and GP-UC groups (weight change: NP group, -1.2% [5.8%], and GP-UC group, -0.6% [5.6%] [P = .37]; and change of waist circumference: NP group, -0.8 [7.1] cm, and GP-UC group, 0.4 [7.2] cm [P = .11]). A significant difference occurred for mean (SD) fasting glucose levels (NP group, -0.02 [0.49] mmol/L, and GP-UC group, 0.10 [0.53] mmol/L [P = .02]) (to convert to milligrams per deciliter, divide by 0.0555) but not for lipid levels and blood pressure. CONCLUSIONS: Lifestyle counseling by NPs did not lead to significantly better prevention of weight gain compared with GPs. In the majority in both groups, lifestyle counseling succeeded in preventing (further) weight gain. TRIAL REGISTRATION: trialregister.nl Identifier: NTR1365.

Changes in lifestyle habits after counselling by nurse practitioners: 1-year results of the Groningen Overweight and Lifestyle study.

OBJECTIVES: The Groningen Overweight and Lifestyle (GOAL) study primarily aims at preventing weight gain by nurse practitioners (NP) guided by a standardized computerized software program. Since favourable changes in physical activity (PA) and diet may improve health independently of weight (loss), insight into effects on lifestyle habits is essential. We examined the 1-year effects of lifestyle counselling by NP on PA and diet, compared with usual care from the general practitioner (GP-UC). DESIGN: A randomized controlled trial. SETTING: Eleven general practice locations in the Netherlands. SUBJECTS: A total of 341 GOAL participants with overweight or obesity and either hypertension or dyslipidaemia, or both, who completed an FFQ and Short Questionnaire to Assess Health-Enhancing Physical Activity (SQUASH) at baseline and after 1 year. RESULTS: After 1 year, the NP group spent 33 min/week more on walking compared with the GP-UC group who spent -5 min/week on walking (P = 0.05). No significant differences were found between the NP and GP-UC groups on the percentage of persons complying with the PA guidelines. In both groups, nutrient intake changed in a favourable direction and participants complied more often with dietary guidelines, but without overall difference between the NP and GP-UC groups. CONCLUSIONS: With the exception of an increase in walking (based on self-reported data) in the NP group, no intervention effects on PA and diet occurred. Positive changes in nutrient intake were seen in both groups.

The LIFESTYLE study: costs and effects of a structured lifestyle program in overweight and obese subfertile women to reduce the need for fertility treatment and improve reproductive outcome. A randomised controlled trial.

BACKGROUND: In the Netherlands, 30% of subfertile women are overweight or obese, and at present there is no agreement on fertility care for them. Data from observational and small intervention studies suggest that reduction of weight will increase the chances of conception, decrease pregnancy complications and improve perinatal outcome, but this has not been confirmed in randomised controlled trials. This study will assess the cost and effects of a six-months structured lifestyle program aiming at weight reduction followed by conventional fertility care (intervention group) as compared to conventional fertility care only (control group) in overweight and obese subfertile women. We hypothesize that the intervention will decrease the need for fertility treatment, diminish overweight-related pregnancy complications, and will improve perinatal outcome. METHODS/DESIGN: Multicenter randomised controlled trial in subfertile women (age 18-39 year) with a body mass index between 29 and 40 kg/m2. Exclusion criteria are azoospermia, use of donor semen, severe endometriosis, premature ovarian failure, endocrinopathies or pre-existent hypertensive disorders.In the intervention group the aim is a weight loss of at least 5% to10% in a six-month period, to be achieved by the combination of a diet, increase of physical activity and behavioural modification. After six months, in case no conception has been achieved, these patients will start fertility treatment according to the Dutch fertility guidelines. In the control group treatment will be started according to Dutch fertility guidelines, independently of the patient's weight. OUTCOME MEASURES AND ANALYSIS: The primary outcome measure is a healthy singleton born after at least 37 weeks of gestation after vaginal delivery. Secondary outcome parameters including pregnancy outcome and complications, percentage of women needing fertility treatment, clinical and ongoing pregnancy rates, body weight, quality of life and costs.Data will be analysed according to the intention to treat principle, and cost-effectiveness analysis will be performed to compare the costs and health effects in the intervention and control group. DISCUSSION: The trial will provide evidence for costs and effects of a lifestyle intervention aiming at weight reduction in overweight and obese subfertile women and will offer guidance to clinicians for the treatment of these patients. TRIAL REGISTRATION: Dutch Trial Register NTR1530.

Preventing weight gain: one-year results of a randomized lifestyle intervention.

BACKGROUND: Lifestyle interventions targeting prevention of weight gain may have better long-term success than when aimed at weight loss. Limited evidence exists about such an approach in the primary care setting. DESIGN: An RTC was conducted. SETTING/PARTICIPANTS: Participants were 457 overweight or obese patients (BMI=25-40 kg/m(2), mean age 56 years, 52% women) with either hypertension or dyslipidemia, or both, from 11 general practice locations in The Netherlands. INTERVENTION: In the intervention group, four individual visits to a nurse practitioner (NP) and one feedback session by telephone were scheduled for lifestyle counseling with guidance of the NP using a standardized computerized software program. The control group received usual care from their general practitioner (GP). MAIN OUTCOME MEASURES: Changes in body weight, waist circumference, blood pressure, and blood lipids after 1 year (dropout <10%). Data were collected in 2006 and 2007. Statistical analyses were conducted in 2007 and 2008. RESULTS: There were more weight losers and stabilizers in the NP group than in the general practitioner usual care (GP-UC) group (77% vs 65%; p<0.05). In men, mean weight losses were 2.3% for the NP group and 0.1% for the GP-UC group (p<0.05). Significant reductions occurred also in waist circumference but not in blood pressure, blood lipids, and fasting glucose. In women, mean weight losses were in both groups 1.6%. In the NP group, obese people lost more weight (-3.0%) than the non-obese (-1.3%; p<0.05). CONCLUSIONS: Standardized computer-guided counseling by NPs may be an effective strategy to support weight-gain prevention and weight loss in primary care, in the current trial, particularly among men. TRIAL REGISTRATION: The study was registered with the Netherlands Trial Register (NTR), www.trialregister.nl, study no. TC 1365.