Risto P. Roine

Gestational Diabetes Mellitus Can Be Prevented by Lifestyle Intervention: The Finnish Gestational Diabetes Prevention Study (RADIEL): A Randomized Controlled Trial.

OBJECTIVE To assess whether gestational diabetes mellitus (GDM) can be prevented by a moderate lifestyle intervention in pregnant women who are at high risk for the disease. RESEARCH DESIGN AND METHODS Two hundred ninety-three women with a history of GDM and/or a prepregnancy BMI of ≥30 kg/m2 were enrolled in the study at <20 weeks of gestation and were randomly allocated to the intervention group (n = 155) or the control group (n = 138). Each subject in the intervention group received individualized counseling on diet, physical activity, and weight control from trained study nurses, and had one group meeting with a dietitian. The control group received standard antenatal care. The diagnosis of GDM was based on a 75-g, 2-h oral glucose tolerance test at 24–28 weeks of gestation. RESULTS A total of 269 women were included in the analyses. The incidence of GDM was 13.9% in the intervention group and 21.6% in the control group ([95% CI 0.40–0.98%]; P = 0.044, after adjustment for age, prepregnancy BMI, previous GDM status, and the number of weeks of gestation). Gestational weight gain was lower in the intervention group (−0.58 kg [95% CI −1.12 to −0.04 kg]; adjusted P = 0.037). Women in the intervention group increased their leisure time physical activity more and improved their dietary quality compared with women in the control group. CONCLUSIONS A moderate individualized lifestyle intervention reduced the incidence of GDM by 39% in high-risk pregnant women. These findings may have major health consequences for both the mother and the child.

Estimating the minimum important change in the 15D scores

PurposeTo facilitate the interpretation of empirical results produced by the 15D, a generic, preference-based instrument for measuring health-related quality of life (HRQoL), a subjective five-category global assessment scale (GAS) was used as an external anchor to determine the minimum important change (MIC) in the 15D scores.MethodsAltogether 4,903 hospital patients representing sixteen disease entities and having the 15D score at baseline repeated the HRQoL assessment at 6xa0months after treatment and answered the question: compared to the situation before treatment, my overall health status is now (1) much better, (2) slightly better, (3) much the same, (4) slightly worse, (5) much worse. Regression analysis was used to estimate the MIC for improvement/deterioration, defined as the lower/upper limit of 99.9xa0% confidence interval of the regression coefficient, standardized for baseline HRQoL, for categories (2) and (4), respectively, and confirmed by ROC curve analysis.ResultsThe limits or intervals for classifying the changes of 15D scores into GAS categories were >.035 for (1), .015–.035 for (2),>−.015 and<.015 for (3), −.035–−.015 for (4) and <−.035 for (5). The lower/upper limits of ±.015 for categories (2) and (4) can be regarded as the generic MIC thresholds for improvement/deterioration, respectively.ConclusionsThe generic MICs for the change of 15D scores are ±.015. Follow-up studies using the 15D should report the mean change in the 15D score, its statistical significance, relationship to the MIC, and the distribution of the changes of the 15D scores into the five categories.

Health-related quality of life among breast, prostate, and colorectal cancer patients with end-stage disease

PurposeTo explore end-stage breast, prostate, and colorectal cancer patients’ health-related quality of life (HRQoL); to compare results obtained by different HRQoL instruments; and to explore factors related to impaired HRQoL.MethodsA cross-sectional observational study utilized two generic HRQoL instruments, the 15D and the EQ-5D, and a cancer-specific instrument, the EORTC QLQ-C30. Patients were recruited from the Helsinki University Hospital’s Department of Oncology and from a local hospice.ResultsOf the 114 palliative care patients included in the analysis, 27 had breast cancer, 30 had prostate cancer, and 57 had colorectal cancer. Of these, 28xa0% died within 3xa0months after their response, while 32xa0% died within three to 6xa0months, and 39xa0% died more than 6xa0months after. Utility values varied widely by instrument: the 15D gave the highest utility values and VAS the lowest (15D: 0.74, EQ-5D: 0.59 and VAS: 55). Patients close to death had lower HRQoL scores independently from the instrument used. The EQ-5D showed a pronounced ceiling effect, with 13xa0% of patients reporting full health, whereas the corresponding figures for the 15D and VAS were 1 and 0xa0%, respectively. Fatigue was the most common symptom and also predicted impaired HRQoL most significantly.ConclusionsAll instruments were applicable for the evaluation of HRQoL among end-stage cancer patients. Fatigue seemed to be the most significant deteriorating factor, whereas clinical and demographic factors had less of an effect on HRQoL.

Multidisciplinary pain treatment – Which patients do benefit?

Abstract Background The prevalence of chronic non-malignant pain in developed countries is high, ranging from 14% to 50%. Patients with chronic pain are active users of health-care services and they report impaired health-related quality of life (HRQoL) when compared with the general population. Psychological distress has been identified as one of the risk factors for pain chronicity. Depression, anxiety and negative beliefs are associated with pain interference and perceived disability. Multidisciplinary pain management (MPM) aims to rehabilitating chronic pain patients by addressing both physical, psychological, social and occupational factors related to the pain problem. MPM programmes have been shown to be effective in reducing pain and improving function in patients with diverse chronic pain states. However, MPM programmes are often heterogeneous and predicting MPM treatment results in different patients groups may be difficult. Methods The present study examined changes in HRQoL after MPM in 439 patients treated at a multidisciplinary pain clinic using the 15D HRQoL questionnaire. The characteristics of the 100 patients with the greatest improvement and the 100 patients with the largest decrease in HRQoL were examined more closely (demographics, characteristics of pain, pain interference, psychiatric comorbidity, employment status, details of MPM) after answering a follow-up 15D questionnaire at three years after their MPM had ended. Result During MPM, HRQoL was significantly improved in 45.6% of the 439 patients, decreased in 30.7% of the patients and did not change in 23.7% of the patients. Patient-related factors that predicted a better HRQoL among the 100 patients with good MPM outcome compared with the 100 patients with poor MPM outcome were higher education and better employment status. Age, gender, marital status, duration of pain, number of pain sites, pain intensity or pain interference at baseline did not differ between the patient groups. Patient expectations regarding MPM were similar. A tendency towards more psychiatric comorbidity in the non-responder group was seen. The duration of MPM in the two patient groups was similar, as well as the number of medications started, the variety of specialists seen and psychiatric counselling with supportive therapy included. More non-responder than responder patients had died during the three-year follow-up period, some of the deaths were related to substance abuse. Conclusions and Implications HRQoL in chronic pain patients was significantly improved during MPM compared with the baseline. Pain duration of several years, multiple pain sites and neuropathic pain were not discerning factors between the responders and non-responders of the present study, implying that a positive change in HRQoL may be achieved by MPM even in these pain patients. In agreement with previous studies, factors predicting poor treatment outcome in the non-responder group of chronic pain patients were not treatment related. To further improve MPM outcome even in pain patients with risk factors for less benefit of treatment such as low education and poor general health, more individualized MPM approaches with emphasis on analysis and treatment of psychological symptoms and patient beliefs is essential.

Impaired health‐related quality of life in Addison's disease – impact of replacement therapy, comorbidities and socio‐economic factors

Patients with Addisons disease (AD) on conventional replacement therapy have impaired health‐related quality of life (HRQoL). It is possible that lower hydrocortisone (HC) doses recommended by current guidelines could restore HRQoL. We compared HRQoL in AD patients treated according to current HC recommendations to that of the age‐ and gender‐standardized general population.

Health-related quality of life after kidney transplantation: who benefits the most?

The influence of dialysis modalities on HRQoL before and after kidney transplantation (KT) and the role of adherence to medication on HRQoL have not been fully studied. Sixty four dialysis patients who answered the 15D HRQoL survey during dialysis were surveyed again after KT. Adherence and employment were also investigated. The mean 15D score was highest among home hemodialysis patients (HHD) and lowest among in‐center hemodialysis patients (icHD). After KT, the mean 15D score improved significantly in 78.6% of peritoneal dialysis patients (PD), 47.6% of HHD, and 53.8% of icHD. Then, mean 15D score remained unchanged in 28.6% of HHD and in 23.1% of icHD patients. A deterioration in the 15D score occurred in 14.3% of PD, 23.1% of icHD, and 23.8% of HHD patients, and this was influenced by the number of pills (P = 0.04). Adherence to medication was the lowest in PD, timing being the most challenging task showing a connection to higher creatinine concentration (never forgot 1.41 mg/dl vs. forgot 2.08 mg/dl P = 0.05). Employed patients had a higher mean 15D score. The icHD and PD patients benefited the most from KT and HHD the least. Low pill burden and employment were linked to a better HRQoL.

Cost‐effectiveness of hysterectomy for benign gynecological conditions: a systematic review

The objective of this study was to assess the cost‐effectiveness of hysterectomy performed for benign indications. Hysterectomy remains the most common major gynecological operation in the Western world. Rates of hysterectomy have not declined as expected with the introduction of new treatment options. Furthermore, use of laparoscopic techniques varies widely within the Nordic countries. We designed a systematic review in a University Central Hospital. The sample included all published studies regarding the cost‐effectiveness of hysterectomy performed for benign indications (n = 1666). Medline, Cochrane Library, PsycINFO, CINAHL, and Nursing databases were searched. Inclusion criteria were the availability of pre‐ and post‐intervention health‐related quality of life measures (HRQoL) and data on costs. HRQoL, costs, and cost‐effectiveness of treatment were the main outcome measures. Studies (n = 24) focused on treatment of symptomatic fibroids (n = 8), treatment of heavy menstrual bleeding (n = 10), various surgical techniques (n = 5) and the effect of various indications for hysterectomy (n = 2). Follow‐up periods varied from 4 months to over 10 years. SF/RAND‐36 or EQ‐5D measures and societal cost perspective were most commonly used. Only 11 studies used individual patient data. HRQoL following hysterectomy was generally good but costs were high. The cost‐effectiveness depended on indication, age, and duration of follow‐up. The cost‐effectiveness of hysterectomy has been surprisingly poorly studied. Conclusions are difficult to draw due to different study designs, indications, follow‐up times, and HRQoL instruments used. Rates of hysterectomy have declined less than expected with the introduction of new treatment modalities. Costs of surgery are high. Laparoscopic hysterectomy seems to be the least cost‐effective, although further data from original patient cohorts with long‐term follow‐up are needed.

Health-related quality of life and burden of disease in chronic pain measured with the 15D instrument.

Abstract Health-related quality of life (HRQoL) measurement aims to capture the complete, subjective health state of the patients and to comprehensively evaluate treatment outcomes. The aim of this study was to assess, using the 15D HRQoL instrument, HRQoL in a sample of 1528 chronic pain patients, referred to the multidisciplinary pain clinic of the Helsinki University Hospital during 2004 to 2012. The 15D results of the chronic pain patients were compared with those of a matched general population. To analyse the properties of the 15D, the results were compared with the preadmission questionnaire of the pain clinic, containing questions about background factors, aspects of the pain, and its impact on life. The mean 15D score of the chronic pain patients was one of the lowest reported using 15D; 0.710 vs 0.922 in the general population. It equalled the score of advanced cancer patients in palliative care. The 15D scores were normally distributed, and 15D showed both statistically and clinically significant discriminative power in pain-related background factors. Visual analogue scale on pain intensity, visual analogue scale on pain-related distress, and the impact of pain on daily life correlated well with the 15D score. Pain intensity did not have independent predictive value on the score. The results indicate heavy perceived burden of illness in chronic pain patients. In light of the questions analysed, 15D appears sensitive and discriminative in chronic pain patients in tertiary care. Instead of pain intensity, the impaired HRQoL in chronic pain was mainly because of the psychosocial aspects of pain.

Normal long-term health-related quality of life can be achieved in patients with functional pituitary adenomas having surgery as primary treatment.

Previous studies report impaired health‐related quality of life (HRQoL) in patients with functional pituitary adenomas (FPA). We assessed HRQoL in FPA patients having undergone surgery at our University Central Hospital between 2000 and 2010, with combined adjuvant treatment given to achieve strict hormonal control.

Heterogeneity of maternal characteristics and impact on gestational diabetes (GDM) risk—Implications for universal GDM screening?

Abstract Objective To study the incidence of gestational diabetes mellitus (GDM) in relation to phenotypic characteristics and gestational weight gain (GWG) among women at high risk for GDM. Materials and methods This is a secondary analysis of a GDM prevention study (RADIEL), a randomized controlled trial conducted in Finland. 269 women with a history of GDM and/or a pre-pregnancy body mass index (BMI)u2009≥u200930 kg/m2 were enrolled before 20 weeks of gestation and divided into four groups according to parity, BMI and previous history of GDM. The main outcome was incidence of GDM. Results There was a significant difference in incidence of GDM between the groups (pu2009<u20090.001). Women with a history of GDM and BMIu2009<30 kg/m2 showed the highest incidence (35.9%). At baseline they had fewer metabolic risk factors and by the second trimester they gained more weight. There was no interaction between GWG and GDM outcome and no significant difference in the prevalence of diabetes-associated antibodies. Conclusion Despite a healthier metabolic profile at baseline the non-obese women with a history of GDM displayed a markedly higher cumulative incidence of GDM. GWG and the presence of diabetes-associated antibodies were not associated with GDM occurrence among these high-risk women. Key message Despite a healthier metabolic profile at baseline the non-obese women with previous gestational diabetes mellitus display a markedly higher cumulative incidence of gestational diabetes mellitus.