Secondary patella resurfacing in painful non-resurfaced total knee arthroplasties : A study of survival and clinical outcome from the Norwegian Arthroplasty Register (1994-2011).

PURPOSE: In Norway, 19 % of revisions of non-resurfaced total knee arthroplasties done for knee pain between 1994 and 2011 were Secondary Patella Resurfacing (SPR). It is, however, unclear whether SPR actually resolves the pain. The aim was to investigate prostheses survival and clinical outcomes following SPR. METHOD: A total of 308 knees (301 patients) with SPR were used to assess implant survival, and a sub-cohort (n = 114 out of 301 patients) with Patient Reported Outcome Measures (PROMs) data were used to assess the clinical outcomes. The EuroQol (EQ-5D), the Knee Injury and Osteoarthritis Outcome Score, and Visual Analogue Scales on satisfaction and pain were used to collect PROM data. Outcomes were analysed by Kaplan-Meier, Cox regression, and multiple linear regression. RESULTS: The five- and ten-year Kaplan-Meier survival percentages were 91 % and 87 %, respectively. Overall, 35 knees were re-revised at a median follow-up of eight years and pain alone (10 knees) was the main cause of re-revision. Younger patients (<60 years) had nearly nine times higher risk of re-revision compared to older patients (>70 years) (RR = 8.6; p < 0.001). Mean EQ-5D index score had improved from 0.41 (SD 0.21) preoperative to 0.56 (SD 0.25) postoperative following SPR. A total of 63 % of patients with PROM data were satisfied with the outcomes of SPR. CONCLUSION: The long-term prostheses survival following SPR was satisfactory, although not as good as for primary knee replacement. Patients' health related quality of life improved significantly following SPR. Still, more than a third of patients with PROMs data were dissatisfied with the outcomes of the SPR procedure.

Assessing fear of hypoglycemia in a population-based study among parents of children with type 1 diabetes - psychometric properties of the hypoglycemia fear survey - parent version.

BACKGROUND: In the treatment of childhood type 1 diabetes, being aware of the parents' fear of hypoglycemia is important, since the parents' fear may influence the management of treatment and the children's blood glucose regulation. The availability of proper instruments to assess the parents' fear of hypoglycemia is essential. Thus, the aim of this study was to examine the psychometric properties of the Hypoglycemia Fear Survey - Parent version (HFS-P). METHODS: In a Norwegian population-based sample, 176 parents representing 102 children with type 1 diabetes (6-15 years old) completed the HFS-P, comprising a 15-item worry subscale and a 10-item behavior subscale. We performed exploratory and confirmatory factor analysis and further analysis of the scales' construct validity, content validity and reliability. RESULTS: The Norwegian version of the HFS-P had an acceptable factor structure and internal consistency for the worry subscale, whereas the structure and internal consistency of the behavior subscale was more questionable. The HFS-P subscales were significantly correlated (from moderately to weakly) with symptoms of emotional distress, as measured by the Hopkins Symptom Checklist - 25 items. The mothers scored higher than fathers on both HFS-P subscales, but the difference was not statistically significant for the worry subscale. CONCLUSIONS: The HFS-P worry subscale seems to be a valid scale for measuring anxiety-provoking aspects of hypoglycemia, and the validity of the HFS-P behavior subscale needs to be investigated further.

Psychometric properties of the Norwegian version of the Audit of Diabetes-Dependent Quality of Life.

PURPOSE: To examine the psychometric properties of the Norwegian version of the Audit of Diabetes-Dependent Quality of Life version 18 (ADDQoL-18). METHODS: We assessed the reliability (Cronbach's alpha and intraclass correlations) and construct validity (confirmatory factor analysis and Pearson's correlation coefficients) of the instrument in a sample of 292 adults in Norway aged 42.3 (SD 14.2) years. RESULTS: Internal consistency (Cronbach's alpha 0.88) and 4-week test-retest stability (intraclass correlations = 0.87) were satisfactory. Confirmatory factor analysis indicated that the one-factor structure of the ADDQoL-18 fits moderately (χ (2)/df ratio = 3.846, comparative fit index = 0.792, root mean square error of approximation = 0.099). Standardized coefficients showed that all domains loaded >0.4, except for one item. We found a satisfactory correlation between the ADDQoL-18 and the SF-36 Health Survey summary scales (physical health and mental health summary scales) and the Hospital Anxiety and Depression Scale. The total score was negatively associated with HbA1c (r = -0.18; P < 0.002), indicating that lower scores on the ADDQoL-18 were related to poorer glycemic control. Analysis regarding discriminant validity showed that the average weighted impact scores were mostly reduced among those reporting neuropathy and foot problems. CONCLUSIONS: The Norwegian version of the ADDQoL-18 showed high internal consistency, good test-retest reliability, and similar construct validity as the original instrument. Overall, the results supported the ADDQoL-18 being feasible for use in Norway.

Challenges in managing elderly people with diabetes in primary care settings in Norway.

OBJECTIVE: To explore the experiences and clinical challenges that nurses and nursing assistants face when providing high-quality diabetes-specific management and care for elderly people with diabetes in primary care settings. DESIGN: Focus-group interviews. SUBJECTS AND SETTING: Sixteen health care professionals: 12 registered nurses and four nursing assistants from nursing homes (10), district nursing service (5), and a service unit (1) were recruited by municipal managers who had local knowledge and knew the workforce. All the participants were women aged 32-59 years with clinical experience ranging from 1.5 to 38 years. RESULTS: Content analysis revealed a discrepancy between the level of expertise which the participants described as important to delivering high-quality care and their capacity to deliver such care. The discrepancy was due to lack of availability and access to current information, limited ongoing support, lack of cohesion among health care professionals, and limited confidence and autonomy. Challenges to delivering high-quality care included complex, difficult patient situations and lack of confidence to make decisions founded on evidence-based guidelines. CONCLUSION: Participants lacked confidence and autonomy to manage elderly people with diabetes in municipal care settings. Lack of information, support, and professional cohesion made the role challenging.

Comparison of health-related quality of life between patients with chronic obstructive pulmonary disease and the general population.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is associated with lower health-related quality of life (HRQOL). Previous research has focused primarily on HRQOL in these patients, whereas few studies have compared HRQOL between patients with COPD and the general population. AIM: The aim of this study was to evaluate differences in HRQOL between patients with COPD stage 2 to COPD stage 4 waiting to begin an outpatient pulmonary rehabilitation (PR) programme and Norwegian individuals with and without other chronic conditions. METHODS: A comparative survey design was used in this study of 100 patients with COPD waiting to begin PR and 3594 individuals from the general population. The SF-36 questionnaire was used to evaluate HRQOL. RESULTS: Compared with the healthy general population, COPD patients waiting to begin PR had lower scores on all SF-36 components and on the physical and mental health summary components (p < 0.001). Scores for physical function, physical role, general health, vitality, social function, emotional role and the physical health component differed markedly between patients and the general population. Patients with COPD stage 4 had lower HRQOL than did the general population and those with COPD stage 2 and COPD stage 3. CONCLUSIONS: The burden of COPD significantly affects HRQOL in patients with COPD waiting to begin PR, and those with COPD stage 4 are most affected. Action should be taken to support especially those patients with COPD stage 4.

Anxiety and depression following pulmonary rehabilitation.

AIM: The aim of this study was to evaluate changes and predictive factors of anxiety and depression in patients with chronic obstructive pulmonary disease (COPD) before and up to 3 months after pulmonary rehabilitation (PR). METHODS: A single group longitudinal design of patients with COPD underwent a PR programme. The measurements took place at baseline (T1: N=100), immediately before (T2: N=66), immediately after (T3: N=54) and 3 months after (T4: N=43) the programme. The programme was a 6-week outpatient programme, including education, psychosocial support and training sessions. Anxiety and depression were measured by the Hospital Anxiety and Depression Scale, self-efficacy by the COPD self-efficacy scale, lung function by spirometry and exercise capacity by incremental shuttle walking test. Mixed effect model analyses were used. RESULTS: Results showed a tendency of less anxiety and depression immediately after (T3) compared with immediately before (T2) the PR programme, but the changes were not significant. Results also showed that female reported significantly more anxiety than male (p=0.019), better exercise capacity predicted significantly less depression (p=0.049), and higher self-efficacy predicted both significantly less anxiety (p=0.001) and less depression (p=0.005). CONCLUSIONS: A tendency of less anxiety and depression during the PR programme was found, but the changes were not significant. Higher level of self-efficacy and better exercise capacity are suggested to relieve anxiety and depression.

Predictors of heart-focused anxiety in patients undergoing genetic investigation and counseling of long QT syndrome or hypertrophic cardiomyopathy: a one year follow-up.

Since Long QT syndrome and Hypertrophic cardiomyopathy are inherited cardiac disorders that may cause syncope, palpitations, serious arrhythmias, and sudden cardiac death, at-risk individuals may experience heart-focused anxiety. In a prospective multi-site study, 126 Norwegian patients attending genetic counseling were followed 1 year with multiple administration of questionnaires, including the Cardiac Anxiety Questionnaire, measuring three distinct symptoms of heart-focused anxiety- avoidance, attention, and fear-in mixed linear analyses. Overall, at 1-year follow-up, patients with clinical diagnosis as compared to patients at genetic risk had significantly higher scores of avoidance (p < .002), attention (p < .005), and fear (p < .007). Sudden cardiac death in close relatives, uncertainty whether other relatives previously had undergone genetic testing, patients' perceived general health, self-efficacy expectations and procedural satisfaction with genetic counseling were influential in predicting the different symptoms of heart-focused anxiety over time.

Perceived family burden and emotional distress: similarities and differences between mothers and fathers of children with type 1 diabetes in a population-based study.

BACKGROUND: Parenting children with diabetes entail an extra burden for the families. More information is needed about associations between perceived family burden and emotional distress in both mothers and fathers. OBJECTIVE: To analyze (i) perceived burden and emotional distress in mothers and fathers of children with type 1 diabetes and (ii) associations between parental burden and distress and factors related to the child. METHODS: Mothers (n = 103) and fathers (n = 97) of 115 children (1-15 yr) with type 1 diabetes participated in this population-based survey. The parents completed the Hopkins Symptom Checklist-25 items (HSCL-25), measuring emotional distress, and the Family Burden Scale, which includes five questions measuring perceived family burden related to the child's diabetes. RESULTS: Both mothers and fathers reported that the greatest burden was related to long-term health concerns. The mothers reported a significantly greater burden related to medical treatment and significantly more emotional distress than the fathers. The mothers' perceived burden was significantly correlated with emotional distress. Nighttime blood glucose measurements were significantly associated with perceived parental burden, and experienced nocturnal hypoglycemia was significantly associated with parental emotional distress. CONCLUSIONS: The higher perceived burden related to medical treatment, the more emotional distress, and the correlations between burdens and emotional distress in mothers vs. fathers emphasize the importance of discussing both parents' roles and responsibilities in relation to the child's diabetes in follow-up. In the consultations, emphasizing nighttime caregiving and nocturnal hypoglycemia might also be important to prevent emotional distress.

General anxiety, depression, and physical health in relation to symptoms of heart-focused anxiety- a cross sectional study among patients living with the risk of serious arrhythmias and sudden cardiac death.

OBJECTIVE: To investigate the role of three distinct symptoms of heart-focused anxiety (cardio-protective avoidance, heart-focused attention, and fear about heart sensations) in relation to general anxiety, depression and physical health in patients referred to specialized cardio-genetics outpatient clinics in Norway for genetic investigation and counseling. METHODS: Participants were 126 patients (mean age 45 years, 53.5% women). All patients were at higher risk than the average person for serious arrhythmias and sudden cardiac death (SCD) because of a personal or a family history of an inherited cardiac disorder (familial long QT syndrome or hypertrophic cardiomyopathy). Patients filled in, Hospital Anxiety and Depression Scale, Short-Form 36 Health Survey, and Cardiac Anxiety Questionnaire, two weeks before the scheduled counseling session. RESULTS: The patients experienced higher levels of general anxiety than expected in the general population (mean difference 1.1 (p < 0.01)). Hierarchical regression analyses showed that avoidance and fear was independently related to general anxiety, depression, and physical health beyond relevant demographic covariates (age, gender, having children) and clinical variables (clinical diagnosis, and a recent SCD in the family). In addition to heart-focused anxiety, having a clinical diagnosis was of importance for physical health, whereas a recent SCD in the family was independently related to general anxiety and depression, regardless of disease status. CONCLUSION: Avoidance and fear may be potentially modifiable symptoms. Because these distinct symptoms may have important roles in determining general anxiety, depression and physical health in at-risk individuals of inherited cardiac disorders, the present findings may have implications for the further development of genetic counseling for this patient group.

Psychosocial family factors and glycemic control among children aged 1-15 years with type 1 diabetes: a population-based survey.

BACKGROUND: Being the parents of children with diabetes is demanding. Jay Belsky's determinants of parenting model emphasizes both the personal psychological resources, the characteristics of the child and contextual sources such as parents' work, marital relations and social network support as important determinants for parenting. To better understand the factors influencing parental functioning among parents of children with type 1 diabetes, we aimed to investigate associations between the children's glycated hemoglobin (HbA1c) and 1) variables related to the parents' psychological and contextual resources, and 2) frequency of blood glucose measurement as a marker for diabetes-related parenting behavior. METHODS: Mothers (n = 103) and fathers (n = 97) of 115 children younger than 16 years old participated in a population-based survey. The questionnaire comprised the Life Orientation Test, the Oslo 3-item Social Support Scale, a single question regarding perceived social limitation because of the child's diabetes, the Relationship Satisfaction Scale and demographic and clinical variables. We investigated associations by using regression analysis. Related to the second aim hypoglycemic events, child age, diabetes duration, insulin regimen and comorbid diseases were included as covariates. RESULTS: The mean HbA1c was 8.1%, and 29% had HbA1c ≤ 7.5%. In multiple regression analysis, lower HbA1c was associated with higher education and stronger perceptions of social limitation among the mothers. A higher frequency of blood glucose measurement was significantly associated with lower HbA1c in bivariate analysis. Higher child age was significantly associated with higher HbA1c both in bivariate and multivariate analysis. A scatterplot indicated this association to be linear. CONCLUSIONS: Most families do not reach recommended treatment goals for their child with type 1 diabetes. Concerning contextual sources of stress and support, the families who successfully reached the treatment goals had mothers with higher education and experienced a higher degree of social limitations because of the child's diabetes. The continuous increasing HbA1c by age, also during the years before puberty, may indicate a need for further exploring the associations between child characteristics, context-related variables and parenting behavior such as factors facilitating the transfer of parents' responsibility and motivation for continued frequent treatment tasks to their growing children.

Health status in patients at risk of inherited arrhythmias and sudden unexpected death compared to the general population.

BACKGROUND: The possibilities in the molecular genetics of long QT syndrome (LQTS) and hypertrophic cardiomyopathy (HCM) has made family screening, with diagnostic and predictive genetic testing part of the health care offer in genetic counselling of inherited arrhythmias, potentially affecting the subjective health among these individuals. The study compared health status among patients at risk of arrhythmia because of family history or clinical diagnosis of LQTS and HCM with reference health status scores of the general population. METHODS: In the period 2005-2007, 127 patients (mean age 45 years, 53.5% women), with a family history of arrhythmia (n = 95) or a clinical diagnosis of LQTS (n = 12) or HCM (n = 19) referred for genetic counselling at the medical genetic departments in Norway filled in a questionnaire (Short Form Health Survey SF-36) measuring health status on eight domains. The patient SF-36 scores were compared to expected scores of the general population by t-test, and the relationship between the socio-demographic variables, clinical status, and SF-36 domains were analysed by multiple linear regression. RESULTS: The total sample reported significant lower SF-36 score as compared to the general population scores for the domain of general health (mean difference -7.3 (<0.001). When analysing the sample in subgroups according to clinical status, the general health was still significant lower for the group of family risk and in the group of HCM. In addition the physical functioning, role physical, vitality and role emotional domains were reduced for the latter group. In general, employment, higher education and being referred to genetic counselling through a family member were associated with better scores on the health status domains. CONCLUSIONS: Having a genetic risk of arrhythmia affects general health significantly. In addition, patients with a clinical diagnosis of HCM demonstrate a significantly poorer health in both physical and mental domains.

Psychometric properties of the Brief Pain Inventory among patients with osteoarthritis undergoing total hip replacement surgery.

BACKGROUND: Pain is a cardinal symptom of osteoarthritis (OA) of the hip and important for deciding when to operate. This study assessed the internal consistency reliability, validity and responsiveness of the Brief Pain Inventory (BPI) among patients with OA undergoing total hip replacement (THR). METHODS: We prospectively included 250 of 356 patients who were accepted to the waiting list for primary THR surgery. All participants responded to the BPI, WOMAC and SF-36 at baseline and 1 year after surgery. RESULTS: Internal consistency reliability (Cronbach's α) was >0.80 for the BPI, the WOMAC and five of the eight SF-36 scales The pattern of associations of the two BPI scales with corresponding and non-corresponding scales of the WOMAC and SF-36 largely supported the construct validity of the BPI. The responsiveness indices for change from baseline to 1 year after THR ranged from 1.52 to 2.05 for the BPI scales, from 1.69 to 2.84 for the WOMAC scales, and from 0.25 (general health) to 2.77 (bodily pain) for the SF-36 scales. CONCLUSIONS: The BPI showed acceptable reliability, construct validity and responsiveness in patients with OA undergoing THR. BPI is short and therefore is easy to use and score, though the instrument offers few advantages over and duplicates scales of more comprehensive instruments, such as the WOMAC and SF-36.

Patient-reported outcomes as predictors of 10-year survival in women after acute myocardial infarction.

BACKGROUND: Patient-reported outcomes are increasingly seen as complementary to biomedical measures. However, their prognostic importance has yet to be established, particularly in female long-term myocardial infarction (MI) survivors. We aimed to determine whether 10-year survival in older women after MI relates to patient-reported outcomes, and to compare their survival with that of the general female population. METHODS: We included all women aged 60-80 years suffering MI during 1992-1997, and treated at one university hospital in Norway. In 1998, 145 (60% of those alive) completed a questionnaire package including socio-demographics, the Sense of Coherence Scale (SOC-29), the World Health Organization Quality of Life Instrument Abbreviated (WHOQOL-BREF) and an item on positive effects of illness. Clinical information was based on self-reports and hospital medical records data. We obtained complete data on vital status. RESULTS: The all-cause mortality rate during the 1998-2008 follow-up of all patients was 41%. In adjusted analysis, the conventional predictors s-creatinine (HR 1.26 per 10% increase) and left ventricular ejection fraction below 30% (HR 27.38), as well as patient-reported outcomes like living alone (HR 6.24), dissatisfaction with self-rated health (HR 6.26), impaired psychological quality of life (HR 0.60 per 10 points difference), and experience of positive effects of illness (HR 6.30), predicted all-cause death. Major adverse cardiac and cerebral events were also significantly associated with both conventional predictors and patient-reported outcomes. Sense of coherence did not predict adverse events. Finally, 10-year survival was not significantly different from that of the general female population. CONCLUSION: Patient-reported outcomes have long-term prognostic importance, and should be taken into account when planning aftercare of low-risk older female MI patients.

A population-based study of associations between current posttraumatic stress symptoms and current fatigue.

This study explores current experience with posttraumatic stress disorder (PTSD) symptoms and other variables (sociodemographic, mental distress, somatic morbidity, self-rated health, and quality of life [QoL]) in relation to fatigue. A representative sample of the Norwegian population (N = 3,944) was invited to participate in a mailed survey, and 1,857 (47%) returned valid responses on the questionnaire that included the Fatigue Severity Scale and the Posttraumatic Symptom Scale-10. Posttraumatic stress disorder symptoms showed a strong association with fatigue in univariate (ß = .41) and multivariate analyses (ß = .33). Associations between psychosocial health variables, QoL, and fatigue were confirmed. However, PTSD symptoms showed the strongest association with fatigue in the analyses. Findings need to be replicated in other population samples and in clinical samples with PTSD and fatigue.

The Norwegian version of the chronic obstructive pulmonary disease self-efficacy scale (CSES): a validation and reliability study.

The aim of this study was to evaluate the feasibility, internal consistency and face and construct validity of the Norwegian version of the Chronic Obstructive Pulmonary Disease Self-Efficacy Scale (CSES). The CSES was translated into Norwegian according to standard procedures for forward and backward translation, and administered to 100 patients with chronic obstructive pulmonary disease (COPD) (51% men, mean age 66.1 years, range 42-82) prior to their participation in an outpatient pulmonary rehabilitation programme. The CSES-N (translated version) consists of 34 items comprising five subscales describing negative affect, intense emotional arousal, physical exertion, weather/environment and behavioural risk factors. Each scale ranges from 1 to 5, with higher scores indicating better self-efficacy. For validation purposes, we measured lung function (FEV(1) , FEV(1) % predicted) and exercise capacity (ISWT), and administered the St. George's Respiratory Questionnaire (SGRQ) and Hospital Anxiety and Depression Scale (HADS). A pilot study confirmed that the CSES-N was clear, understandable and easy to self-administer. Cronbach's alpha was 0.98 for the total score (0.80-0.96 for subscales). Results showed small to medium negative correlations between all CSES-N scales and anxiety, depression (HADS), physical activity, psychosocial impact of disease and total health status (SGRQ) (-0.20 to -0.49). Small or negligible negative correlations between different CSES-N scales and respiratory symptoms (SGRQ) (-0.03 to -0.23) were found. Any correlations among exercise capacity, lung function and different socio-demographic variables (age, gender and education) and CSES-N were also small or negligible (0.00 to 0.23). This study shows acceptable feasibility, internal consistency and face and construct validity for the CSES-N in a sample of Norwegian COPD patients.

Anxiety and depression after acute myocardial infarction: an 18-month follow-up study with repeated measures and comparison with a reference population.

BACKGROUND: Recently, there has been substantial improvement in coronary care and a corresponding reduction in mortality after acute myocardial infarction (AMI). Some studies suggest that improved prognosis has led to reduced levels of anxiety and depression after AMI, in both the short and long term. The aims of this study were to assess symptoms of anxiety and depression from the acute event to 18 months following AMI, and to compare results with levels in the Norwegian reference population. DESIGN AND METHODS: The progress of 288 patients was monitored using self-reports 3, 6, 12 and 18 months after AMI. Anxiety and depression were measured by the Hospital Anxiety and Depression Scale. Reference population data were obtained from the Nord-Trøndelag Health Study 1995-1997 (the HUNT 2 Study). RESULTS: At baseline, 19.7 and 13.6% of AMI patients reported high levels of anxiety and depressive symptoms, respectively. At baseline, AMI patients were more anxious, but not more depressed, when compared with the reference population (P<0.001 and P = 0.092, respectively). After 3-18 months, AMI patients' levels of anxiety and depression were not higher than levels in the reference population. Anxiety and depression at baseline and after 3 months were the best predictors of anxiety and depression after 18 months, although complications, bed days and lifestyle improvement also significantly predicted depression after 18 months. CONCLUSION: Initially, AMI patients had higher levels of anxiety, but not depressive symptoms. After 3-18 months, these patients were not more anxious or depressed than the Norwegian reference population.

The complexity of the relationship between chronic pain and quality of life: a study of the general Norwegian population.

PURPOSE: The aims of this paper were to evaluate the relationship between chronic pain and global quality of life (GQOL) and to explore the effect of possible confounders, mediators, and moderators such as selected demographic variables, chronic illnesses, stress-related symptoms, fatigue, and subjective health of the relationship between chronic pain and GQOL. METHODS: We used a cross-sectional design, including 1,893 respondents from a population of 4,000 of Norwegian citizens, aged 19-81 years, who were randomly drawn from the National Register by Statistics Norway in November 2000 (48.5%). Pain duration of more than 3 months was categorized as having chronic pain. The Quality of Life Scale, the Fatigue Severity Scale, and the Posttraumatic Stress Scale were used as our main dependent and independent variables, respectively. A series of multiple regression analyses (GLM in SPSS) were applied using GQOL as the dependent variable, entering subsets of independent variables in a theoretically predefined sequence. RESULTS: In the total model, there was no significant relationship between chronic pain and GQOL. The model explained 39% of the variance in GQOL. For direct effect sizes, stress-related symptoms were related most strongly to GQOL, followed by subjective health, fatigue, chronic illnesses, and selected demographic variables. CONCLUSION: These findings support the assumption of a complex and indirect relationship between chronic pain and GQOL.

The effect of guided self-determination on self-management in persons with type 1 diabetes mellitus and HbA1c ≥64 mmol/mol: a group-based randomised controlled trial.

OBJECTIVES: To determine whether the impact of guided self-determination (GSD) applied in group training (GSD-GT) in people with chronically elevated HbA1c and type 1 diabetes mellitus (DM) was superior to 'care as usual' in improving HbA1c and psychological functioning. SETTING: An outpatient clinic at a university hospital in Western Norway. PARTICIPANTS: A total of 178 adults (all Caucasian) aged 18-55 (mean age 36.7±10.7, 62% women) with type 1 DM for at least 1 year and HbA1c ≥64 mmol/mol (8.0%) were randomly assigned to participate in either GSD-GT or a control group (CG). Exclusion criteria were severe comorbidity, major psychiatric disorder, cognitive deficiency/language barriers and pregnancy. INTERVENTION: Intervention group met seven times for 2 hours over 14 weeks to promote patient autonomy and intrinsic motivation using reflection sheets and advanced professional communication in accordance with the GSD methodology. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was HbA1c and secondary outcomes (all outcomes 9 months post intervention) were self-monitored blood glucose frequency, self-reported diabetes competence, autonomy support by healthcare providers (Health Care Climate Questionnaire), autonomous versus controlled diabetes motivation (Treatment Self-Regulation Questionnaire), diabetes distress (Problem Areas In Diabetes Scale (PAID) and Diabetes Distress Scale (DDS)), self-esteem (Rosenberg Self-Esteem Scale) and psychological well-being (World Health Organization five-item Well-Being Index scale). RESULTS: Among participants allocated to the GSD-GT (=90) 48 completed the study, whereas 83 completed in the CG (n=88). With 95% CIs GSD-GT did not have effect on HbA1c (B -0.18, CI (-0.48, 0.12), p=0.234). GSD-GT improved autonomy-motivated behaviour (B 0.51, CI (0.25, 0.77), p<0.001), diabetes distress (PAID, B -6.96, CI (-11.40, -2.52), p=0.002), total DDS (B -5.15, CI (-9.34, -0.96), p=0.016), DDS emotional burden (B -7.19, CI (-13.20, -1.19), p=0.019) and self-esteem (B 1.43, CI (0.34, 2.52), p=0.011). CONCLUSIONS: Results from this behavioural intervention must be interpreted cautiously because of recruitment and attrition problems. Medical outcomes did not improve. Psychological outcomes improved, especially reduced diabetes distress. TRIAL REGISTRATION NUMBER: Clinical Trials.gov NCT 01317459.

The relationships among fear of hypoglycaemia, diabetes-related quality of life and psychological well-being in Norwegian adults with Type 1 diabetes.

AIMS: To examine the associations among fear of hypoglycaemia, diabetes-related quality of life and psychological well-being, and determine whether diabetes-related quality of life is a mediator of the relationship between fear of hypoglycaemia and psychological well-being in adults with Type 1 diabetes. METHODS: A total of 235 of 319 invited adults (18-69years) with Type 1 diabetes agreed to participate. Hierarchical linear regression was applied to 188 individuals with complete data. Mediation analysis was used to determine whether diabetes-related quality of life mediated the relationship between fear of hypoglycaemia and psychological well-being. RESULTS: Fear of hypoglycaemia was significantly associated with diabetes-related quality of life and psychological well-being. The behaviour and worry components of fear of hypoglycaemia were significantly associated with diabetes-related quality of life (behaviour component: unstandardised coefficient=-0.04, p<0.001, standardised coefficient=-0.40; worry component: unstandardised coefficient=-0.01, p=0.041, standardised coefficient=-0.18). Fear of hypoglycaemia worry had a significant independent association with psychological well-being (unstandardised coefficient=-0.28, p=0.009, standardised coefficient=-0.25), whereas fear of hypoglycaemia behaviour did not. Diabetes-related quality of life mediated approximately half of the association between fear of hypoglycaemia worry and psychological well-being. CONCLUSIONS: Hypoglycaemic episodes can have serious consequences, and assessing fear of hypoglycaemia might help health care providers offer suitable care strategies to individuals with Type 1 diabetes.

Severity and duration of diabetic foot ulcer (DFU) before seeking care as predictors of healing time: A retrospective cohort study.

OBJECTIVES: To investigate whether A) duration of ulcer before start of treatment in specialist health care, and B) severity of ulcer according to University of Texas classification system (UT) at start of treatment (baseline), are independent predictors of healing time. METHODS: This retrospective cohort study, based on electronic medical record data, included 105 patients from two outpatient clinics in Western Norway with a new diabetic foot ulcer during 2009-2011. The associations of duration of ulcer and ulcer severity with healing time were assessed using cumulative incidence curves and subdistribution hazard ratio estimated using competing risk regression with adjustment for potential confounders. RESULTS: Of the 105 participants, 45.7% achieved ulcer healing, 36.2% underwent amputations, 9.5% died before ulcer healing and 8.5% were lost to follow-up. Patients who were referred to specialist health care by a general practitioner ≥ 52 days after ulcer onset had a 58% (SHR 0.42, CI 0.18-0.98) decreased healing rate compared to patients who were referred earlier, in the adjusted model. High severity (grade 2/3, stage C/D) according to the UT classification system was associated with a decreased healing rate compared to low severity (grade1, stage A/B or grade 2, stage A) with SHR (95% CI) equal to 0.14 (0.05-0.43) after adjustment for referral time and other potential confounders. CONCLUSION: Early detection and referral by both the patient and general practitioner are crucial for optimal foot ulcer healing. Ulcer grade and severity are also important predictors for healing time, and early screening to assess the severity and initiation of prompt treatment is important.