A randomized controlled trial of digital breast tomosynthesis versus digital mammography in population-based screening in Bergen: interim analysis of performance indicators from the To-Be trial.

OBJECTIVES: To describe a randomized controlled trial (RCT) of digital breast tomosynthesis including synthesized two-dimensional mammograms (DBT) versus digital mammography (DM) in a population-based screening program for breast cancer and to compare selected secondary screening outcomes for the two techniques. METHODS: This RCT, performed in Bergen as part of BreastScreen Norway, was approved by the Regional Committees for Medical Health Research Ethics. All screening attendees in Bergen were invited to participate, of which 89% (14,274/15,976) concented during the first year, and were randomized to DBT (n = 7155) or DM (n = 7119). Secondary screening outcomes were stratified by mammographic density and compared using two-sample t-tests, chi-square tests, ANOVA, negative binomial regression and tests of proportions (z tests). RESULTS: Mean reading time was 1 min 11 s for DBT and 41 s for DM (p < 0.01). Mean time spent at consensus was 3 min 12 s for DBT and 2 min 12 s for DM (p < 0.01), while the rate of cases discussed at consensus was 6.4% and 7.4%, respectively for DBT and DM (p = 0.03). The recall rate was 3.0% for DBT and 3.6% for DM (p = 0.03). For women with non-dense breasts, recall rate was 2.2% for DBT versus 3.4% for DM (p = 0.04). The rate did not differ for women with dense breasts (3.6% for both). Mean glandular dose per examination was 2.96 mGy for DBT and 2.95 mGy for DM (p = 0.433). CONCLUSIONS: Interim analysis of a screening RCT showed that DBT took longer to read than DM, but had significantly lower recall rate than DM. We found no differences in radiation dose between the two techniques. KEY POINTS: • In this RCT, DBT was associated with longer interpretation time than DM • Recall rates were lower for DBT than for DM • Mean glandular radiation dose did not differ between DBT and DM.

Costs and Effects of Implementing Digital Tomosynthesis in a Population-Based Breast Cancer Screening Program: Predictions Using Results from the To-Be Trial in Norway.

BACKGROUND: Although several studies from Europe and the US have shown promising screening results favoring digital breast tomosynthesis compared with standard digital mammography (DM), both costs and effects of implementing tomosynthesis in routine screening programs remain uncertain. The cost effectiveness of using tomosynthesis in routine screening is debated in the literature, and model inputs from randomized trials are lacking. Using parameters mainly from a randomized controlled trial (the To-Be trial), we simulated costs and effects of implementing tomosynthesis in the national screening program BreastScreen Norway. METHODS: The To-Be trial was performed in Bergen from 2016 to 2017 within BreastScreen Norway, where females were randomized to either digital breast tomosynthesis including synthetic mammograms (DBT) or DM. The trial was followed by a cohort study offering all females DBT in 2018-2019. The trial included over 37,000 females, and allowed for estimation of short-term costs and effects related to screening, recall examinations and cancer detection. Using these and recent Norwegian estimates for 10-year stage-specific survival and treatment costs, the cost effectiveness of replacing DM with DBT in BreastScreen Norway was simulated in a decision tree model with probabilistic sensitivity analyses. Outcomes included false-positive screening results, screen-detected and interval cancers, stage at diagnosis, all-cause deaths, life-years gained, costs at recall and treatment and incremental cost-effectiveness ratio. RESULTS: The estimated additional cost of DBT was €8.10. Simulating ten rounds of screening from 2018 and 10-year survival and costs, 500 deaths were averted and 2300 life-years gained at an additional screening cost of €29 million for females screened with DBT versus DM. Taking over-diagnosis, recall and treatment costs into account, DBT was dominant in the deterministic analysis. The incremental cost-effectiveness ratio indicated cost savings of €1400 per life-year gained. Probabilistic sensitivity analyses showed that DBT was cost effective in over 50% of the simulations at all willingness-to-pay levels per life-year gained, and in 80% of the simulations at levels above €22,000. If willingness-to-pay levels up to €35,000 were assumed, DBT would be cost effective in over 50% of the simulations for additional costs of DBT of up to €32, almost four times the estimated additional cost of €8.10. CONCLUSION: DBT may be cost effective if implemented in BreastScreen Norway. However, generalizability of results could depend on factors varying between countries, such as recall rates, program sensitivity and specificity, treatment cost and willingness-to-pay levels.

Assessment of breast positioning criteria in mammographic screening: Agreement between artificial intelligence software and radiographers.

OBJECTIVES: To determine the agreement between artificial intelligence software (AI) and radiographers in assessing breast positioning criteria for mammograms from standard digital mammography and digital breast tomosynthesis. METHODS: Assessment of breast positioning was performed by AI and by four radiographers in pairs of two on 156 examinations of women screened in Bergen, April to September 2019, as part of BreastScreen Norway. Ten criteria were used; three for craniocaudal and seven for mediolateral-oblique view. The criteria evaluated the appearance of the nipple, breast rotation, pectoral muscle, inframammary fold and pectoral nipple line. Intraclass correlation and Cohen's kappa coefficient (κ) were used to investigate the correlation and agreement between the radiographer's assessments and AI. RESULTS: The intraclass correlation for the pectoral nipple line between the radiographers and AI was >0.92. A substantial to almost perfect agreement (κ > 0.69) was observed between the radiographers and AI on the nipple in profile criterion. We observed a slight to moderate agreement for the other criteria (κ = 0.06-0.52) and generally a higher agreement between the two pairs of radiographers (mean κ = 0.70) than between the radiographers and AI (mean κ = 0.41). CONCLUSIONS: AI has great potential in evaluating breast position criteria in mammography by reducing subjectivity. However, varying agreement between radiographers and AI was observed. Standardized and evidence-based criteria for definitions, understandings and assessment methods are needed to reach optimal image quality in mammography.

Visualization of the Nipple in Profile: Does It Really Affect Selected Outcomes in Organized Mammographic Screening?

OBJECTIVE: To investigate whether having the nipple imaged in profile was associated with breast characteristics or compression parameters, and whether it affected selected outcomes in screening with standard digital mammography or digital breast tomosynthesis. METHODS: In this IRB-approved retrospective study, results from 87 450 examinations (174 900 breasts) performed as part of BreastScreen Norway, 2016-2019, were compared by nipple in profile status and screening technique using descriptive statistics and generalized estimating equations. Unadjusted and adjusted odds ratios with 95% confidence intervals (95% CIs) were estimated for outcomes of interest, including age, breast volume, volumetric breast density, and compression force as covariates. RESULTS: Achieving the nipple in profile versus not in profile was associated with lower breast volume (845.1 cm3 versus 1059.9 cm3, P < 0.01) and higher mammographic density (5.6% versus 4.4%, P < 0.01). Lower compression force and higher compression pressure were applied to breasts with the nipple in profile (106.6 N and 11.5 kPa) compared to the nipple not in profile (110.8 N and 10.5 kPa, P < 0.01 for both). The adjusted odds ratio was 0.95 (95% CI: 0.88-1.02; P = 0.15) for recall and 0.92 (95% CI: 0.77-1.10; P = 0.36) for screen-detected cancer for nipple in profile versus not in profile. CONCLUSION: Breast characteristics and compression parameters might hamper imaging of the nipple in profile. However, whether the nipple was in profile or not on the screening mammograms did not influence the odds of recall or screen-detected cancer, regardless of screening technique.

Self-reported Pain Associated With Screening With Digital Breast Tomosynthesis.

OBJECTIVE: We aimed to investigate self-reported pain during screening with digital breast tomosynthesis (DBT). METHODS: The study was approved by the Regional Committee for Medical and Health Research Ethics in the South East of Norway (2015/424). Women completed a questionnaire about experienced pain directly after the examination, August-November 2019. A numeric rating scale (NRS, 0-10) was used. Data on compression force (N), pressure (kPa), and compressed breast thickness (mm) were obtained from the Digital Imaging and Communication in Medicine header and density assessment software. Stepwise ordinary least-squares regression was used to estimate mean self-reported pain score with 95% confidence interval (CI) for values of compression force, pressure, and compressed breast thickness. RESULTS: The mean pain score was 1.9, whereof 19.3% (822/4266) of the women reported moderate or severe pain. The mean pain score of 2.6 (95% CI: 2.4-2.7) was observed at a compression force of 60 N, decreasing to 1.3 (95% CI: 1.2-1.4) at 130 N. The mean pain score of 1.3 (95% CI: 1.1-1.4) was at a compression pressure of 6 kPa, increasing to 2.9 (95% CI: 2.7-3.1) at 16 kPa. The mean pain score was 0.6 (95% CI: 0.4-0.6) at a compressed breast thickness of 20 mm, increasing to 2.9 (95% CI: 2.7-3.1) at 90 mm. CONCLUSION: The mean pain score was low, 1.9 on NRS, for women screened with DBT. A compression force of 60-130 N and a pressure 6-16 kPa were associated with no or mild pain.

Sense of coherence--a determinant of quality of life over time in older female acute myocardial infarction survivors.

AIMS: To determine the relationships between different sense of coherence levels and quality of life, and in older female myocardial infarction survivors; to investigate how socio-demographic, clinical characteristics, sense of coherence self-reported symptoms and function affect quality of life; and to determine whether sense of coherence and quality of life are stable during a six-month follow-up. BACKGROUND: Myocardial infraction confers new physical and mental challenges. However, research on sense of coherence and other factors involved in maintaining physical, psychosocial and environmental aspects of quality of life in older female myocardial infraction survivors is scant. DESIGN: Survey. METHODS: A postal survey was conducted of 145 women, aged 62-80 years, three months to five years after myocardial infarction (T1), with a follow-up after six months (T2). Self-reported socio-demographic and clinical data and hospital medical records data were collected. The sense of coherence scale (SOC-29) and the World Health Organization Quality of Life Instrument Abbreviated (WHOQOL-BREF) were used. RESULTS: We found a significant difference in quality of life between weak, moderate, and strong sense of coherence groups (p<0.001). Sense of coherence contributed to the level of all quality of life domains (p<0.001). Several clinical characteristics contributed to quality of life: (1) physical domain: comorbidities (p<0.001), previous myocardial infarction (p = 0.013), ejection fraction (p<0.011), length of hospital stay (p = 0.005) symptoms and function (p<0.001); (2) psychological domain: previous myocardial infarction (p = 0.031) and symptoms and function (p<0.001); and (3) environmental domain: education (p = 0.033) and symptoms and function (p = 0.003). On group level, both sense of coherence and quality of life were stable. Experiencing specific health changes (p<0.001), not major life events, influenced quality of life during the six-month follow-up. CONCLUSION: Sense of coherence was an important stable determinant of quality of life domains in female myocardial infarction survivors. Although other factors were identified, further research is needed to elucidate additional determinants of quality of life. RELEVANCE TO CLINICAL PRACTICE: These specific factors could guide clinicians in making treatment decisions that optimize the quality of life of their patients. Applying a salutogenic perspective through patient education may be important.

The association between history of diabetic foot ulcer, perceived health and psychological distress: the Nord-Trøndelag Health Study.

BACKGROUND: While the adverse impact of a history of a foot ulcer on physical health among persons with diabetes is well known, little is known about the association between foot ulcer, perceived health and psychological distress. Results from various studies are difficult to compare as different study designs, samples and/or different questionnaires have been used. The aim of this study was to compare levels of anxiety and depression, psychological well-being and perceived health between persons with diabetes, with or without a history of foot ulcer, and persons without diabetes in a large study of community-dwelling individuals. METHODS: This study included 65,126 persons, of whom 63,632 did not have diabetes, 1,339 had diabetes without a history of foot ulcer and 155 had diabetes and a history of foot ulcer. Levels of anxiety and depression were assessed by the Hospital Anxiety and Depression Scale (HADS). Psychological well-being was measured on a four-item scale, and perceived health was measured with a one-item question. We investigated whether levels of anxiety, depression, psychological well-being and perceived health were different in the three study groups using multiple regression models controlling for demographic factors, body mass index, smoking and cardiovascular conditions. Separate multivariate analyses comparing the two diabetes samples were additionally adjusted for diabetes-specific variables. RESULTS: A history of foot ulcer was significantly associated with more depressive symptoms, poorer psychological well-being and poorer perceived health compared to participants without diabetes. In multivariate analyses, perceived health and psychological well-being were significantly poorer among those with a history of foot ulcer compared to those without diabetes. Among persons with diabetes, perceived health was significantly worse among those with a history of foot ulcer. After multivariate adjustment, levels of anxiety and depression and psychological well-being did not differ between the two diabetes groups. CONCLUSION: Perceived health and psychological well-being were significantly poorer among participants with diabetes and a history of foot ulcer compared to those without diabetes. Among people with diabetes, a history of foot ulcer had significant negative impact on perceived health but did not independently contribute to psychological distress.

Intrusion and avoidance in subjects undergoing genetic investigation and counseling for hereditary cancer.

GOALS OF WORK: Genetic counseling for hereditary cancer is expected to involve a growing number of individuals in the near future since an increasing number of genetic tests are offered. This study was designed to identify psychosocial variables predicting distress after genetic investigation and genetic counseling (GC) in order to develop new counseling strategies. MATERIALS AND METHODS: A prospective multi-site study was undertaken on 214 patients undergoing GC for hereditary cancer to explore the relationships between socio-demographic variables, medical variables, social support, self-efficacy, physical functioning, satisfaction with GC, the level of worry after GC, results of genetic testing, and the course and outcomes of distress. Distress was measured with the Impact of Event Scale, which includes subscales of intrusion and avoidance. Patients completed questionnaires mailed to them before and after GC. MAIN RESULTS: The mean level of intrusion and avoidance was moderate, even though one quarter of participants reported a severe level of intrusion at baseline. Subjects with a low level of self-efficacy at baseline and high level of worry immediately after GC seemed to be vulnerable to both intrusion and avoidance. Lower level of intrusion was also associated with having a first-degree relative with cancer, while a lower avoidance level was associated with a higher level of education, having cancer, more social support, and higher satisfaction with GC. CONCLUSIONS: In this study, subjects who had lower level of self-efficacy at baseline and a high level of worry immediately after GC seemed to be vulnerable to both intrusion and avoidance in this study.

Does a telephone follow-up intervention for patients discharged with acute myocardial infarction have long-term effects on health-related quality of life? A randomised controlled trial.

AIMS: An earlier combined proactive and reactive telephone follow-up intervention for acute myocardial infarction patients after discharge from hospital showed positive effects after six months. The aim of the present study was to assess whether the intervention has long-term effects up to 18 months after discharge. DESIGN: A prospective randomised controlled trial with 18 months follow-up. METHOD: The trial was conducted with 288 patients allocated to a telephone follow-up intervention group (n = 156) or control group (n = 132). The primary endpoint was health-related quality of life using the SF-36. Secondary endpoints included smoking and exercise habits, return to work and rehospitalisation due to chest pain. RESULTS: There were significant improvements over time on most dimensions of health-related quality of life in both the intervention and control group to US norm population levels on most SF-36 dimensions and summary scores. The intervention group showed no overall significant improvement beyond six months in the physical or mental summary scores, but there was a significant effect for those aged 70 or above. Although there was a promising effect for rehospitalisation due to chest pain, no significant differences were found between the groups on the secondary endpoints after six months. CONCLUSION: This study demonstrated that despite positive short-term effects at six months, the telephone follow-up intervention had no long-term effects on health-related quality of life or secondary endpoints. However, the potential for improvement beyond six months was less than anticipated reflecting a reduced morbidity among acute myocardial infarction patients. RELEVANCE TO CLINICAL PRACTICE: Telephone follow-up after discharge from hospital is an easy implementable follow-up intervention enabling individualised provision of information and support in a time often experienced as stressful by patients. Our study indicates that six months is an adequate support period. Despite positive results six months after discharge no significant added long-term effects of telephone follow-up, compared to usual care were found in this study.

Cancer patients' barriers to pain management and psychometric properties of the Norwegian version of the Barriers Questionnaire II.

The Barriers Questionnaire II (BQ-II) was developed to assess barriers to effective pain management. The purpose of this study was to evaluate the psychometric properties of the BQ-II in a sample of Norwegian cancer patients. The BQ-II was translated into Norwegian and pilot tested with eight oncology outpatients. Then, a convenience sample of 321 cancer patients from two different sites was recruited to maximize the number of questionnaires available for the psychometric analyses. Patients were included if they: were >18 years of age; had a diagnosis of cancer; and self-reported pain and/or use of analgesics. Construct validity of the Norwegian version of the BQ II (NBQ-II) was evaluated using an exploratory factor analysis. A seven-factor solution was found that was more consistent with the original version of the BQ. Construct validity of the NBQ-II was demonstrated through positive correlations between most of the subscale and total scores on the NBQ-II and pain intensity and pain interference scores. Finally, Cronbach's α coefficients of ≥0.7 for six of the seven subscales and 0.89 for the total scale demonstrated acceptable levels of internal consistency. In conclusion, the NBQ-II demonstrated adequate psychometric properties. However, further revision and testing of the questionnaire should be performed to confirm the factor structure that was identified in this study.

Cost differences between digital tomosynthesis and standard digital mammography in a breast cancer screening programme: results from the To-Be trial in Norway.

BACKGROUND: Several studies in Europe and the US have shown promising results favouring digital breast tomosynthesis compared to standard digital mammography (DM). However, the costs of implementing the technology in screening programmes are not yet known. METHODS: A randomised controlled trial comparing the results from digital breast tomosynthesis including synthetic mammograms (DBT) vs. DM was performed in Bergen during 2016 and 2017 as a part of BreastScreen Norway. The trial included 29,453 women and allowed for a detailed comparison of procedure use and screening, recall and treatment costs estimated at the individual level. RESULTS: The increased cost of equipment, examination and reading time with DBT vs. DM was €8.5 per screened woman (95% CI 8.4-8.6). Costs of DBT remained significantly higher after adding recall assessment costs, €6.2 (95% CI 4.6-7.9). Substantial reductions in either examination and reading times, price of DBT equipment or price of IT storage and connectivity did not change the conclusion. Adding treatment costs resulted in too wide confidence intervals to draw definitive conclusions (additional costs of tomosynthesis €9.8, 95% CI -56 to 74). Performing biopsy at recall, radiation therapy and chemotherapy was significantly more frequent among women screened with DBT. CONCLUSION: The results showed lower incremental costs of DBT vs. DM, compared to what is found in previous cost analyses of DBT and DM. However, the incremental costs were still higher for DBT compared with DM after including recall costs. Further studies with long-term treatment data are needed to understand the complete costs of implementing DBT in screening.

Associations between disease severity, coping and dimensions of health-related quality of life in patients admitted for elective coronary angiography - a cross sectional study.

BACKGROUND: In patients with suspected coronary artery disease (CAD), the overall aim was to analyse the relationships between disease severity and both mental and physical dimensions of health related quality of life (HRQOL) using a modified version of the Wilson and Cleary model. METHODS: Using a cross-sectional design, 753 patients (74% men), mean age 62 years, referred for elective cardiac catheterisation were included. The measures included 1) physiological factors 2) symptoms (disease severity, self-reported symptoms, anxiety and depression 3) self-reported functional status, 4) coping, 5) perceived disease burden, 6) general health perception and 7) overall quality of life. To analyse relationships, we performed linear and ordinal logistic regressions. RESULTS: CAD and left ventricular ejection fraction (LVEF) were significantly associated with symptoms of angina pectoris and dyspnea. CAD was not related to symptoms of anxiety and depression, but less depression was found in patients with low LVEF. Angina pectoris and dyspnea were both associated with impaired physical function, and dyspnea was also negatively related to social function. Overall, less perceived burden and better overall QOL were observed in patients using more confronting coping strategy. CONCLUSION: The present study demonstrated that data from cardiac patients to a large extent support the suggested model by Wilson and Cleary.

What determines subjective health status in patients with chronic obstructive pulmonary disease: importance of symptoms in subjective health status of COPD patients.

BACKGROUND: Subjective health status is the result of an interaction between physiological and psychosocial factors in patients with chronic obstructive pulmonary disease (COPD). However, there is little understanding of multivariate explanations of subjective health status in COPD. The purpose of this study was to explore what determines subjective health status in COPD by evaluating the relationships between background variables such as age and sex, predicted FEV1%, oxygen saturation, breathlessness, anxiety and depression, exercise capacity, and physical and mental health. METHODS: This study had a cross-sectional design, and included 100 COPD patients (51% men, mean age 66.1 years). Lung function was assessed by predicted FEV1%, oxygen saturation by transcutaneous pulse oximeter, symptoms with the St George Respiratory Questionnaire and the Hospital Anxiety and Depression Scale, physical function with the Incremental Shuttle Walking Test, and subjective health status with the SF-36 health survey. Linear regression analysis was used. RESULTS: Older patients reported less breathlessness and women reported more anxiety (p < 0.050). Women, older patients, those with lower predicted FEV1%, and those with greater depression had lower physical function (p < 0.050). Patients with higher predicted FEV1%, those with more breathlessness, and those with more anxiety or depression reported lower subjective health status (p < 0.050). Symptoms explained the greatest variance in subjective health status (35%-51%). CONCLUSION: Symptoms are more important for the subjective health status of patients with COPD than demographics, physiological variables, or physical function. These findings should be considered in the treatment and care of these patients.

Anxiety and depression among subjects attending genetic counseling for hereditary cancer.

OBJECTIVES: The main aims of the study were to investigate changes in anxiety and depression over time in subjects attending genetic counseling (GC) for hereditary cancer, and secondly, to identify psychological, social, and medical variables associated with the course and outcome of anxiety and depression. METHODS: Of 275 eligible individuals, 221 consented to participate, 214 returned the baseline questionnaire, and were included in a prospective multi-center study. Questionnaires were mailed to the subjects before and after the GC. RESULTS: The mean values for anxiety and depression were quite low at all assessments. Mixed linear analyzes revealed that both anxiety and depression declined over time. Higher age, GC-related self-efficacy, and social support were associated with lower levels of anxiety. More social support, satisfaction with GC, self-rated physical function, and GC-related self-efficacy were associated with lower levels of depression. The effects of social support on both anxiety and depression had a significant interaction with time. CONCLUSION: The results support the buffer theory, which proposes that social support acts as a buffer, protecting people from the potentially pathogenic influence of stressful life events, such as GC. PRACTICE IMPLICATIONS: Subjects with less social support and less GC-related self-efficacy seem to be more vulnerable to anxiety and depression and should be offered extra attention by counselors.

Cutpoints for mild, moderate and severe pain in patients with osteoarthritis of the hip or knee ready for joint replacement surgery.

BACKGROUND: Cutpoints (CPs) for mild, moderate and severe pain are established and used primarily in cancer pain. In this study, we wanted to determine the optimal CPs for mild, moderate, and severe pain in joint replacement surgery candidates with osteoarthritis (OA) of the hip or knee, and to validate the different CPs. METHODS: Patients (n = 353) completed the Brief Pain Inventory (BPI), the WOMAC Arthritis Index, and the SF-36 health status measure. Optimal CPs for categorizing average pain with three severity levels were derived using multivariate analysis of variance, using different CP sets for average pain as the independent variable and seven interference items from the BPI as the dependent variable. To validate the CPs, we assessed if patients in the three pain severity groups differed in pain as assessed with WOMAC and SF-36, and if BPI average pain with the optimal CPs resulted in higher correlation with pain dimensions of the WOMAC and SF-36 than other CPs. RESULTS: The optimal CPs on the 0-10 point BPI scale were CP (4,6) among hip patients and CP (4,7) among knee patients. The resulting pain severity groups differed in pain, as assessed with other scales than those used to derive the CPs. The optimal CPs had the highest association of average pain with WOMAC pain scores. CONCLUSION: CPs for pain severity differed somewhat for patients with OA of the hip and knee. The association of BPI average pain scores categorized according to the optimal CPs with WOMAC pain scores supports the validity of the derived optimal CPs.

Quality of life in chronic low back pain patients treated with instrumented fusion.

AIM: The aim of this study was to examine pain and quality of life in a group of preoperative chronic low back pain patients (n = 25) and a group of postoperative chronic low back pain patients (n = 101) treated with instrumented fusion 1-8 years ago. BACKGROUND: Reduced quality of life is common in chronic low back pain patients and the aim of treatment is to improve quality of life. DESIGN: In the present study, a comparative survey design was used. METHODS: The McGill Pain Questionnaire and the SF-36 Health Survey were used to examine pain and quality of life. RESULTS: The pre- and postoperative groups did not differ with regard to age, gender, education, other chronic conditions or previous spinal surgery. Compared with the preoperative group, the postoperative group reported significantly lower total, sensory, affective and evaluative pain, used less pain medication (p < 0.05) and reported better scores in all SF-36 components (p < 0.05), except for general health. The effect size was > or =0.8 for all pain components and > or =0.4 for all SF-36 components, except for general health (effect size = 0.009). With regard to long-term follow-up, patients who underwent surgery 5-8 years ago reported better physical role functioning (p < 0.05) compared with those who underwent surgery 1-2 years ago. CONCLUSION: Results showed that the postoperative group reported significantly less pain and better physical and mental health compared with the preoperative group. However, despite surgery, the postoperative group reported suffering from pain and reduced quality of life. Relevance to clinical practice. Psychosocial interventions focusing on psychosocial consequences of pain are needed to modify the pain experience and increase the quality of life in patients who have undergone this kind of surgery.

Factor structure of the revised Jalowiec Coping Scale in patients admitted for elective coronary angiography.

OBJECTIVES: The way patients cope with their illness may influence their well-being, and for the assessment of coping relevant and valid instruments are required. The objective of the present study was to investigate the psychometric properties of the frequently used Jalowiec Coping Scale (JCS) in patients admitted for elective coronary angiography. We examined the original eight-factor model of the 60-item revised JCS and two three-factor models later proposed in the literature. METHODS: Using a cross-sectional design the JCS was completed by outpatients with suspected coronary artery disease 1-4 days prior to angiography. Item analyses and confirmatory factor analysis (CFA) for each model were performed, for those among the 647 participating patients that completed at least half the questions in the JCS. Exploratory post hoc analyses based on modification indices were performed in the case of unsatisfactory model fit. RESULTS: Neither of the proposed structures had satisfactory fit without modifications allowing some items to load on more than one factor. However, one of the two three-factor models performed well in item analysis and the CFA performed mostly satisfactory after some modifications. CONCLUSION: As for most coping scales reported in the literature, the CFA in the present study showed problems with all three proposed models of the JCS. Despite these problems one of the models may be used with caution. Further improvement of the quality of coping instruments, including CFA based on large samples is recommended.

Quality of life after randomization to laparoscopic versus open living donor nephrectomy: long-term follow-up.

BACKGROUND: The aim of this randomized study was to compare patient-reported outcome after laparoscopic versus open donor nephrectomy during 1 year follow-up. The evidence base has so far not allowed for a decision as to which method is superior as seen from a long-term quality of life-perspective. METHODS: The donors were randomized to laparoscopic (n=63) or open (n=59) nephrectomy, with follow-up at 1, 6, and 12 months. Primary outcomes were health status (SF-36) and overall quality of life (QOLS-N). Secondary outcomes were donor perception of the surgical scar, the donation's impact on personal finances, and whether the donor would make the same decision to donate again. RESULTS: There was a significant difference in favor of laparoscopic surgery regarding the SF-36 subscale bodily pain at 1 month postoperatively (P<0.05). Analysis based on intention to treat revealed no long-term differences between groups in SF-36 scores. When subtracting the reoperated/converted donors of the laparoscopic group, significant differences in favor of laparoscopy were revealed in the subscales bodily pain at 6 months (P<0.05) and social functioning at 12 months (P<0.05). No significant differences were found in QOLS-N scores between groups. CONCLUSIONS: Laparoscopic donor nephrectomy is an attractive alternative to open donor nephrectomy because of less postoperative pain. However, long-term comparison only revealed significant differences in favor of laparoscopy when adjusting for reoperations/conversions. Both groups reached baseline scores in most SF-36 subscales at 12 months and this may explain why possible minor benefits are hard to prove.

Health-related quality of life among patients with diabetes and foot ulcers: association with demographic and clinical characteristics.

OBJECTIVE: The purpose of the study was to describe the sociodemographic variables, clinical characteristics, and treatment factors in patients with diabetic foot ulcers (DFU) and to explore the associations between these factors and the patients' health-related quality of life (HRQL). MATERIALS AND METHODS: Cross-sectional data were obtained from 127 patients consecutively recruited from six hospital outpatient clinics. The patients were over 20 years of age, had current DFU, and had been diagnosed with diabetes of either Type 1 or Type 2. Data were obtained by clinical and laboratory examination and by self-completed questionnaires (SF-36). Descriptive analyses, bivariate analyses, and hierarchical regression analyses in three blocks were performed. RESULTS: The patients' mean age was 60 years (S.D., 13.8 years); 72% were men, and 29% had Type 1 diabetes. The most important variables explaining the variance in HRQL were the presence of biochemical signs of inflammation as measured by the detection of C-reactive protein (CRP) >10 mg/l, an ankle-brachial index (ABI) <0.9, an ulcer size > or =5 cm(2), nephropathy, and a body mass index <25 kg/m(2). The strongest association occurred between biochemical signs of inflammation CRP >10 mg/l, ABI <0.9, ulcer size >5 cm(2), and HRQL on physical functioning (adjusted r(2)=24). A major part of the variance remained unexplained and should be investigated in future studies. CONCLUSION: The findings may tend to identify the most vulnerable subgroups among those with DFU and may be useful in the formulation of strategies to improve function and HRQL in these patients.