Retrospective, propensity-score-adjusted (PSA) studies have indicated to practitioners in the field that contrast-induced acute kidney injury (AKI) after contrast-enhanced CT (CECT) is of minor importance or even non-existent. This has led to controversies between clinicians demanding CECT not to miss any diagnoses and radiologists reluctant or even refusing CECT in risky patients. A critical review of AKI/dialysis risk post-CECT in PSA studies was performed based on a Cochrane Library/Embase/PubMed search up to December 2024 with stratification for various populations. Among unselected emergency-/inpatients with chronic kidney disease, CECT was associated with significantly higher AKI incidence than in controls in 8/10 cohorts (weighted absolute risk increase 4.0 percentage points (pp), cohort range -4 to 16.9 pp at glomerular filtration rate (GFR) <30 mL/min/1.73 m2) and dialysis in 5/6 cohorts (weighted absolute risk increase 1.8 pp, cohort range 1.0-5.9 pp at GFR <30 mL/min/1.73 m2). Corresponding figures regarding cohorts with presumed/potentially unstable renal function were 1/10 and 3/8 cohorts, respectively. No increased risk was found in the five miscellaneous cohorts, but with a few patients with low GFR. Associations between individual contrast medium (CM) doses and AKI/dialysis were generally lacking. Marked selection bias was evident in one cohort. Thus, the analyses support an association between CECT and AKI in emergency-/inpatients, including a non-negligible dialysis risk, especially at GFR <30 mL/min/1.73 m2. PSA studies reporting no increased risk of CECT must be interpreted with caution due to risk for selection bias and the potential masking effects of acute kidney functional recovery. Studies on CM dose or gram-iodine/GFR ratio correlation with AKI/dialysis are warranted.
INTRODUCTION:Several ultrasound risk stratification systems have been developed mainly with the aim of identifying benign lesions and thereby avoiding unnecessary fine needle aspiration (FNA) cytology. This randomized controlled trial assessed whether the use of an ultrasound risk stratification system improved identification of lesions requiring surgical treatment. MATERIAL AND METHODS:This was a multi-centre, unblinded and interventional randomized trial comparing selective and non-selective FNA in Western Sweden. Patients were randomized to either selective cytology according to EU-TIRADS criteria or non-selective cytology. RESULTS:A total of 195 patients were included, 93 in the non-selective group and 102 in the selective group, between February 2022 and December 2023. The frequency of nodules with Bethesda category IV-VI (primary outcome) was higher in the selective group (26% versus 13%, P = 0.039). The rate of malignancy (secondary outcome) was similar in both groups; 8% in the selective group versus 5% in the non-selective group. The frequency of patients undergoing cytology was reduced from 83% in the non-selective group to 71% in the selective group. Considering only patients with at least one nodule yielding EU-TIRADS 3 or higher, cytology was omitted in 7% of patients in the selective group, whereas no cytology was omitted in the non-selective group. CONCLUSION:This randomized controlled trial supports the use of EU-TIRADS to correctly select neoplastic nodules for FNA without missing thyroid cancer. The proportion of patients where FNA can be safely omitted using EU-TIRADS may however be exaggerated, indicating a need for further refinement of risk stratification systems for thyroid cancer diagnostics.The trial was registered at ClinicalTrials.gov (NCT05583097).
There is a need to quantify the benefits and harms of colorectal cancer (CRC) screening using primary colonoscopy or fecal immunochemical testing (FIT) compared with usual care with no screening. Guidelines recommend screening in individuals aged 50-75 years using colonoscopy or FIT, and many screening programs use one-sample biennial FIT. Here we compare incidence of diagnosed CRCs and gastrointestinal and cardiovascular events between screening and usual care during the diagnostic phase of the SCREESCO trial. A randomized block method (no masking) assigned 278,280 individuals aged 60 years to once-only colonoscopy, 2 rounds of two-stool FIT with a low cutoff (10 μg g-1 feces) or usual care (control group) in a ratio of 1:6 for colonoscopy versus control and 1:2 for FIT versus control. In the analysis, 31,113 individuals were in the primary colonoscopy arm and 60,267 were in the FIT arm, and there were 186,671 primary colonoscopy controls, of whom 120,521 were also controls for comparison with the FIT arm. After a median follow-up of 4.8 years, the incidence rate of CRC was 107.9 in the colonoscopy arm and 99.9 in controls per 100,000 person-years (incidence rate ratio (IRR): 1.08, 95% confidence interval (CI): 0.91-1.28) and 96.0 in the FIT arm and 103.9 in controls (IRR: 0.92, 95% CI: 0.81-1.05). Rates of stage I-II CRC were higher in the colonoscopy arm (IRR: 1.38, 95% CI: 1.09-1.74) and in the FIT arm (IRR: 1.19, 95% CI: 0.99-1.43) versus controls. Rates of cardiovascular and gastrointestinal events were slightly higher in the intervention arms during the first year and were subsequently more similar to controls. Our findings of an increase in CRC detection implies a benefit of screening while the increase in adverse events suggests some initial harm. ClinicalTrials.gov: NCT02078804 .
BackgroundStandardized care pathway (SCP) for macrohematuria (patients aged ≥50 years) in Sweden includes four-phase computed tomography urography (CTU) before cystoscopy, but targeted SCP lead time for CTU (6 days)/treatment is fulfilled in <25% of patients.PurposeTo retrospectively analyze the incidence of CTU-diagnosed upper urinary tract (UUT), kidney and bladder tumors, calculi, radiation dose, and its implications for SCP.Material and MethodsA total of 4491 consecutive CTU reports on macrohematuria indication were reviewed, mainly during 2022 (86.6%) from nine radiology units: four regions, three university hospitals, and two private units. Tumor findings were verified via biopsy/cytology reports, CTU characteristics, and follow-up. Effective patient radiation doses were calculated.ResultsIn patients aged ≥50 years (n = 3915) the incidence of UUT/kidney/bladder tumors was 0.9%/1.0%/6.9%, respectively, and of calyceal, pelvic, ureteral, and bladder calculi was 13%, 2.0%, 2.7%, and 2.2%, respectively. Median effective dose was 12.9 mSv (range=10-22 mSv) in the six radiology units using four-phase CTU in 87%-100% of the examinations and 9-12 mSv in the three units using four-phase in 3%-53%.ConclusionThe limited incidence of UUT and kidney tumors diagnosed at CTU for macrohematuria necessitates a multidisciplinary discussion on how to improve SCP lead times for the vast majority with urothelial tumors, i.e. bladder tumors. Alternative diagnostic pathways such as cystoscopy and clinical risk evaluation before CTU should be contemplated. Additionally, there is a need to optimize radiation dose by reducing the number of CTU phases on one hand and without losing significant diagnostic accuracy on the other hand.
OBJECTIVE:Renal function and the skeleton are classic target organs in primary hyperparathyroidism (PHPT), affected by the chronic course of the disease. Most patients diagnosed today exhibit mild PHPT, characterized by slight hypercalcemia and no or unspecific symptoms. Concerns have been raised that PHPT could promote deteriorating kidney function and increase cardiovascular risk directly. To examine the effect of parathyroidectomy (PTX) on mild PHPT on renal function and markers for bone turnover, cardiovascular disease (CVD), and vascular inflammation. DESIGN:Prospective randomized controlled trial. ClinicalTrials.gov: NCT00522028. SETTING:Eight Scandinavian referral centers. PARTICIPANTS:From 1998 to 2005, 191 patients with mild PHPT were included in Sweden, Norway, and Denmark. Of these 150 were included in the present analyses. INTERVENTION:Seventy patients were randomized to PTX and 80 to observation without intervention (OBS). MEASURES:e-GFR was calculated based on creatinine and cystatin C. Markers of CVD and systemic inflammation: osteoprotegerin, vascular cell adhesion molecule 1, soluble CD40 ligand, interleukin-1 receptor antagonist, von Willebrand factor. Bone turnover markers: C-terminal telopeptide of type 1 collagen (CTX-1) and serum Procollagen type 1 N-terminal propeptide. RESULTS:No differences in the development of renal function or vascular and systemic inflammation were detected. CTX-1 was lower in PTX after 10 years. LIMITATIONS:Secondary analyses of a randomized controlled trial. CONCLUSION:PTX does not appear to affect renal function or markers of CVD and vascular inflammation in mild PHPT in a ten-year perspective.
To evaluate the learning progress of less experienced readers in prostate MRI segmentation. One hundred bi-parametric prostate MRI scans were retrospectively selected from the Göteborg Prostate Cancer Screening 2 Trial (single center). Nine readers with varying degrees of segmentation experience were involved: one expert radiologist, two experienced radiology residents, two inexperienced radiology residents, and four novices. The task was to segment the whole prostate gland. The expert’s segmentations were used as reference. For all other readers except three novices, the 100 MRI scans were divided into five rounds (cases 1–10, 11–25, 26–50, 51–76, 76–100). Three novices segmented only 50 cases (three rounds). After each round, a one-on-one feedback session between the expert and the reader was held, with feedback on systematic errors and potential improvements for the next round. Dice similarity coefficient (DSC) > 0.8 was considered accurate. Using DSC > 0.8 as the threshold, the novices had a total of 194 accurate segmentations out of 250 (77.6
ObjectivesInvestigating men’s perceived lifetime risk of prostate cancer.DesignSurvey-based study to men invited for prostate-specific antigen (PSA) screening in the GÖTEBORG-2 trial between September 2015 and June 2020.Setting38 775 men in the Gothenburg area, Sweden, were invited for PSA-testing and participated in a survey.Participants17 980 men participated in PSA-testing, of whom 13 189 completed the survey. In addition, 1264 men answered the survey only.InterventionsBefore having the PSA-test, men answered an electronic survey and estimated their lifetime risk of receiving a prostate cancer diagnosis on a visual analogue scale from 0% to 100%.Main outcome measuresThe primary outcome was the median lifetime risk estimation, which was compared with Wilcoxon test to an anticipated lifetime risk of 20% (based on GÖTEBORG-1 trial). The secondary outcome was to determine factors associated with risk estimation in a multivariable linear regression model: previous prostate examination, family history, physical exercise, healthy diet, comorbidity, alcohol consumption, smoking, education level, marital status, urinary symptoms and erectile dysfunction.ResultsAmong PSA-tested men, the median estimated lifetime risk of prostate cancer was 30% (IQR 19% to 50%), corresponding to a 10 percentage-points higher estimation compared with the anticipated risk (p<0.001). Family history of prostate cancer, moderate to severe urinary symptoms and mild to moderate erectile dysfunction were associated with >5 percentage-points higher risk estimation. Similar results were obtained for non-PSA-tested men.ConclusionsMost men overestimated their prostate cancer risk which underscores the importance of providing them accurate information about prostate cancer.Trial registration numberISRCTN94604465.
Background and Objective: Magnetic resonance imaging(MRI) and targeted biopsies reduce overdiagnosis of prostate cancer(PC). It is uncertain how this strategy performs for low PSA levels. The objective was to investigate the PI-RADS distribution, frequency and characteristics of screen-detected PC with PSA of 1.8-<3ng/ml and 3-<10ng/ml. Methods: In the population-based G & ouml;teborg-2 screening study, 17 974 men choose to participate by having a PSA(2015-2020). One-third of the participants(n=6006) were randomized to Arm 3, men with a PSA >= 1.8ng/ml were recommended MRI. Men with positive MRI(PI-RADS3-5) had four targeted biopsies from each MRI-visible lesion. Clinically significant PC was defined as Gleason score >= 3+4. Key Findings and Limitations: 6006 men were included. Median age was 55.9 years. 670 (11%) had PSA of 1.8-<3ng/ml(low-PSA group), median PSA 2.1ng/ml, and 377(6.3%) had PSA of 3-<10ng/ml(high-PSA group), median PSA 3.9ng/ml. PI-RADS scores of 3, 4, and 5 were observed in 7.8%, 15%, and 1.0% in the low-PSA group, and in 6.9%, 17%, and 5.3% in the high-PSA group, respectively. PC was found in 64 men (41%, 95%CI 0.33-0.49) with positive MRI findings in the low-PSA group, 33(21%) had Gleason 6 and 31(20%) had Gleason >= 7. In the high-PSA group, PC was detected in 61men (56%, 95%CI 0.46-0.66), 26(24%) had Gleason 6 and 35(32%) had Gleason >= 7. Limitations include results from only a single screening round. Conclusions and Clinical Implications: A non-negligible number of men with PSA 1.83ng/ml have clinically significant PC. Whether a delay in the diagnosis of these tumors until they reached PSA >= 3ng/ml would impair their chance of cure remains to be evaluated. (c) 2024 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY license (http://creativecommons. org/licenses/by/4.0/).
BACKGROUND Data on the efficacy and safety of screening for prostate cancer with magnetic resonance imaging (MRI) are needed from studies of follow-up screening. METHODS In a population-based trial that started in 2015, we invited men who were 50 to 60 years of age to undergo prostate-specific antigen (PSA) screening. Men with a PSA level of 3 ng per milliliter or higher underwent MRI of the prostate. Men were randomly assigned to the systematic biopsy group, in which they underwent systematic biopsy and, if suspicious lesions were found on MRI, targeted biopsy, or the MRI-targeted biopsy group, in which they underwent MRI-targeted biopsy only. At each visit, men were invited for repeat screening 2, 4, or 8 years later, depending on the PSA level. The primary outcome was detection of clinically insignificant (International Society of Urological Pathology [ISUP] grade 1) prostate cancer; detection of clinically significant (ISUP grade >= 2) cancer was a secondary outcome, and detection of clinically advanced or high-risk (metastatic or ISUP grade 4 or 5) cancer was also assessed. RESULTS After a median follow-up of 3.9 years (approximately 26,000 person-years in each group), prostate cancer had been detected in 185 of the 6575 men (2.8%) in the MRI-targeted biopsy group and 298 of the 6578 men (4.5%) in the systematic biopsy group. The relative risk of detecting clinically insignificant cancer in the MRI-targeted biopsy group as compared with the systematic biopsy group was 0.43 (95% confidence interval [CI], 0.32 to 0.57; P<0.001) and was lower at repeat rounds of screening than in the first round (relative risk, 0.25 vs. 0.49); the relative risk of a diagnosis of clinically significant prostate cancer was 0.84 (95% CI, 0.66 to 1.07). The number of advanced or high-risk cancers detected (by screening or as interval cancer) was 15 in the MRI-targeted biopsy group and 23 in the systematic biopsy group (relative risk, 0.65; 95% CI, 0.34 to 1.24). Five severe adverse events occurred (three in the systematic biopsy group and two in the MRI-targeted biopsy group). CONCLUSIONS In this trial, omitting biopsy in patients with negative MRI results eliminated more than half of diagnoses of clinically insignificant prostate cancer, and the associated risk of having incurable cancer diagnosed at screening or as interval cancer was very low.
Objectives When exposed to iodine contrast medium (ICM), thyroid dysfunction may develop, due to excess amounts of iodide. The incidence of contrast-induced thyroid dysfunction has been difficult to interpret, because of the observational and retrospective designs of most previous studies. With the Swedish CArdioPulmonary bioImage Study (SCAPIS), where randomly selected individuals aged 50–65 years, underwent contrast-enhanced coronary CT angiography (CCTA), we were able to prospectively assess the incidence, magnitude and clinical impact of contrast-induced thyroid dysfunction. Methods In 422 individuals, thyroid hormone levels were analysed before and 4–12 weeks after CCTA. Thyroid-related patient-reported outcome questionnaires (ThyPRO) at the time of pre and post-CCTA blood samplings were provided by 368 of those individuals. Thyroid peroxidase antibodies (TPOab) were analysed and an ultrasound of the thyroid gland was performed to detect any thyroid nodules. Results There was a small statistically significant effect on thyroid hormone levels but no cases of overt hypo- or hyperthyroidism after ICM. Subclinical hypo- or hyperthyroidism or isolated low/high levels of free thyroxine (fT4) developed in 3.5% of the population with normal hormone levels pre-CCTA but without any increased thyroid-related symptoms compared to the remaining cohort. Elevated TPOab and being born outside Sweden were risk factors for developing subclinical hypothyroidism. The presence of thyroid nodules was not associated with ICM-induced thyroid dysfunction. Conclusion The results of this prospective study support the notion that in iodine-sufficient countries, ICM-associated thyroid dysfunction is rare, usually mild, self-limiting and oligo/asymptomatic in subjects aged 50–65 years.
BACKGROUND AND OBJECTIVE:We investigated whether adding 4Kscore as a reflex test to prostate-specific antigen (PSA) could improve the screening algorithm for prostate cancer (PC). METHODS:In the GÖTEBORG-2 PC screening trial, 38 000men (50-60 yr) were invited to PSA testing and, if elevated, followed by magnetic resonance imaging (MRI). For 571 men with PSA ≥3.0 ng/ml and evaluable outcomes, 4Kscore was calculated. The performance using a prespecified 4Kscore cutoff of 7.5% was evaluated. KEY FINDINGS AND LIMITATIONS:The area under the curve for 4Kscore to identify intermediate- and high-risk PC was 0.84 (95% confidence interval 0.79-0.89), and the positive predictive value, and negative predictive value were 15% (0.12-0.20) and 99% (97-100%), respectively. Of the 54 men diagnosed with intermediate- or high-grade PC, two had a 4Kscore cutoff below 7.5%, both with organ-confined intermediate-risk PC. Per 1000 men with elevated PSA, adding 4Kscore would have resulted in avoidance of MRI for 408 (41%) men, biopsies for 95 (28% reduction) men, and diagnosis of 23 low-grade cancers (23% reduction) while delaying the diagnosis of four men with intermediate-grade cancers (4%). CONCLUSIONS AND CLINICAL IMPLICATIONS:Including 4Kscore as a reflex test for men with elevated PSA reduces the need for MRI and biopsy markedly, and results in less overdiagnosis of low-grade PC at the cost of delaying the diagnosis of intermediate-grade PC in a few men. These results add further evidence for including new blood-based biomarkers in addition to PSA to improve the harm and benefit ratio of PC screening and reduce the need for resource-demanding MRI and biopsies.
ObjectivePatients with clinical T1 renal cell carcinoma (cT1RCC) have risks for recurrence and reduced overall survival despite being in the best prognostic group. This study aimed to evaluate the association of different treatments on disease recurrence and overall survival using clinical and pathological characteristics in a nation-wide cT1RCC cohort.Materials and methodsA total of 4,965 patients, registered in the National Swedish Kidney Cancer Register (NSKCR) between 2005 and 2014, with >= 5-years follow-up were identified: 3,040 males and 1,925 females, mean age 65 years. Times to recurrence and overall survival were analyzed with Kaplan-Meier curves, log-rank test, and Cox regression models.ResultsAge, TNM-stage, tumor size, RCC-type, and performed treatment were all associated with disease recurrence. Patients selected for ablative treatments had increased risk for recurrent disease: hazard ratio (HR) = 3.79 [95% confidence interval (CI) = 2.69-5.32]. In multivariate analyses, age, gender, tumor size, RCC-type, N-stage, recurrence and performed treatment were all independently associated with overall survival. Patients with chRCC had a 41% better overall survival (HR = 0.59, 95% CI = 0.44-0.78; p < 0.001) than ccRCC. Patients treated with partial nephrectomy (PN) had an 18% better overall survival (HR = 0.83, 95% CI = 0.71-0.95, p < 0.001) than patients treated with radical nephrectomy.ConclusionsAge, gender, T-stage, tumor size, RCC type and treatment modality are all associated with risk of recurrence. Furthermore, age, male gender, tumor size, N-stage and recurrence are associated with reduced overall survival. Patients with chRCC, compared with ccRCC and pRCC patients, and PN compared with RN treated patients, had an advantageous overall survival, indicating a possible survival advantage of nephron sparing treatment.
Long-term screening with serum prostate-specific antigen (PSA) and systematic prostate biopsies can reduce prostate cancer mortality but leads to unacceptable overdiagnosis. Over the past decade, diagnostic methods have improved and the indolent nature of low-grade prostate cancer has been established. These advances now enable more selective detection of potentially lethal prostate cancer. This non-systematic review summarises relevant diagnostic advances, previous and ongoing screening trials, healthcare policies and important remaining knowledge gaps. Evidence synthesis and conclusions: The strong association between low serum PSA values and minimal long-term risk of prostate cancer death allows for adjusting screening intervals. Use of risk calculators, biomarkers and MRI to select men with a raised PSA value for biopsy and lesion-targeting rather than systematic prostate biopsies reduce the detection of low-grade cancer and thereby overdiagnosis. These improvements recently led the European Union to recommend its member states to evaluate the feasibility and effectiveness of organised screening programmes for prostate cancer. Nonetheless, important knowledge gaps remain such as the performance of modern diagnostic methods in long-term screening programmes and their impact on mortality. The knowledge gaps are currently being addressed in three large randomised screening trials. Population-based pilot programmes will contribute critical practical experience.
BACKGROUND:A prerequisite before introducing a screening program is that the screening examinations are acceptable to participants. OBJECTIVE:To evaluate the acceptance and bother of prostate cancer screening examinations. DESIGN, SETTING, AND PARTICIPANTS:The randomized population-based GÖTEBORG-2 prostate cancer screening trial invited >37 000 men for prostate-specific antigen (PSA) testing followed by magnetic resonance imaging (MRI) in case of elevated PSA and prostate biopsy (targeted and/or systematic) if indicated. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:Participants were asked to fill out a questionnaire and rate the level of bother associated with each examination (PSA, MRI, and prostate biopsy) on a categorical scale ranging from 1 to 5 (1 = "not at all bothersome" and 5 = "very bothersome"), and to rate their willingness to repeat the examinations, by marking an X on a continuous scale ranging from 0 to 10 (0 = "yes, without any hesitation" and 10 = "no, absolutely not"). Wilcoxon signed rank test was used. RESULTS AND LIMITATIONS:Compliance with MRI was 96% (1790/1872), compliance with biopsy was 89% (810/907), and the response rate to the questionnaire was 75% (608/810). Men who underwent all examinations (n = 577) responded that biopsy was more bothersome than PSA test (p < 0.001) and MRI (p < 0.001). High levels of bother (≥4 out of 5) were reported by 2% (12/577) for PSA test, 8% (46/577) for MRI, and 43% (247/577) for biopsy. Men were more willing to repeat MRI than biopsy (p < 0.001), but the difference was small (median 0.2 [interquartile range 0.1-0.6] vs 0.5 [0.1-2.0]). CONCLUSIONS:Biopsies are more bothersome than MRI, but a large majority of men accept to repeat both examinations if necessary. Omitting biopsy for MRI-negative men and shifting to targeted biopsies only will reduce bother for men participating in prostate cancer screening. PATIENT SUMMARY:We asked men how bothersome they found the prostate-specific antigen (PSA) test, magnetic resonance imaging (MRI), and prostate biopsies. Biopsies were more bothersome than PSA and MRI, but most men were willing to repeat all procedures if necessary.
The Swedish Society of Uroradiology has revised their computed tomography (CT) guidelines regarding iodine contrast media-induced acute kidney injury (CI-AKI). They are more cautious compared to the European Society of Urogenital Radiology and the American College of Radiology since the actual risk of CI-AKI remains uncertain in patients with moderate to severe kidney damage due to a lack of prospective controlled studies and mainly based on retrospective propensity score-matched studies with low-grade evidence. Another source of uncertainty is the imprecision of glomerular filtration rate (GFR) estimating equations. However, randomized hydration studies indictae an upper limit risk of CI-AKI of about 5% for outpatients with a GFR in the range of 30–44 or 45–59 mL/min/1.73m2 combined with multiple risk factors. Apart from GFR limits, the guideline also includes limits for systemic contrast medium exposure expressed in gram-iodine/GFR ratio.
ABSTRACT Mild or asymptomatic disease is now the dominating presentation of primary hyperparathyroidism (PHPT). However, bone involvement with decreased bone mineral density (BMD) and an increased risk of fractures has been demonstrated. Indications for parathyroidectomy (PTX) in mild PHPT have been debated for years. There is a need of long‐term randomized studies comparing PTX with observation without intervention (OBS). Here, we present bone health data from the Scandinavian Investigation of Primary Hyperparathyroidism (SIPH), a randomized controlled trial, comparing PTX to OBS. This study included 191 patients (96 OBS/95 PTX), and 129 patients (64 OBS/65 PTX) were followed for 10 years to the end of study (EOS). BMD was measured with dual‐energy X‐ray absorptiometry (DXA), peripheral fractures were noted, and spine radiographs were obtained for vertebral fracture assessment. There was a significant treatment effect of PTX on BMD compared with OBS for all analyzed compartments, most explicit for the lumbar spine (LS) and femoral neck (FN) ( p < 0.001). The mean changes in T ‐score from baseline to 10 years were from 0.41 for radius 33% (Rad33) to 0.58 for LS greater in the PTX group than in the OBS group. There was a significant decrease in BMD for all compartments in the OBS group, most pronounced for FN, Rad33, and ultradistal radius (UDR) ( p < 0.001). Even though there was a significant treatment effect of PTX compared with OBS, there was only a significant increase in BMD over time for LS ( p < 0.001). We found no difference between groups in fracture frequency in the 10‐year cohort, neither with modified intention‐to‐treat (mITT) analysis nor per protocol analysis. Because BMD is only a surrogate endpoint of bone health and PTX did not reduce fracture risk, observation could be considered a safe option for many patients with mild PHPT regarding bone health in a 10‐year perspective. © 2023 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).
Abstract Objective To examine the association between surgical waiting times (SWTs) and all-cause mortality (ACM) in non-metastatic patients with RCC, in relation to tumour stage. Patients and methods This nation-wide population-based cohort study included 9,918 M0 RCC patients registered in the National Swedish Kidney Cancer Register, between 2009 and 2021, followed-up for ACM until 9 December 2021, and having measured SWTs. The associations between primarily SWTs from date of radiological diagnosis to date of surgery (WRS) and secondarily SWTs from date of radiological diagnosis to date of treatment decision (WRT) and date of treatment decision to date of surgery (WTS), in relation to ACM, were analysed using Cox regression analysis, adjusted for clinical and demographic characteristics, stratified and unstratified according to T-stage. Results During a mean follow-up time of 5 years (49,873 person-years), 23% (n = 2291) of the patients died. The adjusted hazard ratio (AHR) for WRS (months) for all patients was 1.03 (95% confidence interval [CI] = 1.02–1.04; p < 0.001). When subdividing WRS on T-stage, the AHRs were 1.03 (95% CI = 1.01–1.04; p < 0.001) and 1.05 (95% CI = 1.02–1.08; p = 0.003) for stages T1 and T3, respectively, while non-significant for T2 (p = 0.079) and T4 (p = 0.807). Similar results were obtained for WRT and WTS. Conclusions Prolonged SWTs significantly increased the risk of early overall death among patients with RCC. The increased risk of early death from any cause show the importance of shortening SWTs in clinical work of patients with this malignant disease.
BACKGROUND:Primary hyperparathyroidism (PHPT) is a common endocrine disorder associated with increased risk for fractures, cardiovascular disease, kidney disease, and cancer and increased mortality. In mild PHPT with modest hypercalcemia and without known morbidities, parathyroidectomy (PTX) is debated because no long-term randomized trials have been performed.OBJECTIVE:To examine the effect of PTX on mild PHPT with regard to mortality (primary end point) and key morbidities (secondary end point).DESIGN:Prospective randomized controlled trial. (ClinicalTrials.gov: NCT00522028).SETTING:Eight Scandinavian referral centers.PATIENTS:From 1998 to 2005, 191 patients with mild PHPT were included.INTERVENTION:Ninety-five patients were randomly assigned to PTX, and 96 were assigned to observation without intervention (OBS).MEASUREMENTS:Date and causes of death were obtained from the Swedish and Norwegian Cause of Death Registries 10 years after randomization and after an extended observation period lasting until 2018. Morbidity events were prospectively registered annually.RESULTS:After 10 years, 15 patients had died (8 in the PTX group and 7 in the OBS group). Within the extended observation period, 44 deaths occurred, which were evenly distributed between groups (24 in the PTX group and 20 in the OBS group). A total of 101 morbidity events (cardiovascular events, cerebrovascular events, cancer, peripheral fractures, and renal stones) were also similarly distributed between groups (52 in the PTX group and 49 in the OBS group). During the study, a total of 16 vertebral fractures occurred in 14 patients (7 in each group).LIMITATION:During the study period, 23 patients in the PTX group and 27 in the OBS group withdrew.CONCLUSION:Parathyroidectomy does not appear to reduce morbidity or mortality in mild PHPT. Thus, no evidence of adverse effects of observation was seen for at least a decade with respect to mortality, fractures, cancer, cardiovascular and cerebrovascular events, or renal morbidities.PRIMARY FUNDING SOURCE:Swedish government, Norwegian Research Council, and South-Eastern Norway Regional Health Authority.
Background: T1a renal cell carcinoma (RCC) is typically considered a curable disease, irrespective of the choice of local treatment modality. Objective: To identify factors associated with the risk of local and distant recurrence, and overall survival (OS) in patients with primary nonmetastatic clinical T1a RCC. Design, setting, and participants: A population-based nationwide register study of all 1935 patients with cT1a RCC, diagnosed during 2005–2012, identified through The National Swedish Kidney Cancer Register, was conducted. Outcome measurements and statistical analysis: Outcome variables were recurrence (local or distant) and OS. Possible explanatory variables included tumor size, RCC type, T stage, surgical technique, age, and gender. Associations with disease recurrence and OS were evaluated by multivariable regression and Cox multivariate analyses, respectively. Results and limitations: Among 1935 patients, 938 were treated with radical nephrectomy, 738 with partial nephrectomy, and 169 with ablative treatments, while 90 patients had no surgery. Seventy-eight (4%) patients were upstaged to pT3. Local or metastatic recurrences occurred in 145 (7.5%) patients, significantly more often after ablation (17.8%). The risk of recurrence was associated with tumor size, upstaging, and ablation. Larger tumor size, disease recurrence, and older age adversely affected OS, whereas partial nephrectomy and chromophobe RCC (chRCC) were associated with improved survival. Limitations include register design and a lack of comorbidity or performance status data. Conclusions: Upstaging and recurrence occurred, respectively, in 4.0% and 7.5% of patients with nonmetastatic RCCs ≤4 cm. Tumor size upstaging and ablation were associated with the risk for recurrence, while tumor size and recurrence were associated with decreased OS. Patients with chRCC and partial nephrectomy had prolonged OS in a real-world setting. Patient summary: We studied factors that may influence the risk of disease recurrence and overall survival, in a large nationwide patient cohort having nonmetastatic renal cell carcinoma ≤4 cm. Tumor size, tumor type, and treatment were associated with the risk of recurrence and overall death. Partial nephrectomy prolonged overall survival.
Different dual-energy x-ray absorptiometry (DXA) hardware can affect bone mineral density (BMD) measurements and different reference populations can affect t-scores. Long-term analyses describing differences in the relationship between BMD and t-scores are lacking. BMD-values were plotted against t-scores for 241 Lunar DXA scans on females obtained over 18 years from several centers in Sweden and Norway. The result of the plot was compared to hardware/software versions, reference populations and different software analysis settings (Basic vs Enhanced analysis for total body and Single Photon Absorptiometry (SPA) vs Lunar calibration for forearm). For the forearm compartments, we found different BMD-t-score relationships depending on the use of SPA or Lunar calibration (p<0.001). With Lunar calibration, BMD-values were 24% higher, but there was no effect on t-scores. Total body measurements with iDXA scanners and Enhanced analysis for Prodigy scanners (software version 14.10) resulted in a different BMD-t-score relationship compared to the other hardware/software versions (p<0.001), with the largest discrepancy for lower BMD-values. Switching from Basic to Enhanced analysis generally decreased BMD-values and often changed t-scores (both increased and decreased). For the femoral neck, there were two different BMD-t-score relationships caused by different reference populations (p<0.001). In contrast to total body, the difference for femoral neck was more pronounced for higher values, with little impact in the clinical decision-making area. Hardware, software, reference populations and software analysis settings can affect the BMD-t-score relationship, but do so differently for different compartments. The BMD-t-score-plot is a simple and effective tool to discover systematic differences. Longitudinal analyses of DXA scans should be performed based on raw data analyzed in "one run" with the same software version and settings, in order to avoid systematic differences.