INTRODUCTION: Patients with prostate cancer (PC) who undergo radical prostatectomy (RP) experience impaired sexual and urinary function.

AIM: To compare the effect of early couple counseling and pelvic floor muscle training (PFMT) with usual care for sexual and urinary dysfunction after RP.

METHODS: The ProCan study was a randomized controlled trial (RCT) with two parallel treatment arms and 1:1 allocation. Between January 2016 and December 2017, candidates for RP were invited to a longitudinal questionnaire study and provided baseline measures before surgery. Patients who underwent RP, had a female partner, and were sexually active were invited to the ProCan RCT. Couples who provided informed consent were allocated to usual care or usual care and up to six couple counseling sessions, up to three instructions in PFMT and a video home-training program. All couples filled in follow-up questionnaires at 8 and 12 months and non-participants provided 12 months' follow-up. Linear mixed-effect models and 95% confidence intervals were used to measure effects of the intervention.

MAIN OUTCOME MEASURE: Primary outcome was erectile function, measured with The International Index of Erectile Function, at 8 and 12 months follow-up. Secondary outcomes were sexual and urinary function and use of treatment for erectile dysfunction (ED) by patients; sexual function in female partners; and relationship function, health-related quality of life, anxiety, depression, and self-efficacy in both patients and female partners.

RESULTS: Thirty-five couples were randomized. No significant effect of the intervention was found on erectile function at 8 months (estimated difference in change, 1.41; 95% CI; -5.51 ; 8.33) or 12 months (estimated difference in change, 0.53; 95% CI; -5.94; 6.99) or in secondary outcomes, except for significantly increased use of ED treatment at 8 months.

CONCLUSION: We found no effect of early couple counseling and PFMT, possibly because of the limited number of participants. Karlsen RV, Bidstrup PE, Giraldi A, et al. Couple Counseling and Pelvic Floor Muscle Training for Men Operated for Prostate Cancer and for Their Female Partners. Results From the Randomized ProCan Trial. Sex Med 2021;9:100350.

Background: The Clinical Assessment of Modes questionnaires (CAMQs) determine clients' preferential modes for therapy (CAM-C1), clients’ perception of modes used by the occupational therapist (OTs) during therapy (CAM-C2), or modes the OTs believed to have used (CAM-T). Access to valid CAMQs for Danish OTs and clients required a rigorous translation and cultural adaptation process. Objectives: To translate and culturally adapt the CAMQs into Danish, examining face validity in a Danish context. Material and methods: A 10-step guideline for the process of translating and culturally adapting questionnaires was followed. Steps 1–6 included translation into Danish, steps 7–8 involved cognitive debriefing interviews and validation based on the Content Validity Index (CVI) analyzed using Kappa statistics. Steps 9–10 finalized the process. Results: CAMQs were translated into Danish. Based on cognitive debriefing interviews and CVIs involving 15 clients and 7 OTs, modifications regarding titles, layouts, instructions, wording and response categories were performed in all Danish CAMQs. The Item CVI and the modified kappa revealed that most participants had a high level of agreement on the cultural relevance. Conclusions and significance: Translated versions of the CAMQs have been culturally adapted into Danish. The current Danish versions seem culturally relevant and useable in Danish occupational therapy.

Background & Aims: Progressive fibrosis has been identified as the major predictor of mortality in patients with non-alcoholic fatty liver disease (NAFLD). Several biomarkers are currently being evaluated for their ability to substitute the liver biopsy as the reference standard. Recent clinical studies in NAFLD/NASH patients support the utility of PRO-C3, a marker of type III collagen formation, as a marker for the degree of fibrosis, disease activity, and effect of treatment. Here we establish the healthy reference range, optimal sample handling conditions for both short- and long-term serum storage, and robustness for the PRO-C3 assay.

Methods: PRO-C3 was measured in 269 healthy volunteers and in 222 NAFLD patients. Robustness of the PRO-C3 assay was measured according to Clinical and Laboratory Standards Institute standards and included validation of interference, precision, and reagent stability, whilst sample stability was defined for storage at different temperatures and for 3 freeze-thaw cycles. Fibrosis scoring was based on histological assessments and used as a reference for the diagnostic ability of PRO-C3 to discriminate between patients with different levels of fibrosis.

Results: Robustness of the PRO-C3 analysis validated by interference, precision, and reagent stability was found to be within the predefined acceptance criteria. The healthy reference range was determined to be 6.1-14.7 ng/ml. Levels of PRO-C3 were not affected by sex, age, BMI, or ethnicity. Levels of PRO-C3 were able to identify patients with clinically significant fibrosis and advanced fibrosis (AUC = 0.83 (95% CI [0.77-0.88], p <0.0001), and AUC = 0.79 (95% CI [0.73-0.85], p <0.0001), respectively).

Conclusions: The assay proved to be robust and sample stability was found to comply with hospital sample handling requirements. PRO-C3 measured in samples from patients with NAFLD/NASH was diagnostic for significant and advanced liver fibrosis.

Lay summary: We showed that PRO-C3 levels were stable under conditions conforming with hospital sample-handling requirements. We determined a healthy reference range and showed that PRO-C3 levels were not associated with sex, age, BMI, or ethnicity. Finally, we provide further evidence of an association of PRO-C3 with increasing liver fibrosis.

PURPOSE: Long-term weight management requires sustained engagement with energy-balance-related behaviours. According to self-determination theory, behaviour goals can support or undermine motivation depending on the quality of their content (i.e., extrinsic and intrinsic motivation). This study aimed to develop and validate the goal content for weight loss maintenance scale (GCWMS).

METHODS: The GCWMS was administered to 1511 participants who had achieved clinically significant weight losses and were taking part in a large weight loss maintenance study: the NoHoW Trial (ISRCTN88405328). The scale derived from two well-established questionnaires regarding exercise goals. Construct validity was examined for 4 theory-driven domains: Health Management, Challenge, Image, and Social Recognition. Split-sample confirmatory factor analysis was conducted to test the factorial validity and multi-group measurement invariance (configural, metric, scalar, and residual invariance). The reliability estimates were also assessed, and discriminant validity was evaluated using 2 conceptually related questionnaires.

RESULTS: The first analysis showed a poor fit of the original factorial structure. Subsequent investigation with a new specified model indicated close fit to the data after removal of 3 items χ2(58) = 599.982; p < .001; χ2/df = 10.345; CFI = 0.940; GFI = 0.941; SRMR = 0.063; RMSEA = 0.079 (LL = 0.073; UL = .084). Good internal consistency was achieved in all subscales (α > .775), convergent and divergent validity were verified through associations with other theoretical related constructs. Findings from multi-group invariance test demonstrated that the specified model of GCWMS achieved full measurement invariance for gender but did not support residual invariance across countries.

CONCLUSION: Findings support the hypothesised four-dimension structure of the GCWMS, confirming reliability and multi-group invariance in factor structure. Analysis also supports valid group means comparisons on latent factors at gender and at cross-cultural level. Ways to improve the quality of the scale are discussed.

LEVEL OF EVIDENCE: Level V, cross-sectional descriptive.

OBJECTIVES: To identify patient-centered core domains for prospective longitudinal observational studies (LOS) in rheumatoid arthritis.

METHODS: Our working group held a virtual meeting in November 2020 to review data from a literature review and patient qualitative interviews, and to discuss strategies to move forward on domain identification and selection using the OMERACT 2.1 domain selection process.

RESULTS: Important candidate domains and subdomains were identified including in the areas of life impact. Consensus was reached on moving forward with a Delphi process.

CONCLUSIONS: The meeting provided future directions to identify and select a core set of domains for use in LOS.

CONTEXT: Apart from ruminant fat, trans-fatty acids are produced during the partial hydrogenation of vegetable oils, (eg, in the production of ultraprocessed foods). Harmful cardiovascular effects of trans-fatty acids are already proven, but the link with cancer risk has not yet been summarized.

OBJECTIVE: A systematic review (following PRISMA guidelines) - including observational studies on the association of trans-fatty acid intake with any cancer risk - was conducted, with no limitations on population types.

DATA SOURCES: The electronic databases PubMed and Embase were searched to identify relevant studies.

DATA EXTRACTION: This systematic review included 46 articles. Quality was assessed via the Newcastle-Ottawa scale. Meta-analyses were conducted if at least 4 articles exploring the same transfat-cancer pairings were found.

DATA ANALYSIS: Nineteen cancer types have been researched in cohort and case-control studies on trans-fatty acids, with breast cancer (n = 17), prostate cancer (n = 11), and colorectal cancer (n = 9) as the most researched. The meta-analyses on total trans-fat showed a significant positive association for prostate cancer (odds ratio [OR] 1.49; 95%CI, 1.13-1.95) and colorectal cancer (OR 1.26; 95%CI, 1.08-1.46) but not for breast cancer (OR 1.12; 95%CI, 0.99-1.26), ovarian cancer (OR 1.10; 95%CI, 0.94-1.28), or non-Hodgkin lymphoma (OR 1.32; 95%CI, 0.99-1.76). Results were dependent on the fatty acid subtype, with even cancer-protective associations for some partially hydrogenated vegetable oils. Enhancing moderators in the positive transfat-cancer relation were gender (direction was cancer-site specific), European ancestry, menopause, older age, and overweight.

CONCLUSION: Despite heterogeneity, higher risk of prostate and colorectal cancer by high consumption of trans-fatty acids was found. Future studies need methodological improvements (eg, using long-term follow-up cancer data and intake biomarkers). Owing to the lack of studies testing trans-fatty acid subtypes in standardized ways, it is not clear which subtypes (eg, ruminant sources) are more carcinogenic.

SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration no. CRD42018105899.

OBJECTIVES: The aim of this study was to determine the diagnostic performance of dual-energy computed tomography (DECT) to detect and distinguish crystal deposits in a phantom. The primary objective was to determine the cutoff DECT ratio and the cross-sectional area (CSA) of a crystal deposit necessary to differentiate monosodium urate (MSU), calcium pyrophosphate (CPP), and calcium hydroxyapatite (HA) using DECT. Our secondary objective was to determine the concentration for limit of detection for MSU, CPP, and HA crystal deposits. Exploratory objectives included the comparison between 2 generations of DECT scanners from the same manufacturer as well as different scanner settings.

MATERIALS AND METHODS: We used a cylindrical soft tissue phantom with synthetic MSU, CPP, and HA crystals suspended in resin. Crystal suspension concentration increased with similar attenuation between MSU, CPP, and HA in conventional CT. The phantom was scanned on 2 dual-source DECT scanners, at 2 dose levels and all available tube voltage combinations. Both scanners had a tin (Sn) filter at the high-energy spectra. Dual-energy CT ratios were calculated for a given tube voltage combination by dividing linear regression lines of CT numbers against concentration. Dual-energy CT ratios were compared using an analysis of covariance. Receiver operating characteristic curves and corresponding areas under the curve (AUCs) were calculated for individual crystal suspension comparisons (HA vs CPP, MSU vs CPP, and MSU vs HA).

RESULTS: At standard clinical scan settings with 8 mGy and 80/Sn150 kV, the DECT ratios were as follows: CPP, 2.02 (95% confidence interval [CI], 1.98-2.07); HA, 2.00 (95% CI, 1.96-2.05); and MSU, 1.09 (95% CI, 1.06-1.11). Ratios varied numerically depending on the scanner and tube voltage combination. Monosodium urate crystal DECT ratios were significantly different from HA and CPP (P < 0.001), whereas DECT ratios for HA and CPP crystals did not differ significantly (P = 0.99). The differentiation of MSU crystals from both calcium crystals (HA and CPP) was excellent with an AUC of 1.00 (95% CI, 1.00-1.00) and an optimal cutoff DECT ratio of 1.43:1.40 depending on the scanner. In addition, differentiation of MSU and calcium-containing crystals (HA and CPP) required a CSA of minimum 4 pixels of crystal at standard clinical scan conditions. In contrast, differentiation between CPP and HA crystals was moderate with AUCs ranging from 0.66 (95% CI, 0.52-0.80) to 0.80 (95% CI, 0.69-0.91) and an optimal cutoff DECT ratio of 2.02:2.06 depending on the scanner. Furthermore, differentiation between CPP and HA crystals required a CSA of minimum 87 pixels of crystal at standard clinical scan conditions, corresponding to a region of interest of 3.7 mm diameter. When scanning at highest possible spectral separation and maximum dose of 50 mGy, the limit of detection for crystals within a region of interest of 50 pixels was 14 mg/cm3 for MSU and 2 mg/cm3 for both CPP and HA.

CONCLUSIONS: This phantom study shows that DECT can be used to detect MSU, CPP, and HA crystal deposits. Differentiation of CPP and HA was not possible in crystals deposits less than 3.7 mm in diameter, but MSU could accurately be differentiated from CPP and HA crystal deposits at standard clinical scan conditions.

On 11 March 2020, a lockdown to limit the spread of COVID-19 was implemented in Denmark. The pandemic and the lockdown might have caused stress, depression, and anxiety in new mothers. Individuals with high resilience to stress may have been less affected. This study aimed to investigate if changes in perceived stress, anxiety, depression, and resilience from the second trimester until two months postpartum were different before and during the COVID-19 pandemic in Denmark in spring 2020. Pregnant women enrolled in an ongoing feasibility study completed an online questionnaire measuring perceived stress, depression, anxiety, and resilience in the second trimester and two months postpartum. Changes in scores between women completing the two-month postpartum questionnaire before (n = 26) or during (n = 47) the COVID-19 pandemic were calculated. No statistically significant differences in changes from baseline to follow-up between pre- and during-pandemic groups in Cohen's Perceived Stress Scale (PSS), the Depression, Anxiety, Stress Scale (DASS), or the Connor-Davidson Resilience Scale (CD-RISC) were found. Adjusted differences in group means were as follows: PSS: 0.70 (CI-2.45; 3.85); DASS Stress: 0.76 (CI-3.59; 2.08); DASS Anxiety: 0.47 (CI-0.84; 1.77); DASS Depression: 0.88 (CI-0.95; 2.71); and CD-RISC: 1.19 (CI-3.16; 5.54). In conclusion, we did not find significant differences in the development of stress, depression, anxiety, or resilience before or during the Danish COVID-19 pandemic in spring 2020.

OBJECTIVE: To determine whether positive expiratory pressure (PEP) by PEP flute self-care is effective in reducing respiratory symptoms among community dwelling adults with SARS-CoV-2 infection and early stage covid-19.

DESIGN: Non-drug, open label, randomised controlled trial.

SETTING: Capital Region and Region Zealand in Denmark from 6 October 2020 to 26 February 2021.

PARTICIPANTS: Community dwelling adults, able to perform self-care, with a new SARS-CoV-2 infection (verified by reverse transcription polymerase chain reaction tests) and symptoms of covid-19.

INTERVENTION: Participants were randomised to use PEP flute self-care in addition to usual care or have usual care only. Randomisation was based on permuted random blocks in a 1:1 ratio, stratified for sex and age (<60 or ≥60 years). The PEP self-care group was instructed to use a PEP flute three times per day during the 30 day intervention.

MAIN OUTCOME MEASURES: Primary outcome was a change in symptom severity from baseline to day 30, as assessed by the self-reported COPD (chronic obstructive pulmonary disease) assessment test (CAT), which was adjusted for baseline values and stratification factors. Participants completed the CAT test questionnaire every day online. Secondary outcomes were self-reported urgent care visits due to covid-19, number of covid-19 related symptoms, and change in self-rated health, all within 30-days' follow-up.

RESULTS: 378 participants were assigned to the PEP flute self-care intervention (n=190) or usual care only (n=188). In the PEP self-care group, the median number of days with PEP flute use was 21 days (interquartile range 13-25). For the intention-to-treat population, a group difference was observed in changes from baseline in CAT scores of -1.2 points (95% confidence interval -2.1 to -0.2; P=0.017) in favour of the PEP flute self-care group. At day 30, the PEP flute self-care group also reported less chest tightness, less dyspnoea, more vigour, and higher level of daily activities, but these differences were small, and no consistent effects were seen on the secondary outcomes. No serious adverse events were reported.

CONCLUSIONS: In community dwelling adults with early covid-19, PEP flute self-care had a significant, yet marginal and uncertain clinical effect on respiratory symptom severity, as measured by CAT scores.

TRIAL REGISTRATION: ClinicalTrials.gov NCT04530435.