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Ultrasound-guided percutaneous irrigation of calcific tendinopathy outside the rotator cuff: short-term evaluation

Skeletal Radiol. 2022 Apr 2. doi: 10.1007/s00256-022-04035-3. Online ahead of print.

ABSTRACT

RATIONALE AND OBJECTIVES: While ultrasound-guided percutaneous irrigation for painful calcific tendinopathy (US-PICT) is the treatment of choice for the rotator cuff, there is a lack of knowledge regarding the treatment of this condition with atypical location. The purpose of our study is to assess if US-PICT can be applied safely and successfully in atypical sites, outside of the rotator cuff.

MATERIALS AND METHODS: We retrospectively reviewed the US-PICT performed outside the rotator cuff, in the last 5 years in a single institution. A total of 16 patients have been included in this study. We collected the values of the numerical rating scale (NRS) for pain pre- and post-procedure (7 days and 3-month follow-up). Moreover, we assessed the imaging studies available pre- and post-procedure (ultrasound and plain radiography) to assess complications.

RESULTS: In all the 16 patients (10F, 6 M; mean age 50.2; range 24-65-year-old), no complications have been observed during and after the procedures. The mean pain NRS before treatment was 8.7 (range 10-6) and dropped to 1.1 (6-0) after 1 week as well after 3 months 1.1 (6-0). The NRS pain reduction from baseline resulted to be statistically significant after 7 days and 3 months (p < 0.001).

CONCLUSION: Our results suggest the safety and efficacy of this procedure, underlining the great potential of US-PICT applied even in different atypical locations.

PMID:35366095 | DOI:10.1007/s00256-022-04035-3

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Acceptability of the ‘Crisis Toolbox’: a skills-based intervention delivered in a Crisis Resolution and Home Treatment Team during COVID-19

Community Ment Health J. 2022 Apr 2. doi: 10.1007/s10597-022-00963-5. Online ahead of print.

ABSTRACT

Crisis Resolution and Home Treatment Teams (CRHTTs) provide 24-hour, seven day per week support for people in crisis. The COVID-19 pandemic has placed significant demand on urgent care and increased the need for brief interventions in CRHTT settings with flexible methods of delivery. This evaluation aimed to examine client satisfaction with the ‘Crisis Toolbox’ (CTB), a brief, skills-based intervention delivered in one CRHTT during COVID-19. All participants who received the CTB completed a satisfaction questionnaire. Descriptive statistics were calculated to quantify acceptability and qualitative themes were generated using thematic analysis. Fifty-eight people participated, all of whom reported high levels of satisfaction with the CTB. Four qualitative themes also emerged relating to ‘Active ingredients of the CTB’, ‘The therapeutic relationship’, ‘Service-user preferences’ and ‘Expectations and continuity of care’. The CTB appears to be a valued intervention. Further research is now needed to assess its clinical impact and effect on operational indicators.

PMID:35366118 | DOI:10.1007/s10597-022-00963-5

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Transosseous repair with a cortical implant for greater tubercle cyst-related rotator cuff tear results in good clinical outcomes, but significant implant migration

Knee Surg Sports Traumatol Arthrosc. 2022 Apr 2. doi: 10.1007/s00167-022-06958-9. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate whether an arthroscopic transosseous technique (ATO) with cortical implants is effective for rotator cuff tear (RCT) repair in patients with cysts of the greater tuberosity (GTC).

METHODS: Patients treated with the ATO technique between January 2013 and October 2017 were evaluated. Inclusion criteria were patients treated for both cyst-related and non-cyst-related RCTs and patients with a moderate-sized tear (1-3 cm) according to the DeOrio and Cofield classification. A total of 39 patients were separated into two groups: Group 1 (n = 16) patients with cyst-associated RCT, and Group 2 (n = 23) patients with no cyst. Implant pull-out and migration were evaluated radiologically on standard antero-posterior shoulder radiographs and rotator cuff re-tear was assessed on magnetic resonance images at the final follow-up examination. Group 1 patients were separated into two subgroups according to cyst size (cyst < 5 mm and cyst ≥ 5 mm) and subgroup analysis was performed. Clinical assessment was performed using a visual analog scale, the Constant score and Oxford shoulder score.

RESULTS: The mean follow-up time was 33.7 ± 11.7 months. The mean cyst size was 5.4 ± 1.5 mm. There was no significant difference in re-tear rates between the cystic and non-cystic groups. The mean implant migration distance was 3.0 ± 2.2 mm in patients with a RCT -related cyst and 0.7 ± 0.8 mm in those without a cyst. A statistically significant difference was found between the groups (p = 0.002). There was no statistically significant difference between the groups in respect of clinical scores. No implant failure was observed.

CONCLUSION: The ATO method performed with a cortical implant in RCTs resulted in satisfactory recovery and clinical outcomes in the short to medium term with low failure rates. While no implant failures were observed, implant migration was associated with cyst presence. Therefore, judicious use is advocated in the choice of transosseous fixation for cyst-related RCTs and patients should be informed of the possibility of implant migration.

LEVEL OF EVIDENCE: III.

PMID:35366077 | DOI:10.1007/s00167-022-06958-9

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Efficacy and safety exposure-response relationships of apalutamide in patients with metastatic castration-sensitive prostate cancer: results from the phase 3 TITAN study

Cancer Chemother Pharmacol. 2022 Apr 2. doi: 10.1007/s00280-022-04427-1. Online ahead of print.

ABSTRACT

PURPOSE: Apalutamide plus androgen-deprivation therapy (ADT) has been approved for treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) based on data from phase 3 TITAN study. This analysis was conducted to describe pharmacokinetics of apalutamide and N-desmethyl-apalutamide and explore relationships between apalutamide exposure and selected clinical efficacy and safety observations.

METHODS: 1052 patients were randomized to apalutamide + ADT (n = 525) or placebo + ADT (n = 527). A previously developed population pharmacokinetic model was applied. Cox regression analysis investigated the relationships between apalutamide exposure and overall survival (OS; n = 1004) and radiographic progression-free survival (rPFS; n = 1003). Logistic regression analysis assessed the relationships between apalutamide exposure and selected clinically relevant adverse events (n = 1051).

RESULTS: Apalutamide + ADT treatment was efficacious in extending rPFS and OS versus placebo + ADT. Within a relatively narrow apalutamide exposure range (coefficient of variation: 22%), no statistical association was detected between rPFS, OS and apalutamide exposure quartiles. Incidence of skin rash and pruritus increased significantly with increasing apalutamide exposure.

CONCLUSIONS: Differences in apalutamide exposure were not associated with clinically relevant differences in rPFS or OS in patients with mCSPC. Patients with increased apalutamide exposure are more likely to develop skin rash and pruritus. Dose reductions may improve these adverse events, based on an individual risk-benefit approach.

PMID:35366072 | DOI:10.1007/s00280-022-04427-1

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Contrast study after gastric repair: a review of incidence, outcomes and risk factors at an adult level 1 trauma center

Eur J Trauma Emerg Surg. 2022 Apr 2. doi: 10.1007/s00068-022-01949-4. Online ahead of print.

ABSTRACT

PURPOSE: The role of contrast study after traumatic gastric repair, continues to be controversial. To that end, we aim to review the incidence, outcomes, and risk factors of patients undergoing contrast study after traumatic gastric repair.

METHODS: This was a retrospective review of all trauma patients admitted to a level 1 trauma center that sustained gastric injuries with subsequent repair between 2011 and 2018. Demographics, surgical interventions, complications, and clinical outcomes were evaluated. Statistical analysis included Chi-square/Fisher exact univariate analysis and multivariate logistic regression analysis with a 5% significance level.

RESULTS: A total of 233 patients received a gastric repair, of whom 49 (21%) had a contrast study performed. Out of 49 patients with a contrast study, one was found to have a gastric leak. Mean time to contrast study was 6.3 ± 2.7 days. There was no statistically significant difference in post-operative complications between non-contrast and contrast study groups. Multivariate logistic regression analysis demonstrated a lack of statistical significance in clinical risk factors that would lead to obtaining a contrast study.

CONCLUSION: Gastric leak after repair is rare and there is no statistically significant difference in clinical outcomes when comparing patients who underwent contrast study to those who did not. Routine contrast study after traumatic gastric repair may not be necessary and further evidence is warranted to determine the risk factors for a selective contrast study.

PMID:35366067 | DOI:10.1007/s00068-022-01949-4

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A risk classification model for prioritising the management of quality issues relating to substandard medicines in Singapore

Pharmacoepidemiol Drug Saf. 2022 Apr 2. doi: 10.1002/pds.5434. Online ahead of print.

ABSTRACT

BACKGROUND: Monitoring for substandard medicines by regulatory agencies is a key post-market surveillance activity. It is important to prioritise critical product defects for review to ensure that prompt risk mitigation actions are taken.

METHODS: A regulatory risk impact prioritisation model for product defects (RISMED) with 11 factors considering the seriousness and extent of impact of a defect was developed. The model generated an overall score that categorised cases into high, medium or low impact. The model was further developed into a statistical risk scoring model (stat-RISMED) using multivariate logistic regression that classified cases into high and non-high impact. Both models were evaluated against an expert-derived gold standard annotation corpus and tested on an independent dataset.

RESULTS: Product defect cases received from January 2011 to June 2020 (n = 660) were used to train stat-RISMED and cases from July 2020 to June 2021 (n = 220) for validation. The stat-RISMED identified four factors associated with high impact cases, namely defect classification based on MedDRA-HSA terms, therapeutic indication of product, detectability of defect and whether any overseas regulatory actions were performed. Compared to RISMED, stat-RISMED achieved an improved sensitivity (94% vs 42%) and positive predictive value (47% vs 43%) for the identification of high impact cases, against the gold standard labels.

CONCLUSIONS: This study reported characteristics that predicts cases with high impact, and the use of a statistical model to identify such cases. The model may potentially be applied to prioritise product defect issues and strengthen overall surveillance efforts of substandard medicines. This article is protected by copyright. All rights reserved.

PMID:35366030 | DOI:10.1002/pds.5434

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Assessing severe acute respiratory syndrome coronavirus 2 infectivity by reverse-transcription polymerase chain reaction: A systematic review and meta-analysis

Rev Med Virol. 2022 Apr 2:e2342. doi: 10.1002/rmv.2342. Online ahead of print.

ABSTRACT

The cornerstone of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection is reverse-transcription polymerase chain reaction (RT-PCR) of viral RNA. As a surrogate assay SARS-CoV-2 RNA detection does not necessarily imply infectivity. Only virus isolation in permissive cell culture systems can indicate infectivity. Here, we review the evidence on RT-PCR performance in detecting infectious SARS-CoV-2. We searched for any studies that used RT-PCR and cell culture to determine infectious SARS-CoV-2 in respiratory samples. We assessed (i) diagnostic accuracy of RT-PCR compared to cell culture as reference test, (ii) performed meta-analysis of positive predictive values (PPV) and (iii) determined the virus isolation probabilities depending on cycle threshold (Ct) or log10 genome copies/ml using logistic regression. We included 55 studies. There is substantial statistical and clinical heterogeneity. Seven studies were included for diagnostic accuracy. Sensitivity ranged from 90% to 99% and specificity from 29% to 92%. In meta-analysis, the PPVs varied across subgroups with different sampling times after symptom onset, with 1% (95% confidence interval [CI], 0%-7%) in sampling beyond 10 days and 27% (CI, 19%-36%) to 46% (CI, 33%-60%) in subgroups that also included earlier samples. Estimates of virus isolation probability varied between 6% (CI, 0%-100%) and 50% (CI, 0%-100%) at a Ct value of 30 and between 0% (CI, 0%-22%) and 63% (CI, 0%-100%) at 5 log10 genome copies/ml. Evidence on RT-PCR performance in detecting infectious SARS-CoV-2 in respiratory samples was limited. Major limitations were heterogeneity and poor reporting. RT-PCR and cell culture protocols need further standardisation.

PMID:35366033 | DOI:10.1002/rmv.2342

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Mitral valve repair versus replacement in severe ischemic mitral regurgitation systematic review and meta-analysis

J Card Surg. 2022 Apr 2. doi: 10.1111/jocs.16477. Online ahead of print.

ABSTRACT

BACKGROUND AND AIM: Ischemic mitral regurgitation (IMR) is a serious consequence of coronary artery disease. The choice of the optimal surgical strategy remains debatable. The aim of the present meta-analysis is to compare the outcomes of mitral valve repair (RPR) versus replacement (RPL) regarding perioperative mortality, overall mortality, reoperation, recurrence of MR, and reverse remodeling after surgery.

METHODS: Electronic searches were performed using the searchable databases of Google Scholar, Pubmed, and Embase, and the search terms mitral valve, IMR, RPR, RPL, and coronary artery bypass grafting. The main outcomes of interest are perioperative mortality, overall mortality, reoperation, recurrence of MR, and reverse remodeling after surgery. Perioperative mortality was defined as death during the surgery or within 30 days after the operation.

RESULTS: There was a trend towards better perioperative survival in the RPR arm. However, the difference fell short of statistical significance [odds ratio (OR) (95% confidence interval [CI]): 0.66 (0.41-1.07), p = 0.09]. Patients submitted to RPR experienced a significantly higher MR recurrence rate when compared with their counterparts submitted to RPL [OR (95% CI): 16.8 (5.07-55.7, p = 0.00001)].

CONCLUSION: There is a trend towards lower perioperative mortality in RPR in comparison to RPL. On the other hand, RPL was associated with significantly lower recurrence rates.

PMID:35366026 | DOI:10.1111/jocs.16477

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Albumin/fibrinogen ratio, an independent risk factor for postoperative delirium after total joint arthroplasty

Geriatr Gerontol Int. 2022 Apr 1. doi: 10.1111/ggi.14381. Online ahead of print.

ABSTRACT

AIM: Postoperative delirium (POD) is a very common and serious complication after total joint arthroplasty (TJA), which is closely associated with many adverse consequences and a poor prognosis. This study aimed to establish the potential risk factors for POD.

METHODS: In total, 336 patients who underwent elective TJA under general anesthesia between 2018 and 2021 were included and deemed eligible for inclusion. POD was diagnosed based on the criteria by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM V). The receiver operating characteristic curve was drawn to evaluate the predictive and cut-off values of continuous variables for POD. Potential risk factors for POD were evaluated by binary univariate and multivariate analysis with the “Enter” method.

RESULTS: According to the criteria by DSM V, 43 patients were categorized into the POD group, with an incidence of 12.8% (43 of 336). The receiver operating characteristic curve showed that albumin/fibrinogen ratio (AFR) was a good predictor for POD with an area under the curve of 0.754, cut-off value of 9.65, sensitivity of 57.00% and specificity of 83.72% (P <0.001). A low preoperative AFR level (<9.65) was determined as the only independent risk factor for POD by the univariate and multivariate logistic regression analyses (OR: 2.45, 95% CI: 2.01-2.94, P = 0.008).

CONCLUSIONS: Our results indicate that a low AFR is an independent risk factor for POD in elderly subjects after TJA. Geriatr Gerontol Int 2022; ••: ••-••.

PMID:35365967 | DOI:10.1111/ggi.14381

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Impact of early postoperative creatinine increase on mid-term renal function after cystectomy

Int J Urol. 2022 Apr 1. doi: 10.1111/iju.14879. Online ahead of print.

ABSTRACT

OBJECTIVES: To determine whether early acute kidney injury affects mid-term renal function, to identify risk factors for impaired mid-term renal function, and to highlight the evolution of plasma creatinine and estimated glomerular filtration rate in the first 12 months after cystectomy and urinary diversion.

METHODS: We conducted a single-center retrospective observational cohort study from 2000 to 2019. We included 900 consecutive patients undergoing cystectomy and urinary diversion. Patients with incomplete data and preoperative hemodialysis were excluded. Early acute kidney injury was defined as an increase in plasma creatinine of >50% or >26.5 μmol/L within 24 h after surgery. Multiple linear regression analysis was performed to model the association between risk factors and change in plasma creatinine and estimated glomerular filtration rate at 12 months.

RESULTS: Early acute kidney injury was diagnosed in 183/900 patients (20.3%) and was associated with significant mid-term plasma creatinine increase compared to preoperative value (+10.0 μmol/L [95% confidence interval -1.5, 25.0] vs +4.0 μmol/L [-7.0, 13.0]; P < 0.001). Similarly, a significant estimated glomerular filtration rate change was found (-11.2 mL/min [95% confidence interval -19.8, 0.6] vs -4.9 mL/min [-15.6, 5.3]; P < 0.001). In the linear regression model, early acute kidney injury increased creatinine at 12 months by 9.8% (estimated glomerular filtration rate: decrease by 6.2 mL/min), male sex by 12.0%. Limitations include retrospective analysis from prospectively assessed data.

CONCLUSIONS: Early acute kidney injury resulted in elevated plasma creatinine and decreased estimated glomerular filtration rate values 12 months postoperatively, albeit the clinical relevance remains questionable.

PMID:35365891 | DOI:10.1111/iju.14879