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Effectiveness and cost-effectiveness of a people-centred care model for community-living older people versus usual care ─ A randomised controlled trial

Res Social Adm Pharm. 2021 Jul 30:S1551-7411(21)00283-7. doi: 10.1016/j.sapharm.2021.07.025. Online ahead of print.

ABSTRACT

BACKGROUND: There is a need for effective and cost-effective interprofessional care models that support older people to maintain their quality of life (QoL) and physical performance to live longer independently in their own homes.

OBJECTIVES: The objectives were to evaluate effectiveness, QoL and physical performance, and cost-utility of a people-centred care model (PCCM), including the contribution of clinically trained pharmacists, compared with that of usual care in primary care.

METHODS: A randomised controlled trial (RCT) with a two-year follow-up was conducted. The participants were multimorbid community-living older people, aged ≥75 years. The intervention comprised an at-home patient interview, health review, pharmacist-led clinical medication review, an interprofessional team meeting, and nurse-led care coordination and health support. At the baseline and at the 1-year and 2-year follow-ups, QoL (SF-36, 36-Item Short-Form Health Survey) and physical performance (SPPB, Short Performance Physical Battery) were measured. Additionally, a physical dimension component summary in the SF-36 was calculated. The SF-36 data were transformed into SF-6D scores to calculate quality-adjusted life-years (QALYs). Healthcare resource use were collected and transformed into costs. A healthcare payer perspective was adopted. Incremental cost-effectiveness ratio (ICER) was calculated, and one-way sensitivity analysis was performed.

RESULTS: No statistically or clinically significant differences were observed between the usual care (n = 126) and intervention group (n = 151) patients in their QoL; at the 2-year follow-up the mean difference was -0.02, (95 % CI -0.07; 0.04,p = 0.56). While the mean difference between the groups in physical performance at the 2-year follow-up was -1.02, (-1.94;-0.10,p = 0.03), between the physical component summary scores it was -7.3, (-15.2; 0.6,p = 0.07). The ICER was -73 638€/QALY, hence, the developed PCCM dominated usual care, since it was more effective and less costly.

CONCLUSIONS: The cost-utility analysis showed that the PCCM including pharmacist-led medication review dominated usual care. However, it had no effect on QoL and the effect towards physical performance remained unclear.

PMID:34344607 | DOI:10.1016/j.sapharm.2021.07.025

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Early Albumin Exposure After Cardiac Surgery

J Cardiothorac Vasc Anesth. 2021 Jul 10:S1053-0770(21)00583-8. doi: 10.1053/j.jvca.2021.07.011. Online ahead of print.

ABSTRACT

OBJECTIVES: To determine whether the early use of albumin after cardiac surgery in the first 24 hours in the intensive care unit (ICU) is associated with reduced mortality.

DESIGN: A single-center nonrandomized retrospective cohort study using the Medical Information Mart in Intensive Care IV database.

SETTING: A single cardiothoracic ICU in the United States during a period between 2008 to 2019.

PARTICIPANTS: Patients undergoing valvular and/or cardiac bypass graft surgeries.

INTERVENTIONS: Albumin administered during the first 24 hours of the ICU admission.

MEASUREMENTS AND MAIN RESULTS: A total of 8,136 patients were included in this study, of whom 4,444 (54.6%) received albumin at any stage during the first 24 hours of ICU admission, and 69 (1.6%) of those patients died. The patient population exposed to albumin had higher comorbidities and illness severity compared to the no-albumin group. Patients exposed to albumin during the first 24 hours of ICU admission had a statistically significant reduction in mortality (odds ratio [OR], 0.68; 95% confidence interval [CI], 0.48-0.97, p < 0.05) after adjustment for age, the Oxford Acute Severity of Illness Score, and the Charlson comorbidity index. A sensitivity analysis of patients who received albumin at any stage during ICU admission showed increased mortality (OR, 1.93; 95% CI, 1.26-3.07, p < 0.01). Patients exposed to albumin had a significant increase in adjusted ICU length of stay (LOS) (geometric mean ratio 1.09; 95% CI, 1.05-1.10, p = < 0.001) and hospital LOS (geometric mean ratio 1.08; 95% CI, 1.05-1.10, p < 0.001).

CONCLUSIONS: Exposure to albumin in the first 24 hours after cardiac surgery is associated with a reduction in adjusted hospital mortality and an increase in both hospital and ICU lengths of stay.

PMID:34344597 | DOI:10.1053/j.jvca.2021.07.011

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Assessing the testicular sperm microbiome: a low-biomass site with abundant contamination

Reprod Biomed Online. 2021 Jun 29:S1472-6483(21)00305-9. doi: 10.1016/j.rbmo.2021.06.021. Online ahead of print.

ABSTRACT

RESEARCH QUESTION: The semen harbours a diverse range of microorganisms. The origin of the seminal microbes, however, has not yet been established. Do testicular spermatozoa harbour microbes and could they potentially contribute to the seminal microbiome composition?

DESIGN: The study included 24 samples, comprising a total of 307 testicular maturing spermatozoa. A high-throughput sequencing method targeting V3 and V4 regions of 16S rRNA gene was applied. A series of negative controls together with stringent in-silico decontamination methods were analysed.

RESULTS: Between 50 and 70% of all the detected bacterial reads accounted for contamination in the testicular sperm samples. After stringent decontamination, Blautia (P = 0.04), Cellulosibacter (P = 0.02), Clostridium XIVa (P = 0.01), Clostridium XIVb (P = 0.04), Clostridium XVIII (P = 0.02), Collinsella (P = 0.005), Prevotella (P = 0.04), Prolixibacter (P = 0.02), Robinsoniella (P = 0.04), and Wandonia (P = 0.04) genera demonstrated statistically significant abundance among immature spermatozoa.

CONCLUSIONS: Our results indicate that the human testicle harbours potential bacterial signature, though in a low-biomass, and could contribute to the seminal microbiome composition. Further, applying stringent decontamination methods is crucial for analysing microbiome in low-biomass site.

PMID:34344601 | DOI:10.1016/j.rbmo.2021.06.021

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Response to comments on the paper “serum uric acid is associated with incident hip fractures in women and men”

Maturitas. 2021 Jul 21:S0378-5122(21)00135-3. doi: 10.1016/j.maturitas.2021.07.008. Online ahead of print.

NO ABSTRACT

PMID:34344569 | DOI:10.1016/j.maturitas.2021.07.008

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Effects of body weight regain on leptin levels: A systematic review and meta-analysis

Cytokine. 2021 Jul 31:155647. doi: 10.1016/j.cyto.2021.155647. Online ahead of print.

ABSTRACT

BACKGROUND: There are different changes observed before and after diet therapy, and also after weight regain. However, there is not sufficient information regarding weight regain and hormonal changes.

PURPOSE: The purpose of this study was to review the connection between weight regain and leptin concentration levels.

METHODS: MEDLINE, SCOPUS, Web of Science, and the Cochrane Library were searched for interventional articles published from January 1, 1980, to June 30, 2020. Randomized clinical trials with parallel or cross over design assessing leptin concentrations at the baseline and at the end of study were reviewed. Two independent reviewers extracted data related to study design, year of publication, country, age, gender, body mass index (BMI), duration of the following up period and mean ± SD of other intended variables.

RESULTS: Four articles were included, published between 2004 and 2016. Three of them were conducted in the US and one of them in Netherland. Sample size of the studies ranged between 25 and 148 participants. The range of following up period was from13 to 48 weeks. The age range of participants was from 34 to 44 years. Our analysis shows that weight regain could reduce leptin levels, but this change is not statistically significant.

CONCLUSION: This review suggests that weight regain may induce a non-significant reduction in leptin level. However, the limited number and great heterogeneity between the included studies may affect the presented results and there are still need to well-designed, large population studies to determine the relationship between weight regain and leptin levels.

PMID:34344588 | DOI:10.1016/j.cyto.2021.155647

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High-risk HPV prevalence among women undergoing cervical cancer screening: Findings a decade after HPV vaccine implementation in British Columbia, Canada

Vaccine. 2021 Jul 31:S0264-410X(21)00868-9. doi: 10.1016/j.vaccine.2021.07.009. Online ahead of print.

ABSTRACT

BACKGROUND: British Columbia (BC) introduced a publicly funded, school-based human papillomavirus (HPV) immunization program in 2008 with the quadrivalent vaccine. In 2010/2011, a baseline evaluation of HPV prevalence was conducted among women undergoing cervical cancer screening. After 10 years of publicly funded HPV vaccination, HPV-type prevalence was re-evaluated.

METHODS: From August 2017 to March 2018, 1107 physicians were invited to return cytobrushes used during routine Pap screening to the Cervical Cancer Screening Laboratory for HPV testing. Only age or year of birth was collected. Specimens were screened for high-risk HPV (hrHPV) and positive samples were genotyped. HPV type prevalence was compared for females 15-22 yrs (those eligible for the school-based vaccination) and 23+ yrs (ineligible for school-based vaccination) for the 2010/2011 and the 2017/2018 data.

RESULTS: There were 3309 valid samples received for testing; of these, 3107 were included in the analysis. The overall hrHPV prevalence was 12.2% (95% CI 11.3-13.3) in 2010/11, and 12.0% (95% CI 10.9-13.2) in 2017/18. For the 15-22 age group, the prevalence for any hrHPV was 26.8% (95% CI 23.1-30.8) in 2010/11 and 25.4% (95% CI 15.3-37.9) in 2017/18. For those aged 15-22, HPV16 prevalence in 2010/11 was 8.8% (95% CI 6.5-11.5) and in 2017/18 was 6.3% (95% CI 1.8-15.5), with corresponding figures for HPV18 3.7% (95% CI 2.3-5.7) and 0% (95% CI 0.0-5.7), respectively. For all hrHPV types, there were no statistically significant differences between the 2010/11 and 2017/18 periods.

CONCLUSIONS: This study illustrates the prevalence of hrHPV in BC over time in women undergoing cervical cancer screening, where an indication of a decline in HPV16/18 is seen in vaccine eligible women.

PMID:34344555 | DOI:10.1016/j.vaccine.2021.07.009

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Effect of Acoustic Parameters and Microbubble Concentration on the Likelihood of Encapsulated Microbubble Coalescence

Ultrasound Med Biol. 2021 Jul 31:S0301-5629(21)00296-9. doi: 10.1016/j.ultrasmedbio.2021.06.020. Online ahead of print.

ABSTRACT

Microbubble contrast agents are commonly used for therapeutic and diagnostic imaging applications. Under certain conditions, these contrast agents can coalesce on ultrasound application and form larger bubbles than the initial population. The formation of large microbubbles potentially influences therapeutic outcomes and imaging quality. We studied clinically relevant ultrasound parameters related to low-pressure therapy and contrast-enhanced ultrasound imaging to determine their effect on microbubble coalescence and subsequent changes in microbubble size distributions in vitro. Results indicate that therapeutic ultrasound at low frequencies, moderate pressures and high duty cycles are capable of forming bubbles greater than two times larger than the initial bubble distribution. Furthermore, acoustic parameters related to contrast-enhanced ultrasound imaging that are at higher frequency, low-pressure and low-duty cycle exhibit no statistically significant changes in bubble diameter, suggesting that standard contrast ultrasound imaging does not cause coalescence. Overall, this work suggests that the microbubble coalescence phenomenon can readily occur at acoustic parameters used in therapeutic ultrasound, generating bubbles much larger than those found in commercial contrast agents, although coalescence is unlikely to be significant in diagnostic contrast-enhanced ultrasound imaging. This observation warrants further expansion of parameter ranges and investigation of resulting effects.

PMID:34344561 | DOI:10.1016/j.ultrasmedbio.2021.06.020

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Multimodal rheumatologic complex treatment in patients with spondyloarthritis – a prospective study

Eur J Intern Med. 2021 Jul 31:S0953-6205(21)00247-8. doi: 10.1016/j.ejim.2021.07.005. Online ahead of print.

ABSTRACT

INTRODUCTION: Aim of this study was to prospectively assess the effects of multimodal rheumatologic complex treatment (MRCT), a special concept of in-patient physical treatment (PT) for treating spondyloarthritis (SpA), namely radiographic (r-) and non-radiographic (nr-) axial (ax-) SpA and psoriatic arthritis (PsA).

METHODS: r-, nr-axSpA and PsA patients receiving a 16-day MRCT were eligible. MRCT was delivered to participants over 64 PT sessions of various modalities with a minimum of 1,400 min of treatment. Primary outcome was a change in pain levels measured on a numeric rating scale (NRS, 0 – 10) between baseline and discharge. Secondary outcomes were assessments of i) disease activity ii) functional disabilities iii) serum cytokine levels iv) analgesic usage v) patient global health assessment and patients’ satisfaction with their therapeutic response to MRCT from baseline to discharge and over a 12-week follow-up.

RESULTS: 50 patients completed the study and were analysed. Pain levels were improved significantly (p < 0.001, 95% confidence interval -2.25 to -0.8,). Further analyses revealed no influencing factors or relevant inter-group differences. Positive effects of MRCT lasted up to 12 weeks after discharge. Analgesic usage was reduced compared to baseline. Patient global health assessment continued to be improved throughout the whole follow-up. No MRCT-related harms were recorded.

CONCLUSION: MRCT as a multimodal treatment concept with a strong emphasis on PT reduces pain in SpA meaningfully and facilitates reduced analgesic usage.

PMID:34344550 | DOI:10.1016/j.ejim.2021.07.005

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Clinical performance of posterior monolithic zirconia implant-supported fixed dental prostheses with angulated screw channels: A 3-year prospective cohort study

J Prosthet Dent. 2021 Jul 31:S0022-3913(21)00361-9. doi: 10.1016/j.prosdent.2021.06.043. Online ahead of print.

ABSTRACT

STATEMENT OF PROBLEM: The choice of retention type of an implant-supported fixed dental prosthesis (FDP) becomes critical when the dental implant is not placed in a prosthetically ideal location. In recent years, computer-aided design and computer-aided manufacturing (CAD-CAM) technology has enabled the correction of the location of screw access hole depending on the clinical needs of the patient. However, how FPDs with angulated screw channels (ASCs) perform clinically is unclear.

PURPOSE: The purpose of this prospective clinical study was to evaluate the mechanical complications and crestal bone loss (CBL) when posterior monolithic zirconia implant-supported FDPs with an ASC are used.

MATERIAL AND METHODS: Participants (N=37) with a missing single posterior tooth or multiple teeth, sufficient bone height, and an implant site without infection were included. Each participant received parallel-walled implants (Nobel Parallel CC) of 7-, 8.5-, or 10-mm length by using a 1-stage approach. After 4 months of healing, a conventional impression was made, and a digital workflow was followed. Monolithic zirconia restorations (Katana ML) were milled, stained, and mechanically attached to a titanium base (NobelProcera ASC abutment). CBL was measured from radiographs at 6, 12, 24, and 36 months after the placement of the prosthesis. Implant and prosthetic characteristics including implant diameter, implant length, screw channel angle (angle≤15 degrees versus angle>16 degrees), prosthetic type (single crown versus multiple-unit FDP), and antagonist dentition (natural versus prosthesis) were also recorded. A generalized linear mixed model with a log link was estimated to assess the independent predictors of CBL among the angles of ASC-retained definitive restorations and the clinically relevant variables (α=.05).

RESULTS: Thirty-seven participants received 51 implants, and the median follow-up period was 30 months (interquartile range: 22-36). Two single-crown implants failed within the first 12 months of delivery. The implant and restoration survival rate was 96% at 36 months. Screw loosening was recorded in 2 study participants. After a follow-up of 36 months, the mean ±standard deviation CBL value was 0.15 ±0.14 mm with an increase over time (P<.001). The effect of the angle of ASC, implant diameter, implant length, prosthetic type, and antagonist on the CBL was not statistically significant (P>.05).

CONCLUSIONS: CBL was not associated with the angle of ASC, implant diameter, implant length, prosthetic type, or antagonist when posterior monolithic zirconia implant-supported FDPs with ASCs were used. Screw loosening in 2 situations was the only mechanical complication during the first 3 years of service.

PMID:34344529 | DOI:10.1016/j.prosdent.2021.06.043

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Real-world incidence of symptomatic skeletal events and bone-modifying agent use in castration-resistant prostate cancer – an Australian multi-centre observational study

Eur J Cancer. 2021 Jul 31:S0959-8049(21)00369-5. doi: 10.1016/j.ejca.2021.06.005. Online ahead of print.

ABSTRACT

INTRODUCTION: Bone metastases occur frequently in castration-resistant prostate cancer (CRPC) and may lead to skeletal-related events (SREs), including symptomatic skeletal events (SSEs). Bone-modifying agents (BMAs) delay SREs and SSEs. However, the real-world use of BMAs is debated given the absence of demonstrated survival advantage and potential adverse events (AEs). Our retrospective study examined BMA use and SSE rates in Australian patients with CRPC.

METHODS: Patients with CRPC and bone metastases were identified from the electronic CRPC Australian Database. Patient characteristics, treatment patterns and AEs were analysed. Descriptive statistics reported baseline characteristics, SSE rates and BMA use. Comparisons between groups used t-tests and Chi-square analyses. Overall survival was calculated by the Kaplan-Meier method.

RESULTS: A total of 532 eligible patients were identified with a median age of 73 years (range: 44-97 years). BMAs were prescribed in 232 men (46%), 183 of whom received denosumab. Patients receiving first-line docetaxel for CRPC were more likely to commence BMAs than those receiving abiraterone or enzalutamide (51% vs 31% vs 38%; p = 0.004). SSEs occurred in 148 men (28%), most commonly symptomatic lesions requiring intervention (75%). At the time of initial SSEs, only 28% were receiving BMAs. Patients treated at sites with lower BMA use (<median) had higher SSE rates (32% vs 22%, p = 0.019).

CONCLUSION: In our real-world cohort, SSEs occurred in almost one-third of patients with CRPC and bone metastases, whereas less than half of patients received BMAs. The lower rate of SSEs in treatment sites with increased BMA use supports their benefit in this setting.

PMID:34344533 | DOI:10.1016/j.ejca.2021.06.005