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Stepping into the real world: a mixed-methods evaluation of the implementation of electronic patient reported outcomes in routine lung cancer care

J Patient Rep Outcomes. 2022 Jun 20;6(1):70. doi: 10.1186/s41687-022-00475-6.

ABSTRACT

BACKGROUND: To realize the broader benefits of electronic patient-reported outcome measures (ePROMs) in routine care, we used the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework to inform the translation of a clinically effective ePROM system (hereafter referred to as the PRM system) into practice. The study aimed to evaluate the processes and success of implementing the PRM system in the routine care of patients diagnosed with lung cancer.

METHOD: A controlled before-and-after mixed-methods study was undertaken. Data sources included a self-report questionnaire and interviews with healthcare providers, electronic health record data for PRMs patients and historical controls, and field notes. Descriptive statistics, logistic regression modelling, negative binomial models, generalized estimating equations and repeated measures ANOVA were used to analyze quantitative data. Qualitative data was thematically analyzed.

RESULTS: A total of 48/79 eligible people diagnosed with lung cancer completed 90 assessments during the 5-month implementation period (RE-AIM reach). Every assessment breached the pre-defined threshold and care coordinators reviewed and actioned 95.6% of breaches, resulting in 146 referrals to allied health services, most frequently for social work (25.3%), dietetics (18.5%), physiotherapy (18.5%) and occupational therapy (17.1%). PRMs patients had significantly fewer visits to the cancer assessment unit for problematic symptoms (M = 0.23 vs. M = 0.43; p = 0.035), and were significantly more likely to be offered referrals (71% vs. 29%, p < 0.0001) than historical controls (RE-AIM effect). The levels of ‘organizational readiness for implementing change’ (ORIC) did not show much differences between baseline and follow-up, though this was already high at baseline; but significantly more staff reported improved confidence when asking patients to complete assessments (64.7% at baseline vs. 88.2% at follow-up, p = 0.0046), and when describing the assessment tool to patients (64.7% at baseline vs. 76.47% at follow-up, p = 0.0018) (RE-AIM adoption). A total of 78 staff received PRM system training, and 95.6% of the PRM system alerts were actioned (RE-AIM implementation); and all lung cancer care coordinators were engaged with the PRM system beyond the end of the study period (RE-AIM maintenance).

CONCLUSION: This study demonstrates the potential of the PRM system in enhancing the routine care of lung cancer patients, through leveraging the capabilities of automated web-based care options. Research has shown the clear benefits of using electronically collected patient-reported outcome measures (ePROMs) for cancer patients and health services. However, we need to better understand how to implement ePROMs as part of routine care. This study evaluated the processes and outcomes of implementing an ePROMs system in the routine care of patients diagnosed with lung cancer. Key findings included: (a) a majority of eligible patients completed the scheduled assessments; (b) patient concerns were identified in every assessment, and care coordinators reviewed and actioned almost all of these, including making significantly more referrals to allied health services; (c) patients completing assessments regularly were less likely to present to the cancer assessment unit with problematic symptoms, suggesting that ePROMs identified patient concerns early and this led to a timely response to concerns; (d) staff training and engagement was high, and staff reporting increased confidence when asking patients to complete assessments and when describing the assessment tool to patients at the end of the implementation period. This study shows that implementing ePROMs in routine care is feasible and can lead to improvements in patient care.

PMID:35723827 | DOI:10.1186/s41687-022-00475-6

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Ruyi Zhenbao Pills for Patients with Motor and Sensory Dysfunction after Stroke: A Double-Blinded, Randomized Placebo-Controlled Clinical Trial

Chin J Integr Med. 2022 Jun 20. doi: 10.1007/s11655-022-3577-9. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the efficacy and safety of Tibetan medicine Ruyi Zhenbao Pills (RZPs) in the treatment of patients with motor and sensory dysfunction after stroke.

METHODS: A total of 120 convalescent stroke patients hospitalized in the Rehabilitation Department of Guangdong Provincial Hospital of Chinese Medicine from June 2017 to December 2019 were enrolled in this trial. Patients were assigned to control (60 cases) and research (60 cases) groups by computer random assignment. All patients received internal treatment and modern rehabilitation training. On this basis, the research group was given oral RZPs for 4 weeks, while the control group was given oral placebo. The primary outcome was motor function of the affected side evaluated by simplified Fugl-Meyer Motion Assessment Scale (FMA-M). The secondary outcomes included sensory function, activity of daily living (ADL), quality of life, balance function, and pain, which were assessed by Fugl-Meyer Sensory Assessment Scale (FMA-S), Modified Barthel Index (MBI), Special Scale of the Quality of Life (SS-QOL), Berg Balance Scale (BBS), and Visual Analogue Scale (VAS), respectively. All of the assessments were performed before treatment, and 4 and 8 weeks after treatment. Vital signs, liver and kidney functions, routine blood test, blood coagulation profile, and routine urinalysis of patients were monitored.

RESULTS: After 4-week treatment, the FMA-M, BBS and FMA-S scores in the research group significantly increased compared with the control group (P<0.05). At 8-week follow-up, the BBS and MBI scores in the research group were higher than the control group (P<0.05). There was no statistical difference between the 2 groups in the SS-QOL and VAS scores at 4 and 8 weeks (P>0.05). Moreover, after treatment, there was no significant difference in vital signs, liver and kidney functions, blood coagulation function, blood routine and urinalysis between the 2 groups (P>0.05).

CONCLUSION: RZPs improved limb motor, balance, and sensory functions of stroke patients during recovery period with good safety. (Trial registration No. NCT04029701).

PMID:35723814 | DOI:10.1007/s11655-022-3577-9

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Decision quality and regret with treatment decisions in women with breast cancer: Pre-operative breast MRI and breast density

Breast Cancer Res Treat. 2022 Jun 20. doi: 10.1007/s10549-022-06648-7. Online ahead of print.

ABSTRACT

PURPOSE: We evaluated self-report of decision quality and regret with breast cancer surgical treatment by pre-operative breast MRI use in women recently diagnosed with breast cancer.

METHODS: We conducted a survey with 957 women aged 18 + with stage 0-III breast cancer identified in the Breast Cancer Surveillance Consortium. Participants self-reported receipt of pre-operative breast MRI. Primary outcomes were process measures in the Breast Cancer Surgery Decision Quality Instrument (BCS-DQI) (continuous outcome) and Decision Regret Scale (dichotomized outcome as any/none). Generalized estimating equations with linear and logit link were used to estimate adjusted associations between breast MRI and primary outcomes. All analyses were also stratified by breast density.

RESULTS: Survey participation rate was 27.9% (957/3430). Study population was primarily > 60 years, White, college educated, and diagnosed with early-stage breast cancer. Pre-operative breast MRI was reported in 46% of women. A higher proportion of women who were younger age (< 50 years), commercially insured, and self-detected their breast cancer reported pre-operative breast MRI use. In adjusted analysis, pre-operative breast MRI use compared with no use was associated with a small but statistically significantly higher decision quality scores (69.5 vs 64.7, p-value = 0.043). Decision regret did not significantly differ in women who reported pre-operative breast MRI use compared with no use (54.2% v. 48.7%, respectively, p-value = 0.11). Study results did not vary when stratified by breast density for either primary outcome.

CONCLUSIONS AND RELEVANCE: Breast MRI use in the diagnostic work-up of breast cancer does not negatively alter women’s perceptions of surgical treatment decisions in early survivorship.

CLINICAL TRIALS REGISTRATION NUMBER: NCT03029286.

PMID:35723793 | DOI:10.1007/s10549-022-06648-7

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Solvent screening, optimization and kinetic parameters of the biocatalytic epoxidation reaction of β-pinene mediated by Novozym®435

Biotechnol Lett. 2022 Jun 20. doi: 10.1007/s10529-022-03265-8. Online ahead of print.

ABSTRACT

Monoterpenes, such as beta-pinene, are secondary metabolites widely used in the flavors and fragrance industries and can have their structure altered to enhance their applicability, such as producing epoxides, which are used as intermediaries for pharmaceuticals. Epoxides are commonly synthesized by the use of inorganic acids as catalysts, although the acid medium induces epoxide degradation. To overcome these limitations biocatalysis is shown as an alternative. Related to, this work aimed to perform the synthesis of β-Pinene epoxide using Pseudozyma antarctica lipase B (Novozym®435) as a biocatalyst, while determining the independent variables that influence the reaction using experimental design tools. Different solvent systems were evaluated (cyclohexane, acetonitrile, ethyl acetate, and dichloromethane) until 72 h reaction time, from which ethyl acetate showed higher conversion into the epoxidized product (40% in 24 h). Under the other solvents systems, several oxidized by-products were obtained, such as ketones and aldehydes. Moreover, applying metrics of green chemistry, ethyl acetate was also corroborated as the most promising solvent, with a higher atom economy (66.8%) in comparison to the others (41.3%), and a smaller E-value (1.19). Ethyl acetate was the solvent/acyl donor of choice and had the molar ratio and percentage of biocatalyst increased, which resulted in 80% of the product after 3 h of reaction. To obtain an optimized model, four independent variables (temperature, stirring, molar ratio, percentage of biocatalyst) were evaluated using experimental design tools, Fractional Factorial Design and Central Composite Rotatable Design, with conversions ranging from 23 to 95% after 3 h. All the independent variables were statistically significant (p < 0.05) and had different degrees of impact on the conversion. Kinetic parameters of the reaction were determined using the Lineweaver-Burk model (results under 30.1 mmol for Km and 10.7 mmol.min-1 for Vmax). In conclusion, the combination of two different tools of experimental design provided the development of an optimized model for beta-Pinene epoxidation, achieving high conversion to the epoxidized product after 3 h.

PMID:35723788 | DOI:10.1007/s10529-022-03265-8

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The correlation between pseudoexfoliation syndrome and the Triglyceride-Glucose index

Graefes Arch Clin Exp Ophthalmol. 2022 Jun 20. doi: 10.1007/s00417-022-05737-z. Online ahead of print.

ABSTRACT

PURPOSE: Pseudoexfoliation (PEX) syndrome is an age-related disease characterized by the accumulation of extracellular material in many ocular structures, skin and internal organs. Recent studies have shown that the Triglyceride-Glucose (TyG) index has clinical importance for the evaluation of vascular damage. The purpose of this study was to determine the relationship between PEX syndrome and TyG index, and to detect the risk in terms of vascular diseases.

METHODS: In the present study, 50 patients with PEX syndrome who were admitted to the ophthalmology outpatient clinic were evaluated along with 50 others who made up the control group. The Triglyceride-Glucose index was calculated with fasting plasma glucose and triglyceride values.

RESULTS: The mean age was 68.2 ± 1.2 years and 61.0% of the patients were male. There was no statistically significant difference between the two groups in terms of blood sugar and lipid profile (except triglyceride) (p > 0.05). The TyG index value was 8.9 ± 0.5 in the PEX group and 8.6 ± 0.6 in the control group. This difference was statistically significant (p = 0.003). In univariate regression analysis, TyG index (OR = 2.81; CI: 1.37-5.75; p = 0.005) was found to be correlated with PEX. In multivariate logistic regression analysis, this correlation remained statistically significant when adjusted for age and sex (OR = 2.89; CI: 1.35-6.18; p = 0.006).

CONCLUSION: Results showed that the TyG index was high in patients diagnosed with PEX. The risk of vascular diseases can be determined by examining the TyG index in patients with PEX, and this predetermination would have significant consequences for public health.

PMID:35723782 | DOI:10.1007/s00417-022-05737-z

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Serum Amino Acid Profile Changes After Repetitive Breath-Hold Dives: A Preliminary Study

Sports Med Open. 2022 Jun 20;8(1):80. doi: 10.1186/s40798-022-00474-3.

ABSTRACT

BACKGROUND: The aim of this work was to investigate the serum amino acid (AA) changes after a breath-hold diving (BH-diving) training session under several aspects including energy need, fatigue tolerance, nitric oxide (NO) production, antioxidant synthesis and hypoxia adaptation. Twelve trained BH-divers were investigated during an open sea training session and sampled for blood 30 min before the training session, 30 min and 4 h after the training session. Serum samples were assayed for AA changes related to energy request (alanine, histidine, isoleucine, leucine, lysine, methionine, proline threonine, valine), fatigue tolerance (ornithine, phenylalanine, tyrosine), nitric oxide production (citrulline), antioxidant synthesis (cystine, glutamate, glycine) and hypoxia adaptation (serine, taurine).

MAIN RESULTS: Concerning the AA used as an energy support during physical effort, we found statistically significant decreases for all the investigated AA at T1 and a gradual return to the basal value at T2 even if alanine, proline and theonine still showed a slight significant reduction at this time. Also, the changes related to the AA involved in tolerance to physical effort showed a statistically significant decrease only at T1 respect to pre-diving value and a returned to normal value at T2. Citrulline, involved in NO production, showed a clear significant reduction both at T1 and T2. Concerning AA involved in endogenous antioxidant synthesis, the behaviour of the three AA investigated is different: we found a statistically significant increase in cystine both at T1 and T2, while glycine showed a statistically significant reduction (T1 and T2). Glutamate did not show any statistical difference. Finally, we found a statistically significant decrease in the AA investigated in other hypoxia conditions serine and taurine (T1 and T2).

CONCLUSIONS: Our data seem to indicate that the energetic metabolic request is in large part supported by AA used as substrate for fuel metabolism and that also fatigue tolerance, NO production and antioxidant synthesis are supported by AA. Finally, there are interesting data related to the hypoxia stimulus that indirectly may confirm that the muscle apparatus works under strong exposure conditions notwithstanding the very short/low intensity of exercise, due to the intermittent hypoxia caused by repetitive diving.

PMID:35723766 | DOI:10.1186/s40798-022-00474-3

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Food insecurity and health outcomes during the coronavirus pandemic in South Africa: a longitudinal study

Health Econ Rev. 2022 Jun 20;12(1):32. doi: 10.1186/s13561-022-00375-x.

ABSTRACT

BACKGROUND: Given that South Africa experienced significant food insecurity even before the COVID-19 pandemic, it is not surprising that the pandemic would result in even greater food insecurity in the country. This paper provides additional evidence on the relationship between food insecurity and health.

METHODS: Data came from the National Income Dynamics Study-Coronavirus Rapid Mobile Survey, a longitudinal survey of adult South Africans. Health was a self-reported indicator of general health, while food insecurity was measured by household hunger, the frequency of household hunger, and households running out of money to buy food. We performed descriptive and econometric analyses.

RESULTS: Food insecurity has remained high even in the face of greater re-opening of the economy. Moreover, among hunger-affected households, between a quarter and a third struggled with hunger almost daily or daily. Belonging to a hunger-affected household was associated with a 7-percentage point higher probability of worse health compared to not experiencing hunger. Compared to being unaffected by hunger, being hungry everyday was associated with a 15-percentage point higher probability of worse health in wave 1, an effect that became statistically insignificant by wave 4.

CONCLUSIONS: These results show the enormity of the hunger problem in South Africa and its adverse effects on health. In the face of economic uncertainty and the removal of COVID-19 palliatives like the grant top-ups, we enjoin policy makers to protect the vulnerable from food insecurity by continuing the implementation of anti-hunger policies and other measures that enhance food security in the country.

PMID:35723759 | DOI:10.1186/s13561-022-00375-x

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The diagnostic importance of periostin as a biomarker in chronic rhinosinusitis with nasal polyp

Eur Arch Otorhinolaryngol. 2022 Jun 20. doi: 10.1007/s00405-022-07492-7. Online ahead of print.

ABSTRACT

PURPOSE: The current studies in the literature report that periostin contributes to the formation of nasal polyps and may be a molecular biomarker for chronic rhinosinusitis with nasal polyps (CRSwNP). This study aims to investigate the effect of periostin in determining polyp burden in CRSwNP patients and evaluate its impact on postoperative surgical results and its functionality as a biomarker.

METHODS: The study included 26 patients who underwent endoscopic sinus surgery due to CRSwNP and 30 patients who were scheduled to undergo septoplasty due to isolated nasal septum deviation. We performed preoperative Lund-Mackay scoring and preoperative and postoperative SNOT-22 and Modified Lund-Kennedy scoring for the patients. Tissue and serum samples were collected from all patients in surgery and another serum sample was taken from CRSwNP patients at postoperative month 6.

RESULTS: Tissue eosinophil (p < 0.001), preoperative serum (p < 0.001), and tissue (p = 0.002) periostin were significantly higher in the CRSwNP group. We observed a statistically significant positive correlation between tissue eosinophil values and tissue periostin values in CRSwNP patients (p = 0.004). We found a statistically significant positive correlation between the tissue periostin values and postoperative SNOT-22 scores of the CRSwNP group patients (p = 0.005).

CONCLUSION: According to the results of our study, we think that periostin can be used as a biomarker in the prediction, determination of disease severity, and prognosis of CRSwNP. Comprehensive cohort studies with larger patient series are needed to provide more information on the role and effects of periostin in cases of CRSwNP undergoing surgical treatment.

PMID:35723731 | DOI:10.1007/s00405-022-07492-7

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Intracranial drainage versus extracranial shunt in the treatment of intracranial arachnoid cysts: a meta-analysis

Childs Nerv Syst. 2022 Jun 20. doi: 10.1007/s00381-022-05585-6. Online ahead of print.

ABSTRACT

OBJECTIVE: To review the literature and analyze the efficacy and safety of two surgery procedures, intracranial drainage and extracranial shunt, for intracranial arachnoid cysts.

METHODS: We searched the online Medlars, PubMed, and Cochrane Central electronic databases and collected studies of patients with intracranial arachnoid cysts treated with two surgical methods.

RESULTS: The meta-analysis results shows that there were not statistically significant in clinical symptoms improvement, cyst reduction, the improvement of epilepsy, epidural hematoma, cerebrospinal fluid leak, and recurrence rate (P > 0.05, with RR values are 0.99, 0.94, 1.00, 0.94, 1.21, and 0.75 respectively). There was statistically significant in the occurrence rate of intracranial infection (P = 0.0004, RR = 0.28). The intracranial drainage group was lower than extracranial shunt group.

CONCLUSION: The results indicated that the efficacy and safety of two surgery procedures are similar in the treatment of intracranial arachnoid cysts, but the intracranial drainage was better than extracranial shunt in reducing the risk of intracranial infection.

PMID:35723726 | DOI:10.1007/s00381-022-05585-6

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Randomized Clinical Trial of a Topical Botanical Patch for the Adjunctive Management of Periodontitis

Oral Health Prev Dent. 2022 Jun 20;20(1):253-262. doi: 10.3290/j.ohpd.b3147141.

ABSTRACT

PURPOSE: This randomized, controlled clinical trial aimed to evaluate the clinical, adjunctive effects of an approved botanical barrier device or patch on probing parameters in patients with periodontitis.

MATERIALS AND METHODS: Eighty patients with periodontitis were recruited for this single-blinded trial. Patient demographic data, including gender, age, self-reported smoking status, and history of diabetes or cardiovascular disease, were collected. At baseline, all patients received a full-mouth probing examination followed by scaling and root planing (SRP). Thereafter, patients were randomized to receive either adjunctive botanical patch applications (i.e. at 2-4 treatment sites with baseline pocket depth PD ≥6 mm) or no additional therapy (SRP alone, control). Patients applied botanical patch devices per randomization to treatment sites three times on day 0 and once daily on days 1-6. Study devices were spontaneously shed or removed by the patient at 2-2.5 h after each application. Patients were recalled for probing reexaminations at 1, 2 and 3 months. Statistical analyses focused on intergroup differences in probing parameters and included ANOVA for baseline measures and ANCOVA controlling for baseline measures at 1, 2 and 3 months in the overall population and in subpopulations (e.g. smokers vs nonsmokers).

RESULTS: Randomized patient groups were balanced with respect to baseline periodontal status (mean and extent PD) but not smoking, with statistically significantly more smokers clustering in the control group (p = 0.002). For the overall population and the non-smoking subpopulation, statistically significantly improved PD and clinical attachment levels (CAL) were observed with adjunctive botanical patch therapy vs control at 1 and 2 months (p < 0.05) but not 3 months (p = 0.08 for PD). For smokers, no statistically significant intergroup differences in PD or CAL were detected with botanical patch treatment.

CONCLUSIONS: The data from this trial indicate short-term improvements in probing parameters with the botanical patch device when used adjunctively with SRP, especially with non-smoking periodontitis patients.

PMID:35723714 | DOI:10.3290/j.ohpd.b3147141