Post Follow-up Research Articles

Assessment of technical adequacy of sacral lateral branches cooled radiofrequency neurotomy

ObjectiveThere were two primary objectives of the study: 1. assessment of the association between diagnostic sacral lateral branches (SLB) blocks and the ensuing numbness in the middle cluneal nerves (MCN) distribution, irrespective of whether the patients had positive or negative responses to blocks. 2. If the consistency of this causal relationship was established, we wanted to investigate a further correlation - hypoesthesia from local anesthetic blocks vs. hypoesthesia from radiofrequency neurotomy (RFN) vs. outcomes. DesignThis is a prospective observational study of sixty consecutive patients with sacroiliac (SI) joint complex pain and failure of previous intraarticular SI joint injection. The patients who had two positive diagnostic SLB blocks defined as ≥ 75% reduction in NRS scores were treated with cooled RFN of the L5 dorsal ramus and S1–S3 lateral branches. The patients were interviewed and evaluated at a one-month post-neurotomy follow-up appointment. Seven patients were also evaluated at a six-month follow-up visit after the procedure. MethodsThe primary outcomes of the study were absence/presence of post-procedural buttock hypoesthesia after diagnostic blocks and absence/presence of post-procedural buttock hypoesthesia at one month after a cooled RFN procedure. The secondary outcome measures related to the effectiveness of this procedure and included: pre- and post-procedure NRS scores; ODI scores initially, and at post RFN follow-up; analgesic consumption initially, and at one-month RFN follow-up; patient satisfaction with the cooled RFN treatment. A procedure was considered categorically successful if the patient gained ≥50% pain relief and was satisfied with its results. Results81/84 (96.4%; 95% CI [89.9%, 99.3%]) of the diagnostic SLB blocks lead to temporary sensory deficit to pinprick in the MCN distribution. If the block was positive, 58/58 (100.00%; 95% CI [93.8, 100.00%]) of the procedures led to hypoesthesia. For negative diagnostic blocks, 3/26 (11.5%; 95% CI [2.4%, 30.2%]) procedures lead to no hypoesthesia. The buttock hypoesthesia persisted in all patients with successful cooled RFN one month after this intervention. Among the patients with unsuccessful RFN, only 2/9 (22.2%, 95%CI [2.8%, 60.0]) still had hypoesthesia, but the rest of this group had no sensory deficit on pinprick examination. At 6-months follow-up buttock hypoesthesia had no association with the success of the procedure.The patients' average NRS scores decreased from baseline 7.1 (SD 1.7) to 4.3 (SD 3.3) at 1-month follow-up after RFN. Categorical success, based on ≥50% pain relief coupled with patients' satisfaction, was achieved in 12/21 (57.1%; 95% CI [34.0%, 78.2%]) of the subjects. Average ODI percentage score decreased from 41.7% (SD 15.1%) to 31.8% (SD 17.8%) at the primary endpoint of the study. ConclusionMCNs provide regular and clinically detectable innervation to the skin area overlaying posterior-medial aspects of the gluteus maximums muscle. Therefore, any technically accurate diagnostic block, irrespective of whether the patients have positive or negative responses, should result in the development of hypoesthesia in the area supplied by the MCNs. Immediately after the completion of the diagnostic procedure, the adequacy of the block should be tested. Absence of hypoesthesia suggests that the block may have been technically inadequate. Numbness in the buttock area innervated by the MCNs may serve as a marker of an adequately performed RFN procedure. If this procedure is unsuccessful in patients who do not develop post-neurotomy numbness in the area supplied by the MCNs, the failure of the intervention may stem from its inaccurate implementation rather than from its inherent ineffectiveness.

Couples Therapy Delivered Through Videoconferencing: Effects on Relationship Outcomes, Mental Health and the Therapeutic Alliance.

Changing technology, and the pervasive demand created by a greater need in the population for access to mental health interventions, has led to the development of technologies that are shifting the traditional way in which therapy is provided. This study investigated the efficacy of a behavioral couples therapy program conducted via videoconferencing, as compared to face-to-face. There were 60 participants, in couples, ranging in age from 21 to 69 years old. Couples had been in a relationship for between 1 to 49 years. The 30 couples were randomly allocated to the face-to-face or videoconferencing group. They all took part in Couple CARE—a couples behavioral education program which promotes self-change in order to increase relationship satisfaction. The six session manualized intervention was offered in an identical manner to all clients, in each condition. Data analysis was based on several questionnaires completed by each couple at pre, post and 3-months follow-up. Results showed that therapeutic alliance ratings did not differ between groups, but increased significantly over time for both groups. Additionally, the results indicated improvements in relationship satisfaction, mental health, and all other outcome scores over time, which did not differ based on condition. This study uniquely contributes to the literature exploring the use of technology to provide therapy. Specifically, the study provides evidence for couples therapy via videoconferencing as a viable alternative to face-to-face interventions, especially for those couples who may not have access to the treatment they require. It is anticipated that the results of this study will contribute to the field of online therapy, and add to fostering confidence in agencies to allow expansion of services conducted via videoconferencing.

Status of Common Serum Minerals and Trace Elements in COVID-19 Follow-up Cases: A Hospital-based Study from Eastern India

Introduction: Management of post Coronavirus Disease-2019 (COVID-19) complications are the new challenges nowadays. It has been observed that in post COVID-19 cases the serum levels of several electrolytes and trace elements are deranged. Aim: This study was conducted to estimate the levels of different serum minerals and trace elements in one month post COVID-19 follow-up patients and compared with normal age- sex matched controls. Materials and Methods: This hospital based cross-sectional study was conducted in the Department of Biochemistry in a tertiary care centre, over a period of six months (from January 2021 to June 2021). After fulfilling proper inclusion criteria, 223 COVID-19 follow-up patients of both genders (134 males and 89 females) were included as ‘case’ group. Age-sex matched 250 healthy volunteers were recruited as ‘control’ group. Levels of serum electrolytes (sodium and potassium) and trace elements (zinc, iron, calcium, phosphate, copper, magnesium and selenium) were estimated, analysed and compared against each other. Tables and statistical analysis was done using Statistical Package for the Social Sciences (SPSS) version 20.0. Results: In this study, the levels of serum zinc and iron were found to be higher and serum calcium, phosphate, copper, magnesium and selenium levels were reduced in post COVID-19 one month follow- up cases in comparison to controls. Female cases were in deficient state of iron, calcium, copper and magnesium but had high serum zinc and phosphate when compared to males. No abnormalities were noted in the level of electrolytes in post COVID-19 cases. Conclusion: Assessment and monitoring of levels of the mineral throughout the course of post COVID-19 follow-up is advisable for timely and appropriate measures to combat with post COVID-19 complications.

Treatment feasibility and preliminary evaluation of group-delivered cognitive behavioral therapy for insomnia adapted for patients with bipolar and related disorders: A pragmatic within-group study

• CBT for insomnia is a feasible treatment in patients with bipolar disorder. • After treatment, insomnia severity is significantly reduced. • Reductions of sleep problem severity are maintained at three-month follow-up. Sleep disturbances, including insomnia, are common in bipolar disorder. Treatment of choice for insomnia is cognitive behavioral therapy (CBT-i), but evidence for CBT-i in patients with bipolar disorder is scarce. We investigated a group delivered treatment based on CBT-I; treatment feasibility in patients with bipolar and related disorders, and improvement in insomnia severity following treatment. This pragmatic within-group evaluation with a pre to post and three-month follow-up design was set at two psychiatric out-patient clinics specialized in bipolar and related disorders. As an adjunct to care-as-usual, the treatment was offered as six two-hour group sessions over eight weeks. Data were analyzed with intent-to-treat using hierarchical linear mixed models. Thirty-four patients (48 [range 19–72] years; 68% female) with bipolar and related disorders and sleep problems provided informed consent. Patients had suffered from sleep problems for 12.7 [range 0.3–65] years, 97% used sleep medications, 91% medicated for their primary disorder. Patient interest, attendance, dropout, satisfaction, credibility, and adverse events met feasibility criteria, and therapists endorsed the manual. Post-treatment, insomnia severity (Insomnia Severity Index; score range 0–28) had improved with 6.1 points (95% CI, 3.27–8.93, g = 1.11, p = 0.0001) and at three months with 7.0 points (95% CI, 4.03–9.97, g = 1.26, p < 0.0001) from pre-treatment. Lack of control group and no control for care-as-usual content. CBT-i adjusted for bipolar disorder delivered as a group treatment is promising for improving insomnia severity in patients with bipolar and related disorders and disturbed sleep.

Outcomes in HIV patients on two different protease inhibitors on second-line antiretroviral therapy: An observational study

Introduction: There were 38 million people living with HIV in the world in 2019, out of which 5.8 million were living within the Asia-Pacific region. Globally, 67% (25.4 million) and within the Asia-Pacific region, 60% (3.5 million) of the individuals living with HIV were accessing anti-retroviral therapy (ART) respectively. Approximately 4% of the patients on ART are on second-line therapy. The aim of this research was to analyze the difference in efficacy and tolerance of boosted lopinavir and boosted atazanavir as part of second-line ART regimens and factors associated with the difference. Materials and Methods: The observational study was conducted at a referral ART clinic of a tertiary care hospital in North India. This was an ambispective study on patients under evaluation for first-line treatment failure. One hundred and fifteen and sixty patients were recruited to lopinavir and atazanavir study groups, respectively. Efficacy was assessed by adequate suppression of plasma viral loads 12 months after starting therapy with protease inhibitors. Results: Both the regimens are highly effective in reducing viral loads. Regarding adverse drug reactions (ADRs), hyperlipidemia and abnormal liver function test (transaminitis) were the most common ADRs in the lopinavir study group, whereas nausea, fever, and indirect hyperbilirubinemia were the most common ADRs in the atazanavir study group. Conclusions: Lopinavir and atazanavir are both highly effective in reducing viral loads and produced comparable CD4 levels post 1-year follow-up.

P032 Clinical Usefulness of Double Balloon Enteroscopy in Patients With Established or Suspected Small Bowel Crohn's Disease.

The diagnosis of isolated small bowel Crohn's disease (CD) can be challenging. Symptoms are non-specific and both imaging and capsule endoscopy (CE) may be misleading as several diseases may mimic CD. Double balloon enteroscopy (DBE) allows a more extensive endoscopic and histologic evaluation of the small bowel. Our aim was to describe the diagnostic utility and impact of DBE on management of patients with known CD and in patients with suspected/rule-out CD. Retrospective review of our institution's DBE database from February 2009 to May 2013. Adult patients referred for DBE for further evaluation of known or suspected CD (due to symptoms, abnormal imaging and/or CE) were included. Patient demographics, clinical characteristics, imaging and CE results, prior DBE, indication for DBE, DBE findings, DBE adverse events, pathology findings, final diagnosis, treatment prior and post DBE and follow-up DBE were abstracted from the electronic medical record. A total of 108 patients were included, 61 (56%) females, mean age 52 years (range 20-83). Indications for DBE included: disease activity assessment/therapeutic in 10 patients with established diagnosis of CD and for diagnostic purposes in 98 patients with suspected CD (31 patients due to abnormal imaging, 29 due to abnormal CE and 26 due to both abnormal imaging and CE). Upper, lower, bidirectional upper and lower, and stomal DBE were performed in 21, 24, 62 and 1 patients, respectively. DBE revealed active disease in 8/10 patients with known CD with one patient undergoing dilation of a stricture. Changes in management were recommended for all patients with active disease - start thiopurine (2), optimize thiopurine dose (1), start biologics (3) change biologics (1), systemic steroids (1) and budesonide (1). The patient who underwent stricture dilation ultimately required surgery. A definitive diagnosis of CD (both endoscopic and histologic) was reached in only 39/98 (40%) patients who were referred for suspected CD. Changes in management were recommended in 32/39 (82%) patients. Interestingly, 24/98 patients had been diagnosed with CD at outside institutions and were recommended to initiate therapy for CD. Of these, CD was confirmed in only 15/24 (63%) patients. Adverse events included perforation in 1 patient (1%) who required surgical management and mouth swelling/abrasion in 3 patients (3%). Follow-up DBE to re-assess disease activity was performed in 10/49 (20%) patients with definitive diagnosis of CD, average time between procedures 4.5 years (range 0.7-11.6). One patient with CD was diagnosed with lymphoma 2.4 years after initial DBE. Changes in management were recommended in 6 patients: de-escalation of therapy (3, two underwent surgery), start thiopurine and/or biologic (2) and switch biologics (1). No complications were seen at follow-up DBE. DBE is a useful technique to confirm a diagnosis in patients who have suspected CD and can help establish a diagnosis of several diseases that may mimic CD on CT scan or CE. Additionally, DBE in patients with established diagnosis of small bowel CD is an effective tool to assess disease activity and guide therapy. Serious complications are infrequent.

Effect of Talent Management Training Program on Head Nurses Leadership Effectiveness

Background: Talent management is increasingly discussed in the human resource management and human resource development literature. It is a set of practices that are implemented in organizations and refers to how organizations attract, select, develop and manage employees in an integrated and strategic way. The study aim: To investigate the effect of talent management training program on head nurses leadership effectiveness. Research design: A quasi-experimental research design was utilized. Setting: The study was conducted at all inpatient units (medical surgical) and critical care units (N=15) Damanhour National Medical Institute (head nurses =120). Tools: Tool I: To assess head nurses’ knowledge regarding talent management (pre/posttest). Tool II: Talent management questionnaire; to assess talent management practices among head nurses. Tool III: Leadership effectiveness questionnaire: to assess leadership effectiveness among head nurses. Results: there is a highly statistically significant improvement in head nurse’s knowledge and practice regarding talent management in the post phase and follow-up phase compared to their pre-intervention. Conclusion: the application of the training program had a positive impact on enhancing head nurses’ knowledge and practice regarding talent management and also total leadership effectiveness level was improved markedly throughout program phases. Recommendations: Conduct a talent management workshop periodically for all head nurses as a refreshment course. Providing talent management programs and workshops for newly hired head nurse in the organization.

COVID-19 Vaccination after Allogeneic Stem Cell Transplantation: Real Word Data on Safety and Efficacy. a Single Center Experience.

IntroductionDifferent vaccines have been recently approved by FDA and EMA for the prevention of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, demonstrating a protection rate ranging from 60% to almost 95% in phase II/III trials. Immunocompromised patients, including those undergoing allogeneic stem cell transplantation (allo-SCT), were excluded from vaccine trials. While EBMT recommended the vaccination for transplanted patients, data concerning efficacy and safety in this particular setting are scarce. Since infections represent a relevant cause of transplant-related mortality and the treatment and management of SARS-CoV-2 infection in allo-SCT patients proved to be challenging and complex, we prospectively evaluated the safety and the development of protective response against SARS-CoV-2 vaccines in our allogeneic transplanted patients.Materials and MethodsStarting in March 2021, allogeneic stem cell transplanted patients with different hematological diseases underwent COVID-19 vaccination. Taking into account the EBMT recommendations, we considered patients suitable for vaccination when (1) they were at least 3-6 months after allo-SCT, (2) didn't have any graft versus host (GvHD) activity, and (3) received less than 0,5 mg/kg steroids as part of the immunosuppressive treatment. There was no recommendation for a specific type of vaccine, with the only exception for life-attenuated vaccines, which are mostly contraindicated in the post allo-SCT setting. Vaccinated patients were regularly monitored for the potential development of adverse events. The anti-SARS-CoV-2 Spike protein antibodies were measured in blood samples to assess the humoral response. In case of no response with undetectable anti-Spike antibodies 2 week after the second dose of vaccine, we repeated the measurements at regular intervals until week + 6-8 after the completion of vaccination. Patients with no measurable antibodies 8 weeks after completion of the vaccination were considered as no responders.ResultsBetween 03/2021 and 06/2021 a total of 83 patients underwent COVID-19 vaccination (including first and second dose) during the post allo-SCT follow-up. Patients' characteristics are listed in Table 1. Most patients (77%) received BNT162b2, while only a small subgroup (8%) underwent a mixed vaccination after a first dose of ChAdOx1-S. We considered the mixed vaccination mostly to maximize the response. Overall, the two vaccine doses were well tolerated, with only 5% of patients developing a reactivation of GvHD. No relevant grade 3 or 4 organ toxicities were observed. Overall, 66% of patients in our cohort showed a humoral response. The incidence of positive serology was lower in patients who underwent the vaccination within the first 18 months after allo-SCT (29% vs 83% for patients >18 months after allo-SCT, p< 0.001). In multivariate analysis other risk factors that were associated with poor or no response were lack of immune reconstitution (p< 0.001) and ongoing immunosuppressive therapy (p= 0.009). The age of patients at the time of vaccination, sex, intensity of conditioning regimen and the use of ATG did not prove to have an influence for a humoral response during the post-transplant follow up.DiscussionThe achievement of a protective immunity against SARS-CoV-2 represents a crucial event for a frail population, like allogeneic stem cell transplanted patients. So far and to our knowledge little is known about the safety and efficacy of the COVID-19 vaccination in this particular setting. Here, we report one of the first series of patients undergoing COVID-19 vaccination after allo-SCT. We demonstrated that a humoral response can be achieved, especially for those patients who are in the long-term follow-up, underwent immune reconstitution and are free from immunosuppressive drugs. For the other patients, who represent the frailer subgroup, in the absence of a documented immune response after 2 doses of vaccine, the option of a third dose in order to increase the probability of response should be evaluated in prospective clinical trials. [Display omitted] DisclosuresViardot: Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; F. Hoffmann-La Roche Ltd: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees; University Hospital of Ulm: Current Employment; Amgen: Membership on an entity's Board of Directors or advisory committees; Kite/Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees. Döhner: Roche: Consultancy, Honoraria; Agios: Consultancy, Honoraria, Research Funding; Astellas: Consultancy, Honoraria, Research Funding; Jazz: Consultancy, Honoraria, Research Funding; Novartis: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding; Ulm University Hospital: Current Employment; Abbvie: Consultancy, Honoraria, Research Funding; Oxford Biomedicals: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Astex: Consultancy, Honoraria; Amgen: Consultancy, Honoraria, Research Funding; AstraZeneca: Consultancy, Honoraria; Bristol Myers Squibb: Consultancy, Honoraria, Research Funding; Helsinn: Consultancy, Honoraria; Pfizer: Research Funding; Berlin-Chemie: Consultancy, Honoraria; Gilead: Consultancy, Honoraria; GEMoaB: Consultancy, Honoraria. Sala: Novartis: Consultancy, Honoraria; Celgene/BMS: Consultancy, Honoraria; Gilead: Consultancy, Honoraria; Jazz: Consultancy, Honoraria.

Assessment of stent optimization in clinical practice using optical coherence tomography: a multicentric observational study

Abstract Background Stent under-expansion obtained at the time of percutaneous coronary intervention (PCI) has been shown to be associated with worse outcomes. Purpose We sought to define OCT assessed optimal stent expansion index which associates with lower incidence of major adverse cardiac events (MACE) during follow-up in a sample of patients stented at five high volume centers of central Europe. Methods We analyzed 370 lesions stented during the period between 2012 and 2018, with their final procedural results imaged using optical coherence tomography (OCT). QIvus Research Edition v3.1 (Medis, Leiden, NL) was used for OCT analysis. The stented segment was split in two equal halves. Stent expansion index (SEI) was calculated for both halves separately by dividing minimum stent area by the mean reference lumen area [(proximal reference area + distal reference area)/2]. Smallest of the two prevailed as the SEI of that case. MACE during post-PCI follow-up was defined as composite of all-cause death, myocardial infarction, stent thrombosis and target lesion revascularization. Data is expressed as mean±SD or median (Interquartile range). Incidence of subsequent MACE is expressed as crude rates (%). Results A total of 316 cases (370 lesions), aged 64.6±11.7 years were included for OCT analysis. Of them, 78.8% were males, 22.8% were diabetics, 75.9% were hypertensives while 35.1% had family history of coronary artery disease. 38.0% of the cases had acute coronary syndrome at presentation. 62.4% of treated lesions were complex (Type B2/C). A mean of 1.11±0.34 stents/scaffolds were implanted per treated lesion. Analyzed segment length was 20.4 (15.17, 27.0) mm. Minimal stent area (MSA) in the overall stented segment was 6.02 mm2 (4.65, 7.93). Median stent expansion index (minimum) was 0.79 (0.71, 0.86). Median follow-up duration was 557 days (326, 1,096). 47 lesions (12.7%) suffered MACE during follow-up. Receiver operating characteristic (ROC) curve analysis using Youden's rule identified 0.84 as SEI cut-off powered to predict post-PCI MACE (AUC= 0.60, sensitivity= 0.85, specificity= 0.34). MACE was observed in 38/249 (15.3%) of lesions with SEI≤0.84 and in 9/121 (7.4%) of lesions with SEI&amp;gt;0.84 (p=0.03). Univariate regression analysis of MACE revealed significant association with SEI≤0.84 (OR=2.2, 95% CI=1.1–4.8, p=0.04) Adaptive Lasso regression identified SEI≤0.84 (OR=4.1, 95% CI=1.3–12.6, p=0.02) and coronary calcification at baseline (OR=2.7, 95% CI=1.1–6.6, p=0.03) as independent predictors of MACE during follow-up. Kaplan-meier curve for MACE free survival with optimal SEI (n=121) and sub-optimal SEI (n=249) subgroups using SEI cut-off of 0.84, however showed modest separation (p=0.11). Conclusions The present study identified SEI&amp;gt;0.84 associated with lower incidence of MACE as optimal cut-off in daily practice. Along with SEI of ≤0.84, coronary calcification was also significantly associated with MACE during post PCI follow-up. Funding Acknowledgement Type of funding sources: None.

Three good things in nature: a nature-based positive psychological intervention to improve mood and well-being for depression and anxiety

Purpose Visiting and connecting with nature through psychological interventions improves well-being within the general population. However, few such interventions have been conducted in clinically relevant populations. This paper aims to address this gap by investigating the effectiveness of a nature-based psychological intervention within a clinically relevant sample. Design/methodology/approach An experimental design using a noticing Three Good Things in Nature (TGTiN) task during a nature based or urban (control) walk was conducted with nature connectedness, well-being, positive and negative affect measured at baseline, post and six-week follow-up. Individuals living with depression and/or anxiety (n = 50; 39 having a diagnosis) were randomly allocated to 30 min walking in nature or urban environments for five consecutive days. Findings An ANCOVA, with age as co-variate, showed a significant effect of time by condition on all variables: nature connectedness ηp2 = 0.34; positive affect ηp2 = 0.42; negative affect ηp2 = 0.66; well-being ηp2 = 0.29. Post-hoc tests indicated a significant increase in nature connectedness and positive affect in the nature versus an urban walk at post and follow-up. Negative affect decreased in the nature walk at post intervention, while well-being was significantly greater in the nature walk at follow-up. Originality/value The TGTiN intervention effectively improves positive affect, and well-being in clinically relevant populations, although replication with a larger sample is warranted.

Standardized IGH-Based Next-Generation Sequencing for MRD Detection in Follicular Lymphoma

Introduction: MRD monitoring is of great value to determine the risk of relapse in patients with follicular lymphoma (FL).However, MRD assessment is mainly restricted to those 50-65% of patients harbouring a PCR-detectable t(14;18) rearrangement as clonal marker for RQ-PCR. Next generation sequencing (NGS) of immunoglobulin (IG) gene rearrangements might overcome limitations of current PCR-based approaches. Our aim was to test the stability and reproducibility of a standardized amplicon-based NGS approach developed by the EuroClonality-NGS Consortium to a): detect clonally rearranged IG clonotypes and b) to use IG-NGS for MRD quantitation in FL.Methods: Peripheral blood (PB) and bone marrow (BM) samples were collected within randomized trials of the German Low-Grade Lymphoma Study Group (GLSG) and Fondazione Italiana Linfomi treating first-line stage III/IV FL with combined immunotherapy regimen. At first we tested the applicability of NGS for MRD marker screening in randomly selected diagnostic samples from 100 patients (50 PB, 50 BM). Next, NGS-MRD was assessed by sequencing IGH clonotypes in 113 FL patients selected according to the presence of a clonal IGH rearrangement by consensus PCR at diagnosis and the availability of post induction follow-up samples for MRD. Paired-end libraries were prepared and sequenced on Illumina MiSeq (2 x 250bp). FU samples were spiked with predefined copy numbers of internal reference DNA to enable assessment of MRD by normalisation of NGS reads after sequencing. Identification of IGH clonotypes and quantitation of MRD was done with the bioinformatic analysis pipeline ARResT/Interrogate (Bystry, Bioinformatics, 2016). For clonotype identification we used a 5% threshold. For validation NGS results were compared to classical RQ-PCR with either t(14;18) RQ-PCR (n=38 pats.) or IGH ASO RQ-PCR (n= 32 pats.).Results: Marker screening by NGS detected clonal IGH-FR2 sequences with comparable frequency of 26/50 in PB and 24/50 BM samples. Additionally, IGK light chain clonotypes were detected with similar frequencies, thus leading to an IG clonotype being detected in 64% of samples.In the patient cohort analysed for MRD NGS identified an IGH clonotype in 105/113 diagnostic samples. MRD results by RQ-PCR were available in parallel from 70 patients. In 5/8 NGS-neg. diagnostic samples RQ-PCR demonstrated circulating FL cells above the quantitative range underlining the role of somatic hypermutation potentially resulting in false-negativity. At follow-up, 43/123 samples were MRD+ and 42 were MRD- by both methods. 32 were MRD+ by RQ-PCR only, 6 by NGS only. 16/32 NGS-/RQ-PCR+ samples showed low-level MRD below <1E-04 by RQ-PCR. MRD results determined by NGS were well correlated to RQ-PCR values (r2=0.599, p<0.00001).Correlation of NGS-MRD response with outcome in 43 patients from the GLSG cohort demonstrated that achievement of MRD response in PB and/or BM at end of induction is associated with a significantly longer median progression free survival of 11 years compared to 2.2 years for MRD+ patients (median follow-up 6.2 years, Figure 1).Conclusions: The standardized EuroClonality NGS approach shows robust identification of IGH clonotypes in FL patients allowing reliable MRD monitoring. Lymphoma infiltration of diagnostic samples and somatic mutation of IGH are critical points for clonotype identification by NGS. IG-NGS can complement current MRD methods allowing MRD assessment in the majority of FL patients. [Display omitted] DisclosuresPott:Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Membership on an entity's Board of Directors or advisory committees. Boccadoro:Novartis: Honoraria, Research Funding; Amgen: Honoraria, Research Funding; AbbVie: Honoraria; Mundipharma: Research Funding; Sanofi: Honoraria, Research Funding; Bristol-Myers Squibb: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Celgene: Honoraria, Research Funding. Kneba:AbbVie: Consultancy, Honoraria, Other: travel support, Research Funding; F. Hoffmann-LaRoche: Consultancy, Honoraria, Other: travel support, Research Funding; Gilead: Consultancy, Honoraria, Other: travel support, Research Funding; Janssen-Cilag: Consultancy, Honoraria, Other: travel support, Research Funding; Mundipharma: Consultancy, Honoraria, Other: travel support, Research Funding. Hoster:Roche: Other: Travel support, Research Funding.

Pilot randomized sham-controlled trial of self-acupressure to manage the symptom cluster of insomnia, depression, and anxiety in cancer patients undergoing chemotherapy.

Current evidence for using self-acupressure to manage the cancer-related symptom cluster of insomnia, depression, and anxiety, while promising, is unknown. This study evaluated the feasibility of self-acupressure to manage this symptom cluster and toexplore its potential effectiveness. Participants were assigned randomly to three study groups, namely the true acupressure (TAP), the sham acupressure (SAP), and the enhanced standard care group (ESC). Participants in the TAP and SAP groups received a training session on acupressure and were required to practice self-acupressure at home once per day for 28 days. The duration of participant involvement was 8 weeks. Patients completed a Numerical Rating Scale (NRS) for each symptom, the Insomnia Severity Index, the Hospital Anxiety and Depression Scale, and the Functional Assessment of Cancer Therapy-General at baseline (T1), post-intervention (T2, week 4), and post follow-up (T3, week 8). The results indicated that the intervention had clinical significance in improving the targeted symptoms and quality of life. In the TAP group, the symptom cluster severity was significantly lower than in the other groups at T2 (p < 0.05). The insomnia severity and anxiety scores in the TAP and SAP groups were significantly lower than those in ESC at T2 and T3 (p < 0.05). The trial was feasible. The promising results of the study suggest that further testing of self-acupressure is warranted to inform its effectiveness on the targeted symptom cluster in patients withcancer. A placebo effect was evident alongside therapeutic effects. ClinicalTrials.gov (ID: NCT03823456) on January 30th, 2019.

Effectiveness of Nursing Intervention Protocol on Nurses’ Performance and Patients’ Self-Care after Cataract Surgery

Context: Cataract is the leading cause of poor vision worldwide. Patients who knowledgeable and skillful nurses well prepare are better prepared to engage in appropriate self-care activities post-cataract surgery.&#x0D; Aim: This study aimed to assess the effectiveness of nursing intervention protocol on nurses' performance and patients’ self-care after cataract surgery.&#x0D; Methods: The study followed a quasi-experimental, pretest-posttest design. The study was conducted in ophthalmology surgical inpatient units and the outpatient clinics at Benha University Hospital. The sample consisted of all available nurses (35) working in the ophthalmology surgical inpatient units, and the outpatient clinics who are willing and agreed to participate in the study and a convenient sample consisted of 50 patients of both genders were also included in the current study before implementing nursing intervention protocol. Three tools were used to conduct the study: A structured interview questionnaire, nurses' practice checklist, and patients’ self-care activity checklist.&#x0D; Results: The results showed statistically significant improvements in nurses' performance (knowledge and practice) immediately post and one-month follow-up post-nursing intervention protocol compared with pre-nursing intervention protocol implementation (p&lt;0.001). General improvement in patients’ self-care activities (41.6±11.042) increased significantly to (64.2±13.65) after nursing intervention protocol implementation at p=0.001. However, after one month of implementing the nursing intervention protocol, a slight decline occurred after one month (52.46±10.97) compared to pre intervention level. Highly statistically significant differences were observed at a p-value ≤0.001.&#x0D; Conclusion: Findings of this study conclude that the nursing intervention protocol was effective in improving nurses' performance, which was reflected in improving the practice of patients' self-care activities cared for by nurses exposed to nursing intervention protocol implementation. It is recommended that further studies are suggested to investigate the outcome of the implementing nursing intervention protocol on decreasing the occurrence of complications post-cataract surgery.

Lung ultrasonography for long-term follow-up of COVID-19 survivors compared to chest CT scan

BackgroundWhile lung ultrasonography (LUS) has utility for the evaluation of the acute phase of COVID-19 related lung disease, its role in long-term follow-up of this condition has not been well described. The objective of this study is to compare LUS and chest computed tomography (CT) results in COVID-19 survivors with the intent of defining the utility of LUS for long-term follow-up of COVID-19 respiratory disease. MethodsProspective observational study that enrolled consecutive survivors of COVID-19 with acute hypoxemic respiratory failure (HARF) admitted to the Respiratory Intensive Care Unit. Three months following hospital discharge, patients underwent LUS, chest CT, body plethysmography and laboratory testing, the comparison of which forms the basis of this report. Results38 patients were enrolled, with a total of 190 lobes analysed: men 27/38 (71.1%), mean age 60.6 y (SD 10.4). LUS findings and pulmonary function tests outcomes were compared between patients with and without ILD, showing a statistically significant difference in terms of LUS score (p: 0.0002), FEV1 (p: 0.0039) and FVC (p: 0.012). ROC curve both in lobe by lobe and in patient's overall analysis revealed an outstanding ILD discrimination ability of LUS (AUC: 0.94 and 0.95 respectively) with a substantial Cohen's coefficient (K: 0.74 and 0.69). ConclusionsLUS has an outstanding discrimination ability compared to CT in identifying an ILD of at least mild grade in the post COVID-19 follow-up. LUS should be considered as the first-line tool in follow-up programs, while chest CT could be performed based on LUS findings.

Feasibility and effectiveness of transcatheter aortic valve implantation in adults with congenital heart disease

AimThis study sought to evaluate the feasibility and effectiveness of TAVI for treatment of aortic stenosis in the ACHD population. Methods and resultsReview of 802 patients that underwent TAVI from January 2008 to November 2019. 13 ACHD patients with different underlying congenital anatomy were identified (isolated bicuspid aortic valve was excluded and not defined as ACHD). The main endpoints were: paravalvular aortic regurgitation> grade 2 post-procedure, and all-cause 30-day mortality. Periprocedural and post-procedural complications were defined according to the UK TAVI registry. Median age was 66.7 years (range 29–84 years). Eleven patients had severe aortic stenosis (AS), 1 had both severe AS and severe aortic regurgitation (AR) and 1 had severe AR. Median hospital stay was 9 days (range 6–28 days). One patient required a pacemaker post-TAVI. No mortality or paravalvular AR > grade 2 at 30-days. Twelve patients had a reduction in NYHA class on their first post TAVI follow-up. ConclusionTAVI is viable option as an alternative to surgery for ACHD patients. Further experience with the use of TAVI in the ACHD patients is required to assess long-term outcomes in this unique group of patients.

Effect of NEuroplasticity-Principles-based SEnsory-Rehabilitation (NEPSER) on sensori-motor recovery in stroke: study protocol for a randomized controlled trial

IntroductionUp to 2/3rd of the stroke subjects may experience impairment in any of the somatosensory modalities such as light touch, proprioception, and stereognosis. The sensory recovery is strongly associated with the level of motor recovery. Very negligible sensory-based interventions have been developed and found to be evident in enhancing the sensory deficit and associated motor recovery. The possible factor for the ineffectiveness of these sensory interventions could be lack of the neuroscientific basis in formulation of the program. Thus, the objective of the study is to determine the effectiveness of a neuralplasticity-principles-based sensory-rehabilitation protocol on motor and sensory recovery, and disability of the post-stroke hemiparetic subjects.MethodsWe propose to recruit 122 poststroke subjects in a randomized controlled, assessor blinded trial to be conducted in a rehabilitation-institute. The key eligibility criteria is age between 20 to 80 years, hemiparesis (right or left), ischemic or hemorrhagic stroke, 1 to 12 months poststroke, and impairment in any of the sensory modalities. The participants in the experimental group will receive NEuroplasticity-Principles-based SEnsory-Rehabilitation (NEPSER) protocol comprising active, repetitive, and meaningful training of the specific sensory modalities utilizing visuo-perceptual, cognitive, motor, and functional tasks will be imparted for 8 weeks, 5 sessions / week, each of 2 h. The control subjects will undergo only standard rehabilitation based on neurophysiological, biomechanical, and rehabilitative approaches. All the participants will be assessed for motor (Fugl-Meyer assessment, upper extremity section) and sensory recovery [Nottingham Sensory assessment (Erasmus MC modification of the revised version)] at baseline, 8-week, and 12-week follow-up. The Semmes weinstein monofilament, two-point discrimination test and modified rankin scale (disability) will be applied as secondary measures. A repeated-measures 2-way ANOVA will be used to estimate difference for the post intervention and follow-up scores between the groups.PerspectiveThe proposed study will lead to development of a novel rehabilitation protocol that will not only enhance the sensory recovery but also the motor and functional recovery. This may reduce the impact of stroke disability and enhance the quality of life.Trial registrationThe trial has been registered under Clinical Trial Registry of India (CTRI) as CTRI/2019/09/021442 on 30th September 2019.

Role of Transtympanic Steroid in Sudden Sensorineural Hearing Loss: A Retrospective Study

Introduction: Sudden Sensorineural Hearing Loss (SNHL) is medical emergency in otology. The diagnosis and treatment of sudden SNHL remains a matter of discussion as no single treatment is gold standard. Antivirals, systemic and intratympanic steroids, vasodilators, antioxidants and hyperbaric oxygen therapy are a few treatment options for sudden SNHL. Aim: To assess role of transtympanic steroid in sudden SNHL cases in view of frequency specific gain and average hearing gain. Materials and Methods: A retrospective cross-sectional study was conducted in Otorhinolaryngology Department of a tertiary teaching hospital, in which records of total 27 patients with diagnosis of sudden SNHL from 1st January 2019 to 31st December 2020 were analysed. All enrolled patient underwent pure tone audiometry before treatment, after 3rd transtympanic injection and On 7th day follow-up. post follow-up. All patient received three transtympanic 0.5 mL methyl prednisolone injection on day 1, day 3 and day 5 of treatment. Pretreatment and post- treatment frequency specific hearing threshold and frequency specific hearing gain along with average hearing gain were assessed. Statistical analysis was done using student paired t-test independent t-test and one-way Analysis of Variance (ANOVA) test. Results: Total 35 case ears were analysed among 27 patients as 8 patients had bilateral sudden SNHL. Average gain for frequency 250 Hz, 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz were 18 dB, 25 dB, 27 dB, 28 dB and 30 dB, respectively. There was average 42% audiometric gain in hearing after transtympanic steroid injection. Cases who received treatment within four days had average gain of 48.5% while those who came after four days had average hearing gain of 39%. Hearing gain in &lt;40 years and &gt;40 years was 44.3% and 41.8% respectively. Hearing gain in bilateral ear was 42.9% and in unilateral ear was 43.5%. Conclusion: Sudden SNHL has high emotional and social impact on patient and family as it has influence on life quality. Transtympanic steroid injection promises good outcome in all patients with sudden SNHL. However, early diagnosis and early management of sudden SNHL is the key in significant success.

COVID-19 or Not, Breast Cancer Treatment Must Go On.

When at the end of last year Professor Traian Patrascu asked me to coordinate an issue of the journal "Chirurgia" dedicated to breast cancer, I was both surprised and intrigued. For two reasons: firstly it seemed to me so little time had passed since the previous issue about this disease and perhaps there weren't many new things to say and secondly I believed that the only topic worth discussing nowadays was the disease that overshadowed anything else: COVID-19. Nevertheless I realized that he was right. More than 3 years had passed since the previous issue and there were many updates related to this subject and COVID-19 or not, the treatment of breast cancer must continue. I am grateful to those who answered to my invitation to write an article. I was amazed by the huge number and the quality of the papers received. They were so numerous that we decided to have a supplement of the journal dedicated to breast cancer edited with the contribution of the Romanian Society of Breast Surgery and Oncology. The COVID-19 pandemic has affected the entire planet in almost every aspect of life, including the medical system. The treatment of other diseases, other than COVID-19, has in some way become secondary, at least for the time being. This had immediate repercussions and will inevitably have a long-term impact as well. Breast cancer patients suffered consequently. Screening, diagnosis, treatments including surgery and post therapeutic follow-ups have been profoundly affected by the pandemic.

Comparative Study of Efficacy and Safety of Coded Unani Formulations–UNIM-001+UNIM-003 with Methoxsalen in Cases of Bars (Vitiligo)

Background: Vitiligo is a common acquired disorder of skin depigmentation in varying patterns, varying from small maculae’s with scalloping borders to near total depigmentation of body. The prevalence of vitiligo in India has been invariably reported between 0.25% and 4% of dermatology outpatients across studies from India and up to 8.8% in Gujarat and Rajasthan. The study was conducted to compare the coded Unani formulation UNIM-001 (tablet) and UNIM-003 (ointment) with Melanocyl tablet (10mg each) (Methoxsalen) as standard control. Methodology: Sixty Five patients of trial group (UNIM-001+ UNIM-003) and sixty seven patients of control group (Comparator group) of 12-50 years of either sex were selected from patients attending the Out Patient Department (OPD), at RRIUM, Aligarh during 2015-18. The patients were treated for eight months with instructions and are followed every month for efficacy and safety of the drug(s). The CRF was maintained, and post treatmet followup was done at 3 months for the repigmentaion retained by the patient. Result: The UNIM-001 (tablets) and UNIM -003 (ointment) and standard control drug Melanocyl tablets (methoxsalen) showed same results and did not show any side effects. Conclusion: The trial drug and the standard control drugs both possess same anti- vitiligo efficacy and are also safe for the patients.

Approaches to Anti-Ageism Interventions

Ageism, a multidimensional construct, is also understood as a relational process whereby perceptions and behaviors toward older individuals by younger individuals not only damage the self-esteem of elders, but also create a hostile environment for their own future social interactions and their own future self-development as elders. Anti-ageism interventions have the hefty task of improving attitudes and behaviors toward aging within all of these contexts. This presentation will discuss findings from two different anti-ageism interventions both designed to mitigate the negative impacts of ageism. Results from a study on an intergenerational arts-based program found that after participation students demonstrated a positive change in their attitudes toward older adults. Findings from a video-based ageism intervention among a sample of 265 staff members in 15 senior living communities demonstrated decreased internalized aging anxiety as well as decreased ageist behaviors directly after the training and at three month post follow-up. Given the complex and systemic nature of ageism, diversity is necessary in scope and type of intervention in order to reach the broadest audience.