Change In Treatment Plan Research Articles

Identifying strategies to support gynaecological cancer patients and carers during COVID-19: Learning from patient-charity interactions.

ObjectivesSupporting cancer patients during COVID‐19 has posed unique challenges for health care providers. We investigated patient and carer–charity interactions to explore the role of charities and identify concerns expressed by patients. The study aims to address these concerns and learn how health care providers can support patients.MethodsDigital interactions on forum posts and social media were collected from four gynaecological cancer charities from March‐May 2019 (before COVID‐19) and 2020 (during COVID‐19). Thematic analysis of forum posts and semistructured charity staff interviews investigated patient and charity‐focused perspectives.ResultsThematic analysis of forum posts and charity staff interviews (n = 8) revealed three consistent themes: (1) Health care changes and the effect on cancer management concerns; (2) psychological impact of lockdown isolation and anxiety of changed treatment; (3) the complexity of shielding guidance on self‐risk assessment. Patients valued cancer charities' responses through digital and conventional methods (webinars, social media, forums, and websites).ConclusionGynaecological cancer patients had concerns about the risk and impact of changed treatment plans, contacting charities as the first port of call when anxious not to burden health systems. Real‐time analysis of charities' communications can be used to identify concerns and to proactively provide patient support, together with health care providers.

Impact evaluation of a brief online training module on physician use of the Maryland, USA, Prescription Drug Monitoring Program.

BackgroundPrescription Drug Monitoring Programs (PDMPs) are electronic databases that track controlled substance prescriptions in a state. They are underused tools in preventing opioid abuse. Most PDMP education research measures changes in knowledge or confidence rather than behavior.ObjectiveTo evaluate the impact of online case-based training on healthcare provider use of the Maryland (USA) PDMP.MethodsWe used e-mail distribution lists to recruit providers to complete a brief educational module. Using a pre-training and post-training survey in the module, we measured self-reported PDMP use patterns and perceived PDMP value in specific clinical situations and compared pre- and post-training responses. Within the module, we presented three fictional pain cases and asked participants how they would manage each, both before, and then after presenting prescription drug history simulating a PDMP report. We measured changes in the fictional case treatment plans before and after seeing prescription history. Finally, we measured and compared how often each participant accessed the Maryland PDMP database before and after completing the educational module. We used multivariate logistic regression to measure the effect of the intervention on actual PDMP use frequency.ResultsOne hundred and fifty participants enrolled and completed the training module, and we successfully retrieved real-world PDMP use data of 137 of them. Participants’ decisions to prescribe opioids changed significantly after reviewing PDMP data in each of the fictional cases provided in the module. In the months following the training, the rate of PDMP use increased by a median of four use-cases per month among providers in practice for less than 20 years (p = 0.039) and two use-cases per month among infrequent opioid prescribers (p = 0.014).ConclusionA brief online case-based educational intervention was associated with a significant increase in the rate of PDMP use among infrequent opioid prescribers and those in practice less than 20 years.

Effectiveness of Topical ρ-Kinase Inhibitors in Veterans with Severe Glaucoma on Maximally Tolerated Medical Therapy.

The real-world pharmacological use of netarsudil shows that it can produce a clinically significant decrease in intraocular pressure for a small group of patients, even if they are already taking three or four other hypotensive glaucoma medication classes. This study aimed to assess the effectiveness of netarsudil in reducing intraocular pressure among veterans with advanced glaucoma on maximally tolerated medical therapy. All patients with glaucoma who received netarsudil between June 2018 and April 2020 from the West Los Angeles Veterans Administration Medical Center were reviewed. Inclusion criteria included a minimum of one intraocular pressure measurement in each of two time windows (within and after 4 months of netarsudil use). Exclusion criteria included medication nonadherence, change in treatment plan before post-treatment intraocular pressure could be obtained, corneal disease precluding reliable measurement, outside follow-up, and loss to follow-up. Intraocular pressure at baseline and that at two time windows were compared using analyses of variance. Relationships between intraocular pressure and number of baseline medications and concurrent statin therapy were evaluated. Netarsudil tolerability was reported. Of 200 patients prescribed netarsudil, 42 patients (eyes) met the enrollment criteria. The mean age of these patients was 75.7 years (95% confidence interval [CI], 73.0 to 78.4 years), 64% were of African descent, 79% had open-angle glaucoma, and the mean number of baseline medications was 3.7 (95% CI, 3.5 to 3.9). Baseline intraocular pressure of 17.2 mmHg (95% CI, 16.1 to 18.2 mmHg) decreased to 15.1 mmHg (95% CI, 14.0 to 16.2 mmHg; P < .001), and a reduction of >20% was seen in 30.9% of patient after 4 months of netarsudil therapy. Intraocular pressure reduction was not associated with number of baseline medications or systemic statin use. Netarsudil may produce a clinically significant intraocular pressure reduction in up to a third of the patients with advanced glaucoma already on maximally tolerated medical therapy.

Exploring the impact of metabolic imaging in head and neck cancer treatment.

BackgroundTarget volume delineation is performed with anatomical imaging for head and neck cancer. Molecular imaging allows the recognition of specific tumor regions. Its inclusion in the pathway could lead to changes in delineation and resultant treatment plans.MethodsPRISMA methodology was adhered to when selecting the articles for analysis and only full articles were quality assessed.ResultsSeventeen articles were included. Gross tumor volume (GTV) primary, GTV nodal, and other target volumes were evaluated. Positron emission tomography/computerized tomography (PET/CT) produced smaller primary GTVs, although not with diffusion‐weighted imaging‐magnetic resonance imaging (DWI‐MRI) or PET/MRI. The impact of these image modalities on GTV nodal did not display any consistency. Additionally, there was considerable heterogeneity in metrics comparing delineations. Four studies included appraised the dosimetric impact of the changes in target volume delineation.ConclusionQuantifying the impact of molecular imaging is difficult, due to heterogeneity in reporting metrics in molecular imaging modalities and a paucity of detail regarding delineation method and guideline adherence.

Is routine magnetic resonance imaging necessary in patients with clinically diagnosed frozen shoulder? Utility of magnetic resonance imaging in frozen shoulder

BackgroundShoulder magnetic resonance imaging (MRI) is commonly performed in patients with frozen shoulder (FS). However, the necessity of MRI and its diagnostic value is questionable. Therefore, the purpose of the present study was to clarify whether routine MRI could identify additional shoulder pathologies not previously suspected in the clinical examination and if any change in the treatment plan based on these additional MRI findings in FS patients was observed.Materials and methodsThe medical records of all patients who presented in our outpatient clinic with a diagnosis of FS from January 2017 to December 2018 were retrospectively reviewed. Patient demographics, the number of patients who received a shoulder MRI, changes in the diagnosis or identification of structural shoulder pathologies following MRI examination (if performed), as well as any alternation in the initially suggested treatment plan were recorded.ResultsA total of 609 patients (male: 241, female: 368) diagnosed with an FS and an average age of 52 ± 10 (range: 18 to 81) years were identified. In 403 of the 609 patients (66%), a shoulder MRI was performed. An additional structural shoulder pathology was identified in 89 of 403 (22%) patients following the shoulder MRI, mostly rotator cuff tears (partial: 46/403 [11.4%], full-thickness: 30/403 [7.4%], rerupture following reconstruction: 10/403 [2.5%]) and labrum tears (3/403 [0.7%]). At minimum 2-year follow-up, 11 of 403 (2.7%) patients were treated surgically for the additional pathology identified on the MRI scan consisting of an arthroscopic rotator cuff reconstruction in 10 patients and a labrum refixation in one patient. Five of the 609 (0.8%) patients were treated for refractory FS by arthroscopic capsulotomy.ConclusionsAlthough additional pathologies were identified in 22% of the patients, a change in treatment plan due to the MRI findings was only observed in 2.7% (37 MRIs needed to identify 1 patient with FS requiring surgery for the additional MRI findings). Therefore, routine use of shoulder MRI scans in patients with FS but without suspicion of an additional pathology may not be indicated.

Short and medium-term outcomes of patients with solid cancer hospitalized with COVID-19 in Belgium according to cancer diagnosis and treatment characteristics.

e24053 Background: Solid cancer is an independent prognostic factor for COVID-19 related mortality. Adverse prognostic factors in these patients include low performance status, lung cancer, advanced cancer stage and recent diagnosis. In this study, we further evaluated prognostic effects of cancer diagnosis and treatment variables and characterized changes in anticancer treatment plans due to COVID-19 diagnosis in a nation-wide cohort study. Methods: Patients with a history of solid cancer hospitalized with COVID-19 between March 2020 and February 2021 in one of the 20 participating institutions in Belgium were included. Patient demographics, comorbidities, COVID-19 hospitalization course and treatment, cancer and anticancer treatment characteristics, treatment changes due to COVID-19 and clinical outcomes in-hospital and during follow-up were retrospectively registered in a central database. The primary objective was to evaluate potential differences in 30-day and 3-month COVID-19-related mortality according to cancer and anticancer treatment characteristics. Results: A total of 946 patients (median age 73y, interquartile range 64-81y) were included. Pre-existing comorbidities were present in 90.1% of patients, and 21.9% had a history of &gt; 1 malignancy. Half of the patients (n = 463, 49.3%) had received anticancer treatment ≤3 months before COVID-19 diagnosis (“active cancer”), of whom 286 (63.1%) in the non-curative setting. The overall 30-day and 3-month COVID-19-related mortality rates in this cohort were 21.4% (n = 178) and 24.1% (n = 194), respectively. COVID-related 3-month mortality was comparable in patients with active cancer (n = 96, 24.3%) and in patients with non-active cancer (n = 97, 24.0%), but within the first group COVID-related mortality was higher in those receiving systemic treatment in the non-curative (28.3%) versus the curative setting (15.2%). A change in the anticancer treatment plan due to COVID-19 was recorded in 148/463 patients with active cancer (32.0%). In patients with changes in systemic treatment plans (n = 146), treatment was delayed in 94 patients (in half of cases for &gt; 1 month) and cancelled in 42 patients. The main reason for modifications in anti-cancer treatment was COVID-19 related complications (79.6%), followed by fear for/existence of anticancer treatment related toxicity (14.8%). Conclusions: Our nation-wide analysis in patients with solid cancer hospitalized with COVID-19 shows comparable 3-month mortality among patients who did and who did not receive anticancer treatment in the three months before COVID-19 diagnosis. Changes in anticancer treatment were very frequent in patients hospitalized with COVID-19. Further monitoring of the long-term impact of COVID-19-related changes to anticancer treatment plans is warranted.

CtDNA in treatment response monitoring in patients with relapsed gynecologic malignancies.

e17501 Background: The role of immunotherapy in gynecologic malignancies continues to evolve. Use of immune checkpoint blockade (ICB) agents have consistently demonstrated less than a 15% response rate in ovarian, cervical, and subsets of endometrial cancer. Given the limited number of responders, a novel approach to treatment monitoring is needed to better sequence therapies. Circulating tumor DNA (ctDNA) surveillance in patients treated with ICB is one such approach that has been shown to predict clinical benefit. We sought to evaluate this approach in patients with recurrent gynecologic malignancies managed with ICB therapy. Methods: In this retrospective analysis of real-world data, plasma samples (n = 208) from 28 patients with recurrent/metastatic ovarian (n = 8), endometrial (n = 14), and cervical (n = 6) cancers were identified as having received ICB therapy. A personalized and tumor-informed multiplex PCR assay (Signatera™ bespoke mPCR NGS assay) was used for the detection of ctDNA in plasma samples. Serial time points were collected to monitor ctDNA levels in response to immunotherapy. Results: Response assessment results and longitudinal plasma samples were available for 19 patients. Pre-ICB plasma samples were available for 11 patients. Of these ctDNA was detected in 73% (8/11) of patients. All patients with progressive disease (10/10) had rising ctDNA levels that preceded radiological findings by a median of 2.8 months. One patient with rising ctDNA concentration presented with stable disease by imaging at the last follow-up. The remaining 8 patients demonstrated response to therapy that coincided with a declining or negative ctDNA level; 5 with partial response had a decline in ctDNA level prior to imaging (n = 3) or lack of ctDNA detection (n = 2), and 3 with complete response remained ctDNA negative, prior to imaging. Patients that exhibited a rise in ctDNA concentration (n = 11) (consecutive time points) while undergoing ICB therapy were associated with resistance to treatment (HR = 4.58 95%CI: 1.048-20.03, p = 0.04). TMB and MSI status (binary) were not predictive of response in univariate (p = 0.8, p = 0.9) analyses. Conclusions: ctDNA monitoring during the course of immunotherapy for relapsed gynecologic malignancies allows for accurate determination of therapeutic response and early prediction of disease progression. This enables timely assessment with imaging, and change in treatment plan. Our data suggest that patients with gynecologic malignancies may benefit from personalized, tumor-informed ctDNA testing to guide treatment decisions. Prospective studies are needed to establish the clinical utility of ctDNA monitoring in patients with gynecologic malignancies undergoing systemic therapies.

513-P: Diabetes Mobile Apps: A Resource for Inpatient Education and Support?

Diabetes mellitus (DM) -related hospitalizations are recognized as important opportunities for self-management intervention. Yet, there remains a need for practical delivery strategies. Objective: To assess provider perspectives on DM mobile apps as a tool for self-management education and support in the inpatient setting. Methods: Healthcare professionals (n=33) who oversee or provide DM care and education to hospitalized patients completed a validated survey about DM mobile apps. Results: Only 21% of respondents had previously used an app for DM education. Of those who had never used a DM app, 100% indicated that they would consider recommending one to their patients. For 82% of respondents, patient access to and interest in app use were rated as the most important factors in their decision to recommend apps. Patient acuity and time were also noted as key considerations. In fact, 54% of respondents were only willing to spend 5 minutes to download and teach app use. Hospitalized patients considered best candidates for apps are those newly diagnosed with DM, new to insulin, admitted with a DM-related complication, or requiring additional education/support (change in treatment plan) . Perceived benefits of apps in relation to self-management were to reinforce education (71%) , support education with trustworthy information (62%) , and serve as a resource after discharge (56%) . Some respondents also foresaw a role for apps in teaching patients during hospitalization, especially younger patients generally viewed as more interested in apps. Most respondents agreed the following features are important for apps in education and support: Content is developed by DM experts (91%) , provide answer to basic DM self-management questions (96%) , user experience can be customized (91%) , and include features for logging/tracking glucose results (91%) . Conclusions: Hospital-based providers offer valuable insights into DM app use. Exposing them to apps to support patient self-management warrants strong consideration. Disclosure J.S.Krall: Research Support; Becton, Dickinson and Company, Sanofi. J.Ng: Research Support; Sanofi. L.M.Siminerio: Advisory Panel; Abbott, Bayer AG, Research Support; Becton, Dickinson and Company, Sanofi. Funding Becton, Dickinson and Company

Analysis of biomarkers in melanoma patients receiving ICI treatments: pre- vs post in responders and progressors

Abstract Markers of immune related adverse events and response in patients treated with immune checkpoint inhibitors (ICI) may shed light into ICI resistance, T cell exhaustion and other combinatorial therapies. The elevated levels of these biomarkers have potential to predict if PD-1 or PD-1/CTLA-4 antagonist combination will be effective in a certain Melanoma patient. Therefore, it may potentially guide healthcare providers to change treatment plans. In this study, the ICI treatments we focused on were PD-1 or combination of PD-1/CTLA-4 blockades. The measurement of the biomarkers was conducted at Mayo Clinic, from serum samples obtained in 2 time points, pre-treatments and 2–3 months after the first ICI treatments. Validated IVD kits were used per manufacture’s instruction. Biomarkers could be measured using stored frozen serum samples according to the instructions on how the biomarkers will be measured. We investigated 13 biomarkers in the sera of 76 melanoma patients who received immune checkpoint therapies. The biomarkers tested were, Human ELAFIN ELISA, Human IL-18 ELISA, Reg3α + Universal kit, Anti-Nuclear Antibody Test System, FLUORO AID-1 Test for anti-mitochondrial antibodies, anti-smooth muscle antibodies and anti-parietal cell antibodies, Anti-MDA5 ELISA Kit, Anti-synthetase ELISA Skin, Antineutrophil cytoplasmic antibodies MPO-ANCA ELISA, Antineutrophil cytoplasmic antibodies PR3-ANCA ELISA, Dsg1, Dsg3 ELISA, BP180, BP230, type-VII collagen. When compared with the samples obtained before treatments, IL-18 levels significantly elevated (p value &amp;lt; 0.0001) in post treatment samples of non-responders. Further studies are needed to confirm if elevated IL-18 contribute to the biology of resistance to ICI therapies. Supported by MBLI

Endoscopic nodal staging in oligometastatic non-small cell lung cancer (NSCLC) being treated with stereotactic ablative radiotherapy (ENDO-SABR)

BackgroundResearch in treatment of non-small cell lung cancer (NSCLC) has shown promising results with stereotactic ablative radiotherapy (SABR) of oligometastatic disease, wherein distant disease may be limited to one or a few distant organs by host factors. Traditionally, PET/CT has been used in detecting metastatic disease and avoiding futile surgical intervention, however, sensitivity and specificity is limited to only 81 and 79%, respectively. Mediastinal staging still identifies occult nodal disease in up to 20% of NSCLC patients initially thought to be operative candidates. Endobronchial ultrasound and transbronchial needle aspiration (EBUS-TBNA) is a minimally invasive tool for the staging and diagnosis of thoracic malignancy. When EBUS is combined with endoscopic ultrasound using the same bronchoscope (EUS-B), the diagnostic sensitivity and negative predictive value increase to 84 and 97%, respectively. Endoscopic staging in patients with advanced disease has never been studied, but may inform treatment if a curative SABR approach is being taken.MethodsThis is a multi-centre, prospective, cohort study with two-stage design. In the first stage, 10 patients with oligometastatic NSCLC (lung tumour ± hilar/mediastinal lymphadenopathy) with up to 5 synchronous metastases will be enrolled An additional 19 patients will be enrolled in the second stage if rate of treatment change is greater than 10% in the first stage. Patients will be subject to EBUS or combined modality EBUS/EUS-B to assess bilateral lymph node stations using a N3 to N2 to N1 progression. Primary endpoint is defined as the rate of change to treatment plan including change from SABR to conventional dose radiation, change in mediastinal radiation field, and change from curative to palliative intent treatment.DiscussionIf a curative approach with SABR for oligometastatic disease is being explored, invasive mediastinal staging may guide treatment and prognosis. This study will provide insight into the use of endoscopic mediastinal staging in determining changes in treatment plan of NSCLC. Results will inform the design of future phase II trials.Trial registrationClinicaltrials.gov identifier NCT04852588. Date of registration: April 19, 2021. Protocol version: 1.1 on December 9, 2021.

P004 A quality improvement project at Bradford Teaching Foundations Hospital to reduce high-cost medication waste and improve medicines optimisation

Abstract Background/Aims Biologics and methotrexate are high-cost medications delivered to patients through pharmacy homecare services prescribed and dispensed at 8-weekly intervals in our Trust. It is estimated nationally, £300 million of NHS prescribed medicines are wasted annually. The aim of this quality improvement project (QiP) was to investigate the extent and reasons for high-cost medication waste within the rheumatology department at BTHFT and develop a service to overcome these issues thereby improving medicine optimisation and reducing waste. Methods Homecare data was reviewed over 12 months from Jan 2020- 21 looking at high-cost medication waste within rheumatology at BTHFT. Two hundred and sixty-seven rheumatology patients were initiated on therapy in this period. Forty-four (16%) patients stopped therapy within a year of initiation. Of the 44 patients, 32 patients stopped within their first 8-week delivery resulting in £17,362 in wastage of medications. On further analysis, reasons for treatment cessation included: adverse effects, non-adherence due to lack of response or patient choice, lack of information and change in treatment plan by overseeing consultant. To overcome some of these issues we changed initial prescribing methods and dispensed 4 weeks supply of medication. We set up a pilot pharmacy telephone clinic between 9th April and 18th June 2021. Patients were phoned 8 weeks after nurse counselling when patients should have been 3 weeks into treatment with their new biologic and provided with further information and reassurance. Any clinical queries outside the pharmacist’s remit were directed to the rheumatology team. If patients were continuing medications, a further appropriate length prescription was dispensed. Results Over the 10-week period of the pilot study, 83 new patients started on therapy, 46 of these were provided with reassurance/support and of those, 9 held/stopped treatment. Through the pharmacy support line, £2,612 of medication cost was saved as these patients had received 4 weeks of medication rather than the usual 8 weeks supply. This translates to approximately a potential of £13,500 of medication waste which can be saved annually through reduced initial prescription of biologics together with implementation of a pharmacy support line through the rheumatology department alone. Another unexpected benefit of the pharmacy support line was improved compliance and adherence to treatment through further counselling and guidance that was delivered to patients who may have stopped treatment without the additional support provided by the pharmacist. Conclusion The introduction of a pharmacy-led telephone support service together with a change in prescribing practice can reduce waste, save money and improve patient outcomes through medicine optimisation. This service could be rolled out to other specialties using high-cost medication with similar intended benefits. Enhancing roles of pharmacists in this way will help meet increasing demand and improve services for patient as recommended by the recent rheumatology GIRFT review. Disclosure P. Sidhu: None. G. Quinn: None. K. Nadesalingam: None.

P116 A quality improvement project at Bradford Teaching Foundations Hospital to reduce high-cost medication waste and improve medicines optimisation

Abstract Background/Aims Biologics and methotrexate are high-cost medications delivered to patients through a pharmacy homecare service prescribed and dispensed at 8 weekly intervals in our Trust. It is estimated nationally, £300 million of NHS prescribed medicines are wasted each year. The aim of this QiP was to investigate the extent and reasons for high-cost medication waste within the rheumatology department at BTHFT and to develop a service to overcome these issues thereby improving medicine optimisation and reducing waste. Methods Homecare data were reviewed over 12 months from Jan 2020-21 looking at high-cost medication waste within rheumatology at BTHFT. Two hundred and sixty-seven rheumatology patients were initiated on therapy in this period. Forty-four (16%) patients stopped therapy within a year of initiation. Of the 44 patients, 32 patients stopped within their first 8-week delivery resulting in £17,362 in wastage of medications. The data were further analysed to assess reasons for treatment cessation. Reasons included adverse effects, non-adherence due to lack of response or patient choice, lack of information and change in treatment plan by overseeing consultant. To overcome some of these issues we changed initial prescribing methods and dispensed 4-weeks supply of medication. We set up a pilot pharmacy telephone clinic between 9th April and 18th June 2021. Patients were phoned 8-weeks after nurse counselling when patients should have been 3-weeks into treatment with their new biologic and provided with further information and reassurance. Any clinical queries outside the pharmacist’s remit were directed to the rheumatology team. If patients were continuing medications, a further appropriate length prescription was dispensed. Results Over the 10-week period of the pilot study, 83 new patients started on therapy, 46 of these were provided with reassurance/support and of those, 9 held/stopped treatment. Through the pharmacy support line, £2,612 of medication cost was saved as these patients had received 4-weeks of medication rather than the usual 8-weeks supply. This translates to approximately £13,500 of medication waste can be saved a year through reduced initial prescription of biologics together with implementation of a pharmacy support line through the rheumatology department alone. Another unexpected benefit of the pharmacy support line was improved compliance and adherence to treatment through further counselling and guidance that was delivered to patients who may have stopped treatment without the additional support provided by the pharmacist. Conclusion The introduction of a pharmacy-led telephone support service together with a change in prescribing practice can reduce waste, save money, and improve patient outcomes through medicine optimisation. This service could be rolled out to other specialties using high-cost medication with similar intended benefits. Enhancing roles of pharmacists in this way will help meet increasing demand and improve services for patient as recommended by the recent rheumatology GIRFT review. Disclosure P. Sidhu: None. K. Nadesalingam: None. G. Quinn: None.

Repercussions of COVID-19 pandemic impacts on non-metastatic HER2-negative breast cancer diagnosis and neoadjuvant treatment over patients’ quality of life and mental health/ Repercussões dos impactos da pandemia COVID-19 no diagnóstico e tratamento neoadjuvante de câncer de mama HER2-negativo não metastático sobre a qualidade de vida e saúde mental das pacientes

OBJECTIVE: To understand if COVID-19 pandemic impacts on delays in non-metastatic HER2-negative breast cancer diagnosis and in the beginning/development of neoadjuvant chemotherapy, as well as on changes in treatment plan to Paclitaxel intensification doses, impaired patients’ quality of life and mental health. METHODS: This is a cross-sectional study of 67 women diagnosed with non-metastatic HER2-negative breast cancer during the first sixteen months of COVID-19 pandemic and receiving neoadjuvant treatment due to pandemic impossibility of immediate definitive cancer surgery following the neoplasm diagnosis. Sociodemographic, Functional Assessment of Cancer Therapy Scale - General, Beck Anxiety and Depression Inventory were used for outcomes assessment. Inferential analysis was performed by Mann-Whitney, Pearson's chi-squared, and Fisher's exact tests. The adopted significance was 5%. RESULTS: The study revealed that the oncological diagnosis delays caused a worsening of the patients' physical (8 x 21; p = 0.001), functional (13 x 21; p = 0.03) and general (61 x 83; p = 0.004) well-being; retardment in the beginning of neoadjuvant chemotherapy decreased physical well-being (13 x 21; p = 0.01). Changes in treatment plan, to Paclitaxel doses intensification, had a negative effect on functional well-being (20 x 25.5; p = 0.04). COVID-19 pandemic impacts on neoplasm diagnosis and neoadjuvant treatment delays were also associated with psychosocial manifestations, including higher levels of severe anxiety (60% x 14.5%; p = 0.03 and 40% x 14%; p = 0.04) and depression (40% x 3.2%; p = 0.004 and 60% x 5.3%; p = 0.03) respectively. CONCLUSION: The present study shows that COVID-19 pandemic impacts on non-metastatic HER2-negative breast cancer patients’ diagnosis and neoadjuvant chemotherapy impaired patients' quality of life and mental health.

The added value of conventional defecography and MRI defecography in clinical decision making on treatment for posterior compartment prolapse

Introduction and hypothesisConventional defecography and MRI defecography can be requested as an additional test for diagnosing and differentiating the type of posterior compartment prolapse and/or obstructive defecation disorders. The objective of this study was to determine the added value of conventional defecography, conventional defecography and MRI defecography for clinical decision-making on treatment for patients with posterior compartment prolapse.MethodsFour gynecologists were asked to fill in their treatment plan per patient for 32 cases for three different steps. Step 1 consisted of information on the anamnesis and physical examination (POP-Q). Step 2 consisted of Step 1, including conventional defecography (group A) or MRI defecography (group B). In Step 3, all gynecologists received the information on Step 1 including both conventional defecography and MRI defecography. Data analysis solely focused on the assessment of changes in the gynecological treatment plan of the posterior compartment.ResultsAfter Step 2 a change in treatment plan occurred in 37% and 48% of the women in groups A and B, respectively. Accordingly, after Step 3 (including all imaging data), a change in treatment plan occurred in 19% and 52% of the women in groups A and B, respectively. A change within the surgery group (when a different type of surgery was selected) was seen for a total of 11 cases in group A and 20 in group B in all steps combined.ConclusionsBoth conventional defecography and MRI defecography had an large effect on the treatment plan for patients with posterior compartment prolapse. The dedicated added value of the imaging modality individually cannot be concluded yet.

Impact of the Harm Review Service for Patients Awaiting Elective Hip and Knee Surgeries for More Than 52 Weeks.

BackgroundThe coronavirus disease 2019 (COVID-19) pandemic has affected medical practice worldwide. In the UK, elective operative lists had to be postponed to accommodate the increase in hospital admissions. Within our local trauma and orthopaedic department, a harm review clinic was developed for these postponed elective cases. The purpose of this clinic was to evaluate the impact and outcomes of the delay in elective hip and knee procedures.MethodologyThe elective list database of William Harvey Hospital, Kent, from April to December 2020 was retrospectively analysed. Inclusion criteria included all lower limb primary arthroplasty, elective lower limb revision surgery, and other hip and knee procedure patients waiting more than 52 weeks for surgery. All patients had telephone consultations averaging 10 minutes. Data included patients’ symptoms, fresh investigations, changes in treatment plans, mental health status, and value of consultation were assessed and recorded.ResultsA total of 242 patients from eight lower limb consultants were analysed. Patients with hip pathology accounted for 39.2% (95 patients) versus knee pathology accounting for 60.7% (147 patients). In total, 13 (5.37%) patients reported improvement in their physical symptoms, whereas 46 (19%) felt their symptoms worsen. Overall, 26 (10.7%) patients had a change in their treatment plan following the consultation. In total, 18 (7.4%) patients required further face-to-face follow-up following the telephone consultation There were no patients who had significant physical or mental harm.ConclusionsThe COVID-19 pandemic has brought changes in how we practice medicine. The harm review service has been a valuable service to both patients and the orthopaedic department. This harms review clinic was able to identify changes in treatment plans for patients. A small percentage of patients required face-to-face appointments. We suggest telephone assessment should be the first mode of communication with patients. Further studies should be conducted in other specialities to determine if there are similar outcomes.

Quality of Life, Anxiety, Depression and Psychological Distress in Patients with Cancer During the COVID 19 Pandemic: A Systematic Review

Introduction and Objectives: Quality of life (QOL) and psychological wellbeing deteriorate during the COVID 19 pandemic in patients with cancer. Purpose: This study aims to review the current evidence of QOL, anxiety, depression, psychological distress, and their inter-relationship in patients with cancer and survivors during the COVID 19 pandemic. Moreover, this study identifies factors associated with QOL and mental health in patients with cancer and survivors during the COVID 19 pandemic. Methods: An extensive electronic database search was conducted. Articles published in English assessing cancer patients and cancer survivors’ QOL and psychological wellbeing. Results: Twenty-seven articles with 22,134 participants were included. Concerns related to contracting COVID 19, along with potential treatment plans were predictors of impaired QOL. Advanced age, family support, being identified as a male and having less comorbid conditions were associated with the high level of QOL. Delay or change in treatment plan, contact with COVID 19 positive individuals, and emotional vulnerability were found to be independently associated with high levels of anxiety, depression, and distress. Conclusion: Health professionals, caregivers and support services should pay more attention on QOL and psychological wellbeing of the patients with cancer. Counselling sessions, support services should be established to improve their life satisfaction and wellbeing.

Tingkat Kecemasan Pasien Kanker yang Menjalani Kemoterapi di Masa Pandemi Covid-19: Literature Review

The high morbidity and mortality of Covid-19 causes fear and anxiety about the risk of exposure to this disease in everyone, including cancer patients. Objective: To identify the anxiety level of cancer patients undergoing chemotherapy during the Covid-19 pandemic. Methods: Article searches through Pubmed, ProQuest, ScienceDirect, Wiley, and Google Scholar identified 20,489 articles, then restricted based on inclusion criteria: a study with samples of cancer patients undergoing chemotherapy during the Covid-19 pandemic; a study that assessed the anxiety level of cancer patients undergoing chemotherapy during the Covid-19 pandemic; published in the last three years; have full text in English and Indonesian, so that 6 articles are obtained. Results: Of the six articles reviewed, one study reported that during Covid-19 all cancer patients undergoing chemotherapy experienced increased anxiety (57%); two studies reported severe anxiety (36.7%; p=0.000 and 33%); two studies reported moderate anxiety with respective scores (22.3; p=0.000; and 18.5; p=0.037); and one study of mild anxiety (25.8% women and 16.8% men; p=0.159). Anxiety experienced by patients is caused by a number of factors, including fear of being infected with Covid-19, type of cancer, age and gender, delays or changes in treatment and treatment plans, excessive exposure to information, uncertainty over the end of Covid-19, lack of understanding and information related to Covid -19, hospital restrictions, and feelings of loneliness. Conclusion: Based on the results of a review of six articles, it was concluded that cancer patients undergoing chemotherapy during the Covid-19 pandemic experienced anxiety that varied from mild to severe anxiety depending on the influencing factors

COVID-19 Pandemic Impact on Surgical Treatment Methods for Early-Stage Cervical Cancer: A Population-Based Study in Romania.

Being one of the most common malignancies in young women, cervical cancer is frequently successfully screened around the world. Early detection enables for an important number of curative options that allow for more than 90% of patients to survive more than three years without cancer relapse. Unfortunately, the COVID-19 pandemic put tremendous pressure on healthcare systems and access to cancer care, determining us to develop a study on the influence the pandemic had on surgical care of cervical cancer, and to assess changes in its management and outcomes. A retrospective study design allowed us to compare cervical cancer trends of the last 48 months of the pre-pandemic period with the first 24 months during the COVID-19 pandemic, using the database from the Timis County Emergency Clinical Hospital. New cases of cervical cancer presented to our clinic in more advanced stages (34.6% cases of FIGO stage III during the pandemic vs. 22.4% before the pandemic, p-value = 0.047). These patients faced significantly more changes in treatment plans, postponed surgeries, and postponed radio-chemotherapy treatment. From the full cohort of cervical cancer patients, 160 were early stages eligible for curative intervention who completed a three-year follow-up period. The disease-free survival and overall survival were not influenced by the surgical treatment of choice, or by the SARS-CoV-2 infection (log-rank p-value = 0.449, respectively log-rank p-value = 0.608). The individual risk factors identified for the three-year mortality risk were independent of the SARS-CoV-2 infection and treatment changes during the COVID-19 pandemic. We observed significantly fewer cases of cervical cancer diagnosed per year during the first 24 months of the COVID-19 pandemic, blaming the changes in healthcare system regulations that failed to offer the same conditions as before the pandemic. Even though we did not observe significant changes in disease-free survival of early-stage cervical cancers, we expect the excess of cases diagnosed in later stages to have lower survival rates, imposing the healthcare systems to consider different strategies for these patients while the pandemic is still ongoing.

Geriatric assessment tool application in treatment recommendations for older women with breast cancer

IntroductionTreatment of early breast cancer in older women is usually not guideline concordant owing to lack of routine evaluation of their potential frailty. We assessed the feasibility and impact of a self-administered geriatric assessment on the decision-making process in women aged 65 and above treated in a UK District General Hospital. MethodsOne hundred and one patients, aged 65 and above, with early stage, non-metastatic breast cancer were prospectively recruited between Dec-2018 and March-2021. Patients with metastatic breast cancer, a previous history of cancer and dementia were excluded. All patients had a geriatric assessment with a self-administered questionnaire (mycarg.org). All cases were discussed in the multidisciplinary meeting (MDT) and a pre geriatric assessment recommendations was made, based on the tumour grade, size, node status and receptor status. The findings of the assessment were later discussed in a second meeting and a further recommendation was made based on the geriatric assessment. Any change in the proposed treatment was recorded. Potential factors (age, Body Mass Index, co-morbidities, medications, instrumental activities of daily living, and basic activities of daily living, social support and psychological status) associated with a change in the treatment recommendation were compared using Pearson's Chi square tests for categorized data, and Mann Whitney U test for continuous data. A multivariate logistic regression was performed to test the association between geriatric assessment domains and change in treatment decision. The multivariate model was built using variables which were associated in the bivariate analysis with a p-value< 0.20. ResultsPatients aged less than 70 years were more likely to be diagnosed through screening programme as compared to older women (64.4% vs. 35.6%, p = 0.001).Self-administered geriatric assessment identified patients who were requiring assistance in their daily routine activities, and hence, were assessed to have higher morbidity status. A third of patients required assistance in their routine activities, with 18/101 patients requiring significant help during self-care. 90% patients were independent for Activity of Daily Living (ADL) at baseline and 34.76% for Instrumental Activity of Daily Living (IADL).Among the 101 patients evaluated, proposed change in the initial cancer treatment plan was made in 21.8% of patients after the second MDT. Omission of chemotherapy was recommended in 4 patients, omission of radiotherapy in 15 patients and omission of both chemo and radiotherapy in 2 patients. One patient was advised to omit Zolidronic acid, as she was noted to have renal impairment. No patient in this cohort had suggestion for omission of surgery or endocrine therapy. In the bivariate analysis, need for assistance for activities of daily living (ADLs), low physical performance (KPS), polypharmacy (3 or more medications), lack of social support as assessed using the Social Support: Medical Outcomes Study (MOS) Social Support Survey and high BMI (30 or more) all showed significance but on multivariate analysis only polypharmacy was significantly associated with change in the initial cancer treatment plan. ConclusionsThe results of this study of breast cancer patients aged 65 and above suggest that a self-administered geriatric assessment may influence treatment recommendations in a subset of patients. Recommendations that were influenced by the geriatric assessment mainly included those related to the significant morbidity that may have impacted the use of chemotherapy and/or radiotherapy.

On top of that all, now Covid-19, too. A scoping review of specificities and correlates of fear of cancer recurrence in breast cancer patients during COVID-19.

Fear of cancer recurrence (FCR) is a normal response in cancer survivors and one of the most prevalent reactions reported by up to 87% of them. However, elevated levels of FCR impair well-being, quality of life and professional functioning, and lead to anxiety, depression or PTSD. COVID-19 pandemic can exacerbate FCR symptoms, given the restricting access to follow-up investigations and treatment, the isolation restrictions imposed and the possibility of the medical system becoming overworked. This scoping review's objective was to synthesize the literature investigating the factors associated with higher levels of FCR in cancer survivors during the COVID-19 pandemic. The focus was on FCR in breast cancer patients, including most of the studies (5 out of 9) on this topic. However, given the novelty of the subject, the increased interest in it, and the fact that there are few studies in this field, the review included 4 other studies with mixed samples of patients with breast cancer and other oncological pathologies. Following rigorous methodological criteria, 9 studies with quantitative or mixed methodology were included (N = 4831 patients). The results indicate that high levels of FCR are associated with distress and concerns regarding the pandemic impact, with most common concerns of patients being changes in treatment plan (delays and interruptions), dysfunctional communication with medical staff or difficult access to food or medicine. The most common correlates of FCR during the pandemic are marital status, childlessness, low financial status, level of education, type of cancer diagnosis, generalized anxiety and depression.