| 1. |
- Alkner, Sara, et al.
(författare)
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Quality assessment of radiotherapy in the prospective randomized SENOMAC trial
- 2024
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Ingår i: Radiotherapy and Oncology. - : Elsevier. - 0167-8140 .- 1879-0887. ; 197
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Tidskriftsartikel (refereegranskat)abstract
- Background and purpose: Recommendations for regional radiotherapy (RT) of sentinel lymph node (SLN)-positive breast cancer are debated. We here report a RT quality assessment of the SENOMAC trial. Materials and Methods: The SENOMAC trial randomized clinically node-negative breast cancer patients with 1-2 SLN macrometastases to completion axillary lymph node dissection (cALND) or SLN biopsy only between 2015-2021. Adjuvant RT followed national guidelines. RT plans for patients included in Sweden and Denmark until June 2019 were collected (N = 1176) and compared to case report forms (CRF). Dose to level I (N = 270) and the humeral head (N = 321) was analyzed in detail.
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| 2. |
- Appelgren, M., et al.
(författare)
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Patient-reported outcomes one year after positive sentinel lymph node biopsy with or without axillary lymph node dissection in the randomized SENOMAC trial
- 2022
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Ingår i: Breast. - : Elsevier BV. - 0960-9776 .- 1532-3080. ; 63, s. 16-23
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: This report evaluates whether health related quality of life (HRQoL) and patient-reported arm morbidity one year after axillary surgery are affected by the omission of axillary lymph node dissection (ALND). Methods: The ongoing international non-inferiority SENOMAC trial randomizes clinically node-negative breast cancer patients (T1-T3) with 1-2 sentinel lymph node (SLN) macrometastases to completion ALND or no further axillary surgery. For this analysis, the first 1181 patients enrolled in Sweden and Denmark between March 2015, and June 2019, were eligible. Data extraction from the trial database was on November 2020. This report covers the secondary outcomes of the SENOMAC trial: HRQoL and patient-reported arm morbidity. The EORTC QLQC30, EORTC QLQ-BR23 and Lymph-ICF questionnaires were completed in the early postoperative phase and at one-year follow-up. Adjusted one-year mean scores and mean differences between the groups are presented corrected for multiple testing.
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| 3. |
- Bergkvist, Anna, et al.
(författare)
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A multi-intervention approach on drug therapy can lead to a more appropriate drug use in the elderly. LIMM-Landskrona Integrated Medicines Management
- 2009
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Ingår i: Journal of Evaluation in Clinical Practice. - : Wiley. - 1365-2753 .- 1356-1294. ; 15:4, s. 660-667
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Tidskriftsartikel (refereegranskat)abstract
- Rationale, aims and objectives To evaluate if an integrated medicines management can lead to a more appropriate drug use in elderly inpatients. Method The study was an intervention study at a department of internal medicine in southern Sweden. During the intervention period pharmacists took part in the daily work at the wards. Systematic interventions aiming to identify, solve and prevent drug-related problems (DRPs) were performed during the patient's hospital stay by multidisciplinary teams consisting of physicians, nurses and pharmacists. DRPs identified by the pharmacist were put forward to the care team and discussed. Medication Appropriateness Index (MAI) was used to evaluate the appropriateness in the patients' drug treatment at admission, discharge and 2 weeks after discharge. In total 43 patients were included, 28 patients in the intervention group and 25 patients in the group which was used as control. Results For the intervention group there was a significant decrease in the number of inappropriate drugs compared with the control group (P = 0.049). Indication, duration and expenses were the MAI-dimensions with most inappropriate ratings, and the drugs with most inappropriate ratings were anxiolytics, hypnotics and sedatives. Conclusion This kind of systematic approach on drug therapy can result in a more appropriate drug use in the elderly.
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| 4. |
- Bergkvist, Anna, et al.
(författare)
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Improved quality in the hospital discharge summary reduces medication errors-LIMM: Landskrona Integrated Medicines Management.
- 2009
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Ingår i: European Journal of Clinical Pharmacology. - : Springer Science and Business Media LLC. - 1432-1041 .- 0031-6970. ; 65, s. 1037-1046
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Tidskriftsartikel (refereegranskat)abstract
- PURPOSE: We have developed a model for integrated medicines management, including tools and activities for medication reconciliation and medication review. In this study, we focus on improving the quality of the discharge summary including the medication report to reduce medication errors in the transition from hospital to primary and community care. METHODS: This study is a longitudinal study with an intervention group and a control group. The intervention group comprised 52 patients, who were included from 1 March 2006 until 31 December 2006, with a break during summer. Inclusion in the control group was performed in the same wards during the period 1 September 2005 until 20 December 2005, and 63 patients were included in the control group. In order to improve the quality of the medication report, clinical pharmacists reviewed and gave feedback to the physician on the discharge summary before patient discharge, using a structured checklist. Medication errors were then identified by comparing the medication list in the discharge summary with the first medication list used in the community health care after the patient had returned home. RESULTS: By improving the quality of the discharge summary, patients had on average 45% fewer medication errors per patient (P = 0.012). The proportion of patients without medication errors was 63.5% in the control group and 73.1% in the intervention group. However, this increase was not significant (P = 0.319). Patients who used a specific medication dispensing system (ApoDos) had a 5.9-fold higher risk of suffering from medication errors than those without this medication dispensing system (P < 0.001). CONCLUSION: Review and feedback on errors in the discharge summary, including the medication report and a correct medication list, reduced medication errors during the transfer of information from hospital to primary and community care.
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| 5. |
- Bergkvist, Anna, et al.
(författare)
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The process of identifying, solving and preventing drug related problems in the LIMM-study
- 2011
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Ingår i: International Journal of Clinical Pharmacy. - : Springer Science and Business Media LLC. - 2210-7703 .- 2210-7711. ; 33:6, s. 1010-1018
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Tidskriftsartikel (refereegranskat)abstract
- Objective To avoid negative effects of drug treatment and need for additional medical care, drug treatment must be individualised. Our research group has developed a model for clinical pharmacy which improves several aspects of the patient's drug treatment. This study describes the process behind these improvements, i.e. drug related problems identified by pharmacists within a clinical pharmacy service. Setting Three wards at a department of internal medicine. Method Pharmacists performed systematic interventions during the patient's hospital stay, aiming to identify, solve and prevent drug related problems in the elderly. Identified drug related problems were put forward to the health care team and discussed. Information on identified problems, and their outcomes was collected and analysed. A questionnaire was used to evaluate the health care personnel's attitudes towards the process. Main outcome measure The number of drug related problems identified by the clinical pharmacists, the proportion of problems discussed with the physicians, the proportion of problems adjusted by the physicians and whether pharmacists and physicians prioritised any subgroup of drug related problems when choosing which problems to address. Finally, we wanted to evaluate the health care personnel's attitudes towards the model. Results In total, 1,227 problem were identified in 190 patients. The pharmacists discussed 685 (55.8%) of the identified problems with the physicians who accepted 438 (63.9%) of the suggestions. There was no significant difference in which subgroup to put forward and which to adjust. There was a high response rate (84%) to the questionnaire, and the health care personnel estimated the benefits to be very high, both for the patients and for themselves. Conclusion The process for identifying, solving and preventing drug related problems was good and the different types of problems were considered equally important. The addition of a clinical pharmacy service was considered very useful. This suggests that the addition of our clinical pharmacy service to the hospital setting add skills of great importance.
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| 6. |
- Bergkvist, Lisa, et al.
(författare)
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Carbon Sequestration Potential f Agroforestry Systems For Phytoremediation In Chinandega, Nicaragua
- 2018
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Ingår i: Linnaeus Eco-Tech 2018. ; , s. 211-211
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Greenhouse gases in the atmosphere have increased to earlier unrecorded levels, causing global climate change that increases GMT and threaten ecosystems and livelihoods. IPCC report suggest that agroforestry offers considerable carbon sequestration (c seq.) potential, especially for developing countries. The purpose of this study is to estimate the c seq. potential in different agroforestry systems suitable in Chinandega, Nicaragua - a deforested region where the ground is polluted by toxaphene and other POP:s. Three scenarios where studied; Shading system using Tectona grandis and Pogostemon cablin; Alley cropping using Erythrina poeppigiana and Ricinus communis and Silvopasture using Cordia alliodora and Brachiaria ruziziensis, the last scenario being divided into two subscenarios; unmanaged (grazed) and managed (harvested) grass. Calculations were performed using the modelling program CO2FIX v. 3.2, with a runtime of 100 years and assuming deforested area with no previous land use. Results show a significantly higher c seq. potential in Shading system (168/217 MgC/ha). Alley cropping yields 71 MgC/ha and Silvopasture results in 80/84 MgC/ha unmanaged and 65/70 MgC/ha managed. The higher number includes products from harvest. All scenarios show fluctuations over time due to thinning and harvesting practices. Phytoremediation potential of POPs has been shown in Ricinus communis and grass species. Soil c seq. is especially important to consider in longterm scenarios as this c seq. can be sustained over longer time. The inclusion of crop residue, the effect of grazing animals or changes in density of trees and crops and environmental fate of the toxic compounds need further assessment before considering large scale applications. Agroforestry practices could contribute to several benefits, including climate change mitigation and phytoremediation.
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| 7. |
- de Boniface, Jana, et al.
(författare)
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Completion axillary lymph node dissection for the identification of pN2–3 status as an indication for adjuvant CDK4/6 inhibitor treatment : a post-hoc analysis of the randomised, phase 3 SENOMAC trial
- 2024
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Ingår i: The Lancet Oncology. - : Elsevier. - 1470-2045 .- 1474-5488. ; 25:9, s. 1222-1230
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Tidskriftsartikel (refereegranskat)abstract
- Background: In luminal breast cancer, adjuvant CDK4/6 inhibitors (eg, abemaciclib) improve invasive disease-free survival. In patients with T1–2, grade 1–2 tumours, and one or two sentinel lymph node metastases, completion axillary lymph node dissection (cALND) is the only prognostic tool available that can reveal four or more nodal metastases (pN2–3), which is the only indication for adjuvant abemaciclib in this setting. However, this technique can lead to substantial arm morbidity in patients. We aimed to pragmatically describe the potential benefit and harm of this strategy on the individual patient level in patients from the ongoing SENOMAC trial.Methods: In the randomised, phase 3, SENOMAC trial, patients aged 18 years or older, of any performance status, with clinically node-negative T1–T3 breast cancer and one or two sentinel node macrometastases from 67 sites in five European countries (Denmark, Germany, Greece, Italy, and Sweden) were randomly assigned (1:1), via permutated block randomisation (random block size of 2 and 4) stratified by country, to either cALND or its omission (ie, they had a sentinel lymph node biopsy only). The primary outcome is overall survival, which is yet to be reported. In this post-hoc analysis, patients from the SENOMAC per-protocol population, with luminal oestrogen-receptor positive, HER2-negative, T1–2, histological grade 1–2 breast cancer, with tumour size of 5 cm or smaller were selected to match the characteristics of cohort 1 of the monarchE trial who would only have an indication for adjuvant abemaciclib if found to have 4 or more nodal metastases. The primary study objective was to determine the number of patients who developed patient-reported severe or very severe impairment of physical arm function after cALND (as measured by the Lymphedema Functioning, Disability, and Health [Lymph-ICF] Questionnaire) 1 year after surgery to avoid one invasive disease-free survival event at 5 years with 2 years of adjuvant abemaciclib, using invasive disease-free survival event data from cohort 1 of the monarchE trial. The SENOMAC trial is registered with ClincialTrials.gov, NCT02240472, and is closed to accrual and ongoing.Findings: Between Jan 31, 2015, and Dec 31, 2021, 2766 patients were enrolled in SENOMAC and randomly assigned to cALND (n=1384) or sentinel node biopsy only (n=1382), of whom 2540 were included in the per-protocol population. 1705 (67%) of 2540 patients met this post-hoc study's eligibility criteria, of whom 802 (47%) had a cALND and 903 (53%) had a sentinel lymph node biopsy only. Median age at randomisation was 62 years (IQR 52–71), 1699 (>99%) of 1705 patients were female, and six (<1%) were male. Among 1342 patients who responded to questionnaires, after a median follow-up of 45·2 months (IQR 25·6–59·8; data cutoff Nov 17, 2023), patient-reported severe or very severe impairment of physical arm function was reported in 84 (13%) of 634 patients who had cALND versus 30 (4%) of 708 who had sentinel lymph node biopsy only (χ2 test p<0·0001). To avoid one invasive disease-free survival event at 5 years with adjuvant abemaciclib, cALND would need to be performed in 104 patients, and would result in nine patients having severe or very severe impairment of physical arm function 1 year after surgery.Interpretation: As a method to potentially identify an indication for abemaciclib, and subsequently avoid invasive disease-free survival events at 5 years with 2 years of adjuvant abemaciclib, cALND carries a substantial risk of severe or very severe arm morbidity and so cALND should be discouraged for this purpose. Funding: Swedish Research Council, the Swedish Cancer Society, the Nordic Cancer Union, and the Swedish Breast Cancer Association.
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| 8. |
- de Boniface, J., et al.
(författare)
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Survival and axillary recurrence following sentinel node-positive breast cancer without completion axillary lymph node dissection: the randomized controlled SENOMAC trial
- 2017
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Ingår i: BMC Cancer. - : Springer Science and Business Media LLC. - 1471-2407. ; 17
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Tidskriftsartikel (refereegranskat)abstract
- Background: The role of axillary lymph node dissection (ALND) has increasingly been called into question among patients with positive sentinel lymph nodes. Two recent trials have failed to show a survival difference in sentinel node-positive breast cancer patients who were randomized either to undergo completion ALND or not. Neither of the trials, however, included breast cancer patients undergoing mastectomy or those with tumors larger than 5 cm, and power was debatable to show a small survival difference. Methods: The prospective randomized SENOMAC trial includes clinically node-negative breast cancer patients with up to two macrometastases in their sentinel lymph node biopsy. Patients with T1-T3 tumors are eligible as well as patients prior to systemic neoadjuvant therapy. Both breast-conserving surgery and mastectomy, with or without breast reconstruction, are eligible interventions. Patients are randomized 1: 1 to either undergo completion ALND or not by a web-based randomization tool. This trial is designed as a non-inferiority study with breast cancer-specific survival at 5 years as the primary endpoint. Target accrual is 3500 patients to achieve 80% power in being able to detect a potential 2.5% deterioration of the breast cancer-specific 5-year survival rate. Follow-up is by annual clinical examination and mammography during 5 years, and additional controls after 10 and 15 years. Secondary endpoints such as arm morbidity and health-related quality of life are measured by questionnaires at 1, 3 and 5 years. Discussion: Several large subgroups of breast cancer patients, such as patients undergoing mastectomy or those with larger tumors, have not been included in key trials; however, the use of ALND is being questioned even in these groups without the support of high-quality evidence. Therefore, the SENOMAC Trial will investigate the need of completion ALND in case of limited spread to the sentinel lymph nodes not only in patients undergoing any breast surgery, but also in neoadjuvantly treated patients and patients with larger tumors.
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| 9. |
- de Boniface, J., et al.
(författare)
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The generalisability of randomised clinical trials: an interim external validity analysis of the ongoing SENOMAC trial in sentinel lymph node-positive breast cancer
- 2020
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Ingår i: Breast Cancer Research and Treatment. - : Springer Science and Business Media LLC. - 0167-6806 .- 1573-7217. ; 180:1, s. 167-176
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Tidskriftsartikel (refereegranskat)abstract
- Purpose None of the key randomised trials on the omission of axillary lymph node dissection (ALND) in sentinel lymph-positive breast cancer have reported external validity, even though results indicate selection bias. Our aim was to assess the external validity of the ongoing randomised SENOMAC trial by comparing characteristics of Swedish SENOMAC trial participants with non-included eligible patients registered in the Swedish National Breast Cancer Register (NKBC). Methods In the ongoing non-inferiority European SENOMAC trial, clinically node-negative cT1-T3 breast cancer patients with up to two sentinel lymph node macrometastases are randomised to undergo completion ALND or not. Both breast-conserving surgery and mastectomy are eligible interventions. Data from NKBC were extracted for the years 2016 and 2017, and patient and tumour characteristics compared with Swedish trial participants from the same years. Results Overall, 306 NKBC cases from non-participating and 847 NKBC cases from participating sites (excluding SENOMAC participants) were compared with 463 SENOMAC trial participants. Patients belonging to the middle age groups (p = 0.015), with smaller tumours (p = 0.013) treated by breast-conserving therapy (50.3 versus 47.1 versus 65.2%, p < 0.001) and less nodal tumour burden (only 1 macrometastasis in 78.8 versus 79.9 versus 87.3%, p = 0.001) were over-represented in the trial population. Time trends indicated, however, that differences may be mitigated over time. Conclusions This interim external validity analysis specifically addresses selection mechanisms during an ongoing trial, potentially increasing generalisability by the time full accrual is reached. Similar validity checks should be an integral part of prospective clinical trials. Trial registration: NCT 02240472, retrospective registration date September 14, 2015 after trial initiation on January 31, 2015
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| 10. |
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