| 11. |
- Gahm, Jessica, et al.
(författare)
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Effectiveness of single vs multiple doses of prophylactic intravenous antibiotics in implant-based breast reconstruction : A randomized clinical trial
- 2022
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Ingår i: JAMA Network Open. - : American Medical Association (AMA). - 2574-3805. ; 5:9
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Tidskriftsartikel (refereegranskat)abstract
- Importance: Multiple-dose antibiotic prophylaxis is widely used to prevent infection after implant-based breast reconstruction despite the lack of high-level evidence regarding its clinical benefit.Objective: To determine whether multiple-dose antibiotic prophylaxis is superior to single-dose antibiotic prophylaxis in preventing surgical site infection (SSI) after implant-based breast reconstruction.Design, Setting, and Participants: This prospective, multicenter, randomized clinical superiority trial was conducted at 7 hospitals (8 departments) in Sweden from April 25, 2013, to October 31, 2018. Eligible participants were women aged 18 years or older who were planned to undergo immediate or delayed implant-based breast reconstruction. Follow-up time was 12 months. Data analysis was performed from May to October 2021.Interventions: Multiple-dose intravenous antibiotic prophylaxis extending over 24 hours following surgery, compared with single-dose intravenous antibiotic. The first-choice drug was cloxacillin (2 g per dose). Clindamycin was used (600 mg per dose) for patients with penicillin allergy.Main Outcomes and Measures: The primary outcome was SSI leading to surgical removal of the implant within 6 months after surgery. Secondary outcomes were the rate of SSIs necessitating readmission and administration of intravenous antibiotics, and clinically suspected SSIs not necessitating readmission but oral antibiotics.Results: A total of 711 women were assessed for eligibility, and 698 were randomized (345 to single-dose and 353 to multiple-dose antibiotics). The median (range) age was 47 (19-78) years for those in the multiple-dose group and 46 (25-76) years for those in the single-dose group. The median (range) body mass index was 23 (18-38) for the single-dose group and 23 (17-37) for the multiple-dose group. Within 6 months of follow-up, 30 patients (4.3%) had their implant removed because of SSI. Readmission for intravenous antibiotics because of SSI occurred in 47 patients (7.0%), and 190 women (27.7%) received oral antibiotics because of clinically suspected SSI. There was no significant difference between the randomization groups for the primary outcome implant removal (odds ratio [OR], 1.26; 95% CI, 0.69-2.65; P = .53), or for the secondary outcomes readmission for intravenous antibiotics (OR, 1.18; 95% CI, 0.65-2.15; P = .58) and prescription of oral antibiotics (OR, 0.72; 95% CI, 0.51-1.02; P = .07). Adverse events associated with antibiotic treatment were more common in the multiple-dose group than in the single-dose group (16.4% [58 patients] vs 10.7% [37 patients]; OR, 1.64; 95% CI, 1.05-2.55; P = .03).Conclusions and Relevance: The findings of this randomized clinical trial suggest that multiple-dose antibiotic prophylaxis is not superior to a single-dose regimen in preventing SSI and implant removal after implant-based breast reconstruction but comes with a higher risk of adverse events associated with antibiotic treatment.Trial Registration: EudraCT 2012-004878-26.
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| 12. |
- Gonzalez, Virginia, et al.
(författare)
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Impact of preoperative breast MRI on 10-year survival outcome of patients included in the Swedish randomized multicenter POMB trial
- 2021
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Ingår i: BJS Open. - : Oxford University Press. - 2474-9842. ; 5:5
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Tidskriftsartikel (refereegranskat)abstract
- ABSTRACTBackground: The value of preoperative breast magnetic resonance imaging (MRI) as an adjunct technique regarding its effect on re-excision rates has been a subject of discussion. No survival data regarding preoperative breast MRI are available from randomized studies. Methods: Ten-year follow-up of the previous randomized multicentre study (POMB) was reported, evaluating MRI and its effect on disease-free survival (DFS) and overall survival (OS). A total of 440 patients with newly diagnosed breast cancer were randomized to either preoperative MRI (n = 220) group or conventional imaging (n = 220; control) group. Kaplan–Meier plots were used to analyze DFS and OS. Cox regression was used to estimate hazard ratios (HRs). Results: The median follow-up time for each group was 10 years. DFS rates were 85.5% and 80.0% for the MRI and control groups, respectively (P = 0.099). The risk of relapse or death was 46% higher in the control group (HR 1.46, 95% confidence interval 0.93–2.29). OS rates after 10 years were 90.9% and 88.6% for the MRI and control groups, respectively (P = 0.427). The risk of death was 27% higher in the control group (HR 1.27, 95% confidence interval 0.71–2.29). Locoregional, distant, and contralateral recurrence outcomes combined, were increased in the control group (P = 0.048). A subgroup analysis of patients with breast cancer stages I–III showed that preoperative MRI improved DFS compared with conventional imaging but this did not reach statistical significance (P = 0.057). Conclusion: After 10 years of follow-up, preoperative breast MRI as an adjunct to conventional imaging resulted in slightly, but non-significantly, improved DFS and OS.ClinicalTrials.gov Identifier: POMB NCT01859936
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| 13. |
- Gonzalez, Virginia, et al.
(författare)
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Preoperative MRI of the Breast (POMB) Influences Primary Treatment in Breast Cancer: A Prospective, Randomized, Multicenter Study
- 2012
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Ingår i: World Journal of Surgery. ; :38, s. 1685-1693
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Tidskriftsartikel (refereegranskat)abstract
- Abstract Background Breast magnetic resonance imaging (MRI) has shown high sensitivity in determining tumor extent, multifocality, and occult contralateral breast cancer. Low specificity, unnecessary mastectomies, and costs are argu- ments against MRI. The purpose of this study was to determine whether preoperative breast MRI would affect primary surgical management, reduce reexcision/reopera- tion procedures, and influence the choice of neoadjuvant treatment in patients with newly diagnosed breast cancer. Methods This prospective, randomized, multicenter study included 440 breast cancer patients younger than aged 56 years from three, Swedish, large-volume breast units. Patients were randomly allocated on a 1:1 basis to either preoperative staging with breast MRI (n = 220) or no breast MRI (n = 220) (control group). Treatment planning of all patients was discussed at multidisciplinary team conferences. Results In patients randomized to the MRI group, who had an observed higher percentage of planned breast-con- serving surgery (BCS) compared with the control group, a change from suggested breast conservation to mastectomy occurred in 23 of 153 (15 %) patients. Breast MRI pro- vided additional information in 83 of 220 (38 %) patients, which caused a change in treatment plan in 40 (18 %). The breast reoperation rate was significantly lower in the MRI group: 11 of 220 (5 %) versus 33 of 220 (15 %) in the control group (p \ 0.001). The number of mastectomies, axillary reoperations, and the number of patients receiving neoadjuvant chemotherapy after definitive treatment did not differ significantly between the groups. Conclusions Preoperative staging with breast MRI in women younger than age 56 years altered the treatment plan in 18 % of the patients. Although a higher MRI- related conversion rate from breast conservation to mas- tectomy was found, the final numbers of mastectomies did not differ between the two groups. The breast reoperation rate in the MRI group was significantly reduced.
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| 14. |
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| 15. |
- Isaksson, Karin, et al.
(författare)
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Bilateral risk-reducing mastectomies with implant-based reconstructions followed long term : a consecutive series of 185 patients
- 2019
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Ingår i: World Journal of Surgery. - : Springer Science and Business Media LLC. - 0364-2313 .- 1432-2323. ; 43:9, s. 2262-2270
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Bilateral risk-reducing mastectomy (BRRM) is the most effective method to prevent breast cancer in genetically predisposed women and is often performed concomitantly with breast reconstruction. The reconstruction time varies and corrective surgeries are common.METHODS: This study evaluated 185 consecutive cases of BRRM and immediate breast reconstruction with implants with regard to surgical outcome and resource consumption. With an 18-year observation period, it was possible to compare permanent expander implants (PEIs) with permanent fixed volume implants (PIs).RESULTS: A minimum follow-up of 2 years for all participants but one was achieved. Seventy-five percent (n = 138) of the women received PEI and 25% (n = 47) PI. In a multivariate analysis including age, BMI (<25, ≥25), smoking (yes, no), implant type (PEI, PI), incision technique, operation time and specimen weight <350 g, ≥350 g), only BMI ≥25 was associated with an increased risk of an early complication (OR 7.1, 95% CI 2.44-20.4). As expected, there was a significant difference in median reconstruction time between PEI and PI (12.4 vs. 1.0 months, p < 0.001). The cumulative reoperation-free 2-year survival was significantly higher in the PI than in the PEI group (81% vs. 26%, p < 0.001).CONCLUSION: Implant-based reconstruction remains a valid option after BRRM in high-risk women. Whenever possible (low BMI and small breast volume without severe ptosis), permanent fixed volume implants can be safely recommended and are resource saving in comparison with permanent expander implants.
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| 16. |
- Karlsson, Anders, et al.
(författare)
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The accuracy of incremental pre-operative breast MRI findings - Concordance with histopathology in the Swedish randomized multicenter POMB trial
- 2019
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Ingår i: European Journal of Radiology. - : ELSEVIER IRELAND LTD. - 0720-048X .- 1872-7727. ; 114, s. 185-191
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: The Pre-Operative MRI of the Breast (POMB) trial was a randomized, prospective, multicenter trial evaluating the impact of pre-operative breast MRI on treatment regimens and short-term surgical outcomes in women up to 56 years of age with breast cancer. The purpose of this study was to evaluate the performance of pre-operative breast MRI in the POMB trial with respect to incremental MRI findings - over conventional breast imaging methods - and their concordance with histopathology.Patients and methods: Two-hundred and ten patients (n = 210) participating in the POMB trial underwent preoperative breast MRI at two Swedish breast units. Positive predictive values (PPV) for the incremental MRI findings were calculated for three subgroups of patients with: 1. alteration/alterations of treatment plan; 2. no alteration of treatment plan; and, 3. MRI-related conversion from BCS to mastectomy. Area under the receiver operating characteristic curve (AUC) was calculated using in-breast BI-RADS based ratings for the whole MRI group.Results: After exclusions a total number of 99 incremental findings in 78 patients were eligible for statistical analysis resulting in a PPV = 74%: (95% CI 60-84%) in 39 patients with MRI related alterations of initial treatment plans and 27%: (95% CI 14-44%) in 39 patients without. Positive predictive values of incremental findings decisive for specific treatment alteration/s were 83% (95% CI 68-92%) in patients with any alteration of initial treatment plans and 91% (95% CI 70-98%) for patients (n = 20/22) with conversion from breast conserving surgery to mastectomy. The empirical AUC for the incremental findings in the whole MRI group was 85% (95% CI 78-91%).Conclusion: Breast MRI, performed and evaluated together with conventional breast imaging methods can provide relevant information at a high degree of accuracy in the pre-operative setting.
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| 17. |
- Martinsson, Lisa, 1985-
(författare)
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Quality improvement in palliative care : the role of a national quality register and perceptions of information during palliative chemotherapy
- 2015
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- IntroductionThere is a need in palliative care for development of structured methods to assess quality and support improvement. This need is present both within and outside specialised palliative care.Honest information from physicians is regarded as an important part of palliative care. Information about the transition to end-of-life care (ITEOL), conveyed by physicians to patients, has also been described as a ‘breakpoint conversation’.Quality registers enable monitoring and improvement of quality of care, and clinical research. The Swedish Register of Palliative Care (SRPC) is a Swedish national quality register that collects data from hospitals, hospices, nursing homes and home care, with an end-of-life questionnaire (ELQ) about palliative care content focusing on the last week of life.AimsStudy I – The aim was to examine the validity of the ELQ from the SRPC.Study II – The aim was to examine whether participation in the SRPC increases the quality of palliative care over a three-year period regarding eight items in the ELQ.Study III – The aim was to examine whether an educational intervention for physicians and nurses in nursing homes and hospitals increases the proportion of patients who receive ITEOL.Study IV – The aim was to describe how patients with cancer perceive the information they receive from physicians during palliative chemotherapy.MethodsStudy I – Data from 100 medical records and data from the paper versions of the ELQ filled in at a specialised palliative unit were compared with data reported to the SRPC.Study II – Data from eight items in the ELQ reported to the SRPC from all healthcare units that had reported patients continuously during a three-year period were compared year-by-year with logistic regression.Study III – Two municipalities (in charge of nursing homes) and two hospitals were randomised to receive an interactive half-day course about ITEOL for physicians and nurses. Four hospitals and four municipalities were assigned matched controls. The proportion of patients who received ITEOL before and after the intervention was measured with the ELQ. The effect of the intervention was analysed with a multivariable logistic regression model.Study IV – Fifteen semi-structured interviews with patients with incurable cancer were conducted, transcribed verbatim and analysed with qualitative content analysis.ResultsStudy I – The questions in the ELQ showed a congruity of 22% to 100% when comparing data from medical records with data reported to the SRPC. Eight questions fell below 80%. The paper versions filled in at the unit and the data reported to the SRPC showed a congruity of between 91% and 100%.Study II – The prevalence of six symptoms decreased. The prescription of PRN (pro re nata – ‘as needed’) medications for pain, nausea, anxiety and death rattle increased. A higher proportion of patients died in their place of preference. The patient’s next of kin was more often offered a follow-up appointment after the patient’s death. There was no change in the proportion of patients or next of kin who received ITEOL.Study III – The proportion of patients in the intervention group who received ITEOL increased from 35.1% (during a six-month period before the intervention) to 42.0% (during a six-month period after the intervention). The proportion in the control group increased from 30.4% to 33.7%. The effect of the intervention was significant (p=0.005) in the multivariable model.Study IV – Three categories were disclosed during the analytical process: ‘living with a death sentence’, ‘depending on chemotherapy’, and ‘living with uncertainty’.ConclusionsA national quality register has the potential of contributing to quality improvement in palliative care. Study I showed varied validity in the ELQ, implying a need to modify the questionnaire. Study II showed that participation in the SRPC was covariant with quality improvements in end-of-life care over time. Study III showed that more patients received ITEOL after an educative half-day intervention directed to physicians and nurses. Study IV showed that patients undergoing palliative chemotherapy perceived that their disease was incurable and deadly, and that conditions for future treatment and survival were uncertain.
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| 18. |
- Pawitan, Yudi, et al.
(författare)
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Gene expression profiling spares early breast cancer patients from adjuvant therapy : derived and validated in two population-based cohorts
- 2005
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Ingår i: Breast cancer research : BCR. - : Springer Science and Business Media LLC. - 1465-5411 .- 1465-542X. ; 7:6, s. R953-64
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: Adjuvant breast cancer therapy significantly improves survival, but overtreatment and undertreatment are major problems. Breast cancer expression profiling has so far mainly been used to identify women with a poor prognosis as candidates for adjuvant therapy but without demonstrated value for therapy prediction. METHODS: We obtained the gene expression profiles of 159 population-derived breast cancer patients, and used hierarchical clustering to identify the signature associated with prognosis and impact of adjuvant therapies, defined as distant metastasis or death within 5 years. Independent datasets of 76 treated population-derived Swedish patients, 135 untreated population-derived Swedish patients and 78 Dutch patients were used for validation. The inclusion and exclusion criteria for the studies of population-derived Swedish patients were defined. RESULTS: Among the 159 patients, a subset of 64 genes was found to give an optimal separation of patients with good and poor outcomes. Hierarchical clustering revealed three subgroups: patients who did well with therapy, patients who did well without therapy, and patients that failed to benefit from given therapy. The expression profile gave significantly better prognostication (odds ratio, 4.19; P = 0.007) (breast cancer end-points odds ratio, 10.64) compared with the Elston-Ellis histological grading (odds ratio of grade 2 vs 1 and grade 3 vs 1, 2.81 and 3.32 respectively; P = 0.24 and 0.16), tumor stage (odds ratio of stage 2 vs 1 and stage 3 vs 1, 1.11 and 1.28; P = 0.83 and 0.68) and age (odds ratio, 0.11; P = 0.55). The risk groups were consistent and validated in the independent Swedish and Dutch data sets used with 211 and 78 patients, respectively. CONCLUSION: We have identified discriminatory gene expression signatures working both on untreated and systematically treated primary breast cancer patients with the potential to spare them from adjuvant therapy.
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| 19. |
- Robertson, Stephanie, et al.
(författare)
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Waiting times for cancer patients in Sweden : A nationwide population-based study
- 2017
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Ingår i: Scandinavian Journal of Public Health. - : SAGE PUBLICATIONS LTD. - 1403-4948 .- 1651-1905. ; 45:3, s. 230-237
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Tidskriftsartikel (refereegranskat)abstract
- Aims: The reported long waiting times for cancer patients have mostly been related to prognostic outcome and less to patient-related experience to outcome. We assessed waiting times for patients with cancer of the breast, prostate, colon or rectum in Sweden.Methods: The median time from referral to start of treatment was assessed using data from clinical cancer registers for patients who received curative treatment during 2011, 2012 and 2013.Results: The median overall waiting time in different counties ranged from 7 to 28 days for breast cancer, from 117 to 280 days for prostate cancer, from 27 to 64 days for colon cancer and from 48 to 80 days for rectal cancer. For the entire nation, the median time from referral to start of treatment remained unchanged from 2011 to 2013 for each cancer diagnosis.Conclusions: Large variations were found in waiting times between different counties in Sweden and between different types of cancer. The long waiting times identified in this study emphasize the need to improve national programmes for more rapid diagnosis and treatment.
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| 20. |
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