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| 2. |
- Nilsson, Stefan, 1972, et al.
(författare)
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Evaluating pictorial support in person-centred care for children (PicPecc) : A protocol for a crossover design study
- 2021
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Ingår i: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 11:5
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Tidskriftsartikel (refereegranskat)abstract
- Introduction This study protocol outlines the evaluation of the pictorial support in person-centred care for children (PicPecc). PicPecc is a digital tool used by children aged 5-17 years to self-report symptoms of acute lymphoblastic leukaemia, who undergo high-dose methotrexate treatments. The design of the digital platform follows the principles of universal design using pictorial support to provide accessibility for all children regardless of communication or language challenges and thus facilitating international comparison.Methods and analysis Both effect and process evaluations will be conducted. A crossover design will be used to measure the effect/outcome, and a mixed-methods design will be used to measure the process/implementation. The primary outcome in the effect evaluation will be self-reported distress. Secondary outcomes will be stress levels monitored via neuropeptides, neurosteroids and peripheral steroids indicated in plasma blood samples; frequency of in-app estimation of high levels of distress by the children; children's use of analgesic medicine and person centeredness evaluated via the questionnaire Visual CARE Measure. For the process evaluation, qualitative interviews will be carried out with children with cancer, their legal guardians and case-related healthcare professionals. These interviews will address experiences with PicPecc in terms of feasibility and frequency of use from the child's perspective and value to the caseworker. Interview transcripts will be analysed using an interpretive description methodology.Ethics and dissemination Ethical approval was obtained from the Swedish Ethical Review Authority (reference 2019-02392; 2020-02601; 2020-06226). Children, legal guardians, healthcare professionals, policymaking and research stakeholders will be involved in all stages of the research process according to Medical Research Council's guidelines. Research findings will be presented at international cancer and paediatric conferences and published in scientific journals.Trial registration ClinicalTrials.gov; NCT04433650.
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- Correa-Marinez, Adiela, et al.
(författare)
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Stoma-related complications: a report from the Stoma-Const randomized controlled trial
- 2021
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Ingår i: Colorectal Disease. - : Wiley. - 1462-8910 .- 1463-1318. ; 23:5, s. 1091-1101
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Tidskriftsartikel (refereegranskat)abstract
- Aim: The impact of construction techniques on the development of stoma complications is partly undiscovered. The aim of this paper was to report and analyse the impact of the three surgical techniques in a randomized controlled trial Stoma-Const on stoma-related complications as well as identifying risk factors and patient-reported stoma function as a planned secondary analysis. Methods: This was a randomized, multicenter trial where all patients scheduled to receive an end colostomy were invited to participate. Patients were randomized to one of three techniques for stoma construction; cruciate fascial incision, circular incision or prophylactic mesh. Stoma complications were assessed by a surgeon and stoma care nurses within 1 year postoperatively. Results: Two hundred and nine patients were randomized. Patient demographics were similar in all three groups. Data on stoma-related complications were available for analysis in 201 patients. A total of 127 patients (63%) developed some type of stoma complication within 1 year after surgery. The risk ratio (95% CI) for stoma complications was 0.93 (0.73; 1.2) between cruciate vs. circular incision groups and 1.02 (0.78; 1.34) between cruciate vs. mesh groups. There were no statistically significant differences between the groups regarding parastomal hernia rate and no risk factors could be identified. Conclusion: This randomized trial confirmed a high prevalence of stoma-related complications but could not identify an impact of surgical technique or identify modifiable risk factors for stoma-related complications.
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| 4. |
- Gehrman, Jacob, 1986, et al.
(författare)
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Cost-effectiveness analysis of laparoscopic and open surgery in routine Swedish care for colorectal cancer
- 2020
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Ingår i: Surgical Endoscopy. - : Springer Science and Business Media LLC. - 0930-2794 .- 1432-2218. ; 24:4403-4412
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Tidskriftsartikel (refereegranskat)abstract
- Background: Laparoscopic surgery for colorectal cancer has been shown in clinical trials to be effective regarding short-term outcomes and oncologically safe. Health economic analyses have been performed early in the learning curve when adoption of laparoscopic surgery was not extensive. This cost-effectiveness analysis evaluates laparoscopic versus open colorectal cancer surgery in Swedish routine care. Methods: In this national retrospective cohort study, data were retrieved from the Swedish ColoRectal Cancer Registry. Clinical effectiveness, resource use and unit costs were derived from this and other sources with nationwide coverage. The study period was 2013 and 2014 with 1 year follow-up. Exclusion criterion comprised cT4-tumors. Clinical effectiveness was estimated in a composite endpoint of all-cause resource-consuming events in inpatient care, readmissions and deaths up to 90days postoperatively. Up to 1 year, events predefined as related to the primary surgery were included. Costs included resource-consuming events, readmissions and sick leave and were estimated for both the society and healthcare. Multivariable regression analyses were used to adjust for differences in baseline characteristics between the groups. Results: After exclusion of cT4 tumors, the cohort included 7707 patients who underwent colorectal cancer surgery: 6060 patients in the open surgery group and 1647 patients in the laparoscopic group. The mean adjusted difference in clinical effectiveness between laparoscopic and open colorectal cancer surgery was 0.23 events (95% CI 0.12 to 0.33). Mean adjusted differences in costs (open minus laparoscopic surgery) were $4504 (95% CI 2257 to 6799) and $4480 (95% CI 2739 to 6203) for the societal and the healthcare perspective respectively. In both categories, resource consuming events in inpatient care were the main driver of the results. Conclusion: In a national cohort, laparoscopic colorectal cancer surgery was associated with both superior outcomes for clinical effectiveness and cost versus open surgery. © 2019, The Author(s).
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- Johansson, Mia, 1977, et al.
(författare)
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Long-term survival after treatment for primary anal cancer– results from the Swedish national ANCA cohort study
- 2022
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Ingår i: Acta Oncologica. - 0284-186X. ; 61:4, s. 478-83
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Tidskriftsartikel (refereegranskat)abstract
- Background: Squamous cell carcinoma of the anus is increasing in incidence but remains a rare disease with good 3- and 5-year recurrence free and overall survival rates of 63%–86%. The treatment includes chemoradiotherapy, mainly with 5-fluoruracil (5FU) and mitomycin. The aim of this study was to describe long-term (up to 9years after treatment) oncological outcome and the types of treatments given, in a Swedish national cohort of patients diagnosed with anal cancer between 2011 and 2013. Method: Patients were identified in the Swedish Cancer Registry. Patients still alive were contacted and asked for consent. Clinical data were retrieved from National Patient Register at the Swedish National Board of Health and Welfare and from medical records. Unadjusted and adjusted analyses were performed for overall survival. Results: Three hundred and eighty-eight patients were included in the study of which 338 patients (87%) received treatment with a curative intent. Follow up was 85months (0–113months) for patients treated with curative intent (information missing in one patient) 7.5months (0–55) for patients with treated with a palliative intent. Curative treatment varied and consisted of both chemoradiotherapy and radiotherapy (46–64 Gy) alone. 5-FU, mitomycin and cisplatin were the most used chemotherapy agents. Five-year overall survival for patients treated with curative intent was 73%. In an adjusted analysis 5-FU and mitomycin is associated with a lower mortality than 5-FU and cisplatin but the association was weaker (HR 1.61 (95% CI: 0.904; 2.85) than in the unadjusted analysis Conclusions: In this national cohort overall five-year survival was 73% for patients treated with curative intent. As reported by others our results indicate that 5-FU and mitomycin C should be the preferred chemotherapy in treatment for cure. © 2022 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
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- Park, Jennifer, et al.
(författare)
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Cost analysis in a randomized trial of early closure of a temporary ileostomy after rectal resection for cancer (EASY trial).
- 2020
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Ingår i: Surgical endoscopy. - : Springer Science and Business Media LLC. - 1432-2218 .- 0930-2794. ; 34:1, s. 69-76
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Tidskriftsartikel (refereegranskat)abstract
- Hospital costs associated with the treatment of rectal cancer are considerable and the formation of a temporary stoma accounts for additional costs. Results from the EASY trial showed that early closure of a temporary ileostomy was associated with significantly fewer postoperative complications but no difference in health-related quality of life up to 12months after rectal resection. The aim of the present study was to perform a cost analysis within the framework of the EASY trial.Early closure (8-13days) of a temporary stoma was compared to late closure (>12weeks) in the randomized controlled trial EASY (NCT01287637). The study period and follow-up was 12months after rectal resection. Inclusion of participants was made after index surgery. Exclusion criteria were diabetes mellitus, steroid treatment, signs of postoperative complications or anastomotic leakage. Clinical effectiveness and resource use were derived from the trial and unit costs from Swedish sources. Costs were calculated for the year 2016 and analysed from the perspective of the healthcare sector.Fifty-five patients underwent early closure, and 57 late closure in eight Swedish and Danish hospitals between 2011 and 2014. The difference in mean cost per patient was 4060 US dollar (95% confidence interval 1121; 6999, p value<0.01) in favour of early closure. A sensitivity analysis, taking protocol-driven examinations into account, resulted in an overall difference in mean cost per patient of $3608, in favour of early closure (95% confidence interval 668; 6549, p value 0.02). The predominant cost factors were reoperations, readmissions and endoscopic examinations.The significant cost reduction in this study, together with results of safety and efficacy from the randomized controlled trial, supports the routine use of early closure of a temporary ileostomy after rectal resection for cancer in selected patients without signs of anastomotic leakage.Registered at clinicaltrials.gov, clinical trials identifier NCT01287637.
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| 7. |
- Ullmark, Jenny Heiman, 1980, et al.
(författare)
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Sick leave and predictive factors for sick leave at 12 months after breast cancer surgery in the randomized controlled physical activity trial (PhysSURG-B)
- 2023
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Ingår i: Surgeon-Journal of the Royal Colleges of Surgeons of Edinburgh and Ireland. - : Elsevier BV. - 1479-666X. ; 21:5
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To evaluate sick leave 12 months after breast cancer surgery, to analyze the effect of adjuvant chemotherapy and to identify predictive factors for sick leave, based on a randomized controlled trial of a non-supervised physical activity intervention (PhysSURGB).Methods: Sick leave days (for patients age 18-67) were collected from the Swedish Social Insurance Agency, and compared between the intervention and control arm in the trial. A random forest model was used to analyze predictive factors for sick leave, including baseline patient and tumor characteristics as well as patient-reported outcomes measuring quality of life, personality traits, pain, anxiety and depression.Results: A total of 203 patients were analyzed, and when comparing intervention to control, there was no differences in sick leave days (117 vs 55 days, odds ratio 1.21; 95% CI 0.75 -1.96). Adjuvant chemotherapy significantly increased days of sick leave (323 vs 42 days, odds ratio 17.3; 95% CI 9.15-34.2). Factors predicting prolonged sick leave were adjuvant chemotherapy, young age, previous mental health problems and low quality of life (measured as FACT-B score) at baseline.Conclusion: A non-supervised physical activity intervention had no effect on sick leave 12 months after surgery. Significantly longer sick leave was seen in patients treated by adjuvant chemotherapy. Factors predicting prolonged sick leave can be recognized at baseline and utilized when designing future interventions.
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