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  1. Article ; Online: The impact of COVID-19 lockdown on glycaemic control and use of health services among children followed at a Danish diabetes clinic.

    Kofoed, Poul-Erik / Timm, Signe

    Acta paediatrica (Oslo, Norway : 1992)

    2021  Volume 111, Issue 2, Page(s) 368–375

    Abstract: Aim: During COVID-19 restrictions, the paediatric clinic only accepted essential outpatient visits, schools closed, sports activities and social life were limited. Most employees worked at home. This quasi-experiment evaluates how this affected ... ...

    Abstract Aim: During COVID-19 restrictions, the paediatric clinic only accepted essential outpatient visits, schools closed, sports activities and social life were limited. Most employees worked at home. This quasi-experiment evaluates how this affected glycaemic control and use of health services among children with diabetes.
    Methods: Paired t-tests were used to compare HbA1c-values before, during and after lockdown. Sub-analyses were stratified by pre-lockdown HbA1c-values.
    Results: Overall mean HbA1c decreased from 58.3 to 56.9 mmol/mol (p = 0.025) from pre- to post-lockdown, a decrease also seen during the same season the previous year. HbA1c decreased by -4.2 mmol/mol (p = 0.002) for patients with pre-lockdown HbA1c > 59 mmol/mol, but increased slightly by 0.8 mmol/mol (p = 0.176) for patients with HbA1c < 52 mmol/mol. HbA1c measured 8 months post-lockdown increased again, most pronounced for patients with lowest HbA1c. During lockdown, virtual contacts increased from 0.1 to 0.5 contacts/patient/month and stayed post-lockdown at 0.3 contacts/patient/month.
    Conclusion: Compared to 2019, overall the COVID-19 restrictions did not influence the glycaemic control negatively. However, patients with pre-lockdown HbA1c < 52 mmol/mol experienced a deterioration, whereas those with HbA1c > 59 mmol/mol experienced an improvement. Less stress and more contact with parents may contribute to the last-mentioned finding. The lockdown enforced more virtual contacts between patients and the clinic.
    MeSH term(s) Blood Glucose ; COVID-19/prevention & control ; Child ; Communicable Disease Control ; Denmark ; Diabetes Mellitus/therapy ; Glycated Hemoglobin A/analysis ; Glycemic Control ; Health Services ; Humans
    Chemical Substances Blood Glucose ; Glycated Hemoglobin A
    Language English
    Publishing date 2021-10-05
    Publishing country Norway
    Document type Journal Article
    ZDB-ID 203487-6
    ISSN 1651-2227 ; 0365-1436 ; 0803-5253
    ISSN (online) 1651-2227
    ISSN 0365-1436 ; 0803-5253
    DOI 10.1111/apa.16128
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Methylated Cell-Free Tumor DNA in Sputum as a Tool for Diagnosing Lung Cancer-A Systematic Review and Meta-Analysis.

    Wen, Sara Witting Christensen / Borg, Morten / Timm, Signe / Hansen, Torben Frøstrup / Hilberg, Ole / Andersen, Rikke Fredslund

    Cancers

    2024  Volume 16, Issue 3

    Abstract: Lung cancer is the leading cause of cancer-related mortality worldwide. Early diagnosis is pivotal for the prognosis. There is a notable overlap between lung cancer and chronic bronchitis, and the potential use of methylated tumor DNA in sputum as a ... ...

    Abstract Lung cancer is the leading cause of cancer-related mortality worldwide. Early diagnosis is pivotal for the prognosis. There is a notable overlap between lung cancer and chronic bronchitis, and the potential use of methylated tumor DNA in sputum as a biomarker for lung cancer detection is appealing. This systematic review and meta-analysis followed the PRISMA 2020 statement. A comprehensive search was conducted in Embase, Medline, Web of Science, and the Cochrane Library, using these search strings: Lung cancer, sputum, and methylated tumor DNA. A total of 15 studies met the eligibility criteria. Studies predominantly utilized a case-control design, with sensitivity ranging from 10 to 93% and specificity from 8 to 100%. A meta-analysis of all genes across studies resulted in a summary sensitivity of 54.3% (95% CI 49.4-59.2%) and specificity of 79.7% (95% CI 75.0-83.7%). Notably, two less explored genes (TAC1, SOX17) demonstrated sensitivity levels surpassing 85%. The study's findings highlight substantial variations in the sensitivity and specificity of methylated tumor DNA in sputum for lung cancer detection. Challenges in reproducibility could stem from differences in tumor site, sample acquisition, extraction methods, and methylation measurement techniques. This meta-analysis provides a foundation for prioritizing high-performing genes, calling for a standardization and refinement of methodologies before potential application in clinical trials.
    Language English
    Publishing date 2024-01-24
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2527080-1
    ISSN 2072-6694
    ISSN 2072-6694
    DOI 10.3390/cancers16030506
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Missingness mechanisms and generalizability of patient reported outcome measures in colorectal cancer survivors - assessing the reasonableness of the "missing completely at random" assumption.

    Lyhne, Johanne Dam / Smith, Allan 'Ben' / Jensen, Lars Henrik / Hansen, Torben Frøstrup / Frostholm, Lisbeth / Timm, Signe

    BMC medical research methodology

    2024  Volume 24, Issue 1, Page(s) 104

    Abstract: Background: Patient-Reported Outcome Measures (PROM) provide important information, however, missing PROM data threaten the interpretability and generalizability of findings by introducing potential bias. This study aims to provide insight into ... ...

    Abstract Background: Patient-Reported Outcome Measures (PROM) provide important information, however, missing PROM data threaten the interpretability and generalizability of findings by introducing potential bias. This study aims to provide insight into missingness mechanisms and inform future researchers on generalizability and possible methodological solutions to overcome missing PROM data problems during data collection and statistical analyses.
    Methods: We identified 10,236 colorectal cancer survivors (CRCs) above 18y, diagnosed between 2014 and 2018 through the Danish Clinical Registries. We invited a random 20% (2,097) to participate in a national survey in May 2023. We distributed reminder e-mails at day 10 and day 20, and compared Initial Responders (response day 0-9), Subsequent Responders (response day 10-28) and Non-responders (no response after 28 days) in demographic and cancer-related characteristics and PROM-scores using linear regression.
    Results: Of the 2,097 CRCs, 1,188 responded (57%). Of these, 142 (7%) were excluded leaving 1,955 eligible CRCs. 628 (32%) were categorized as initial responders, 418 (21%) as subsequent responders, and 909 (47%) as non-responders. Differences in demographic and cancer-related characteristics between the three groups were minor and PROM-scores only marginally differed between initial and subsequent responders.
    Conclusion: In this study of long-term colorectal cancer survivors, we showed that initial responders, subsequent responders, and non-responders exhibit comparable demographic and cancer-related characteristics. Among respondents, Patient-Reported Outcome Measures were also similar, indicating generalizability. Assuming Patient-Reported Outcome Measures of subsequent responders represent answers by the non-responders (would they be available), it may be reasonable to judge the missingness mechanism as Missing Completely At Random.
    MeSH term(s) Humans ; Colorectal Neoplasms/therapy ; Patient Reported Outcome Measures ; Female ; Male ; Cancer Survivors/statistics & numerical data ; Aged ; Middle Aged ; Denmark ; Surveys and Questionnaires ; Registries/statistics & numerical data ; Adult ; Quality of Life ; Aged, 80 and over
    Language English
    Publishing date 2024-05-03
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2041362-2
    ISSN 1471-2288 ; 1471-2288
    ISSN (online) 1471-2288
    ISSN 1471-2288
    DOI 10.1186/s12874-024-02236-z
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: Methylated Circulating Tumor DNA in Blood as a Tool for Diagnosing Lung Cancer: A Systematic Review and Meta-Analysis.

    Borg, Morten / Wen, Sara Witting Christensen / Andersen, Rikke Fredslund / Timm, Signe / Hansen, Torben Frøstrup / Hilberg, Ole

    Cancers

    2023  Volume 15, Issue 15

    Abstract: Lung cancer is the leading cause of cancer-related deaths, and early detection is crucial for improving patient outcomes. Current screening methods using computed tomography have limitations, prompting interest in non-invasive diagnostic tools such as ... ...

    Abstract Lung cancer is the leading cause of cancer-related deaths, and early detection is crucial for improving patient outcomes. Current screening methods using computed tomography have limitations, prompting interest in non-invasive diagnostic tools such as methylated circulating tumor DNA (ctDNA). The PRISMA guidelines for systematic reviews were followed. The electronic databases MEDLINE, Embase, Web of Science, and Cochrane Library were systematically searched for articles. The search string contained three main topics: Lung cancer, blood, and methylated ctDNA. The extraction of data and quality assessment were carried out independently by the reviewers. In total, 33 studies were eligible for inclusion in this systematic review and meta-analysis. The most frequently studied genes were SHOX2, RASSF1A, and APC. The sensitivity and specificity of methylated ctDNA varied across studies, with a summary sensitivity estimate of 46.9% and a summary specificity estimate of 92.9%. The area under the hierarchical summary receiver operating characteristics curve was 0.81. The included studies were generally of acceptable quality, although they lacked information in certain areas. The risk of publication bias was not significant. Based on the findings, methylated ctDNA in blood shows potential as a rule-in tool for lung cancer diagnosis but requires further research, possibly in combination with other biomarkers.
    Language English
    Publishing date 2023-08-03
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2527080-1
    ISSN 2072-6694
    ISSN 2072-6694
    DOI 10.3390/cancers15153959
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  5. Article ; Online: Ceramic-on-Ceramic Total Hip Arthroplasty and Noises: A Prospective Blinded Randomized Controlled Trial of Influence of Component Design.

    Paulsen, Rune T / Revald, Peter H / Kjærsgaard-Andersen, Per / Timm, Signe / Varnum, Claus

    The Journal of arthroplasty

    2023  Volume 39, Issue 3, Page(s) 734–738

    Abstract: Background: Noises have been associated with ceramic-on-ceramic bearings in total hip arthroplasties. The etiology is multifactorial, but a high prevalence of noises was reported in studies using a specific acetabular component system. We examined if ... ...

    Abstract Background: Noises have been associated with ceramic-on-ceramic bearings in total hip arthroplasties. The etiology is multifactorial, but a high prevalence of noises was reported in studies using a specific acetabular component system. We examined if specific ceramic component designs are associated with the prevalence of noises in 2 commonly used component systems. We hypothesized that there would be no difference in noises between the 2 systems.
    Methods: In this randomized controlled trial, 2 different component designs with ceramic bearings were compared. Inclusion criteria were primary total hip arthroplasties, age between 18 and 65 years, and body mass index less than 35. The primary outcome was prevalence of noises, whereas secondary outcomes consisted of European Quality of Life index, visual analog scale, and University of California and Los Angeles activity scale. Follow-up data were collected at 3 and 12 months postoperatively. Data were available for 91 patients in Group 1 and for 92 patients in Group 2. Preoperative patient characteristics were comparable between groups.
    Results: At 12-month follow-up, the prevalence of noises was 19% in Group 1 and 14% in Group 2 (P = .41). European Quality of Life index were 0.89 in Group 1 versus 0.90 in Group 2 (P = .42). The visual analog scale was 81 in both groups (P = .88). When evaluating level of activity, University of California and Los Angeles activity scale scores were 8.2 in both groups (P = .92).
    Conclusion: At 12-month follow-up, there was no difference in the prevalence of noises between the 2 component designs.
    MeSH term(s) Humans ; Adolescent ; Young Adult ; Adult ; Middle Aged ; Aged ; Arthroplasty, Replacement, Hip ; Hip Prosthesis ; Prospective Studies ; Quality of Life ; Ceramics ; Prosthesis Design ; Follow-Up Studies ; Treatment Outcome ; Prosthesis Failure
    Language English
    Publishing date 2023-08-29
    Publishing country United States
    Document type Randomized Controlled Trial ; Journal Article
    ZDB-ID 632770-9
    ISSN 1532-8406 ; 0883-5403
    ISSN (online) 1532-8406
    ISSN 0883-5403
    DOI 10.1016/j.arth.2023.08.076
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  6. Article ; Online: The prognostic value of tumor budding in a thoroughly characterized stage II colon cancer population in the context of a national screening program.

    Pihlmann Kristensen, Maria / Korsgaard, Ulrik / Timm, Signe / Hansen, Torben Frøstrup / Zlobec, Inti / Hager, Henrik / Kjær-Frifeldt, Sanne

    Human pathology

    2024  Volume 146, Page(s) 15–22

    Abstract: Tumor budding as a prognostic marker in colorectal cancer has not previously been investigated in a cohort of screened stage II colon cancer patients. We assessed the prognostic significance of tumor budding in a thoroughly characterized stage II colon ... ...

    Abstract Tumor budding as a prognostic marker in colorectal cancer has not previously been investigated in a cohort of screened stage II colon cancer patients. We assessed the prognostic significance of tumor budding in a thoroughly characterized stage II colon cancer population comprising surgically resected patients in the Region of Southern Denmark from 2014 to 2016. Tumors were re-staged according to the 8th edition of UICC TNM Classification, undergoing detailed histopathological evaluation and tumor budding assessment following guidelines from the International Tumor Budding Consensus Conference. Prognostic evaluation utilized Kaplan-Meier curves, log-rank tests, and Cox proportional hazard models for time to recurrence (TTR), recurrence-free survival (RFS), and overall survival (OS). Out of 497 patients, 20% were diagnosed through the national colorectal cancer screening program. High-grade tumor budding (Bd3) was found in 19% of tumors and was associated with glandular subtype, perineural invasion, mismatch repair proficient tumors, and tumor recurrence (p < 0.001, p < 0.001, p = 0.045, and p = 0.007 respectively). In multivariable Cox regression, high-grade budding was a significant prognostic factor for TTR compared to low-grade (Bd3 HR 2.617; p = 0.007). An association between tumor budding groups and RFS was observed, and the difference was significant in univariable analysis for high-grade compared to low-grade tumor budding (Bd3 HR 1.461; p = 0.041). No significant differences were observed between tumor budding groups and OS. High-grade tumor budding is a predictor of recurrence in a screened population of patients with stage II colon cancer and should be considered a high-risk factor in a shared decision-making process when stratifying patients to adjuvant chemotherapy.
    MeSH term(s) Humans ; Female ; Male ; Aged ; Colonic Neoplasms/pathology ; Colonic Neoplasms/mortality ; Neoplasm Staging ; Middle Aged ; Prognosis ; Denmark/epidemiology ; Neoplasm Recurrence, Local/pathology ; Early Detection of Cancer/methods ; Aged, 80 and over
    Language English
    Publishing date 2024-02-28
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 207657-3
    ISSN 1532-8392 ; 0046-8177
    ISSN (online) 1532-8392
    ISSN 0046-8177
    DOI 10.1016/j.humpath.2024.02.010
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  7. Article ; Online: Diffusion-Weighted MRI in Patients with Testicular Tumors-Intra- and Interobserver Variability.

    Pedersen, Malene Roland Vils / Loft, Martina Kastrup / Dam, Claus / Rasmussen, Lone Ærenlund Lohmann / Timm, Signe

    Current oncology (Toronto, Ont.)

    2022  Volume 29, Issue 2, Page(s) 837–847

    Abstract: In general, magnetic resonance (MR) diffusion-weighted imaging (DWI) has shown potential in clinical settings. In testicles parenchyma, the DW imaging helps differentiate and characterize benign from malignant lesions. Placement and size of the region of ...

    Abstract In general, magnetic resonance (MR) diffusion-weighted imaging (DWI) has shown potential in clinical settings. In testicles parenchyma, the DW imaging helps differentiate and characterize benign from malignant lesions. Placement and size of the region of interest (ROI) may affect the ADC value. Therefore, the aim of this study was to investigate the intra- and interobserver variability in testicular tumors when measuring ADC using various types of regions of interest (ROI). Two observers performed the ADC measurements in testicular lesions based on three ROI methods: (1)
    MeSH term(s) Diffusion Magnetic Resonance Imaging/methods ; Humans ; Magnetic Resonance Imaging ; Male ; Observer Variation ; Reproducibility of Results ; Testicular Neoplasms/diagnostic imaging
    Language English
    Publishing date 2022-02-02
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 1236972-x
    ISSN 1718-7729 ; 1198-0052
    ISSN (online) 1718-7729
    ISSN 1198-0052
    DOI 10.3390/curroncol29020071
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  8. Article ; Online: Validity and screening capacity of the FCR-1r for fear of cancer recurrence in long-term colorectal cancer survivors.

    Lyhne, Johanne Dam / Smith, Allan Ben / Timm, Signe / Simard, Sébastien / Jensen, Lars Henrik / Frostholm, Lisbeth / Fink, Per

    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer

    2023  Volume 31, Issue 12, Page(s) 690

    Abstract: Purpose: Existing fear of cancer recurrence (FCR) screening measures is being shortened to facilitate clinical use. This study aimed to evaluate the validity and screening capacity of a single-item FCR screening measure (FCR-1r) in long-term colorectal ... ...

    Abstract Purpose: Existing fear of cancer recurrence (FCR) screening measures is being shortened to facilitate clinical use. This study aimed to evaluate the validity and screening capacity of a single-item FCR screening measure (FCR-1r) in long-term colorectal cancer (CRC) survivors with no recurrence and assess whether it performs as well in older as in younger survivors.
    Methods: All Danish CRC survivors above 18, diagnosed and treated with curative intent between 2014 and 2018, were located through a national patient registry. A questionnaire including the FCR-1r, which measures FCR on a 0-10 visual analog scale, alongside the validated Fear of Cancer Recurrence Inventory Short Form (FCRI-SF) as a reference standard was distributed between November 2021 and May 2023. Screening capacity and cut-offs were evaluated with a receiver-operating characteristic analysis (ROC) in older (≥ 65 years) compared to younger (< 65 years) CRC survivors. Hypotheses regarding associations with other psychological variables were tested as indicators of convergent and divergent validity.
    Results: Of the CRC survivors, 2,128/4,483 (47.5%) responded; 1,654 (36.9%) questionnaires were eligible for analyses (median age 76 (range 38-98), 47% female). Of the responders, 85.2% were aged ≥ 65. Ninety-two participants (5.6%) reported FCRI-SF scores ≥ 22 indicating clinically significant FCR. A FCR-1r cut-off ≥ 5/10 had 93.5% sensitivity and 80.4% specificity for detecting clinically significant FCR (AUC = 0.93, 95% CI 0.91-0.94) in the overall sample. The discrimination ability was significantly better in older (AUC = 0.93, 95% CI 0.91-0.95) compared to younger (0.87, 95% (0.82-0.92), p = 0.04) CRC survivors. The FCR-1r demonstrated concurrent validity against the FCRI-SF (r = 0.71, p < 0.0001) and convergent validity against the short-versions of the Symptom Checklist-90-R subscales for anxiety (r = 0.38, p < 0.0001), depression (r = 0.27, p < 0.0001), and emotional distress (r = 0.37, p < 0.0001). The FCR-1r correlated weakly with employment status (r =  - 0.09, p < 0.0001) and not with marital status (r = 0.01, p = 0.66) indicating divergent validity.
    Conclusions: The FCR-1r is a valid tool for FCR screening in CRC survivors with excellent ability to discriminate between clinical and non-clinical FCR, particularly in older CRC survivors.
    MeSH term(s) Humans ; Female ; Aged ; Male ; Phobic Disorders/psychology ; Early Detection of Cancer ; Neoplasm Recurrence, Local/diagnosis ; Neoplasm Recurrence, Local/psychology ; Fear/psychology ; Survivors/psychology ; Colorectal Neoplasms/diagnosis ; Colorectal Neoplasms/psychology
    Language English
    Publishing date 2023-11-11
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 1134446-5
    ISSN 1433-7339 ; 0941-4355
    ISSN (online) 1433-7339
    ISSN 0941-4355
    DOI 10.1007/s00520-023-08159-7
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Study protocol: fish oil supplement in prevention of oxaliplatin-induced peripheral neuropathy in adjuvant colorectal cancer patients - a randomized controlled trial. (OxaNeuro).

    Gehr, Nina Lykkegaard / Karlsson, Páll / Timm, Signe / Christensen, Signe / Hvid, Christian Andreas / Peric, Jana / Hansen, Torben Frøstrup / Lauritzen, Lotte / Finnerup, Nanna Brix / Ventzel, Lise

    BMC cancer

    2024  Volume 24, Issue 1, Page(s) 168

    Abstract: Background: Oxaliplatin-induced peripheral neuropathy (OIPN) in general and painful OIPN in particular is a debilitating late effect that severely affects cancer survivors' quality of life and causes premature cessation of potentially lifesaving ... ...

    Abstract Background: Oxaliplatin-induced peripheral neuropathy (OIPN) in general and painful OIPN in particular is a debilitating late effect that severely affects cancer survivors' quality of life and causes premature cessation of potentially lifesaving treatment. No preventive treatments and no effective treatment for chronic OIPN exist despite many attempts. One of several suggested mechanisms includes neuroinflammation as a contributing factor to OIPN. Fish oil containing long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFAs) are precursors to specialized proresolving mediators that mediate the resolution of inflammation. Our primary hypothesis is that a high supplementation of n-3 LCPUFAs will lower the prevalence and severity of OIPN.
    Methods: The OxaNeuro project is an investigator-initiated, multicenter, double-blinded, randomized, placebo-controlled clinical study. We will include 120 patients eligible to receive adjuvant oxaliplatin after colorectal cancer surgery. Patients will receive fish oil capsules containing n-3 LCPUFAs or corn oil daily for 8 months. The primary endpoint is the prevalence of OIPN at 8 months defined as relevant symptoms, including one of the following: abnormal nerve conduction screening, abnormal vibration threshold test, abnormal skin biopsy, or abnormal pinprick test. Additional endpoints include the intensity and severity of OIPN-related neuropathic pain, patient-reported OIPN symptoms, quality of life, mental health symptoms, body composition, and cognitive evaluation. Furthermore, we will evaluate inflammatory biomarkers in blood samples and skin biopsies, including the potential OIPN biomarker neurofilament light protein (NfL) which will be measured before each cycle of chemotherapy.
    Discussion: If readily available fish oil supplementation alleviates OIPN prevalence and severity, it will significantly improve the lives of both cancer survivors and palliative cancer patients receiving oxaliplatin; it will improve their quality of life, optimize chemotherapeutic treatment plans by lowering the need for dose reduction or premature cessation, and potentially increase survival.
    Trial registration: ClinicalTrial.gov identifier: NCT05404230 Protocol version: 1.2, April 25
    MeSH term(s) Humans ; Oxaliplatin/adverse effects ; Fish Oils/therapeutic use ; Quality of Life ; Peripheral Nervous System Diseases/chemically induced ; Peripheral Nervous System Diseases/prevention & control ; Peripheral Nervous System Diseases/diagnosis ; Dietary Supplements ; Adjuvants, Immunologic/therapeutic use ; Colorectal Neoplasms/drug therapy ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic
    Chemical Substances Oxaliplatin (04ZR38536J) ; Fish Oils ; Adjuvants, Immunologic
    Language English
    Publishing date 2024-02-03
    Publishing country England
    Document type Clinical Trial Protocol ; Journal Article
    ZDB-ID 2041352-X
    ISSN 1471-2407 ; 1471-2407
    ISSN (online) 1471-2407
    ISSN 1471-2407
    DOI 10.1186/s12885-024-11856-z
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  10. Article ; Online: Shared decision making with breast cancer patients - does it work? Results of the cluster-randomized, multicenter DBCG RT SDM trial.

    Søndergaard, Stine Rauff / Bechmann, Troels / Maae, Else / Nielsen, Anders W Mølby / Nielsen, Mette Holck / Møller, Mette / Timm, Signe / Lorenzen, Ebbe Laugaard / Berry, Leonard L / Zachariae, Robert / Offersen, Birgitte Vrou / Steffensen, Karina Dahl

    Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology

    2024  Volume 193, Page(s) 110115

    Abstract: Background and purpose: Shared decision making (SDM) is a patient engaging process advocated especially for preference-sensitive decisions, such as adjuvant treatment after breast cancer. An increasing call for patient engagement in decision making ... ...

    Abstract Background and purpose: Shared decision making (SDM) is a patient engaging process advocated especially for preference-sensitive decisions, such as adjuvant treatment after breast cancer. An increasing call for patient engagement in decision making highlights the need for a systematic SDM approach. The objective of this trial was to investigate whether the Decision Helper (DH), an in-consultation patient decision aid, increases patient engagement in decisions regarding adjuvant whole breast irradiation.
    Material and methods: Oncologists at four radiotherapy units were randomized to practice SDM using the DH versus usual practice. Patient candidates for adjuvant whole breast irradiation after breast conserving surgery for node-negative breast cancer were eligible. The primary endpoint was patient-reported engagement in the decision process assessed with the Shared Decision Making Questionnaire (SDM-Q-9) (range 0-100, 4 points difference considered clinical relevant). Other endpoints included oncologist-reported patient engagement, decisional conflict, fear of cancer recurrence, and decision regret after 6 months.
    Results: Of the 674 included patients, 635 (94.2%) completed the SDM-Q-9. Patients in the intervention group reported higher level of engagement (median 80; IQR 68.9 to 94.4) than the control group (71.1; IQR 55.6 to 82.2; p < 0.0001). Oncologist-reported patient engagement was higher in the invention group (93.3; IQR 82.2 to 100) compared to control group (73.3; IQR 60.0 to 84.4) (p < 0.0001).
    Conclusion: Patient engagement in medical decision making was significantly improved with the use of an in-consultation patient decision aid compared to standard. The DH on adjuvant whole breast irradiation is now recommended as standard of care in the Danish guideline.
    MeSH term(s) Humans ; Female ; Decision Making, Shared ; Decision Making ; Breast Neoplasms/surgery ; Neoplasm Recurrence, Local ; Patient Participation ; Aminoacridines
    Chemical Substances SDM (50815-81-1) ; Aminoacridines
    Language English
    Publishing date 2024-02-03
    Publishing country Ireland
    Document type Randomized Controlled Trial ; Multicenter Study ; Journal Article
    ZDB-ID 605646-5
    ISSN 1879-0887 ; 0167-8140
    ISSN (online) 1879-0887
    ISSN 0167-8140
    DOI 10.1016/j.radonc.2024.110115
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