scholarly journals Novel longitudinal Multiple Overall Toxicity (MOTox) score to quantify adverse events experienced by patients during chemotherapy treatment: a retrospective analysis of the MRC BO06 trial in osteosarcoma

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e053456
Author(s):  
Marta Spreafico ◽  
Francesca Ieva ◽  
Francesca Arlati ◽  
Federico Capello ◽  
Federico Fatone ◽  
...  
Keyword(s):  
Adverse Events ◽  
Retrospective Analysis ◽  
Controlled Trial ◽  
Haematological Toxicity ◽  
Population Based ◽  
Toxicity Data ◽  
Time Dimension ◽  
High Grade Osteosarcoma ◽  
Randomised Controlled ◽  
The Impact

ObjectivesThis study aims at exploring and quantifying multiple types of adverse events (AEs) experienced by patients during cancer treatment. A novel longitudinal score to evaluate the Multiple Overall Toxicity (MOTox) burden is proposed. The MOTox approach investigates the personalised evolution of high overall toxicity (high-MOTox) during the treatment.DesignRetrospective analysis of the MRC-BO06/EORTC-80931 randomised controlled trial for osteosarcoma.SettingInternational multicentre population-based study.ParticipantsA total of 377 patients with resectable high-grade osteosarcoma, who completed treatment within 180 days after randomisation without abnormal dosages (+25% higher than planned).InterventionsPatients were randomised to six cycles of conventional versus dose-intense regimens of doxorubicin and cisplatin. Non-haematological toxicity data were collected prospectively and graded according to the Common Terminology Criteria for Adverse Events (CTCAE).Main outcome measuresThe MOTox score described the overall toxicity burden in terms of multiple toxic AEs, maximum-severity episode and cycle time-dimension. Evolution of high-MOTox was assessed through multivariable models, that investigated the impact of personalised characteristics (eg, achieved chemotherapy dose, previous AEs or biochemical factors) cycle-by-cycle.ResultsA cycle-by-cycle analysis identifies different evolutions of MOTox levels during treatment, detecting differences in patients’ health. Mean MOTox values and percentages of patients with high-MOTox decreased cycle-by-cycle from 2.626 to 1.953 and from 57.8% to 36.6%, respectively. High-MOTox conditions during previous cycles were prognostic risk factors for a new occurrence (ORs range from 1.522 to 4.439), showing that patient’s history of toxicities played an important role in the evolution of overall toxicity burden during therapy. Conventional regimen may be preferred to dose-intense in terms of AEs at cycles 2–3 (p<0.05).ConclusionsThe novel longitudinal method developed can be applied to any cancer studies with CTCAE-graded toxicity data. After validation in other studies, the MOTox approach may lead to improvements in healthcare assessment and treatment planning.Trial registration numberISRCTN86294690; Post-results.

scholarly journals Method to measure the mismatch between target and achieved received dose intensity of chemotherapy in cancer trials: a retrospective analysis of the MRC BO06 trial in osteosarcoma

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e022980 ◽  
Author(s):  
Carlo Lancia ◽  
Jakob Anninga ◽  
Cristian Spitoni ◽  
Matthew R. Sydes ◽  
Jeremy Whelan ◽  
...  
Keyword(s):  
Retrospective Analysis ◽  
Controlled Trial ◽  
Dose Intensity ◽  
Population Based ◽  
Secondary Outcome ◽  
Individual Level ◽  
Study Results ◽  
Treatment Data ◽  
High Grade Osteosarcoma ◽  
Randomised Controlled

ObjectivesIn cancer studies, the target received dose intensity (tRDI) for any regimen, the intended dose and time for the regimen, is commonly taken as a proxy for achieved RDI (aRDI), the actual individual dose and time for the regimen. Evaluating tRDI/aRDI mismatches is crucial to assess study results whenever patients are stratified on allocated regimen. The manuscript develops a novel methodology to highlight and evaluate tRDI/aRDI mismatches.DesignRetrospective analysis of a randomised controlled trial, MRC BO06 (EORTC 80931).SettingPopulation-based study but proposed methodology can be applied to other trial designs.ParticipantsA total of 497 patients with resectable high-grade osteosarcoma, of which 19 were excluded because chemotherapy was not started or the estimated dose was abnormally high (>1.25 × prescribed dose).Intervention(s)Two regimens with the same anticipated cumulative dose (doxorubicin 6×75 mg/m2/week; cisplatin 6×100 mg/m2/week) over different time schedules: every 3 weeks in regimen-C and every 2 weeks in regimen-DI.Primary and secondary outcome measurestRDI distribution was measured across groups of patients derived from k-means clustering of treatment data. K-means creates groups of patients who are aRDI-homogeneous. The main outcome is the proportion of tRDI values in groups of homogeneous aRDI.ResultsFor nearly half of the patients, there is a mismatch between tRDI and aRDI; for 21%, aRDI was closer to the tRDI of the other regimen.ConclusionsFor MRC BO06, tRDI did not predict well aRDI. The manuscript offers an original procedure to highlight the presence of and quantify tRDI/aRDI mismatches. Caution is required to interpret the effect of chemotherapy-regimen intensification on survival outcome at an individual level where such a mismatch is present.The study relevance lies in the use of individual realisation of the intended treatment, which depends on individual delays and/or dose reductions reported throughout the treatment.Trial registration numberISRCTN86294690.

scholarly journals Maternal dietary selenium intake is associated with increased gestational length and decreased risk of preterm delivery

2019 ◽  
Vol 123 (2) ◽  
pp. 209-219
Author(s):  
Malin Barman ◽  
Anne Lise Brantsæter ◽  
Staffan Nilsson ◽  
Margaretha Haugen ◽  
Thomas Lundh ◽  
...  
Keyword(s):  
Preterm Delivery ◽  
Genome Wide Association Study ◽  
Controlled Trial ◽  
Maternal Blood ◽  
Population Based ◽  
Gestational Length ◽  
Gestational Week ◽  
Randomised Controlled ◽  
The Impact ◽  
Se Status

AbstractThe first positive genome-wide association study on gestational length and preterm delivery showed the involvement of an Se metabolism gene. In the present study, we examine the association between maternal intake of Se and Se status with gestational length and preterm delivery in 72 025 women with singleton live births from the population-based, prospective Norwegian Mother, Father and Child Cohort Study (MoBa). A self-reported, semi-quantitative FFQ answered in pregnancy week 22 was used to estimate Se intake during the first half of pregnancy. Associations were analysed with adjusted linear and Cox regressions. Se status was assessed in whole blood collected in gestational week 17 (n 2637). Median dietary Se intake was 53 (interquartile range (IQR) 44–62) µg/d, supplements provided additionally 50 (IQR 30–75) µg/d for supplement users (n 23 409). Maternal dietary Se intake was significantly associated with prolonged gestational length (β per sd = 0·25, 95 % CI, 0·07, 0·43) and decreased risk of preterm delivery (n 3618, hazard ratio per sd = 0·92, 95 % CI, 0·87, 0·98). Neither Se intake from supplements nor maternal blood Se status was associated with gestational length or preterm delivery. Hence, the present study showed that maternal dietary Se intake but not intake of Se-containing supplements, during the first half of pregnancy was significantly associated with decreased risk of preterm delivery. Further investigations, preferably in the form of a large randomised controlled trial, are needed to elucidate the impact of Se on pregnancy duration.

scholarly journals Examining the impact of oral hygiene advice and/or scale and polish on periodontal disease: the IQuaD cluster factorial randomised controlled trial

BDJ ◽  
2021 ◽  
Vol 230 (4) ◽  
pp. 229-235
Author(s):  
Jan Clarkson ◽  
Craig Ramsay ◽  
Thomas Lamont ◽  
Beatriz Goulao ◽  
Helen Worthington ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Periodontal Disease ◽  
Oral Hygiene ◽  
Controlled Trial ◽  
Randomised Controlled ◽  
The Impact

Feasibility study of a communication and education asthma intervention for general practitioners in Australia

2010 ◽  
Vol 16 (1) ◽  
pp. 75 ◽  
Author(s):  
Smita Shah ◽  
Brett G. Toelle ◽  
Susan M. Sawyer ◽  
Jessica K. Roydhouse ◽  
Peter Edwards ◽  
...  
Keyword(s):  
General Practitioners ◽  
Controlled Trial ◽  
Communication Strategies ◽  
Asthma Management ◽  
Doctor Patient Communication ◽  
Children With Asthma ◽  
The Usa ◽  
Randomised Controlled ◽  
Communication Behaviours ◽  
The Impact

The Physician Asthma Care Education (PACE) program significantly improved asthma prescribing and communication behaviours of primary care paediatricians in the USA. We tested the feasibility and acceptability of a modified PACE program with Australian general practitioners (GP) and measured its impact on self-reported consulting behaviours in a pilot study. Recruitment took place through a local GP division. Twenty-five GP completed two PACE Australia workshops, which incorporated paediatric asthma management consistent with Australian asthma guidelines and focussed on effective communication strategies. Program feasibility, usefulness and perceived benefit were measured by questionnaires before the workshop and 1 month later, and an evaluation questionnaire after each workshop. GP were universally enthusiastic and supportive of the workshops. The most useful elements they reported were communication skills, case studies, device demonstrations and the toolkit provided. GP self reports of the perceived helpfulness of the key communication strategies and their confidence in their application and reported frequency of use increased significantly after the workshops. The PACE program shows promise in improving the way in which Australian GP manage asthma consultations, particularly with regard to doctor–patient communication. The impact of the modified PACE Australia program on the processes and outcomes of GP care of children with asthma is now being measured in a randomised controlled trial.

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