63 research outputs found
Trialists perspectives on sustaining, spreading, and scaling-up of quality improvement interventions
No full textAbstract
Background
Quality improvement (QI) evaluations rarely consider how a successful intervention can be sustained long term, nor how to spread or scale to other locations. A survey of authors of randomized trials of diabetes QI interventions included in an ongoing systematic review found that 78% of trials reported improved quality of care, but 40% of these trials were not sustained. This study explores why and how the effective interventions were sustained, spread, or scaled.
Methods
A qualitative approach was used, focusing on case examples. Diabetes QI program trial authors were purposefully sampled and recruited for telephone interviews. Authors were eligible if they had completed the author survey, agreed to follow-up, and had a completed a diabetes QI trial they deemed “effective.” Snowball sampling was used if the participant identified someone who could provide a different perspective on the same trial. Interviews were transcribed verbatim. Inductive thematic analysis was conducted to identify barriers and facilitators to sustainability, spread, and/or scale of the QI program, using case examples to show trajectories across projects and people.
Results
Eleven of 44 eligible trialists participated in an interview. Four reported that the intervention was “sustained” and nine were “spread,” however, interviews highlighted that these terms were interpreted differently over time and between participants. Participant stories highlighted the varied trajectories of how projects evolved and how some research careers adapted to increase impact. Three interacting themes, termed the “3C’s,” helped explain the variation in sustainability, spread, and scale: (i) understanding the concepts of implementation, sustainability, sustainment, spread, and scale; (ii) having the appropriate competencies; and (iii) the need for individual, organizational, and system capacity.
Conclusions
Challenges in defining sustainability, spread and scale make it difficult to fully understand impact. However, it is clear that from the beginning of intervention design, trialists need to understand the concepts and have the competency and capacity to plan for feasible and sustainable interventions that have potential to be sustained, spread and/or scaled if found to be effective
An aphasia research agenda–a consensus statement from the collaboration of aphasia trialists
No full textCoordination of international aphasia research would minimise duplication of effort, support synergistic international activities across languages and multidisciplinary perspectives, and promote high-quality conduct and reporting of aphasia research, thereby increasing the relevance, transparency, and implementation of findings. The Collaboration of Aphasia Trialists (CATs) sought to develop an aphasia research agenda to direct future research activities, based on priorities shared by people with aphasia, family members, and healthcare professionals. Our established international research network spanning 33 countries contributed to this activity. Research literature reporting the priorities of stakeholders was reviewed and synthesized (phase 1). Representatives from Working Groups on Aphasia Assessment & Outcomes, Prognosis & Predictors of Recovery, Effectiveness of Interventions, and Societal Impact & Reintegration participated in a two-day research agenda-setting meeting. The CATs expert panel refined research objectives and identified constituent components of research and methodological developments required to address these research components. The objectives and research components were grouped into overarching themes (phase 2). The resultant list was then circulated to more than 180 CATs members for review, revision, and approval. Consensus on the final aphasia research agenda and roadmap was reached by CATs executive committee (phase 3). The expert panel identified five overarching research themes: (i) evidence-based interventions for people with aphasia, (ii) effective interventions to support those communicating with people with aphasia, (iii) cross-linguistic assessment and core outcomes for aphasia research, (iv) predictors of language recovery, and (v) clinical implementation of research findings. Within these broad themes, 30 research objectives and 91 individual aphasia research components were identified and sequentially ordered. This agenda builds on research priorities identified by people with aphasia and their families, and includes priorities of healthcare professionals and researchers, and will support the rehabilitation and recovery of people with aphasia. Our internationally relevant research agenda promotes rigor in methodology, considers international applicability, synergistic activities, and sharing of resources and expertise. © 2021 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group
Extra-pleural pneumonectomy versus no extra-pleural pneumonectomy for patients with malignant pleural mesothelioma: clinical outcomes of the Mesothelioma and Radical Surgery (MARS) randomised feasibility study.
No full textBACKGROUND: The effects of extra-pleural pneumonectomy (EPP) on survival and quality of life in patients with malignant pleural mesothelioma have, to our knowledge, not been assessed in a randomised trial. We aimed to assess the clinical outcomes of patients who were randomly assigned to EPP or no EPP in the context of trimodal therapy in the Mesothelioma and Radical Surgery (MARS) feasibility study. METHODS: MARS was a multicentre randomised controlled trial in 12 UK hospitals. Patients aged 18 years or older who had pathologically confirmed mesothelioma and were deemed fit enough to undergo trimodal therapy were included. In a prerandomisation registration phase, all patients underwent induction platinum-based chemotherapy followed by clinical review. After further consent, patients were randomly assigned (1:1) to EPP followed by postoperative hemithorax irradiation or to no EPP. Randomisation was done centrally with computer-generated permuted blocks stratified by surgical centre. The main endpoints were feasibility of randomly assigning 50 patients in 1 year (results detailed in another report), proportion randomised who received treatment, proportion eligible (registered) who proceeded to randomisation, perioperative mortality, and quality of life. Patients and investigators were not masked to treatment allocation. This is the principal report of the MARS study; all patients have been recruited. Analyses were by intention to treat. This trial is registered, number ISRCTN95583524. FINDINGS: Between Oct 1, 2005, and Nov 3, 2008, 112 patients were registered and 50 were subsequently randomly assigned: 24 to EPP and 26 to no EPP. The main reasons for not proceeding to randomisation were disease progression (33 patients), inoperability (five patients), and patient choice (19 patients). EPP was completed satisfactorily in 16 of 24 patients assigned to EPP; in five patients EPP was not started and in three patients it was abandoned. Two patients in the EPP group died within 30 days and a further patient died without leaving hospital. One patient in the no EPP group died perioperatively after receiving EPP off trial in a non-MARS centre. The hazard ratio [HR] for overall survival between the EPP and no EPP groups was 1·90 (95% CI 0·92-3·93; exact p=0·082), and after adjustment for sex, histological subtype, stage, and age at randomisation the HR was 2·75 (1·21-6·26; p=0·016). Median survival was 14·4 months (5·3-18·7) for the EPP group and 19·5 months (13·4 to time not yet reached) for the no EPP group. Of the 49 randomly assigned patients who consented to quality of life assessment (EPP n=23; no EPP n=26), 12 patients in the EPP group and 19 in the no EPP group completed the quality of life questionnaires. Although median quality of life scores were lower in the EPP group than the no EPP group, no significant differences between groups were reported in the quality of life analyses. There were ten serious adverse events reported in the EPP group and two in the no EPP group. INTERPRETATION: In view of the high morbidity associated with EPP in this trial and in other non-randomised studies a larger study is not feasible. These data, although limited, suggest that radical surgery in the form of EPP within trimodal therapy offers no benefit and possibly harms patients. FUNDING: Cancer Research UK (CRUK/04/003), the June Hancock Mesothelioma Research Fund, and Guy's and St Thomas' NHS Foundation Trust
Randomized Polypill Crossover Trial in People Aged 50 and Over
No full textPMCID: PMC3399742This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Screening for Future Cardiovascular Disease Using Age Alone Compared with Multiple Risk Factors and Age
No full textThis is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
OA 02.07 Surgical Selection in Pleurectomy Decortication for Mesothelioma – an Overview from Screening and Selection from MARS 2 Pilot
No full textOpen data, trials and new ethics of using others\u27 work.
No full textData and ideas are the capital of research productivity. Is it ethical to preempt the publication of another researcher\u27s unpublished data or preliminary analysis, perhaps without citation? The long-established answer is \u27certainly not\u27-but recent \u27open data\u27 use suggests otherwise. A research competition was held using data from The Systolic Blood Pressure Intervention Trial (SPRINT). This SPRINT Data Analysis Challenge created a novel environment for using open data as data became open early. This allowed third-party researchers the opportunity to assess some of the trial\u27s outcomes before trialists. Could this infringe on trialists\u27 right to analyse their data? Simultaneously, trialists had access to analyses from submissions to the competition that were not formally \u27published\u27 with a typical author credit or citation. Therefore, trialists had the opportunity to view the competition submissions and published on those ideas first without a typical way to cite the source of that idea. Could this infringe on researchers\u27 right to be credited for their ideas? This is not intended as a criticism of open data, the SPRINT Data Analysis Challenge, or similar systems/ventures, but is an effort to objectively note what may be remediable flaws in the worthwhile, growing and dynamic uses of open data. We offer preliminary analytics to shed more light and provide fodder for additional discussion
Preventative therapies for healthy women at high risk of breast cancer
No full textIvana Sestak Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, Charterhouse Square, London, UKAbstract: Tamoxifen has been shown to reduce the risk of developing estrogen receptor (ER)-positive breast cancer by at least 50%, in both pre- and postmenopausal women. The current challenge is to find new agents with fewer side effects and to find agents that are specifically suitable for premenopausal women with ER-negative breast cancer. Other selective estrogen receptor modulators (SERMs), such as raloxifene, arzoxifene, and lasofoxifene, have been shown to reduce the incidence of breast cancer by 50%–80%. SERMs are interesting agents for the prevention of breast cancer, but longer follow-up is needed for some of them for a complete risk–benefit profile of these drugs. Aromatase inhibitors have emerged as new drugs in the prevention setting for postmenopausal women. In the Mammary Prevention 3 (MAP3) trial, a 65% reduction in invasive breast cancer with exemestane was observed, and the Breast Cancer Intervention Study-II trial, which compared anastrozole with placebo, reported a 60% reduction in those cancers. Although SERMs and aromatase inhibitors have been proven to be excellent agents in the preventive setting specifically for postmenopausal women and ER-positive breast cancer, newer agents have to be found specifically for ER-negative breast cancers, which mostly occur in premenopausal women. Keywords: breast cancer, preventive therapy, selective estrogen receptor modulators, aromatase inhibitors, high-risk wome
Rofecoxib and cardiovascular adverse events in adjuvant treatment of colorectal cancer
No full textBackground
Selective cyclooxygenase inhibitors may retard the progression of cancer, but they
have enhanced thrombotic potential. We report on cardiovascular adverse events in
patients receiving rofecoxib to reduce rates of recurrence of colorectal cancer.
Methods
All serious adverse events that were cardiovascular thrombotic events were reviewed
in 2434 patients with stage II or III colorectal cancer participating in a randomized,
placebo-controlled trial of rofecoxib, 25 mg daily, started after potentially curative
tumor resection and chemotherapy or radiotherapy as indicated. The trial was terminated
prematurely owing to worldwide withdrawal of rofecoxib. To examine possible
persistent risks, we examined cardiovascular thrombotic events reported up to 24
months after the trial was closed.
Results
The median duration of active treatment was 7.4 months. The 1167 patients receiving
rofecoxib and the 1160 patients receiving placebo were well matched, with a median
follow-up period of 33.0 months (interquartile range, 27.6 to 40.1) and 33.4 months
(27.7 to 40.4), respectively. Of the 23 confirmed cardiovascular thrombotic events,
16 occurred in the rofecoxib group during or within 14 days after the treatment
period, with an estimated relative risk of 2.66 (from the Cox proportional-hazards
model; 95% confidence interval [CI], 1.03 to 6.86; P = 0.04). Analysis of the Antiplatelet
Trialists’ Collaboration end point (the combined incidence of death from
cardiovascular, hemorrhagic, and unknown causes; of nonfatal myocardial infarction;
and of nonfatal ischemic and hemorrhagic stroke) gave an unadjusted relative
risk of 1.60 (95% CI, 0.57 to 4.51; P = 0.37). Fourteen more cardiovascular thrombotic
events, six in the rofecoxib group, were reported within the 2 years after trial
closure, with an overall unadjusted relative risk of 1.50 (95% CI, 0.76 to 2.94;
P = 0.24). Four patients in the rofecoxib group and two in the placebo group died
from thrombotic causes during or within 14 days after the treatment period, and
during the follow-up period, one patient in the rofecoxib group and five patients in
the placebo group died from cardiovascular causes.
Conclusions
Rofecoxib therapy was associated with an increased frequency of adverse cardiovascular
events among patients with a median study treatment of 7.4 months’ duration.
(Current Controlled Trials number, ISRCTN98278138.
Use of methods for specifying the target difference in randomised controlled trial sample size calculations : Two surveys of trialists' practice
No full text© The Author(s), 2014.Peer reviewe
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