Cancer of Oesophagus or Gastricus – New Assessment of Technology of Endosonography (COGNATE): report of pragmatic randomised trial

Russell, Ian; Edwards, Rob; Gliddon, A.; Ingledew, David K.; Russell, Daphne; Whitaker, Rhiannon; Yeo, Seow Tien; Attwood, Stephen; Barr, H; Nanthakumaran, Shayanthan; Park, K G M

doi:10.3310/hta17390

Cited by 18 publications

(31 citation statements)

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“…a difference between infliximab and ciclosporin groups of at least 0.35 of the population standard error), with 80% power when using a 5% significance level, required that we analysed at least 250 of the 270 participants recruited to the trial. Although more than 10% of CONSTRUCT participants were likely to drop out over the follow-up period of at least 12 months, all analyses exploited the techniques of statistical imputation used successfully by the Cancer of the Oesophagus or Gastricus: New Assessment of the Technology of Endosonography 58 and Folate Augmentation of Treatment -Evaluation of Depression 59 trials to maintain the effective sample size at 250. Our initial, more conservative, power calculation had proposed to recruit 480 participants (to yield an analysable sample of 360); not to impute missing data statistically, therefore to allow for 25% loss to follow-up; and thus to yield 80% power to detect a slightly smaller effect size of 0.30 in CUCQ scores.…”

Section: Power Calculationmentioning

confidence: 99%

“…To detect an effect size of 0.35 in these scores with 80% power when using a 5% significance level, required that we analyse at least 250 trial participants. We used the techniques of statistical imputation applied successfully by the Cancer of the Oesophagous or Gastricus: New Assessment of the Technology of Endosonography 58 and Folate Augmentation of Treatment -Evaluation of Depression (FolATED) 59 trials to achieve an effective sample size of 250 for CONSTRUCT.…”

Section: Sample Size and Powermentioning

confidence: 99%

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Comparison Of iNfliximab and ciclosporin in STeroid Resistant Ulcerative Colitis: pragmatic randomised Trial and economic evaluation (CONSTRUCT)

Williams

Alam

Alrubaiy

et al. 2016

Health Technol Assess

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BackgroundThe efficacy of infliximab and ciclosporin in treating severe ulcerative colitis (UC) is proven, but there has been no comparative evaluation of effectiveness.ObjectiveTo compare the clinical effectiveness and cost-effectiveness of infliximab and ciclosporin in treating steroid-resistant acute severe UC.MethodBetween May 2010 and February 2013 we recruited 270 participants from 52 hospitals in England, Scotland and Wales to an open-label parallel-group, pragmatic randomised trial. Consented patients admitted with severe colitis completed baseline quality-of-life questionnaires before receiving intravenous hydrocortisone. If they failed to respond within about 5 days, and met other inclusion criteria, we invited them to participate and used a web-based adaptive randomisation algorithm to allocate them in equal proportions between 5 mg/kg of intravenous infliximab at 0, 2 and 6 weeks or 2 mg/kg/day of intravenous ciclosporin for 7 days followed by 5.5 mg/kg/day of oral ciclosporin until 12 weeks from randomisation. Further treatment was at the discretion of physicians responsible for clinical management. The primary outcome was quality-adjusted survival (QAS): the area under the curve (AUC) of scores derived from Crohn’s and Ulcerative Colitis Questionnaires completed by participants at 3 and 6 months, and then 6-monthly over 1–3 years, more frequently after surgery. Secondary outcomes collected simultaneously included European Quality of Life-5 Dimensions (EQ-5D) scores and NHS resource use to estimate cost-effectiveness. Blinding was possible only for data analysts. We interviewed 20 trial participants and 23 participating professionals. Funded data collection finished in March 2014. Most participants consented to complete annual questionnaires and for us to analyse their routinely collected health data over 10 years.ResultsThe 135 participants in each group were well matched at baseline. In 121 participants analysed in each group, we found no significant difference between infliximab and ciclosporin in QAS [mean difference in AUC/day 0.0297 favouring ciclosporin, 95% confidence interval (CI) –0.0088 to 0.0682;p = 0.129]; EQ-5D scores (quality-adjusted life-year mean difference 0.021 favouring ciclosporin, 95% CI –0.032 to 0.096;p = 0.350); Short Form questionnaire-6 Dimensions scores (mean difference 0.0051 favouring ciclosporin, 95% CI –0.0250 to 0.0353;p = 0.737). There was no statistically significant difference in colectomy rates [odds ratio (OR) 1.350 favouring infliximab, 95% CI 0.832 to 2.188;p = 0.223]; numbers of serious adverse reactions (event ratio = 0.938 favouring ciclosporin, 95% CI 0.590 to 1.493;p = 0.788); participants with serious adverse reactions (OR 0.660 favouring ciclosporin, 95% CI 0.282 to 1.546;p = 0.338); numbers of serious adverse events (event ratio 1.075 favouring infliximab, 95% CI 0.603 to 1.917;p = 0.807); participants with serious adverse events (OR 0.999 favouring infliximab, 95% CI 0.473 to 2.114;p = 0.998); deaths (all three who died received infliximab;p = 0.247) or concomitant use of immunosuppressants. The lower cost of ciclosporin led to lower total NHS costs (mean difference –£5632, 95% CI –£8305 to –£2773;p < 0.001). Interviews highlighted the debilitating effect of UC; participants were more positive about infliximab than ciclosporin. Professionals reported advantages and disadvantages with both drugs, but nurses disliked the intravenous ciclosporin.ConclusionsTotal cost to the NHS was considerably higher for infliximab than ciclosporin. Nevertheless, there was no significant difference between the two drugs in clinical effectiveness, colectomy rates, incidence of SAEs or reactions, or mortality, when measured 1–3 years post treatment. To assess long-term outcome participants will be followed up for 10 years post randomisation, using questionnaires and routinely collected data. Further studies will be needed to evaluate the efficacy and effectiveness of new anti-tumour necrosis factor drugs and formulations of ciclosporin.Trial registrationCurrent Controlled Trials ISRCTN22663589.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 44. See the NIHR Journals Library website for further project information.

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Section: Power Calculationmentioning

confidence: 99%

Section: Sample Size and Powermentioning

confidence: 99%

Comparison Of iNfliximab and ciclosporin in STeroid Resistant Ulcerative Colitis: pragmatic randomised Trial and economic evaluation (CONSTRUCT)

Williams

Alam

Alrubaiy

et al. 2016

Health Technol Assess

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“…Five of the studies included in the review were US studies, and one was a UK study. Of the three economic analysis studies, two were cost analyses [26, 27] and one was a cost-effectiveness analysis [11]. Of the three economic modelling studies, two were cost-minimisation analyses [29, 30] and one was a cost-effectiveness analysis [31].…”

Section: Resultsmentioning

confidence: 99%

“…The sensitivity of EUS for staging of GOC has been widely evaluated; however, the economic evidence of EUS staging in the management of GOC patients is scarce. Furthermore, the effectiveness and cost-effectiveness of EUS staging of GOC had not been assessed, particularly in the form of randomised controlled trials (RCT), until the establishment of “COGNATE” trial - a HTA-funded RCT UK study [11].…”

Section: Introductionmentioning

confidence: 99%

Endoscopic ultrasound staging in patients with gastro-oesophageal cancers: a systematic review of economic evidence

et al. 2019

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Background The sensitivity of endoscopic ultrasound (EUS) in staging gastro-oesophageal cancers (GOCs) has been widely studied. However, the economic evidence of EUS staging in the management of patients with GOCs is scarce. This review aimed to examine all economic evidence (not limited to randomised controlled trials) of the use of EUS staging in the management of GOCs patients, and to offer a review of economic evidence on the costs, benefits (in terms of GOCs patients’ health-related quality of life), and economic implications of the use of EUS in staging GOCs patients. Methods The protocol was registered prospectively with PROSPERO (CRD42016043700; http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42016043700). MEDLINE (ovid), EMBASE (ovid), The Cochrane Collaboration Register and Library (including the British National Health Service Economic Evaluation Database), CINAHL (EBSCOhost) and Web of Science (Core Collection) as well as reference lists were systematically searched for studies conducted between 1996 and 2018 (search update 28/04/2018). Two authors independently screened the identified articles, assessed study quality, and extracted data. Study characteristics of the included articles, including incremental cost-effectiveness ratios, when available, were summarised narratively. Results Of the 197 articles retrieved, six studies met the inclusion criteria: three economic studies and three economic modelling studies. Of the three economic studies, one was a cost-effectiveness analysis and two were cost analyses. Of the three economic modelling studies, one was a cost-effectiveness analysis and two were cost-minimisation analyses. Both of the cost-effectiveness analyses reported that use of EUS as an additional staging technique provided, on average, more QALYs (0.0019–0.1969 more QALYs) and saved costs (by £1969–£3364 per patient, 2017 price year) compared to staging strategy without EUS. Of the six studies, only one included GOCs participants and the other five included oesophageal cancer participants. Conclusions The data available suggest use of EUS as a complementary staging technique to other staging techniques for GOCs appears to be cost saving and offers greater QALYs. Nevertheless, future studies are necessary because the economic evidence around this EUS staging intervention for GOCs is far from robust. More health economic research and good quality data are needed to judge the economic benefits of EUS staging for GOCs. PROSPERO Registration Number CRD42016043700.

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“…Confidence intervals (CI) for costs and health-related QoL were estimated using non-parametric bootstrapping methods. 28 , 29 A simulation of 5000 non-parametric bootstrapping iterations was run to construct 95% CI around estimates of costs and QoL scores using Microsoft Excel 2013.…”

Section: Methodsmentioning

confidence: 99%

Randomised feasibility study to compare the use of Therabite ® with wooden spatulas to relieve and prevent trismus in patients with cancer of the head and neck

Lee

Yeo

Rogers

et al. 2018

British Journal of Oral and Maxillofacial Surgery

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Our aim was to compare the efficacy of the Therabite® jaw motion rehabilitation system (Atos Medical) with that of wooden spatulas to relieve and prevent trismus in patients who have had radiotherapy for stage three and four oral and oropharyngeal cancer. Secondary aims were to assess the feasibility and the impact of exercise on health-related quality of life (QoL), and the use of health services after treatment. We designed a randomised, open-label, controlled, three-centre feasibility study to compare the effectiveness and cost of the Therabite® and wooden spatulas. We studied compliance with exercises and health-related QoL, assessed cost using three health economics measures, and conducted semistructured interviews with patients. Patients were randomised into two groups: the Therabite® group (n = 37) and the wooden spatula group (n = 34). All patients had some sense of jaw tightening before the study started. Mean mouth opening after six months increased in both groups, but the difference between the groups was not significant (p = 0.39). Completion rates for the three economic measures were good. There was no significant difference between the two groups in frequency of contact with care services or in QoL. Exercises during and after radiotherapy can ameliorate trismus in patients with stage three and four oral and oropharygeal cancers, but differences between groups in efficacy, compliance, QoL, or use of hospital or community health services, were not significant.

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Cancer of Oesophagus or Gastricus – New Assessment of Technology of Endosonography (COGNATE): report of pragmatic randomised trial

Cited by 18 publications

References 73 publications

Comparison Of iNfliximab and ciclosporin in STeroid Resistant Ulcerative Colitis: pragmatic randomised Trial and economic evaluation (CONSTRUCT)

Comparison Of iNfliximab and ciclosporin in STeroid Resistant Ulcerative Colitis: pragmatic randomised Trial and economic evaluation (CONSTRUCT)

Endoscopic ultrasound staging in patients with gastro-oesophageal cancers: a systematic review of economic evidence

Randomised feasibility study to compare the use of Therabite ® with wooden spatulas to relieve and prevent trismus in patients with cancer of the head and neck

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