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Dive into the research topics where Zoe Skea is active.

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Featured researches published by Zoe Skea.


BMJ | 2011

Impact of CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of random sample of 300 trials, 2000-8

Noah Ivers; Monica Taljaard; Stephanie N. Dixon; Carol Bennett; Andrew D McRae; Julia Taleban; Zoe Skea; Jamie C. Brehaut; Robert F. Boruch; Martin P Eccles; Jeremy Grimshaw; Charles Weijer; Merrick Zwarenstein; Allan Donner

Objective To assess the impact of the 2004 extension of the CONSORT guidelines on the reporting and methodological quality of cluster randomised trials. Design Methodological review of 300 randomly sampled cluster randomised trials. Two reviewers independently abstracted 14 criteria related to quality of reporting and four methodological criteria specific to cluster randomised trials. We compared manuscripts published before CONSORT (2000-4) with those published after CONSORT (2005-8). We also investigated differences by journal impact factor, type of journal, and trial setting. Data sources A validated Medline search strategy. Eligibility criteria for selecting studies Cluster randomised trials published in English language journals, 2000-8. Results There were significant improvements in five of 14 reporting criteria: identification as cluster randomised; justification for cluster randomisation; reporting whether outcome assessments were blind; reporting the number of clusters randomised; and reporting the number of clusters lost to follow-up. No significant improvements were found in adherence to methodological criteria. Trials conducted in clinical rather than non-clinical settings and studies published in medical journals with higher impact factor or general medical journals were more likely to adhere to recommended reporting and methodological criteria overall, but there was no evidence that improvements after publication of the CONSORT extension for cluster trials were more likely in trials conducted in clinical settings nor in trials published in either general medical journals or in higher impact factor journals. Conclusion The quality of reporting of cluster randomised trials improved in only a few aspects since the publication of the extension of CONSORT for cluster randomised trials, and no improvements at all were observed in essential methodological features. Overall, the adherence to reporting and methodological guidelines for cluster randomised trials remains suboptimal, and further efforts are needed to improve both reporting and methodology.


BMJ | 2011

Inadequate Reporting of Research Ethics Review and Informed Consent in Cluster Randomised Trials: Review of Random Sample of Published Trials

Monica Taljaard; Andrew McRae; Charles Weijer; Carol Bennett; Stephanie N. Dixon; Julia Taleban; Zoe Skea; Martin Eccles; Jamie C. Brehaut; Allan Donner; Raphael Saginur; Robert F. Boruch; Jeremy Grimshaw

Objectives To investigate the extent to which authors of cluster randomised trials adhered to two basic requirements of the World Medical Association’s Declaration of Helsinki and the International Committee of Medical Journal Editors’ uniform requirements for manuscripts (namely, reporting of research ethics review and informed consent), to determine whether the adequacy of reporting has improved over time, and to identify characteristics of cluster randomised trials associated with reporting of ethics practices. Design Review of a random sample of published cluster randomised trials from an electronic search in Medline. Setting Cluster randomised trials in health research published in English language journals from 2000 to 2008. Study sample 300 cluster randomised trials published in 150 journals. Results 77 (26%, 95% confidence interval 21% to 31%) trials failed to report ethics review. The proportion reporting ethics review increased significantly over time (P<0.001). Trials with data collection interventions at the individual level were more likely to report ethics review than were trials that used routine data sources only (79% (n=151) v 55% (23); P=0.008). Trials that accounted for clustering in the design and analysis were more likely to report ethics review. The median impact factor of the journal of publication was higher for trials that reported ethics review (3.4 v 2.3; P<0.001). 93 (31%, 26% to 36%) trials failed to report consent. Reporting of consent increased significantly over time (P<0.001). Trials with interventions targeting participants at the individual level were more likely to report consent than were trials with interventions targeting the cluster level (87% (90) v 48% (41); P<0.001). Trials with data collection interventions at the individual level were more likely to report consent than were those that used routine data sources only (78% (146) v 29% (11); P<0.001). Conclusions Reporting of research ethics protections in cluster randomised trials is inadequate. In addition to research ethics approval, authors should report whether informed consent was sought, from whom consent was sought, and what consent was for.


British Journal of Obstetrics and Gynaecology | 2004

Women's perceptions of decision-making about hysterectomy

Zoe Skea; V. Harry; Sohinee Bhattacharya; Vikki Entwistle; Brian Williams; Graeme MacLennan; A. Templeton

Objective  To explore womens views of decision‐making relating to hysterectomy.


Health Expectations | 2017

We need to talk about purpose: a critical interpretive synthesis of health and social care professionals’ approaches to self‐management support for people with long‐term conditions

Heather Morgan; Vikki Entwistle; Alan Cribb; Simon Christmas; John Owens; Zoe Skea; Ian Watt

Health policies internationally advocate ‘support for self‐management’, but it is not clear how the promise of the concept can be fulfilled.


Trials | 2011

Developing a placebo-controlled trial in surgery: Issues of design, acceptability and feasibility

Marion K Campbell; Vikki Entwistle; Brian H. Cuthbertson; Zoe Skea; Ag Sutherland; Alison McDonald; John Norrie; Rv Carlson; S Bridgman

BackgroundSurgical placebos are controversial. This in-depth study explored the design, acceptability, and feasibility issues relevant to designing a surgical placebo-controlled trial for the evaluation of the clinical and cost effectiveness of arthroscopic lavage for the management of people with osteoarthritis of the knee in the UK.MethodsTwo surgeon focus groups at a UK national meeting for orthopaedic surgeons and one regional surgeon focus group (41 surgeons); plenary discussion at a UK national meeting for orthopaedic anaesthetists (130 anaesthetists); three focus groups with anaesthetists (one national, two regional; 58 anaesthetists); two focus groups with members of the patient organisation Arthritis Care (7 participants); telephone interviews with people on consultant waiting lists from two UK regional centres (15 participants); interviews with Chairs of UK ethics committees (6 individuals); postal surveys of members of the British Association of Surgeons of the Knee (382 surgeons) and members of the British Society of Orthopaedic Anaesthetists (398 anaesthetists); two centre pilot (49 patients assessed).ResultsThere was widespread acceptance that evaluation of arthroscopic lavage had to be conducted with a placebo control if scientific rigour was not to be compromised. The choice of placebo surgical procedure (three small incisions) proved easier than the method of anaesthesia (general anaesthesia). General anaesthesia, while an excellent mimic, was more intrusive and raised concerns among some stakeholders and caused extensive discussion with local decision-makers when seeking formal approval for the pilot.Patients were willing to participate in a pilot with a placebo arm; although some patients when allocated to surgery became apprehensive about the possibility of receiving placebo, and withdrew. Placebo surgery was undertaken successfully.ConclusionsOur study illustrated the opposing and often strongly held opinions about surgical placebos, the ethical issues underpinning this controversy, and the challenges that exist even when ethics committee approval has been granted. It showed that a placebo-controlled trial could be conducted in principle, albeit with difficulty. It also highlighted that not only does a placebo-controlled trial in surgery have to be ethically and scientifically acceptable but that it also must be a feasible course of action. The place of placebo-controlled surgical trials more generally is likely to be limited and require specific circumstances to be met. Suggested criteria are presented.Trial registration numberThe trial was assigned ISRCTN02328576 through http://controlled-trials.com/ in June 2006. The first patient was randomised to the pilot in July 2007.


Health Expectations | 2010

‘They’re doing surgery on two people’: a meta‐ethnography of the influences on couples’ treatment decision making for prostate cancer

Kate Schumm; Zoe Skea; Lorna McKee; James N’Dow

Background  Current orthodoxy suggests that patients need to be provided with full information about their care and that treatment options should be discussed with patients and family members. This imperative is especially challenging when there is a lack of consensus about treatment effectiveness and equivocacy over different types of interventions. In the case of prostate cancer, evidence is contested as to the efficacy of different treatments. Thus, involving patients and their family members in treatment choices is complex and little is known about how patients and their partners process these decisions when there is uncertainty about different outcomes. This paper has reviewed the literature on the way couples approach such decision making in relation to treatment for prostate cancer.


Trials | 2014

Patient information leaflets (PILs) for UK randomised controlled trials : a feasibility study exploring whether they contain information to support decision making about trial participation

Katie Gillies; Wan Huang; Zoe Skea; Jamie C. Brehaut; Seonaidh Cotton

BackgroundInformed consent is regarded as a cornerstone of ethical healthcare research and is a requirement for most clinical research studies. Guidelines suggest that prospective randomised controlled trial (RCT) participants should understand a basic amount of key information about the RCTs they are being asked to enrol in in order to provide valid informed consent. This information is usually provided to potential participants in a patient information leaflet (PIL). There is evidence that some trial participants fail to understand key components of trial processes or rationale. As such, the existing approach to information provision for potential RCT participants may not be optimal. Decision aids have been used for a variety of treatment and screening decisions to improve knowledge, but focus more on overall decision quality, and may be helpful to those making decisions about participating in an RCT. We investigated the feasibility of using a tool to identify which items recommended for good quality decision making are present in UK PILs.MethodsPILs were sampled from UK registered Clinical Trials Unit websites across a range of clinical areas. The evaluation tool, which is based on standards for supporting decision making, was applied to 20 PILs. Two researchers independently rated each PIL using the tool. In addition, word count and readability were assessed.ResultsPILs scored poorly on the evaluation tool with the majority of leaflets scoring less than 50%. Specifically, presenting probabilities, clarifying and expressing values and structured guidance in deliberation and communication sub-sections scored consistently poorly. Tool score was associated with word count (r = 0.802, P <0.01); there was no association between score and readability (r = -0.372, P = 0.106).ConclusionsThe tool was feasible to use to evaluate PILs for UK RCTs. PILs did not meet current standards of information to support good quality decision making. Writers of information leaflets could use the evaluation tool as a framework during PIL development to help ensure that items are included which promote and support more informed decisions about trial participation. Further research is required to evaluate the inclusion of such information.


Health Technology Assessment | 2010

Effectiveness and cost-effectiveness of arthroscopic lavage in the treatment of osteoarthritis of the knee: a mixed methods study of the feasibility of conducting a surgical placebo-controlled trial (the KORAL study)

Marion K Campbell; Zoe Skea; Alasdair George Sutherland; Brian H. Cuthbertson; Vikki Entwistle; Alison McDonald; John Norrie; R V Carlson; S Bridgman

OBJECTIVE To assess the clinical effectiveness and cost-effectiveness of photodynamic diagnosis (PDD) compared with white light cystoscopy (WLC), and urine biomarkers [fluorescence in situ hybridisation (FISH), ImmunoCyt, NMP22] and cytology for the detection and follow-up of bladder cancer. DATA SOURCES Major electronic databases including MEDLINE, MEDLINE In-Process, EMBASE, BIOSIS, Science Citation Index, Health Management Information Consortium and the Cochrane Controlled Trials Register were searched until April 2008. REVIEW METHODS A systematic review of the literature was carried out according to standard methods. An economic model was constructed to assess the cost-effectiveness of alternative diagnostic and follow-up strategies for the diagnosis and management of patients with bladder cancer. RESULTS In total, 27 studies reported PDD test performance. In pooled estimates [95% confidence interval (CI)] for patient-level analysis, PDD had higher sensitivity than WLC [92% (80% to 100%) versus 71% (49% to 93%)] but lower specificity [57% (36% to 79%) versus 72% (47% to 96%)]. Similar results were found for biopsy-level analysis. The median sensitivities (range) of PDD and WLC for detecting lower risk, less aggressive tumours were similar for patient-level detection [92% (20% to 95%) versus 95% (8% to 100%)], but sensitivity was higher for PDD than for WLC for biopsy-level detection [96% (88% to 100%) versus 88% (74% to 100%)]. For more aggressive, higher-risk tumours the median sensitivity of PDD for both patient-level [89% (6% to 100%)] and biopsy-level [99% (54% to 100%)] detection was higher than those of WLC [56% (0% to 100%) and 67% (0% to 100%) respectively]. Four RCTs comparing PDD with WLC reported effectiveness outcomes. PDD use at transurethral resection of bladder tumour resulted in fewer residual tumours at check cystoscopy [relative risk, RR, 0.37 (95% CI 0.20 to 0.69)] and longer recurrence-free survival [RR 1.37 (95% CI 1.18 to 1.59)] compared with WLC. In 71 studies reporting the performance of biomarkers and cytology in detecting bladder cancer, sensitivity (95% CI) was highest for ImmunoCyt [84% (77% to 91%)] and lowest for cytology [44% (38% to 51%)], whereas specificity was highest for cytology [96% (94% to 98%)] and lowest for ImmunoCyt [75% (68% to 83%)]. In the cost-effectiveness analysis the most effective strategy in terms of true positive cases (44) and life-years (11.66) [flexible cystoscopy (CSC) and ImmunoCyt followed by PDD in initial diagnosis and CSC followed by WLC in follow-up] had an incremental cost per life-year of over 270,000 pounds. The least effective strategy [cytology followed by WLC in initial diagnosis (average cost over 20 years 1403 pounds, average life expectancy 11.59)] was most likely to be considered cost-effective when societys willingness to pay was less than 20,000 pounds per life-year. No strategy was cost-effective more than 50% of the time, but four of the eight strategies in the probabilistic sensitivity analysis (three involving a biomarker or PDD) were each associated with a 20% chance of being considered cost-effective. In sensitivity analyses the results were most sensitive to the pretest probability of disease (5% in the base case). CONCLUSIONS The advantages of PDDs higher sensitivity in detecting bladder cancer have to be weighed against the disadvantages of a higher false-positive rate. Taking into account the assumptions made in the model, strategies involving biomarkers and/or PDD provide additional benefits at a cost that society might be willing to pay. Strategies replacing WLC with PDD provide more life-years but it is unclear whether they are worth the extra cost.


Clinical Trials | 2013

Challenges in the research ethics review of cluster randomized trials: International survey of investigators

Shazia H Chaudhry; Jamie C. Brehaut; Jeremy Grimshaw; Charles Weijer; Robert F. Boruch; Allan Donner; Martin Eccles; Andrew D McRae; Raphael Saginur; Zoe Skea; Merrick Zwarenstein; Monica Taljaard

Background Cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines for several reasons. For one, the units of allocation, intervention, and observation often may differ within a single trial. In the absence of tailored and internationally accepted ethics guidelines for CRTs, researchers and research ethics committees have no common standard by which to judge ethically appropriate practices in CRTs. Moreover, lack of familiarity with and consideration of the unique features of the CRT design by research ethics committees may cause difficulties in the research ethics review process, and amplify problems such as variability in the requirements and decisions reached by different research ethics committees. Purpose We aimed to characterize research ethics review of CRTs, examine investigator experiences with the ethics review process, and assess the need for ethics guidelines for CRTs. Methods An electronic search strategy implemented in MEDLINE was used to identify and randomly sample 300 CRTs published in English language journals from 2000 to 2008. A web-based survey with closed- and open-ended questions was administered to corresponding authors in a series of six contacts. Results The survey response rate was 64%. Among 182 of 285 eligible respondents, 91% indicated that they had sought research ethics approval for the identified CRT, although only 70% respondents reported research ethics approval in the published article. Nearly one-third (31%) indicated that they have had to meet with ethics committees to explain aspects of their trials, nearly half (46%) experienced variability in the ethics review process in multijurisdictional trials, and 38% experienced negative impacts of the ethics review process on their trials, including delays in trial initiation (28%), increased costs (10%), compromised ability to recruit participants (16%), and compromised methodological quality (9%). Most respondents (74%; 95% confidence interval (CI): 67%–80%) agreed or strongly agreed that there is a need to develop ethics guidelines for CRTs, and (70%; 95% CI: 63%–77%) that ethics committees could be better informed about distinct ethical issues surrounding CRTs. Limitations Thirty-six percent of authors did not respond to the survey. Due to the absence of comparable results from a representative sample of authors of individually randomized trials, it is unclear to what extent the reported challenges result from the CRT design. Conclusions CRT investigators are experiencing challenges in the research ethics review of their trials, including excessive delays, variability in process and outcome, and imposed requirements that can have negative consequences for study conduct. Investigators identified a clear need for ethics guidelines for CRTs and education of research ethics committees about distinct ethical issues in CRTs.


Clinical Trials | 2013

Determining information for inclusion in a decision-support intervention for clinical trial participation: a modified Delphi approach.

Katie Gillies; Zoe Skea; Sara MacLennan; Craig Ramsay; Marion K Campbell

Background The use of decision-support interventions in the context of decisions about trial participation is an emergent field. There is a lack of evidence about what information is deemed important to support decisions about informed consent for clinical trials, and whether different groups agree on the information for inclusion. Purpose The overall objective was to determine the items which different stakeholder groups viewed to be important for inclusion in a decision-support tool when making decisions about clinical trial participation, with a view to use these as a framework for developing decision-support tools in this context. This is the first study to have addressed this issue. Methods A modified Delphi method was used to determine agreement on importance of items. The ‘stakeholder’ panel was made up of 49 individuals from 5 groups: 11 trialists, 6 research nurses, 7 ethics committee chairs, 9 decision-support experts, and 16 patients (9 trial experienced and 7 trial non-experienced). Two rounds of rating were completed. Items with a median of 7–10 with ≥65% of any one group (from aggregate ratings) in agreement were considered important for inclusion. Results The stakeholder panel achieved consensus on the majority of items included (60/66), agreeing that these were important for inclusion in a decision-support tool for trial participation. These included items covering information about trial participation and standard care, information on the likelihood of receiving different treatments, information to help patients determine what matters most to them, ensuring that the information is balanced, guidance on how to make a decision, disclosure of any conflicts of interest, using plain language in the tool, and guidance on the decision-support development process. Some areas of divergence among the panel were also identified relating to the use of patient stories. Limitations Selection bias may be a limitation in this study due to the manner in which the participants were invited to take part, and therefore, the representativeness, and reproducibility with another group of stakeholders, may differ. Conclusions Agreement was obtained on a number of items, which we recommend should be used as a framework to develop useful tools to support decision-making about participation in clinical trials.

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Jamie C. Brehaut

Ottawa Hospital Research Institute

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Allan Donner

University of Western Ontario

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Charles Weijer

University of Western Ontario

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Jeremy Grimshaw

Ottawa Hospital Research Institute

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