The Two-Week Rule for NHS Gastrointestinal Cancer Referrals: A Systematic Review of Diagnostic Effectiveness

Aim: To systematically review the impact of the Two-Week Rule in increasing the pick-up rate of colorectal cancers and Upper Gastrointestinal (GI) cancers in the NHS.Materials and Methods: Data were combined for meta-analyses to determine (1) the Two-Week Rule pick-up rate for each cancer type and (2) the proportion of patients referred using the Two-Week Rule. Overall results were given as weighted averages.Results: There were 20 articles and 27 peer-reviewed abstracts included in this review. Colorectal Cancer: Only 9.5% of patients referred by the Two-Week Rule were eventually diagnosed with colorectal cancer (n = 24). When examining the referral origin of all colorectal cancer patients diagnosed during the time of 19 studies with this data, 32.2% had been referred using the Two-Week Rule. Upper GI Cancer: Only 5.5% of patients referred by the Two-Week Rule were eventually diagnosed with Upper GI cancer (n = 23). When examining the referral origin of all Upper GI cancer patients diagnosed during the time of 17 studies with this data, 23.6% had been referred using the Two-Week Rule.Conclusion: The Two-Week Rule is not sufficiently effective in diagnosing neither upper GI nor colorectal cancers in patients presenting to their General Practitioner

Qualitative research within trials: developing a standard operating procedure for a clinical trials unit

BackgroundQualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design.MethodsHealth services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP).ResultsThe qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component.ConclusionsWe recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trial

Group-based positive psychotherapy for people living with acquired brain injury: a protocol for a feasibility study

BackgroundAcquired brain injury (ABI) and other chronic conditions are placing unprecedented pressure on healthcare systems. In the UK, 1.3 million people live with the effects of brain injury, costing the UK economy approximately £15 billion per year. As a result, there is an urgent need to adapt existing healthcare delivery to meet increasing current and future demands. A focus on wellbeing may provide an innovative opportunity to reduce the pressure on healthcare services while also supporting patients to live more meaningful lives. The overarching aims of the study are as follows: (1) evaluate the feasibility of conducting a positive psychotherapy intervention for individuals with ABI and (2) ascertain under what conditions such an intervention would merit a fully powered randomised controlled trial (RCT) compared to a standard control group (TAU).Methods and analysisA randomised, two-arm feasibility trial involving allocation of patients to either a treatment group (positive psychotherapy) or control group (treatment as usual) group, according to a 1:1 ratio. A total of 60 participants at three sites will be recruited including 20 participants at each site. Assessments will be conducted at baseline, on completion of the 8-week intervention and 3 months following completion. These will include a range of questionnaire-based measures, psychophysiology and qualitative outcomes focusing on feasibility outcomes and participant experience. This study has been approved by the Wales Research Ethics Committee (IRAS project ID: 271,251, REC reference: 19/WA/0336).DiscussionThis study will be the first to examine the feasibility of an innovative, holistic positive psychotherapy intervention for people living with ABI, focused on individual, collective and planetary wellbeing, and will enable us to determine whether to proceed to a full randomised controlled trial