Development of a core outcome set for informed consent for therapy: An international key stakeholder consensus study.

BACKGROUND: 300 million operations and procedures are performed annually across the world, all of which require a patient's informed consent. No standardised measure of the consent process exists in current clinical practice. We aimed to define a core outcome set for informed consent for therapy. METHODS: The core outcome set was developed in accordance with a predefined research protocol and the Core OutcoMes in Effectiveness Trials (COMET) methodology comprising systematic review, qualitative semi structured interviews, a modified Delphi process and consensus webinars to ratify outcomes for inclusion in the final core outcome set. (Registration- https://www.comet-initiative.org/Studies/Details/1024 ). Participants from all key stakeholder groups took part in the process, including patients and the public, healthcare practitioners and consent researchers. RESULTS: 36 outcome domains were synthesised through systematic review and organised into a consent taxonomy. 41 semi-structured interviews were performed with all consent stakeholders groups. 164 participants from all stakeholder groups across 8 countries completed Delphi Round 1 and 125 completed Round 2. 11 outcomes met the 'consensus in' criteria. 6 met 'consensus in' all stakeholder groups and were included directly in the final core outcome set. 5 remaining outcomes meeting 'consensus in' were ratified over two consensus webinars. 9 core outcomes were included in the final core outcome set: Satisfaction with the quality and amount of information, Patient feeling that there was a choice, Patient feeling that the decision to consent was their own, Confidence in the decision made, Satisfaction with communication, Trust in the clinician, Patient satisfaction with the consent process, Patient rated adequacy of time and opportunity to ask questions. CONCLUSION: This international mixed-methods qualitative study is the first of its kind to define a core outcome set for informed consent for intervention. It defines what outcomes are of importance to key stakeholders in the consent process and is a forward step towards standardising future consent research.

The role of biodegradable stents in the management of benign and malignant oesophageal strictures: A cohort study.

BACKGROUND: Oesophageal strictures can be caused by benign or malignant processes. Up to 10% of patients with a benign stricture are refractory to pneumatic dilatation and may benefit from biodegradable stent (BD) insertion. Biodegradable stents also have a role in malignant oesophageal strictures to facilitate enteral nutrition while staging or neo-adjuvant treatment is completed. The aim of this study was to review the safety and efficacy of BD stents in the management of benign or malignant oesophageal strictures. METHODS: A single centre retrospective cohort study was performed. Dysphagia was graded before and after stenting using a validated score. All patients were followed up for at least 30 days and all adverse events were recorded. RESULTS: Twenty eight stents were inserted in 20 patients; 11 for malignant and 17 for benign disease. One further attempted stenting was impossible due to a high benign stricture. There were no perforations and the 30-day mortality rate was zero. Mean dysphagia scores improved from 2.65 to 1.00 (p value <0.001) in benign disease and from 3.27 to 1.36 (p value <0.001) in patients with malignant disease. Surgical resection was not compromised following stent insertion in the malignant group. CONCLUSIONS: Biodegradable stent insertion is a safe and efficacious adjunct in the treatment of benign and malignant oesophageal strictures. In malignant disease, BD stent insertion can maintain enteral nutrition while staging or neo-adjuvant therapy is completed without adversely impacting on surgical resection.

Multi-excitation Raman spectroscopy technique for fluorescence rejection.

Multi-excitation Raman spectroscopy filters out Raman signals from a fluorescent background by sequentially using multiple excitation frequencies. The filtering method exploits the shift of the Raman spectra with excitation frequency and the static response of the fluorescent background. This technique builds upon previous work which used two slightly shifted excitations, Shifted Excitation Raman Difference Spectroscopy (SERDS), in order to filter the Raman signal. An Expectation-Maximization algorithm is used to estimate the Raman and fluorescence signals from multiple spectra acquired with slightly shifted excitation frequencies. In both simulation and experiment, the efficacy of the algorithm increases with the number of excitation frequencies even when holding the total excitation energy constant, such that the signal to noise ratio is inversely proportional to the number of excitation frequencies. In situations where the intense fluorescence causes significant shot noise compared to the weak Raman signals, the multi-excitation approach is more effective than non-iterative techniques such as polynomial background subtraction.

Evaluating interventions for informed consent for surgery (ICONS): Protocol for the development of a core outcome set.

BACKGROUND: The concept of informed consent is fundamental to medical practice. Shortcomings in the process can lead to patient complaints, litigation, unmet expectations and poor outcomes. Consent research has focused on developing tools to improve patient recall and understanding. However, the definitions, methods of measurement and timing of measurement vary widely across the studies that have been done. Although a Cochrane review has reported that many of these interventions appear to work, the high level of heterogeneity in outcome reporting prevents the identification of those interventions that work best and why they do so. It is also not clear which outcomes are most important to each party involved in the consent process and why. METHODS/DESIGN: This project will develop a core outcome set for assessing the effects of interventions aimed at improving informed consent for surgery and other invasive procedures for adult patients with the capacity to consent for themselves. We will conduct a systematic review of the qualitative and quantitative literature to identify outcomes used to date in consent research and map these into domains. A series of semi-structured key stakeholder interviews will also be used to identify relevant outcomes. These processes will produce a list of potential outcomes for assessing the effects of interventions to improve consent, which will be refined through an international Delphi survey and consensus webinars involving key stakeholders to produce the core outcome set. DISCUSSION: The ICONS study aims to develop a core outcome set for use in trials and reviews of interventions designed to improve the informed consent process for surgery and other invasive procedures. Our aim is that this core outcome set will reduce the level of selection and reporting bias in consent research and help clinicians to compare tools to improve consent.

Epididymal polar dissociation: a previously undescribed anatomical variant.

The normal male external genitalia include the testicles with the epididymis attached posteriorly and the vas deferens arising from this. This case describes an anatomical variation of this normal anatomy not previously reported in the literature. A 17-year-old boy presented with symptoms of intermittent testicular torsion and underwent scrotal exploration. On the left side there was a bell-clapper deformity with the epididymis separated into two parts with the lower pole high in the scrotum and attached to the tunica vaginalis. A normal vas deferens was seen to arise from the isolated lower pole of the epididymis. There was no connection between the vas deferens and the testis or upper pole of epidiymis. This case reminds us of the possibility of anatomical variations and the importance of keeping them in mind to prevent complications at time of surgery.

Recycling of jejunal effluent to enable enteral nutrition in short bowel syndrome.

A 41-year-old woman developed severe abdominal pain, distension and faeculent vomiting. CT of abdomen and pelvis revealed small bowel malrotation with a right paraduodenal hernia. At emergency laparotomy, a right paraduodenal hernia containing jejunum and ileum was identified. She had a viable duodenum with 50 cm of ischaemic proximal jejunum which was exteriorised as an end jejunostomy; 180 cm of infarcted jejunum and ileum was resected. The proximal end of 150 cm of healthy ileum was exteriorised as a closed mucous fistula and 50 cm distally a feeding ileostomy was constructed. On day 5 postoperatively, jejunal effluent began to be recycled via her feeding ileostomy and she never required parenteral nutrition. Despite having only 50 cm of jejunum proximal to her stoma, recycling of effluent enabled her electrolytes to remain normal. She put on weight postoperatively and proceeded to closure of her stomas at 6 months, not requiring laparotomy.

Referral patterns, clinical examination and the two-week-rule for breast cancer: a cohort study.

INTRODUCTION: Current NHS guidelines require patients with suspected breast cancer to be seen urgently at a specialist breast clinic. The aim of this study was to assess referral patterns and clinical findings of patients referred to a specialist breast clinic. MATERIALS AND METHODS: A prospective database was maintained for consecutive patients referred. Symptoms and clinical findings in primary and secondary care were recorded. Correlation with final diagnoses was made. Tertiary referral patients were excluded. RESULTS: 1098 patients attended a specialist breast clinic over six months. 588 (54%) were referred as urgent, 285 (26%) routinely and 225 (20%) were unspecified. 492 (45%) patients were referred with the incorrect referral priority. 42 patients were unexamined in primary care. Examination findings in primary and secondary care correlated in only 487 (46%) patients. Examination in primary care when compared with secondary care was highly sensitive for detecting breast lumps, but specificity was low. 86 patients (8%) were diagnosed with breast cancer, 72 (84%) were referred urgently, 6 (7%) routinely and 8 (9%) as unspecified priority. Regardless of the clinical expertise of the referrer, sensitivity and specificity of the two-week guidelines for cancer are low. CONCLUSIONS: Examination findings in primary and secondary care correlate in only 46% of referrals. Additionally, 55% of referrals were of the correct priority. The two-week rule guidelines have poor sensitivity and specificity for cancer. The safest and fairest policy would be to abandon the concept of urgent referral criteria and see all patients in a timely fashion. Alternatively, simplifying the referral criteria would improve sensitivity and specificity for cancer without leading to increased waiting times.

Static two-dimensional aperture coding for multimodal, multiplex spectroscopy.

We propose a new class of aperture-coded spectrometer that is optimized for the spectral characterization of diffuse sources. The instrument achieves high throughput and high spectral resolution by replacing the slit of conventional dispersive spectrometers with a more complicated spatial filter. We develop a general mathematical framework for deriving the required aperture codes and discuss several appealing code families. Experimental results validate the performance of the instrument.