The patient and clinician experience of informed consent for surgery: a systematic review of the qualitative evidence.

BACKGROUND: Informed consent is an integral component of good medical practice. Many researchers have investigated measures to improve the quality of informed consent, but it is not clear which techniques work best and why. To address this problem, we propose developing a core outcome set (COS) to evaluate interventions designed to improve the consent process for surgery in adult patients with capacity. Part of this process involves reviewing existing research that has reported what is important to patients and doctors in the informed consent process. METHODS: This qualitative synthesis comprises four phases: identification of published papers and determining their relevance; appraisal of the quality of the papers; identification and summary of the key findings from each paper while determining the definitiveness of each finding against the primary data; comparison of key themes between papers such that findings are linked across studies. RESULTS: Searches of bibliographic databases returned 11,073 titles. Of these, 16 studies met the inclusion criteria. Studies were published between 1996 and 2016 and included a total of 367 patients and 74 health care providers. Thirteen studies collected data using in-depth interviews and constant comparison was the most common means of qualitative analysis. A total of 94 findings were extracted from the primary papers and divided into 17 categories and ultimately 6 synthesised findings related to: patient characteristics, knowledge, communication, the model patient, trust and decision making. CONCLUSIONS: This qualitative meta-aggregation is the first to examine the issue of informed consent for surgery. It has revealed several outcomes deemed important to capture by patients and clinicians when evaluating the quality of a consent process. Some of these outcomes have not been examined previously in research comparing methods for informed consent. This review is an important step in the development of a COS to evaluate interventions designed to improve the consent process for surgery. REGISTRATION: The study protocol was registered on the international prospective register for systematic reviews (PROSPERO ID: CRD42017077101).

Re-Staging Following Long-Course Chemoradiotherapy For Rectal Cancer: Does It Influence Management?

BACKGROUND: In patients with locally advanced or low rectal cancers, long-course chemoradiotherapy (LCCRT) is recommended prior to surgical management.1 The need for restaging afterwards has been questioned as it may be difficult to interpret imaging due to local tissue effects of chemoradiotherapy. The purpose of this study was to determine if restaging affected the management of patients receiving long-course chemoradiotherapy for rectal cancer. METHODS: A retrospective review of patients with rectal cancer discussed at the South Eastern Health and Social Care Trust Lower Gastrointestinal Multi-Disciplinary Team Meeting (LGIMDT) in 2013 who had received long-course chemoradiotherapy was performed. Patients were identified from the Trust Audit Department, LGIMDT notes and patient records. Imaging results and outcomes from meetings were obtained through the Northern Ireland Picture Archiving and Communications System® (NIPACS) and Electronic Care Record® (ECR). Data including patient demographics, initial radiological staging and LGIMDT discussion, restaging modality and result, outcome from post-treatment LGIMDT discussion and recorded changes in management plans were documented using a proforma. RESULTS: Seventy-one patients with rectal cancer were identified as having LCCRT in 2013 (M:F 36:35; age range 31 - 85 years). Fifty-nine patients were restaged following long-course treatment with computed tomography (CT) and magnetic resonance imaging (MRI). Twelve patients did not undergo restaging. Data was not available for 6 patients, one patient underwent emergency surgery, two patients were not fit for treatment, one failed to attend for restaging and two patients died prior to completion of treatment. Of the 59 patients restaged, 19 patients (32%) had their management plan altered from that which had been proposed at the initial LGIMDT discussion. The most common change in plan was not to operate. Ten patients had a complete clinical and radiological response to treatment and have undergone intensive follow-up. Nine patients had disease progression, with 3 requiring palliative surgery and 6 referred for palliative care. CONCLUSION: Of those patients who were restaged, 32% had their management plan altered from that recorded at the initial LGIMDT discussion. Seventeen per cent of patients in this group had a complete clinical and radiological response to treatment. Fifteen percent demonstrated disease progression. We recommend, therefore, that patients with rectal cancer be restaged with CT and MRI following long-course chemoradiotherapy as surgery may be avoided in up to 27% of cases.

Changes in management and outcome of patients with rectal cancer in Northern Ireland: 1996-2006.

AIM: This study aimed to document developments in rectal cancer services in a UK population and evaluate changes in outcome over a 10-year period. METHOD: Patients diagnosed with primary rectal carcinoma in 1996, 2001 and 2006 were identified by the Northern Ireland Cancer Registry. Data were retrospectively collected on presentation, investigation, treatment and staging. Differences over the period were analysed using the chi-squared test; Kaplan-Meier and Cox regression tests were used for survival analysis. RESULTS: After exclusions there were 636 patients, including 187 presenting in 1996, 203 in 2001 and 246 in 2006. The use of preoperative MRI of the rectum, endorectal ultrasound and abdominal CT increased during the study period. For patients treated by surgery, total mesorectal excision (TME) increased from 19% in 1996 to 64% in 2006 (P < 0.001). The use of radiotherapy (27% in 1996, 47% in 2006) and chemotherapy (21% in 1996, 32% in 2006) increased. The overall 5-year survival improved significantly between 1996 and 2006 from 34% in 1996 to 45% in 2006 (P = 0.02). Among patients having surgery, 5-year survival increased from 43% in 1996 to 63% in 2006 (P < 0.001). Multivariate analysis showed that the improvement in survival was associated with TME and chemotherapy, while radiotherapy was not. CONCLUSION: Survival of patients with rectal cancer in Northern Ireland has improved significantly over the last decade, probably due to the increased use of TME and chemotherapy.

A case of a gastrointestinal stromal tumour presenting as acute abdomen.

BACKGROUND: Gastrointestinal stromal tumour (GIST) has many modes of presentation. This is the first reported GIST presenting as an acute abdomen. METHODS: A man presented with signs and symptoms suggestive of acute appendicitis. Examination under anaesthesia revealed a mass. At laparotomy a strangulated mass was found originating from the greater curve of the stomach. Subsequent histopathology confirmed this to be a gastrointestinal stromal tumour, probably of a benign nature. Post-operative investigations did not show any metastatic spread. CONCLUSIONS: GISTs arise from the gastrointestinal tract, omentum, and mesentery. Presentation is generally non-specific and it is rare for them to present acutely. Management should include staging to exclude any metastatic spread.

Hartmann procedure revisited.

OBJECTIVE: To assess the complications and results of Hartmann's procedure and secondary restoration of continuity for left-sided colonic disease. DESIGN: Retrospective study. SETTING: University hospitals, Northern Ireland. SUBJECTS: 72 Patients who required a Hartmann's procedure over a 13 year period (1985-1998). INTERVENTION: Of these 45 (63%) were done as emergencies and 27 (38%) as elective procedures. The indications for an emergency procedure were obstruction and perforation. MAIN OUTCOME MEASURES: Mortality, morbidity, reversal of stoma rate. RESULTS: The overall postoperative mortality was 7/72 (10%), with no significant difference between the emergency (4/45, 9%) and the elective (3/27, 11%) groups. Postoperative complications occurred in 31 patients (43%), and 8 developed wound infections (11%). Of the 43 surviving patients who where deemed suitable for re-establishment of continuity, 30 (70%) have had it done. There were no postoperative deaths or anastomotic dehiscences after the restoration of continuity. CONCLUSION: Hartmann's procedure remains a safe and suitable option in patients with left sided colonic emergencies.

Screening for colorectal cancer.

Colorectal carcinoma represents a major cause of cancer deaths in the United Kingdom. Tumours detected at an early or even premalignant stage have a better prognosis. In this review we consider the argument for screening for colorectal carcinomas and discuss the means available and the implications of implementing screening programmes using some of these methods. A suggestion is made for the more rational use of limited resources to target those at greatest risk.

Familial adenomatous polyposis.

Familial adenomatous polyposis (FAP) is an autosomal dominant condition resulting in the development of more than 100 adenomatous polyps in the large bowel. In addition, a number of extracolonic manifestations of the condition may occur. Recently, increasing knowledge relating to the extracolonic abnormalities, and localization and sequencing of the gene for FAP, have had important implications for screening and long-term follow-up of those affected. In this review the natural history of the disease and the extracolonic manifestations associated with it are considered. Surgical management and advances in understanding at a molecular level are discussed, as well as the problems relating to screening for FAP and the implications of the new knowledge.

The role of congenital hypertrophy of the retinal pigment epithelium in screening for familial adenomatous polyposis.

Retinal examination by indirect ophthalmoscopy was performed on seventy members from 20 kindreds demonstrating the clinical manifestations of familial adenomatous polyposis and forty controls. Thirty-four of 43 affected patients manifested CHRPE lesions compared with 2 of 27 at risk and 2 of 40 controls giving a sensitivity of 79% and specificity of 95% based on the control group. The difference between the affected and at risk groups was significant (Chi-squared = 34.098, 1 df, P = 0.001). The low sensitivity and variation in incidence of CHRPE in FAP patients and general population documented in the world literature prevent its use as a sole marker for the condition. With advances in knowledge of the disease at a molecular level it is now possible to alter risks for families by DNA analysis. There remain a number of patients in whom such techniques do not significantly alter risks. In these families by combining the results of DNA analysis, sigmoidoscopy and retinal examination it may be possible to alter risks by a significant degree. Retinal examination should be reserved for those families in whom risks cannot be altered sufficiently by DNA analysis alone.

Expression of fibroblast growth factor receptors by embryonal carcinoma cells and early mouse embryos.

We have previously shown that differentiation of embryonal carcinoma (EC) cells leads to both increased binding of FGF (fibroblast growth factor) and suppression of k-FGF expression. In the current study, we examined the expression of FGF receptors by EC cells, EC-derived differentiated cells and early mammalian embryos using the technique of reverse transcription-polymerase chain reaction (RT-PCR). We determined that both mouse, F9, and human, NT2/D1, EC cells as well as their differentiated counterparts express transcripts for two forms of FGF receptors, bek (bacterially expressed kinase) and flg (fms-like gene). In addition, we determined that mouse blastocysts express flg transcripts. The presence of FGF receptor transcripts in early embryos and the previous finding of FGF-related activity in medium conditioned by mouse blastocysts argue that the FGF family plays important roles during early mammalian development.

Benign lymphangioma of the jejunal mesentery: an unusual cause of small bowel obstruction.

Lymphangiomas are rare tumours of lymphatic vessels, most commonly found in children. We present the unusual case of small bowel obstruction caused by benign lymphangioma in a middle aged woman.

The surgical management of familial adenomatous polyposis in Northern Ireland.

Sixty-eight patients from 18 families have been identified as having familial adenomatous polyposis during the past 30 years in Northern Ireland (population 1.5 million). Six of the 18 probands (33%) had developed colonic carcinoma when first seen at mean age 34 years. Ten of the 44 patients identified by surgical screening (21%) at a significantly lower mean age of 23 years had colonic carcinoma. Surgical management has generally been by subtotal colectomy with ileorectal anastomosis, or by panproctocolectomy and ileostomy.

Expression of transforming growth factor-beta 3 by embryonal carcinoma cells, parietal endoderm-like cells and early mouse embryos.

Utilizing the technique of reverse transcription-polymerase chain reaction (RT-PCR), we have examined the expression of transforming growth factor-beta 3 (TGF-beta 3) by embryonal carcinoma (EC) cells, EC-derived differentiated cells and early mammalian embryos. Using a TGF-beta bioassay, we determined that PYS-2 cells express considerable TGF-beta activity that cannot be completely neutralized by antibodies specific for TGF-beta 1 and TGF-beta 2. We also have determined that PYS-2 cells, as well as F9 EC cells and their differentiated cells, express transcripts for TGF-beta 3. In addition, we have determined that blastocysts, cultured for three days in serum-containing medium, express TGF-beta 3 transcripts. Thus, our data suggest that expression of TGF-beta 3 is initiated during early stages of mammalian development.

Regulation and expression of transforming growth factor type-beta during early mammalian development.

We have examined the effect of differentiation on the expression of different members of the transforming growth factor type-beta (TGF-beta) family using embryonal carcinoma (EC) cells and early mammalian embryos. We determined that TGF-beta activity increases approximately 25-100% when the mouse EC cell line, F9, is induced to differentiate with retinoic acid (RA). Interestingly, the increased TGF-beta activity reflects the induction of TGF-beta 2 secretion following differentiation of both F9 EC cells and the human EC cell line, NT2/D1. Using the technique of reverse transcription-polymerase chain reaction (RT-PCR), we have verified that differentiation induces the expression of TGF-beta 2 as well as a distant member of the TGF-beta family, Vgr-1. Transcripts for TGF-beta 2 and Vgr-1 were readily detected in the differentiated cells of F9 and PC-13 but not in their undifferentiated counterparts. Moreover, TGF-beta 2 mRNA was readily detected in NT2/D1 cells following differentiation. In addition, transcripts for TGF-beta 2 were detected by RT-PCR in mouse morulae, preimplantation blastocysts and cultured blastocysts. Based on the data presented, it appears that the expression of both TGF-beta 2 and Vgr-1 is closely associated with the induction of differentiation during early development.

Subungal melanoma.

Subungal melanoma is a rare condition accounting for 1-3% of all melanomas. It has been associated with a poor prognosis, with a 10-30% 5 year survival usually attributed to the delay in diagnosis. Early biopsy of suspicious lesions followed by amputation of the digit in those proving positive is the treatment of choice.