Phase III development of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire module for women undergoing breast reconstruction.

BACKGROUND: Comprehensive outcome assessments after breast reconstruction (BRR) require surgery-specific patient-reported outcome measures. The aims of this study were to assess the relevance, acceptability and redundancy of questions/items (phase III pretesting) of a new BRR questionnaire evaluating patients' health-related quality of life before and after BRR. Phase III occurred in collaboration with the European Organization for Research and Treatment of Cancer (EORTC) following earlier development phases that identified 31 items. METHODS: The EORTC BRR subgroup applied decision-making rules to each question according to eight EORTC criteria. A total of 197 patients (from the UK, Austria, Belgium, Italy and Sweden) were recruited. Forty-seven patients completed pre- and post-BRR questionnaires prospectively, and 150 reported post-BRR questionnaires only retrospectively. Qualitative debriefing interviews were undertaken in 189 patients. Preliminary psychometric analyses were performed. RESULTS: Thirty-one items fulfilled 'relevance', with none producing 'difficulties'. Ten items were not a priority for 10 per cent of respondents. Of these, two questions concerning muscle twitching in the affected breast and problem with donor-site swelling were deleted. Three redundant items were deleted: weakness in arm, which correlated significantly to the Quality of Life Questionnaire (QLQ) BR23 breast questionnaire, and shape and colour of the affected nipple. Descriptive statistics reduced the module to 26 items conceptualized into three provisional scales (disease treatment/surgery-related symptoms, sexuality and cosmetic outcome) within the newly completed questionnaire, EORTC QLQ-BRR26. CONCLUSION: The QLQ-BRR26 is available for psychometric validation in a large-field international sample. The intended use for QLQ-BRR26 is alongside EORTC QLQ-C30 and QLQ-BR23, in women treated by mastectomy for breast cancer and undergoing all types of BRR.

Health-related quality of life assessment after breast reconstruction.

BACKGROUND: Health-related quality of life (HRQL) is an important outcome following breast reconstruction. This study evaluated current methods of HRQL assessment in patients undergoing latissimus dorsi breast reconstruction, hypothesizing that early surgical morbidity would be reflected by poorer HRQL scores. METHODS: Patients completed the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and breast module (QLQ-BR23), the Functional Assessment of Cancer Therapy (FACT) general measure, and breast module and arm subscale (FACT-B + 4), and the Body Image Scale and Hospital Anxiety and Depression Scale (HADS) 3 months after surgery. They also reported additional HRQL problems not included in the questionnaires. HRQL scores were compared between patients with and without early surgical morbidity. RESULTS: Sixty women completed the questionnaires, of whom 25 (42 per cent) experienced complications. All EORTC and FACT subscale and HADS scores were similar in patients with or without morbidity. Women with complications were twice as likely to report feeling less feminine and dissatisfied with the appearance of their scar than those without problems. Thirty-two women (53 per cent) complained of problems not covered by the questionnaires, most commonly donor-site morbidity. CONCLUSION: Existing HRQL instruments are not sufficiently sensitive to detect clinically relevant problems following breast reconstruction.

Active observation in acute abdominal pain.

Only a minority of patients admitted with acute abdominal pain require urgent operation, but the identification of those who need an operation may be difficult. Many surgeons adopt a radical approach and operate when the diagnosis is doubtful, which often leads to 20 percent rate of negative findings on laparotomy. In this study, 220 patients of all ages admitted with acute abdominal pain were studied prospectively, and when the diagnosis on admission was uncertain, a policy of active observation was employed. In all, 39 percent of the patients underwent operation and only 5 percent had negative findings on laparotomy. No patient suffered as a result of this policy, which is recommended as a safe and effective approach to the management of acute abdominal pain.

Informed consent: a case for more education of the surgical team.

A questionnaire was given to 37 members of staff of the Department of Surgery, Addenbrooke's Hospital, Cambridge, in order to determine whether their knowledge was adequate to give accurate information to patients regarding operations and thus to obtain properly informed consent for that operation. Each participant was asked to estimate the 24-h and 30-day mortality for five common elective operations. A wide range of answers was given for operations by all groups. Estimates of 24-h mortality after unilateral inguinal herniorrhaphy differed between staff grades by a factor of 3, but estimates of 24-h mortality after thyroidectomy differed by a factor of 100 between consultant surgeons and staff nurses. Our findings suggest that some members of the surgical team have insufficient knowledge about common operations to obtain properly informed consent from patients.

Endoscopic pancreatography in cystadenoma of the pancreas.

A case of mucinous cystadenoma of the tail of the pancreas is reported in which endoscopic retrograde cholangiopancreatography was used to define the surgical anatomy prior to operation. The demonstration of a normal proximal main duct allowed simple ligation of the body of the gland when the tail was excised.

The early development phases of a European Organisation for Research and Treatment of Cancer (EORTC) module to assess patient reported outcomes (PROs) in women undergoing breast reconstruction.

INTRODUCTION: A comprehensive evaluation of breast reconstruction (BRR) surgery includes measurement of patient reported outcomes (PROs). There is, however, a lack of validated BRR-specific PRO measures (PROMs) that adequately assess relevant issues. This study is developing a European Organisation for Research and Treatment of Cancer (EORTC) questionnaire/module specific for PROs in BRR to supplement the cancer-core and breast cancer EORTC questionnaires, respectively: the QLQ-C30 and QLQ-BR23. METHODS: Phases I and II of questionnaire development followed EORTC guidelines including a systematic literature review to identify all potential 'issues' (concepts relevant to PROs) and semi-structured interviews with 89 patients and 9 European multi-disciplinary health care professionals (HCPs) (Sweden, Italy and the United Kingdom [UK]). Interviewers asked participants the 'relevance' of outcomes identified in the literature and captured additional 'issues' of importance. RESULTS: The literature search and interviews of patients and HCPs yielded 69 issues relating to BRR operationalised into 31 provisional items (single questions) for the module, which was conceptualised to contain five scales: treatment/surgery related symptoms (affecting the shoulder, arm and reconstructed breast), body image, sexuality, cosmetic outcomes (pertaining to three areas: breast, donor site and nipple) and overall satisfaction. DISCUSSION: The provisional development of the EORTC BRR module has 31 items addressing issues of importance to patients as well as HCPs. Further international testing is underway as a UK National Cancer Research Network trial to ensure that this PROM will be psychometrically and clinically robust and applicable for use in clinical trials, cohort studies, national audit and clinical practice.

Long term results of a consistent policy of sphincter preservation in the treatment of carcinoma of the rectum.

With increasing emphasis on sphincter preservation in the treatment of low carcinomas of the rectum, it is important to know whether such a policy results in satisfactory rectal function and long term survival. In 368 patients operated upon for carcinoma of the rectum between 1958 and 1980, a consistent policy of sphincter preservation was followed, and resulted in 222 (61 per cent) patients having a restorative resection (RR), whilst 132 (37 per cent) had an abdominoperineal excision (APE); 271 (76 per cent) had a radical operation with a hope of cure. Overall operative mortality was 5 per cent (2.6 per cent in the radical group) and the leakage rate in the 222 restorative anastomoses was 5 per cent. Follow-up of 98 per cent of patients treated over 5 years ago has been possible. Special attention has been paid to the late results in patients having a restorative resection of tumours at and below 8 cm: all these patients are continent and there is no excess of late pelvic recurrent. Corrected 5-year survival rates are 72 per cent for abdominoperineal excision and 84 per cent for restorative resection.

The effect of breakfast on minor anal complaints: a matched case-control study.

With the objective of exploring the association between breakfast and minor anal complaints, an age, sex and pregnancy matched case-control study was carried out in the out-patient clinics at Birmingham Heartlands Hospital. Patients were selected after personal interviews using a structured questionnaire in out-patient clinics. Information on age, sex, occupation and breakfast habits, as well as on haemorrhoids and anal fissure, was obtained. Patients who had haemorrhoids or anal fissure were placed in the case group; the remainder were controls. Any patient with diverticulosis, inflammatory bowel disease, colon cancer or bowel resection for any reason was excluded from the study. The main outcome measures were the odds of developing haemorrhoids or fissure in patients who did not eat breakfast. The results are based on 47 cases that were age, sex and pregnancy matched. Of the case group, 36% did not eat breakfast, compared with 11% in the control group. The analysis demonstrated a 7.5-fold increase in the odds of suffering from haemorrhoids or anal fissures in matched subjects who did not eat breakfast, with a very high level of significance (P = 0.0036). This indicates that there is a very strong association between failure to eat breakfast and haemorrhoids or anal fissure. It is anticipated that educating the public to eat breakfast would lead to a long-term fall in the incidence of anal complaints, in the attendant morbidity for the patients and in the cost to the health service.

Submucosal collagen changes in the normal colon and in diverticular disease.

Full thickness specimens of normal colon (n = 15), and colon from patients with diverticular disease (n = 5) were obtained at operation or autopsy. In the isolated submucosa the ultrastructure of the constituent collagen fibres was examined by transmission electron microscopy. Collagen fibrils in the left colon become smaller (p less than 0.001) and more tightly packed (p less than 0.001) than those in the right colon with increasing age. This difference is accentuated in diverticular disease (p less than 0.01). Factors which contribute to the development of colonic diverticulosis, such as raised intraluminal pressure, may be responsible for premature change in submucosal structure.

CT-guided drainage of pelvic abscesses: the peranal transrectal approach.

Five patients with deep pelvic abscesses underwent computed tomography (CT)-guided catheter drainage using a transrectal approach. The use of an outer removable plastic sheath over the catheter to facilitate positioning and prevent inadvertent damage to the mucosal wall is described. This new approach using CT guidance is discussed and the alternative routes reviewed.

Consent for mastectomy.

The value of a system for reducing the number of women with breast lumps who consent unnecessarily to mastectomy was assessed. Sixty-one patients with breast lumps were divided preoperatively into three groups with benign, doubtful, and malignant lumps according to clinical, mammographic and ultrasound criteria. On the basis of these criteria written consent was requested from 29 patients for mastectomy and from 32 for only excision of the lump. Fourteen of the 29 patients who gave consent for mastectomy had carcinomas, and none of the 32 patients consenting to only lump excision. In an attempt to improve further on these results the same 61 patients were analysed retrospectively. Criteria based on age and the results of clinical examination and mammography were devised. By using these criteria only 19 women would have had to give consent for mastectomy. This new policy, which was devised to spare many women the stress of consenting unnecessarily to mastectomy, requires to be tested further in a much larger series of patients.

The submucosa of the human colon.

Full-thickness specimens of colon were obtained at operation or autopsy from 20 patients. The submucosa was isolated from the mucosa and muscularis externa, with confirmation by light microscopy. Submucosal specimens were then fixed and prepared for scanning and transmission electron microscopy, with preservation of their orientation. The submucosa was found to consist of a series of layers of collagen fibres, each layer 0.5-2.0 microns thick. The fibres within each layer were co-directionally orientated. The autopsy specimens were comparable in appearance with the operative ones. The mean diameter of the collagen fibrils was 69 +/- 13 nm, and the mean fibril count per unit area was 159 +/- 58/microns2.

Diagnosis of acute pancreatitis: a proposed sequence of biochemical investigations.

In 60 controls and 108 patients admitted with acute abdominal pain, Rapignost urinary amylase correctly identified (++) 18 of the 23 patients with acute pancreatitis (AP), with 8 results being equivocal (+), and 1 false negative. This is a suitable screening test for AP, but an equivocal result requires further investigation. In 14 patients with AP the serum amylase was over 1000 U/l with no false-positive results, whereas when 316 U/l was used as the diagnostic threshold, 22 cases were identified (but with 2 false positives). Serum lipase was 100% sensitive in the diagnosis of AP, but there were three false-positive results.

Intracerebroventricular neuropeptide Y stimulates bile secretion via a vagal mechanism.

UNLABELLED: The effect of intracerebroventricular injection of neuropeptide Y on biliary secretion was studied in conscious dogs, prepared with gastric and duodenal fistulas and cerebroventricular guides. Bile secretion was increased in a dose-dependent fashion by intracerebroventricular neuropeptide Y. The peak increase was seen after 500 pM/kg of neuropeptide Y which resulted in a 30 x 2% increase in bile flow over the period 30-150 minutes after injection. ( CONTROL: 23 x 2 (1 x 2) ml/2 hours; neuropeptide Y 500 pM/kg: 30 x 5 (1 x 1) ml/2 hours). Biliary lipid composition was not altered significantly but bicarbonate output was increased at all doses tested. Intravenous infusion of neuropeptide Y (1000 pM) for 1 hour had no significant effect. Intracerebroventricular neuropeptide Y (1000 pM/250-300 mg body weight) also increased bile flow in urethane-anaesthetised rats. This effect was abolished by cervical vagotomy. The demonstration of a central stimulation of alkaline bile flow suggests that bile secretion may be subject to central modulation.