Management of small (T1-T2) anal margin squamous cell carcinoma: clinical outcomes following local excision alone.

AIM: Squamous cell carcinomas of the anus are normally treated with synchronous chemoradiotherapy (CRT). Small, localized anal margin tumours may be adequately treated by local excision (LE) alone. This study aims to investigate the outcomes of patients with anal margin tumours treated with LE alone, reserving the use of CRT for salvage on local recurrence (LR). METHODS: Patients with small, localized (stage I/IIA) anal margin tumours treated by LE from October 1999 to September 2018 were identified. The effect of tumour size and resection margin on LR risk was analysed. Outcomes of overall survival and disease-free survival were measured. RESULTS: Fifty-five patients with anal margin tumours were identified. Overall 5-year LR, overall survival and disease-free survival rates were 8%, 86% and 82% respectively. Of the seven LRs, five were successfully salvaged with CRT with no further recurrence and two were not fit for CRT. Resection margins in non-fragmented tumours and tumour size did not significantly influence LR risk. CONCLUSIONS: Most small, localized anal margin tumours can be adequately treated by LE alone with low LR rates. Most patients who developed LR were salvaged using CRT, with no cancer-related deaths reported.

Patient experience of telephone consultations in gynaecology: a service evaluation.

OBJECTIVE: To investigate patient perspective of telephone consultations (TCs) in gynaecology and identify which patients benefit most from a telemedicine system. DESIGN: Service evaluation. SETTING: Gynaecology outpatient services at a tertiary referral hospital. POPULATION: Patients who received a TC during May and June 2020. METHODS: Postal questionnaire combining three validated tools: QQ-10, Patient Enablement Index (PEI) and National Health Service Friends and Family Test (NHS-FFT). Quantitative data and free text responses were analysed. MAIN OUTCOME MEASURES: Responses to QQ-10, PEI and NHS-FFT. RESULTS: In total, 1307 patients were contacted and 504 patients responded (39%). Most (89%) described their experience as 'Very good' or 'Good' (NHS-FFT). Positive themes from responses included 'convenience', 'effectiveness' and 'equivalent care'. QQ-10 responses demonstrated a high Value score of 79 (0-100) and a low Burden score of 15. PEI scores suggested that most patients felt better or much better able to understand and cope with their condition following TC. The majority of patients (77%) would 'Strongly agree' or 'Mostly agree' to a repeat TC. Regarding patient outcomes, 21% were discharged and 71% required follow up. Menopause, fertility and endometriosis follow-up clinic patients benefited most from TC. Gynaecology-oncology patients found TC least acceptable. CONCLUSION: We report a large questionnaire survey of patient experience of TC in gynaecology. Telemedicine is convenient, acceptable and effective for conducting care in selected groups. TC can support patients in communicating intimate symptoms. TWEETABLE ABSTRACT: Telephone consultations are a convenient, acceptable and effective medium for conducting patient care in gynaecology.

Electronic personal assessment questionnaire for vascular conditions (ePAQ-VAS): development and validity.

BACKGROUND: This paper describes the development and validation of an electronic personal assessment questionnaire for vascular conditions (ePAQ-VAS) that captures the symptomatology, quality of life and clinically relevant data of patients presenting to vascular services. METHODS: A two-stage survey was conducted in patients attending a tertiary vascular department. Patients completed the ePAQ-VAS remotely online, or on site using an electronic tablet. In the first stage of the survey, the responses were used to perform confirmatory factor analysis to assess the construct validity and remove redundant items. The internal reliability of disease-specific scales was investigated. In the second stage of the survey, the acceptability, known-group validity, test-retest reliability, and responsiveness of ePAQ-VAS was assessed. RESULTS: In total, 721 patients completed ePAQ-VAS. Their mean(s.d.) age was 63·5(15·7) years and 468 (64·9 per cent) were men. Some 553 patients (76·7 per cent) completed the questionnaire in clinic and the remainder completed the questionnaire online. The results of the confirmatory factor analysis confirmed the conceptual model for ePAQ-VAS structure and eliminated six items. Internal reliability was acceptable for all the scales (Cronbach's α greater than 0·7). The test-retest reliability measured by the intraclass correlation coefficient ranged from 0·65 to 0·99. The results showed that the instrument was responsive over time with the standardized response mean ranging from 0·69 to 1·60. CONCLUSION: ePAQ-VAS is a holistic data-collection process that is relevant to vascular service users and has potential to contribute to patient-focused care and the collection of aggregate data for service evaluation. A demonstration version of the final version of ePAQ can be viewed at http://demo-questionnaire.epaq.co.uk/home/project?id=VASC_1.7&page=1.

ANTECEDENTES: Este artículo describe el desarrollo y la validación de un cuestionario electrónico de evaluación personal para enfermedades vasculares (ePAQ-VAS) que incluye la sintomatología, la calidad de vida y los datos clínicamente relevantes para los pacientes que son atendidos en los servicios de patología vascular. MÉTODOS: Se llevó a cabo una encuesta en dos fases entre los pacientes atendidos en un servicio de patología vascular de tercer nivel. Los pacientes completaron el cuestionario ePAQ-VAS a distancia en línea o bien en el centro hospitalario mediante una tableta electrónica. En la primera fase de la encuesta, las respuestas se utilizaron para realizar un análisis factorial de confirmación para evaluar la validez del diseño y eliminar los elementos redundantes. Se investigó la fiabilidad interna de las escalas específicas de la enfermedad. En la segunda fase de la encuesta, se evaluó la aceptabilidad, la validez de grupo conocida, la fiabilidad test-retest y la capacidad de respuesta del ePAQ-VAS. RESULTADOS: En total, 721 pacientes completaron el ePAQ-VAS, la edad media fue de 63,5 años (DE 15,7); el 64,9% eran varones (468); el 76% de los pacientes (553) completaron el cuestionario en la clínica y los pacientes restantes lo hicieron electrónicamente a distancia. Los resultados del análisis factorial de confirmación confirmaron el modelo conceptual para la estructura ePAQ-VAS y eliminaron seis ítems. La fiabilidad interna fue aceptable para todas las escalas (alfa de Cronbach > 0,7). La fiabilidad test-retest medida por el coeficiente de correlación intraclase osciló entre 0,65-0,99. Los resultados mostraron que el instrumento responde con el tiempo con una media de respuesta estandarizada que varía de 0,69 a 1,60. CONCLUSIÓN: El ePAQ-VAS es un proceso holístico de recopilación de datos que es relevante para los usuarios de servicios de patología vascular y tiene el potencial de contribuir a la atención centrada en el paciente y a la recopilación de datos agregados para la evaluación del servicio.

Anti-TNF therapy is not associated with an increased risk of post-colectomy complications, a population-based study.

AIM: Previous studies have raised concerns that the use of anti-tumour necrosis factor (anti-TNF) therapy in patients with ulcerative colitis (UC) undergoing surgery may increase the risk of postoperative complications. We have taken a population-based approach to investigate whether there is an association between anti-TNF therapy and postoperative complications in UC patients undergoing subtotal colectomy. METHOD: Hospital Episode Statistics (HES) data and procedural coding were used to identify all patients in England between April 2006 and March 2015 undergoing subtotal colectomy for UC. Patients were grouped into those who received anti-TNF therapy within 12 or 4 weeks of surgery and those who did not. The incidence of postoperative complications was evaluated by HES coding and compared between groups. RESULTS: In all, 6225 UC patients underwent subtotal colectomy. 753 patients received anti-TNF therapy within 12 weeks prior to surgery (418 within 4 weeks). There was no difference in postoperative complications between groups although groups were not comparable for age and comorbidities. Logistic regression with complications as the outcome variable did not show any significant association between anti-TNF therapy and complications. Colectomy performed during an unplanned admission (vs planned admission) and smoking were associated with complications. CONCLUSION: This large population-based study does not demonstrate any association between preoperative anti-TNF therapy and postoperative complications in UC patients undergoing subtotal colectomy. The only variables associated with complications were colectomy performed during an unplanned admission and smoking.

Does percutaneous tibial nerve stimulation improve global pelvic function in women with faecal incontinence?

AIM: Percutaneous tibial nerve stimulation (PTNS) is a minimally invasive treatment for faecal incontinence. Many patients with faecal incontinence have coexisting pelvic floor disorders such as urinary incontinence and vaginal symptoms. We utilized a pelvic floor assessment tool to analyse any effect of PTNS on global pelvic floor function. METHODS: Patients with faecal incontinence attending our institution who had failed to respond sufficiently to biofeedback were offered a course of PTNS. Patients underwent pre- and post-stimulation assessment with a validated electronic Personal Assessment Questionnaire - Pelvic Floor (ePAQ-PF) for pelvic floor disorders. Scores were compared to assess the effect of treatment on global pelvic floor function. RESULTS: During the study period pre- and post-stimulation ePAQ-PF data were available for 60 patients (55% of all patients starting PTNS). In this cohort there was a significant improvement in bowel continence, bowel related quality of life, irritable bowel syndrome and bowel evacuation with a large effect size for continence and bowel related quality of life. There was also a significant improvement in non-bowel related symptoms, including urinary pain and stress incontinence, urinary related quality of life and bowel related sexual function. Sixty-five per cent of those who answered the question reported improvement in global health after stimulation. CONCLUSION: For patients presenting with faecal incontinence, PTNS appears to have a positive effect on bowel related function in approximately two-thirds of patients. However, for treatment responders, improvement appears to relate mainly to improvement in bowel related function rather than a global pelvic floor effect.

Introduction of enhanced recovery for elective caesarean section enabling next day discharge: a tertiary centre experience.

BACKGROUND: The widespread adoption of enhanced recovery programmes in various surgical specialties has resulted in patient benefits including reduced morbidity, reduced length of stay and an earlier return to normal activities. This evidence, along with the increased financial pressures in the UK National Health Service, has led many units to consider introducing such a programme for obstetric surgery. We report our experience in setting up an enhanced recovery programme for women undergoing elective caesarean section and a prospective analysis of factors that influence length of stay. METHODS: An enhanced recovery pathway was designed by a multidisciplinary team and introduced in March 2012. Factors influencing length of stay were determined using a log normal model. RESULTS: The proportion of women discharged on Day 1 increased from 1.6% in the first quarter of 2012 to 25.2% in the first quarter of 2014. The 30-day readmission rate was 4.4% for those discharged on Day 1 and 5.6% for Day 2. Earlier gestation, multiple birth, intention to breast feed, longer surgery and more time in the post-anaesthesia recovery unit were all independently associated with a longer postoperative stay. Women presenting for obstetric surgery with the indication "one previous caesarean section" were more likely to leave hospital earlier compared to most other indications. CONCLUSION: An enhanced recovery programme was successfully introduced into our unit. Many of the interventions were straightforward and could be adopted easily elsewhere.

Does sacral nerve stimulation improve global pelvic function in women?

AIM: Many women undergoing sacral neuromodulation for faecal incontinence have coexisting pelvic floor dysfunction. We used a global pelvic-floor assessment questionnaire to evaluate the effect of sacral neuromodulation on non-bowel related symptomatology. METHOD: The electronic Personnel Assessment Questionnaire - Pelvic Floor (ePAQ-PF) is a validated Web-based electronic pelvic floor questionnaire. Women with faecal incontinence underwent assessment using the ePAQ. Pre- and poststimulator data were analysed over a 4.5-year period. RESULTS: Forty-three women (mean age 56.5 years; median follow up 6.8 months) were included. All (100%) had urinary symptoms, 81.4% had vaginal symptoms and 85.7% described some sexual dysfunction. There was a significant improvement in faecal incontinence and in bowel-related quality of life (P < 0.005) as well as in irritable bowel syndrome (IBS)-related symptoms (P < 0.01) and in bowel-related sexual heath (P < 0.01). Symptoms of vaginal prolapse significantly improved (P = 0.05). There was also improvement in symptoms of overactive bladder (P = 0.005) and in urinary-related quality of life (P < 0.05). A global health improvement was reported in 58.1%, mainly in bowel evacuation (P < 0.01) and in vaginal pain and sensation (P < 0.05). In sexually active female patients, significant improvements in vaginal and bowel-related sexual health were seen (P < 0.005). Improvement in general sex life following stimulation was reported in 53.3%. CONCLUSION: A Web-based electronic pelvic-floor assessment questionnaire has demonstrated global improvement in pelvic floor function in bowel, urinary, vaginal and sexual dimensions in women following sacral neuromodulation for faecal incontinence.

Development of an instrument to measure face validity, feasibility and utility of patient questionnaire use during health care: the QQ-10.

OBJECTIVE: To develop and establish the psychometric properties of an instrument to measure face validity, feasibility and utility of patient questionnaires used during health care. DESIGN: Our instrument, QQ-10, is a 10-item self-completed questionnaire, which was developed during the evaluation of another questionnaire (ePAQ-PF), to assess patients' views on questionnaire use during health care. SETTING: Urogynaecology Department, Royal Hallamshire Hospital, Sheffield, UK. PARTICIPANTS: The Sheffield maternity patient user group identified 10 key themes relating to patients' views on using questionnaires; these themes translated into 10 statements, each using the same 5-point Likert response scale. INTERVENTION: Not applicable. Outcome Measures Principal component analysis established the factor structure of our instrument. Internal reliability was assessed using Cronbach's alpha. Construct validity was assessed using Spearman's rho. RESULTS: Factor analysis yielded two meaningful factors: Value and Burden, both achieving Cronbach's alpha scores >0.7. Significant correlations were found between scores for Value and communication experience and between scores for Burden and barriers to health care. CONCLUSIONS: Our instrument offers a valid, reliable measure of patients' views relating to value and burden of using health-related quality of life questionnaires. Its two domains show good internal reliability and with its free text items, it may offer a valuable, standardized assessment of face validity and utility of other questionnaires used in health care.

The effects of vault drainage on postoperative morbidity after vaginal hysterectomy for benign gynaecological disease: a randomised controlled trial.

OBJECTIVE: To evaluate the efficacy of vault drainage in reducing the immediate postoperative morbidity associated with vaginal hysterectomy carried out for benign gynaecological conditions. DESIGN: Randomised controlled trial. SETTING: A tertiary referral gynaecology centre in UK. POPULATION: A total of 272 women who underwent vaginal hysterectomy for benign conditions between March 2005 and June 2010. METHODS: The 272 women were randomised to have a drain inserted or not inserted, 'drain' or 'no drain', respectively, before vault closure during vaginal hysterectomy, using a sealed envelope technique. The surgical procedures were performed using the surgeons' standard technique and postoperative care was delivered according to the unit's protocol. MAIN OUTCOME MEASURES: The primary outcome measure was reduction in postoperative febrile morbidity. Secondary outcome measures were hospital readmission rate, blood transfusion, change in postoperative haemoglobin and length of stay. RESULTS: In all, 135 women were randomised to have a drain and 137 to 'no drain'. There were no differences in the incidence of febrile morbidity, length of stay, change in haemoglobin or need for postoperative blood transfusion between the two groups. CONCLUSIONS: The routine use of vault drain at vaginal hysterectomy for benign disorders has no significant effect on postoperative morbidity. The use of vault drain in this context is not recommended.

Adult idiopathic jejuno-ileal intussusception.

This 67-year-old woman, with numerous previous abdominal operations, presented to her general practitioner 3 years ago with generalised abdominal pain and diarrhoea. With unremarkable haematology tests and a CT scan at that time she was given the diagnosis of irritable bowel syndrome. During the next 3 years her symptoms continued intermittently and now associated with vomiting and weight loss. This time both a barium follow-through followed by a CT scan demonstrated a small bowel intussusception. A laparotomy was done but surprisingly no intussusception was found, only a single adhesional band which was divided. She was discharged 5-days postoperative but re-admitted 3 days later with abdominal discomfort, bloating and vomiting. A repeat CT scan again showed the presence of a small bowel intussusception and a second laparotomy was performed, this time demonstrating a jejuno-ileal intussusception which was reduced and resected with primary anastomosis. Her postoperative course was without incidents.

Responsiveness of the electronic Personal Assessment Questionnaire-Pelvic Floor (ePAQ-PF).

This study aimed to evaluate the responsiveness of the electronic Personal Assessment Questionnaire-Pelvic Floor (ePAQ-PF) in women undergoing surgery for pelvic floor disorders. Fifty-four women undergoing tension-free vaginal tape (TVT) and 47 women undergoing prolapse surgery completed ePAQ-PF at baseline and 3 months postoperatively. Responsiveness was calculated using effect sizes, standardized response means, responsiveness statistic, and minimally important difference. In the TVT group, the largest effect sizes were seen in the urinary domains for stress urinary incontinence (2.4), quality of life (2.2), and overactive bladder (0.9). In the prolapse group, the largest effect sizes were seen in the vaginal domains for prolapse (2.1) and quality of life (1.0). ePAQ-PF is responsive to change in women undergoing TVT or prolapse surgery in the salient and expected domains of stress incontinence and prolapse and quality of life and can be recommended for outcome measurement in this context.

Retrospective analysis of pre- and peri-operative imaging in confirmed proximal colonic cancers--possible implications for screening flexible sigmoidoscopy.

OBJECTIVE: Faecal occult blood testing is being introduced for population screening in the United Kingdom. Flexible sigmoidoscopy may provide a viable alternative. The outcomes of the flexible sigmoidoscopy trial are awaited but the most obvious disadvantage is that only the lower third of the colon is examined and proximal pathology cannot be excluded. The relationship between proximal pathology and distal findings at flexible sigmoidoscopy is uncertain. The aim of this study was to determine the incidence of distal neoplasia in patients with confirmed proximal cancers of the colon. METHOD: All confirmed proximal colonic cancers (defined as those proximal to the splenic flexure) were identified from a database of pathology specimens at a single centre between January 1999 and August 2006. A retrospective analysis of preoperative and peri-operative mucosal imaging (contrast enema, colonoscopy and CT colonography) was conducted to identify any distal neoplasia in these patients. RESULTS: A total of 348 patients were identified. Pre- or peri-operative mucosal imaging was identified in 231 (66%) and 49 (21%) had distal neoplasia. Nineteen (8%) of these patients would have gone on to have a colonoscopy based on the UK flexible sigmoidoscopy trial protocol and 92% of the cohort would not have had a colonoscopy. CONCLUSION: Nearly 80% of confirmed proximal cancers in our series did not have any demonstrable distal neoplasia. Only 8% of our cohort would have proceeded to colonoscopy. A very significant number of proximal cancers would not have been detected.

Metachronous squamous-cell carcinoma of the colon and treatment of rectal squamous carcinoma with chemoradiotherapy.

Rectal squamous-cell carcinoma is a rare tumour with an incidence of less than 1 per 1000 cases. We report such a case treated with chemoradiotherapy. The patient developed a metastasis in the spleen and a further squamous tumour in the right colon, both of which were successfully resected. No histological evidence of recurrent rectal tumour has been found. Two years following presentation, the patient remains disease-free although symptomatic from a radiotherapy-induced stricture of the rectum.

Electronic pelvic floor symptoms assessment: tests of data quality of ePAQ-PF.

The objective of the study was to test the data quality, scaling assumptions and scoring algorithms underlying the electronic personal assessment questionnaire-pelvic floor (ePAQ-PF). A cross-sectional survey of 599 women with pelvic floor disorders was carried out. Tests of data quality included secondary factor analysis, internal reliability, descriptive statistics, levels of missing data, floor and ceiling effects, item-to-total correlation scores, item discriminant and convergent validity. Secondary factor analysis verified the domain structure of ePAQ-PF. All 19 domains were internally reliable with Cronbach's alpha scores ranging from 0.71 to 0.93. Missing response rates ranged from 0.2% to 1.3%, and all items were found to be most highly correlated with their own corrected scale. Results confirmed the factor structure, data quality and scoring and scaling assumptions of ePAQ-PF, thereby verifying its suitability for measuring symptoms, bother and quality of life in women with pelvic floor disorders.

Does the mode of delivery predispose women to anal incontinence in the first year postpartum? A comparative systematic review.

OBJECTIVES: To assess if mode of delivery is associated with increased symptoms of anal incontinence following childbirth. DESIGN: Systematic review of all relevant studies in English. DATA SOURCES: Medline, Embase, Cochrane Library, bibliographies of retrieved primary articles and consultation with experts. STUDY SELECTION AND DATA EXTRACTION: Data were extracted on study characteristics, quality and results. Exposure to risk factors was compared between women with and without anal incontinence. Categorical data in 2 x 2 contingency tables were used to generate odds ratios. RESULTS: Eighteen studies met the inclusion criteria with 12,237 participants. Women having any type of vaginal delivery compared with a caesarean section have an increased risk of developing symptoms of solid, liquid or flatus anal incontinence. The risk varies with the mode of delivery ranging from a doubled risk with a forceps delivery (OR 2.01, 95% CI 1.47-2.74, P < 0.0001) to a third increased risk for a spontaneous vaginal delivery (OR 1.32, 95% CI 1.04-1.68, P = 0.02). Instrumental deliveries also resulted in more symptoms of anal incontinence when compared with spontaneous vaginal delivery (OR 1.47, 95% CI 1.22-1.78). This was statistically significant for forceps deliveries alone (OR 1.5, 95% CI 1.19-1.89, P = 0.0006) but not for ventouse deliveries (OR 1.31, 95% CI 0.97-1.77, P = 0.08). When symptoms of solid and liquid anal incontinence alone were assessed, these trends persisted but were no longer statistically significant. CONCLUSION: Symptoms of anal incontinence in the first year postpartum are associated with mode of delivery.

Early results of immediate repair of obstetric third-degree tears: 65% are completely asymptomatic despite persistent sphincter defects in 61%.

OBJECTIVE: The outcome of immediate repair of obstetric third-degree tears is poorly documented. Immediate repair may give better functional results than delayed repair because scarring is reduced. This aim of this prospective study was to examine the early outcome of immediate repair of third-degree tears. METHOD: A total of 121 women who had immediate repair of obstetric third-degree tears underwent interview, anal ultrasonography and anorectal physiology. RESULTS: At review, 79 (65%) were completely asymptomatic (score = 0), 23 (19%), had minor flatus incontinence or mild urgency causing no compromise to their quality of life (score 1-4), and 19 (16%) had clinically embarrassing faecal incontinence (score 5-24). Thirty-nine (32%) had an intact internal anal sphincter (IAS) and external anal sphincter (EAS) (i.e. a successful repair), eight (7%) had a defect in the IAS alone but the EAS was intact (i.e. a successful repair but a residual IAS defect), 43 (35%) had a residual defect in the EAS alone (IAS intact) and 31 (26%) had a persistent defect in the IAS and EAS. Residual defects in either or both of the sphincters were associated with a significantly higher incidence of abnormal resting and squeeze anal pressures. Anal manometry had no correlation with symptoms. The highest proportion of severe incontinence was in those with an IAS defect alone (37%) and when there was a residual IAS and EAS defect (24%). Only 2 of 39 (5%) with an intact IAS and EAS had severe incontinence and only 8 of 43 (18%) with a residual EAS defect alone had severe faecal incontinence. CONCLUSION: These results indicate a good outcome following immediate repair of third-degree obstetric tears and emphasize the role of the IAS in providing continence.

Criterion validity of the BBUSQ-22: a questionnaire assessing bowel and urinary tract symptoms in women.

To evaluate the criterion validity of the Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ-22). Forty-four women presenting with urinary or bowel symptoms to a urogynaecology/functional bowel clinic, completed three disease-specific questionnaires (Birmingham Bowel and Urinary Symptoms Questionnaire, Sheffield Prolapse Symptoms Questionnaire and King's Health Questionnaire) and two generic questionnaires (SF-36 and EuroQol). Wilcoxon rank sum tests, Spearman's rank correlations and multiple regression analyses were undertaken. All clinically hypothesised correlations between the questionnaires' domains were found significant, and all domains hypothesised to be predictors of the BBUSQ-22 domains were proven to be prognostic, without explaining too much variability to doubt their uniqueness. The similarity among the measures has been proved without such relationships being too strong to call into question the distinctiveness of the concepts being measured. Overall, criterion validity is demonstrated, and the clinical usefulness of the addition this questionnaire makes to the area is highlighted.

Questionnaires to assess urinary and anal incontinence: review and recommendations.

PURPOSE: We reviewed and provide recommendations about the most scientifically robust and appropriate questionnaires for evaluating symptoms and the quality of life impact of urinary and/or anal incontinence, and vaginal and pelvic floor problems. We also investigated the use of these questionnaires in randomized, controlled trials of treatment strategies. MATERIALS AND METHODS: The Symptom and Quality of Life Committee of the International Consultation on Incontinence performed a systematic review of questionnaires related to urinary and anal incontinence, and vaginal and pelvic floor problems, searching MEDLINE, The Cochrane Library and other electronic databases between 2001 and 2004. RESULTS: A total of 23 robust and relevant questionnaires could be recommended in clinical practice and research. The development of questionnaires to assess anal incontinence, and pelvic floor and vaginal problems has been limited with some promising measures but with none achieving the highest level of rigor. From 2001 to 2004 there were 150 published randomized trials of treatments for incontinence. Increasingly trials of incontinence are using recommended measures (38% of those for urinary incontinence and 22% of those for anal incontinence used the highest quality questionnaires in 2001 to 2004) but none of vaginal and pelvic floor problems used recommended questionnaires. CONCLUSIONS: With increasing acknowledgment of the value of patient based assessment much attention has been given to the development of questionnaires to assess symptoms and quality of life. Sufficient measures are now available for urinary incontinence, and researchers and clinicians are encouraged to use the 18 achieving the highest level of rigor and their validated translations. In contrast, the development of questionnaires for anal incontinence and pelvic/vaginal problems is in its infancy and further study in this area is needed. Randomized trials of treatments for incontinence should use only questionnaires achieving the highest level of scientific rigor.

Methods of repair for obstetric anal sphincter injury.

BACKGROUND: Anal sphincter injury during childbirth - obstetric anal sphincter injuries (OASIS) - is associated with significant maternal morbidity including perineal pain, dyspareunia and anal incontinence. Anal incontinence affects women psychologically and physically. Many do not seek medical attention because of embarrassment. The two recognised methods for the repair of damaged external anal sphincter (EAS): are end-to-end (approximation) repair and overlap repair. OBJECTIVES: To compare the effectiveness of overlap repair versus end-to-end repair following OASIS in reducing subsequent anal incontinence, perineal pain, dyspareunia and improving quality of life. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 January 2006), MEDLINE (January 1966 to 31 January 2006), EMBASE (January 1974 to 31 January 2006), SciSearch (January 1974 to 31 January 2006) and conference proceedings of obstetrics and gynaecology, surgery and coloproctology. SELECTION CRITERIA: Randomised controlled trials comparing different techniques of immediate primary repair of EAS following OASIS. DATA COLLECTION AND ANALYSIS: Trial quality was assessed independently by all authors. MAIN RESULTS: Three eligible trials, of grade A quality, involving 279 women, were included. There was considerable heterogeneity in the outcome measures, time points and reported results. Meta-analyses showed that there was no statistically significant difference in perineal pain (relative risk (RR) 0.08, 95% confidence interval (CI) 0.00 to 1.45, one trial, 52 women), dyspareunia (RR 0.62, 95% CI 0.11 to 3.39, one trial, 52 women), flatus incontinence (RR 0.93, 95% CI 0.26 to 3.31, one trial, 52 women) and faecal incontinence (RR 0.07, 95% CI 0.00 to 1.21, one trial, 52 women) between the two repair techniques at 12 months but showed a statistically significantly lower incidence in faecal urgency (RR 0.12, 95% CI 0.02 to 0.86, one trial, 52 women) and lower anal incontinence score (weighted mean difference -1.70, 95% CI -3.03 to -0.37) in the overlap group. Overlap technique was also associated with a statistically significant lower risk of deterioration of anal incontinence symptoms over 12 months (RR 0.26, 95% CI 0.09 to 0.79, one trial, 41 women). There was no significant difference in quality of life. AUTHORS' CONCLUSIONS: The limited data available show that compared to immediate primary end-to-end repair of OASIS, early primary overlap repair appears to be associated with lower risks for faecal urgency and anal incontinence symptoms. As the experience of the surgeon is not addressed in the three studies reviewed, it woudl be inappropriate to recommend one type of repair in favour of another.