Perianal fistulizing Crohn's disease-associated anorectal and fistula cancers: systematic review and expert consensus.

BACKGROUND AND AIMS: Perianal fistulizing Crohn's disease (PFCD)-associated anorectal and fistula cancers are rare but often devastating diagnoses. However, given the low incidence and consequent lack of data and clinical trials in the field, there is little to no guidance on screening and management of these cancers. To inform clinical practice, we developed consensus guidelines on PFCD-associated anorectal and fistula cancers by multidisciplinary experts from the international TOpClass consortium. METHODS: We conducted a systematic review by standard methodology, using the Newcastle-Ottawa Scale quality assessment tool. We subsequently developed consensus statements using a Delphi consensus approach. RESULTS: Of 561 articles identified, 110 were eligible, and 76 articles were included. The overall quality of evidence was low. The TOpClass consortium reached consensus on six structured statements addressing screening, risk assessment, and management of PFCD-associated anorectal and fistula cancers. Patients with longstanding (>10 years) PFCD should be considered at small but increased risk of developing perianal cancer, including squamous cell carcinoma of the anus(SCCA) and anorectal carcinoma. Risk factors for SCCA, notably human papilloma virus (HPV), should be considered. New, refractory, or progressive perianal symptoms should prompt evaluation for fistula cancer. There was no consensus on timing or frequency of screening in patients with asymptomatic perianal fistula. Multiple modalities may be required for diagnosis, including an exam under anesthesia (EUA) with biopsy. Multidisciplinary team efforts were deemed central to the management of fistula cancers. CONCLUSION: Inflammatory bowel disease (IBD) clinicians should be aware of the risk of PFCD-associated anorectal and fistula cancers in all patients with PFCD. The TOpClass consortium consensus statements outlined herein offer guidance in managing this challenging scenario.

Golimumab effectiveness and safety in clinical practice for moderately active ulcerative colitis.

BACKGROUND AND AIMS: Golimumab (GLB) is an antitumour necrosis factor-α (anti-TNF) therapy that has shown efficacy as induction and maintenance therapy for ulcerative colitis (UC). We aimed to describe the outcome of GLB therapy for UC in a real-world clinical practice. PATIENTS AND METHODS: Consecutive patients receiving GLB for UC in six Irish Academic Medical Centres were identified. The primary study endpoint was the 6-month corticosteroid-free remission rate. The secondary endpoints included the 3-month clinical response, time free of GLB discontinuation and adverse events. RESULTS: Seventy-two patients were identified [57% men; median (range) age of 41.4 years (20.3-76.8); disease duration 6.6 years (0-29.9); follow-up 8.7 months (0.4-39.2)]. Sixty-four percent of patients were anti-TNF naive. The 3-month clinical response and the 6-month corticosteroid-free remission rates were 55 and 39%, respectively. Forty-four percent of patients discontinued GLB during the follow-up, median (95% confidence interval) time to GLB discontinuation 18.7 months (9.2-28.1). A C-reactive protein more than 5 mg/l at baseline was associated with failure to achieve 6-month corticosteroid-free remission and a shorter time to GLB discontinuation, odds ratio 0.2 (0.1-0.7), P=0.008, and hazard ratio (95% confidence interval) 2.8 (1.3-5.7), P=0.007, respectively. Adverse events occurred in 7% of patients (n=5), all of which were minor and self-limiting. CONCLUSION: These real-world clinical data suggest that GLB is an effective and safe therapy for a UC cohort with significant previous anti-TNF exposure. An elevated baseline C-reactive protein, likely reflective of increased inflammatory burden, is associated with a reduced likelihood of a successful outcome of GLB therapy.

Postnatal debriefing interventions to prevent maternal mental health problems after birth: exploring the gap between the evidence and UK policy and practice.

BACKGROUND: Postnatal mental health problems range from transient psychological problems to depression, anxiety, psychosis, and post-traumatic stress disorder (PTSD). Debriefing is a structured psychological intervention to prevent postnatal psychological problems, particularly PTSD and depression. Many UK maternity service providers have established postnatal debriefing services, in some cases supported by policy, despite a lack of robust evidence. In this article, current evidence of the effectiveness of postnatal debriefing and the availability and current provision of debriefing offered in UK maternity services is described. METHODS: A structured literature review was undertaken. FINDINGS: Eight randomized controlled trials were conducted to evaluate debriefing or counseling interventions in childbirth settings, and seven studies were done to evaluate debriefing or counseling interventions provided within UK maternity services or describe the availability of such services. Results of six RCTs were that no differences in outcomes were found, one report indicated possible harm from debriefing, and two indicated a positive association related to a psychological intervention. Methodological issues might account for differing trial outcomes. No standard intervention was used in any RCTs or service interventions. Confusion apparently exists in use of the term "debriefing" in UK maternity service policy and practice. Although service evaluations showed that women valued opportunities to discuss their birth, evidence to support the content and timing of service provision and effectiveness of this was lacking. DISCUSSION: It might be appropriate to consider offering women an opportunity to discuss their childbirth experience and to differentiate this discussion from the offer of a formal debriefing, which is unsupported by evidence. IMPLICATIONS FOR PRACTICE/CONCLUSION: Midwives and other health care professionals who provide opportunities for women to talk about childbirth should be clear about terms used to describe the intervention, as well as the purpose and content of this. Differentiating between women who perceive their experience of childbirth as traumatic and those who develop symptoms of PTSD (for whom specific treatment may be required) is important. All health care professionals should be aware of the signs and symptoms of mental health problems after birth, which may include depression, anxiety, or psychosis in addition to PTSD.

Evaluation of the use of health care assistants to support disadvantaged women breastfeeding in the community.

There is little experience of the use of health care assistants in the community to support breastfeeding in the UK. The aim of this project was to evaluate the implementation of a small-scale pilot project using health care assistants in the community to support disadvantaged women breastfeeding. The evaluation was funded as part of the Department of Health's Infant Feeding Initiative. A longitudinal observational and quasi-experimental design was used. The project involved women, who had recently given birth, living in an area of London identified by the government's Sure Start scheme as socio-economically disadvantaged. This paper focuses mainly on the findings drawn from the qualitative data focusing on the process of implementation, the role of the Support Worker and women's perceptions of the support. The findings suggest that the use of health care assistants in the community may offer a practical and encouraging approach in supporting breastfeeding which is acceptable to both breastfeeding women and health care professionals. More research is needed to establish whether the intervention significantly increases breastfeeding rates.