Socioeconomic differences impact overall survival in advanced ovarian cancer (AOC) prior to achievement of standard therapy.

PURPOSE: Survival difference between socioeconomic groups with ovarian cancer has persisted in the United Kingdom despite efforts to reduce disparities in care. Our aim was to delineate critical episodes in the patient journey, where deprivation has most impact on survival. METHODS: A retrospective review of 834 patients with advanced ovarian cancer (AOC) between 16/8/07-16/2/17 at a large cancer centre serving one of the most deprived areas of the UK. Using the Index of Multiple Deprivation (IMD), patients were categorised into five groups. RESULTS: Surgery was more common in less deprived patients (p < 0.00001). Across IMD groups, there were no differences in complete (R0) cytoreduction rate (r = 0.18, p > 0.05), age, or comorbidity. The R0/total cohort rate increased with increasing IMD group (p < 0.0001). Patients refusing any intervention belonged exclusively to the three most deprived groups; 5/7 patients who refused surgery belonged to the most deprived IMD group. Overall survival in the total patient group was less in IMD group 1-2 compared to 9-10 (p = 0.002). On multivariate analysis, IMD group was not an independent predictor of survival (p > 0.05). CONCLUSIONS: Socioeconomic differences in survival manifest in patients not receiving surgical treatment for AOC and are not purely explained by comorbidity, age, stage, or histological factors.

Evaluation and stages of surgical innovations.

Surgical innovation is an important part of surgical practice. Its assessment is complex because of idiosyncrasies related to surgical practice, but necessary so that introduction and adoption of surgical innovations can derive from evidence-based principles rather than trial and error. A regulatory framework is also desirable to protect patients against the potential harms of any novel procedure. In this first of three Series papers on surgical innovation and evaluation, we propose a five-stage paradigm to describe the development of innovative surgical procedures.

No surgical innovation without evaluation: the IDEAL recommendations.

Surgery and other invasive therapies are complex interventions, the assessment of which is challenged by factors that depend on operator, team, and setting, such as learning curves, quality variations, and perception of equipoise. We propose recommendations for the assessment of surgery based on a five-stage description of the surgical development process. We also encourage the widespread use of prospective databases and registries. Reports of new techniques should be registered as a professional duty, anonymously if necessary when outcomes are adverse. Case series studies should be replaced by prospective development studies for early technical modifications and by prospective research databases for later pre-trial evaluation. Protocols for these studies should be registered publicly. Statistical process control techniques can be useful in both early and late assessment. Randomised trials should be used whenever possible to investigate efficacy, but adequate pre-trial data are essential to allow power calculations, clarify the definition and indications of the intervention, and develop quality measures. Difficulties in doing randomised clinical trials should be addressed by measures to evaluate learning curves and alleviate equipoise problems. Alternative prospective designs, such as interrupted time series studies, should be used when randomised trials are not feasible. Established procedures should be monitored with prospective databases to analyse outcome variations and to identify late and rare events. Achievement of improved design, conduct, and reporting of surgical research will need concerted action by editors, funders of health care and research, regulatory bodies, and professional societies.

Challenges in evaluating surgical innovation.

Research on surgical interventions is associated with several methodological and practical challenges of which few, if any, apply only to surgery. However, surgical evaluation is especially demanding because many of these challenges coincide. In this report, the second of three on surgical innovation and evaluation, we discuss obstacles related to the study design of randomised controlled trials and non-randomised studies assessing surgical interventions. We also describe the issues related to the nature of surgical procedures-for example, their complexity, surgeon-related factors, and the range of outcomes. Although difficult, surgical evaluation is achievable and necessary. Solutions tailored to surgical research and a framework for generating evidence on which to base surgical practice are essential.

Information and cervical screening: a qualitative study of women's awareness, understanding and information needs about HPV.

OBJECTIVES: To explore women's attitudes towards the information about human papilloma virus (HPV) provided during cervical screening and to describe women's HPV information needs. SETTING: Women with a range of screening results (normal, inadequate, borderline and abnormal) were identified by three screening centres in England. Two consecutive samples of women attending for colposcopy for the first time following screening were also approached. METHODS: Seven focus groups were conducted between May 2005 and April 2006 with 38 women who had recently been for cervical screening or had attended a colposcopy appointment. RESULTS: Most women had no prior awareness of HPV. Many women queried the importance of being informed about HPV as no preventive advice or treatment is available. The HPV information included in the UK national screening programme abnormal result leaflet left women with more questions than answers (a list of unanswered questions is included with the results). Further information was requested about HPV detection, infection and transmission as well as the natural history and progression of cervical cancer. No consensus was reached regarding the best time to provide HPV information. CONCLUSIONS: Clear communication of the complicated issues surrounding HPV infection and the natural history of cervical cancer is a considerable educational challenge for screening providers. As awareness of HPV becomes more widespread and HPV testing is explored as a triage during cervical screening, women are likely to require more information about the virus and the implications of infection. Consideration should be given to the production of a separate national screening programme HPV leaflet.

Assessment of abnormal bleeding in menopausal women: an update.

Peri and postmenopausal bleeding, with or without the use of hormone replacement therapy, is a common clinical problem. The exclusion of endometrial hyperplasia and carcinoma is the key issue in the evaluation of patients with abnormal uterine bleeding. Transvaginal ultrasound measurement of endometrial thickness has become a routine procedure and an initial investigation in patients with abnormal uterine bleeding. There is debate as to whether a cut-off of 5 or 4 mm endometrial thickness should be employed. If the endometrial thickness is above these values, polyps have been diagnosed or the patient is presenting with recurrent bleeding, endometrial disease has to be excluded by histological assessment. Outpatient aspiration curettage has superseded dilatation and curettage, which was previously considered to be the gold standard for obtaining endometrial tissue, and provides the same sensitivity in detecting endometrial disease. Hysteroscopy allows visualisation of the uterine cavity and the opportunity for targeted biopsy and removal of endometrial polyps.