This study reports the immediate feedback on the procedure of HRA by patients. This procedure is for the detection of anal cancer precursors, and in those at high risk, needs to be carried out regularly in order to maintain surveillance. From the patients who filled out the relevant section of the survey, the procedure including taking of biopsies and treatment does appear to be highly acceptable to them. Current management of anal HSIL in many areas of the UK involve multiple biopsies under general anaesthetic, usually without the high-resolution element to allow targeting of biopsies. HRA involves not only directed biopsies, hence fewer in number, but is carried out as a no/ local anaesthetic procedure.
Prospective evaluation of a service has the advantage of ensuring that data collection can be adequately planned, and pain assessment is contemporaneous and is more likely to be complete. By employing this method, we had an excellent response rate to this evaluation.
There is an increasing trend in healthcare evaluation to ensure that patients’ views and opinions are taken into account http://www.healthknowledge.org.uk/public-health-textbook/research-methods/1c-health-care-evaluation-health-care-assessment/study-design-assessing-effectiveness (accessed on 5/11/2017). This enables the analysis of health care provision from the patients’ rather than healthcare providers’ perspective.
The team at Homerton anal neoplasia service (HANS) consists of a number of HRA practitioners and this study reflects the overall performance of the whole team at HANS. It may be possible for us to bench-mark patient initiated scores of pain and overall satisfaction of care for our service, for comparison with other services, as well as individual practitioners in the future. Patients at high-risk of anal carcinoma include HIV-positive men and women [8], those on immune-suppressants such as renal transplant recipients [9] or patients with systemic lupus erythematosus [10], and the experience of HRA examination may vary in different patient groups. Although the HRA practice standards have been published and will help guide HRA practice, an important element of assessing performance will be to utilise patient experience.
Rates of overall questionnaire answering were high but not all patients completed all the questions. This was the price of anonymity which we felt was important, in order to encourage truthful answers. HRA involves intimate examination and biopsy under local anaesthetic.
Treatment with laser ablation is one form of ablative treatment for anal HSIL. In a randomised controlled study comparing 3 different treatments for anal neoplasia, pain was assessed as a side effect to treatment [11]. This study did not distinguish between pain felt during the procedure and pain that occurred during the recovery period. The pain assessment was retrospective and not contemporaneous in nature. This study indicates that pain during the procedure for small office-based ablative procedures under local anaesthetic is acceptable.
In our study, pain scores were essentially similar between the new cases, treatment cases and those attending for surveillance. Although ‘problematic pain’ defined as a pain score of ≥7 was uncommon in this cohort of patients, a relatively larger number of women reported ‘problematic pain’. This may relate to the fact that women have multizonal assessment which includes examination of the cervix, vagina and vulvar regions at the same visit as high resolution anoscopy. Previous anecdotal observations suggest that the duration of examination may determine the level of pain or discomfort experienced by the patient. The guidelines for international practice standards recognises the duration of HRA examination to be important [6]. In the light of our study’s findings, going forward, we will have a lower threshold for offering women multizonal HRA assessment under general anaesthesia.
We compared nurse and physician assessment of pain with patients’ own pain (Table 2a and b). There were 2 patients out of 220 with clinician scores of 0–3, where the patient recorded a pain score of 7 or more. The opposite case, where a high score was assigned by the clinician, but the patient rated this at 0–3 occurred in 6 out of 220. Nursing evaluation missed severe pain in 10 / 325 and overestimated the pain in 7 / 325. Overall, correlation was fairly accurate with assessment by nurses and clinicians, hence abandoning the office procedure if pain is experienced, and rebooking it with sedation or general anaesthetic is a possible solution for that small percentage who found the procedure painful.
In our cohort of patients, women were equally satisfied with the care they received as men and almost all men and women were willing to return for a future examination. In a study looking at the psychological impact of being screened for anal cancer in HIV-positive men who have sex with men, patients were more likely to have higher negative impact scores immediately after being screened, compared to at other time points such as pre-screen and post-results [12]. This supports the timing of patient acceptability feedback that we carried out. Further, patient’s recollection of their pain experience seems to rely on the peak intensity of the pain during the procedure and on the intensity of the pain recorded during the last 3 min of the procedure, when measured for colonoscopy and lithotripsy [13]. This may explain the occasions when recollected patient pain score did not correlate with clinician-awarded pain score.
HRA examination is thought to be the ideal method for the diagnosis of high grade anal neoplasia, through directed biopsies [14]. It enables a reduction in anal cancer progression rates when used for diagnosis, treatment and surveillance of anal HSIL [15]. Preliminary data indicate that HRA may help to reduce local disease failure of T1–3 anal cancer cases (TNM classification), when used for surveillance after treatment [16]. It is noteworthy that anal HSIL often occur in association with anal squamous carcinoma, and is believed to be the precursor to anal carcinoma [4]. HRA surveillance enables detection and adequate treatment of anal HSIL.
This study has several limitations. The National Health Service in the UK advocates routine collection of patient feed-back on services. We obtained patient feed-back over a 10-month period, from patients seeing different members of staff. Due to the anonymous nature of the survey, we could not stratify the results according to the clinician who saw the patient. A small number of patients (~ 5%) may have attended twice and filled out two separate forms. This may have ‘amplified’ feed-back results. Our patient cohort consisted of those who had HRA only, those who had one or more biopsies, and those who received treatment. The patients undergoing treatment and surveillance were by definition groups who had already attended at least once previously and thus may bias the results in favour of patients willing to return for a further examination. However, there were no significant differences between these three groups in terms of willingness to return.
No sample size calculations were conducted but we found a difference in pain scores between men and women; further studies and replication of the findings are necessary. The overall response rate was high it was not 100%, and not all patients answered all questions. This may have reflected a failure of trust in the anonymization process, leading to a refusal to fill out any deemed to be a critical or negative response. Both these factors could bias the results in favour of those who experienced less pain/were more willing to return. Finally, the feedback audit was conducted in a tertiary referral unit, and thus the results may not be generalizable to other populations.
Our results are encouraging in that due to low pain scores and a high proportion of patients being willing to return for further visits, we feel that HRA can be supported as an outpatient procedure, including for small volume ablative treatments. Access to general anaesthetic or sedation may be required for patients, particularly women, who may experience pain during examination and for larger volume ablative treatments.
