Closing the feedback loop: an audit of the use of imiquimod for the treatment of genital warts

A retrospective case-note audit of 74 patients with 81 treatment episodes of anogenital warts with imiquimod from April 1999 until July 2000 was performed. The majority of patients had failed to clear their warts with other treatments, had recurrences after other treatments, or had other medical problems complicating their genital wart treatment. The overall clinically confirmed complete clearance rate was 33%. This is lower than other published data, but may be so because it includes patients with immunosuppression and difficult-to-treat warts. The complete clearance rate in immunocompetent patients was 37%. In addition, in this audit of clinical practice 17% of the patients did not return for full response to be assessed. The complete clearance rate in those who were able to tolerate treatment and who returned for follow-up was 45%. Based on the results of the audit we have extended the indications for the use of imiquimod in the clinic treatment guidelines. Patients are now offered imiquimod if six or more episodes of other treatments fail to give a good response. Earlier treatment with imiquimod is also offered to those patients with recurrent anogenital warts, and it is recommended as a first-line therapy for patients with multiple keratinized warts.     

Sildenafil citrate decreases sFlt-1 and sEng in pregnant l-NAME treated Sprague-Dawley rats

Objective

The aim of this study is to implement the Ten Group Classification System (TGCS) and evaluate whether the introduction of the medical audit cycle reduces the cesarean section (CS) rate without increasing maternal-fetal risk.

Study design

A prospective cohort study was performed including all women who gave birth during 21 months. The study was subdivided into three consecutive periods: (1) implementation of the TGCS identifying the major CS rate contributor groups (three months), (2) audit and report changes in the CS rates to the medical and midwifery staff according to the TGCS (6 months) and (3) discontinue interventions but continue auditing the CS rates (6 months).

Results

The first period CS rate of 36.8% was reduced to 26.5% after the introduction of interventions in the second period (RR 0.71 IC 0.63-0.81). After the intervention was stopped, the CS rate increased again to 31.8% (RR 1.19 IC 1.09-1.32). This is a decrease of 5.08% from the basal period (RR 0.86 IC 0.76-0.97). The asphyxia rate remained unchanged for the periods studied.

Conclusion

Auditing through the TGCS and feedback is an effective, safe, and easy-to-implement strategy to reduce the CS rate. Its diffusion would allow reduction of the CS rates in countries as ours, and by means of the TGCS, figures can be compared within individual entities and others.     

High complication rate after low anterior resection for mid and high rectal cancer; results of a population-based study

Background

Surgical resection is the cornerstone of treatment for rectal cancer patients. Treatment options consist of a primary anastomosis, anastomosis with defunctioning stoma or end-colostomy with closure of the distal rectal stump. This study aimed to compare postoperative outcome of these three surgical options.

Methods

Data was derived from the national database of the Dutch Surgical Colorectal Audit. Mid and high rectal cancer patients who underwent rectal cancer resection between January 2011 and December 2012 were included. Endpoints were postoperative complications including anastomotic leakage, reinterventions, hospital stay and mortality within 30 days postoperative.

Results

In total, 2585 patients were included. Twenty-five per cent of all patients received a primary anastomosis; 51% an anastomosis with defunctioning stoma, and 24% an end-colostomy. More than one third of patients developed postoperative complications, the lowest rate being in the primary anastomosis group. Anastomotic leakage rates were 12% in patients with a primary anastomosis, and 9% in patients with an anastomosis with defunctioning stoma (p < 0.05). Multivariate analysis showed more postoperative complications, prolonged hospital stay, and increased mortality rates in patients with a defunctioning stoma or end-colostomy. The latter had proportionally less invasive reinterventions when compared to the other two groups.

Conclusions

Patients with a primary anastomosis had the best postoperative outcome. A defunctioning stoma leads to a lower anastomotic leakage rate, though is associated with higher rates of complications, prolonged hospital stay and mortality. The decision to create a defunctioning stoma should be focus of future studies.     

Preoperative radiotherapy for rectal cancer: a comparative study of quality control adherence at two cancer hospitals in Spain and Poland

Background

We performed a clinical audit of preoperative rectal cancer treatment at two European radiotherapy centres (Poland and Spain). The aim was to independently verify adherence to a selection of indicators of treatment quality and to identify any notable inter-institutional differences.

Methods

A total of 162 patients, in Catalan Institute of Oncology (ICO) 68 and in Greater Poland Cancer Centre (GPCC) 94, diagnosed with locally advanced rectal cancer and treated with preoperative radiotherapy or radio-chemotherapy were included in retrospective study. A total of 7 quality control measures were evaluated: waiting time, multidisciplinary treatment approach, portal verification, in vivo dosimetry, informed consent, guidelines for diagnostics and therapy, and patient monitoring during treatment.

Results

Several differences were observed. Waiting time from pathomorphological diagnosis to initial consultation was 31 (ICO) vs. 8 (GPCC) days. Waiting time from the first visit to the beginning of the treatment was twice as long at the ICO. At the ICO, 82% of patient experienced treatment interruptions. The protocol for portal verification was the same at both institutions. In vivo dosimetry is not used for this treatment localization at the ICO. The ICO utilizes locally-developed guidelines for diagnostics and therapy, while the GPCC is currently developing its own guidelines.

Conclusions

An independent external clinical audit is an excellent approach to identifying and resolving deficiencies in quality control procedures. We identified several procedures amenable to improvement. Both institutions have since implemented changes to improve quality standards. We believe that all radiotherapy centres should perform a comprehensive clinical audit to identify and rectify deficiencies.     

Validation and utilisation of high-coverage next-generation sequencing to deliver the pharmacological audit trail

Background:

Predictive biomarker development is a key challenge for novel cancer therapeutics. We explored the feasibility of next-generation sequencing (NGS) to validate exploratory genomic biomarkers that impact phase I trial selection.

Methods:

We prospectively enrolled 158 patients with advanced solid tumours referred for phase I clinical trials at the Royal Marsden Hospital (October 2012 to March 2013). After fresh and/or archived tumour tissue were obtained, 93 patients remained candidates for phase I trials. Results from tumour sequencing on the Illumina MiSeq were cross-validated in 27 out of 93 patients on the Ion Torrent Personal Genome Machine (IT-PGM) blinded to results. MiSeq validation with Sequenom MassARRAY OncoCarta 1.0 (Sequenom Inc., San Diego, CA, USA) was performed in a separate cohort.

Results:

We found 97% concordance of mutation calls by MiSeq and IT-PGM at a variant allele frequency ⩾13% and ⩾500 × depth coverage, and 91% concordance between MiSeq and Sequenom. Common ‘actionable'' mutations involved deoxyribonucleic acid (DNA) repair (51%), RAS-RAF-MEK (35%), Wnt (26%), and PI3K-AKT-mTOR (24%) signalling. Out of 53, 29 (55%) patients participating in phase I trials were recommended based on identified actionable mutations.

Conclusions:

Targeted high-coverage NGS panels are a highly feasible single-centre technology well-suited to cross-platform validation, enrichment of trials with molecularly defined populations and hypothesis testing early in drug development.     

Current issues and actions in radiation protection of patients

Medical application of ionizing radiation is a massive and increasing activity globally. While the use of ionizing radiation in medicine brings tremendous benefits to the global population, the associated risks due to stochastic and deterministic effects make it necessary to protect patients from potential harm. Current issues in radiation protection of patients include not only the rapidly increasing collective dose to the global population from medical exposure, but also that a substantial percentage of diagnostic imaging examinations are unnecessary, and the cumulative dose to individuals from medical exposure is growing. In addition to this, continued reports on deterministic injuries from safety related events in the medical use of ionizing radiation are raising awareness on the necessity for accident prevention measures. The International Atomic Energy Agency is engaged in several activities to reverse the negative trends of these current issues, including improvement of the justification process, the tracking of radiation history of individual patients, shared learning of safety significant events, and the use of comprehensive quality audits in the clinical environment.     

Development of a clinical chart audit programme

Radiation oncology charts containing medical information and treatment details are the major methods of communication between the various personnel involved in delivering radiation therapy to the patient. It is paramount to good patient care for this communication to be clear, precise and accurate in detail. A regular chart audit should be a part of the quality assurance programme of every radiation oncology department. The primary aim of this study was to develop and assess an objective and quantitative programme for reviewing radiation oncology charts, thereby improving the quality of communication and hence patient management. A secondary aim was to compare the charts of radically treated patients with those treated palliatively. A pilot study using a new chart review tool, developed at the Perth Radiation Oncology Centre, was carried out over an 8‐month period. A sample of charts, representing 25% of our treatment group, were assessed using the tool on a monthly basis. A total of 156 charts were reviewed during this time period. Fifty‐six per cent were radical treatments and 44% were palliative. The overall mean chart scores significantly improved over the time of this study (P < 0.001). The individual radiation oncologists’ scores were also seen to improve during the study period. The alpha coefficients for intra‐rater and inter‐rater reliability were 0.99 and 0.88, respectively. The chart review programme was found to be an easy‐to‐use and a reliable tool by both medical and non‐medical reviewers. It appeared to have a positive influence on the standard of radiation oncology charts in our department.     

The effect of education, assessment and a standardised prescription on postoperative pain management The value of clinical audit in the establishment of acute pain services

A study involving 2738 patients in 15 hospitals in the United Kingdom was undertaken to evaluate the effect of simple methods of pain assessment and management on postoperative pain. The study consisted of four parts: a survey of current practice in each hospital; a programme of education for staff and patients regarding pain and its management; the introduction of formal assessment and recording of pain and the use of a simple algorithm to allow more flexible, yet safe, provision of intermittent intramuscular opioid analgesia; and a repeat survey of practice. One hospital from each of the former health regions of England and Wales was selected for inclusion in the project. Hospitals included representatives of different size units (university, large and small district general hospitals). As a result of the study, there was an overall reduction in the percentage of patients who experienced moderate to severe pain at rest from 32% to 12%. The incidence of severe pain on movement decreased from 37% to 13% and moderate to severe pain on deep inspiration from 41% to 22%. Similar decreases were seen in the incidence of nausea and vomiting. There was also a slight reduction in the incidence of postoperative complications. This study shows that simple techniques for the management of postoperative pain are effective in reducing the incidence of pain both at rest and during movement and should form part of any acute pain management strategy.     

椎动脉型颈椎病致颈性眩晕的观察与护理

通过对３１例椎动脉型颈椎病致颈性眩晕患者的临床观察与护理，总结了颈性眩晕的临床表现及特点，提出应严密观察发作期患者的血压、心率、心电图及水、电解质变化，及时给予相应处理。加强基础及心理护理，以减轻患者的恐惧心理，避免各种诱发因素，配合医生治疗。