The basis of a manuscript is the research question, which is reported within a standard publication structure. The ‘Background’ section clarifies the question. The ‘Methods’ section describes what ...was done in the study. The ‘Results’ section describes the data observed and the analysis of these data. The ‘Discussion’ section describes how findings of the study relate to current knowledge and the practical implications of the results, and suggests future studies. This structure differs from that of a thesis, the aims of which are broader than reporting on a specific research question.
The drug cost of adjuvant trastuzumab to benefit one patient with localised human epidermal growth factor receptor 2 (HER2)-positive breast cancer depends on the baseline survival rate (BLSR) of the ...prognostic group of the patient. This varies from ZAR13 752 900 (BLSR 90%) to ZAR4 006 100 (BLSR 60%). All treated patients are exposed to potential toxicity. The value and affordability of treatments need to be considered, as there are finite resources available in our healthcare system. All patients must have access to cost-effective treatments. However, patient selection for expensive treatments is important, as expenditure on patients where the gains are relatively small will result in resources not being available for other patients. The state, healthcare institutions and the pharmaceutical industry need to work together to optimise the benefits of treatment to patients.
Background. Evaluation of the quality of healthcare depends on measures of structures, processes and outcomes. Progress in recording data allows for better measures of processes, such as the ...completeness of clinical data, the performance of professional tasks and the use of checklists. Objectives. To report the results of a radiotherapy (RT) workflow audit and a subsequent online survey of user experience. Methods. The RT workflow audit was developed in 2016 and has been undertaken twice a year at 28 facilities or units, with a total of 32 linear accelerators. Electronic patient folders were reviewed to assess the documentation of 90 task items, of which 64 were scored. The auditor came from another facility. The online survey took place in July 2020. It contained questions on the audit's process, professional value and future use. Invitations were sent by email to the 151 radiotherapist staff at the 28 units where the audit had been implemented. Responses were anonymous. Results. For the RT workflow audit, scores improved from 60% in some units in 2016 to >90% in all units for at least 2 years since 2018. The number of responders to the online survey was 58, giving a responder rate of 38%. The margin of error of the results was 10%. The audit's task items were considered appropriate by 77% of responders, and feedback was reported by 78% of them. The audit was considered very or extremely valuable to their unit's service delivery by 58% of responders. Changes in the unit as a result of the audit were reported by 77% of responders. The audit was very useful or extremely useful to 75% of responders in maintaining personal professional standards. The proportion of responders who were very or extremely supportive of continuing with the audit was 77%. The comments in the online survey will be helpful for ongoing review of the RT workflow audit. Conclusions. The RT workflow audit extends the scope of accreditation audits by including measures of processes. Users of the audit evaluate its processes favourably and report that it has value both in their unit's clinical service and for their personal professional standards. The audit is effective in developing quality improvement programmes.
Background: Vinorelbine (VRL) has been shown to be active in hormone-refractory prostate cancer (HRPC) in phase II studies, alone or in combination. Its moderate toxicity profile is well tolerated in ...elderly patients. Patients and methods: Patients with metastatic prostate cancer, progressive after primary hormonal therapy, were randomised to receive intravenous VRL 30 mg/m2 on days 1 and 8 every 3 weeks, and hydrocortisone 40 mg/day or hydrocortisone alone until disease progression. Centres could choose to add aminoglutethimide 1000 mg/day to hydrocortisone as second-line hormone therapy (HT) for all their patients. Randomisation was stratified by centre. Further chemotherapy was allowed after progression. The primary end point was progression-free survival (PFS). The final analysis was performed on a total of 414 patients. Reported results were all based on intention-to-treat analyses. All progressions and responses were reviewed by an independent panel. Results: PFS was significantly prolonged in the VRL plus HT arm compared with the HT alone arm, according to the statistical hypothesis of the protocol (P=0.055 in the two-sided log-rank test with a pre-specified significance level of 10%). The 6-month PFS rates were 33.2% versus 22.8%, and the median durations of PFS were 3.7 versus 2.8 months. In the multivariate Cox analysis, which included age, Karnofsky performance status (PS), haemoglobin, alkaline phosphatase at study entry and number of prior hormonal treatments, the P value was decreased to 0.005. The prostate-specific antigen (PSA) response rate (≥50% decline sustained for at least 6 weeks) was significantly higher for VRL plus HT compared with HT (30.1% versus 19.2%; P=0.01). Clinical benefit, defined as a decrease in pain intensity or analgesic consumption or an improvement of Karnofsky PS for at least 9 weeks, and at least stable assessment in the other two, was also more frequently observed in patients who received VRL plus HT versus HT alone (30.6% and 19.2%; P=0.008). There was no statistical difference in overall survival. Forty-three per cent of patients in the HT arm received at least one line of further chemotherapy after progression, compared with 28% of patients in the VRL-based arm. Aminoglutethimide did not seem to result in better efficacy for either arm. VRL plus HT was well tolerated, with a median administered relative dose intensity of 90%; grade 4 neutropenia occurred in 6.5% of patients and non-haematological toxicity was rare. Conclusions: The combination of VRL and hydrocortisone compared with hydrocortisone alone resulted in improved clinical benefit, PFS and PSA response rate. This therapeutic gain is similar to that previously reported with mitoxantrone in combination with low-dose corticosteroids. There was no gain in survival; however, the combination is well tolerated in this elderly group of patients, who often present cardiac co-morbidities, and therefore offers an active and safe therapeutic option for patients with hormone-refractory prostate cancer.
Audits of oncology units are part of all quality-assurance programmes. However, they do not always come across as pragmatic and helpful to staff.
To report on the results of an online survey on the ...usefulness and impact of an audit process for oncology units.
Staff in oncology units who were part of the audit process completed the audit self-assessment form for the unit. This was followed by a visit to each unit by an assessor, and then subsequent personal contact, usually via telephone. The audit self-assessment document listed quality-assurance measures or items in the physical and functional areas of the oncology unit. There were a total of 153 items included in the audit. The online survey took place in October 2016. The invitation to participate was sent to 59 oncology units at which staff members had completed the audit process.
The online survey was completed by 54 (41%) of the 132 potential respondents. The online survey found that the audit was very or extremely useful in maintaining personal professional standards in 89% of responses. The audit process and feedback was rated as very or extremely satisfactory in 80% and 81%, respectively. The self-assessment audit document was scored by survey respondents as very or extremely practical in 63% of responses. The feedback on the audit was that it was very or extremely helpful in formulating improvement plans in oncology units in 82% of responses. Major and minor changes that occurred as a result of the audit process were reported as 8% and 88%, respectively.
The survey findings show that the audit process and its self- assessment document meet the aims of being helpful and pragmatic.
The aim of this study was to examine the efficacy of a regimen of initial gemcitabine followed by cisplatin in patients with advanced non-small-cell lung cancer (NSCLC).
Fifty-three patients (36 men ...and 17 women; age range, 35 to 74 years) were enrolled. Patients had bidimensionally measurable disease. Gemcitabine (phase-specific agent) was administered on days 1, 8, and 15 at a dose of 1,000 mg/m2. Cisplatin (cycle-specific agent) was administered on day 15 (100 mg/m2). Chemotherapy was administered in 28-day cycles.
Of 53 patients enrolled, 50 were assessable for response. The overall response rate was 52%. There were two complete responses (4%) and 24 partial responses (48%). The median survival duration was 13 months and the 1-year survival rate was 61%. The regimen was generally well tolerated. World Health Organization (WHO) grade 3 and 4 neutropenia occurred in 38.8% and 19.2% of patients, respectively. Grade 3 and 4 thrombocytopenia occurred in 13.3% and 7.7% of patients, respectively. Most patients experienced mild nausea and vomiting. Few patients had hair loss and oral toxicity was mild. Relatively few patients required dose modifications for any of the three weekly doses of chemotherapy. For the first two cycles of chemotherapy, the dose-intensity per infusion was 947 mg/m2 for gemcitabine and 85 mg/m2 for cisplatin.
This regimen of gemcitabine and cisplatin was effective, with high response and survival rates and few dosage modifications during its administration. Prospective randomized studies with other cisplatin-based combination chemotherapy regimens are indicated.
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