Repeatability of Manual Coding Of Cancer Reports in the South African National Cancer Registry; 2010

"Data validity is a very important aspect of cancer registries in ensuring data quality for research and interventions. This study focused on evaluating the repeatability of manual coding of cancer reports in the South African National Cancer Registry (NCR). This cross-sectional study used the Delphi technique to classify 48 generic tumour sites into sites that would be most likely (""difficult"") and least likely (""not difficult"") to give rise to discordant results among coders. Reports received from the Charlotte Maxeke Academic Hospital were manually recoded by five coders (2 301 reports; e.g. approximately 400 reports each) for intracoder agreement; and by four coders (400 reports) for inter-coder agreement. Unweighted kappa statistics were calculated and interpreted using Byrts' criteria. After four rounds of the Delphi technique; consensus was reached on the classification of 91.7 (44/48) of the sites. The remaining four sites were classified according to modal expert opinion. The overall kappa was higher for intra-coder agreement (0.92) than for inter-coder agreement (0.89). ""Not difficult"" tumour sites reflected better agreement than ""difficult"" tumour sites. Ten sites (skin other; basal cell carcinoma of the skin; connective tissue; other specified; lung; colorectal; prostate; oesophagus; naso-oropharynx and primary site unknown) were among the top 80 misclassified sites. The repeatability of manual coding at the NCR was rated as ""good"" according to Byrts' criteria. Misclassified sites should be prioritised for coder training and the strengthening of the quality assurance system."

A pharmacovigilance study of adults on highly active antiretroviral therapy, South Africa: 2007 - 2011.

BACKGROUND: Of the 1.6 million South African people infected with human immunodeficiency virus (HIV), approximately 970,000 (55%) have been initiated on HAART. Despite these numbers, very little has been published about the safety profile of antiretroviral (ARV) medicines in the country. This study was performed at the Medunsa National Pharmacovigilance Centre and aimed to describe the demographic characteristics of patients enrolled in the pharmacovigilance surveillance study; highly active antiretroviral therapy (HAART) initiation regimen patterns; reasons for regimen changes; and adverse effects of ARV medicines. METHODS: A cohort study of HIV-infected individuals aged 15 years or older who were on ARV medicines was conducted at four sentinel sites. RESULTS: After HAART initiation, with an average lapse of 17.8 months (range: 0 - 83.8 months), 2,815 patients were enrolled into the study. Results show that patients were observed for 1,606.2 person-years for pharmacy visits (collection of ARV medicines) and 817.1 person-years for clinical visits (consultation with the doctor). Females constituted 69.6% (1,958/2,815) of the study population. Almost all patients initiated HAART on first-line regimens (2,801/2,815). Some patients (6.7%, 190/2,815) dropped out of the study after HAART initiation. Reasons for regimen changes were not recorded for 2.5% (22/891) of the patients who changed regimens. The primary reason for regimen changes was drug-related toxicity (76.1%, 678/891), mostly evident in patients taking first-line regimens. Adverse effects experienced by patients were polyneuropathy (24.0%, 163/678); lipodystrophy (23.9%, 162/678); neuropathy (10.6%, 72/678); and suspected lactic acidosis (3.8%, 26/678). CONCLUSION: The majority of prescribers complied with the HAART guidelines and initiated most patients on first-line regimens. However, adverse effects are evident in patients taking first-line regimens. We recommend that the Department of Health should introduce less toxic first-line ARV regimens. Future efforts will aim to initiate patients on HAART and enrol them into the study simultaneously to determine early risk profiles of ARV medicines.

A Pharmacovigilance Study of Adults on Highly Active Antiretroviral Therapy; South Africa: 2007-2011

Background: Of the 1.6 million South African people infected with human immunodeficiency virus (HIV); approximately 970;000 (55) have been initiated on HAART. Despite these numbers; very little has been published about the safety profile of antiretroviral (ARV) medicines in the country. This study was performed at the Medunsa National Pharmacovigilance Centre and aimed to describe the demographic characteristics of patients enrolled in the pharmacovigilance surveillance study; highly active antiretroviral therapy (HAART) initiation regimen patterns; reasons for regimen changes; and adverse effects of ARV medicines. Methods: A cohort study of HIV-infected individuals aged 15 years or older who were on ARV medicines was conducted at four sentinel sites. Results: After HAART initiation; with an average lapse of 17.8 months (range: 0 - 83.8 months); 2;815 patients were enrolled into the study. Results show that patients were observed for 1;606.2 person-years for pharmacy visits (collection of ARV medicines) and 817.1 person-years for clinical visits (consultation with the doctor). Females constituted 69.6 (1;958/2;815) of the study population. Almost all patients initiated HAART on first-line regimens (2;801/2;815). Some patients (6.7; 190/2;815) dropped out of the study after HAART initiation. Reasons for regimen changes were not recorded for 2.5(22/891) of the patients who changed regimens. The primary reason for regimen changes was drug-related toxicity (76.1; 678/891); mostly evident in patients taking first-line regimens. Adverse effects experienced by patients were polyneuropathy (24.0; 163/678); lipodystrophy (23.9; 162/678); neuropathy (10.6; 72/678); and suspected lactic acidosis (3.8; 26/678). Conclusion: The majority of prescribers complied with the HAART guidelines and initiated most patients on first-line regimens. However; adverse effects are evident in patients taking first-line regimens. We recommend that the Department of Health should introduce less toxic first-line ARV regimens. Future efforts will aim to initiate patients on HAART and enrol them into the study simultaneously to determine early risk profiles of ARV medicines