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Major criteria for publication of replication papers include (i) theoretical significance of the finding being replicated, (ii) statistical power of the study that is carried out, and (iii) the number and power of previous replications of the same finding.
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Systematic reviews of disease management for COPD patients emphasise the need for well-designed, practical multicenter trials [22, 23], including broad representative patient samples [24], with a wide range of physicians and settings to improve external validity [23]. Furthermore, authors of systematic reviews advocate studies designed to evaluate the long-term effectiveness of IDM, [23] and advise more health economic studies across different care settings [24]. When considering the large number of eligible patients for IDM in the community, the potential impact is high. However, no trials have been published that are specifically targeted to measure the cost-effectiveness of IDM in patients recruited in primary care.
The current level of COPD care was assessed at baseline in all general practices to be able to report any difference in quality of care at 12-months follow-up. Therefore, from the EMRs we extracted the following performance indicators: registration of smoking status and stop-smoking advice, registration of body mass index, assessment of spirometry and inhalation technique in the last year, the number of patients with monitored functioning by means of the CCQ, MRC, or the number of patients with controlled physical activity in the last year.
Cluster randomization was at the level of the primary care team. The first author recruited the practices, and the selected participants were checked by the GP against formal inclusion and exclusion criteria before the intervention started. To enhance comparability between the intervention and control group, the clusters were matched and randomized by a researcher who was blinded to the identity of the practices. Matching was into pairs according to the following criteria: (i) percentage of patients from ethnic minorities, (ii) type of practice, (iii) practice location (urban/rural), (iv) age of GP, and (v) gender of the GP. Subsequently, the matched practices were randomized to the intervention group or the control group by using a computer-generated random number list.
Finally, this study differs from the other studies in that we based our sample size estimates on the a priori planned subgroup of patients with an MRC dyspnea score >2. We earlier reported that we found the greatest improvements on quality of life in these patients [25]. It is probably that lung function is still relatively well maintained at this stage, while patients experience considerable dyspnea and an impaired quality of life [20]. As a result of this pre-planned subgroup power analysis and to compensate for the intra-clustering, we allocated almost 1100 patients in the present trial according to protocol. As can be seen in Table 7, this number is much higher than that of earlier studies in this field.
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Since its inception in 1997, the National Committee on Confidential Enquiries into Maternal Deaths (NCCEMD) which records and analyses all institutional maternal deaths (maternal deaths that occur outside the state facilities are excluded in these records and analyses) has published seven reports on maternal deaths in South Africa. These reports describe at length the magnitude of the problem of maternal deaths, the pattern of disease causing maternal deaths, the avoidable factors, missed opportunities and substandard care related to these deaths. Thereafter, they make recommendations to health officials and the national Department of Health regarding approaches to be employed towards reducing the number of maternal deaths [2, 6,7,8,9,10,11]. Moreover, the reporting of maternal deaths has vastly improved and has become more efficient and reliable leading to early identification of problems such as preventable deaths, poor clinical assessment, delays in referral, poor monitoring of patients and lack of appropriately trained doctors. Notwithstanding these successes there is still much to do to improve and reduce maternal mortality ratio in South Africa to acceptable levels.
Data for this study was converted from ASCII format to SPSS 25 (2017) and Software-R (2019) which were used for the analyses [19, 20]. All cases with the variable pregnant were selected from the nine causes of death data sets and new files were created and merged to form one file. The following variables were considered in the analysis: age in 5 year categories, province of death, place of death (hospital, home, other), occupation (professional, semi-professional, unspecified, non-professional), education (none, primary, high school, university, unspecified), marital status (unmarried, married/living together, unspecified), direct and indirect causes of death. Overall, several variables had a number of unspecified categories: 46.2% for education, 13.4% for marital status, 13.7% for occupation, 17.1% for place of death and 0.2% for province of death. Nevertheless, these variables were included in the analysis as they individually constituted less than 50% of missing values which is the maximum percentage statistically accepted for inclusion of missing values in statistical analyses [21]. Caution is advised when interpreting results for education, due to the huge under representation of the various categories in this variable.
The data for the 9 years was pooled first and subsequently broken down into triennia for further analyses and to get a more balanced MMR. The MMRs reported in this study (formula below) were calculated by dividing the recorded/estimated number of maternal deaths by the total recorded/estimated number of live births between 2007 and 2015 and multiplying the result by 100,000 [22, 23].
The occupation variable (in the original dataset) had a category of armed forces which included occupations that could not be classified elsewhere making it difficult to analyze. There was a high number of deaths in all seven indirect causes and miscellaneous indirect causes among non-professional women. Similarly, those with unspecified educational status had the highest number of deaths in five of the seven indirect causes and miscellaneous indirect causes. Unmarried women had the highest number of deaths in all indirect causes and miscellaneous indirect causes.
GT had the highest number of deaths from seven direct causes and miscellaneous direct causes. The majority of maternal deaths from direct causes occurred in a health care facility. The majority of professionals died from miscellaneous direct causes, while non-professionals had the highest number of deaths in all ten main direct causes of death. Maternal deaths among those with unspecified educational status were highest in all ten direct causes and miscellaneous direct causes closely followed by those who had a high school education (Table 3).
Variations and uncertainties in MMR in South Africa are well-documented and recognized [25,26,27,28]. The RMS 2018 report [4] published estimates of MMRs and pregnancy-related mortality ratios (PRMRs) from various sources that were quite similar although produced from different data sources. Furthermore, the RMS report highlights the similarities in the incline and decline in MMR from these various sources. The current study found similar results to the RMS estimates. NCCEMD reports [6,7,8,9,10,11] published prior to the 2018 report have shown an increase in both the numbers and mortality ratios of iMMR in South Africa with the iMMR reaching a peak of 189 deaths per 100,000 live births in 2009. However, the 2018 report shows that since 2010 the iMMR declined substantially to 135 deaths per 100,000 live births in 2016 although that is still a long way to reach the SDG 3.1 global target of 70 deaths per 100,000 li0ve births goal by 2030 [1]. A similar trend to the above figures has been seen in this study where there was an incline in maternal deaths and MMR between 2007 and 2009 and both declined significantly after this period. The MMR in this study declined substantially from a high of 191 deaths per 100,000 live births in 2007 to a low of 139 deaths per 100,000 live births in 2015. These estimates are similar to the findings of the NCCEMD indicated above although the NCCEMD does not capture maternal deaths that occur outside the health care facilities. This significant decline in the MMR during the period under study indicates great strides in the improvement of maternal health in order to meet SDG 3.1 [1]. Tlou (2018) suggests that the higher iMMR between 2007 and 2010 was probably driven by the HIV epidemic which is embedded in our infection category and disproportionately affects pregnant women in South Africa [12]. Furthermore, the 2018 NCCEMD report, advocates that the decline in both maternal deaths and iMMR are largely due to improvements in HIV treatment with the extensive provision of Antiretroviral drugs (ARVs) to pregnant women [2, 3]. While such improvement is impressive, some provinces had maternal mortality ratios at least twice as high as the national level in 2015. Different socio-economic, demographic and environmental features in the provinces may be responsible for the differences in the maternal deaths and MMR. 2ff7e9595c
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