12 research outputs found

    Addressing the Challenge of P-Value and Sample Size when the Significance is Borderline: The Test of Random Duplication of Participants as a New Approach

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    The issue of borderline p-value seems to divide health scientists into two schools of thought. One school of thought argues that when the p-value is greater than or equal to the statistical significance cut-off level of 0.05, it should not be considered statistically significant and the null hypothesis should be accepted no matter how close the p-value is to the 0.05. The other school of thought believes that by doing so one might be committing a Type 2 error and possibly missing valuable information. In this paper, we discuss an approach to address this issue and suggest the test of random duplication of participants as a way to interpret study outcomes when the statistical significance is borderline. This discussion shows the irrefutability of the concept of borderline statistical significance, however, it is important that one demonstrates whether a borderline statistical significance is truly borderline or not. Since the absence of statistical significance is not necessarily evidence of absence of effect, one needs to double check if a borderline statistical significance is indeed borderline or not. The p-value should not be looked at as a rule of thumb for accepting or rejecting the null hypothesis but rather as a guide for further action or analysis that leads to correct conclusions

    SD Bioline malaria antigen Pf (HRP-2/pLHD) for assessing efficacy of artemisinin combination therapy against Plasmodium falciparum in pediatric patients in the Democratic Republic of the Congo

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    Introduction: The emergence of Plasmodium falciparum resistance to artemisinin combination therapy (ACT) is a worrying development. It calls for close surveillance to monitor the efficacy of the drugs. The objectives of this study were to determine the performance of SD Bioline malaria AgPf(HRP-2/pLDH) 3  band Rapid Diagnostic Test (RDT) against Giemsa-stained blood smear and evaluate the suitability of this test in assessing the therapeutic efficacy of ACT in pediatric malaria patients in the Democratic Republic of the Congo (DRC). Methods: Five hundred and one patients with malaria symptoms were screened for P. falciparum in  Kinshasa, DRC. Of the 166 patients who tested positive for P. falciparum at recruitment (day 0), 103 consented to participate in this study and were followed up and retested for P. falciparum on day 3, day 7, day 14, day 21 and day 28. Results: Sensitivity and specificity of the test were significantly high on day 0 and so were their positive and negative predictive values. Higher proportions of false positive cases were observed on the HRP-2 band irrespective of patient parasite densities during the follow up but these were barely seen on the pLDH band. Some patients turned positive during follow up but pLDH readings remained consistent with bloodsmear readings. Conclusion: SD Bioline malaria AgPf(HRP-2/pLDH) RDT demonstrated high performance in DRC. Thus, the test can be employed to assess the efficacy of ACT in pediatric malaria patients and prioritize areas that require the deployment of advanced testing like polymerase chain reaction (PCR).Key words: Malaria, AgPf(HRP-2/pLDH) RDT, artemisinin combination therapy, Democratic Republic of the Cong

    Glycaemic, blood pressure and low-density lipoprotein-cholesterol control among patients with diabetes mellitus in a specialised clinic in Botswana: a cross-sectional study

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    OBJECTIVE: Control of glycaemic, hypertension and low-density lipoprotein-cholesterol (LDL-C) among patients with type 2 diabetes mellitus (T2DM) is vital for the prevention of cardiovascular diseases. The current study was an audit of glycaemic, hypertension and LDL-C control among ambulant patients with T2DM in Botswana. Also, the study aimed at assessing factors associated with attaining optimal glycaemic, hypertension and LDL-C therapeutic goals. DESIGN: A cross-sectional study. SETTING: A specialised public diabetes clinic in Gaborone, Botswana. PARTICIPANTS: Patients with T2DM who had attended the clinic for ≥3 months between August 2017 and February 2018. PRIMARY OUTCOME MEASURE: The proportion of patients with optimal glycaemic (HbA1c<7%), hypertension (blood pressure <140/90 mm Hg) and LDL-C (<1.8 mmol/L) control. RESULTS: The proportions of patients meeting optimal targets were 32.3% for glycaemic, 54.2% for hypertension and 20.4% for LDL-C. Age≥ 50 years was positively associated with optimal glycaemic control (adjusted OR [AOR] 5.79; 95% CI 1.08 to 31.14). On the other hand, an increase in diabetes duration was inversely associated with optimal glycemic control (AOR 0.91; 95% CI 0.85 to 0.98). Being on an ACE inhibitor was inversely associated with optimal hypertension control (AOR 0.35; 95% CI 0.14 to 0.85). Being female was inversely associated with optimal LDL-C control (AOR 0.24; 95% CI (0.09 - 0.59). CONCLUSION: Patients with T2DM in Gaborone, Botswana, presented with suboptimal control of recommended glycaemic, hypertension and LDL-C targets. These findings call for urgent individual and health systems interventions to address key determinants of the recommended therapeutic targets among patients with diabetes in this setting

    Relationships between environmental risk factors, parasitic infections and health outcomes in an urban African setting

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    The relationships between parasitic infections, environmental and living conditions, and health outcomes were studied in subdivisions of lower (LSES) and higher (HSES) socio-economic status Lubumbashi, Zaire. The two LSES subdivisions had higher prevalences of Plasmodium infection and higher rates of stunting, abdominal pain and low packed cell volume (PCV) than the HSES subdivision. The prevalence and intensity of Ascaris lumbricoides and Trichuris trichiura was not associated with socio-economic status. Maternal education was a significant predictor of A. lumbricoides intensity in both LSES and HSES subdivisions. Factors related to poor sanitation were risk factors for A. lumbricoides in LSES subdivisions, whereas a high ratio of relatives to immediate family members per household predicted high intensity infection in the HSES subdivision. The risk of stunting was higher in children with A. lumbricoides, that of wasting was higher in children with A. lumbricoides or T. trichiura whereas the risk of kwashiorkor was high with T. trichiura but very reduced in those with A. lumbricoides. The four most common clinical conditions were diarrhea, abdominal pain, fever and low PCV. Hookworm infection, T. trichiura infection, young age and residence in LSES subdivisions were determinants of diarrhea. T. trichiura infection, young age and living in a LSES subdivision were risk factors for abdominal pain. Plasmodium infection and young age were associated with fever. LSES was predictive of low PCV. No combination of parasites had antagonistic or synergistic effects on clinical indicators examined. Based on this study, it is suggested that one parasite will increase the risk of infection with another. Although maternal education should be improved in all subdivisions, attention to sanitation, crowding and diet in the LSES subdivisions, and to the role of relatives and visitors in parasite transmission in the HSES subdivision should be priorities

    Relationship between combination antiretroviral therapy regimens and diabetes mellitus-related comorbidities among HIV patients in Gaborone Botswana

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    Abstract Background Combination antiretroviral therapy (cARTs) regiments are known to prolong the recipients’ life even though they are risk factors for diabetes mellitus-related comorbidities (DRCs). We sought to: (i) examine cART relationship with DRCs among patients attending HIV clinics in Gaborone, Botswana (which cART regimens are associated with shorter/longer time to the event), (ii) characterize patients’ underlying biomedical and demographic risk factors of DRC and identify the most important, (iii) investigate survival of patients on different cART regimens in the presence of these risk factors. Methods Data from two major HIV clinics in Botswana were reviewed. Relationships between different cART regimens and DRCs were investigated among 531 recipients. Recipients’ DRC risk factors were identified. Cox regression model was run. Unadjusted and adjusted hazard ratios were computed, and hazard and survival functions for different cART regimens were plotted. Results Major findings were: patients on second- and third-line cART were less likely to develop DRCs earlier than those on first-line cART. Patients with CD4 count ≤ 200 cells/mm3 at cART initiation were more likely to develop DRCs earlier than those who had CD4 count > 200 cells/mm3. Overweight patients at cART initiation had a higher risk of developing DRCs earlier than those who had normal body mass index. Males had a lower risk of developing DRCs earlier than females. Conclusion The risk of new onset of DRC among cART recipients is a function of the type of cART regimen, duration of exposure and patients’ underlying biomedical and demographic DRC risk factors. The study has provided a survival model highlighting DRCs’ significant prognostic factors to guide clinical care, policy and management of recipients of cARTs. Further studies in the same direction will likely improve the survival to the development of DRC of every cART recipient in this community

    Overweight and Obesity among Recipients of Antiretroviral Therapy at HIV Clinics in Gaborone, Botswana: Factors Associated with Change in Body Mass Index

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    Background. Factors associated with overweight/obesity among antiretroviral therapy (ART) recipients have not been sufficiently studied in Botswana. Objectives. To: (i) estimate the prevalence and trends in overweight/obesity by duration of exposure to ART among recipients, (ii) assess changes in BMI categories among ART recipients between their first clinic visit (BMI-1) and their last clinic visit (BMI-2), (iii) identify ART regimen that predicts overweight/obesity better than the others and factors associated with BMI changes among ART recipients. Methods. A 12-year retrospective record-based review was conducted. Potential predictors of BMI change among patients after at least three years of ART exposure were examined using a multiple logistic regression model. Adjusted odds ratios (AOR) and their 95% confidence intervals (CIs) were computed. ART regimens, duration of exposure to ART, and recipients’ demographic and biomedical characteristics including the presence or absence of diabetes mellitus-related comorbidities (DRC), defined as any morbidity associated with type 2 diabetes as described in the international statistical classification of diseases and related health problems (ICD-10-CM) codebook index, were investigated as potential predictors of overweight/obesity. Results. Twenty-nine percent of recipients were overweight, 16.6% had obesity of whom 2.4% were morbidly-obese at the last clinic visit. Overweight/obese recipients were more likely to be female, to have DRC and less likely to have CD4 count between 201 and 249 cells/mm3. Neither the first-line nor the second-, third-line ART regimens predicted overweight/obesity better than the other and neither did the duration of exposure to ART. No significant linear trends were observed in the prevalence of overweight/obesity by the duration of exposure to ART. Conclusion. These results suggest that the ART regimens studied have a comparable effect on overweight/obesity and that the duration of exposure does not affect the outcome. This study calls for further research to elucidate the relative contribution of various factors to BMI change among recipients, including ART regimens
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