scholarly journals Survey design to monitor drug efficacy for the control of soil-transmitted helminthiasis and schistosomiasis

Author(s):  
Luc E Coffeng ◽  
Bruno Levecke ◽  
Jan Hattendorf ◽  
Martin Walker ◽  
Matthew J Denwood

Abstract Background Control of soil-transmitted helminthiasis and schistosomiasis relies heavily on regular preventive chemotherapy. Monitoring drug efficacy is crucial to provide early warning of treatment failures. The World Health Organization (WHO) recommends a survey design in which only egg-positive individuals are retested after treatment. Although this practice makes more efficient use of resources, it may lead to biased drug efficacy estimates. Methods We performed a simulation study to assess the potential for bias when evaluating drug efficacy using the WHO-recommended survey design, and to identify alternative designs for evaluating drug efficacy that are less affected by bias. These designs were also based on selection of egg-positive individuals, but involve retesting them a second time at baseline and up to two times at follow-up. The utility of the different designs was compared fairly by constraining them to the same budget. Results The standard procedure of selecting egg-positive individuals can introduce a substantial positive bias in drug efficacy due to regression towards the mean, particularly when infection levels or drug efficacy are low. This bias was completely eliminated by using a second baseline sample, conditionally on the first sample being excluded from analysis. Precision of estimates can be improved by increasing the number of thick smears and/or samples per person at follow-up, despite fewer individuals being tested within the same budget. Discussion We present optimised survey designs to monitor drug efficacy in field settings which are highly relevant for sustained control of soil-transmitted helminths and schistosomiasis, as well as onchocerciasis and lymphatic filariasis.

2020 ◽  
Vol 58 (12) ◽  
pp. 2025-2035
Author(s):  
María Sol Ruiz ◽  
María Belén Sánchez ◽  
Yuly Masiel Vera Contreras ◽  
Evangelina Agrielo ◽  
Marta Alonso ◽  
...  

AbstractObjectivesThe quantitation of BCR-ABL1 mRNA is mandatory for chronic myeloid leukemia (CML) patients, and RT-qPCR is the most extensively used method in testing laboratories worldwide. Nevertheless, substantial variation in RT-qPCR results makes inter-laboratory comparability hard. To facilitate inter-laboratory comparative assessment, an international scale (IS) for BCR-ABL1 was proposed.MethodsThe laboratory-specific conversion factor (CF) to the IS can be derived from the World Health Organization (WHO) genetic reference panel; however, this material is limited to the manufacturers to produce and calibrate secondary reference reagents. Therefore, we developed secondary reference calibrators, as lyophilized cellular material, aligned to the IS. Our purpose was both to re-evaluate the CF in 18 previously harmonized laboratories and to propagate the IS to new laboratories.ResultsOur field trial including 30 laboratories across Latin America showed that, after correction of raw BCR-ABL1/ABL1 ratios using CF, the relative mean bias was significantly reduced. We also performed a follow-up of participating laboratories by annually revalidating the process; our results support the need for continuous revalidation of CFs. All participating laboratories also received a calibrator to determine the limit of quantification (LOQ); 90% of them could reproducibly detect BCR-ABL1, indicating that these laboratories can report a consistent deep molecular response. In addition, aiming to investigate the variability of BCR-ABL1 measurements across different RNA inputs, we calculated PCR efficiency for each individual assay by using different amounts of RNA.ConclusionsIn conclusion, for the first time in Latin America, we have successfully organized a harmonization platform for BCR-ABL1 measurement that could be of immediate clinical benefit for monitoring the molecular response of patients in low-resource regions.


Author(s):  
Praveen Indraratna ◽  
Uzzal Biswas ◽  
Jennifer Yu ◽  
Guenter Schreier ◽  
Sze-Yuan Ooi ◽  
...  

Introduction: Mobile phone-based interventions in cardiovascular disease are growing in popularity. A randomised control trial (RCT) for a novel smartphone app-based model of care, named TeleClinical Care - Cardiac (TCC-Cardiac), commenced in February 2019, targeted at patients being discharged after care for an acute coronary syndrome or episode of decompensated heart failure. The app was paired to a digital sphygmomanometer, weighing scale and a wearable fitness band, all loaned to the patient, and allowed clinicians to respond to abnormal readings. The onset of the COVID-19 pandemic necessitated several modifications to the trial in order to protect participants from potential exposure to infection. The use of TCC-Cardiac during the pandemic inspired the development of a similar model of care (TCC-COVID), targeted at patients being managed at home with a diagnosis of COVID-19. Methods: Recruitment for the TCC-Cardiac trial was terminated shortly after the World Health Organization announced COVID-19 as a global pandemic. Telephone follow-up was commenced, in order to protect patients from unnecessary exposure to hospital staff and patients. Equipment was returned or collected by a ‘no-contact’ method. The TCC-COVID app and model of care had similar functionality to the original TCC-Cardiac app. Participants were enrolled exclusively by remote methods. Oxygen saturation and pulse rate were measured by a pulse oximeter, and symptomatology measured by questionnaire. Measurement results were manually entered into the app and transmitted to an online server for medical staff to review. Results: A total of 164 patients were involved in the TCC-Cardiac trial, with 102 patients involved after the onset of the pandemic. There were no hospitalisations due to COVID-19 in this cohort. The study was successfully completed, with only three participants lost to follow-up. During the pandemic, 5 of 49 (10%) of patients in the intervention arm were readmitted compared to 12 of 53 (23%) in the control arm. Also, in this period, 28 of 29 (97%) of all clinically significant alerts received by the monitoring team were managed successfully in the outpatient setting, avoiding hospitalisation. Patients found the user experience largely positive, with the average rating for the app being 4.56 out of 5. 26 patients have currently been enrolled for TCC-COVID. Recruitment is ongoing. All patients have been safely and effectively monitored, with no major adverse clinical events or technical malfunctions. Patient satisfaction has been high. Conclusion: The TCC-Cardiac RCT was successfully completed despite the challenges posed by COVID-19. Use of the app had an added benefit during the pandemic as participants could be monitored safely from home. The model of care inspired the development of an app with similar functionality designed for use with patients diagnosed with COVID-19.


2014 ◽  
Vol 58 (10) ◽  
pp. 5643-5649 ◽  
Author(s):  
Katherine Kay ◽  
Eva Maria Hodel ◽  
Ian M. Hastings

ABSTRACTIt is now World Health Organization (WHO) policy that drug concentrations on day 7 be measured as part of routine assessment in antimalarial drug efficacy trials. The rationale is that this single pharmacological measure serves as a simple and practical predictor of treatment outcome for antimalarial drugs with long half-lives. Herein we review theoretical data and field studies and conclude that the day 7 drug concentration (d7c) actually appears to be a poor predictor of therapeutic outcome. This poor predictive capability combined with the fact that many routine antimalarial trials will have few or no failures means that there appears to be little justification for this WHO recommendation. Pharmacological studies have a huge potential to improve antimalarial dosing, and we propose study designs that use more-focused, sophisticated, and cost-effective ways of generating these data than the mass collection of single d7c concentrations.


2021 ◽  
Vol 42 (2) ◽  
pp. 394-402
Author(s):  
O.B. Aribodor ◽  
C.E. Okaka ◽  
S.O. Sam-Wobo ◽  
B.C. Okpala ◽  
D.N. Aribodor ◽  
...  

Urinary schistosomiasis is considered a major public health parasitic disease in African communities. Prior to this study, Nsugbe community was not considered endemic for the disease and as such was not involved in Praziquantel-Preventive Chemotherapy (PC). Longitudinal study of 281 consented pupils aged 5-16 years was carried out with aim of determining the status of urinary schistosomiasis. Urinalysis laboratory test strip, urine filtration technique and syndromic diagnosis were used for the confirmation of the presence of haematuria in urine samples, identification of Schistosoma haematobium ova and the confirmation of female genital schistosomiasis (FGS), respectively. Risk factors for urinary schistosomiasis infection were determined using pre-tested structured questionnaire. Data were analyzed using Minitab 17 software and intensity of infection categorized following World Health Organization (WHO) recommendations. Of the 281 pupils, 117 (42%) were males and 164 (58%) were females with mean age of 9 years. At baseline, an overall prevalence of 0.4% (1/281) which was of light intensity was established. At follow-up, an overall prevalence of 2.1% (6/281) which was of both light (16.7%) and heavy infection (83.3%) was established. The result of the clinical examination showed eggs of S. haematobium in and around the vaginal area indicating FGS of a female pupil aged 12 years. This was treated. Identified risk factors for S. haematobium infection in the community include water-contact activities, ignorance, source of water supply among others. The study revealed the need for an all inclusive mass administration of Praziquantel-PC in the study community for effective control and possible elimination.


2010 ◽  
Vol 134 (2) ◽  
pp. 271-275 ◽  
Author(s):  
Qing Dong ◽  
Shuang Pan ◽  
Li-Sha Sun ◽  
Tie-Jun Li

Abstract Context.—Orthokeratinized odontogenic cyst (OOC) is a relatively uncommon developmental cyst comprising about 10% of cases that had been previously coded as odontogenic keratocysts. Odontogenic keratocyst was designated as keratocystic odontogenic tumor (KCOT) in the new World Health Organization classification and OOC should be distinguished from KCOT for differences in histologic features and biologic behavior. Objective.—To analyze the clinicopathologic features of 61 cases of OOC in a Chinese population. Design.—Clinicopathologic analysis was performed on 61 cases of OOC. Immunohistochemical expression of Ki-67 and p63 was evaluated in 15 OOCs and 15 typical KCOTs. Results.—The 61 patients with OOC ranged from 13 to 75 years (average, 38.93 years). The lesions developed mainly in the third and fourth decades (57.38%) with a distinct predilection for males (72.13%). Six (9.84%) lesions were found in the maxilla and 55 (90.16%) in the mandible. The most common sites were in the mandibular molar and ramus region. Of the 54 cases with radiographic record, 47 (87.04%) were unilocular and 7 (12.96%) were multilocular radiolucencies. Twenty-seven of the 54 cysts were associated with an impacted tooth. Follow-up of 42 patients revealed no recurrence during an average period of 76.8 months after surgery. Compared with KCOTs, expression level of Ki-67 and p63 was significantly lower in OOCs, suggesting a lower proliferative activity. Conclusion.—Orthokeratinized odontogenic cyst is clinicopathologically distinct from KCOT and should constitute its own clinical entity.


2021 ◽  
Vol 16 (02) ◽  
pp. 074-079
Author(s):  
Hasan Kucukkendirci ◽  
Fatih Kara ◽  
Gulsum Gulperi Turgut

AbstractObjective According to the 2017 report of the World Health Organization (WHO), ∼1.5 million people die from vaccine preventable diseases. The WHO is working to generate and popularize effective vaccination programs. However, the concept of “vaccine rejection,” which first started in Europe and United States, has started to make an impact in Turkey during the past 10 years. It is therefore seen as a growing danger in future. This study was conducted to determine, detect, and prevent the reasons of vaccine rejection that have increased in recent years.Methods A cross-sectional study was conducted between June and December at 2015. In all districts of Konya (n = 31), it was aimed to reach all 242 families who rejected vaccination to their 0 to 2 years old babies. Families having more than one child refused to vaccinate all of their children. A questionnaire consisting of 47 questions was prepared by the researchers, using the standard trainings of the Ministry of Health and the literature. A total of 172 families agreed to participate in this study. The questionnaire was applied to the parents using the telephone interview technique. Data were presented as mean ± standard deviation and percentage.Results About 41.3% (n = 71) of the mothers were high school graduates, 50.6% (n = 87) of their fathers were university graduates. About 82.6% (n = 142) of the participants received examination, treatment and follow-up services from family physicians and family health personnel. About 20.9% (n = 36) of the children were the only children of the family. About 55.8% (n = 96) of the families also refused the vaccination for other children. About 83.7% (n = 144) of the unvaccinated children had infants/children follow-up care. While all participants stated that vaccines had side effects, 31.4% (n = 54) of these believed that vaccines cause autism or paralysis in infants. About 62.2% (n = 107) of their mothers did not receive tetanus vaccine during pregnancy. The highest rate of nonvaccination was with the second dose of hepatitis A vaccine, which 96.5% (n = 166) refused. The most accepted vaccine was the first dose of hepatitis B vaccine, which was refused by 18.0% (n = 31). About 79.7% (n = 137) of the participants did not know the reason for the vaccination and 95.9% (n = 165) thought that the vaccines were not required. All participants received information from the health personnel about the vaccines. While 9.9% (n = 17) of the families thought that vaccines cause infertility, 44.8% (n = 77) did not receive vaccination because the vaccines were produced abroad.Conclusion A growing number of families refuse to have their babies vaccinated. The production of vaccines abroad is a major cause of insecurity. There are also beliefs that vaccines cause infertility. Vaccine production in Turkey should be accelerated and public education about vaccines should be reviewed. Training provided to families about vaccines should also be reviewed.


2015 ◽  
Vol 7 (2) ◽  
Author(s):  
Stéphane Amadéo ◽  
Moerani Rereao ◽  
Aurelia Malogne ◽  
Patrick Favro ◽  
Ngoc Lam Nguyen ◽  
...  

The World Health Organization <em>Suicide trends in at-risk territories</em> study is a multi-site regional research program operating first in French Polynesia and countries of the Western Pacific, then extended to the world. The aims of the study were to establish a monitoring system for suicidal behaviors and to conduct a randomised control trial intervention for non-fatal suicidal behaviors. The latter part is the purpose of the present article. Over the period 2008-2010, 515 patients were admitted at the Emergency Department of the Centre Hospitalier de Polynésie Française for suicidal behavior. Those then hospitalized in the Psychiatry Emergency Unit were asked to be involved in the study and randomly allocated to either Treatment As Usual (TAU) or TAU plus Brief Intervention and Contact (BIC), which provides a psycho-education session and a follow-up of 9 phone contacts over an 18-months period. One hundred persons were assigned to TAU, while 100 participants were allocated to the BIC group. At the end of the follow-up there were no significant differences between the two groups in terms of number of presentations to the hospital for repeated suicidal behaviors. Although the study could not demonstrate the superiority of a treatment over the other, nevertheless – given its importance – the investigation captured public attention and was able to contribute to the awareness of the need of suicide prevention in French Polynesia. The BIC model of intervention seemed to particularly suit the geographical and health care context of the country.


2010 ◽  
Vol 197 (4) ◽  
pp. 278-284 ◽  
Author(s):  
Eva Velthorst ◽  
Dorien H. Nieman ◽  
Don Linszen ◽  
Hiske Becker ◽  
Lieuwe de Haan ◽  
...  

BackgroundDecline in social functioning occurs in individuals who later develop psychosis.AimsTo investigate whether baseline differences in disability are present in those who do and those who do not make a transition to psychosis in a group clinically at high risk and whether disability is a risk factor for transition.MethodProspective multicentre, naturalistic field study with an 18-month follow-up period on 245 help-seeking individuals clinically at high risk. Disability was assessed with the Disability Assessment Schedule of the World Health Organization (WHODAS–II).ResultsAt baseline, the transition group displayed significantly greater difficulties in making new friends (z =−3.40, P = 0.001), maintaining a friendship (z =−3.00, P = 0.003), dealing with people they do not know (z =−2.28, P = 0.023) and joining community activities (z =−2.0, P = 0.05) compared with the non-transition group. In Cox regression, difficulties in getting along with people significantly contributed to the prediction of transition to psychosis in our sample (β = 0.569, s.e. = 0.184, Wald = 9.548, P = 0.002, hazard ratio (HR) = 1.767, 95% CI 1.238–2.550).ConclusionsCertain domains of social disability might contribute to the prediction of psychosis in a sample clinically at high risk.


Author(s):  
Sulikah Asmorowati ◽  
Inge Dhamanty

The high rate of deaths caused by serious illnesses has led the World Health Organization (WHO) to recommend palliative care that is considered to be able to improve the quality of patient’s live Palliative care or service is service for patients with serious illnesses, such as cancer (stadium or end-stage). In this activity, however, palliative care and service is extended so that it includes diseases that are not contagious but deadly (thus, contributed significantly to mortality rate), including such illnesses as diabetes, high-blood pressure, cholesterol, stroke and other similar illnesses. These illnesses are now increasingly being suffered by and become the major cause of death (caused by illnesses) amongst Indonesians. In order to increase the availability of palliative services in the target area, this community project provides training and assistance to develop women’s capacity in the villages of Kambingan and Ngembung, Cerme, Gresik, so that they are ready to volunteers for palliative care and service in their respective communities. The projects were conducted by providing material through lectures, and modules; followed by assistance to form a team of palliative case and service. At the end, this project resulted in the increasing understanding, and capacity of women (and mothers or PKK member), as the target groups about palliative care and services. In turn, the women were then ready to become volunteers for palliative care and program.abstrakTingginya tingkat kematian akibat penyakit serius membuat WHO menyarankan untuk melakukan perawatan paliatif yang dianggap dapat meningkatkan kualitas hidup pasien. Program atau layanan paliatif adalah pelayanan kepada pasien dengan penyakit berat, yaitu kanker (stadium akhir). Dalam kegiatan pengabdian masyarakat (pengmas) ini, layanan paliatif diperluas sehingga meliputi pula penyakit-penyakit yang tidak menular namun mematikan, seperti penyakit diabates, darah tinggi, kolesterol, stroke dan sejenisnya yang dewasa ini semakin banyak di derita masyarakat Indonesia. Kegiatan pengmas ini memberikan pelatihan dan pendampingan untuk mengembangkan kapasitas ibu-ibu tim penggerak dan anggota PKK di Desa Kambingan dan Desa Ngembung, Kecamatan Cerme, Kabupaten Gresik agar siap untuk menjadi relawan program paliatif di lingkungan masyarakat masing-masing. Metode yang digunakan dalam kegiatan ini adalah dengan pemberian materi melalui ceramah, pemberian modul, serta pendampingan pembentukan tim paliatif sebagai follow-up kegiatan. Hasil yang dicapai dari kegiatan pengabdian masyarakat ini adalah meningkatnya pemahaman masyarakat khususnya ibu-ibu tentang layanan paliatif, serta meningkatnya kapasitas mereka,sehingga siap menjadi relawan program paliatif.


Author(s):  
Shaun Purkiss ◽  
Tessa Keegel ◽  
Hassan Vally ◽  
Dennis Wollersheim

BackgroundQuantifying the mortality risk for people with diabetes is challenging because of associated comorbidities. The recording of cause specific mortality from accompanying cardiovascular disease in death certificate notifications has been considered to underestimate the overall mortality risk in persons with diabetes. Main AimDevelop a technique to quantify mortality risk from pharmaceutical administrative data and apply it to persons diagnosed with diabetes, and associated cardiovascular disease and dyslipidaemia before death. MethodsPersons with diabetes, cardiovascular disease and dyslipidaemia were identified in a publicly available Australian Pharmaceutical data set using World Health Organization anatomic therapeutic codes assigned to medications received. Diabetes associated multi-morbidity cohorts were constructed and a proxy mortality (PM) event determined from medication and service discontinuation. Estimates of mortality rates were calculated from 2004 for 10 years and compared persons with diabetes alone and associated cardiovascular disease and dyslipidemia. ResultsThis study identified 346,201 individuals within the 2004 calendar year as having received treatments for diabetes (n=51,422), dyslipidaemia (n=169,323) and cardiovascular disease including hypertension (n=280,105). Follow up was 3.3 x 106 person-years. Overall crude PM was 26.1 per 1000 person-years. PM rates were highest in persons with cardiovascular disease and diabetes in combination (47.5 per 100 person years). Statin treatments significantly improved the mortality rates in all persons with diabetes and cardiovascular disease alone and in combination over age groups >44 years (p<.001). Age specific diabetes PM rates using pharmaceutical data correlated well with Australian data from the National Diabetes Service Scheme (r=0.82) ConclusionProxy mortality events calculated from medication discontinuation in persons with chronic conditions can provide an alternative method to estimate disease mortality rates. The technique also allows the assessment of mortality risk in persons with chronic disease multi-morbidity.


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