scholarly journals Trials and Tribulations: mHealth Clinical Trials in the COVID-19 Pandemic

2021 ◽  
Author(s):  
Praveen Indraratna ◽  
Uzzal Biswas ◽  
Jennifer Yu ◽  
Guenter Schreier ◽  
Sze-Yuan Ooi ◽  
...  
Keyword(s):  
Decompensated Heart Failure ◽  
Hospital Staff ◽  
Outpatient Setting ◽  
World Health ◽  
Randomised Control Trial ◽  
Contact Method ◽  
Model Of Care ◽  
Coronary Syndrome ◽  
Health Organization

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.

scholarly journals Programme for Harmonization to the International Scale in Latin America for BCR-ABL1 quantification in CML patients: findings and recommendations

2020 ◽  
Vol 58 (12) ◽  
pp. 2025-2035
Author(s):  
María Sol Ruiz ◽  
María Belén Sánchez ◽  
Yuly Masiel Vera Contreras ◽  
Evangelina Agrielo ◽  
Marta Alonso ◽  
...  
Keyword(s):  
Latin America ◽  
Myeloid Leukemia ◽  
World Health ◽  
Molecular Response ◽  
Limit Of Quantification ◽  
International Scale ◽  
Deep Molecular Response ◽  
Health Organization ◽  
First Time

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.

Orthokeratinized Odontogenic Cyst: A Clinicopathologic Study of 61 Cases

2010 ◽  
Vol 134 (2) ◽  
pp. 271-275 ◽  
Author(s):  
Qing Dong ◽  
Shuang Pan ◽  
Li-Sha Sun ◽  
Tie-Jun Li
Keyword(s):  
Odontogenic Cyst ◽  
World Health ◽  
Keratocystic Odontogenic Tumor ◽  
Impacted Tooth ◽  
Ki 67 ◽  
Orthokeratinized Odontogenic Cyst ◽  
Clinicopathologic Study ◽  
Mandibular Molar ◽  
Health Organization

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.

Reasons for Vaccine Rejection in 0 to 2 Years Old Children Registered to Family Health Centers in Konya

2021 ◽  
Vol 16 (02) ◽  
pp. 074-079
Author(s):  
Hasan Kucukkendirci ◽  
Fatih Kara ◽  
Gulsum Gulperi Turgut
Keyword(s):  
Health Personnel ◽  
Family Health ◽  
Cross Sectional Study ◽  
World Health ◽  
University Graduates ◽  
Cross Sectional ◽  
Vaccination Programs ◽  
Vaccine Preventable Diseases ◽  
Health Organization

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.

scholarly journals Testing brief intervention and phone contact among subjects with suicidal behavior: a randomized controlled trial in French Polynesia in the frames of the World Health Organization/Suicide Trends in At-Risk Territories study

2015 ◽  
Vol 7 (2) ◽  
Author(s):  
Stéphane Amadéo ◽  
Moerani Rereao ◽  
Aurelia Malogne ◽  
Patrick Favro ◽  
Ngoc Lam Nguyen ◽  
...  
Keyword(s):  
At Risk ◽  
World Health Organization ◽  
Brief Intervention ◽  
Suicidal Behavior ◽  
French Polynesia ◽  
World Health ◽  
Suicidal Behaviors ◽  
The World ◽  
Health Organization

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.

scholarly journals Disability in people clinically at high risk of psychosis

2010 ◽  
Vol 197 (4) ◽  
pp. 278-284 ◽  
Author(s):  
Eva Velthorst ◽  
Dorien H. Nieman ◽  
Don Linszen ◽  
Hiske Becker ◽  
Lieuwe de Haan ◽  
...  
Keyword(s):  
High Risk ◽  
Help Seeking ◽  
Cox Regression ◽  
World Health ◽  
Disability Assessment ◽  
Community Activities ◽  
Transition Group ◽  
The World ◽  
Health Organization

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.

scholarly journals PENGEMBANGAN KAPASITAS PEREMPUAN BAGI IBU-IBU RELAWAN PROGRAM PALIATIF DI DESA KAMBINGAN DAN DESA KREMBUNG, KECAMATAN CERME, KABUPATEN GRESIK

2020 ◽  
Vol 4 (1) ◽  
pp. 189
Author(s):  
Sulikah Asmorowati ◽  
Inge Dhamanty
Keyword(s):  
Palliative Care ◽  
High Rate ◽  
World Health ◽  
Target Area ◽  
Target Groups ◽  
Community Project ◽  
Health Organization ◽  
End Stage

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.

scholarly journals Estimates of mortality rates in people with diabetes and cardiovascular disease using administrative pharmaceutical data

2019 ◽  
Vol 4 (3) ◽  
Author(s):  
Shaun Purkiss ◽  
Tessa Keegel ◽  
Hassan Vally ◽  
Dennis Wollersheim
Keyword(s):  
Cardiovascular Disease ◽  
Mortality Risk ◽  
Age Groups ◽  
Mortality Rates ◽  
World Health ◽  
Data Set ◽  
Medication Discontinuation ◽  
Disease Mortality ◽  
Health Organization

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.

scholarly journals Giant Cell Urothelial Carcinoma of Bladder

2021 ◽  
Vol 2021 ◽  
pp. 1-5
Author(s):  
Harshima Disvini Wijesinghe ◽  
Ajith Malalasekera
Keyword(s):  
Urothelial Carcinoma ◽  
Giant Cell ◽  
Early Stage ◽  
Giant Cells ◽  
World Health ◽  
World Health Organization Classification ◽  
Health Organization

Giant cell urothelial carcinoma is a rare variant of bladder cancer recognized by the current World Health Organization classification of urologic tumours. It is an aggressive tumour with a poor prognosis that usually presents at an advanced stage. It is characterized histologically by pleomorphic giant cells. We discuss a case of giant cell urothelial carcinoma presenting at an early stage in a previously well 62-year-old woman. Histology showed a tumour comprising pancytokeratin positive bizarre mononuclear and multi-nuclear giant cells admixed with areas of conventional urothelial carcinoma and carcinoma in situ. Three-month follow-up cystoscopy and magnetic resonance imaging showed no evidence of recurrence or pelvic lymphadenopathy.

Healthy Mind Healthy You: An Online Study Comparing Standard Mindfulness-Based Cognitive Therapy with a Brief Mindfulness Program to Improve Well-Being (Preprint)

2021 ◽  
Author(s):  
Louisa G Sylvia ◽  
Mitchell R Lunn ◽  
Juno Obedin-Maliver ◽  
Robert N McBurney ◽  
W Benjamin Nowell ◽  
...  
Keyword(s):  
Cognitive Therapy ◽  
Well Being ◽  
Mindfulness Training ◽  
Mindfulness Practice ◽  
World Health ◽  
Present Moment ◽  
Intervention Period ◽  
Model Based ◽  
Health Organization

BACKGROUND Mindfulness can improve overall well-being by training individuals to focus on the present moment without judging their thoughts. However, it is unknown how much mindfulness practice and training are necessary to improve well-being. OBJECTIVE The purpose of this study was to compare standard with brief mindfulness training to improve overall well-being. METHODS Participants were recruited from 17 Patient-Powered Research Networks, online communities of stakeholders interested in a common area of research. Participants were randomized to either a standard 8-session mindfulness based cognitive therapy (MBCT) or a brief 3-session mindfulness training intervention accessed online. Participants were followed for 12 weeks. The primary outcome of the study was well-being as measured by the World Health Organization (WHO)-5 Index. We hypothesized that MBCT would be superior to brief mindfulness training. RESULTS We randomized 4,411 participants, 88% of whom were white and 80% female sex assigned at birth. Baseline WHO-5 score mean was 50.3 (SD = 20.7). Average self-reported well-being in each group increased over the intervention period (baseline to 8 weeks) (model-based slope [95% CI] for MBCT group: 0.78 [0.63, 0.93]; brief mindfulness group: 0.76 [0.60, 0.91]) as well as the full study period (i.e., intervention plus follow-up; baseline to 20 weeks) (model-based slope [95% CI] for MBCT group: 0.41 [0.34, 0.48]; brief mindfulness group: 0.33 [0.26, 0.40]). Change in self-reported well-being was not statistically significantly different between MBCT and brief mindfulness during the intervention period (model-based difference in slopes [95% CI]: -0.02 [-0.24, 0.19], P = .80) or during the intervention period plus 12-week follow-up (-0.08 [-0.18, 0.02], P = .10). During the intervention period, younger participants (P = .05) and participants who completed a higher percentage of intervention sessions (P = .005) experienced greater improvements in well-being across both interventions, effects that were stronger for participants in the MBCT condition. CONCLUSIONS Standard MBCT improved well-being but was not superior to a brief mindfulness intervention. Younger patients and those able to complete more training sessions improved the most. CLINICALTRIAL ClinicalTrials.gov, NCT03844321, https://clinicaltrials.gov/ct2/show/NCT03844321

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