scholarly journals Short-Term Rationing of Combination Antiretroviral Therapy: Impact on Morbidity, Mortality, and Loss to Follow-Up in a Large HIV Treatment Program in Western Kenya

2012 ◽  
Vol 2012 ◽  
pp. 1-9 ◽  
Author(s):  
April J. Bell ◽  
Kara Wools-Kaloustian ◽  
Sylvester Kimaiyo ◽  
Hai Liu ◽  
Adrian Katschke ◽  
...  
Keyword(s):  
Median Number ◽  
Hiv Treatment ◽  
Adverse Outcomes ◽  
Short Term ◽  
Cox Models ◽  
Western Kenya ◽  
Loss To Follow Up ◽  
Risk Of Mortality ◽  
Short Period

Background. There was a 6-month shortage of antiretrovirals (cART) in Kenya.Methods. We assessed morbidity, mortality, and loss to follow-up (LTFU) in this retrospective analysis of adults who were enrolled during the six-month period with restricted cART (cap) or the six months prior (pre-cap) and eligible for cART at enrollment by the pre-cap standard. Cox models were used to adjust for potential confounders.Results. 9009 adults were eligible for analysis: 4,714 pre-cap and 4,295 during the cap. Median number of days from enrollment to cART initiation was 42 pre-cap and 56 for the cap (P<0.001). After adjustment, individuals in the cap were at higher risk of mortality (HR=1.21; 95% CI : 1.06–1.39) and LTFU (HR=1.12; 95% CI : 1.04–1.22). There was no difference between the groups in their risk of developing a new AIDS-defining illness (HR=0.9295% CI 0.82–1.03).Conclusions. Rationing of cART, even for a relatively short period of six months, led to clinically adverse outcomes.

scholarly journals Influence of gender on loss to follow-up in a large HIV treatment programme in western Kenya

2010 ◽  
Vol 88 (9) ◽  
pp. 681-688 ◽  
Author(s):  
Vincent Ochieng-Ooko ◽  
Daniel Ochieng ◽  
John E Sidle ◽  
Margaret Holdsworth ◽  
Kara Wools-Kaloustian ◽  
...  
Keyword(s):  
Hiv Treatment ◽  
Treatment Programme ◽  
Western Kenya ◽  
Loss To Follow Up

Prospective cohort study of Kaposi sarcoma treated under real-world conditions in Malawi.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11569-11569
Author(s):  
Edwards Kasonkanji ◽  
Yolanda Gondwe ◽  
Morgan Dewey ◽  
Joe Gumulira ◽  
Matthew Painschab ◽  
...  
Keyword(s):  
Cohort Study ◽  
Kaposi Sarcoma ◽  
Median Number ◽  
Sub Saharan Africa ◽  
Worst Case ◽  
Loss To Follow Up ◽  
Presenting Symptoms ◽  
Grade 3 ◽  
Lost To Follow Up

11569 Background: Kaposi sarcoma (KS) is the leading cancer in Malawi (34% of cancers). Outside of clinical trials, prospective KS studies from sub-Saharan Africa (SSA) are few and limited by loss to follow up. We conducted a prospective KS cohort study of standard of care bleomycin/vincristine (BV) at Lighthouse HIV clinic, in Lilongwe, Malawi. Methods: We enrolled pathologically confirmed, newly diagnosed, HIV+ KS patients from Feb 2017 to Jun 2019. We collected clinical and treatment characteristics, toxicity, and outcomes of KS with follow-up censored Jun 2020. Patients were treated with bleomycin (25 mg/m2) and vincristine (0.4 mg/m2) every 14 days for a planned maximum of 16 cycles. STATA v13.0 was used to calculate descriptive statistics and Kaplan Meier survival analysis. Toxicity was graded using NCI CTCAE v5.0. Results: We enrolled 138 participants, median age 36 (IQR 32-44) and 110 (80%) male. By ACTG staging, 107 (78%) were T1 (tumour severity), 46 (33%) were S1 (illness severity) and 46 (33%) had Karnofsky performance status ≤70. Presenting symptoms included edema in 69 (53%), visceral disease in 9 (7%), and oral involvement in 43 (33%). Prior to KS diagnosis, 70 (51%) participants were aware of being HIV+ for median 17 months (IQR 6-60) and had been on ART for median 16 months (IQR 6-60). Median CD4 count was 197 (IQR 99-339), median HIV-viral load was 2.6 log copies/mL (IQR 1.6 – 4.8) and 57% were HIV-suppressed ( < 1000 HIV copies/ml). The median number of cycles was 16 (IQR 7-16). 62 (45%) participants missed at least one dose due to stock out. Amongst patients with missed doses, the median number was 3 (IQR 2-4) for bleomycin and 2 (IQR 1-3) for vincristine. 14 (10%) participants experienced at least one reduced dose due to toxicity. 5 (4%) participants suffered grade ≥3 anaemia, 13 (9%) grade ≥3 neutropenia, and one participant had grade 4 bleomycin-induced dermatitis. There was no reported grade ≥3 bleomycin lung toxicity or vincristine-induced neuropathy. Of 115 evaluable participants, responses at the end of therapy were: complete response in 52 (45%), partial response in 27 (23%) stable disease in 5 (4%), and progressive disease in 31 (28%). Median duration of follow-up was 20 months. At censoring, 69 (50%) were alive, 36 (26%) dead, and 33 (24%) lost to follow-up. Overall survival is shown Table as crude and worst-case scenario; worst-case assumes all participants lost to follow up died. Conclusions: Here, we present one of the most complete characterizations of KS presentation and treatment from SSA. As in other studies from the region, the majority of patients presented with advanced disease, chemotherapy stock-outs and loss to follow up were common, and mortality was high. Studies are planned to understand the virologic characteristics, improve therapies, and better implement existing therapies.[Table: see text]

scholarly journals Developing a composite outcome measure for frailty prevention trials – rationale, derivation and sample size comparison with other candidate measures

2020 ◽  
Author(s):  
Miles D. Witham ◽  
James Wason ◽  
Richard M Dodds ◽  
Avan A Sayer
Keyword(s):  
Sample Size ◽  
Transition Probabilities ◽  
Adverse Outcomes ◽  
Transition Rates ◽  
Composite Outcome ◽  
Composite Measure ◽  
Sample Sizes ◽  
Loss To Follow Up ◽  
Prevention Trials

Abstract Introduction Frailty is the loss of ability to withstand a physiological stressor, and is associated with multiple adverse outcomes in older people. Trials to prevent or ameliorate frailty are in their infancy. A range of different outcome measures have been proposed, but current measures require either large sample sizes, long follow-up, or do not directly measure the construct of frailty. Methods We propose a composite outcome for frailty prevention trials, comprising progression to the frail state, death, or being too unwell to continue in a trial. To determine likely event rates, we used data from the English Longitudinal Study for Ageing, collected 4 years apart. We calculated transition rates between non-frail, prefrail, frail or loss to follow up due to death or illness. We used Markov state transition models to interpolate one- and two-year transition rates, and performed sample size calculations for a range of differences in transition rates using simple and composite outcomes. Results The frailty category was calculable for 4650 individuals at baseline (2226 non-frail, 1907 prefrail, 517 frail); at follow up, 1282 were non-frail, 1108 were prefrail, 318 were frail and 1936 had dropped out or were unable to complete all tests for frailty. Transition probabilities for those prefrail at baseline, measured at wave 4 were respectively 0.176, 0.286, 0.096 and 0.442 to non-frail, prefrail, frail and dead/dropped out. Interpolated transition probabilities were 0.159, 0.494, 0.113 and 0.234 at two years, and 0.108, 0.688, 0.087 and 0.117 at one year. Required sample sizes for a two-year outcome were between 1000 and 7200 for transition from prefrailty to frailty alone, 250 to 1600 for transition to the composite measure, and 75 to 350 using the composite measure with an ordinal logistic regression approach. Conclusion Use of a composite outcome for frailty trials offers reduced sample sizes and could ameliorate the effect of high loss to follow up inherent in such trials due to death and illness.

scholarly journals Developing a composite outcome measure for frailty prevention trials – rationale, derivation and sample size comparison with other candidate measures

2019 ◽  
Author(s):  
Miles D. Witham ◽  
James Wason ◽  
Richard M Dodds ◽  
Avan A Sayer
Keyword(s):  
Sample Size ◽  
Transition Probabilities ◽  
Adverse Outcomes ◽  
Transition Rates ◽  
Composite Outcome ◽  
Composite Measure ◽  
Sample Sizes ◽  
Loss To Follow Up ◽  
Prevention Trials

Abstract Introduction Frailty is the loss of ability to withstand a physiological stressor, and is associated with multiple adverse outcomes in older people. Trials to prevent or ameliorate frailty are in their infancy. A range of different outcome measures have been proposed, but current measures require either large sample sizes, long follow-up, or do not directly measure the construct of frailty. Methods We propose a composite outcome for frailty prevention trials, comprising progression to the frail state, death, or being too unwell to continue in a trial. To determine likely event rates, we used data from the English Longitudinal Study for Ageing, collected 4 years apart. We calculated transition rates between non-frail, prefrail, frail or loss to follow up due to death or illness. We used Markov state transition models to interpolate one- and two-year transition rates, and performed sample size calculations for a range of differences in transition rates using simple and composite outcomes. Results The frailty category was calculable for 4650 individuals at baseline (2226 non-frail, 1907 prefrail, 517 frail); at follow up, 1282 were non-frail, 1108 were prefrail, 318 were frail and 1936 had dropped out or were unable to complete all tests for frailty. Transition probabilities for those prefrail at baseline, measured at wave 4 were respectively 0.176, 0.286, 0.096 and 0.442 to non-frail, prefrail, frail and dead/dropped out. Interpolated transition probabilities were 0.159, 0.494, 0.113 and 0.234 at two years, and 0.108, 0.688, 0.087 and 0.117 at one year. Required sample sizes for a two-year outcome were between 1000 and 7200 for transition from prefrailty to frailty alone, 250 to 1600 for transition to the composite measure, and 75 to 350 using the composite measure with an ordinal logistic regression approach. Conclusion Use of a composite outcome for frailty trials offers reduced sample sizes and could ameliorate the effect of high loss to follow up inherent in such trials due to death and illness.

Abstract 14499: Impact of Pre-existing and New Incident Atrial Fibrillation on Outcomes of Patients With Acute Pulmonary Embolism: Findings From an International Registry

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Behnood Bikdeli ◽  
David Jimenez ◽  
Jorg Del Toro ◽  
Gregory Piazza ◽  
Augussina Rivas ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Embolism ◽  
Ischemic Stroke ◽  
Acute Pulmonary Embolism ◽  
Adverse Outcomes ◽  
Risk Of Mortality ◽  
Patient Groups ◽  
The Impact ◽  
Related Mortality

Background: Atrial fibrillation (AF) may occur prior to or early in the course of acute pulmonary embolism (PE). The impact of AF on outcomes of patients with PE remains uncertain. Methods: Using the data from a large prospective multicenter registry of patients with objectively-confirmed PE (04/2014 to 01/2020), we identified three patient groups: 1) those with pre-existing AF 2) patients with newly identified AF within 2 days from the index PE (incident AF) and 3) patients without AF. We assessed the 90-day and 1-year risk of mortality and stroke in patients with AF, in unadjusted and multivariable adjusted models considering those without AF as referent. Results: Among 16,497 patients with PE, 792 had pre-existing AF. Compared with those without AF, patients with pre-existing AF, had increased odds of 90-day all-cause (Odds ratio [OR]: 2.81 (95% confidence interval [CI]: 2.33-3.38) and PE-related mortality (OR: 2.38, 95% CI: 1.37-4.14). After multivariable adjustment, pre-existing AF significantly increased the odds of all-cause mortality (OR: 1.91, 95% CI: 1.57-2.32) but not PE-related mortality (OR: 1.50; 95% CI: 0.85-2.66). Pre-existing AF was associated with increased hazard for ischemic stroke at 1-year follow-up (hazard ratio [HR]: 5.48; 95% CI: 3.10-9.69). Among 16,497 patients with PE, 445 developed incident AF within 2 days of acute PE. Incident AF was associated with increased odds of 90-day all-cause (OR: 2.28; 95% CI: 1.75-2.97) and PE-related (OR: 3.64; 95% CI: 2.01-6.59) mortality. Findings were similar in multivariable analyses and at 1-year follow-up (Figure). No patients with incident AF developed ischemic stroke. Conclusion: In patients with acute symptomatic PE, both pre-existing AF and incident AF predict an adverse clinical course, although the type of adverse outcomes may be different depending on the timing of AF onset.

Abstract P179: Comparison of Earlier versus Later Orthostatic Hypotension Assessment Times in Middle-Age Adults of the Atherosclerosis Risk in Communities Study (ARIC)

Circulation ◽  
2017 ◽  
Vol 135 (suppl_1) ◽  
Author(s):  
Stephen P Juraschek ◽  
Natalie Daya ◽  
Andreea M Rawlings ◽  
Lawrence J Appel ◽  
Edgar R Miller ◽  
...  
Keyword(s):  
Orthostatic Hypotension ◽  
Standing Position ◽  
Adverse Outcomes ◽  
Cox Models ◽  
Atherosclerosis Risk In Communities ◽  
Adverse Health Outcomes ◽  
History Of ◽  
Risk Of Fall

Background: Guidelines recommend assessing orthostatic hypotension (OH) 3 minutes after rising from supine to standing positions. Hypothesis: Measurements performed immediately after standing will be as informative as measurements performed closer to 3 minutes after standing with regards to symptoms of dizziness or risk of adverse outcomes. Methods: OH, defined as a drop in blood pressure (systolic ≥20 mm Hg or diastolic ≥10 mm Hg) from the supine to standing position, was measured up to five times at 25 seconds intervals in middle-aged (range 44 to 66 years) ARIC participants (1987-1989). Associations between each measurement and history of dizziness upon standing were examined via logistic regression. We used Cox models to examine the association between each of five measurements with risk of fall, fracture, syncope, and all-cause mortality over a median follow-up of 23 years. Results: In 11,449 participants (mean age 54 years, 54% women, 26% black) 10% reported a history of dizziness upon standing. OH assessed at measurement 1 (performed at a mean of 28 seconds after standing) was associated with risk of fall ( P = 0.03), fracture ( P = 0.05), syncope ( P <0.001), and mortality ( P < 0.001) ( Table ). Furthermore, measurement 1 was the only measurement associated with higher odds of dizziness upon standing (OR: 1.5; P = 0.001). Measurement 2 (performed on average 53 seconds after standing) was associated with all long-term outcomes. Measurements 4 and 5 (mean 100 and 116 seconds after standing) were generally less informative with regards to prospective outcomes than earlier measurements and were not statistically associated with history of dizziness. Conclusions: OH measurements obtained, on average, within the first 30 seconds of standing were predictive of long-term adverse health outcomes and were the most strongly related to symptoms of dizziness compared to later measurements. These findings suggest that BP measurements for determining orthostatic hypotension should be performed immediately after standing.

scholarly journals Universal Definition of Loss to Follow-Up in HIV Treatment Programs: A Statistical Analysis of 111 Facilities in Africa, Asia, and Latin America

PLoS Medicine ◽  
2011 ◽  
Vol 8 (10) ◽  
pp. e1001111 ◽  
Author(s):  
Benjamin H. Chi ◽  
Constantin T. Yiannoutsos ◽  
Andrew O. Westfall ◽  
Jamie E. Newman ◽  
Jialun Zhou ◽  
...  
Keyword(s):  
Latin America ◽  
Statistical Analysis ◽  
Hiv Treatment ◽  
Treatment Programs ◽  
Loss To Follow Up ◽  
Universal Definition ◽  
Definition Of

scholarly journals Stigma and Lack of Social Support Contribute to Loss-To-Follow-Up in a Cervical Cancer Prevention Program in Western Kenya

2020 ◽  
Author(s):  
Carissa Novak ◽  
Bonnie Kaiser ◽  
Lawrence Park ◽  
Sandra Yvonne ◽  
Saduma Ibrahim ◽  
...  
Keyword(s):  
Social Support ◽  
Cervical Cancer ◽  
Peer Support ◽  
Sub Saharan Africa ◽  
Treatment Access ◽  
Western Kenya ◽  
Loss To Follow Up ◽  
Modifiable Factors ◽  
Hpv Test

Abstract Background While highly preventable, cervical cancer remains a leading contributor to the global burden of cancer among women globally, with disproportionate impacts in Sub-Saharan Africa. Human papillomavirus (HPV) testing is a cost-effective screening strategy with the potential to increase screening uptake; however, the two-visit requirement often leads to substantial loss-to-follow-up (LTFU) for treatment. Understanding modifiable factors that contribute to LTFU is essential to ensuring maximal program impact. Methods We carried out a mixed-methods study to understand factors related to LTFU following an HPV-based cervical cancer screening campaign in rural Western Kenya. We randomly selected participants among women testing HPV positive as part of an existing intervention study to complete quantitative surveys, seeking equal numbers of treated and LTFU women. A subset of women from both groups was selected for in-depth interviews (IDIs). Results Sixty-one treated and 39 LTFU women completed the quantitative survey, and 10 women from each group completed IDIs. Cost of transportation and distance to the hospital were barriers among all women, who often depended on their partners to facilitate this. Among treated women 67% (n = 41) reported that their peers knew their HPV test result, compared to 38% (n = 15) among LTFU women (p = .007). Stigma and lack of partner and peer support emerged as strong barriers among LTFU women. Women proposed peer encouragement, including men in educational sessions, bringing facilities closer, and providing transportation as facilitators to treatment access. Conclusion Lack of partner and social support emerged as key barriers to treatment uptake among LTFU women. Future interventions should explore stigma reduction, male involvement, peer support, and alternative transportation options as potential facilitators to treatment seeking.

scholarly journals suPAR Cut-Offs for Risk Stratification in Patients With Symptoms of COVID-19

2021 ◽  
Vol 16 ◽  
pp. 117727192110346
Author(s):  
Izzet Altintas ◽  
Jesper Eugen-Olsen ◽  
Santeri Seppälä ◽  
Jens Tingleff ◽  
Marius Ahm Stauning ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Predictive Value ◽  
Risk Groups ◽  
Adverse Outcomes ◽  
Central Hospital ◽  
Urokinase Plasminogen Activator Receptor ◽  
Risk Of Mortality ◽  
Observational Cohort ◽  
Plasminogen Activator Receptor

Objectives: Elevated soluble urokinase Plasminogen Activator Receptor (suPAR) is a biomarker associated with adverse outcomes. We aimed to investigate the associations between plasma suPAR levels (testing the cut-offs ⩽4, 4-6, and ⩾6 ng/mL) with risk of 14-day mortality, and with the risk of mechanical ventilation in patients that tested positive for SARS-CoV-2. Methods: Observational cohort study of patients presenting with symptoms of COVID-19 at Department of Emergency Medicine, Amager and Hvidovre Hospital, Denmark from March 19th, 2020 to April 3rd, 2020. Plasma suPAR was measured using suPARnostic technologies. Patients were followed for development of mechanical ventilation and mortality for 14 days. Validation of our findings were carried out in a similar sized COVID-19 patient cohort from Mikkeli Central Hospital, Finland. Results: Among 386 patients with symptoms of COVID-19, the median (interquartile range) age was 64 years (46-77), 57% were women, median suPAR was 4.0 ng/mL (2.7-5.9). In total, 35 patients (9.1%) died during the 14 days follow-up. Patients with suPAR ⩽4 ng/mL (N = 196; 50.8%) had a low risk of mortality (N = 2; 1.0%; negative predictive value of 99.0%, specificity 55.3%, sensitivity 95.2%, positive predictive value 17.4%). Among patients with suPAR ⩾6 ng/mL (N = 92; 23.8%), 16 died (17.4%). About 99 patients (25.6%) tested positive for SARS CoV-2 and of those 12 (12.1%) developed need for mechanical ventilation. None of the SARS-CoV-2 positive patients with suPAR ⩽4 ng/mL (N = 28; 38.8%) needed mechanical ventilation or died. The Mikkeli Central Hospital validation cohort confirmed our findings concerning suPAR cut-offs for risk of development of mechanical ventilation and mortality. Conclusions: Patients with symptoms of COVID-19 and suPAR ⩽4 or ⩾6 ng/mL had low or high risk, respectively, concerning the need for mechanical ventilation or mortality. We suggest cut-offs for identification of risk groups in patients presenting to the ED with symptoms of or confirmed COVID-19.

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