scholarly journals A pragmatic stepped-wedge cluster randomized trial to evaluate the effectiveness and cost-effectiveness of active case finding for household contacts within a routine tuberculosis program, San Juan de Lurigancho, Lima, Peru

2020 ◽  
Vol 100 ◽  
pp. 95-103
Author(s):  
Lena Shah ◽  
Marlene Rojas Peña ◽  
Oscar Mori ◽  
Carlos Zamudio ◽  
Jay S. Kaufman ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Case Finding ◽  
San Juan ◽  
Active Case Finding ◽  
Stepped Wedge ◽  
Active Case ◽  
Household Contacts ◽  
Cluster Randomized

scholarly journals Cost-effectiveness of active case-finding of household contacts of pulmonary tuberculosis patients in a low HIV, tuberculosis-endemic urban area of Lima, Peru

2017 ◽  
Vol 145 (6) ◽  
pp. 1107-1117 ◽  
Author(s):  
L. SHAH ◽  
M. ROJAS ◽  
O. MORI ◽  
C. ZAMUDIO ◽  
J. S. KAUFMAN ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Diagnostic Test ◽  
Cost Effective ◽  
Case Finding ◽  
Self Report ◽  
Urban Setting ◽  
Active Case Finding ◽  
Active Case ◽  
Household Contacts ◽  
Life Years

SUMMARYWe compared the cost-effectiveness (CE) of an active case-finding (ACF) programme for household contacts of tuberculosis (TB) cases enrolled in first-line treatment to routine passive case-finding (PCF) within an established national TB programme in Peru. Decision analysis was used to model detection of TB in household contacts through: (1) self-report of symptomatic cases for evaluation (PCF), (2) a provider-initiated ACF programme, (3) addition of an Xpert MTB/RIF diagnostic test for a single sputum sample from household contacts, and (4) all strategies combined. CE was calculated as the incremental cost-effectiveness ratio (ICER) in terms of US dollars per disability-adjusted life years (DALYs) averted. Compared to PCF alone, ACF for household contacts resulted in an ICER of $2155 per DALY averted. The addition of the Xpert MTB/RIF diagnostic test resulted in an ICER of $3275 per DALY averted within a PCF programme and $3399 per DALY averted when an ACF programme was included. Provider-initiated ACF of household contacts in an urban setting of Lima, Peru can be highly cost-effective, even including costs to seek out contacts and perform an Xpert/MTB RIF test. ACF including Xpert MTB/RIF was not cost-effective if TB cases detected had high rates of default from treatment or poor outcomes.

scholarly journals Effect of community active case-finding strategies for detection of tuberculosis in Cambodia: study protocol for a pragmatic cluster randomized controlled trial

2020 ◽  
Author(s):  
Alvin Kuo Jing Teo ◽  
Kiesha Prem ◽  
Konstantin Evdokimov ◽  
Chetra Ork ◽  
Sothearith Eng ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Controlled Trial ◽  
Case Finding ◽  
Cluster Randomized Controlled Trial ◽  
Active Case Finding ◽  
Active Case ◽  
Randomized Controlled ◽  
Secondary Endpoints ◽  
Cluster Randomized

Abstract • Background: Cambodia has made notable progress in the fight against tuberculosis (TB). However, these gains are impeded by a significant proportion of undiagnosed cases. To effectively reach people with TB, active case finding (ACF) strategies have been adopted by countries affected by the epidemic, including Cambodia, alongside passive case finding (PCF). Despite increased efforts to improve case detection, approximately 40% of TB cases in Cambodia remained undiagnosed in 2018. In Cambodia, several community-based TB ACF modalities have been implemented, but their effectiveness has yet to be systematically assessed.• Methods: This pragmatic cluster randomized controlled trial will be conducted between December 2019 and June 2021. We will randomize eight operational districts (cluster) in seven provinces (Kampong Cham, Kampong Thom, Prey Veng, Thbong Khmum, Kampong Chhnang, Kandal, and Kampong Speu) to either the control group (PCF) or the intervention groups (ACF using a seed-and-recruit model, ACF targeting household and neighborhood contacts, and ACF targeting persons aged ≥55 using mobile screening units). The primary endpoints will be TB case notification rates, additionality, and cumulative yield of TB cases. The secondary endpoints include treatment outcomes, the number needed to screen to find one TB case, and cost-effectiveness outcome measures. We will analyze the primary and secondary endpoints by intention-to-treat. We will compare cluster and individual-level characteristics using student’s t-test and hierarchical or mixed-effect models to estimate the ratio of these means. Incremental cost-effectiveness ratio per disability-adjusted life year averted will also be considered as a benchmark to determine if the interventions are cost-effective.• Discussion: This study will build an evidence base to inform future scale-up, implementation, and sustainability of ACF strategies in Cambodia and other similar settings. Implementation of this study will also complement TB control strategies in Cambodia by conducting ACF in operational districts without active interventions to find TB cases currently. Those who are ill and might have TB will be promptly screened, diagnosed, and linked to care. Early diagnosis and treatment initiation will also benefit their community by interrupting transmission and prevent further infections. The experience gained from this project will inform future attempts in conducting pragmatic trials in low-resource settings.• Trial registration: This trial is registered at ClinicalTrials.gov, NCT04094350. Registered 18 September 2019.

scholarly journals Effect of community active case-finding strategies for detection of tuberculosis in Cambodia: study protocol for a pragmatic cluster randomized controlled trial

2020 ◽  
Author(s):  
Alvin Kuo Jing Teo ◽  
Kiesha Prem ◽  
Konstantin Evdokimov ◽  
Chetra Ork ◽  
Sothearith Eng ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Controlled Trial ◽  
Case Finding ◽  
Cluster Randomized Controlled Trial ◽  
Active Case Finding ◽  
Active Case ◽  
Randomized Controlled ◽  
Secondary Endpoints ◽  
Cluster Randomized

Abstract Background: Cambodia has made notable progress in the fight against tuberculosis (TB). However, these gains are impeded by a significant proportion of undiagnosed cases. To effectively reach people with TB, active case finding (ACF) strategies have been adopted by countries affected by the epidemic, including Cambodia, alongside passive case finding (PCF). Despite increased efforts to improve case detection, approximately 40% of TB cases in Cambodia remained undiagnosed in 2017. In Cambodia, several community-based TB ACF modalities have been implemented, but their effectiveness has yet to be systematically assessed. Methods: This pragmatic cluster randomized controlled trial will be conducted between December 2019 and June 2021. We will randomize eight operational districts (cluster) in 7 provinces (Kampong Cham, Kampong Thom, Prey Veng, Thbong Khmum, Kampong Chhnang, Kandal, and Kampong Speu) to either the control group (PCF) or the intervention groups (ACF using a seed-and-recruit model, ACF targeting household and neighborhood contacts, and ACF targeting persons aged ≥55 using mobile screening units). The primary endpoints will be TB case notification rates, additionality, and cumulative yield of TB cases. The secondary endpoints include treatment outcomes, the number needed to screen to find one TB case, and cost-effectiveness outcome measures. We will analyze the primary and secondary endpoints by intention-to-treat. We will compare cluster and individual-level characteristics using student’s t-test and hierarchical or mixed-effect models to estimate the ratio of these means. Incremental cost-effectiveness ratio per disability-adjusted life year averted will also be considered as a benchmark to determine if the interventions are cost-effective. Discussion: This study will build an evidence base to inform future scale-up, implementation, and sustainability of ACF strategies in Cambodia and other similar settings. Implementation of this study will also complement TB control strategies in Cambodia by conducting ACF in operational districts without active interventions to find TB cases currently. Those who are ill and might have TB will be promptly screened, diagnosed, and linked to care. Early diagnosis and treatment initiation will also benefit their community by interrupting transmission and prevent further infections. The experience gained from this project will inform future attempts in conducting pragmatic trials in low-resource settings. Trial registration: This trial is registered at ClinicalTrials.gov, NCT04094350. Registered 18 September 2019.

Digital Adherence Technology for Tuberculosis Treatment Supervision: A Stepped-Wedge Cluster Randomized Trial

2020 ◽  
Author(s):  
Adithya Cattamanchi ◽  
Rebecca R. Crowder ◽  
Alex Kityamuwesi ◽  
Noah Kiwanuka ◽  
Maureen Lamunu ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Tuberculosis Treatment ◽  
Stepped Wedge ◽  
Cluster Randomized

On the centrosymmetry of treatment effect estimators for stepped wedge and related cluster randomized trial designs

2021 ◽  
Vol 172 ◽  
pp. 109022
Author(s):  
Rhys Bowden ◽  
Andrew B. Forbes ◽  
Jessica Kasza
Keyword(s):  
Randomized Trial ◽  
Treatment Effect ◽  
Cluster Randomized Trial ◽  
Stepped Wedge ◽  
Cluster Randomized

scholarly journals Spread and scale of an electronic deprescribing software to improve health outcomes of older adults living in nursing homes: study protocol for a stepped wedge cluster randomized trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marc-Eric Nadeau ◽  
Justine L. Henry ◽  
Todd C. Lee ◽  
Émilie Bortolussi-Courval ◽  
Carole Goodine ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Trial ◽  
Study Design ◽  
Long Term Care ◽  
Cluster Randomized Trial ◽  
Stepped Wedge ◽  
Term Care ◽  
Medication Reviews ◽  
Cluster Randomized

Abstract Background Medication overload or problematic polypharmacy is a major problem causing widespread harm, particularly to older adults. Taking multiple medications increases the risk of potentially inappropriate medications (PIMs), and residents in long-term care (LTC) are frequently prescribed 10 or more medications at once. One strategy to address this problem is for the physician and/or pharmacist to perform regular medication reviews; however, this process can be complicated and time-consuming. With a prescription review, medications may be decreased, changed, or stopped altogether. MedReviewRx is a software that runs an analysis using deprescribing rules to produce a report to guide medication reviews addressing medication overload for residents in LTC. Methods This study will employ a mixed methods effectiveness-implementation hybrid type 2 study design. To measure effectiveness, a stepped wedge cluster randomized trial design is planned, which allows us to approximate a randomized clinical trial. Approximately 1000 residents living in LTC will be recruited from five facilities in New Brunswick. The study will begin with 3 months of baseline data on rates of deprescribing. Thereafter, every 3 months a new cluster will enter the intervention mode. The intervention consists of medication reviews augmented with the MedReviewRx software, which will be used by staff and clinicians in the facilities. The estimated study duration is 18 months and the main outcome will be the proportion of patients with one or more PIMs deprescribed (reduced/stopped or changed to a safer alternative) in the 90 days following a prescription review. The goal is to study the impact of MedReviewRx on medication overload among older adults living in LTC. In typical fashion of a stepped wedge cluster randomized trial, each cluster acts as an internal control (before and after) as well as a control for the other clusters (external control). Qualitative data collected will include resident/caregiver attitudes towards deprescribing and semi-structured interviews with staff working in the long-term care homes. Discussion This study design addresses issues with seasonality and allows all clusters to participate in the intervention, which is an advantage when the intervention is related to quality improvement. This study will provide valuable information on PIM use, cost savings, and facilitators and challenges associated with medication reviews and deprescribing. This study represents an important step towards understanding and promoting tools to guide safe and rational reduction of PIM use among older adults. Trial registration NCT04762303, Registered February 21, 2021.

Variance formulae for multiphase stepped wedge cluster randomized trial

2020 ◽  
Vol 39 (28) ◽  
pp. 4147-4168 ◽  
Author(s):  
Pengyue Zhang ◽  
Abigail Shoben ◽  
Rebecca Jackson ◽  
Soledad Fernandez
Keyword(s):  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Stepped Wedge ◽  
Cluster Randomized
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