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.

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 Stratified care integrated with eHealth versus usual primary care physiotherapy in patients with neck and/or shoulder complaints: protocol for a cluster randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mark L. van Tilburg ◽  
Corelien J. J. Kloek ◽  
Martijn F. Pisters ◽  
J. Bart Staal ◽  
Johanna M. van Dongen ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Care Delivery ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Stratified Care ◽  
Cluster Randomized ◽  
Blended Care

Abstract Background Neck and shoulder complaints are common in primary care physiotherapy. These patients experience pain and disability, resulting in high societal costs due to, for example, healthcare use and work absence. Content and intensity of physiotherapy care can be matched to a patient’s risk of persistent disabling pain. Mode of care delivery can be matched to the patient’s suitability for blended care (integrating eHealth with physiotherapy sessions). It is hypothesized that combining these two approaches to stratified care (referred to from this point as Stratified Blended Approach) will improve the effectiveness and cost-effectiveness of physiotherapy for patients with neck and/or shoulder complaints compared to usual physiotherapy. Methods This paper presents the protocol of a multicenter, pragmatic, two-arm, parallel-group, cluster randomized controlled trial. A total of 92 physiotherapists will be recruited from Dutch primary care physiotherapy practices. Physiotherapy practices will be randomized to the Stratified Blended Approach arm or usual physiotherapy arm by a computer-generated random sequence table using SPSS (1:1 allocation). Number of physiotherapists (1 or > 1) will be used as a stratification variable. A total of 238 adults consulting with neck and/or shoulder complaints will be recruited to the trial by the physiotherapy practices. In the Stratified Blended Approach arm, physiotherapists will match I) the content and intensity of physiotherapy care to the patient’s risk of persistent disabling pain, categorized as low, medium or high (using the Keele STarT MSK Tool) and II) the mode of care delivery to the patient’s suitability and willingness to receive blended care. The control arm will receive physiotherapy as usual. Neither physiotherapists nor patients in the control arm will be informed about the Stratified Blended Approach arm. The primary outcome is region-specific pain and disability (combined score of Shoulder Pain and Disability Index & Neck Pain and Disability Scale) over 9 months. Effectiveness will be compared using linear mixed models. An economic evaluation will be performed from the societal and healthcare perspective. Discussion The trial will be the first to provide evidence on the effectiveness and cost-effectiveness of the Stratified Blended Approach compared with usual physiotherapy in patients with neck and/or shoulder complaints. Trial registration Netherlands Trial Register: NL8249. Officially registered since 27 December 2019. Date of first enrollment: 30 September 2020. Study status: ongoing, data collection.

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