PMID- 35394996
OWN - NLM
STAT- MEDLINE
DCOM- 20220422
LR  - 20220716
IS  - 1935-2735 (Electronic)
IS  - 1935-2727 (Print)
IS  - 1935-2727 (Linking)
VI  - 16
IP  - 4
DP  - 2022 Apr
TI  - Two-stage lot quality assurance sampling framework for monitoring and evaluation 
      of neglected tropical diseases, allowing for imperfect diagnostics and spatial 
      heterogeneity.
PG  - e0010353
LID - 10.1371/journal.pntd.0010353 [doi]
LID - e0010353
AB  - BACKGROUND: Monitoring and evaluation (M&E) is a key component of large-scale 
      neglected tropical diseases (NTD) control programs. Diagnostic tests deployed in 
      these M&E surveys are often imperfect, and it remains unclear how this affects 
      the population-based program decision-making. METHODOLOGY: We developed a 2-stage 
      lot quality assurance sampling (LQAS) framework for decision-making that allows 
      for both imperfect diagnostics and spatial heterogeneity of infections. We 
      applied the framework to M&E of soil-transmitted helminth control programs as a 
      case study. For this, we explored the impact of the diagnostic performance 
      (sensitivity and specificity), spatial heterogeneity (intra-cluster correlation), 
      and survey design on program decision-making around the prevalence decisions 
      thresholds recommended by WHO (2%, 10%, 20% and 50%) and the associated total 
      survey costs. PRINCIPAL FINDINGS: The survey design currently recommended by WHO 
      (5 clusters and 50 subjects per cluster) may lead to incorrect program decisions 
      around the 2% and 10% prevalence thresholds, even when perfect diagnostic tests 
      are deployed. To reduce the risk of incorrect decisions around the 2% prevalence 
      threshold, including more clusters (>/=10) and deploying highly specific diagnostic 
      methods (>/=98%) are the most-cost saving strategies when spatial heterogeneity is 
      moderate-to-high (intra-cluster correlation >0.017). The higher cost and lower 
      throughput of improved diagnostic tests are compensated by lower required sample 
      sizes, though only when the cost per test is <6.50 US$ and sample throughput is 
      >/=3 per hour. CONCLUSION/SIGNIFICANCE: Our framework provides a means to assess 
      and update M&E guidelines and guide product development choices for NTD. Using 
      soil-transmitted helminths as a case study, we show that current M&E guidelines 
      may severely fall short, particularly in low-endemic and post-control settings. 
      Furthermore, specificity rather than sensitivity is a critical parameter to 
      consider. When the geographical distribution of an NTD within a district is 
      highly heterogeneous, sampling more clusters (>/=10) may be required.
FAU - Kazienga, Adama
AU  - Kazienga A
AUID- ORCID: 0000-0002-6093-9648
AD  - Department of Translational Physiology, Infectiology and Public Health, Ghent 
      University, Merelbeke, Belgium.
FAU - Coffeng, Luc E
AU  - Coffeng LE
AUID- ORCID: 0000-0002-4425-2264
AD  - Department of Public Health, Erasmus MC, University Medical Center Rotterdam, 
      Rotterdam, The Netherlands.
FAU - de Vlas, Sake J
AU  - de Vlas SJ
AUID- ORCID: 0000-0002-1830-5668
AD  - Department of Public Health, Erasmus MC, University Medical Center Rotterdam, 
      Rotterdam, The Netherlands.
FAU - Levecke, Bruno
AU  - Levecke B
AUID- ORCID: 0000-0001-8912-5595
AD  - Department of Translational Physiology, Infectiology and Public Health, Ghent 
      University, Merelbeke, Belgium.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220408
PL  - United States
TA  - PLoS Negl Trop Dis
JT  - PLoS neglected tropical diseases
JID - 101291488
RN  - 0 (Soil)
SB  - IM
MH  - Animals
MH  - *Helminths
MH  - Humans
MH  - Lot Quality Assurance Sampling
MH  - Neglected Diseases/diagnosis/epidemiology
MH  - Prevalence
MH  - Soil
MH  - *Tropical Medicine
PMC - PMC9020685
COIS- The authors have declared that no competing interests exist.
EDAT- 2022/04/09 06:00
MHDA- 2022/04/23 06:00
PMCR- 2022/04/08
CRDT- 2022/04/08 17:10
PHST- 2021/10/11 00:00 [received]
PHST- 2022/03/28 00:00 [accepted]
PHST- 2022/04/20 00:00 [revised]
PHST- 2022/04/09 06:00 [pubmed]
PHST- 2022/04/23 06:00 [medline]
PHST- 2022/04/08 17:10 [entrez]
PHST- 2022/04/08 00:00 [pmc-release]
AID - PNTD-D-21-01489 [pii]
AID - 10.1371/journal.pntd.0010353 [doi]
PST - epublish
SO  - PLoS Negl Trop Dis. 2022 Apr 8;16(4):e0010353. doi: 10.1371/journal.pntd.0010353. 
      eCollection 2022 Apr.