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Adoption and use of real-world data (RWD) for decision-making has been complicated by concerns regarding whether RWD was fit-for-purpose or was of sufficient validity to support the creation of credible RWE. This has greater urgency as regulatory agencies begin to use real world evidence (RWE) to inform decisions about treatment effectiveness. Researchers need an efficient and systematic method to screen the quality of RWD sources considered for use in studies of effectiveness and safety. Based on a literature review we developed a listing of screening criteria that have been previously proposed to assess the quality of RWD sources. We also developed an additional criterion based on Modern Validity Theory. While there has occurred some convergence of conceptual frameworks to assess data quality (DQ) and there is much agreement on specific assessment criteria, consensus has yet to emerge on how to assess whether a specific RWD source is reliable and fit-for-purpose. To create a user-friendly tool to assess whether RWD sources may have sufficient quality to support a well-designed RWE study for submission to a regulatory authority, we grouped the quality criteria with a view to harmonize published frameworks and to be consistent with how researchers generally evaluate existing RWD sources for research that they intend to submit to regulatory agencies. Screening data quality criteria were grouped into five dimensions after a comprehensive literature review via PubMed: authenticity, transparency, relevance, accuracy, and track record. The resultant tool was tested for its response burden using a hypothetical administrative claims data source. Providing responses to the screening criteria required only few hours effort by an experienced data source manager. Thus, the tool should not be an onerous burden on data source providers if asked by prospective researchers to provide the required information. Assessing whether a particular data source is fit-for-purpose will be facilitated by the use of this tool, but it will not be sufficient by itself. Fit-for-purpose judgements will still require further careful consideration based on the context and the specific scientific question of interest. Unlike prior DQ frameworks (DQF), the track record dimension of the tool adds the consideration of experience with RWD sources consistent with Modern Validity Theory. However, the tool does not address issues of study design and analysis that are critical to regulatory agencies in evaluating the robustness and credibility of the real-world evidence generated. [ABSTRACT FROM AUTHOR]

Purpose: There has been rapid growth in the variety and number of real‐world data (RWD) sources, as well as the number of regulatory documents that provide guidance for assessing the suitability of RWD sources for pharmacoepidemiology studies. This study aims to assess differences in RWD guidance and variability in current practice for identifying and assessing RWD for studies with regulatory purpose. Methods: Key criteria for feasibility assessment were mapped against relevant regulatory guidance documents across US, EU, and Asia‐Pacific regions. An online survey was designed and deployed to International Society for Pharmacoepidemiology members to understand current practice. Findings were summarized and used to inform key considerations and recommendations. Results: Eleven RWD guidance documents were identified and mapped against 14 RWD assessment criteria. Variability was seen across these documents in guidance for these criteria. Between December 2022 and January 2023, 37 survey respondents reported having used RWD for post‐marketing commitments (34, 92%) and/or background epidemiology (28, 76%). RWD were mostly identified through literature (33, 89%) and data landscaping (26, 70%); guidance documents referenced included: Food and Drug Administration (20, 54%), European Network for Centres for Pharmacoepidemiology and Pharmacovigilance (17, 46%), European Medical Agency (16, 43%), and Structured Process to Identify Fit‐For‐Purpose Data (11, 30%). Challenges for conducting feasibility assessments included RWD accessibility, ability to complete validation, and RWD provider responsiveness. Conclusions: Existing guidelines are used extensively by researchers, but key criteria for RWD identification and feasibility assessment are not reflected consistently and challenges remain. Recommendations have been made reflecting study findings. [ABSTRACT FROM AUTHOR]

Occupant behavior (OB) is one of the significant sources of uncertainty in building performance simulation. While OB modeling has received increased attention in the past decade, research on the degree of granularity or level of detail (LoD) required for representing occupants is still in the nascent stages. This paper analyzes the modeling and applicability of three LoDs to represent occupants in building performance assessment. A medium-sized prototype office building located in Chicago, Illinois is used as the simulation case study. Ten occupant-centric attributes are adopted to develop the LoDs for OB representation. We first demonstrate the different modeling approaches required for simulating the three fidelity levels. Later, we illustrate the suitability of the developed LoDs in supporting six building performance use cases across different lifecycle stages. This study intends to provide guidance for the building simulation community on appropriate OB representation to support various use cases.

An investigation is presented in this paper to predict Overland Flows (OF) from Rain-Falls (RF) and a set of covariates in semi-arid catchments. The study area comprises 8 catchments in the basin of Lake Urmia and its vicinity, where the catchments are at risk of land subsidence through mismanagement triggered by groundwater over-abstraction but received wisdom often implicates the problems with climate change. The paper presents a new perspective, where land subsidence by over-abstraction can impact OF regimes and thereby infiltration regimes. A strategy is formulated at three levels to abstract information from the data/results. At innovative Level 1, the research direction is scoped critically and referenced with reality. At Level 2, modelling results are catered for to be fit-for-purpose. At Level 3, the data/results are critically examined for learning. The data/results are found consistent with the observed reality that (i) a fit-for-purpose OF predictive model can be derived in terms of RF and covariates; (ii) indirect evidence reveals flow regimes of infiltration (interflow and percolation), OF and groundwater are altering, such that percolation is likely to decline and undermine aquifer replenishment regimes when exposed to subsidence risk with subsequent permanent damage. This makes a case for research, effective planning and sustainable drainage systems. [ABSTRACT FROM AUTHOR]

Millions of formal and informal land rights are still undocumented worldwide and there is a need for scalable techniques to facilitate that documentation. In this context, sketch mapping based on printed high-resolution satellite or aerial imagery is being promoted as a fit-for-purpose land administration method and can be seen as a promising way to collect cadastral and land use information with the community in a rapid and cost-effective manner. The main disadvantage of paper-based mapping is the need for digitization to facilitate the integration with existing land administration information systems and the sustainable use of the data. Currently, this digitization is mostly done manually, which is time-consuming and error-prone. This article presents the SmartLandMaps approach to land rights mapping and digitization to address this gap. The recording involves the use of sketches during participatory mapping activities to delineate parcel boundaries, and the use of mobile phones to collect attribute information about spatial units and land rights holders. The digitization involves the use of photogrammetric techniques to derive a digital representation from the annotated paper maps, and the use of computer vision techniques to automate the extraction of parcel boundaries and stickers from raster maps. The approach was deployed in four scenarios across Africa, revealing its simplicity, versatility, efficiency, and cost-effectiveness. It can be regarded as a scalable alternative to traditional paper-based participatory land rights mapping. [ABSTRACT FROM AUTHOR]

Cultural confirmation following detection of a Listeria monocytogenespresumptive positive can take 3–7 days to finalize; this uncertainty is a point of frustration for food producers needing to make time-sensitive disposition decisions. To address the demand for shortened time-to-results, an alternative L. monocytogenes confirmation method consisting of two components, (i) a secondary screen using a different rapid method, and (ii) concurrent cultural isolation followed by next-day colony identification was evaluated. For the study, four food matrices (hot dogs, peanut butter, frozen vegetables, and multicomponent frozen meals) were inoculated with low levels (0.36–1.39 MPN/125 g) of L. monocytogenes per the AOAC guidelines for a matrix study. Analyses were performed on 125 g test portions and started with a PCR primary screen (Bio-Rad iQ-Check Listeria monocytogenes II). Next, all enriched food samples underwent a secondary screen by bioMérieux’s GENE-UP LMO2 Real-Time PCR and VIDAS LMX ELFA along with streaking onto RAPID’L.mono Agar. Presumptive positive L. monocytogenes colonies were identified utilizing a high throughput rapid identification method (Hygiena’s BAX System L. monocytogenes Real-Time PCR assay, Neogen’s ANSR isothermal nucleic acid amplification assay, and Bruker’s MALDI Biotyper). Importantly, this study evaluated multiple commercially available options for the secondary screen (n = 2) and rapid identification (n = 3) to allow for easy adoption by testing laboratories. Overall, there was no statistically significant difference (p ≤ 0.05) between the number of L. monocytogenes-positive 125 g samples obtained by the cultural reference method and the alternative confirmation methods (regardless of which method combinations were evaluated). Additionally, this study supports that, when both the primary and secondary screen methods yield a positive result, the sample could be considered a confirmed positive for L. monocytogenes.

Fit-for-purpose land administration (FFPLA) seeks to simplify cadastral mapping via lowering the costs and time associated with conventional surveying methods. This approach can be applied to both the initial establishment and on-going maintenance of the system. In Ethiopia, cadastral maintenance remains an on-going challenge, especially in rapidly urbanizing peri-urban areas, where farmers' land rights and tenure security are often jeopardized. Automatic Feature Extraction (AFE) is an emerging FFPLA approach, proposed as an alternative for mapping and updating cadastral boundaries. This study explores the role of the AFE approach for updating cadastral boundaries in the vibrant peri-urban areas of Addis Ababa. Open-source software solutions were utilized to assess the (semi-) automatic extraction of cadastral boundaries from orthophotos (segmentation), designation of "boundary" and "non-boundary" outlines (classification), and delimitation of cadastral boundaries (interactive delineation). Both qualitative and quantitative assessments of the achieved results (validation) were undertaken. A high-resolution orthophoto of the study area and a reference cadastral boundary shape file were used, respectively, for extracting the parcel boundaries and validating the interactive delineation results. Qualitative (visual) assessment verified the completed extraction of newly constructed cadastral boundaries in the study area, although non-boundary outlines such as footpaths and artifacts were also retrieved. For the buffer overlay analysis, the interactively delineated boundary lines and the reference cadastre were buffered within the spatial accuracy limits for urban and rural cadastres. As a result, the quantitative assessment delivered 52% correctness and 32% completeness for a buffer width of 0.4 m and 0.6 m, respectively, for the interactively delineated and reference boundaries. The study proposed publicly available software solutions and outlined a workflow to (semi-) automatically extract cadastral boundaries from aerial/satellite images. It further demonstrated the potentially significant role AFE could play in delivering fast, affordable, and reliable cadastral mapping. Further investigation, based on user input and expertise evaluation, could help to improve the approach and apply it to a real-world setting. [ABSTRACT FROM AUTHOR]

Bahlburg et al. re-implemented eight growth models of Antarctic krill and showed that their predictions are all over the place. The authors discuss the reasons for this and how more coherence in modelling could be achieved through systematic model comparison and integration. For this, we need a common language. [ABSTRACT FROM AUTHOR]

This study aims at a comparative analysis of quantitative data, namely, OSM and BDOT10k. Analyses were conducted in a 1 km2 hexagonal grid, in seven test counties located in different regions of Poland, differing in the degree of urbanization, land cover and natural environment. It is assumed that the authors' consolidated regional classification of the Compound Correspondence Index CCIRn is attributed to the geometric mapping unit based on TOPSIS values, and their statistical measure of dispersion enables the comparison of datasets for individual geographically disjointed areas according to uniform criteria, e.g., the number of topographic features stored in analyzed datasets, both polygonal (buildings, forests, surface water) and linear (roads, watercourses, railroads). The final results of the regional assessment outperform the local classification giving a higher level of data compliance. Overestimation of regional concordance ranges from 9 to 20% of the county area, with an average of 3% reduction in the area where the two datasets (BDOT10k and OSM) have comparable information ranges. Areas of medium and high nonconformity are decreased by an average of 2.4%. [ABSTRACT FROM AUTHOR]

Millions of formal and informal land rights are still undocumented worldwide and there is a need for scalable techniques to facilitate that documentation. In this context, sketch mapping based on printed high-resolution satellite or aerial imagery is being promoted as a fit-for-purpose land administration method and can be seen as a promising way to collect cadastral and land use information with the community in a rapid and cost-effective manner. The main disadvantage of paper-based mapping is the need for digitization to facilitate the integration with existing land administration information systems and the sustainable use of the data. Currently, this digitization is mostly done manually, which is time-consuming and error-prone. This article presents the SmartLandMaps approach to land rights mapping and digitization to address this gap. The recording involves the use of sketches during participatory mapping activities to delineate parcel boundaries, and the use of mobile phones to collect attribute information about spatial units and land rights holders. The digitization involves the use of photogrammetric techniques to derive a digital representation from the annotated paper maps, and the use of computer vision techniques to automate the extraction of parcel boundaries and stickers from raster maps. The approach was deployed in four scenarios across Africa, revealing its simplicity, versatility, efficiency, and cost-effectiveness. It can be regarded as a scalable alternative to traditional paper-based participatory land rights mapping.

A detailed understanding of the molecular and immunological changes that occur longitudinally across tumors exposed to immune checkpoint inhibitors is a significant knowledge gap in oncology. To address this unmet need, we created a statewide biospecimen collection and clinical informatics system to enable longitudinal tumor and immune profiling and to enhance translational research. The Texas Immuno-Oncology Biorepository (TIOB) consents patients to collect, process, store, and analyze serial biospecimens of tissue, blood, urine, and stool from a diverse population of over 100,000 cancer patients treated each year across the Baylor Scott & White Health system. Here we sought to demonstrate that these samples were fit for purpose with regard to downstream multi-omic assays. Plasma, urine, peripheral blood mononuclear cells, and stool samples from 11 enrolled patients were collected from various cancer types. RNA isolated from extracellular vesicles derived from plasma and urine was sufficient for transcriptomics. Peripheral blood mononuclear cells demonstrated excellent yield and viability. Ten of 11 stool samples produced RNA quality to enable microbiome characterization. Sample acquisition and processing methods are known to impact sample quality and performance. We demonstrate that consistent acquisition methodology, sample preparation, and sample storage employed by the TIOB can produce high-quality specimens, suited for employment in a wide array of multi-omic platforms, enabling comprehensive immune and molecular profiling. [ABSTRACT FROM AUTHOR]

Despite the significant and explicit focus on the United Nations Sustainable Development Goals (SDGs), much of the world's land rights remain unrecorded and outside formal government systems. Blame is often placed on land administration processes that are considered slow, expensive, and expertise-dependent. Fit-For-Purpose Land Administration (FFPLA) has been suggested as an alternative, time and cost-effective approach. Likewise, the UN endorsed Framework for Effective Land Administration (FELA) demands attention to worldwide tenure insecurity by directly linking it to responsible land administration. Implementation of FFPLA and FELA is country-context dependent, and there are now many lessons of execution from various jurisdictions. Undertaken in 2022, this study synthesizes a review of experiences to provide a further update on the best global FFPLA implementation practices and inform approaches for future FFPLA projects. A systematic review is adopted as the research methodology, and contemporary articles from the internationally recognized land administration discourse are examined. The studies focus on FFPLA implementation practices and innovative approaches for delivering land tenure security. A checklist is developed, based on the FELA strategic pathways and the FFPLA fundamental framework principles and characteristic elements, to identify best implementation practices. Success stories across the globe show that the FFPLA characteristic elements and the FELA pathway goals are achieved through effective execution of the FFPLA framework key principles. As a result, the study identified successful FFPLA implementation practices in Asia and Africa, which can be synthesized and extended to realize tenure security in rapidly urbanizing areas. However, further study is necessary to determine the efficacy, practicability, innovativeness, and transferability of the best practices to other land administration scenarios. [ABSTRACT FROM AUTHOR]

Background: Biobanks have been supporting longitudinal prospective and retrospective studies by providing standardized services for the acquisition, transport, processing, storage, and distribution of high-quality biological material and associated data. Here, we describe how the Dog Aging Project (DAP), a large-scale longitudinal study of the domestic dog (Canis familiaris) with translational applications for humans, developed a biobank of canine biospecimens and associated data. Design and methods: This was accomplished by working with the Cornell Veterinary Biobank, the first biobank in the world to receive accreditation to ISO 20387:2018—General Requirements for Biobanking. The biobank research team was involved in the early collection stages of the DAP, contributing to the development of appropriate workflows and processing fit-for-purpose biospecimens. In support of a dynamic strategy for real-time adjustment of processes, a pilot phase was implemented to develop, test, and optimize the biospecimen workflows, followed by an early phase of collection, processing, and banking of specimens from DAP participants. Results: During the pilot and early phases of collection, the DAP Biobank stored 164 aliquots of whole blood, 273 aliquots of peripheral blood mononuclear cells, 130 aliquots of plasma, and 70 aliquots of serum, and extracted high molecular weight genomic DNA suitable for whole-genome sequencing from 109 whole blood specimens. These specimens, along with their associated preanalytical data, have been made available for distribution to researchers. Conclusion: We discuss the challenges and opportunities encountered during the implementation of the DAP Biobank, along with novel strategies for promoting biobanking sustainability such as partnering with a DAP quality assurance manager and a DAP marketing and communication specialist and developing a pilot grant structure to fund small innovative research projects. [ABSTRACT FROM AUTHOR]

Secure land and natural resource rights are key ingredients for rural transformation, social inclusion, and the realization of the Sustainable Development Goals. In many cases, these rights are not formally recorded, and statutory land administration systems are inaccessible to rural communities. The rapid development of geospatial technologies and systems, combined with participatory methods for social empowerment, have contributed significantly to addressing these challenges and in developing fit-for-purpose land administration/land recordation systems that promote land tenure security, but with the plethora of options currently available, it is challenging to know which technologies are appropriate for what circumstances and purposes. This paper reports on the findings from a joint FAO/IFAD project that addresses this problem. Thirteen one-hour interviews were conducted with knowledgeable experts to showcase which technologies are being used for what purposes and by whom, the associated benefits and challenges, and what the future may hold. We conclude that technologies are best used in partnership with communities and as integrated solutions, that successful implementations must incorporate maintenance plans, and that the real challenge is not the technology–it is the social, legal, and political context. These findings are useful for governments, NGOs, academia, donors, and others involved in land-related projects aimed at benefitting small-scale farmers. [ABSTRACT FROM AUTHOR]

Abstract This conference report summarized a full-day workshop, “best practices for the development and fit-for-purpose validation of biomarker methods,” which was held prior to the American Association of Pharmaceutical Scientists (AAPS) PharmSci360 Congress, San Antonio, TX, November 2019. The purpose of the workshop was to bring together thought leaders in biomarker assay development in order to identify which assay parameters and key statistical measures need to be considered when developing a biomarker assay. A diverse group of more than 40 scientists participated in the workshop. The workshop and subsequent working dinner stimulated robust discussion. While a consensus on best practices was not achieved, some common themes and major points to consider for biomarker assay development have been identified and agreed on. The focus of this conference report is to summarize the presentations and discussions which occurred at the workshop. Biomarker assay validation is a complex and an evolving area with discussions ongoing.

• Validation parameters set to evaluate method fitness-for-purpose • Validation experiments acquired in untargeted acquisition mode across 3 batches • 55 and 47 metabolites, respectively, validated on HILIC-ESI−- and RPLC-ESI+-HRMS • Full validation reports are presented for metabolites (level 1) in serum samples • Levelled QCs used to monitor response linearity between batches Untargeted metabolomics by LC HRMS is a powerful tool to enhance our knowledge of pathophysiological processes. Whereas validation of a bioanalytical method is customary in most analytical chemistry fields, it is rarely performed for untargeted metabolomics. This study aimed to establish and validate an analytical platform for a long-term, clinical metabolomics study. Sample preparation was performed with an automated liquid handler and four analytical methods were developed and evaluated. The validation study spanned three batches with twelve runs using individual serum samples and various quality control samples. Data was acquired with untargeted acquisition and only metabolites identified at level 1 were evaluated. Validation parameters were set to evaluate key performance metrics relevant for the intended application: reproducibility, repeatability, stability, and identification selectivity, emphasizing dataset intrinsic variance. Concordance of semi-quantitative results between methods was evaluated to identify potential bias. Spearman rank correlation coefficients (r s) were calculated from individual serum samples. Of the four methods tested, two were selected for validation. A total of 47 and 55 metabolites (RPLC-ESI+- and HILIC-ESI−-HRMS, respectively) met specified validation criteria. Quality assurance involved system suitability testing, sample release, run release, and batch release. The median repeatability and within-run reproducibility as coefficient of variation% for metabolites that passed validation on RPLC-ESI+- and HILIC-ESI−-HRMS were 4.5 and 4.6, and 1.5 and 3.8, respectively. Metabolites that passed validation on RPLC-ESI+-HRMS had a median D -ratio of 1.91, and 89 % showed good signal intensity after ten-fold dilution. The corresponding numbers for metabolites with the HILIC-ESI−-HRMS method was 1.45 and 45 %, respectively. The r s median ({range}) for metabolites that passed validation on RPLC-ESI+- was 0.93 (N = 9 {0.69–0.98}) and on HILIC-ESI−-HRMS was 0.93 (N = 22 {0.55–1.00}). The validated methods proved fit-for-purpose and the laboratory thus demonstrated its capability to produce reliable results for a large-scale, untargeted metabolomics study. This validation not only bolsters the reliability of the assays but also significantly enhances the impact and credibility of the hypotheses generated from the studies. Therefore, this validation study serves as a benchmark in the documentation of untargeted metabolomics, potentially guiding future endeavors in the field. [ABSTRACT FROM AUTHOR]

Fit-for-purpose land administration (FFPLA) seeks to simplify cadastral mapping via lowering the costs and time associated with conventional surveying methods. This approach can be applied to both the initial establishment and on-going maintenance of the system. In Ethiopia, cadastral maintenance remains an on-going challenge, especially in rapidly urbanizing peri-urban areas, where farmers’ land rights and tenure security are often jeopardized. Automatic Feature Extraction (AFE) is an emerging FFPLA approach, proposed as an alternative for mapping and updating cadastral boundaries. This study explores the role of the AFE approach for updating cadastral boundaries in the vibrant peri-urban areas of Addis Ababa. Open-source software solutions were utilized to assess the (semi-) automatic extraction of cadastral boundaries from orthophotos (segmentation), designation of “boundary” and “non-boundary” outlines (classification), and delimitation of cadastral boundaries (interactive delineation). Both qualitative and quantitative assessments of the achieved results (validation) were undertaken. A high-resolution orthophoto of the study area and a reference cadastral boundary shape file were used, respectively, for extracting the parcel boundaries and validating the interactive delineation results. Qualitative (visual) assessment verified the completed extraction of newly constructed cadastral boundaries in the study area, although non-boundary outlines such as footpaths and artifacts were also retrieved. For the buffer overlay analysis, the interactively delineated boundary lines and the reference cadastre were buffered within the spatial accuracy limits for urban and rural cadastres. As a result, the quantitative assessment delivered 52% correctness and 32% completeness for a buffer width of 0.4 m and 0.6 m, respectively, for the interactively delineated and reference boundaries. The study proposed publicly available software solutions and outlined a workflow to (semi-) automatically extract cadastral boundaries from aerial/satellite images. It further demonstrated the potentially significant role AFE could play in delivering fast, affordable, and reliable cadastral mapping. Further investigation, based on user input and expertise evaluation, could help to improve the approach and apply it to a real-world setting.

Abstract Background The 2009 Food and Drug Administration (FDA) patient-reported outcome (PRO) guidance outlines characteristics of rigorous PRO-measure development. There are a number of widely used PRO measures for Systemic Lupus Erythematosus (SLE), but it is unknown how well the development processes of SLE PRO measures align with FDA guidance; including updated versions. The objective of this study was to assess how well the LupusQoL and LupusPRO, and corresponding updated versions, LupusQoL-US and LupusPROv1.8, align with Food and Drug Administration (FDA) 2009 patient-reported outcome (PRO) guidance. Methods LupusQoL and LupusPRO were selected as the most widely studied and used Lupus PROs in the UK and US. Original (LupusQoL (2007) and LupusQoL-US (2010)) and revised (LupusPROVv1.7 (2012) and LupusPROv1.8 (2018)) versions were reviewed. We used FDA PRO guidance to create evaluation criteria for key components: target population, concepts measured, measurement properties, documentation across the phases of content validity (item-generation and cognitive interviewing, separately) and other psychometric-property testing. Two reviewers abstracted data independently, compared results, and resolved discrepancies. Results For all measures, the target population was unclear as population characteristics (e.g., ethnicity, education, disease severity) varied, and/or were not consistently reported or not considered across the three phases (e.g., LupusQoL item-generation lacked male involvement, LupusPRO cognitive-interviewing population characteristics were not reported). The item-generation phase for both original measures was conducted with concepts elicited via patient-engagement interviews and item derivation from experts. Cognitive interviewing was conducted via patient feedback with limited item-tracking for original measures. In contrast, the revised measures assumed content validity. Other psychometric testing recommendations (reliability, construct validity, ability to detect change) were reported for both original and revised measures, except for ability to detect change for revised measures. Conclusions The SLE PRO measures adhere to some but not all FDA PRO guidance recommendations. Limitations in processes and documentation of the study population, make it unclear for which target population(s) the current Lupus measures are fit-for-purpose.

Background: Scale development is a complex activity requiring significant investments of time and money to produce evidence of a scale's ability to produce reliable scores and valid inferences. With increasing use of clinical outcome assessments (COAs) in medical product development, evidentiary expectations of regulatory bodies to support inferences are a key consideration. The goal of this paper is to demonstrate how existing methods in measurement science can be used to identify and fill evidence gaps when considering re-purposing an existing scale for a new use case (e.g., new patient population, altering the recall period), rather than creating a new COA tool. Methods: We briefly review select validity theory and psychometric concepts, linking them to the nomenclature in the COA/regulated space. Four examples (two in-text and two in online supplemental materials) of modifications are presented to demonstrate these ideas in practice for quality of life (QOL)-related measures. Results: Each example highlights the initial process of evaluating the desired validity claims, identifying gaps in evidence to support these claims, and determining how such gaps could be filled, often without having to develop a new measure. Conclusions: If an existing scale, with minimal modification or additional evidence, can be shown to be fit for a new purpose, considerable effort can be saved and research waste avoided. In many cases, a new instrument is simply unnecessary. Far better to recycle an "old" scale for a new use–with sufficient evidence that it is fit for that purpose–than to "buy" a new one. [ABSTRACT FROM AUTHOR]

Decades of discussion and publication have gone into the guidance from the scientific community and the regulatory agencies on the use and validation of pharmacokinetic and toxicokinetic assays by chromatographic and ligand binding assays for the measurement of drugs and metabolites. These assay validations are well described in the FDA Guidance on Bioanalytical Methods Validation (BMV, 2018). While the BMV included biomarker assay validation, the focus was on understanding the challenges posed in validating biomarker assays and the importance of having reliable biomarker assays when used for regulatory submissions, rather than definition of the appropriate experiments to be performed. Different from PK bioanalysis, analysis of biomarkers can be challenging due to the presence of target analyte(s) in the control matrices used for calibrator and quality control sample preparation, and greater difficulty in procuring appropriate reference standards representative of the endogenous molecule. Several papers have been published offering recommendations for biomarker assay validation. The situational nature of biomarker applications necessitates fit-for-purpose (FFP) assay validation. A unifying theme for FFP analysis is that method validation requirements be consistent with the proposed context of use (COU) for any given biomarker. This communication provides specific recommendations for biomarker assay validation (BAV) by LC-MS, for both small and large molecule biomarkers. The consensus recommendations include creation of a validation plan that contains definition of the COU of the assay, use of the PK assay validation elements that support the COU, and definition of assay validation elements adapted to fit biomarker assays and the acceptance criteria for both. [ABSTRACT FROM AUTHOR]

In recent years, the use of crowdsourcing has positively transformed the way geographic information is collected, stored and analyzed. Many countries have promoted and funded research into the potential of using crowdsourcing in various fields of governance. This paper focuses on developing a methodology for fast, low-cost and reliable coastal management for touristic purposes in Greece. In particular, a group of a professional surveyor have developed the methodology and trained two volunteers to collect a variety of data points of interest about a public coastal zone, such as the area size of free and unused public space, rocky areas, parking spaces (organized or not), land use types, build up and green areas, municipal lighting, pedestrian crossing points, beach umbrellas, path routes, street furniture, etc. A pilot case study was compiled for a part of the Athenian Riviera to check the methodology. Derived conclusions point out that the developed methodology may be successfully used for managing the 16,000 km length of the coastal zone of Greece for touristic purposes. Considerations for further improvements to the methodology are given.

This conference report summarized a full-day workshop, "best practices for the development and fit-for-purpose validation of biomarker methods," which was held prior to the American Association of Pharmaceutical Scientists (AAPS) PharmSci360 Congress, San Antonio, TX, November 2019. The purpose of the workshop was to bring together thought leaders in biomarker assay development in order to identify which assay parameters and key statistical measures need to be considered when developing a biomarker assay. A diverse group of more than 40 scientists participated in the workshop. The workshop and subsequent working dinner stimulated robust discussion. While a consensus on best practices was not achieved, some common themes and major points to consider for biomarker assay development have been identified and agreed on. The focus of this conference report is to summarize the presentations and discussions which occurred at the workshop. Biomarker assay validation is a complex and an evolving area with discussions ongoing. [ABSTRACT FROM AUTHOR]

Background: The 2009 Food and Drug Administration (FDA) patient-reported outcome (PRO) guidance outlines characteristics of rigorous PRO-measure development. There are a number of widely used PRO measures for Systemic Lupus Erythematosus (SLE), but it is unknown how well the development processes of SLE PRO measures align with FDA guidance; including updated versions. The objective of this study was to assess how well the LupusQoL and LupusPRO, and corresponding updated versions, LupusQoL-US and LupusPROv1.8, align with Food and Drug Administration (FDA) 2009 patient-reported outcome (PRO) guidance. Methods: LupusQoL and LupusPRO were selected as the most widely studied and used Lupus PROs in the UK and US. Original (LupusQoL (2007) and LupusQoL-US (2010)) and revised (LupusPROVv1.7 (2012) and LupusPROv1.8 (2018)) versions were reviewed. We used FDA PRO guidance to create evaluation criteria for key components: target population, concepts measured, measurement properties, documentation across the phases of content validity (item-generation and cognitive interviewing, separately) and other psychometric-property testing. Two reviewers abstracted data independently, compared results, and resolved discrepancies. Results: For all measures, the target population was unclear as population characteristics (e.g., ethnicity, education, disease severity) varied, and/or were not consistently reported or not considered across the three phases (e.g., LupusQoL item-generation lacked male involvement, LupusPRO cognitive-interviewing population characteristics were not reported). The item-generation phase for both original measures was conducted with concepts elicited via patient-engagement interviews and item derivation from experts. Cognitive interviewing was conducted via patient feedback with limited item-tracking for original measures. In contrast, the revised measures assumed content validity. Other psychometric testing recommendations (reliability, construct validity, ability to detect change) were reported for both original and revised measures, except for ability to detect change for revised measures. Conclusions: The SLE PRO measures adhere to some but not all FDA PRO guidance recommendations. Limitations in processes and documentation of the study population, make it unclear for which target population(s) the current Lupus measures are fit-for-purpose. [ABSTRACT FROM AUTHOR]

New therapies are being developed for breast cancer, and in this process, some "old" biomarkers are reutilized and given a new purpose. It is not always recognized that by changing a biomarker's intended use, a new biomarker assay is created. The Ki-67 biomarker is typically assessed by immunohistochemistry (IHC) to provide a proliferative index in breast cancer. Canadian laboratories assessed the analytical performance and diagnostic accuracy of their Ki-67 IHC laboratory-developed tests (LDTs) of relevance for the LDTs' clinical utility. Canadian clinical IHC laboratories enrolled in the Canadian Biomarker Quality Assurance Pilot Run for Ki-67 in breast cancer by invitation. The Dako Ki-67 IHC pharmDx assay was employed as a study reference assay. The Dako central laboratory was the reference laboratory. Participants received unstained slides of breast cancer tissue microarrays with 32 cases and performed their in-house Ki-67 assays. The results were assessed using QuPath, an open-source software application for bioimage analysis. Positive percent agreement (PPA, sensitivity) and negative percent agreement (NPA, specificity) were calculated against the Dako Ki-67 IHC pharmDx assay for 5%, 10%, 20%, and 30% cutoffs. Overall, PPA and NPA varied depending on the selected cutoff; participants were more successful with 5% and 10%, than with 20% and 30% cutoffs. Only 4 of 16 laboratories had robust IHC protocols with acceptable PPA for all cutoffs. The lowest PPA for the 5% cutoff was 85%, for 10% was 63%, for 20% was 14%, and for 30% was 13%. The lowest NPA for the 5% cutoff was 50%, for 10% was 33%, for 20% was 50%, and for 30% was 57%. Despite many years of international efforts to standardize IHC testing for Ki-67 in breast cancer, our results indicate that Canadian clinical LDTs have a wide analytical sensitivity range and poor agreement for 20% and 30% cutoffs. The poor agreement was not due to the readout but rather due to IHC protocol conditions. International Ki-67 in Breast Cancer Working Group (IKWG) recommendations related to Ki-67 IHC standardization cannot take full effect without reliable fit-for-purpose reference materials that are required for the initial assay calibration, assay performance monitoring, and proficiency testing., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Despite the significant and explicit focus on the United Nations Sustainable Development Goals (SDGs), much of the world’s land rights remain unrecorded and outside formal government systems. Blame is often placed on land administration processes that are considered slow, expensive, and expertise-dependent. Fit-For-Purpose Land Administration (FFPLA) has been suggested as an alternative, time and cost-effective approach. Likewise, the UN endorsed Framework for Effective Land Administration (FELA) demands attention to worldwide tenure insecurity by directly linking it to responsible land administration. Implementation of FFPLA and FELA is country-context dependent, and there are now many lessons of execution from various jurisdictions. Undertaken in 2022, this study synthesizes a review of experiences to provide a further update on the best global FFPLA implementation practices and inform approaches for future FFPLA projects. A systematic review is adopted as the research methodology, and contemporary articles from the internationally recognized land administration discourse are examined. The studies focus on FFPLA implementation practices and innovative approaches for delivering land tenure security. A checklist is developed, based on the FELA strategic pathways and the FFPLA fundamental framework principles and characteristic elements, to identify best implementation practices. Success stories across the globe show that the FFPLA characteristic elements and the FELA pathway goals are achieved through effective execution of the FFPLA framework key principles. As a result, the study identified successful FFPLA implementation practices in Asia and Africa, which can be synthesized and extended to realize tenure security in rapidly urbanizing areas. However, further study is necessary to determine the efficacy, practicability, innovativeness, and transferability of the best practices to other land administration scenarios.

Existing clinical tools that measure non-seizure outcomes lack the range and granularity needed to capture skills in developmental and epileptic encephalopathy (DEE)-affected individuals who also fall in the severe to profound range of intellectual disability. This effectively excludes those with severe impairments from clinical trials, impeding the ability of sponsors to evaluate disease-modifying therapies (DMTs). The Inchstone Project, an international, patient advocate-led collaboration, brings together leading researchers, clinicians, pharmaceutical companies, and advocates to develop an adapted, validated assessment battery within 5 years. The goal is to support trials of DMTs for the DEEs by providing sufficiently sensitive measurement tools to demonstrate therapeutic efficacy. An initial pilot study administered 7 established assessments to 10 individuals affected by SCN2A-DEE, identifying specific limitations of existing measures and areas for improvement. It was clear that most tools do not account for challenges throughout the DEE population, including vision impairments, significant motor impairments and profound intellectual disability, which need to be accounted for in creating a 'fit-for-purpose' battery for the DEE population. Several novel assessments, including two measures of responsivity developed for use in monitoring recovery after acquired brain injury as well as individualized Goal Attainment Scaling, showed promise in this group. The team also completed a DEE-wide survey with over 270 caregivers documenting their children's abilities and priorities for their improvement from new treatments. The Inchstone team is using this information to evaluate how existing tools might be updated to better capture what is most important to families and measure their child's small but important improvements over time. These efforts are building a coherent picture across multiple DEEs of what domains, or concepts of interest, have the greatest impact on most patients and families. The Inchstone team is on course to adapt non-seizure outcome measures that are (1) sufficiently sensitive to measure small increments of meaningful change ('Inchstones') and (2) applicable to multiple DEE conditions., Competing Interests: The authors declare that there is no conflict of interest., (© The Author(s), 2024.)

Receptor occupancy (RO) assessment by flow cytometry is an important pharmacodynamic (PD) biomarker in the clinical development of large molecules such as monoclonal therapeutic antibodies (mAbs). The total‐drug‐bound RO assay format directly assesses mAb binding to cell surface targets using anti‐drug detection antibodies. Here, we generated a flow cytometry detection antibody specifically binding to mAbs of the IgG1 P329GLALA backbone. Using this reagent, we developed a total‐drug‐bound RO assay format for RG7769, a bi‐specific P329GLALA containing mAb targeting PD‐1 and TIM3 on T cells. In its fit‐for‐purpose validated version, this RO assay has been used in the Phase‐I dose escalation study of RG7769, informing on peripheral T cell RO and RG7769 antibody binding capacity (ABC). We assessed RG7769 RO in checkpoint‐inhibitor (CPI) naïve patients and anti‐PD‐1 CPI experienced patients using our novel assay. Here, we show that in both groups, complete T cell RO can be achieved (~100%). However, we found that the maximum number of T cell binding sites for RG7769 pre‐dosing was roughly twofold lower in patients recently having undergone anti‐PD‐1 treatment. We show that this is due to steric hindrance exerted by competing mAbs masking the available drug binding sites. Our findings highlight the importance of quantitative mAb assessment in addition to relative RO especially in the context of patients who have previously received anti‐PD‐1 treatment. [ABSTRACT FROM AUTHOR]

Secure land and natural resource rights are key ingredients for rural transformation, social inclusion, and the realization of the Sustainable Development Goals. In many cases, these rights are not formally recorded, and statutory land administration systems are inaccessible to rural communities. The rapid development of geospatial technologies and systems, combined with participatory methods for social empowerment, have contributed significantly to addressing these challenges and in developing fit-for-purpose land administration/land recordation systems that promote land tenure security, but with the plethora of options currently available, it is challenging to know which technologies are appropriate for what circumstances and purposes. This paper reports on the findings from a joint FAO/IFAD project that addresses this problem. Thirteen one-hour interviews were conducted with knowledgeable experts to showcase which technologies are being used for what purposes and by whom, the associated benefits and challenges, and what the future may hold. We conclude that technologies are best used in partnership with communities and as integrated solutions, that successful implementations must incorporate maintenance plans, and that the real challenge is not the technology–it is the social, legal, and political context. These findings are useful for governments, NGOs, academia, donors, and others involved in land-related projects aimed at benefitting small-scale farmers.

Introduction: In December 2021, U.S. Food & Drug Administration (FDA) will issue guidance on the use of real-world evidence (RWE) to support new indications or expanded product labeling. While difficult to foresee what FDA will require, learnings can be gleaned from previous paradigm shifts at FDA, such as for patient reported outcomes (PROs) in 2006–2009. Methods: We contrast published requirements for justifying PROs as fit-for-purpose for a specific labeling claim with a potential approach to justify RWE as fit-for-purpose to support expanded labeling or a new indication. Results: PRO labeling claims require a PRO Evidence Dossier that includes: specific wording of claim, clinical trial hypothesis structure and endpoint model, and justification that the PRO is relevant and meaningful to patients in the target population (content validity) with adequate psychometric properties. FDA's 2018 RWE Framework outlined critical considerations for using RWE to support regulatory decisions, including data quality, relevancy, provenance, and transparency. Strong parallels exist between the evidence required to justify that PROs are fit-for-purpose to support specific labeling claims and evidence to justify RWE as fit-for-purpose for specific research questions and labeling. Early discussion with FDA is encouraged. Conclusion: Drawing on parallels with use of PROs in labeling, RWE for regulatory purposes should be evaluated within the context of specific labeling or indication, specific study design and analysis plans, and the data attributes of data source. Sponsors seeking a new indication or labeling expansion based on RWE should justify that a specific data source and specific study design are fit-for-purpose. [ABSTRACT FROM AUTHOR]

As a key component in the building process of a smart city, smart water systems greatly contribute to relieving the pressure of monitoring and maintaining water resource systems as well as improving allocation rationality. However, the existing smart water systems have a wide variety of types and designs without a unified optimal evaluation method. Unlike other scientific models, the majority of end users for smart water system are the government and the public who may not be familiar with complex and academic principles, making it difficult to determine the applicability of the current system to local demands. Accordingly, we proposed an evaluation method for the smart water system based on the concept of fit-for-purpose. The proposed method enables a comprehensive evaluation in three dimensions: usefulness of the system, reliability in results, and feasibility in practice, to make sure that a smart water system can achieve the specified purposes required by the certain environment and users in its optimum state. In this study, we applied this approach to a typical smart water system with the main purpose of water system scheduling and flood control in Fuzhou, China to (1) evaluate the current system on three dimensions; and (2) reconstruct the system for identifying the improvement details that fit for intended requirements. We found that the new evaluation method showed good adaptability to the smart water system: (1) For a built smart water system, the method provides users with acceptance and improvement references through comprehensive evaluation and re-construction; (2) For a proposed smart water system, the method can contribute to pragmatic design suggestions that make the system fit for purpose from the beginning. Overall, the evaluation method based on Fit-for-Purpose can serve as the basis for future smart water and smart city, hence improving resource efficiency and facilitating the development of digital urban water management. • The study fills the gap of a general evaluation method for smart water system. • System's usefulness, reliability and feasibility are assessed based on "Fit-for-Purpose". • The proposed method can provide suggestions for both new and existing system. • Dynamics and quantification of the F4P-based evaluation method should be enhanced. [ABSTRACT FROM AUTHOR]

There is a need to improve the Australian conformance practice for construction products. This paper presents an overview of the current operating environment of Australia and discusses the different ways in which a product may not be fit for its intended use. Issues discussed in this paper include methods for identifying problematic products, multi-level conformity assessment system and how to make the Australian system perform better. Various institutions have made independent proposals to improve different aspects of the system. These efforts will be much more effective if coordinated into a national system. [ABSTRACT FROM AUTHOR]

We critically engage two traditional views of scientific data and outline a novel philosophical view that we call the pragmatic-representational (PR) view of data. On the PR view, data are representations that are the product of a process of inquiry, and they should be evaluated in terms of their adequacy or fitness for particular purposes. Some important implications of the PR view for data assessment, related to misrepresentation, context-sensitivity, and complementary use, are highlighted. The PR view provides insight into the common but little-discussed practices of iteratively reusing and repurposing data, which result in many datasets’ having a phylogeny—an origin and complex evolutionary history—that is relevant to their evaluation and future use. We relate these insights to the open-data and data-rescue movements, and highlight several future avenues of research that build on the PR view of data. [ABSTRACT FROM AUTHOR]

• This paper describes 9 electronic healthcare datasources covering more than 40 million persons. • Background rates for 11 events of interest and pertussis vaccine coverage were benchmarked. • All datasources were fit-for-purpose to generate reliable evidence on vaccine coverage, benefits and risks. The public-private ADVANCE consortium (Accelerated development of vaccine benefit-risk collaboration in Europe) aimed to assess if electronic healthcare databases can provide fit-for purpose data for collaborative, distributed studies and monitoring of vaccine coverage, benefits and risks of vaccines. To evaluate if European healthcare databases can be used to estimate vaccine coverage, benefit and/or risk using pertussis-containing vaccines as an example. Characterisation was conducted using open-source Java-based (Jerboa) software and R scripts. We obtained: (i) The general characteristics of the database and data source (meta-data) and (ii) a detailed description of the database population (size, representatively of age/sex of national population, rounding of birth dates, delay between birth and database entry), vaccinations (number of vaccine doses, recording of doses, pattern of doses by age and coverage) and events of interest (diagnosis codes, incidence rates). A total of nine databases (primary care, regional/national record linkage) provided data on events (pertussis, pneumonia, death, fever, convulsions, injection site reactions, hypotonic hypo-responsive episode, persistent crying) and vaccines (acellular pertussis and whole cell pertussis) related to the pertussis proof of concept studies. The databases contained data for a total population of 44 million individuals. Seven databases had recorded doses of vaccines. The pertussis coverage estimates were similar to those reported by the World Health Organisation (WHO). Incidence rates of events were comparable in magnitude and age-distribution between databases with the same characteristics. Several conditions (persistent crying and somnolence) were not captured by the databases for which outcomes were restricted to hospital discharge diagnoses. The database characterisation programs and workflows allowed for an efficient, transparent and standardised description and verification of electronic healthcare databases which may participate in pertussis vaccine coverage, benefit and risk studies. This approach is ready to be used for other vaccines/events to create readiness for participation in other vaccine related studies. [ABSTRACT FROM AUTHOR]

Many impact assessment studies have been using reanalysis precipitation data as an alternative to observed rainfall data even where few rainfall records are available. For that reason, this study investigated fit-to-observations and fit-for-purpose of hybrid rainfall data using four strategically located rainfall stations in the Wami-Ruvu basin, Tanzania. Hybrid rainfall data were generated by randomly filling 15% to 70% hypothetical missing data in the observed records at the rainfall stations with reanalysis precipitation data from nearby grids. Fit-to-observations was used to evaluate the performance of the whole time series of hybrid rainfall data in mimicking that of observed rainfall data at the stations. Fit-for-purpose was used to evaluate the performance of trend and seasonal components of the whole time series of hybrid rainfall data in mimicking those of the whole time series of observed rainfall data at the stations. The findings showed that hybrid rainfall data are superior to reanalysis precipitation data in mimicking observed rainfall data. The findings also revealed that in most cases, trend and seasonal components have greater performances than the whole time series at high degrees of hybridization. Therefore, hybridization of rainfall data is highly encouraged especially in data-scarce regions.

A functioning land administration sector is the foundation for economic growth. Unfortunately, effective land registry and cadastral systems with national coverage exist in only a fraction of the world’s countries. Cadasta Foundation is working to overcome this challenge by developing simple digital tools and technology to help partners efficiently document, analyze, store, and share critical land and resource rights information. By creating an accessible digital record of land, property, and resource rights, Cadasta works to empower individuals, organizations, communities, governments, and businesses with the information they need to make data-driven decisions and put vulnerable communities and their needs on the map.

Agricultural land is a limited resource. Poland has implemented new legal regulations to protect the sale of agricultural land. An Agricultural Land Sales Control System (ALSCS) has been called into existence for the purpose of real estate marketing. The currently implemented National Land Administration System, referred to as the Integrated Real Estate Information System (IREIS), was analysed to determine the extent to which it supports farmland management policies. The results of the study indicate that the IREIS is a fit-for-purpose ALSCS which offers a high degree of protection for agricultural land. The IREIS can effectively protect agricultural land during market transactions. [ABSTRACT FROM AUTHOR]

Occupant behaviour (OB) is recognized as a leading source of uncertainty in building performance predictions. Neglecting the potential influence of uncertainties on building performance could result in erroneous decision-making during the design phase. Therefore, it is essential that uncertainties are appropriately considered within building performance simulation (BPS) models. As for OB, there are various approaches to model occupant presence and actions in BPS tools. Literature shows that the appropriate modelling approach depends on the object and purpose of the simulation, which makes it difficult to favour a method over another a priori. Moreover, there is very little support for selecting the most appropriate modelling approach. As a result, OB is modelled in practice in various ways, mostly dictated by intuition and habit. This study builds on previous literature to introduce and test a complete approach for appropriate OB modelling. The method can be generalized and readily applied to design questions. [ABSTRACT FROM AUTHOR]

Background: A formal method validation for biospecimen processing in the context of accreditation in laboratories and biobanks is lacking. A previously optimized stool processing protocol was validated for fitness-for-purpose for downstream microbiome analysis. Materials and Methods: DNA extraction from human stool was validated with various collection tubes, stabilizing solutions and storage conditions in terms of fitness-for-purpose for downstream microbiome analysis, robustness, and sample stability. Acceptance criteria were based on accurate identification of a reference material, homogeneity of extracted samples, and sample stability in a 2-year period. Results: The automated DNA extraction using the chemagic™ Magnetic Separation Module I (MSM I) extracted 8 out of 8 bacteria in the ZymoBIOMICS® Microbial Community Standard. Seven tested stabilizing solutions (OMNIgene®•GUT, RNAlater®, AquaStool™, RNAssist, PerkinElmer SEB lysis buffer, and DNA Genotek's CP-150) were all compatible with the chemagic MSM I and showed no significant difference in microbiome alpha diversity and no significant difference in the overall microbiome composition compared to the baseline snap-frozen stool sample. None of the stabilizing solutions showed intensive polymerase chain reaction (PCR) inhibition in the SPUD assay. However, when we take into account more stringent criteria which include a higher double-stranded DNA yield, higher DNA purity, and absence of PCR inhibition, we recommend the use of OMNIgene•GUT, RNAlater, or AquaStool as alternatives to rapid freezing of samples. The highest sample homogeneity was achieved with RNAlater- and OMNIgene•GUT -stabilized samples. Sample stability after a 2-year storage in −80°C was seen with OMNIgene•GUT -stabilized samples. Conclusions: We validated a combination of a stool processing method with various collection methods, suitable for downstream microbiome applications. Sample collection, storage conditions and DNA extraction methods can influence the microbiome profile results. Laboratories and biobanks should ensure that these conditions are systematically recorded in the scope of accreditation. [ABSTRACT FROM AUTHOR]

Land is a critical factor of production for improving the living conditions of people everywhere. The search for tools (or approaches or strategies or methods) for ensuring that land challenges are resolved in ways that quickly respond to local realities is what led to the development of the fit-for-purpose land administration. This article provides evidence that the fit-for-purpose land administration—as a land-based instrument for development—represents an unprecedented opportunity to provide tenure security in Africa. The article presents case studies from three sub-Saharan African countries on local-level experiences in the applications of fit-for-purpose guidelines as an enabler for engaging in tenure security generating activities in communities. These case studies, drawn from Ghana, Kenya, and Namibia, are based on hands-on local land administration projects that demonstrate how the features of the fit-for-purpose guideline were adopted. Two of the case studies are based on demonstrative projects directly conducted by the researchers (Ghana and Kenya), while the other (Namibia) is based on their engagement in an institutional project in which the Global Land Tool Network (GLTN) and other local partners were involved. This work is relevant because it paves a path for land administration practitioners to identify the core features necessary for land-based projects.