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. 2024 Dec 2;19(12):e0313957. doi: 10.1371/journal.pone.0313957

Perspectives on the implementation of post-validation surveillance for lymphatic filariasis in the Pacific Islands: A nominal group technique-based study protocol

Adam T Craig 1,*, Harriet Lawford 1, Satupaitea Viali 2,3, George Tuitama 2, Colleen L Lau 1
Editor: Swaminathan Subramanian4
PMCID: PMC11611168  PMID: 39621605

Abstract

Introduction

Lymphatic filariasis (LF) is a neglected tropical disease caused by parasitic worms, transmitted via mosquito bites. Significant global efforts have led to the interruption of LF transmission, with eight of the 16 previously endemic Pacific Island countries and territories (PICTs) validated by WHO as having eliminated the disease as a public health problem. Post-validation surveillance (PVS) is recommended to verify the absence of a resurgence in transmission; however, there are no guidelines on how to implement such surveillance effectively.

Aim

This protocol outlines a research study that aims to explore, synthesise, and prioritise the perspectives of LF program staff from LF-eliminated PICTs. The study will focus on identifying the challenges faced in implementing PVS in the PICT settings and determining corresponding context-relevant operational research priorities.

Method

The study will employ a nominal group technique (NGT) involving representatives from LF-eliminated PICTs. The NGT will adhere to a structured process for generating, ranking, and prioritising ideas, followed by group discussions, debates, and the collation of shared views.

Discussion

The research will provide insights into the most significant challenges faced in implementing PVS in the PICTs. It will also identify priority areas where operational research is required to inform policy and practice. To our knowledge, this study is the first to apply a rigorous consensus group method to distil challenges and research priorities for LF PVS in PICTs. We expect that this research will inform the development of national and regional LF guidelines.

Introduction

Consensus group methods are widely used to synthesise expert opinions when evidence is insufficient or conflicting. These methods have been applied across multiple disciplines, including healthcare, education, engineering, and management [1, 2], to inform a variety of health-related activities. These include defining diagnostic criteria, classifying diseases, selecting quality indicators, informing management guidelines, and educating healthcare professionals [15].

Nominal group technique (NGT) was originally developed for effective group decision-making within social psychological research [3]. The NGT follows a structured format to generate, rank, or prioritise ideas. The process typically involves presenting a nominal question; participants generating and reporting of ideas; group clarification, debate, and discussion; ranking and voting; and results and conclusion generation [6]. NGT is recognised for adhering to the foundational principles of consensus decision-making methods [2].

One distinctive feature of NGT is its emphasis on structured discussion and debate, which allows diverse ideas on shared interests to be expressed, explored, and collated. Where differences in opinion arise, the reasons for these can be discussed. This collaborative approach has been suggested to enhance stakeholders’ sense of ownership over the resulting research and increase the likelihood of influencing practice or policy change [3]. While NGT’s structured nature and engagement are key advantages, its limitations include the relatively small number of participants and the potential for dominant voices to influence group decisions.

Lymphatic filariasis (LF) is a neglected tropical disease (NTD) caused by three species of filarial worm: Wuchereria bancrofti, Brugia malayi, and B. timori and transmitted between humans by a range of mosquito species including Aedes, Culex, and Anopheles [7, 8]. W. bancrofti is the only filarial worm species found in the Pacific Islands [9]. Adult worms reside in the lymphatic system and can cause chronic damage over time if left untreated.

Lymphatic filariasis has affected about 882 million people, primarily in tropical and subtropical regions of Africa, Southeast Asia, the Pacific Islands, and the Americas [10]. As of 2018, 51 million people were infected—a 74% decline since the start of WHO’s Global Programme to Eliminate Lymphatic Filariasis in 2000 [11]. Since 2000, over 9.7 billion treatments for LF have been administered through mass drug administration (MDA) campaigns, reaching more than 943 million people. In 2023, the number of people that require MDA was 657 million [12].

The Pacific Islands include 22 small island countries and territories located over one-third of the Earth’s surface and are home to around 15 million people [13]. In 2000, the Global Programme to Eliminate LF (GPELF) was launched by the World Health Organization (WHO). The GPELF’s main objective was to achieve the elimination of LF as a public health problem across 73 endemic nations, including 16 in the Pacific Islands region, by 2020 [14, 15]. Through multiple rounds of MDA over many years, eight previously endemic Pacific Island Countries and Territories (PICTs) have reduced the prevalence of LF to below the microfilaria-positive prevalence threshold of 1% where transmission is thought to be no longer sustainable [16]. The WHO has validated these countries as having achieved the elimination of LF as a public health problem. Eight other PICTs have yet to eliminate LF, and six are considered non-endemic for LF (Table 1) with no recorded evidence of LF transmission [12].

Table 1. Pacific Island country and territory lymphatic filariasis endemicity and elimination status (2024).

Pacific island countries and territories (PICTs) Year validated by WHO as having eliminated LF Mid-year population estimate (2022)# Year most recent published survey was conducted^ Summary of findings
PICTs that have eliminated lymphatic filariasis as a public health problem
Cook Islands 2016 15,406 2013–14 [17] 2,903 participants from ten islands were tested. Only one person (an adult) was antigen (Ag) positive for LF. No Ag-positive individuals were found on the other 11 islands. The national Ag prevalence was calculated at 0.23%.
Niue 2016 1,543 2009 [18] A whole-population survey (n = 1,378) found an overall LF Ag prevalence of 0.5% with no cases in six to seven-year-old children.
Vanuatu 2016 307,941 2010–12 [19] 4,480 school-aged children were surveyed in three sampling units; no Ag-positive cases were found. Subsequently, a transmission assessment survey was conducted in one sampling unit that found two Ag-positive children out of 933 tested. The national Ag prevalence was calculated at 0.2%.
Wallis and Futuna 2016 11,304 2012 [20] A survey of 939 school-age children found three were Ag-positive cases, giving an overall Ag prevalence of 0.3%.
Palau 2017 17,976 2001 [21] A baseline assessment survey conducted in 2001 found nine Ag-positive cases (all from the same village) out of 2,031 people examined. The Ag prevalence was calculated at 0.4%.
Tonga 2017 99,283 2015 [22] The survey of 2,806 children from across all five administrative divisions found one Ag-positive case, giving an overall Ag prevalence of 0.04%.
Marshall Islands 2017 54,446 2003 [21] A 2001 baseline assessment survey of 2,003 people on two islands found two positive cases on Mejit Island, giving an Ag prevalence of 0.1%. In 2002, a blood antigen survey on Mejit and Alluk islands found 130 Ag-positive cases among 294 people (44.2%) and 71 Ag-positive cases among 244 (29%), respectively. A similar survey conducted in 2003 found no positive cases among 217 people examined on Wotje Atoll and the 318 people examined on Ebon Atoll.
Kiribati 2019 122,735 1999–2000 [21] A baseline assessment A survey found an Ag prevalence of 1.7%.
PICTs that have not yet eliminated lymphatic filariasis as a public health problem
American Samoa - 57,085 2016 [23, 24] 135 of 2,671 survey participants were Ag-positive giving an Ag prevalence of 5.1%, confirming ongoing LF transmission in previously known clusters and hotspots, and identifying new potential hotspots that warrant investigation.
Fiji - 901,603 2007 [25] A nationwide stratified cluster survey found the Ag prevalence to be 9.5%, ranging from 0.9% in the Western Division to 15.4% in the Eastern Division. Microfilaria (Mf) prevalence was 1.4%.
French Polynesia - 280,855 2008 [26] A cross-sectional, stratified, three-cluster sampling study of inhabitants aged 2 years and older found an ICT-positive prevalence of 11.3% and Mf-prevalence of 10%.
Federated States of Micronesia - 105,987 2003 [27] A survey of 233 participants on Satawal Islands found 96 (38%) were Ag-positive. 55 (22%) were found to have circulating Mf.
New Caledonia - 274,330 2013 [28] A survey of 1,035 participants identified seven Ag-positive cases. All participants tested negative for Mf blood smears and filarial DNA. The overall LF Ag prevalence was 0.62% (95% CI [0.60–0.63]). Although this is below the WHO threshold for elimination, the absence of epidemiological evidence excluding potential domestic transmission has prompted health authorities to consider the possibility of ongoing disease circulation.
Papua New Guinea - 9,311,874 Multiple years [29, 30] Multiple surveys using different methods have been conducted in different locations. Graves et al. (2013) summary showed LF prevalences of 30.4–64.7% for the period 1983–92, 30.1–56.9% for the period 1993–2000, and 7.8–12.8% for the period 2003–11.
Samoa - 200,999 2023 [31] 623 participants aged >5 years from 125 randomly selected households in eight sampling units were surveyed. Ag-positive cases were found in six of the eight sampling units. The adjusted Ag prevalence was 9.9% (95% CI 3.5–21.0).
Tuvalu - 10,778 2004 [21] A whole-population serosurvey found 973 Ag-positive cases among 8,173 people tested, giving an Ag-positive prevalence of 11.9%.
PICTs where lymphatic filariasis is not endemic
Guam (population: 179,900); Nauru (11,974); Northern Mariana Islands (56,986); Pitcairn Island (50), Solomon Islands (744,407); Tokelau (1,497).

# Source: [32]. Population figures are mid-year estimates based on interpolating nations’ census data and projections. The futures may differ from the actual census count in census years due to adjustments made by the Pacific Data Hub to allow comparability.

^The information presented is derived from publicly available sources. More recent but unpublished results may also exist. Additionally, some data pertain to specific sampling units or subsets within a country, and, as such, readers are advised to refer to the source document (cited) for a detailed account of the sampling frame used and results.

Countries that have received WHO validation of elimination of LF as a public health problem are encouraged to conduct periodic post-validation surveillance (PVS) to ensure that LF transmission has not been re-established; however, to date, there are no official WHO guidelines on how best or how frequently to conduct PVS [8].

Aim

This manuscript presents the study protocol for research that will use NGT to explore, synthesise, and prioritise the views of NTD program staff from LF-eliminated PICTs regarding the challenges faced in implementing surveillance for LF. Building on the main challenges identified, the study aims to develop a list of priority operational research questions that, once answered, will inform context-relevant policy and programmatic design. Further, the findings from this research are expected to inform national and regional LF guideline development, including the ’in draft’ WHO guidelines for PVS of LF.

Methods

Participant recruitment and target sample size

A letter inviting participation in the NGT will be sent by email to national NTD program staff from LF-eliminated PICTs who are registered to attend the Coalition for Operational Research into Neglected Tropical Diseases (COR-NTD) meeting for the Pacific Islands in Brisbane, Australia on 25–26 September 2024. The letter will explain the study’s objectives, rationale, risks, and benefits for participants. It will also provide a study participant information sheet and consent form and convey that the study has received ethical approval from The University of Queensland Human Research Ethics Committee. The timing of the NGT is opportunistic, as representatives from across the PICTs will be attending the COR-NTD meeting.

We aim to have one or two representatives from each PICT that has eliminated LF as a public health problem in the study (i.e., a purposefully selected sample of eight to 16). We propose to limit NGT discussion groups to a maximum of ten participants (i.e., if >10 participants elect to participate, two groups of NGT discussion will be formed).

Eligibility criteria

To be eligible for the NGT, a participant must have at least two years’ experience with their national NTD program and, during this time, have been involved in LF-related planning, surveillance, or response activities.

Consent process

A study participant information sheet and consent form will be attached to the email sent to participants. The email will request that the consent form be returned before the NGT. Verbal confirmation of consent will be obtained at the start of NGT, and participants will be advised that they can withdraw their consent at any time without prejudice. Consent will also be obtained to audio-recorded the NGT session.

We do not anticipate that participants will experience harm or psychological distress because of participating in the NGT. Participants are health professionals who routinely engage in stakeholder consultation activities.

Ethics

This study has the approval of The University of Queensland’s Human Research Ethics Committee (Project# 2024/HE000224).

Nominal group technique implementation

Room set-up, equipment, and facilitation

The NGT will take place during a 2-hour face-to-face meeting. Participants will be arranged in a circle to ensure an egalitarian atmosphere, eliminating any sense of dominance or hierarchy. Each participant will receive a clipboard, adhesive note paper (i.e., a ‘Post-it’ notepad), and a pen. Additionally, a space on the wall will be designated for displaying and making participant-generated ideas visible to everyone.

One researcher will facilitate the NGT, guiding the process and providing explanations. A co-investigator will assist the facilitator as needed.

Introducing the NGT process

At the start of the NGT, the facilitator will welcome the participants and invite them to introduce themselves, serving as an icebreaker. The facilitator will then spend 5–10 minutes explaining the purpose of the research and providing a step-by-step overview of the NGT process. This explanation will be supported by a visual aid and a simple example to ensure clarity. Participants will be invited to ask questions and seek clarification throughout this introductory phase.

Step 1. Presentation of a nominal question, group members idea generation, clarification

To begin, the facilitator will present a nominal question verbally and on a poster for visibility. The question will be: “What do you consider to be the most significant challenges you face, or anticipate facing, in implementing PVS for LF in your setting?” Participants will be reminded that the aim is to gather the full range of responses, and that no response is wrong.

Participants will then have 2 minutes to reflect on the question and make individual notes. Following this, the facilitator will invite one participant to share one of their responses. This response will be clarified, recorded briefly on a Post-it note, and displayed on the wall. Participants will be limited to one response at a time to ensure dominant voices do not overpower others’ ability to make contributions. The facilitator will continue to invite participants, one-by-one, to contribute one response at a time until all responses are captured. This may take several ‘rounds’ of idea generation.

Once all responses are displayed, participants will gather around the wall. The facilitator will prompt the group to identify overlapping responses and suggest possible merges. Participants will also be encouraged to seek clarification on any responses and revise wording if necessary. Participants will be invited to add any new ideas they may have, which will be incorporated into the display.

Step 2. Individual ranking

The next step of the NGT involves participants reflecting on and ranking the responses generated by the group. This will be done individually using a simple voting method developed by Delbecq [33], where each participant is allocated a set number of votes (e.g., ten) to distribute among the ideas as they choose. Participants may allocate all votes to one idea or distribute them across multiple ideas according to their perspectives.

The votes will be collected and tallied once all participants have completed the ranking. During this process, participants will be invited to take a 5-minute break. Upon their return, the facilitator will arrange the Post-it notes displaying the ideas in rank order. Ideas resonating most with the group are expected to appear higher in the order, while those considered less critical will rank lower. The facilitator will emphasise that the rankings are relative and that a lower rank does not imply the idea is unimportant.

The facilitator will then open a discussion about the rankings, asking questions such as, "Is this what you expected?" or "Would those who ranked this idea highest like to explain their reasoning?" If significant differences in opinion arise, the discussion will continue, and participants will have the option to repeat the ranking exercise if they are willing (i.e., conduct Step 2 again).

Step 3. Scoping priory research questions related to highly ranked challenges

The final step of the NGT will focus on generating operational research questions identified by national officers. The facilitator will invite participants to reframe the three highest-ranking responses to the nominal question into operational research questions. Given the uncertainty surrounding the nature of the emerging questions and the limited time available, a specific framework for drafting operational research questions is not proposed at this stage. Such refinement will occur at a later point.

When addressed, these questions will provide critical, context-specific insights to inform LF surveillance practices and strategy development across the PICTs. We recognise that identifying and refining operational research priorities, as well as securing political and financial commitments for action, is a time-intensive process. Therefore, we propose this stage of the NGT be the initial step towards developing a Pacific officer-led operational research agenda for LF.

Analysis

The ranking data will be quantitatively described, while discussions regarding the prioritisation, rationale for decision-making, and sentiments expressed will be qualitatively analysed using an inductive thematic approach, as outlined by Braun and Clarke [34], and Terry and colleagues [35]. Comparisons will be made between groups based on LF status, recency of LF surveillance activities, and demographic and economic factors, among other relevant variables.

Discussion

This research aims to gather insights into the primary challenges faced by health officers in PICTs that have eliminated LF, particularly regarding PVS. Additionally, it will initiate discussions on the research priorities of national health officers related to LF surveillance, with the goal of generating knowledge that is directly relevant to PICTs’ policy and practice for LF surveillance.

Consensus group methods are widely employed to identify and assess areas where evidence is incomplete [5, 36, 37]. While numerous consensus methods have been developed, including the Delphi technique, the Consensus Development Conference approach, and the Research and the Development/University of California Los Angeles (RAND/UCLA) Appropriateness method [38], NGT was chosen for this study as it facilitates rapid, time-bound group decisions. Its structure enables real-time feedback and controlled interaction, ensuring all voices in the group contribute equally. The participants in the NGT are experts in LF surveillance in their relevant context, which positively influences the findings’ validity, credibility, reliability, and acceptability [37]. Key advantages of NGT include the generation of numerous ideas in a relatively short timeframe [38], equal participation and prioritisation of ideas, ‘ownership’ of the outcomes, and immediate feedback [34]. Noted limitations include a relatively small number of participants and a facilitator, as well as the need to overcome logistical challenges, such as the need for participants to be in the same location [38].

To the best of our knowledge, this study represents the first application of a methodologically rigorous consensus group method to gather insights and identify operational research priorities for surveillance of LF, or any other disease, in the PICTs. Consequently, it will offer a novel approach to stakeholder consultation for end-user priority setting that will inform future program design. Specifically, the findings from this research are expected to inform national and regional LF PVS guideline development, including the ’in draft’ WHO guidelines for PVS of LF.

Data Availability

No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.

Funding Statement

The author(s) received no specific funding for this work.

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Decision Letter 0

Swaminathan Subramanian

21 Oct 2024

PONE-D-24-41211Challenges in implementation of post-validation surveillance for lymphatic filariasis in the Pacific Islands: A nominal group technique-based research study protocolPLOS ONE

Dear Dr. Craig,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

ACADEMIC EDITOR:

​I have invited five experts to review the manuscript. Of them, three agreed to review the ms. All the three reviewers considered the protocol is timely and relevant in the context of post-validation surveillance for lymphatic filariasis. But also raised both major and minor comments. I would request the authors to focus on the major comments on the methodology related to how to elicit meaningful responses from participants or how program personnel would able to identify challenges and provide insights especially in the absence of clear guidance from WHO or other stake holders.

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Academic Editor

PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Partly

Reviewer #2: Yes

Reviewer #3: Yes

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Partly

Reviewer #2: Yes

Reviewer #3: Yes

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

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(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Comments on the paper titled Challenges in implementation of post-validation surveillance for lymphatic filariasis in

the Pacific Islands: A nominal group technique-based research study protocol

Post-validation surveillance (PVS) is an important component of the national Lymphatic filariasis (LF) elimination programs. The progress of PVS is tardy, so far, in the countries that have eliminated LF as a public health problem. In this context, the objective of the authors to identify the challenges in implementing PVS and operational research areas in Pacific island countries is timely and relevant.

As the authors noted (Line 13), there is limited guidance from WHO or other stakeholders regarding the components and strategies of post-validation surveillance (PVS). Many programs, whether in the PVS phase or post-MDA surveillance phase, may lack a clear understanding of how to organize and implement PVS or estimate its costs. In this context, it is unclear how the authors expect to elicit meaningful responses from participants or how program personnel would be able to identify challenges and provide insights, especially in the absence of concrete guidance. For instance, if I were a program manager or deputy with little knowledge of PVS strategies, it would be difficult to identify challenges or offer perspectives. The authors should address this gap in detail.

The other points are as follows:

Line 11: It is not 'eradicated'; it is 'eliminated'

Lines 56-60: The figures 120 million people and 40 million people refer to the years prior to launching the LF elimination program. The current figures are much lower due to the impact of the LF elimination programs. The authors should provide either current figures or correct the sentence to indicate the figures pertain to pre-GPELF period.

Line 68: threshold of 1% - provide whether it is Ag prevalence or Mf prevalence.

Line 93: COR NTD meeting: The dates and venue details of the meeting should be provided.

Reviewer #2: The manuscript is technically sound, and the authors have well described the protocol for a NGT-based research study addressing the pertinent issue of challenges in the implementation of post validation surveillance for LF.

There are a few minor clarifications and suggestions that may be addressed by the authors:

Line no. 52: "potential for dominant voices to influence group decisions"- how this will be addressed in the study shall be briefly explained in the Methods section.

Line nos. 56-60: Reference no. 8 is quite old. Recent figures and reference shall be provided.

Line no. 67: "..prevalence of LF to below the prevalence threshold of 1%.."- I suppose it means Mf prevalence<1%. The sentence shall be reframed for better clarity.

Line nos. 61-71: The paragraph discusses about the LF situation in the PICTs. A line on the parasite (W.b/ B.m) and vector species involved in transmission in PICTs can be included for better understanding of the readers.

Line nos. 95-98 and Line nos. 108-110, 117-118 are repeated.

Line no. 128: A sentence on consent for audio recording shall be included under "Consent process"

Line no. 189: Under Discussion, the authors can briefly discuss the advantages of NGT over Delphi method and any other consensus method available.

Line no. 198 is unclear and shall be reframed: co-design what?

Line no. 200: :"..in draft WHO guidelines for PVS of LF"- the same shall be mentioned in Introduction after line no: 79-80

Reviewer #3: Comments on the paper entitled “Challenges in implementation of post-validation surveillance for lymphatic filariasis in the Pacific Islands: A nominal group technique-based research study protocol”

PLOS ONE accepts submissions for publication of Study Protocols for any study type within the journal’s scope. The proposed study Protocols describe detailed plans for conducting research, including the background, rationale, objectives, methodology, statistical plan, and organization of a research project. This protocol can be considered for publication as the study plans to use consensus group method by following nominal group technique and bring out the challenges faced in implementing surveillance for LF and research priorities for LF LF-PVS, with an ultimate objective of developing national and regional guidelines.

Abstract

1. Line 11: replace “eradicated the disease” by “eliminated”

2. Line 12: replace “prevent the” by “verify absence of resurgence and …..”

3. Line 30: add “post validation” before “surveillance”

4. Line 31: add Nominal Group technique

Introduction

5. Line 39: remove “method”

6. Line 64: add “in 16 countries” after (WHO)

7. Line 67-68: add after have “cleared Transmission Assessment Survey” and delete “reduced the prevalence of LF to below the prevalence threshold of 1%”.

8. Line 70: before “to” add “achieve elimination of LF” and delete eliminate

9. Line 73: replace figure1 by table 1

10. Table 1: Add a column “population” before “Year validated by WHO as having eliminated LF”, and give the latest population

Methods

11. Line 89: is it not biased to include NTD programme staff from LF-eliminated PICTs who are registered to attend the Coalition for Operational Research into Neglected Tropical Diseases (COR-NTD) meeting for the Pacific Islands, scheduled in September 2024?.

12. Line 102: rephrase as “two groups of NGT discussion will be formed”

13. Line 107: consent procedure is a repeat of lines 95-98. The text in lines 95-98 can be deleted.

14. Line 123-125: Additionally, a space on the wall will be designated for displaying and making participant-generated ideas visible to everyone. Should it mean flip chart?

15. Line 140: does it refer post validation surveillance?

Discussion

16. Line 192: does it mean post validation surveillance?

**********

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: Yes: Krishnamoorthy Kaliannagounder

**********

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PLoS One. 2024 Dec 2;19(12):e0313957. doi: 10.1371/journal.pone.0313957.r002

Author response to Decision Letter 0


22 Oct 2024

Reviewer #1:

Post-validation surveillance (PVS) is an important component of the national Lymphatic filariasis (LF) elimination programs. The progress of PVS is tardy, so far, in the countries that have eliminated LF as a public health problem. In this context, the objective of the authors to identify the challenges in implementing PVS and operational research areas in Pacific island countries is timely and relevant.

-- Noted

As the authors noted (Line 13), there is limited guidance from WHO or other stakeholders regarding the components and strategies of post-validation surveillance (PVS). Many programs, whether in the PVS phase or post-MDA surveillance phase, may lack a clear understanding of how to organize and implement PVS or estimate its costs. In this context, it is unclear how the authors expect to elicit meaningful responses from participants or how program personnel would be able to identify challenges and provide insights, especially in the absence of concrete guidance. For instance, if I were a program manager or deputy with little knowledge of PVS strategies, it would be difficult to identify challenges or offer perspectives. The authors should address this gap in detail.

-- While the absence of global guidance on PVS implementation may have impeded understanding and commitment, it has not been our experience that NTD program managers and staff are unaware of the rationale or epidemiological principles underlying PVS. Many Pacific Ministry of Health staff have extensive experience with LF elimination, having worked tirelessly to reduce LF prevalence significantly in their countries. Given their role, experience with LF and other NTD program delivery, and insights into the leavers that drive national policy and program decision-making processes, we believe these individuals are the most appropriate and among the best equipped to offer meaningful insights into the challenges faced in the delivery of PVS the Pacific context.

The other points are as follows:

Line 11: It is not 'eradicated'; it is 'eliminated'

-- Our mistake, thank you. The word has been changed.

Lines 56-60: The figures 120 million people and 40 million people refer to the years prior to launching the LF elimination program. The current figures are much lower due to the impact of the LF elimination programs. The authors should provide either current figures or correct the sentence to indicate the figures pertain to pre-GPELF period.

-- The text has been updated and now reads, “Lymphatic filariasis has affected about 882 million people, primarily in tropical and subtropical regions of Africa, Southeast Asia, the Pacific Islands, and the Americas [10]. As of 2018, 51 million people were infected – a 74% decline since the start of WHO’s Global Programme to Eliminate Lymphatic Filariasis in 2000 [11]. Since 2000, over 9.7 billion treatments for LF have been administered through mass drug administration (MDA) campaigns, reaching more than 943 million people. In 2023, the number of people that require MDA was 657 million [12].” (around line 58)

1.5. Line 68: threshold of 1% - provide whether it is Ag prevalence or Mf prevalence.

-- The text has been updated to read, “reduced the prevalence of LF to below the microfilaria-positive prevalence threshold of 1%.” (around line 65).

1.6. Line 93: COR NTD meeting: The dates and venue details of the meeting should be provided.

-- The text has been updated to read “in Brisbane, Australia, on 25-26 September 2024.” (around line 89)

Reviewer #2:

The manuscript is technically sound, and the authors have well described the protocol for a NGT-based research study addressing the pertinent issue of challenges in the implementation of post validation surveillance for LF.There are a few minor clarifications and suggestions that may be addressed by the authors:

2.1. Line no. 52: "potential for dominant voices to influence group decisions"- how this will be addressed in the study shall be briefly explained in the Methods section.

-- At around line 142, we have edited the text to read, “Participants will be limited to one response at a time to ensure dominant voices do not overpower others’ ability to make contribution. The facilitator will continue to invite participant, one-by-one,to contribute one response at a time until all responses are captured. This may take several ‘rounds’ of idea generation.”

2.2. Line nos. 56-60: Reference no. 8 is quite old. Recent figures and reference shall be provided.

This passage and reference have been replaced with the following. ““Lymphatic filariasis has affected about 882 million people, primarily in tropical and subtropical regions of Africa, Southeast Asia, the Pacific Islands, and the Americas [10]. As of 2018, 51 million people were infected – a 74% decline since the start of WHO’s Global Programme to Eliminate Lymphatic Filariasis in 2000 [11]. Since 2000, over 9.7 billion treatments for LF have been administered through mass drug administration (MDA) campaigns, reaching more than 943 million people. In 2023, the number of people that require MDA was 657 million [12].” (around line 58)

Line no. 67: "..prevalence of LF to below the prevalence threshold of 1%.."- I suppose it means Mf prevalence<1%. The sentence shall be reframed for better clarity.

-- The text has been revised and now reads, “reduced the prevalence of LF to below the microfilaria-positive prevalence threshold of 1%.” (around line 65).

Line nos. 61-71: The paragraph discusses about the LF situation in the PICTs. A line on the parasite (W.b/ B.m) and vector species involved in transmission in PICTs can be included for better understanding of the readers.

-- In response, the following text has been added around line 52. “Lymphatic filariasis (LF) is a neglected tropical disease (NTD) caused by three species of filarial worm: Wuchereria bancrofti, Brugia malayi, and B. timori and transmitted between humans by a range of mosquito species including Aedes, Culex, and Anopheles [7, 8]. W. bancrofti is the only filarial worm species found in the Pacific Islands.”

Line nos. 95-98 and Line nos. 108-110, 117-118 are repeated.

-- The second and third mentions of the letter of invitation have been removed, and the first instance (around line 90) edited to read, “A letter inviting participation in the NGT will be sent by email to national NTD program staff from LF-eliminated PICTs who are registered to attend the Coalition for Operational Research into Neglected Tropical Diseases (COR-NTD) meeting for the Pacific Islands in Brisbane, Australia on 25-26 September 2024. The letter will explain the study's objectives, rationale, risks, and benefits for participants. It will also provide a study participant information sheet and consent form, and convey that the study has received ethical approval from The University of Queensland Human Research Ethics Committee. The timing of the NGT is opportunistic, as representatives from across the PICTs will be attending the COR-NTD meeting.”

Line no. 128: A sentence on consent for audio recording shall be included under "Consent process"

-- The statement has been moved to the consent section (around line 118) and text tweaked for clarity. It now reads, “Consent will also be obtained to audio-recorded the NGT session.”

Line no. 189: Under Discussion, the authors can briefly discuss the advantages of NGT over Delphi method and any other consensus method available.

-- In response, from around line 213, we have added the following. “Consensus group methods are widely employed to identify and assess areas where evidence is incomplete [5, 35, 36]. While numerous consensus methods have been developed, including the Delphi technique, the Consensus Development Conference approach, and the Development/University of California Los Angeles (RAND/UCLA) Appropriateness method [36], NGT was chosen for this study as it facilitates rapid, time-bound group decisions. Its structure enables real-time feedback and controlled interaction, ensuring all voices in the group contribute equally. The participants in the NGT are experts in LF surveillance in their relevant context, which positively influences the findings' validity, credibility, reliability, and acceptability [36]. Key advantages of NGT include the generation of numerous ideas in a relatively short timeframe [37], equal participation and prioritisation of ideas, ‘ownership’ of the outcomes, and immediate feedback [35]. Noted limitations include a relatively small number of participants and a facilitator, as well as the need to overcome logistical challenges, such as the need for participants to be in the same location [37].”

Line no. 198 is unclear and shall be reframed: co-design what?

-- Thank you for the comment. The wording has been changed to “… inform future program design.”

Line no. 200: :"..in draft WHO guidelines for PVS of LF"- the same shall be mentioned in Introduction after line no: 79-80

The sentence, “Further, the findings from this research are expected to inform national and regional LF guideline development, including the 'in draft' WHO guidelines for PVS of LF” has been added to the aims section, around line 87 on the marked up version of the revised manuscript.

Reviewer #3:

Comments on the paper entitled “Challenges in implementation of post-validation surveillance for lymphatic filariasis in the Pacific Islands: A nominal group technique-based research study protocol”

PLOS ONE accepts submissions for publication of Study Protocols for any study type within the journal’s scope. The proposed study Protocols describe detailed plans for conducting research, including the background, rationale, objectives, methodology, statistical plan, and organization of a research project. This protocol can be considered for publication as the study plans to use consensus group method by following nominal group technique and bring out the challenges faced in implementing surveillance for LF and research priorities for LF LF-PVS, with an ultimate objective of developing national and regional guidelines.

Abstract

1. Line 11: replace “eradicated the disease” by “eliminated”

-- this change has been made. Apologies for this obvious error. (around line 11)

2. Line 12: replace “prevent the” by “verify absence of resurgence and …..”

-- The suggested change has been made. (around line 12)

3. Line 30: add “post validation” before “surveillance”

-- the keyword “post-validation surveillance” has been added to the list of terms.

4. Line 31: add Nominal Group technique

-- The keyword “Nominal Group Technique” has been added to the list of terms.

Introduction

5. Line 39: remove “method”

-- the word “method” has been removed. (around line 39)

6. Line 64: add “in 16 countries” after (WHO)

-- the sentence has been updated to read, “The GPELF’s main objective was to achieve the elimination of LF as a public health problem across 73 endemic nations, , including 16 in the Pacific Islands region, by 2020 [13].” (around line 64)

7. Line 67-68: add after have “cleared Transmission Assessment Survey” and delete “reduced the prevalence of LF to below the prevalence threshold of 1%”.

8. Line 70: before “to” add “achieve elimination of LF” and delete eliminate

-- The suggested change has been made. (around line 72).

9. Line 73: replace figure1 by table 1

-- The figure heading of has been changed ‘table.’

10. Table 1: Add a column “population” before “Year validated by WHO as having eliminated LF”, and give the latest population

-- The suggestion has been accepted and the table modified accordingly. We report population data as done by the Pacific Data Hub and include the following footnote to the table. “Source: [28]. Population figures are mid-year estimates based on interpolating nations’ census data and projections. The futures may differ from the actual census count in census years due to adjustments made by the Pacific Data Hub to allow comparability.”

Methods

11. Line 89: is it not biased to include NTD programme staff from LF-eliminated PICTs who are registered to attend the Coalition for Operational Research into Neglected Tropical Diseases (COR-NTD) meeting for the Pacific Islands, scheduled in September 2024?.

-- As the proposed research is not experimental, we seek input from purposefully selected officers with experience and insights to share.

12. Line 102: rephrase as “two groups of NGT discussion will be formed”

-- The suggested wording has been adopted. (around line 115)

13. Line 107: consent procedure is a repeat of lines 95-98. The text in lines 95-98 can be deleted.

-- This has been addressed, as per a response to a comment above. See the revised consent section, around line 120.

14. Line 123-125: Additionally, a space on the wall will be designated for displaying and making participant-generated ideas visible to everyone. Should it mean flip chart?

-- No, we mean wall space as stated.

15. Line 140: does it refer post validation surveillance?

-- Yes. The sentence has been revised and now reads, “The question will be: “What do you consider to be the most significant challenges you face, or anticipate facing, in implementing PVS for LF in your setting?” (around line 154)

Discussion

16. Line 192: does it mean post validation surveillance?

-- Yes. The sentence has been revised and now reads, “Specifically, the findings from this research are expected to inform national and regional LF PVS guideline development…” (around line 216)

Decision Letter 1

Swaminathan Subramanian

4 Nov 2024

Perspectives on the implementation of post-validation surveillance for lymphatic filariasis in the Pacific Islands: A Nominal Group Technique-based study protocol

PONE-D-24-41211R1

Dear Dr. Craig,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

An invoice will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, please contact our Author Billing department directly at authorbilling@plos.org.

If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Swaminathan Subramanian, Ph.D.

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Dear Authors,

We are pleased to inform you that all the three reviewers have recommended to accept the ms for publication in PLOS ONE (review reports attached). However, there are minor corrections from one of the reviewers (Reviewer 3). I would request you to take care of the minor corrections while submitting the final version.

Best wishes

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Partly

Reviewer #2: Yes

Reviewer #3: Yes

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Partly

Reviewer #2: Yes

Reviewer #3: Yes

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Comments on Perspectives on the implementation of post-validation surveillance for lymphatic filariasis in the Pacific Islands: A Nominal Group Technique-based study protocol

The contribution of PIC to the field of epidemiology and the control of lymphatic filariasis (LF) since the 1960s, as well as to LF elimination efforts since 2000, is indeed significant and commendable. However, this history alone does not necessarily establish PIC or any other region as “among the best equipped to offer meaningful insights into the challenges faced in the delivery of PVS in the Pacific context.” Without a well-defined strategy, discussing effective delivery and associated challenges seems premature. Therefore, the authors’ argument lacks sufficient support. That said, I appreciate the enthusiasm and dedication of the authors, and I encourage them to publish and implement their protocol.

Reviewer #2: The authors have addressed all comments in the revised version of manuscript. The necessary changes made are appropriate and acceptable.

Reviewer #3: This paper may be accepted for publication in the PLOS One Journal as the author have responded to the comments of reviewer 3. However, the authors need to respond to the following two comments:

Previous comment 6:. Line 64: add “in 16 countries” after (WHO):

Authors’ response: the sentence has been updated to read, “The GPELF’s main objective was to achieve the elimination of LF as a public health problem across 73 endemic nations, including 16 in the Pacific Islands region, by 2020 [13].” (around line 64)

Present comment: Line 69-71 of the revised manuscript: Correct the sentence “The GPELF’s main objective was to achieve the elimination of LF as a public health problem across 73 endemic nations, including 16 in the Pacific Islands region, by 2020 [15] [16]]” as “The GPELF’s main objective was to achieve the elimination of LF as a public health problem across 72 endemic nations, including 16 in the Pacific Islands region, by 2020 [15]. [16]

Previous comment 7: Line 67-68: add after have “cleared Transmission Assessment Survey” and delete

“reduced the prevalence of LF to below the prevalence threshold of 1%”.

The authors are yet to respond to this comment.

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: No

Reviewer #3: Yes: Krishnamoorthy Kaliannagounder

**********

Acceptance letter

Swaminathan Subramanian

18 Nov 2024

PONE-D-24-41211R1

PLOS ONE

Dear Dr. Craig,

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on behalf of

Dr. Swaminathan Subramanian

Academic Editor

PLOS ONE

Associated Data

    This section collects any data citations, data availability statements, or supplementary materials included in this article.

    Data Availability Statement

    No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.


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