Skip to main content
NCBI home page
PLOS One logoLink to PLOS One
. 2025 Aug 21;20(8):e0330448. doi: 10.1371/journal.pone.0330448

Assessment of the psychometric properties of self-management measurement instruments for individuals with type 2 diabetes: A systematic review protocol

José Alexandre Barbosa de Almeida 1,2, Karolinne Souza Monteiro 1,3, Thayla Amorim Santino 2, Rêncio Bento Florêncio 4, Ana Tereza do Nascimento Sales Figueiredo Fernandes 2, Lucien Peroni Gualdi 1,3,*
Editor: Manuela Mendonça Figueirêdo Coelho5
PMCID: PMC12370044  PMID: 40839640

Abstract

Context and objectives

The type 2 diabetes mellitus (T2DM) negatively impacts patients’ quality of life, affecting their physical and mental functioning as well as social relationships. Self-management is essential for T2DM control, as it involves self-care behaviors and self-efficacy, leading to better health outcomes such as better glycemic control. There are a variety of instruments in the literature capable of measuring self-management in T2DM population. Therefore, the aim of this review is to identify the available T2DM self-management instruments and evaluate their measurement properties, as well as to analyze their contents based on the international classification of functioning, disability and health.

Methods

The systematic review will follow the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines, and its protocol has been registered in the International Prospective Register of Systematic Reviews (PROSPERO) (registration CRD42024605840). Searches will be conducted in MEDLINE, Web of Science, Scopus, PsycINFO, Embase, and CINAHL. Additionally, a manual search will be conducted in the databases: PROQOLID, PROMIS, and Medical Outcome Trust. Studies on the development and validation of patient-reported outcome measures assessing self-management in individuals with T2DM will be included, with no restrictions on language or publication date. Data extraction will use tools recommended by COSMIN. The modified Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach will determine the quality of the evidence. Instruments will be categorized according to COSMIN recommendations. All steps will be conducted by two independent reviewers, with a third reviewer consulted in case of discrepancies. Additionally, the content of the instruments will be analyzed and linked to the ICF.

Discussion

This systematic review may guide researchers and healthcare professionals to choose the most suitable instrument for their target population.

Ethics and dissemination

Ethical approval is not required, as this study is a review of published data. The results will be disseminated through publication in peer-reviewed journals.

Introduction

According to the International Diabetes Federation (IDF), approximately 537 million adults were diagnosed with diabetes mellitus (DM) in 2021. This number is projected to reach 643 million by 2030 and 783 million by 2045, with about 90% of these cases corresponding to Type 2 Diabetes Mellitus (T2DM) [1,2]. These statistics are concerning given the chronic nature of T2DM and its negative impact on physical functioning, mental health, and social relationships. Thus, further studies should aim to reduce these impacts, as well as develop more effective assessment methods for this population [3–5].

Self-management is crucial for individuals with T2DM, as behavioral management is key to achieving goals, providing support, gaining knowledge about the disease, making informed decisions, and mastering essential skills, which positively impact their health and well-being [6–8]. Proper self-management enables individuals with T2DM to maintain good glycemic control and reduce the complications of the disease [7].

Self-management encompasses a range of self-care behaviors and self-efficacy, reflecting the ability to perform specific tasks effectively [9]. These tasks include physical activity, exercise, diet, glycemic control, daily living activities, medication adherence, and foot care [9,10]. Therefore, it is important to measure self-management levels, particularly using patient-reported outcome measures [11].

There is a variety of validated instruments available for individuals with T2DM [12] which can make choosing a suitable tool difficult. Although there are systematic reviews assessing their quality [12,13], these studies have limitations. One study [12] specifically evaluates self-management measurement instruments for this population it showed some limitations. First, it did not include instruments for general chronic diseases which may have excluded T2DM participants as well as it only included instruments in English and Chinese languages. The second limited the inclusion of generic studies [13]. Thus, this study aims to systematically assess the measurement properties of self-management instruments for individuals with T2DM (including generic instruments used for this population), as well as to analyze the extracted content and link them to the International Classification of Functioning, Disability, and Health (ICF).

Methods

Study design and registration

This protocol follows the recommendations of the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) [14] and the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) [15]. The PRISMA-COSMIN [16] will be used to report the full study. The protocol has been submitted to the International Prospective Register of Systematic Reviews (PROSPERO) under registration number CRD42024605840. Any changes to the systematic review will be documented in PROSPERO and published in the final study report.

Eligibility criteria

Studies on the development and validation of self-management measurement instruments (including self-care and self-efficacy) for adults with T2DM will be included. Studies on translation and cross-cultural adaptation assessing the same construct will also be included. Additionally, studies on self-management instruments for chronic diseases will be considered, if they include adult participants with T2DM. There will be no restrictions on language or publication date. Language experts will be consulted if necessary.

Studies with different methodological designs, such as cohort studies, clinical trials, cross-sectional studies, post-intervention analyses, and case-control studies, will be excluded. Instruments that assess more than one construct, that have self-management only as a subscale and those used for validating another instrument will also be excluded.

Search strategy

The search will be conducted in the following databases: MEDLINE (Ovid), Web of Science, Scopus, PsycINFO (APA), Embase and CINAHL (EBSCOhost). Additionally, a manual search will be performed in questionnaire databases: PROQOLID (http://www.proqolid.org), PROMIS (http://www.nihpromis.org), and Medical Outcome Trust (http://www.outcomes-trust.org).

A manual search will also be conducted in the reference lists of all primary studies, systematic reviews, and gray literature to include potential studies. These searches will be performed from the inception date up to the finalization of the systematic review, ensuring that any studies published after the initial search are identified.

To develop search strategies, international recommendations for systematic reviews will be followed [14,17]. The following aspects will be considered: (1) construct of interest (self-management, self-care, self-efficacy); (2) target population (adults with T2DM); (3) types of instruments (self-report scales and questionnaires); and (4) measurement properties, using a combination of sensitive filters recommended by COSMIN [17]. Search strategies are detailed in S1 File.

Screening and study selection

The search results will be imported into the reference management tool Mendeley (https://www.mendeley.com) [18], and duplicates will be removed before screening. Then, the reference list will be exported to the systematic review platform Rayyan Qatar Computing Research Institute (http://rayyan.qcri.org) [19]. The detailed selection process will be documented and presented in a PRISMA flow diagram [16,20].

Two independent reviewers (JABA and KSM) will screen studies by title and abstract, followed by full-text review of potentially eligible studies. Ineligible studies will be identified, and reasons for exclusion will be recorded and displayed in the PRISMA flow diagram [16,20]. In cases of disagreement, a third reviewer (LPG) will be consulted for discussion. If missing data or any relevant information is necessary, study authors will be contacted via email.

Data extraction

A standardized and pre-piloted form will be developed for data extraction by the authors. The extracted information will include: 1) Study characteristics (title, author, year, study type, administration mode, data collection period, data collection method, inclusion and exclusion criteria, instruments used, response rate); 2) General characteristics of the target population (number of participants, age, gender, country, language, participant conditions, collection setting, education level, socioeconomic status); 3) Instrument characteristics (construct, subscales, items, version for different populations, original version for cross-cultural adaptations, scoring); 4) Measurement properties results (reliability, validity, responsiveness); 5) Evidence on questionnaire interpretability and feasibility of included instruments.

Data extraction will be performed by two independent reviewers (JABA, TAS), and in case of discrepancies, a third reviewer (ATNSFF) will be consulted to reach a consensus. If missing data or additional information is required, study authors will be contacted via email.

Methodological quality and measurement properties assessment

Two independent reviewers (JABA, RBF) will assess the methodological quality of the studies. In cases of disagreement, a third reviewer (LPG) will be consulted. The COSMIN Risk of Bias checklist, which includes 116 items, will be used to critically appraise the methodological quality of included studies [21,22]. This tool evaluates 10 measurement properties. Each item is rated on four levels: inadequate (I), doubtful (D), adequate (A), and very good (V). The lowest rating in a section will determine the overall rating for that property [14].

Each instrument will then be classified using the updated three-point scale for good measurement properties: sufficient (+), insufficient (-), or indeterminate (?) [14,21,22].

Content analysis of instrument items and linkage to the ICF

The content of the included instruments will be extracted, analyzed, and linked to the International Classification of Functioning, Disability, and Health (ICF). Two independent reviewers (JABA, ATNSFF) will extract the content and subsequently link it to the ICF according to standardized linking rules [23–26]. In case of discrepancies between reviewers, a third reviewer (LPG) will be consulted.

Data synthesis

A structured narrative synthesis of the included studies’ results will be developed. If a validation study of the same instrument for different populations exists, its measurement properties results will be considered as a single instrument, but specific characteristics of each version will be discussed. This combination of results will provide the overall evidence for the instrument.

Additionally, the narrative synthesis will be conducted according to the following steps [27]: 1) grouping studies by construct and measurement properties assessed; 2) describing the methodological quality of each study based on the COSMIN Risk of Bias checklist; 3) summarizing the results for each measurement property, including consistency across studies; and 4) drawing overall conclusions for each measurement property per instrument, in accordance to the COSMIN and GRADE recommendations.

Thus, two reviewers (JABA, LPG) will assess and summarize the results in groups according to the criteria for good measurement properties. The 10 measurement properties will be rated as sufficient (+), insufficient (-), inconsistent (±), or indeterminate (?). The final rating for a measurement property will correspond to its lowest rating [14,22]. A third reviewer (ATSNFF) will be consulted if necessary.

Instruments will also be grouped into the following categories: 1) General disease management; 2) Management of symptoms and complications; 3) Psychosocial impact management; 4) Lifestyle management (nutrition, smoking, physical activity, and exercise); 5) Treatment and medication management; 6) Empowerment tools (self-efficacy, self-care); 7) Disease knowledge; 8) Well-being and quality of life management; 9) Health beliefs and perceptions; 10) Obstacles and problem-solving management. This categorization will help readers identify instruments according to their relevant domains.

Certainty of evidence and instrument recommendation

To determine the certainty of evidence, two reviewers (JABA, ATSNFF) will apply a modified approach of the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) recommended by COSMIN [14]. The classification will be based on result inconsistency, sample imprecision, and indirectness, which refers to the applicability of results to the population. Instruments will be categorized into four levels of evidence quality: high, moderate, low, or very low. If disagreement arises between the two reviewers, a third reviewer (LPG) will conduct a review.

For instrument recommendations, the COSMIN guideline will be considered [14,16]. Each instrument will be classified and justified into one of three categories: (A) The instrument is recommended for use, and the results are reliable; (B) The instrument may be recommended but requires further research to assess its quality; (C) The instrument should not be recommended. Additionally, suggestions will be provided based on feasibility considerations.

Ethics and dissemination

This study does not require ethical committee approval, as it is based on published data. The results of this systematic review will be disseminated through publication in peer-reviewed journals and presentations at scientific conferences.

Discussion

Study protocols on systematic reviews help prevent arbitrary decisions during study eligibility and data extraction, reducing bias risks and ensuring reliable results [28,29].

In this way, this protocol aims to ensure the methodology and reliability of the systematic review of self-management instruments for individuals with T2DM.

Although a systematic review of self-management instruments for individuals with diabetes already exists [13], it is limited to specific diabetes instruments. Moreover, it does not include instruments developed and validated for chronic diseases (including T2DM) and is restricted to English and Mandarin-language instruments. The proposed review protocol has significant strengths, including instruments in multiple languages and a content analysis of instrument items linked to the ICF. Such linkage is essential, as the ICF provides a standardized global language for functionality and rehabilitation.

Although the protocol is methodologically adequate for the construction of a systematic review, some limitations may be found. One of them is the heterogeneity of self-management instruments, since we have a vast number of specific and generic tools for T2DM. To minimize this limitation, the instruments will be grouped and categorized into 10 groups. This categorization will help the authors in the review construction and the readers to identify instruments according to their relevant domains.

Besides the limitations, the authors believe the review will be able to provide a comprehensive overview of the instruments available for this population in different contexts, their measurement properties and content regarding the ICF. Consequently, we believe that the use of appropriate instruments may improve clinical and functional assessment which contributes to better treatment choices and rehabilitation programs.

Upon completing the review, we aim to provide a summarized and critically evaluated compilation of self-management instruments for individuals with T2DM. This document will guide researchers and healthcare professionals in selecting the most suitable instrument based on its measurement properties and relevance to their target population.

Conclusion

In conclusion, this review will fill in an important gap in the literature by synthesizing all self-management tools for individuals with T2DM. The expected results will contribute not only to future research but will also have clinical implications, such as better assessment and interventions planning in the care of individuals with T2DM.

Supporting information

S1 File. Search Strategies.

(DOCX)

pone.0330448.s001.docx (15.9KB, docx)
S2 File. Table_PRISMA-P 2015 Checklist.

(DOCX)

pone.0330448.s002.docx (27.9KB, docx)

Data Availability

All relevant data will be available within the manuscript and its Supporting information files when the study is completed and published.

Funding Statement

This study was partly financed by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES). Finance Code 001. This funding source had no role in the preparation or decision of the manuscript. There was no additional external funding received for this study.

References

  • 1.Magliano DJ, Boyko EJ. IDF Diabetes Atlas 10th edition scientific committee. Brussels; 2021. [Google Scholar]
  • 2.Sun H, Saeedi P, Karuranga S, Pinkepank M, Ogurtsova K, Duncan BB, et al. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022;183:109119. doi: 10.1016/j.diabres.2021.109119 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 3.Izzo A, Massimino E, Riccardi G, Della Pepa G. A Narrative Review on Sarcopenia in Type 2 Diabetes Mellitus: Prevalence and Associated Factors. Nutrients. 2021;13(1):183. doi: 10.3390/nu13010183 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 4.Cepeda Marte JL, Ruiz-Matuk C, Mota M, Pérez S, Recio N, Hernández D, et al. Quality of life and metabolic control in type 2 diabetes mellitus diagnosed individuals. Diabetes Metab Syndr. 2019;13(5):2827–32. doi: 10.1016/j.dsx.2019.07.062 [DOI] [PubMed] [Google Scholar]
  • 5.Bingham CO, Noonan VK, Auger C, Feldman DE, Ahmed S, Barlett SJ. Montreal Accord on Patient-Reported Outcomes Use Series – Paper 4: Patient Reported Outcomes (PRO) Can Inform Clinical Decision-Making in Chronic Care. Physiology & Behavior. 2017;176:139–48. doi: 10.1002/hep.30150 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 6.American Diabetes Association. 12. Older Adults: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020;43(Suppl 1):S152–62. doi: 10.2337/dc20-S012 [DOI] [PubMed] [Google Scholar]
  • 7.Emery KA, Robins J, Salyer J, Thurby-Hay L, Djira G. Type 2 Diabetes Self-Management Variables and Predictors. Clin Nurs Res. 2022;31(7):1250–62. doi: 10.1177/10547738211067322 [DOI] [PubMed] [Google Scholar]
  • 8.Chen J, Luo W-X, Yang X-F, Xiao J-L, Zhan B-X, Liu Y, et al. Self-management theories, models and frameworks in patients with chronic heart failure: A scoping review. Nurs Open. 2024;11(1):e2066. doi: 10.1002/nop2.2066 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 9.Adam L, O’Connor C, Garcia AC. Evaluating the Impact of Diabetes Self-Management Education Methods on Knowledge, Attitudes and Behaviours of Adult Patients With Type 2 Diabetes Mellitus. Can J Diabetes. 2018;42(5):470-477.e2. doi: 10.1016/j.jcjd.2017.11.003 [DOI] [PubMed] [Google Scholar]
  • 10.Powers MA, Bardsley JK, Cypress M, Funnell MM, Harms D, Hess-Fischl A, et al. Diabetes Self-management Education and Support in Adults With Type 2 Diabetes: A Consensus Report of the American Diabetes Association, the Association of Diabetes Care & Education Specialists, the Academy of Nutrition and Dietetics, the American Academy of Family Physicians, the American Academy of PAs, the American Association of Nurse Practitioners, and the American Pharmacists Association. Diabetes Care. 2020;43(7):1636–49. doi: 10.2337/dci20-0023 [DOI] [PubMed] [Google Scholar]
  • 11.Skovlund SE, Lichtenberg TH, Hessler D, Ejskjaer N. Can the Routine Use of Patient-Reported Outcome Measures Improve the Delivery of Person-Centered Diabetes Care? A Review of Recent Developments and a Case Study. Curr Diab Rep. 2019;19(9):84. doi: 10.1007/s11892-019-1190-x [DOI] [PubMed] [Google Scholar]
  • 12.Langendoen-Gort M, Groeneveld L, Prinsen CAC, Beulens JW, Elders PJM, Halperin I, et al. Patient-reported outcome measures for assessing health-related quality of life in people with type 2 diabetes: A systematic review. Rev Endocr Metab Disord. 2022;23(5):931–77. doi: 10.1007/s11154-022-09734-9 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 13.Jiang T, Li A, Zhang M, Zhou Z, Wang L, Zhang X, et al. Measuring Self-management Among People with Diabetes Mellitus: A Systematic Review of Patient-Reported Diabetes-Specific Instruments in English and Chinese. Adv Ther. 2023;40(3):769–813. doi: 10.1007/s12325-022-02361-5 [DOI] [PubMed] [Google Scholar]
  • 14.Mokkink LB, Elsman EBM, Terwee CB. COSMIN guideline for systematic reviews of patient-reported outcome measures version 2.0. Qual Life Res. 2024;33(11):2929–39. doi: 10.1007/s11136-024-03761-6 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 15.Shamseer L, Moher D, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015;350:g7647. doi: 10.1136/bmj.g7647 [DOI] [PubMed] [Google Scholar]
  • 16.Elsman EBM, Mokkink LB, Terwee CB, Beaton D, Gagnier JJ, Tricco AC, et al. Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024. Qual Life Res. 2024;33(8):2029–46. doi: 10.1007/s11136-024-03634-y [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 17.Terwee CB, Jansma EP, Riphagen II, de Vet HCW. Development of a methodological PubMed search filter for finding studies on measurement properties of measurement instruments. Qual Life Res. 2009;18(8):1115–23. doi: 10.1007/s11136-009-9528-5 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 18.Elston DM. Mendeley. J Am Acad Dermatol. 2019;81(5):1071. doi: 10.1016/j.jaad.2019.06.1291 [DOI] [PubMed] [Google Scholar]
  • 19.Ouzzani M, Hammady H, Fedorowicz Z, Elmagarmid A. Rayyan-a web and mobile app for systematic reviews. Syst Rev. 2016;5(1):210. doi: 10.1186/s13643-016-0384-4 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 20.Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: An updated guideline for reporting systematic reviews. J Clin Epidemiol. 2021;134:178–89. doi: 10.1016/j.jclinepi.2021.03.001 [DOI] [PubMed] [Google Scholar]
  • 21.Mokkink LB, de Vet HCW, Prinsen CAC, Patrick DL, Alonso J, Bouter LM, et al. COSMIN Risk of Bias checklist for systematic reviews of Patient-Reported Outcome Measures. Qual Life Res. 2018;27(5):1171–9. doi: 10.1007/s11136-017-1765-4 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 22.Mokkink LB, Boers M, van der Vleuten CPM, Bouter LM, Alonso J, Patrick DL, et al. COSMIN Risk of Bias tool to assess the quality of studies on reliability or measurement error of outcome measurement instruments: a Delphi study. BMC Med Res Methodol. 2020;20(1):293. doi: 10.1186/s12874-020-01179-5 [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 23.Hennaert S, Decuman S, Désiron H, Braeckman L, De Baets S, Van de Velde D. IMBA-ICF linking by integrating consensus methods: How group consensus of experts can contribute to in-depth linking of instruments to the ICF. Work. 2023;75(2):479–93. doi: 10.3233/WOR-210256 [DOI] [PubMed] [Google Scholar]
  • 24.Cieza A, Fayed N, Bickenbach J, Prodinger B. Refinements of the ICF Linking Rules to strengthen their potential for establishing comparability of health information. Disabil Rehabil. 2019;41(5):574–83. doi: 10.3109/09638288.2016.1145258 [DOI] [PubMed] [Google Scholar]
  • 25.Cieza A, Geyh S, Chatterji S, Kostanjsek N, Ustün B, Stucki G. ICF linking rules: an update based on lessons learned. J Rehabil Med. 2005;37(4):212–8. doi: 10.1080/16501970510040263 [DOI] [PubMed] [Google Scholar]
  • 26.Cieza A, Brockow T, Ewert T, Amman E, Kollerits B, Chatterji S, et al. Linking Health-Status Measurements to the International Classification of Functioning, Disability and Health. Journal of Rehabilitation Medicine. 2002;34(5):205–10. doi: 10.1080/165019702760279189 [DOI] [PubMed] [Google Scholar]
  • 27.Popay J, Roberts H, Sowden A, Petticrew M, Arai L, Rodgers M, et al. Guidance on the conduct of narrative synthesis in systematic reviews: A product from the ESRC Methods Programme. Lancaster: Institute for Health Research, Lancaster University; 2006. Available from: https://www.lancaster.ac.uk/media/lancaster-university/content-assets/documents/fhm/dhr/chir/NSsynthesisguidanceVersion1-April2006.pdf [Google Scholar]
  • 28.Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, et al. Cochrane Handbook for Systematic Reviews of Interventions, version 6.4 (updated August 2023); London, UK; Cochrane: 2023. [Google Scholar]
  • 29.Straus S, Moher D. Registering systematic reviews. CMAJ. 2010;182(1):13–4. doi: 10.1503/cmaj.081849 [DOI] [PMC free article] [PubMed] [Google Scholar]

Decision Letter 0

Manuela Mendonça Figueirêdo Coelho

28 May 2025

Dear Dr. Almeida,

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.

Please submit your revised manuscript by Jul 12 2025 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org . When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

  • A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.

  • A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.

  • An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols . Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols .

We look forward to receiving your revised manuscript.

Kind regards,

Manuela Mendonça Figueirêdo Coelho, Ph.D

Academic Editor

PLOS ONE

Journal Requirements:

When submitting your revision, we need you to address these additional requirements.

1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at

https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and

https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf

2. Thank you for stating in your Funding Statement: [This study was partly financed by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES). Fiance Code 001.].

Please provide an amended statement that declares *all* the funding or sources of support (whether external or internal to your organization) received during this study, as detailed online in our guide for authors at http://journals.plos.org/plosone/s/submit-now.  Please also include the statement “There was no additional external funding received for this study.” in your updated Funding Statement.

Please include your amended Funding Statement within your cover letter. We will change the online submission form on your behalf.

3. When completing the data availability statement of the submission form, you indicated that you will make your data available on acceptance. We strongly recommend all authors decide on a data sharing plan before acceptance, as the process can be lengthy and hold up publication timelines. Please note that, though access restrictions are acceptable now, your entire data will need to be made freely accessible if your manuscript is accepted for publication. This policy applies to all data except where public deposition would breach compliance with the protocol approved by your research ethics board. If you are unable to adhere to our open data policy, please kindly revise your statement to explain your reasoning and we will seek the editor's input on an exemption. Please be assured that, once you have provided your new statement, the assessment of your exemption will not hold up the peer review process.

[Note: HTML markup is below. Please do not edit.]

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?

Reviewer #1: Yes

Reviewer #2: Partly

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??>

Reviewer #1: Yes

Reviewer #2: Partly

Reviewer #3: Yes

**********

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

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: No

**********

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

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.

Reviewer #1: Thank you for the opportunity to contribute as a reviewer for this manuscript. I believe this review is important and valuable for advancing the field of T2DM care.

Abstract:

• It is a good, concise introduction. I think it would be better to be more clearly specifying the importance of self-management in relation to T2DM. The current version makes me understand that self-management is essential for disease control in general e.g. other chronic diseases (not specific to T2DM).

• The last sentence mentioning the use of ICF as a guide for data analysis which I think it might better fit under the “Methods” rather than “Context and Objectives”.

Introduction:

• The introduction is concise and easy to understand. However, in line 78-84, could you explain more the rationale for the need of this study according to the limitation of previous study (limitations regarding the inclusion of instruments for individuals with T2DM) and show how your review addresses this gap in knowledge.

Methods:

• Eligibility criteria: I am wondering why study designs such as cross-sectional studies and post-intervention analyses will be excluded, and what study design or research type will be included in this review (e.g. psychometric study)? I understand that this review is focussing on the study targeting the development and validation of instrument. In case of the paper regarding instrument development were reported in qualitative study, would it be included or excluded?

• Search strategy:

o Would the hand search of the reference lists (backward citation tracking) of all study mean those study met eligibility criteria, or all study retrieved from databases?

o I am thinking that forward citation tracking could also be beneficial for this review.

o Well-structured and thorough search terms (according to Supplementary File 1).

Certainty of evidence and instrument recommendation: The instrument recommendation within this review is very important and it will benefit research and practice in the field of T2DM.

Data synthesis:

• You mentioned that you will use a narrative synthesis. My thinking is that it would be good to give citation to make it clearer that which (version of) narrative synthesis you will be using. I also think it could be helpful for reader if you can provide a very short list/steps of narrative synthesis you are planning to do.

• It is a good point that you mentioned “If a validation study of the same instrument for different populations exists, its measurement properties results will be considered as a single instrument”. I noticed that one of your inclusion criteria is to include cultural adaptation study and that I would assume that you might include this kind of study which may have different language versions of instrument. It would be good to mention this as well.

Discussion: Clear justification to conduct this review and provided implication of the result of this review.

Reviewer #2: The manuscript is well-organized for a systematic review. The design follows recognized guidelines (COSMIN, PRISMA-P, and GRADE), reflecting good methodological rigor. However, there are areas that need improvement.

Abstract:

The objective is valid but could be rephrased to be clearer and more concrete. It would be ideal to add a final sentence summarizing what is expected to learn or contribute with this review. Additionally, including main results and conclusions is recommended.

Introduction:

The study’s justification is relevant, but it could be enriched with a brief overview of existing instruments for self-management in T2DM, as well as a critical reflection on previous reviews. This would help better position the manuscript’s added value.

Methods:

Search strategy: It would be useful to specify an estimated cutoff date for the bibliographic searches.

Contact with authors: Though mentioned later, it would be worth clarifying whether any contact was made with the authors of the reviewed articles and under what terms.

Results:

As a systematic review, it would be interesting to include the results of each search conducted across different databases, along with a brief outline of how the instruments will be classified.

Discussion:

The current section is somewhat generic. To strengthen it, we could delve deeper into the clinical and methodological implications of the study, anticipate potential limitations, and highlight how this review surpasses or complements previous work. Also, consider adding conclusions from the systematic review.

Finally, the basis for classifying the reviewed instruments and their analysis is unclear.

Reviewer #3: General assessment

This is a well-designed and timely protocol for a systematic review of self-management instruments in type 2 diabetes mellitus (T2DM), including an evaluation of their psychometric properties and linkage to the International Classification of Functioning, Disability and Health (ICF). The protocol is clearly structured, adheres to COSMIN guidelines, and proposes a comprehensive search strategy.

The inclusion of instrument databases such as PROMIS and PROQOLID is a notable strength, and the authors’ decision to assess content via ICF coding adds an innovative dimension. The protocol addresses an important topic with practical implications for clinical and research contexts, particularly in the identification of reliable and valid tools for assessing self-management in chronic illness.

Major points for clarification and improvement

1. Instruments with subscales for self-management

The exclusion of instruments measuring more than one construct is understandable; however, many validated instruments include distinct subscales for self-management. It is unclear whether such tools will be excluded altogether or considered based on the relevance of the subscale. The authors are encouraged to clarify this point, as it could impact the comprehensiveness of the review.

2. Choice of databases – rationale for excluding Cochrane and PEDro

The protocol omits both the Cochrane Library and PEDro, despite their relevance. Cochrane CENTRAL could include validation studies nested within trials, and PEDro may contain relevant psychometric evaluations in physiotherapy contexts. If these databases were deliberately excluded, the authors should briefly justify this decision.

3. Lack of explicit quality thresholds for instrument evaluation

While the authors refer to COSMIN and GRADE frameworks, there is no indication of the thresholds that will be used to assess whether an instrument demonstrates adequate reliability, validity, or responsiveness (e.g., Cronbach’s alpha ≥ 0.70). Including these definitions would strengthen the transparency and reproducibility of the review.

4. Handling of shortened or alternate versions of instruments

The protocol does not specify how the authors will deal with instruments that have short forms or multiple validated versions. Will these be reviewed separately, combined, or will only the original versions be considered? This decision should be made explicit.

5. Purpose and operationalization of ICF linkage

Although the plan to link instrument content to the ICF is an interesting innovation, the rationale and utility of this approach remain vague. Will this linkage be used to recommend instruments for specific clinical needs or populations? How will it inform the interpretation or selection of tools?

6. Language strategy in search procedures

The authors state that there will be no language restrictions, but the search strategies do not indicate how non-English terms will be incorporated. Will search terms be translated into other languages? Will translators be used to assess studies in different languages? Clarifying the technical implementation of this inclusive strategy would be helpful.

7. Lack of data sharing plan

The protocol does not specify whether and where the extracted data, quality assessments, or ICF mappings will be made available upon completion of the review. Including a plan for data sharing (e.g. via OSF, Figshare, or journal supplements) would align the protocol with open science practices and enhance its utility for researchers and practitioners.

Summary

This is a promising and well-constructed protocol with strong methodological foundations. Addressing the six points listed above would enhance its clarity, transparency, and completeness, ensuring the resulting review is as rigorous and comprehensive as possible.

**********

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: Yes:  Natthapon Inta

Reviewer #2: No

Reviewer #3: Yes:  Andrzej Śliwerski

**********

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/ . PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org . Please note that Supporting Information files do not need this step.

Attachment

Submitted filename: Reviewed Manuscript PONE-D-25-17107.docx

pone.0330448.s003.docx (17.3KB, docx)
PLoS One. 2025 Aug 21;20(8):e0330448. doi: 10.1371/journal.pone.0330448.r002

Author response to Decision Letter 1

14 Jul 2025

PONE-D-25-17107

Manuscript entitled: “Assessment of the Psychometric Properties of Self-Management Measurement Instruments for Individuals with Type 2 Diabetes: A Systematic Review Protocol”.

Dear editor and reviewers,

Thank you very much for your suggestion on our manuscript. We carefully considered your comments and revised the paper based on those comments and recommendations. We hope that these revisions improve the quality of the paper. You will find detailed responses to the comments made by you as well as those of the reviewers below.

Editor(s)' Comments

1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming.

Authors’ response: we appreciate your suggestion and ensure that we have checked all style requirements to meet the journal rules.

2. Thank you for stating in your Funding Statement: [This study was partly financed by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES). Fiance Code 001.]. Please provide an amended statement that declares *all* the funding or sources of support (whether external or internal to your organization) received during this study, as detailed online in our guide for authors at http://journals.plos.org/plosone/s/submit-now. Please also include the statement “There was no additional external funding received for this study.” in your updated Funding Statement. Please include your amended Funding Statement within your cover letter. We will change the online submission form on your behalf.

Authors’ response: We appreciate your concern. When we declare that “This study was partly financed by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES). Finance Code 001” we mean that Alexandre Almeida, as a post-graduation student, receives a scholarship that covers his PhD fees. There is no additional funding for this study as well as CAPES has no interference with the publications. It is worth highlighting that the statement is in accordance with the institution rules for publication. In this way we have included the following statement in the revised cover letter.

“This study was partly financed by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES). Finance Code 001. This funding source had no role in the preparation or decision of the manuscript . There was no additional external funding received for this study.”

3. When completing the data availability statement of the submission form, you indicated that you will make your data available on acceptance. We strongly recommend all authors decide on a data sharing plan before acceptance, as the process can be lengthy and hold up publication timelines. Please note that, though access restrictions are acceptable now, your entire data will need to be made freely accessible if your manuscript is accepted for publication. This policy applies to all data except where public deposition would breach compliance with the protocol approved by your research ethics board. If you are unable to adhere to our open data policy, please kindly revise your statement to explain your reasoning and we will seek the editor's input on an exemption. Please be assured that, once you have provided your new statement, the assessment of your exemption will not hold up the peer review process.

Authors’ response: we appreciate your concern and agree that if we had any data to share at this moment it would be worth having an established plan to make them public. However, as a systematic review protocol we have no data available yet as the search did not start. As soon as we start data collection we will make a data share plan. In this way we would like to apologize if we have made any mistake by filling in this submission section. Moreover, we kindly ask the editor to consider our explanation and disregard the information filled during the submission process.

Reviewer #1

Thank you for the opportunity to contribute as a reviewer for this manuscript. I believe this review is important and valuable for advancing the field of T2DM care.

Abstract:

Comment 1: It is a good, concise introduction. I think it would be better to be more clearly specifying the importance of self-management in relation to T2DM. The current version makes me understand that self-management is essential for disease control in general e.g. other chronic diseases (not specific to T2DM).

Authors’ response: We appreciate your suggestion and have added some other information regarding self-management for the T2DM population specifically. Such inclusion may be seen on page 02, lines 34-36.

Comment 2: The last sentence mentioning the use of ICF as a guide for data analysis which I think it might better fit under the “Methods” rather than “Context and Objectives”.

Authors’ response: We appreciate your concern with this information. However, one of the secondary aims of the study is to analyze the extracted content of the items and link them to the International Classification of Functioning, Disability, and Health (ICF). In this way, it is mentioned at the end of the introduction session where we describe the study aims (page 02, lines 36-39). Moreover, it is also mentioned in the methods session ( page 02, lines 51-54).

Introduction:

Comment 3: The introduction is concise and easy to understand. However, in line 78-84, could you explain more the rationale for the need of this study according to the limitation of previous study (limitations regarding the inclusion of instruments for individuals with T2DM) and show how your review addresses this gap in knowledge.

Authors’ response: We appreciate your suggestion. To make it clear we have better explained the limitations of the previous studies. Moreover, the methodology shows how we plan to fill these gaps as we are including generic instruments that included T2DM participants and have no language restrictions. Changes may be seen on page 03, lines 79-86.

Methods:

Comment 4: (Eligibility criteria) I am wondering why study designs such as cross-sectional studies and post-intervention analyses will be excluded, and what study design or research type will be included in this review (e.g. psychometric study)? I understand that this review is focussing on the study targeting the development and validation of instrument. In case of the paper regarding instrument development were reported in qualitative study, would it be included or excluded?

Authors’ response: We appreciate your concern with this information. However, the eligibility, inclusion and exclusion criteria were constructed following the COSMIN guidelines, which recommends the exclusion of studies that use instruments to compare outcomes (such as cohort studies, clinical trials, cross-sectional studies, post-intervention analyses, and case-control studies). Moreover, according to COSMIN* “Including them would require a more extensive and time-consuming search to find all studies on the mediation properties of any instrument in the population of interest, in addition to being unfeasible to read all studies, since some instruments used may not be reported in their abstracts.”

*Mokkink LB, Elsman EBM, Terwee CB. COSMIN guideline for systematic reviews of patient-reported outcome measures version 2.0. Qual Life Res. 2024 Nov;33(11):2929-2939. doi: 10.1007/s11136-024-03761-6. Epub 2024 Aug 28. PMID: 39198348; PMCID: PMC11541334.

Comment 5: (Search strategy) Would the hand search of the reference lists (backward citation tracking) of all study mean those study met eligibility criteria, or all study retrieved from databases? I am thinking that forward citation tracking could also be beneficial for this review. Well-structured and thorough search terms (according to Supplementary File 1).

Authors’ response: We appreciate your question. Hand search will be performed in reference lists of all primary studies, systematic reviews, and gray literature to include potential studies. Such information is shown in the search strategy session.

Comment 6: (Certainty of evidence and instrument recommendation) The instrument recommendation within this review is very important and it will benefit research and practice in the field of T2DM.

Authors’ response: We appreciate your comment and we also believe that we may bring some benefit to the practice in T2DM field.

Comment 7: (Data synthesis) You mentioned that you will use a narrative synthesis. My thinking is that it would be good to give citation to make it clearer that which (version of) narrative synthesis you will be using. I also think it could be helpful for reader if you can provide a very short list/steps of narrative synthesis you are planning to do.

Authors’ response: We appreciate your concern and agree that a list of steps may help the reader to understand such information. In this way, we have added on page 6, lines 190 to 195 of the revised manuscript the following paragraph:

“Additionally, the narrative synthesis will be conducted according to the following steps: 1) grouping studies by construct and measurement properties assessed; 2) describing the methodological quality of each study based on the COSMIN Risk of Bias checklist; 3) summarizing the results for each measurement property, including consistency across studies; and 4) drawing overall conclusions for each measurement property per instrument, in accordance to the COSMIN* and GRADE recommendations.”

Besides the narrative synthesis the measurement properties will be rated as s sufficient (+), insufficient (-), inconsistent (±), or indeterminate (?). The final rating of a measurement property will correspond to its lowest rating. The complete information is written on page 6, lines 196 to 200.

*Mokkink LB, Elsman EBM, Terwee CB. COSMIN guideline for systematic reviews of patient-reported outcome measures version 2.0. Qual Life Res. 2024 Nov;33(11):2929-2939. doi: 10.1007/s11136-024-03761-6. Epub 2024 Aug 28. PMID: 39198348; PMCID: PMC11541334.

Comment 8: It is a good point that you mentioned “If a validation study of the same instrument for different populations exists, its measurement properties results will be considered as a single instrument”. I noticed that one of your inclusion criteria is to include cultural adaptation study and that I would assume that you might include this kind of study which may have different language versions of instrument. It would be good to mention this as well.

Authors’ response: We appreciate your concern. Such information is explained in the data synthesis session as shown bellow and on page 06, lines 185-188.

"If a validation study of the same instrument for different populations exists, its measurement properties results will be considered as a single instrument, but specific characteristics of each version will be discussed"

Discussion:

Comment 9: Clear justification to conduct this review and provided implication of the result of this review.

Authors’ response: Thank you for your comment.

Reviewer #2

The manuscript is well-organized for a systematic review. The design follows recognized guidelines (COSMIN, PRISMA-P, and GRADE), reflecting good methodological rigor. However, there are areas that need improvement.

Abstract:

Comment 1: The objective is valid but could be rephrased to be clearer and more concrete. It would be ideal to add a final sentence summarizing what is expected to learn or contribute with this review. Additionally, including main results and conclusions is recommended.

Authors’ response: we appreciate your suggestion. The aim was rephrased as seen in page 02, lines 36-39 as well as a discussion topic was added to explain the contributions of the review (page 02, lines 54-56). On the other hand we were not able to add results and conclusions as this is a systematic review protocol study.

Introduction:

Comment 2: The study’s justification is relevant, but it could be enriched with a brief overview of existing instruments for self-management in T2DM, as well as a critical reflection on previous reviews. This would help better position the manuscript’s added value.

Authors’ response: Thank you for your observation. We have made the recommended adjustments, improving the justification in a reflective way on what is available in the literature and the gaps that still exist (page 03, lines 79-86).

Methods:

Comment 3: (Search strategy) It would be useful to specify an estimated cutoff date for the bibliographic searches.

Authors’ response: We appreciate your suggestion however, considering that there is no date restriction for the protocol we did not include a cutoff point for it. Moreover, the final review will bring this information on the results session.

Comment 4: (Contact with authors) Though mentioned later, it would be worth clarifying whether any contact was made with the authors of the reviewed articles and under what terms.

Authors’ response: We appreciate your suggestion. However, considering that this is the systematic review protocol we did not start the search strategy. In this way we do not know yet if we will need to contact any authors or if all documents will be available. In case we need to contact any authors we will send an email asking for the full document.

Results:

Comment 5: As a systematic review, it would be interesting to include the results of each search conducted across different databases, along with a brief outline of how the instruments will be classified.

Authors’ response: Thank you for your concern. This information cannot be included as we have not started the searches yet. Since this is only a review protocol, we are following the schedule made during its registration at PROSPERO (CRD42024605840). However, the systematic review, when published, will bring all information regarding your questioning.

Discussion:

Comment 6: The current section is somewhat generic. To strengthen it, we could delve deeper into the clinical and methodological implications of the study, anticipate potential limitations, and highlight how this review surpasses or complements previous work. Also, consider adding conclusions from the systematic review.

Authors’ response: We appreciate your suggestion. The discussion section was rewritten according to suggestions and included more detailed information regarding the benefits of the review and its limitations. Such changes may be seen on page 7, lines 232-233 and page 8, lines 234-259. Regarding the suggestion to add conclusions from the systematic review we highlight that this is the review protocol. In this way, we have not started data collection and analysis which does not allow us to make any conclusion. Moreover, this study is a systematic review protocol and similar studies already published present the topic of discussion superficially, since there is no data to be discussed and even no conclusion.

Comment 7: Finally, the basis for classifying the reviewed instruments and their analysis is unclear.

Authors’ response: We appreciate your concern. We highlight that each instrument will be classified and justified into one of three categories according to the COSMIN recommendations as well as their analysis. Based on this recommendation the categories are grouped as: (A) The instrument is recommended for use, and the results are reliable; (B) The instrument may be recommended but requires further research to assess its quality; (C) The instrument should not be recommended. We will also provide suggestions based on feasibility considerations. This information is shown on page 7, lines 219-224. The reference used to classify the categories is shown bellow:

Mokkink LB, Elsman EBM, Terwee CB. COSMIN guideline for systematic reviews of patient-reported outcome measures version 2.0. Qual Life Res. 2024 Nov;33(11):2929-2939. doi: 10.1007/s11136-024-03761-6. Epub 2024 Aug 28. PMID: 39198348; PMCID: PMC11541334.

Reviewer #3

General assessment:

Comment 1: This is a well-designed and timely protocol for a systematic review of self-management instruments in type 2 diabetes mellitus (T2DM), including an evaluation of their psychometric properties and linkage to the International Classification of Functioning, Disability and Health (ICF). The protocol is clearly structured, adheres to COSMIN guideli

Attachment

Submitted filename: Point_by_point_PLOS_T2DM.docx

pone.0330448.s005.docx (38.7KB, docx)

Decision Letter 1

Manuela Mendonça Figueirêdo Coelho

1 Aug 2025

Assessment of the Psychometric Properties of Self-Management Measurement Instruments for Individuals with Type 2 Diabetes: A Systematic Review Protocol

PONE-D-25-17107R1

Dear Dr. Almeida,

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. For questions related to billing, please contact billing support .

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,

Manuela Mendonça Figueirêdo Coelho, Ph.D

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Dear Authors,

We are pleased to inform you that your revised manuscript has been accepted for publication in PLOS ONE.

The revisions made in response to the editorial and peer reviewer comments have significantly improved the clarity, methodological rigor, and transparency of the protocol. We commend your team for the thoughtful and thorough responses provided, as well as for the scientific quality and relevance of the proposed systematic review.

Your study addresses a important gap in the literature by mapping and evaluating self-management instruments for individuals with type 2 diabetes mellitus, and we believe it will make a valuable contribution to both research and clinical practice.

Congratulations on the acceptance of your manuscript. You will receive a follow-up message from the production team regarding the final steps for publication.

Thank you for choosing PLOS ONE as the venue for your work.

Reviewers' comments:

Acceptance letter

Manuela Mendonça Figueirêdo Coelho

PONE-D-25-17107R1

PLOS ONE

Dear Dr. Almeida,

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team.

At this stage, our production department will prepare your paper for publication. This includes ensuring the following:

* All references, tables, and figures are properly cited

* All relevant supporting information is included in the manuscript submission,

* There are no issues that prevent the paper from being properly typeset

You will receive further instructions from the production team, including instructions on how to review your proof when it is ready. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few days to review your paper and let you know the next and final steps.

Lastly, if your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. 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.

You will receive an invoice from PLOS for your publication fee after your manuscript has reached the completed accept phase. If you receive an email requesting payment before acceptance or for any other service, this may be a phishing scheme. Learn how to identify phishing emails and protect your accounts at https://explore.plos.org/phishing.

If we can help with anything else, please email us at customercare@plos.org.

Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr. Manuela Mendonça Figueirêdo Coelho

Academic Editor

PLOS ONE

Associated Data

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

    Supplementary Materials

    S1 File. Search Strategies.

    (DOCX)

    pone.0330448.s001.docx (15.9KB, docx)
    S2 File. Table_PRISMA-P 2015 Checklist.

    (DOCX)

    pone.0330448.s002.docx (27.9KB, docx)
    Attachment

    Submitted filename: Reviewed Manuscript PONE-D-25-17107.docx

    pone.0330448.s003.docx (17.3KB, docx)
    Attachment

    Submitted filename: Point_by_point_PLOS_T2DM.docx

    pone.0330448.s005.docx (38.7KB, docx)

    Data Availability Statement

    All relevant data will be available within the manuscript and its Supporting information files when the study is completed and published.

    Articles from PLOS One are provided here courtesy of PLOS

    RESOURCES