REVIEW PROTOCOL

Instruments with evidence of validity on male sexual dysfunction: scoping review protocol

Dayane Abreu Ribeiro1, André Carlos Santos Ferreira1, Cassia Regina Gontijo Gomes2, Cissa Azevedo3, Fábio da Costa Carbogim4, M. Graça Pereira5, Luciana Regina Ferreira da Mata1

1Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil

2Faculdade Pitágoras, Betim, MG, Brazil

3Universidade Federal de São João del-Rei, Divinopolis, MG, Brazil

4Universidade Federal de Juiz de Fora, Juiz de Fora, MG, Brazil

5Universidade do Minho, Braga, Portugal

ABSTRACT

Objective: to map instruments with evidence of validity that assess male sexual dysfunction. Method: a scoping review based on the methodology of the Joanna Briggs Institute, in conjunction with the PRISMA-ScR checklist. The search will be carried out in three stages. The main data sources include: Virtual Health Library, MEDLINE via PubMed, Cochrane Library, Scopus, Web of Science, Embase, and PsycInfo. In addition, additional sources such as OpenGrey and the Brazilian Digital Library of Theses and Dissertations will be used. The selection of studies will be done independently by two reviewers using the Rayyan software, and a third reviewer will resolve divergences. Data extraction will be conducted using a form created by the authors. This protocol will guide the scoping review in enumerating and mapping the results, which will be presented through a narrative discussion, tables, summaries, and flowcharts. This study is ongoing, and the protocol is registered with the Open Science Framework: https://osf.io/jdh78.

Descriptors: Physiological Sexual Dysfunctions; Male; Surveys and Questionnaires.

INTRODUCTION

Sexuality is a basic human need that involves multidimensional aspects: biological, psychological, social, cultural, and historical(1,2). It is an important predictor of health-related quality of life (QoL), influencing thoughts, attitudes, feelings, and social interactions and affecting physical and emotional health. The human sexual cycle consists of four phases, each with its neurophysiology: 1) desire, which is the interest in sexual activity; 2) arousal, referring to the sensation of sexual pleasure; 3) orgasm, characterized by muscle contractions and a feeling of relief; and 4) resolution, which is the feeling of well-being after muscle relaxation(3).

Sexual dysfunction (SD) is defined as any alteration or disturbance in an individual’s sexual response cycle, whether in the phase of desire, arousal, and/or orgasm, which results in an unsatisfactory and unrewarding sexual experience(2). Among the leading male DS are erectile dysfunction (ED), Peyronie’s disease (PD), ejaculatory disorders (e.g., premature and delayed ejaculation), and sexual desire problems(4).

A Polish study that assessed the prevalence of SD in men and women aged 18 to 70 found that, among the 1,054 male participants, 36.5% had some form of SD(5). Another study, carried out in Germany with 2,500 men, revealed that 30% had SD, 21% with ED, 7.2% with low libido, and 5.2% with premature ejaculation(6).

Male SD can affect men of all ages and is associated with adverse health conditions and various risk factors, such as age, sedentary lifestyle, smoking, excessive alcohol consumption, depression, and cardiovascular diseases. Clinical assessment is therefore essential to diagnose this condition(7). In this context, the importance of Patient-Reported Outcome Measures (PROMs) to aid clinical decision-making and better understand the impact of SD on individuals’ QoL is highlighted. These tools objectively measure subjective information and are helpful in research and clinical practice(8).

Various instruments are designed to assess phenomena in the health area based on different constructs. It is essential that these instruments are validated through psychometric analysis to guarantee validity, reliability, practicability, sensitivity, and responsiveness(9).

A preliminary search was carried out in December 2022 and updated on November 4, 2023, in the following databases: Virtual Health Library (VHL), MEDLINE (Medical Literature Analysis and Retrieval System Online) via Pubmed, Cochrane, Scopus, Web Of Science, Embase (Excerpta Medica Database) and Psycinfo (Psychological Information Database). The research indicated that, in the context of male SD, there are instruments that assess ED, sexual desire, and ejaculation time, among other components(10,11). However, no review studies were found that specifically addressed the topic of interest.

A study of 2,021 men validated the Colombian version of the International Index of Erectile Function (IIFE-5), an instrument consisting of five items in Likert format(11). The results showed that the IIFE-5 has adequate psychometric properties, confirmed the scale's one-dimensional factorization, and presented evidence of validity and reliability. The authors stress that instruments like this are essential for assessing and guiding the treatment of SD(11).

This justifies the relevance of this scoping review, which aims to map the instruments with evidence of validity that assess male SD. It is hoped that by using valid instruments, a detailed and individualized assessment of SD will be possible, allowing appropriate clinical decisions in line with patients' expectations and needs.

METHOD

This is a scoping review protocol. To guarantee the quality and rigor of this type of study, the guidelines of the Joanna Briggs Institute (JBI)(12), in conjunction with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses—Extension for Scoping Reviews (PRISMA-ScR)(13), will be considered. The protocol was registered on the Open Science Framework (OSF) platform and can be accessed at https:osf.io/jdh78.

Review question

The PCC (Population, Concept, and Context) mnemonic was used to formulate the guiding question of this review: “What instruments exist in the literature with evidence of validity to assess male SD?”

Inclusion criteria

Participants

Studies with men of any age that deal with the psychometric analysis of instruments to measure the construct of interest will be considered.

Concept

For the purposes of conceptualization, this review will include male SD diagnoses listed in the ICD-11, such as hypoactive sexual desire disorder, ED, anorgasmia, and ejaculatory disorders (premature and delayed)(14).

According to the Standards for Educational and Psychological Testing(15), the pentagonal model will be used to verify the validity of the instruments. The pentagonal model covers: test content, response process, internal structure, relationship with other variables, and test consequences. At least one of these criteria must be met.

Context

The study context is clinical health practice, including outpatient settings, hospitals, or any other setting related to DS care. Studies that use instruments only to evaluate clinical outcomes in intervention research or to evaluate the psychometric properties of different instruments will be excluded.

Type of evidence sources

Quantitative, mixed, experimental, quasi-experimental, observational, and qualitative validation and methodological studies will be considered. Conference abstracts, materials presented orally at events, editorials, systematic reviews, and narratives will be excluded.

Search strategy

According to the JBI, the search strategy consists of three stages: in the first stage, a limited search was carried out in the VHL and the MEDLINE database, using the descriptors: “Physiological Sexual Dysfunctions”, “Male”, “Validation Study”, “Surveys and Questionnaires”, and “Erectile Dysfunction”. Next, the keywords and indexing terms in the title and abstract of the retrieved articles used to identify studies were analyzed. In the second stage, a search will be carried out using all the identified keywords and indexing terms in the BVS, MEDLINE via PubMed, Cochrane Library, Scopus, Web of Science, Embase, and PsycInfo databases. A search of the gray literature will also be carried out through the OpenGrey and Brazilian Digital Library of Theses and Dissertations (BDBTD) databases. In the third stage, the researchers will manually screen the references of the studies selected in the review to identify potentially eligible studies. If necessary, the authors of the selected studies will be contacted via e-mail to obtain further information. The full description of the search strategy is shown in Figure 1. The strategy was developed by the reviewers in conjunction with a librarian from the Federal University of Minas Gerais (UFMG), with no time or language restrictions.

Figure 1 – Database search strategy. Belo Horizonte, MG, Brazil, 2024

Study selection

The identified studies will be exported to the online software Endnote Web (Clarivate Analytics, PA, USA) to store and correctly organize the references obtained in the search. Duplicates will be removed, and the data will be exported to the Rayyan software(16), in which two reviewers will assess the studies independently so that one reviewer will not have access to the decisions of the other. Disagreements will be resolved by a third reviewer. The initial selection will be based on reading the titles and abstracts, followed by reading the full text of the articles included. Both stages will be based on meeting the inclusion criteria of the study objective.

Data extraction

Data extraction will be done using a form drawn up by the reviewers based on the JBI manual(9) (Figure 2).

The form may be adjusted during the completion phase, with any changes recorded in the review report. Two reviewers will carry out the extraction independently, with subsequent comparisons. A third reviewer will analyze points of disagreement to decide whether or not to include the study.

Figure 2 – Data extraction tool. Belo Horizonte, MG, Brazil, 2024

Presentation of results

The results will be presented using charts, tables, summaries, flowcharts, and narrative discussion to provide an overview of the instruments that assess male SD, their validity evidence, and psychometric properties.

REFERENCES

1. Chen L, Shi GR, Huang DD, Li Y, Ma CC, Shi M, et al. Male sexual dysfunction: A review of literature on its pathological mechanisms, potential risk factors, and herbal drug intervention. Biomed Pharmacother. 2019;112:108585. https://doi.org/10.1016/j.biopha.2019.01.046

2. Nosrati F, Nikoobakht MR, Oskouie IM, Rahimdoost N, Inanloo H, Abolhassani M, et al. Does Significant Weight Loss After Bariatric Surgery Affect Sexual Function and Urinary Symptoms? An Iranian Study. Obes Surg. 2023;33(8):2509-2516. https://doi.org/10.1007/s11695-023-06717-w

3. Nicol A, Chung E. Male sexual dysfunction: Clinical diagnosis and management strategies for common sexual problems. Aust J Gen Pract. 2023;52(1-2):41-45. https://doi.org/10.31128/AJGP-09-22-6559

4. Anderson D, Laforge J, Ross MM, Vanlangendonck R, Hasoon J, Viswanath O, et al. Male sexual dysfunction. Health Psychol Res. 2022;10(3):37533. https://doi.org/10.52965/001c.37533

5. Lew-Starowicz Z, Czajkowska K. Prevalence of sexual dysfunctions and associated risk factors in Poland. Arch Med Sci. 2019;18(4):1031-1040. https://doi.org/10.5114/aoms.2019.86794

6. Herkommer K, Meissner VH, Dinkel A, Jahnen M, Schiele S, Kron M, et al. Prevalence, lifestyle, and risk factors of erectile dysfunction, premature ejaculation, and low libido in middle-aged men: first results of the Bavarian Men's Health-Study. Andrology. 2023;1-8. https://doi.org/10.1111/andr.13524

7. Calogero AE, Burgio G, Condorelli RA, Cannarella R, La Vignera S. Epidemiology and risk factors of lower urinary tract symptoms/benign prostatic hyperplasia and erectile dysfunction. Aging Male. 2019;22(1):12–19. https://doi.org/10.1080/13685538.2018.1434772

8. Churruca K, Pomare C, Ellis LA, Longa JC, Henderson SB, Murphy ED, et al. Patient-reported outcome measures (PROMs): A review of generic and condition-specific measures and a discussion of trends and issues. Health Expect. 2021;24(4):1015-1024. https://doi.org/10.1111/hex.13254

9. Nora CRD, Zoboli E, Vieira MM. Validation by experts: importance in translation and adaptation of instruments. Rev Gaúcha Enferm. 2017;38(3):e64851. http://dx.doi.org/10.1590/1983- 1447.2017.03.64851

10. Przydacz M, Golabek T, Dudek P, Chlosta P. The Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-15): translation, adaptation and validation of the Polish version for patients with multiple sclerosis and spinal cord injury. BMC Neurol. 2021;21(1):103. https://doi.org/10.1186/s12883-021-02132-9

11. Vallejo-Medina P, Saffon JP, Álvarez-Muelas A. Colombian Clinical Validation of the International Index of Erectile Function (IIEF-5). Sex Med. 2022;10(1):100461. https://doi.org/10.1016/j.esxm.2021.100461

12. Peters MDJ, Godfrey C, McInerney P, Munn Z, Tricco AC, Khalil, H. Chapter 11: Scoping Reviews (2020 version). In: Aromataris E, Munn Z, editors. JBI Manual for Evidence Synthesis [Internet]. Adelaide: JBI; 2020 [citado 2022 mai 23]. Available from: https://synthesismanual.jbi.global

13. Tricco AC, Lillie E, Zarin W, O'Brien KK, Colquhoun H, Levac D, et al. PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation. Ann Intern Med. 2018;169(7):467-473. http://dx.doi.org/10.7326/M18-0850

14. World Health Organization. ICD-11 for Mortality and Morbidity Statistics [Internet]. Geneva: WHO; 2021 [citado 2022 Mai 22]. Available from: https://icd.who.int/browse11/l-m/en#/http://id.who.int/icd/entity/16069046

15. American Educational Research Association; American Psychological Association; National Council on Measurement in Education. Standards for educational and psychological testing [internet]. Washington (DC): American Education Research Association; 2014 [citado 2022 Mai 22]. Available from:

https://www.testingstandards.net/uploads/7/6/6/4/76643089/standards_2014edition.pdf

16. Ouzzani M, Hammady H, Fedorowicz Z, Elmagarmid A. Rayyan-a web and mobile app for systematic reviews. Syst Rev. 2016;5(1):210. https://doi.org/10.1186/s13643-016-0384-4

Submission: 15-Dec-2023

Approved: 28-Jul-2024