Recommendations for Self-Report Outcome Measures in Vulvodynia Clinical Trials

Background: Provoked vestibulodynia (PVD) is a prevalent and disabling condition in women that may be associated with reduced quality of life and impairment of physical functioning. Aim: To investigate whether women with PVD have different motor functions, posture and breathing patterns, and whether they perceive their physical health differently, compared with asymptomatic controls. Methods and Main Outcome Measure: The Standardized Mensendieck Test (SMT) and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) were used to assess differences between 35 women with PVD and 35 healthy controls. Results: There were no statistically significant differences in any of the 5 motor domains of the SMT between the women with PVD and those without PVD: standing posture, 4.0 (0.6) vs 5.0 (0.6); gait, 4.7 (0.6) vs 4.8 (0.6); movement, 4.8 (0.8) vs 5.1 (0.6); sitting posture, 4.7 (1.0) vs 4.9 (0.8); respiration, 4.7 (1.0) vs 4.7 (0.9). Women with PVD scored significantly lower in all domains on the SF-36 (adjusted Bonferroni P ¼ .002) except physical functioning. Clinical Implications: Given the lack of difference in the SF-36 physical functioning domain and in all 5 domains of the SMT between women with PVD and those without PVD, the value of interventions focusing on general physical function is unclear. Strengths & Limitations: A study strength is the use of an assessor-blinded case-control design, trained physiotherapists to conduct the tests, and valid and reliable outcome measures. A limitation is the homogeneity of the sample of young nulliparous women, which limits the generalizability of our findings to other study populations. Conclusion: Young nulliparous women with PVD did not score differently from a group of healthy controls on assessment of overall physical functioning or on standing posture, gait, movement, sitting posture, and respiration. However, the score for perception of general health was lower in the women with PVD compared with controls. I.

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“…20 The SF-36 is recommended for use in vulvodynia clinical trials as a selfreport outcome measure. 30…”

Section: Secondary Outcome: Sf-36mentioning

confidence: 99%

Motor Function and Perception of Health in Women with Provoked Vestibulodynia

Næss

Frawley

Bø

2019

The Journal of Sexual Medicine

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“…83 Indeed, alternative models, such as biopsychosocial models of vulvodynia, emphasize that improving functional capacity and reducing symptom-related distress are also essential markers of treatment efficacy. 8 , 84 Recent IMMPACT (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials) guidelines on vulvodynia urge researchers to consider emotional function, quality of life, and sexual well-being as core measurement domains in clinical trials for vulvodynia. 84 Several recent studies have pointed to other potentially important markers of treatment success, including reductions in sexual distress 29 and fear-avoidance variables (eg, fear of pain, pain catastrophizing, pain hypervigilance), 47 as well as increases in pain self-efficacy 85 and pain acceptance.…”

Section: Clinical Challenges and Solutions In Conducting Vulvodynia Rmentioning

confidence: 99%

“… 8 , 84 Recent IMMPACT (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials) guidelines on vulvodynia urge researchers to consider emotional function, quality of life, and sexual well-being as core measurement domains in clinical trials for vulvodynia. 84 Several recent studies have pointed to other potentially important markers of treatment success, including reductions in sexual distress 29 and fear-avoidance variables (eg, fear of pain, pain catastrophizing, pain hypervigilance), 47 as well as increases in pain self-efficacy 85 and pain acceptance. 48 Therefore, while pain and sexual function remain the primary presenting problems that treatments aim to address, 84 in future, researchers are encouraged to assess additional outcomes, as they may meaningfully capture the degree of improvement experienced by women undergoing treatment for vulvodynia.…”

Section: Clinical Challenges and Solutions In Conducting Vulvodynia Rmentioning

confidence: 99%

Vulvodynia: a consideration of clinical and methodological research challenges and recommended solutions

Corsini‐Munt¹,

Rancourt²,

Dubé³

et al. 2017

JPR

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Vulvodynia, an idiopathic chronic vulvar pain, is a prevalent genital pain condition that results in significant impairment to sexual, relational, and psychological functioning of affected women and their romantic partners. Despite its high prevalence, there remain gaps in knowledge and health care access for women coping with vulvodynia, given its varied clinical presentation and no widely accepted treatment protocol. The past several decades have seen important advancements in understanding vulvodynia and developing effective treatments; however, progress has been impeded due to clinical and methodological challenges in conducting research with this vulnerable population. This review presents a brief overview of vulvodynia correlates, consequences, etiology, and treatment, and then turns its attention to considering the clinical and methodological challenges that hinder vulvodynia research. Identifying these barriers alongside potential mitigating solutions is essential to developing empirically supported treatments for all women affected by vulvodynia, across all age and minority groups. Potential solutions will require researchers to broaden eligibility criteria, examine subgroups of women, and expand definitions of treatment outcomes, and may be best facilitated by more active collaboration among research groups and across relevant disciplines. Engagement in these solutions may contribute to more representative findings and the development and dissemination of empirically based treatment options for this complex pain condition.

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“…However, overall, the VAS and NRS scores corresponded and the authors concluded that the NRS, VAS, or verbal categorical rating scale all worked quite well (Hjermstad et al, 2011). However, there are advantages to using the NRS as it can be incorporated into physical examinations and can be used in distance assessment of pain, such as telephone interviews (Pukall, Bergeron, Brown, Bachmann, & Wesselmann, 2017).…”

Section: Introductionmentioning

confidence: 99%

Measurement tools and intensity of nipple pain among women with or without damaged nipples: A quantitative systematic review

Coca

Amir

Alves

et al. 2019

Journal of Advanced Nursing

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Aims To describe and evaluate pain scales used to measure nipple pain in breastfeeding women and to identify nipple pain intensity in women with or without nipple damage. Background Nipple pain is one of the most common reasons given for premature cessation of breastfeeding. However, there are no agreed tools to measure pain and no previous reviews have provided summary estimates of pain scores. Design Systematic review. Data sources Medline, CINAHL, Scopus, Web of Science, SciELO, and LILACS. Review methods We followed the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses. The guiding question was: How is nipple pain in breastfeeding women measured and how severe is it? We analysed articles published up to February 2018, excluded review articles and those that did not present the level of nipple pain or tools to estimate pain severity. Results A total of 1,023 articles were identified and 25 were included in the review after applying the exclusion criteria. The Numeric Rating Scale (nine studies) and Visual Analogue Scale (seven studies) were the most prevalent tools for measuring pain. Using a pain score between 0–10, women with nipple damage reported a weighted mean of 6.2 in the first week and 5.8 after that period; women without damage reported a weighted mean of 2.7. Conclusion Women with nipple damage consistently reported a higher level of pain than women without damage. To prevent premature cessation of breastfeeding, it is important to help new mothers avoid nipple damage.

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Recommendations for Self-Report Outcome Measures in Vulvodynia Clinical Trials

Abstract: Measures that are specific to vulvovaginal pain are ideal for adoption in PVD clinical trials, and many such measures currently exist that allow the relevant IMMPACT domains to be captured.

Cited by 53 publications

References 90 publications

Motor Function and Perception of Health in Women with Provoked Vestibulodynia

Motor Function and Perception of Health in Women with Provoked Vestibulodynia

Vulvodynia: a consideration of clinical and methodological research challenges and recommended solutions

Measurement tools and intensity of nipple pain among women with or without damaged nipples: A quantitative systematic review

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