Exame das funções sensoriais e musculares do assoalho pélvico (EFSMAP): desenvolvimento, confiabilidade e validação para mulheres com incontinência urinária.

Abstract

Introduction: Pelvic floor muscle functions (PFMF) are important targets for the physical therapy interventions for women with pelvic floor dysfunctions (PFD), including urinary incontinence (UI). Pelvic floor muscle training (PFMT) is recommended as first line treatment for those women, as pelvic floor muscles (PFM) are part of the continence mechanism and support pelvic organs. Nevertheless, to train muscle strength and endurance other muscle functions, such as ability to contract and coordination are mandatory. The examination of all PFMF would allow the identification of which are the relevant functions for which women. Then, it would be possible to set a dose specific physical therapy approach for the patient, expanding the range of women who would benefit from the the conservative treatment. Albeit there is a large number of studies about PFM in women, the variety of terms used to describe those functions, as well as the variation in their measurement methods prevents data gathering and the advance in scientific knowledge in the field. Also, it compromises communication among researchers, health care professionals and the women themselves. The development of an exam of the relevant PFMF for women with PFD, that presents clear, valid and reproducible conceptual and operational definitions will contribute to interprofissional communication, to scientific and service data gathering and to the prescription of a dose-specific rehabilitation program for each woman. Aims: The goal of this thesis was to develop, test reproducibility and validity of a pelvic floor muscle evaluation for women with PFD with the following specific aims: 1) to identify which are the most investigated PFMF in women and the adopted terminology regarding terms, conceptual and operational definitions; 2) to propose the use of a universal and standardized terminology based on International Classification of Functioning, Disability and Health (ICF) from World Health Organization (WHO); 3) to develop the PFMF exam based on information identified in aims 1 and 2 and test reproducibility of the exam; 4) to test construct validity of the exam for women with PFD. Methods: To answer those aims, this thesis is constituted of four studies. Study 1: Systematic literature review, in which three independent reviewers took part and retrieved observational studies investigating any PFMF of women with or without PFD, published in English, Spanish or Portuguese, from 2005 to 2017 in PUBMED, CINAHL, LILACS and SCIELO. The risk of bias was assessed by a questionnaire on quality of observational studies. Data on terminology was extracted as terms, conceptual and operational definitions of PFMF, and synthesized according to key- words, key-ideas, and key-operationalization respectively. All steps were carried by two independent researchers and disagreements were discusses with a third researcher. Study 3: Methodological study to develop and test the reproducibility of the Pelvic Floor Sensory and Muscle Function Exam (EFSMAP-Exame das Funções Sensoriais e Musculares do Assoalho Pélvico) proposed from the identification of the most relevant PFMF, from the adequate terminology used to describe those functions and from valid, reliable and accessible instruments to measure them. Those information emerged from studies 1 and 2. PFMF were evaluated by vaginal palpation and manometry (Peritron®). For interrater analysis, two raters evaluated participants in a 10 to 20 minute interval. Intrarater analysis was conducted by one rater in a one week interval. Main outcomes were sensorial functions: Proprioceptive (ICF code: b260) and Pain (b28018); muscle and movement functions: Tone (b7350) Control (contraction and relaxation) (b7608), Coordination (b7602), Involuntary movement reaction (cough) (b755), Power (b7300) and Endurance (duration and repetitions) (b7408). Percent agreement, Kappa (K) and linear weighted Kappa (Kw), limits of agreement and Intraclass Correlation Coefficient (ICC) were calculated. Study 4: Methodological study. The known groups method procedure was used to test construct validity of the EFSMAP by comparing a group of women with PFD, mostly UI with a non-IU. Two previously trained physical therapists examined women according to the EFSMAP. Sensitivity and specificity were calculated for categorical data. For ordinal and continuous variables, Receiver Operating Characteristic (ROC) curves were calculated and the cutoff points for those functions were set based on the highest sum of sensitivity and specificity. Results: Study 1 - Sixty-four studies were included in the systematic review. All studies presented terms and operational definitions of PFMF, but only 29.7% presented conceptual definitions of those terms. One hundred and ninety six different terms referred to PFMF. According to similarities in terminology, 161 PFMF could be grouped into 26, but the other 35 were left ungrouped. Therefore, a total of 61 PFMF with different terminology were identified in the literature. Study 2 - 93.8% of the terms used to describe the PFMF could be linked to six neuromusculoskeletal and movement-related functions, described in chapter 7 of ICF. Twelve functions (6.25%) were found to be not covered by the ICF. Percentage agreement in independent linking was 73.2%. The most investigated PFMF were, consecutively, Power of isolated muscles and muscle groups (25.6%), Involuntary movement reaction functions (21.9%), Endurance of muscle groups (17.2%), Control of simple voluntary movements (14.1%), Coordination of voluntary movements (9.9%) and Tone of isolated muscles and muscle groups (4.2%). There was a wide variation in instruments used to measure PFMF. Vaginal palpation was the only method employed to measure all six PFMF investigated. Vaginal manometry was the most used instrument to measure Power (40.9%), and the second most frequently used to measure Endurance (36.4%). Peritron® was the most used manometer (60% of the times to measure Power and 75% to measure Endurance). Study 3 - Data obtained in studies 1 and 2 allowed the identification of the most relevant PFMF to be investigated in women with and without UI, along with the most used and accessible instruments to measure them. Thereby, the Pelvic Floor Sensory and Muscle Function Exam - EFSMAP - emerged. Thirty women with PFD, mainly IU, and without UI took part to the reliability study, with mean age of 51.2 (14.7) years. Intra and interrater reproducibility indices of the EFSMAP were good to excellent (e.g.: Kw=0.67; 95%CI=0.40-0.94 for Tone; ICC=0.97; 95%CI=0.92-0.99 for Endurance-duration) for most functions. Reproducibility indexes for the functions Pain (presence and intensity) and Tone (right) were poor. Agreement was substantial for most PFMF measured. Study 4 - For the construct validity study, 182 women (91 in UI group, and 91 in non-UI), paired by age, volunteered. Median age was 50.9, 26-91 years and 46.0, 27-87years, respectively. Control (contraction and relaxation), Pain presence, and Coordination had excellent (95.6%) to good specificity indexes (above 70%), but low sensitivity (below 60%). Conversely, Involuntary movement reaction during cough had high sensitivity (82.56%), but low specificity (37.36%). Tone did not distinguish those groups. Strength and Endurance (duration) distinguished women with UI from those with no UI, with area under the ROC curve above 0.70. Cutoff values were 3 in Modified Oxford Scale, 45.9cmH2O in vaginal manometry for Strength; and 6.5 seconds in vaginal palpation for Endurance. Conclusion: A large variation in PFMF terminology was identified. Linking PFMF to ICF terminology was found to be feasible and valid towards a standardized and universal language based on terms and conceptual definitions anchored on a sound theoretical framework. This process allowed the organization of the EFSMAP, an exam fostered to evaluate sensory and muscle function of the pelvic floor for women with PFD. This exam was proved to be reproducible for women with PFD, mainly with UI complaints. To reach reproducibility, it is recommended that the conceptual and operational definitions be as clear as possible and that the raters be systematically trained. Also, the EFSMAP presented construct validity, as most tested functions distinguished women with UI from those without UI. The exam was more specific than sensitive for discriminative purposes. The cutoff values for Strength and Endurance may guide physical therapists to set treatment goals towards a more effective and lower cost therapeutic program for those women. Therefore, the use of the EFSMAP both in research and in clinical setting, can provide to the professionals who deal with women’s health field: a) a tool that adopts a clear, standardized and universal language on pelvic floor sensory and muscle functions and it is founded on a sound theoretical framework, fostering communication and advance in the field; b) a tool that allows a reliable and valid identification of sensory and muscle impairments in those functions that are relevant to be assessed in women with UI, and rehabilitated as well; c) a starting point to the development of a thorough physical therapy assessment focused on women’s functionality, rather than on the disease.