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Measuring Pelvic Floor Disorder Symptoms Using Patient-Reported Instruments

医学 盆底 生活质量(医疗保健) 医疗保健 人口 工作组 梅德林 家庭医学 物理疗法 护理部 外科 经济 法学 环境卫生 经济增长 计算机科学 计算机网络 政治学
作者
Liliana Bordeianou,Jennifer T. Anger,Marylise Boutros,Elisa H. Birnbaum,Joseph C. Carmichael,Kathleen A. Connell,Elise De,Anders Mellgren,Kyle Staller,Sarah A. Vogler,Milena M. Weinstein,Faysal A. Yafi,Tracy L. Hull
出处
期刊:Diseases of The Colon & Rectum [Ovid Technologies (Wolters Kluwer)]
卷期号:63 (1): 6-23 被引量:24
标识
DOI:10.1097/dcr.0000000000001529
摘要

The Pelvic Floor Disorders Consortium (PFDC) is a multidisciplinary organization of colorectal surgeons, urogynecologists, urologists, gynecologists, gastroenterologists, physiotherapists, and other advanced care practitioners. These practitioners, along with their respective societies, research foundations, and committees, are committed to enhancing the care of patients with pelvic floor disorders. The PFDC’s goal is to collaborate through clinical care and research to develop and evaluate educational programs, create clinical guidelines and algorithms, and promote overall quality of care in this unique population. The recommendations arising from this effort below represent the work product of the PFDC Working Group on Patient-Reported Outcomes. The objective of this workgroup, which included specialists from 12 countries, was to generate inclusive, rather than prescriptive, guidelines for all practitioners, irrespective of discipline, in the care and treatment of patients with pelvic floor disorders. STATEMENT OF THE PROBLEM The patient-reported outcome (PRO) is defined as a report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.1 Beginning with the introduction of the Karnofsky performance status scale in 1948,2 health-related quality of life (HRQoL) has become an increasingly important metric in the field of health care research. The growing prominence of HRQoL signifies a shift in focus from clinical outcomes related solely to survival and complications, to outcomes that include the patient’s perspective. Studies have shown that clinicians’ assessments of outcomes that matter often differ significantly from outcomes reported by patients. A considerable disconnect can occur between what the observer deems important versus what the patient considers important in terms of symptom management and the balance between relief and quality of life.3,4 The importance of PROs is evident in the wide recognition they have received by major health care providers and organizations. For example, the US Food and Drug Administration enhanced its scrutiny of available instruments5 following the publication of guidelines for PRO instruments used as effectiveness end points in clinical trials.1 Likewise, the National Health Service (NHS) in the United Kingdom mandated funded providers to report PRO measures for certain elective surgical procedures. Finally, many clinicians now use PROs to follow their patients over time and between treatments to help guide patient care.6 To function effectively as a quality-of-care instrument, the PRO must be accurately communicated and compared. This is especially critical for surgical interventions. Compared to other areas of medicine, treating pelvic floor disorders relies heavily on patient-reported symptoms, and frequently, the outcomes cannot be measured, compared, or quantified by objective tests or imaging. Hence, to ensure clear communication between providers and researchers, validated instruments have been created to reliably measure patient-reported functional status. Additionally, these instruments must have reasonable sensitivity and specificity to detect changes in patient condition over time, as well as differences between patients and patient populations. Furthermore, to achieve optimal outcomes in patients with pelvic floor disorders, a consensus is required to identify the best available validated instruments for capturing patient-reported symptoms, such as fecal incontinence, urinary incontinence, constipation, lower urinary tract symptoms, and sexual dysfunction. In general, a common language is desirable because it fosters accurate interpretation and comparison of treatments and facilitates pooling of data for meta-analysis and systematic review. Unfortunately, the failure of many recent attempts to achieve data consolidation in this area are due to the lack of consensus among clinicians and researchers regarding which instrument(s) should be used and reported in research publications.7 This document describes the process the PFDC working group followed to reach consensus as to which of the many existing validated instruments should be recommended to health care providers, irrespective of discipline (ie, colorectal surgeon, urogynecologist, urologist, gastroenterologist, or physiotherapist). After reviewing all of the major existing instruments and generating a standardized list of those most accurate and practical to use, the working group created a common initial patient assessment measure for every clinical setting, regardless of which specialist saw the patient first. Ultimately, consensus was reached regarding the best tool for each condition. The agreed upon battery of recommended validated instruments was ultimately labeled IMPACT (Initial Measurement of Patient-Reported Pelvic Floor Complaints Tool). The panel concurred that, even though it may be possible to identify a better instrument for a given symptom (eg, fecal incontinence versus urinary incontinence), not having a standardized instrument was a hindrance to large-scale multidisciplinary collaboration in clinical and scientific research. It also hindered communication between experts about specific patients and the perceived severity of their condition. The members believed strongly that a simple consensus document, such as IMPACT, could remedy the situation and foster progress toward a common language for patient-reported pelvic floor disorder clinical outcomes. METHODOLOGY This document was created at the initiative of the Pelvic Floor Disorders Consortium (PFDC) Working Group on Patient Reported Outcomes. The PFDC is composed of clinicians with demonstrated expertise in the care and treatment of pelvic floor conditions. The Working Group on Patient-Reported Outcomes was created by enlisting Pelvic Floor Consortium volunteers. Invitation criteria included leadership in the field of pelvic floor disorders with academic scholarship and history of cross-disciplinary collaboration. Literature Search An organized search of MEDLINE, PubMed, EMBASE, and the Cochrane Database of Collected Reviews was performed on July 1, 2018, and repeated on September 1, 2018. Retrieved publications were limited to the English language, but no limits on year of publication were applied. The search terms also included “fecal incontinence, urinary incontinence, constipation, lower urinary tract symptoms in men and women, and sexual dysfunction in men and women.” The search strategies used “patient reported outcomes,” “validated instruments,” and “questionnaires” as primary search terms. Other terms included “fecal incontinence,” “constipation,” obstructed defecation syndrome,” “intestinal function,” “bowel function,” “gastrointestinal symptoms,” “sexual function in men,” “sexual function in women,” “urinary incontinence,” “lower urinary tract symptoms,” “bladder dysfunction,” and “quality of life.” Directed searches of the embedded references from the primary articles were also performed in certain circumstances. Thus, 3211 references were retrieved by the working groups, and most were excluded to arrive at 182 instruments. Criteria for inclusion were instruments that underwent score validation, scores that were commonly used in clinical practice, and scores that have been demonstrated to have ability to discriminate well by disease populations. Thus, from 182 articles, each workgroup arrived at 10 to 15 final articles selected for further detailed analysis. Preliminary Workgroup Considerations and Deliberations Six multidisciplinary workgroups were created, each assigned to investigate a specific symptom: fecal incontinence, constipation, urinary incontinence, lower urinary tract symptoms, male sexual function, and female sexual function. Each group evaluated the top 10 to 15 tools identified in the literature search, focusing on validity, reliability, sensitivity to change, number of questions and domains, degree of use in the literature, applicability to both sexes, and free access. The participants ranked tools by using consistent criteria to reach a >70% consensus regarding the top 3 to 4 instruments that warranted further in-depth consideration by the PFDC. In preliminary preparations and discussions, committee members considered instrument validation to be crucial. Workgroups also confirmed whether the instruments were studied for reliability. In addition, the workgroup members also assessed the number of Google Scholar citations for each instrument, which served as a rough estimated index of scholarly impact. Pelvic Floor Consortium Expert Meeting The Pelvic Floor Consortium Expert Meeting convened on October 13, 2018 in Chicago, Illinois. It included more than 100 international experts from 12 countries and included 5 subspecialties: colorectal surgery, gastroenterology, urogynecology, urology, and physiotherapy. The meeting was funded by the American Society of Colon and Rectal Surgery and the American Urogynecologic Society. These experts belong to numerous societies involved in treating pelvic floor disorders, including, but not limited to, the American Society of Colon and Rectal Surgery and the American Urogynecologic Society (AUGS). Formal auditors were present from the International Continence Society, the Society of Abdominal Radiology, and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU). The participants at the expert consensus meeting analyzed all of the proposed instruments, measuring each of the conditions reviewed in this statement, ultimately recommending instrument(s) for each set of complaints. Tools were added to the final consensus document if and when discussants reached consensus regarding the tool’s usefulness and practicality. Consensus was again defined as agreement by 70% or more of the participants. When consensus was not reached, the workgroups performed additional research and literature reviews to clarify additional questions raised. A subsequent committee meeting was held to conduct final voting on the instruments, while keeping the directives of the expert consensus panel discussions in mind. The final recommended list of previously validated instruments was called IMPACT (Initial Measurement of Patient-Reported Pelvic Floor Complaints Tool). The IMPACT Long Form is a combination of all the tools chosen by the experts in each category in their unaltered form. An IMPACT Short Form version was also created to avoid duplication of questions. Final Review Once the final combined IMPACT tool long form was voted on and the short form was created, the path leading to its development was documented and presented for review by the American Society of Colon and Rectal Surgeons (ASCRS) Pelvic Floor Disorders Steering Committee. This steering committee is directed to develop clinical practice recommendations on colorectal pelvic floor disorders based on best available evidence. The ASCRS Steering Committee edited the document and sent it to the ASCRS Executive Committee for final approval for publication. Similar reviews and endorsements were also given by the American Society of Urogynecology (AUGS) Publication Committee, the International Continence Society Board of Directors and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) Board of Directors. The document was also reviewed by the Executive Board of the Society of Gynecological Surgeons, who voted to support the document’s recommendations for female patients (could not comment on the male instruments because their members generally do not treat males). RECOMMENDATIONS I. Measurement of Fecal Incontinence Severity The consortium recommends the use of both the Cleveland Clinic Florida Incontinence Score (5 questions) and the St. Mark’s Incontinence Score (7 questions). The use of both tools will allow assessment of the severity of fecal incontinence, while also allowing discrimination of the impact of urgency and constipating medications on the ultimate severity of fecal incontinence. Total number of questions: 12 Nine colorectal surgeons and 3 urogynecologists participated as expert workgroup panelists. The initial instruments reviewed by the workgroup members are listed in Supplemental Table 1, https://links.lww.com/DCR/B58. Panelists agreed that instruments should generally have the greatest applicability to the pelvic floor disorders population across disciplines and exhibit the best combination of validity, comprehensiveness, and practicality. Instruments that rate the severity of fecal incontinence and rectal urgency are preferred because this often unpredictable symptom causes much distress to people with fecal incontinence (FI).8 Diagnostic/severity instruments were prioritized over quality-of-life instruments. The workgroup panelists reached >70% consensus that 4 instruments would be brought for in-depth discussion before the Pelvic Floor Consortium Expert Meeting: the Cleveland Clinic Florida Incontinence Scale (CCFIS), Fecal Incontinence Severity Index (FISI), the Fecal Incontinence and Constipation Assessment (FICA), and the St. Mark’s Incontinence Score (SMIS). These instruments were chosen over other instruments based on validity, ease of use, ability to assess change in symptoms, and recognition and familiarity across different specialties. In addition, the Fecal Incontinence Quality of Life scale (FIQOL) was selected as the preferred quality-of-life (QOL) instrument. Fecal Incontinence Severity Index is a tool that assesses severity of fecal incontinence using a 20-cell matrix table with 4 domains (leakage of gas, mucous, liquid stool, and solid stool).4,9 It has been used to evaluate the efficacy of treatments for fecal incontinence, and it is validated and reliable. It is a weighted summary score based on a combination of colorectal surgeon and patient results. It is a popular tool because it shows correlation with patient perception of symptoms related to incontinence. However, the FISI does not characterize urgency or the volume of leakage; scoring can be cumbersome and therefore difficult to complete in a clinical setting. The Fecal Incontinence and Constipation Assessment was recommended because it is the most comprehensive, validated instrument for evaluating the severity of fecal incontinence evaluated by the workgroup.10–13 It is the only instrument that captures the volume of stool leakage, which was deemed essential for characterizing the severity of FI by a State of the Science Conference organized by the National Institutes of Health.14 Thus, it captures the severity of fecal incontinence, fecal urgency, and constipation, in addition to quality-of-life measurement. Although the entire instrument comprises 98 items, which is too long for a clinical visit, the severity of fecal incontinence can be fully characterized and readily analyzed with 5 questions. The length of this instrument has limited its use in the literature. The CCFIS was published in 1993 and includes 5 questions pertaining to frequency of incontinence with different stool consistencies, use of a pad, and lifestyle alteration. Each question contributes equally to the severity score (score range 0–20).15 It was initially described as a clinical aid, but subsequent research has been conducted to validate it and to assess its reliability and sensitivity to change.16 The CCFIS allows for measurement of therapeutic success after intervention and is the most widely used instrument in the peer-reviewed literature (Google scholar citations 2504 as of September 13, 2018). It is also easily understood by patients and has been shown to have a high correlation to patients’ subjective perception of symptoms.17–19 The results can be gathered quickly during an office visit. This instrument fails to capture the symptom of fecal urgency, volume of leakage, or impact on quality of life. The SMIS is similar to CCIFS and incorporates the same 5 questions.16 In addition, this score also captures symptoms of urgency and quantifies the impact of constipating medications on the symptoms of incontinence, making it 7 questions in total. The SMIS defines rectal urgency as less than 15 minutes to reach the toilet. However, this is perhaps too long because, on average, healthy women reported they could defer defecation for 9 minutes.20 St. Mark’s Incontinence Score is validated and reliable. Similar to CCFIS it is used in numerous studies evaluating the impact of different treatments on fecal incontinence and the severity of incontinence in different patient populations (Google scholar with 906 citations as of August 14, 2018). The biggest strength of SMIS is the additional measurements captured (urgency and constipating medications) in comparison to CCFIS. However, these additional measures do make the tool slightly more difficult to use clinically. During the discussion at the PFDC meeting, there was more than 70% consensus that the final measure chosen needed to be brief to allow for consistent use. Consensus was also reached that the measurement of mucus incontinence was not essential because mucus drainage is commonly attributed to mucosal prolapse and enlarged hemorrhoids rather than a form of true bowel incontinence. Ultimately, these considerations led to the exclusion of FISI and FICA. The expert discussions also reached significant consensus that the final tool should provide a way of discerning the impact of urgency on the severity of incontinence. The SMIS offers this measure. However, a concern was raised that SMIS seems to paradoxically worsen when patients stop taking fiber supplementation. This weakness stopped SMIS from reaching 70% consensus as becoming the final recommended tool in isolation. The CCFIS had many supporters because it allowed for a clear and logical measurement of disease severity, but the lack of urgency measure stopped it from reaching the 70% consensus needed to become the final recommended tool in isolation. Given the impasse, the original expert workgroup used the information gained from the PFDC meeting to reevaluate the CCFIS and SMIS. This group reconvened and reached a >70% consensus that a combination of CCFIS and SMIS could be used to provide the highest level of quantifying symptoms of FI, impact of treatment, severity, quality of life, and practical ease of data collection in clinical practice, while sustaining the goal for multidisciplinary consensus. II. Measurement of Constipation Severity The consortium recommends the use of both the Patient Assessment of Constipation (12 questions) and Constipation Severity Instrument (16 questions) together. It was felt that use of both tools was needed to allow assessment of the severity of the various subsets of constipation (obstructed defecation syndrome, slow transit constipation, and irritable bowel syndrome) to allow full delineation and characterization of the full spectrum of this condition. Total number of questions: 28 Nine colorectal surgeons and 3 gastroenterologists participated as expert workgroup panelists. The initial instruments reviewed by the workgroup members are listed in Supplemental Table 2, https://links.lww.com/DCR/B59. Panelists agreed that instruments should generally have the greatest applicability to the pelvic floor disorders population across disciplines and exhibit the best combination of validity, comprehensiveness, and practicality. Diagnostic/severity instruments were prioritized over quality-of-life instruments. The workgroup panelists debated vigorously among a set of multiple excellent instruments, many of them highly quoted in the literature, and ultimately reached >70% consensus to bring 3 severity-measuring instruments forward before the larger Pelvic Floor Consortium Expert Meeting: Fecal Incontinence and Constipation Assessment (FICA),9 Patient Assessment of Constipation–Symptoms (PAC-SYM),21 and Patient-reported Outcomes Measurement Information System (PROMIS) constipation module.22 In addition, Patient Assessment of Constipation—Quality of Life23 was selected as the preferred QOL instrument. At the in-person Pelvic Floor Consortium Expert Meeting, the strengths and weaknesses of the instruments were presented to the larger group. The FICA (98 questions, 2 domains) was felt to be the most comprehensive of instruments with construct validity, content validity, and criterion validity5 (results compared to daily bowel diaries). Additionally, FICA was the only instrument to incorporate the Bristol Stool Scale, noted by panelists to be a useful surrogate for colonic transit testing, and also distinguishes between functional constipation and constipation-predominant irritable bowel syndrome.24 Although FICA includes a fecal incontinence assessment, the group found its complete length, 98 questions, to be unwieldy for multidisciplinary office use. Of these, 32 questions comprehensively characterize constipation. Additionally, severity is not measured and responsiveness to change has not been assessed. Although a condensed version was suggested, the group felt that the instrument was not validated in its component parts. The PROMIS constipation module (9 questions, no subscales) is the newest instrument available and was noted for its validation across multiple general GI and specialty practices with easy comparison to standardized, US controls via an easily interpretable “heatmap.” Important to a multidisciplinary group such as the PFDC, there is some experience differentiating urinary incontinence subtypes based on the constipation module alone.25 Concern was raised that abdominal pain and bloating, 2 symptoms commonly seen in this population, required different modules. A recent analysis demonstrated that the PROMIS constipation scale was not responsive to change.26 Finally, the PAC-SYM (12 questions, 3 domains) was found to be partly validated and used across multiple treatment sites and multiple populations with responsiveness over time and ability to distinguish between treatment responders and nonresponders. The gastroenterologists felt comfortable with this instrument, because it has been used in some clinical trials for chronic idiopathic constipation. However, the correlation between symptoms evaluated with the PAC-SYM instrument and daily diaries is weak, likely due to recall bias. Also, although panelists appreciated that symptoms could be divided into 3 domains (Rectal Symptoms, Stool Symptoms, and Abdominal Symptoms), there is no evidence (eg, comparison with objective features of pelvic floor dysfunction or colonic transit) to support these domains. Also, this instrument does not assess for the need for manual maneuvers to facilitate defecation, which they felt was an essential screening question in this population. Additionally, PAC-SYM was criticized for the lack of a threshold value or values with which to distinguish severe symptoms. Although the constipation working group presented the aforementioned 3 instruments to the larger PFDC, other members of the larger body felt that that the Constipation Severity Instrument (CSI)27 (ranked 4 in the panel discussion before the workgroup review) needed further consideration. They found that the CSI had been validated instrument against SF-36 (QOL) and PAC-SYM scores. Many PFDC members felt that the three domains assessed by the CSI (Obstructive Defecation, Colonic Inertia, and Pain) were useful for binning patients based on potential physiologic abnormalities. Others, however, argued that specific symptoms and the categories identified by the CSI have not been validated against physiologic abnormalities—particularly in regard to dyssynergic defecation.28 In light of the input from the wider PFDC expert group, the constipation working group ultimately reconvened and reached a >70% consensus that a combination of the PAC-SYM and CSI would provide the greatest breadth of information for all PFDC specialties with an eye still toward practicality. III. Measurement of Urinary Incontinence Severity The consortium recommends the use of the short form of the Urogenital Distress Inventory (UDI) in the final combined IMPACT tool to allow identification of both stress and overflow incontinence and its degree of bother to patients. Number of questions: 6. Two colorectal surgeons, 1 urologist, 5 urogynecologists, and 1 pelvic floor physiotherapist participated as expert workgroup panelists. The initial instruments reviewed by the workgroup members are listed in Supplemental Table 3, https://links.lww.com/DCR/B60. Panelists agreed that instruments should generally have the greatest applicability to the pelvic floor disorders population across disciplines and exhibit the best combination of validity, comprehensiveness, and practicality. Diagnostic/severity instruments were prioritized over quality- of-life instruments. The workgroup panelists reached >70% consensus that 3 instruments would be brought before the larger PFDC meeting: The chosen scores were the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI-SF),29 Urogenital Distress Inventory 6 questionnaire (UDI-6),30 and ICIQ Male/Female Lower Urinary Tract Symptom Questionnaires.31,32 These scores were unanimously chosen because they were each well validated, robust, heavily cited, easy-to-use, and free to reproduce. The scores that were eliminated were either focused primarily on urinary incontinence (UI) quality of life rather than UI symptom scoring, covered a range of symptoms other than UI, or were limited to specific types of UI. The committee presented their results to the members of the consortium in an in-person meeting. It was unanimously decided that the ICIQ Male/Female Lower Urinary Tract Symptom Questionnaires were better suited for the assessment of bladder dysfunction (a different workgroup). Thus, ICIQ-UI-SF and UDI-6 were discussed as the top 2 UI symptom scoring instruments. Both instruments were selected for their validity, sensitivity to change, brevity (4 and 6 questions, respectively), and scholarly use (2280 on October 1, 2018, and 1119 on September 30, 2018 google scholar citations, respectively). In addition, the ICIQ-UI-SF had many favorable characteristics including its suitability for both men and women, its inclusion of a symptom bother scale, and its assessment of the type of UI. Aspects of the UDI-6 that were highly favored included that it addressed a variety of UI symptoms (urine leakage, difficulty emptying, and pain), different types of UI, degree of symptom bother, and the inclusion of a summative score. Furthermore, the UDI-6 is a commonly used instrument in routine clinical work and research. Following the consensus meeting, the UI and bladder dysfunction steering committees took a final vote and the UDI-6 was chosen as the most suitable instrument for assessing UI symptoms for clinical and research purposes across specialties. The UDI-6 only contains 6 questions and covers the type of UI, symptoms associated with UI, severity of symptoms and symptom bother. Furthermore, the UDI-6 conveniently gives a summative score that has been demonstrated to be sensitive to change with treatment and correlates with quality-of-life indices. IV. Lower Urinary Tract Symptoms in Men and Women The consortium recommends tailoring the measurement of lower urinary tract function in patients by sex: a. In women, the consortium recommends the use of the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS). Number of questions: 25 b. In men, the consortium recommends the use of the International Prostate Symptoms Screening (IPSS). Number of questions: 8 Three colorectal surgeons, 3 urologists, and 2 urogynecologists participated as expert workgroup panelists. The initial instruments reviewed by the workgroup members are listed in Supplemental Table 4, https://links.lww.com/DCR/B61. The inclusion criteria for instruments were validation and reliability testing within the appropriate sexes. Questionnaires were then evaluated as to whether each tool assessed severity of symptoms vs quality-of-life measures. Priority was given to questionnaires that were free and accessible, could be easily administered, were well recognized across specialties, and could be applied to the general population. During this process, it became clear that many of the validated questionnaires for voiding dysfunction were aimed at specific populations, disproportionately studying men and patients with neurogenic bladder. The great variability in the instruments highlighted the significant role of sex-based differences and disease processes in the symptomatology of voiding dysfunction. Therefore, the questionnaires were evaluated in terms of whether they could be used to screen both sexes and applied to a general population. Also, many validated instruments did not screen for both severity of symptoms and QOL. Therefore, a usefulness score was devised to rank the ability of a questionnaire to screen these measures. These scores were evaluated if none, some, most, or all the questions could be used to assess severity of symptoms and QOL. A spreadsheet was compiled of the evaluations of each questionnaire from all panelists, and the usefulness scores were consistent in >90% of responses. These data were presented at the Pelvic Floor Consortium Expert Meeting to obtain input from the membership on how to best choose the tool most likely to be used by most members. The top selected questionnaires recommended by the participants at the expert meeting included the International Prostate Symptoms Screening (IPSS)33 and the ICIQ Female Lower Urinary Tract Symptoms.34 The experts also took another look at the UDI-6,35 which they previously voted as their instrument of choice for the measurement of urinary i
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