Accidental Bowel Leakage Evaluation: A New Patient-Centered Validated Measure of Accidental Bowel Leakage Symptoms in Women.
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ABSTRACT:
SUBMITTER: Rogers RG
PROVIDER: S-EPMC7243684 | biostudies-literature | 2020 May
REPOSITORIES: biostudies-literature
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Accidental Bowel Leakage Evaluation: A New Patient-Centered Validated Measure of Accidental Bowel Leakage Symptoms in Women.
Rogers Rebecca G RG Sung Vivian W VW Lukacz Emily S ES Fairchild Pamela P Arya Lily A LA Barber Matthew D MD Markland Alayne D AD Siddiqui Nazema Y NY Bann Carla M CM
Diseases of the colon and rectum 20200501 5
<h4>Background</h4>Questionnaires assessing accidental bowel leakage lack important patient-centered symptoms.<h4>Objective</h4>We aimed to create a valid measure of accidental bowel leakage symptoms.<h4>Design</h4>We previously created a conceptual framework capturing patient-centered accidental bowel leakage symptoms. The framework included bowel leakage type, severity and bother, and ancillary bowel symptoms, including predictability, awareness, leakage control, emptying disorders, and discom ...[more]
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Project description:IntroductionTo determine whether percutaneous tibial nerve stimulation (PTNS) is superior to sham stimulation for the treatment of fecal incontinence (FI) in women refractory to first-line treatments.MethodsWomen aged 18 years or older with ≥3 months of moderate-to-severe FI that persisted after a 4-week run-in phase were randomized 2:1 (PTNS:sham stimulation) to 12 weekly 30-minute sessions in this multicenter, single-masked, controlled superiority trial. The primary outcome was change from baseline FI severity measured by St. Mark score after 12 weeks of treatment (range 0-24; minimal important difference, 3-5 points). The secondary outcomes included electronic bowel diary events and quality of life. The groups were compared using an adjusted general linear mixed model.ResultsOf 199 women who entered the run-in period, 166 (of 170 eligible) were randomized, (111 in PTNS group and 55 in sham group); the mean (SD) age was 63.6 (11.6) years; baseline St. Mark score was 17.4 (2.7); and recording was 6.6 (5.5) FI episodes per week. There was no difference in improvement from baseline in St. Mark scores in the PTNS group when compared with the sham group (-5.3 vs -3.9 points, adjusted difference [95% confidence interval] -1.3 [-2.8 to 0.2]). The groups did not differ in reduction in weekly FI episodes (-2.1 vs -1.9 episodes, adjusted difference [95% confidence interval] -0.26 [-1.85 to 1.33]). Condition-specific quality of life measures did not indicate a benefit of PTNS over sham stimulation. Serious adverse events occurred in 4% of each group.DiscussionAlthough symptom reduction after 12 weeks of PTNS met a threshold of clinical importance, it did not differ from sham stimulation. These data do not support the use of PTNS as conducted for the treatment of FI in women.
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Project description:Introduction and hypothesisIn randomized trials both percutaneous tibial nerve stimulation (PTNS) and sham result in clinically significant improvements in accidental bowel leakage (ABL). We aimed to identify subgroups who may preferentially benefit from PTNS in women enrolled in a multicenter randomized trial.MethodsThis planned secondary analysis explored factors associated with success for PTNS vs sham using various definitions: treatment responder using three cutoff points for St. Mark's score (≥3-, ≥4-, and ≥5-point reduction); Patient Global Impression of Improvement (PGI-I) of ≥ much better; and ≥50% reduction in fecal incontinence episodes (FIEs). Backward logistic regression models were generated using elements with significance of p<0.2 for each definition and interaction terms assessed differential effects of PTNS vs sham.ResultsOf 166 women randomized, 160 provided data for at least one success definition. Overall, success rates were 65% (102 out of 158), 57% (90 out of 158), and 46% (73 out of 158) for ≥3-, ≥4-, and ≥5-point St Mark's reduction respectively; 43% (68 out of 157) for PGI-I; and 48% (70 out of 145) for ≥50% FIEs. Of those providing data for all definitions of success, 77% (109 out of 142) met one success criterion, 43% (61 out of 142) two, and 29% (41 out of 142) all three success criteria. No reliable or consistent factors were associated with improved outcomes with PTNS over sham regardless of definition.ConclusionsDespite exploring diverse success outcomes, no subgroups of women with ABL differentially responded to PTNS over sham. Success results varied widely across subjective and objective definitions. Further investigation of ABL treatment success definitions that consistently and accurately capture patient symptom burden and improvement are needed.
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Project description:BackgroundBlepharitis is an ocular surface disease and chronic ophthalmic condition. This paper reports on the development of psychometric evaluation of a patient-reported measure of blepharitis symptoms.MethodsSelf-reports of 13 blepharitis symptoms collected in a Phase 3 multi-site, randomized, double-masked, 4-arm parallel group, clinical trial of 907 individuals with blepharitis (mean age = 62, range: 19-93; 57% female) were analyzed. Symptoms asked about were: eyes that itch; eyes that burn; eyelids feel heavy or puffy; feel like something is in your eye; dry eyes; gritty eyes; irritated eyes; eyes that tear or water; crusty eyes; flaking from your eyelids; eyelids that are stuck together; red eyes or eyelids; and debris like pieces of skin or dandruff in your eyes.ResultsCategorical factor analyses provided support for two multi-item symptom scales: Irritation (9 items, alpha = 0.88) and Debris (4 items, alpha = 0.85). Spearman-rank order correlations of the Irritation and Debris scales with the Ocular Surface Disease total score were 0.63 and 0.41, respectively (p's < 0.001). Rank-order correlations between ratings of clinicians and self-reports of puffy eyes (r = 0.07, p < .05), red eyes (r = 0.12, p < .001), debris (r = 0.03, p > 0.05), and irritation (r = 0.47, p < .001).ConclusionsThis study provides support for the psychometric properties and construct validity of the Irritation and Debris scales for assessing symptoms of blepharitis. The associations between the self-reports and clinician ratings of 4 symptoms indicate substantial unique information in the new self-reported symptom items.Trial registrationThe trial was registered at ClinicalTrials.gov under the registry number NCT01408082 .
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Project description:ObjectivesHigh-level evidence for second-line noninvasive treatments for fecal incontinence in women is limited. We present the rationale for and design of the NeuromOdulaTion for Accidental Bowel Leakage trial, a randomized controlled trial of percutaneous tibial nerve stimulation (PTNS) and validated sham stimulation in women with refractory accidental bowel leakage.MethodsThe rationale and goals for a 2-part study with a run-in phase, use of a generic pulse generator for PTNS and sham stimulation, masking, participant inclusion, primary and secondary outcome measures, and adverse event collection are described. A superiority design will be used to compare change from baseline in St. Mark's score after 12 weekly stimulation sessions between PTNS and sham. Responders to initial treatment (PTNS or sham) will be assigned to scheduled or "as needed" intervention for up to 1 year. Secondary outcome measures include incontinence episodes and other bowel events recorded in a 14-day electronic bowel diary, general and condition-specific quality of life instruments, adaptive behavior, global impression of improvement, symptom control, and sexual function.ResultsSample size calculations determined that 165 participants (110 PTNS and 55 sham) would provide 90% power to detect greater than or equal to 4-point difference between PTNS and sham in change from baseline in St. Mark's score at 12 weeks.ConclusionsThe methods for the NeuromOdulaTion for Accidental Bowel Leakage trial will provide high-level evidence of the effectiveness and optimal maintenance therapy schedule of a low-cost PTNS protocol in community-dwelling women seeking second-line intervention for refractory accidental bowel leakage.
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Project description:IntroductionFecal incontinence (FI) is characterized by both irregular and unpredictable bowel symptoms. An accurate history of symptoms is important for diagnosis and guiding management. Whether a patient's history of bowel symptoms is reliable or if there is recall bias is unknown.AimTo evaluate the accuracy of FI symptoms based on patient's recall compared with a prospective stool diary.MethodsFI (Rome IV) patients completed a bowel questionnaire that included leakage episodes and stool consistency. Subsequently they completed a one-week FI stool diary. Agreement and correlation between historical recall and stool diary were compared.ResultsOne hundred patients participated. On average they reported 12 bowel movements (BMs) and five FI episodes per week. Fifty-two percent had completed under-graduation, 33% high school and 15% postgraduation. Using recall, 23% of patients accurately reported the number of FI episodes, whereas 41% underestimated and 36% overestimated its prevalence compared to the FI diary. Similarly, the concordance for the number of BMs was 30%, urgency was 54%, amount of stool leakage was 16%, and stool consistency was 12.5%. The concordance for nocturnal FI events, use of pads and lack of stool awareness were 63%, 75%, and 66.6% respectively.ConclusionThere is poor concordance for key bowel symptoms including the number of FI episodes as reported by FI patients, suggesting significant recall bias. Thus, historical recall of chronic FI symptoms may be less accurate. A prospective stool diary could provide more accurate information for the evaluation of FI patients.
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Project description:ObjectivesMeasuring patient experience of gastrointestinal (GI) procedures is a key component of evaluation of quality of care. Current measures of patient experience within GI endoscopy are largely clinician derived and measured; however, these do not fully represent the experiences of patients themselves. It is important to measure the entirety of experience and not just experience directly during the procedure. We aimed to develop a patient-reported experience measure (PREM) for GI procedures.DesignPhase 1: semi-structured interviews were conducted in patients who had recently undergone GI endoscopy or CT colonography (CTC) (included as a comparator). Thematic analysis identified the aspects of experience important to patients. Phase 2: a question bank was developed from phase 1 findings, and iteratively refined through rounds of cognitive interviews with patients who had undergone GI procedures, resulting in a pilot PREM. Phase 3: patients who had attended for GI endoscopy or CTC were invited to complete the PREM. Psychometric properties were investigated. Phase 4 involved item reduction and refinement.ResultsPhase 1: interviews with 35 patients identified six overarching themes: anxiety, expectations, information & communication, embarrassment & dignity, choice & control and comfort. Phase 2: cognitive interviews refined questionnaire items and response options. Phase 3: the PREM was distributed to 1650 patients with 799 completing (48%). Psychometric properties were found to be robust. Phase 4: final questionnaire refined including 54 questions assessing patient experience across five temporal procedural stages.ConclusionThis manuscript gives an overview of the development and validation of the Newcastle ENDOPREM™, which assesses all aspects of the GI procedure experience from the patient perspective. It may be used to measure patient experience in clinical care and, in research, to compare patients' experiences of different endoscopic interventions.
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Project description: Not available
| S-EPMC7605445 | biostudies-literature
Project description:ObjectiveTo develop and test a measure of patient-centered care (PCC) culture in hospital-based perinatal care.Data sourcesData were obtained from US perinatal hospitals: one provided survey development data and 14 contributed data for survey testing.Study designWe used qualitative and quantitative methods to develop the mother-infant centered care (MICC) culture survey. Qualitative methods included observation, focus group, interviews, and expert consultations to adapt items from other settings and create new items capturing dimensions of PCC articulated by The Commonwealth Fund. We quantitatively assessed survey psychometric properties using reliability (Cronbach's α and Pearson correlation coefficients) and validity (exploratory and confirmatory factor analysis [CFA]) statistics, and refined the survey. After confirming aggregation suitability (ICCs), we calculated "MICC culture scores" at the individual, unit, and hospital level and assessed associations between scores and survey-collected, staff-reported outcomes to evaluate concurrent validity.Data collectionSurvey development included 12 site-visit observations, one semi-structured focus group (five participants), two semi-structured interviews, five cognitive interviews, and three expert consultations. Survey testing used online surveys administered to obstetric and neonatal unit staff (N = 316).Principal findingsUsing responses from 10 hospitals with ≥4 responses from both units (n = 240), the 20-item MICC culture survey demonstrated reliability (Cronbach's α = 0.95) while capturing all PCC dimensions (subscale Cronbach's α = 0.72-0.87). CFA showed validity through goodness-of-fit (overall chi-square = 214 [p-value = 0.012], SRMR = 0.056, RMSEA = 0.041, CFI = 0.97, and TLI = 0.96). Aggregation statistics (ICCs < 0.05) justify unit- and hospital-level aggregation. Demonstrating preliminary validity, individual-, unit-, and hospital-level MICC culture scores were associated with all outcomes (satisfaction with care provided, within-unit team effectiveness, and relational coordination [RC] between units) (p-values < 0.05), except for neonatal unit scores and RC (p-value = 0.11).ConclusionsThe MICC culture survey is a psychometrically sound measure of PCC culture for hospital-based perinatal care. Survey scores are associated with staff-reported outcomes. Future studies with patient outcomes will aid identification of improvement opportunities in perinatal care.
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