Dataset Information

Gaining the patient perspective on pelvic floor disorders' surgical adverse events.

ABSTRACT: BACKGROUND:The Institute for Healthcare Improvement defines an adverse event as an unintended physical injury resulting from or contributed to by medical care that requires additional monitoring, treatment, or hospitalization or that results in death. The majority of research has focused on adverse events from the provider's perspective. OBJECTIVE:The objective of this qualitative study was to describe patient perceptions on adverse events following surgery for pelvic floor disorders. STUDY DESIGN:Women representing the following 3 separate surgical populations participated in focus groups: (1) preoperative (women <12 weeks prior to surgery); (2) short-term postoperative (women up to 12 weeks after surgery); and (3) long-term postoperative (women 1-5 years after surgery). Deidentified transcripts of audio recordings were coded and analyzed with NVivo 10 software to identify themes, concepts, and adverse events. Women were asked to rank patient-identified and surgeon-identified adverse events in order of perceived severity. RESULTS:Eighty-one women participated in 12 focus groups. Group demographics were similar between groups, and all groups shared similar perspectives regarding surgical expectations. Women commonly reported an unclear understanding of their surgery and categorized adverse events such as incontinence, constipation, nocturia, and lack of improvement in sexual function as very severe, ranking these comparably with intensive care unit admissions or other major surgical complications. Women also expressed a sense of personal failure and shame if symptoms recurred. CONCLUSION:Women consider functional outcomes such as incontinence, sexual dysfunction, and recurrence of symptoms as severe adverse events and rate them as similar in severity to intensive care unit admissions and death.

SUBMITTER: Dunivan GC

PROVIDER: S-EPMC6351201 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Gaining the patient perspective on pelvic floor disorders' surgical adverse events.

Dunivan Gena C GC Sussman Andrew L AL Jelovsek J Eric JE Sung Vivian V Andy Uduak U UU Ballard Alicia A Jakus-Waldman Sharon S Amundsen Cindy L CL Chermansky Christopher J CJ Bann Carla M CM Mazloomdoost Donna D Rogers Rebecca G RG

American journal of obstetrics and gynecology 20181026 2

<h4>Background</h4>The Institute for Healthcare Improvement defines an adverse event as an unintended physical injury resulting from or contributed to by medical care that requires additional monitoring, treatment, or hospitalization or that results in death. The majority of research has focused on adverse events from the provider's perspective.<h4>Objective</h4>The objective of this qualitative study was to describe patient perceptions on adverse events following surgery for pelvic floor disord ...[more]

PMID: 30612960

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Project description:ImportancePelvic floor disorders (eg, urinary incontinence), which affect approximately 25% of women in the United States, are associated with childbirth. However, little is known about the course and progression of pelvic floor disorders over time.ObjectiveTo describe the incidence of pelvic floor disorders after childbirth and identify maternal and obstetrical characteristics associated with patterns of incidence 1 to 2 decades after delivery.Design, setting, and participantsWomen were recruited from a community hospital for this cohort study 5 to 10 years after their first delivery and followed up annually for up to 9 years. Recruitment was based on mode of delivery; delivery groups were matched for age and years since first delivery. Of 4072 eligible women, 1528 enrolled between October 2008 and December 2013. Annual follow-up continued through April 2017.ExposuresParticipants were categorized into the following mode of delivery groups: cesarean birth (cesarean deliveries only), spontaneous vaginal birth (≥1 spontaneous vaginal delivery and no operative vaginal deliveries), or operative vaginal birth (≥1 operative vaginal delivery).Main outcomes and measuresStress urinary incontinence (SUI), overactive bladder (OAB), and anal incontinence (AI), defined using validated threshold scores from the Epidemiology of Prolapse and Incontinence Questionnaire, and pelvic organ prolapse (POP), measured using the Pelvic Organ Prolapse Quantification Examination. Cumulative incidences, by delivery group, were estimated using parametric methods. Hazard ratios, by exposure, were estimated using semiparametric models.ResultsAmong 1528 women (778 in the cesarean birth group, 565 in the spontaneous vaginal birth group, and 185 in the operative vaginal birth group), the median age at first delivery was 30.6 years, 1092 women (72%) were multiparous at enrollment (2887 total deliveries), and the median age at enrollment was 38.3 years. During a median follow-up of 5.1 years (7804 person-visits), there were 138 cases of SUI, 117 cases of OAB, 168 cases of AI, and 153 cases of POP. For spontaneous vaginal delivery (reference), the 15-year cumulative incidences of pelvic floor disorders after first delivery were as follows: SUI, 34.3% (95% CI, 29.9%-38.6%); OAB, 21.8% (95% CI, 17.8%-25.7%); AI, 30.6% (95% CI, 26.4%-34.9%), and POP, 30.0% (95% CI, 25.1%-34.9%). Compared with spontaneous vaginal delivery, cesarean delivery was associated with significantly lower hazard of SUI (adjusted hazard ratio [aHR], 0.46 [95% CI, 0.32-0.67]), OAB (aHR, 0.51 [95% CI, 0.34-0.76]), and POP (aHR, 0.28 [95% CI, 0.19-0.42]), while operative vaginal delivery was associated with significantly higher hazard of AI (aHR, 1.75 [95% CI, 1.14-2.68]) and POP (aHR, 1.88 [95% CI, 1.28-2.78]). Stratifying by delivery mode, the hazard ratios for POP, relative to a genital hiatus size less than or equal to 2.5 cm, were 3.0 (95% CI, 1.7-5.3) for a genital hiatus size of 3 cm and 9.0 (95% CI, 5.5-14.8) for a genital hiatus size greater than or equal to 3.5 cm.Conclusions and relevanceCompared with spontaneous vaginal delivery, cesarean delivery was associated with significantly lower hazard for stress urinary incontinence, overactive bladder, and pelvic organ prolapse, while operative vaginal delivery was associated with significantly higher hazard of anal incontinence and pelvic organ prolapse. A larger genital hiatus was associated with increased risk of pelvic organ prolapse independent of delivery mode.

Project description:IntroductionPelvic/acetabular fractures are associated with significant morbidity, mortality and cost to the society. We sought to utilize a national surgical database to assess the incidence and factors associated with prolonged length of stay (LOS), non-home discharge destination, 30-day adverse events and readmissions following surgical fixation of pelvic/acetabular fractures.Materials & methodsThe 2011-2016 ACS-NSQIP database files were queried using CPT codes (27215, 27217, 27218, 27226, 27227, 27228) for patients undergoing open reduction/internal fixation (ORIF) for pelvic/acetabular fractures. Patients undergoing additional procedures for associated fractures (vertebral fractures, distal radius/ulna fractures or femoral neck/hip fractures) were excluded from the analysis to ensure that a relevant population of patients with isolated pelvic/acetabular injuries were included in the analysis. A total of 572 patients were included in the final cohort. Severe adverse events (SAE) were defined as: death, ventilator use >48 h, unplanned intubation, stroke, deep venous thrombosis, pulmonary embolism, cardiac arrest, myocardial infarction, acute renal failure, sepsis, septic shock, re-operation, deep SSI and organ/space SSI. Minor adverse events (MAE) included - wound dehiscence, superficial SSI, urinary tract infection (UTI) and progressive renal insufficiency. An extended LOS was defined as >75th centile (>9days).ResultsFactors associated with AAE were partially dependent functional health status pre-operatively (p = 0.020), transfusion ≥1 unit of packed RBCs (p = 0.001), and ASA > II (p < 0.001). Experiencing a SAE was associated with congestive heart failure (CHF) pre-operatively [p = 0.005), total operative time >140 min (p = 0.034) and Hct <36 pre-operatively (p = 0.003). MAE was associated with transfusion≥1 unit of packed RBCs (p = 0.022) and ASA > II (p = 0.007). Patients with an ASA > II (p = 0.001), total operative time>140 min (p < 0.001) and Hct <36 (p = 0.006) were more likely to have a LOS >9 days. Male gender (p = 0.026), prior history of CHF (p = 0.024), LOS >9 days (p = 0.030) and >10% bodyweight loss in last 6 months before the procedure (p = 0.002) were predictors of 30-day mortality.ConclusionPatients with ASA grade > II, greater co-morbidity burden and prolonged operative times were likely to experience adverse events and have a longer length of stay. Surgeons can utilize this data to risk stratify patients so that appropriate pre-operative and post-operative medical optimization can take place.

Project description:BackgroundAn estimated 17,000 patients are treated annually in the UK with radical radiotherapy (RT) for pelvic cancer. New treatment approaches in RT have increased survivorship and changed the subjective toxicity profile for patients who experience acute and long-term pelvic-related adverse events (AE). Multi-disciplinary follow-up creates difficulty for monitoring and responding to these events during treatment and beyond. Originally developed for use in systemic oncology therapy eRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) is an online system for patients to report AEs from home. eRAPID enables patient data to be integrated into the electronic patient records for use in clinical practice, provides patient management advice for mild and moderate AE and advice to contact the hospital for severe AE. The system has now been developed for pelvic RT patients, and we aim to test the intervention in a pilot study with staff and patients to inform a future randomised controlled trial (RCT).MethodsEligible patients are those attending St James's University hospital cancer centre and The Christie Hospital Manchester undergoing pelvic radiotherapy+/-chemotherapy/hormonotherapy for prostate, lower gastrointestinal and gynaecological cancers. A prospective 1:1 randomised (intervention or usual care) parallel group design with repeated measures and mixed methods will be employed. We aim to recruit 168 patients following recommendations for sample size estimates for pilot studies. Participants using eRAPID will report AE (at least weekly) from home weekly for 6 weeks and 6 weeks post-treatment (12-week total) then at 18 and 24 weeks. Hospital staff will review eRAPID reports and use information during consultations. Notifications will be sent to the relevant clinical team when severe symptoms are reported. We will measure patient-reported outcomes using validated questionnaires (Functional Assessment in Cancer Therapy Scale-General (FACT-G), European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC-QLQ-C30), process of care impact (hospital records of patient contacts and admissions) and economic variables (EQ5D-5L, patient use of resources)). Staff and patient experiences will be explored via semi-structured interviews.DiscussionThe objectives are to establish feasibility, recruitment, integrity of the system and attrition rates, determine effect sizes and aid selection of the primary outcome measure for a future RCT. We will also refine the intervention by exploring staff and patient views. The overall goal of this complex intervention is to improve the safe delivery of cancer treatments, enhance patient care and standardise documentation of AE within the clinical datasets.Trial registrationClinicalTrials.gov NCT02747264.

Dataset Information

Gaining the patient perspective on pelvic floor disorders' surgical adverse events.

Publications

Gaining the patient perspective on pelvic floor disorders' surgical adverse events.

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