Faculty Scholarship

Objective:  To assess the efficacy and comparative effectiveness of surgical and nonsurgical treatments for fecal incontinence (FI) in adults. 

Data sources: Ovid MEDLINE®, Embase®, PEDro®, CINAHL®, AMED, and the Cochrane Central Register of Controlled Trials (CENTRAL); hand searches of systematic reviews. 

 Methods: Two investigators screened abstracts of identified references for eligibility (examined treatments in adults with FI published from 1980 to the present that had a control/comparator group; case series were included for surgical interventions). Full-text articles were reviewed to identify patient-reported outcomes (FI episodes, FI severity, quality of life, urgency, pain, other). We extracted data, assessed risk of bias of individual studies, and evaluated strength of evidence for each comparison and outcome.

 Results:  Sixty-three unique studies met inclusion criteria; an additional 53 surgical case series were examined for adverse effects. Enrolled adults were mostly female with mixed FI etiologies. Most randomized controlled trials (RCTs) were nonsurgical (n = 38); 13 examined pelvic floor muscle training (PFMT) and PFMT with biofeedback (PFMT-BF). Meta-analysis was not possible because numerous outcomes were used. Low-strength evidence suggests that dietary fiber (psyllium) decreases FI episodes (-2.5 per week) at 1 month; clonidine has no effect; and PFMT-BF with electrostimulation is no more effective than PFMT-BF for FI severity and the FI Quality of Life scale (FIQL) over 2 to 3 months. Low-strength evidence at 6 months suggests that dextranomer anal bulking injections are more effective than sham injections on the FIQL, the number of FI-free days, and the percent of adults with at least 50-percent reduction from baseline in FI episodes, but no more effective than PFMT-BF with or without electrostimulation on FI severity (PFMT-BF -5.4 vs. dextranomer -4.6 point Vaizey score improvements) and the FIQL, and no more effective than sham injection on FI severity (-2.5 vs. -1.7 point sham improvement in Cleveland Clinic FI score [CCFIS]) or FI episode frequency. Moderate-strength evidence suggests that Durasphere® (off label) bulking injections reduce FI severity up to 6 months (-4 to -5 points CCFIS), but gains diminish thereafter. Evidence was insufficient for all other surgical and nonsurgical comparisons. Surgical improvements varied. Noninvasive nonsurgical treatments had few minor adverse effects (AEs). Surgical treatments were associated with more frequent and more severe complications than nonsurgical interventions. AEs were most frequent for the artificial bowel sphincter (22–100% of adults). Surgical AEs ranged from minor to major (infection, bowel obstruction, perforation, fistula). Major surgical complications often required reoperation; fewer required permanent colostomy. Only 12 percent of RCTs were high quality.   

Conclusion: We found limited evidence to support any FI treatments beyond 3 to 6 months. Comparing the effectiveness of FI surgical and nonsurgical treatments is difficult because nonsurgical approaches generally precede surgery. Most current interventions show modest improvements in FI outcomes that meet minimal important differences (MIDs) in the short term, where MID is known. More invasive surgical procedures have substantial complications.

Background: No systematic review has examined the collective randomized and nonrandomized evidence for fecal incontinence treatment effectiveness across the range of surgical treatments.

Objective: The purpose of this study was to assess the efficacy, comparative effectiveness, and harms of surgical treatments for fecal incontinence in adults.

Data sources: Ovid MEDLINE, EMBASE, Physiotherapy Evidence Database, Cumulative Index to Nursing and Allied Health Literature, Allied and Complementary Medicine, and the Cochrane Central Register of Controlled Trials, as well as hand searches of systematic reviews, were used as data sources.

Study selection: Two investigators screened abstracts for eligibility (surgical treatment of fecal incontinence in adults, published 1980-2015, randomized controlled trial or observational study with comparator; case series were included for adverse effects). Full-text articles were reviewed for patient-reported outcomes. We extracted data, assessed study risk of bias, and evaluated strength of evidence for each treatment-outcome combination.

Interventions: Surgical treatments for fecal incontinence were included interventions.

Main outcome measures: Fecal incontinence episodes/severity, quality of life, urgency, and pain were measured.

Results: Twenty-two studies met inclusion criteria (13 randomized trials and 9 observational trials); 53 case series were included for harms. Most patients were middle-aged women with mixed FI etiologies. Intervention and outcome heterogeneity precluded meta-analysis. Evidence was insufficient for all of the surgical comparisons. Few studies examined the same comparisons; no studies were high quality. Functional improvements varied; some authors excluded those patients with complications or lost to follow-up from analyses. Complications ranged from minor to major (infection, bowel obstruction, perforation, and fistula) and were most frequent after the artificial bowel sphincter (22%-100%). Major surgical complications often required reoperation; few required permanent colostomy.

Limitations: Most evidence is intermediate term, with small patient samples and substantial methodologic limitations.

Conclusions: Evidence was insufficient to support clinical or policy decisions for any surgical treatments for fecal incontinence in adults. More invasive surgical procedures had substantial complications. The lack of compliance with study reporting standards is a modifiable impediment in the field. Future studies should focus on longer-term outcomes and attempt to identify subgroups of adults who might benefit from specific procedures.

There are substantial research knowledge gaps regarding orthopaedic outcomes after surgical procedures to treat hip fractures in vulnerable elderly patients. The article by Heng et al. serves to remind us that treating hip fractures must be done thoughtfully. Given the risks related to surgical hip fracture treatment, attention should be paid to treatment decisions for subgroups of high-risk patients. Not all older patients are equally likely to benefit from standard orthopaedic care. Some older adults are at high risk for inpatient hospital complications such as delirium, particularly those with prefracture cognitive impairment. Geriatric hip fractures are associated with high morbidity, mortality, and prolonged functional impairment. At least one-third of patients die within 1 year after a hip fracture and less than one-half ever regain their prefracture level of function. Given this trajectory, efforts such as cognitive screening and other measures of frailty can provide useful insights in planning treatment.

Objective. We conducted a systematic review to examine the long-term consequences of discontinuing disease-modifying treatment (DMT) for multiple sclerosis (MS) by examining the long-term benefits and harms, and the reasons for discontinuing treatment. We also examined the evidence for people’s values, beliefs, and preferences regarding discontinuing DMT.   

Methods. Two investigators screened abstracts and full texts of identified references for eligibility. Eligible studies included studies of over 3 years that examined Food and Drug Administration–approved DMTs compared with placebo, other active DMT, or no DMT for adults with clinically isolated syndrome or MS in outpatient settings for patient-centered outcomes. We excluded studies of mitoxantrone, since it has a maximum lifetime dosage. Timing was relaxed for women who were considering pregnancy or already pregnant or patients discontinuing natalizumab due to risk factor changes. We extracted data, assessed risk of bias of individual studies, and evaluated strength of the body of evidence for each comparison and outcome. We also evaluated, using Technical Brief methods, studies of any design that examined individuals’ attitudes, values, and preferences for discontinuing treatments and health states, or factors and processes patients with MS and clinicians use in shared decisionmaking. 

Results. We identified 27 unique studies with discontinuation information: 16 of these contained complete information to allow full analysis of long-term benefits and harms. Evidence was insufficient for long-term benefits of DMTs for secondary progressive MS patients and most outcomes for relapsing-remitting MS (RRMS) patients. Low-strength evidence suggests higher long-term all-cause survival for treatment-naïve RRMS patients who did not delay starting interferon beta-1b by 2 years and used DMTs for a longer duration than for those who started later. Low-strength evidence suggests that interferon did not change RRMS patients’ disability progression. Limited low-strength evidence suggests that long-term harms do not differ from short-term harms. The majority of discontinuation tends to occur within 2 to 3 years. Another 25 unique studies provided intrapersonal, interpersonal, and shared decisionmaking information. No study directly asked why people may be reluctant to discontinue when treatment no longer seems effective; taken as a whole, the literature set provides some insight. The preferences literature underscores the complexity of the topic and the processes underlying decisionmaking. 

 Conclusions. MS patients and providers have little information to guide decisions to discontinue DMT.  

Objective:  We conducted a systematic literature review of clinical trials to assess the comparative effectiveness of treatments for fibromyalgia in subgroups of highly affected or clinically complex adults. We focused on patient subgroups rather than overall treatment effects to complement a large systematic review being conducted on fibromyalgia treatments at McMaster University. 

Data sources:  We searched Medline®, Embase®, PsycINFO®, AMED, and the Cochrane Central Register of Controlled Trials (CENTRAL) plus reference lists of included studies and recent systematic reviews. 

Methods: Two investigators screened abstracts of identified references for eligibility (enrolled adults with fibromyalgia, examined treatment effects, had a control group, and assessed outcomes at least 3 months after treatment initiation). Full-text articles were reviewed to identify outcomes reporting for at least one adult subgroup: women, older or obese adults, individuals with coexisting mental health conditions, high severity or longer fibromyalgia duration, multiple medical comorbidities, or other chronic pain conditions. Primary outcomes included pain, symptom improvement, function, fatigue, sleep quality, participation, and health-related quality of life. We extracted data, assessed risk of bias of individual studies, and evaluated strength of evidence for each comparison and outcome. 

Results: We identified 22 randomized controlled trials (RCTs), 8 pooled analyses of patientlevel RCT data, and 4 observational studies that met inclusion criteria; 59 percent were drug trials. Adults with fibromyalgia and major depressive disorder (MDD) were studied most often; drug studies also reported outcomes by age, sex, race, and anxiety. Most drug trials examined duloxetine effects on pain and global improvement; trial duration was typically 3 months. Lowstrength evidence for duloxetine suggests that subgroups of adults with fibromyalgia and MDD do not experience differential short-term treatment effects. Other subgroup evidence is largely insufficient. For nearly all comparisons, treatment-by-subgroup interactions were not significant. Most interaction results were reported in text; only two RCTs and five pooled RCT analyses displayed data on subgroup outcomes. Losses to followup were considerable; dropout reporting was not subgroup specific. Adverse effects were reported for the MDD subgroup in one duloxetine pooled analysis; these were similar to overall adverse effects. Studies were not powered to detect subgroup effects. 

Conclusion: Despite the prevalent belief that fibromyalgia treatments may behave differently in subgroups, evidence to date is largely insufficient for fibromyalgia subgroup effects of interventions other than duloxetine in adults with concomitant MDD. Future studies should be designed to support subgroup analysis to improve clinical applicability.

Evaluation of systematic review outputs and outcomes is necessary to ensure user needs are being met, demonstrate impact, plan future dissemination, and justify funding. While the EPC program has been in operation for some time, efforts to evaluate the use of our CERs are still being developed. One important ongoing activity is conducted by one of the AHRQ-funded EPCs, ECRI, which monitors and documents CER use as measured by citation in clinical practice guidelines. The RTI-UNC EPC conducted a special project to analyze the impact of two CERs, with emphasis on the creation of new research opportunities.  AHRQ, with assistance from a student intern, completed a Web utilization project, based upon report hits and downloads, for a sample of CERs. Other efforts have assessed utilization by third party payers. None of the use monitoring activities or projects to date has addressed an increasingly popular type of resource for clinicians, clinical point-of-care (POC) tools.