Successful de-implementation of an ineffective practice: The fall of docusate.

BACKGROUND: Reducing wasteful practices optimizes value in medicine. Docusate lacks treatment efficacy yet is widely prescribed. This quality improvement project aimed to de-implement docusate in place of a new evidence-based order set. METHODS: This is an ambidirectional study of inpatient laxative orders from 2018 to 2022 â€‹at one institution. We stratified docusate data by service/unit to target prospective deimplementation initiatives. A new evidence-based constipation order set was embedded in Cerner. RESULTS: There were 701,732 docusate orders across 75 services on 68 units. Top docusate ordering services were Trauma, Obstetrics and Hospitalist. Docusate administration rates were higher than for other laxatives. Our efforts reduced docusate orders by 44% over 4 months. PEG and senna orders increased by 58% and 35%. CONCLUSION: Docusate has no efficacy yet is widely prescribed. A structured de-implementation strategy can drive systematic change by leveraging technology and applying multidisciplinary improvement efforts. Our work removed docusate from the inpatient formulary.

Efficacy of One Dose of Laxative on Postoperative Constipation Following Total Knee Arthroplasty.

Postoperative constipation is a common problem among orthopaedic surgical patients leading to discomfort, increased length of stay, and other complications. The primary purpose of this study was to determine the effectiveness of polyethylene glycol compared with docusate sodium for the prevention of constipation, after total knee arthroplasty. The secondary purpose was to examine the effectiveness of polyethylene glycol on pain and strain with bowel movement. A two-group nonequivalent cohort design was used to evaluate the effect of one 17-g dose of polyethylene glycol by mouth on postoperative day 1 compared with usual care with docusate sodium 100 mg starting the day of surgery and continued twice daily at home. There was no significant difference in the rate of constipation between the two cohorts in the 3 days after surgery. There was no difference in reported pain and strain. Future research should focus on the use of pharmacologic and nursing interventions together for prevention of postoperative constipation in patients with arthroplasty surgery.

A Quality Improvement Approach to Decrease the Utilization of Docusate in Hospitalized Patients.

BACKGROUND AND OBJECTIVES: Docusate sodium is a commonly prescribed medication to relieve constipation, but several studies have demonstrated its ineffectiveness. Its continued use in the hospital setting adds unnecessary cost and risk to patients. At the Mayo Clinic Florida campus, docusate was ordered for 9.7% of patients admitted to the internal medicine resident (IMED) teaching services during the month of January 2020, and the average hospital length of stay (LOS) was 3.1 days. METHODS: A multidisciplinary team of internal medicine resident physicians and pharmacists collaborated to address this quality gap through a quality improvement project. It sought to reduce the number of patients admitted to the IMED teaching services who had an order placed for docusate by 50% in less than 6 months without adversely impacting hospital LOS. Two separate interventions were devised using Six Sigma methodology and implemented to reduce the frequency of docusate orders, which involved educating internal medicine residents and hospital pharmacists, and creating an additional process-related barrier to docusate orders. RESULTS: The percentage of docusate orders decreased from 9.7% to 2.4% ( P = .004) with a grossly unchanged LOS of 3.1 days to 2.7 days ( P = .12) after 5 weeks. CONCLUSION: The implementation of a dual-pronged intervention successfully decreased the use of an ineffective medication in hospitalized patients without impacting the balancing measure, and serves as a model that can be adopted at other institutions with the hope of promoting evidence-based medical care.

Colostomy as a definitive treatment in an ALS patient with acute colonic Pseudo-obstruction refractory to medical management, a case report.

BACKGROUND: Amyotrophic lateral sclerosis (ALS) is a fatal motor neuron disease, and ALS patients may experience disturbed gastrointestinal motility often resulting in acute colonic pseudo-obstruction (ACPO). There is currently a paucity in the literature to guide the treatment of patients with both ALS and ACPO. CASE PRESENTATION: Here we describe a 39-year-old male patient with advanced ALS who developed ACPO. His condition was refractory to both medical and procedural managements including polyethylene glycol, senna, and docusate suppository, metoclopramide, linaclotide, erythromycin, prucalopride, neostigmine, and repeated colonoscopies. He ultimately underwent successful colostomy for palliation. Here we report the peri-operative multidisciplinary approach taken with this case, the surgical procedures, the potential risks, and the outcome. CONCLUSION: The patient is delighted with the result and requested publication of this case to raise awareness of constipation in ALS patients and promote the consideration of colostomy as a treatment option for patients with ileus resistant to conservative management. Ultimately, a multidisciplinary team approach is required to properly assess the risks and benefits to achieve good clinical outcomes.

Effects of magnesium sulfate and dioctyl sodium sulfosuccinate on fecal hydration, output and systemic hydration in healthy horses / [Efeitos do sulfato de magnésio e do dioctil-sulfossuccinato de sódio na hidratação e eliminação fecal e sobre a hidratação sistêmica de cavalos saudáveis]

Magnesium sulphate (MS) and dioctyl sodium sulphosuccinate (DSS) are laxative drugs frequently used for the treatment of impactions. The aim of this study was to compare the effects of MS and DSS in fecal hydration, output and systemic hydration in healthy horses. Five healthy horses received 3 treatments with a 21-day interval. Treatment 1 was performed with administration of 4 liters of warm water; treatment 2: administration of 4 liters of warm water associated with 1g/kg of MS; and treatment 3: administration of 4 liters of warm water associated with 20mg/kg DSS. General and specific physical examination of the digestive system were performed, alongside with packed cell volume and total plasma protein measurement, abdominal ultrasonography and quantification of the amount and hydration of feces, before and 6, 12, 24, 36 and 48 hours after the treatments. No adverse effects were observed. The administration of laxatives promoted greater fecal output and hydration without resulting in systemic dehydration, yet no differences were observed between treatments. The absence of adverse effects of DSS demonstrates the safety of its use as a laxative drug at a dose of 20mg/kg. Studies comparing the effects of the laxative drugs in horses with large colon impaction are needed.(AU)

O sulfato de magnésio (SM) e o dioctil-sulfossuccinato de sódio (DSS) são drogas laxativas frequentemente utilizadas no tratamento da compactação. O objetivo deste estudo foi comparar os efeitos do SM e do DSS na hidratação e eliminação fecal, e na hidratação sistêmica de cavalos saudáveis. Cinco cavalos receberam três tratamentos, com intervalo de 21 dias. O tratamento 1 consistiu na administração de quatro litros de água morna; o tratamento 2: administração de quatro litros de água morna associada a 1g/kg de SM; e o tratamento 3: administração de quatro litros de água morna associada a 20mg/kg de DSS. Foram realizados exames físicos gerais e específicos do trato digestivo, hematócrito e proteína plasmática total, ultrassonografia abdominal e mensuração da quantidade e hidratação das fezes antes e após seis, 12, 24, 36 e 48 horas dos tratamentos. Não foram observados efeitos adversos. A administração de ambos os laxantes promoveu maior produção fecal e hidratação, sem resultar em desidratação sistêmica, entretanto não houve diferença entre os tratamentos. A ausência de efeitos adversos do DSS demonstra a segurança de seu uso como medicamento laxante na dose de 20mg/kg. São necessários estudos que comparem o efeito dos laxantes em equinos portadores de compactação de cólon.(AU)

Chronic Constipation in the United States: Results From a Population-Based Survey Assessing Healthcare Seeking and Use of Pharmacotherapy.

OBJECTIVES: Chronic idiopathic constipation (CIC) is characterized by unsatisfactory defecation and difficult or infrequent stools. CIC affects 9%-20% of adults in the United States, and although prevalent, gaps in knowledge remain regarding CIC healthcare seeking and medication use in the community. We recruited a population-based sample to determine the prevalence and predictors of (i) individuals having discussed their constipation symptoms with a healthcare provider and (ii) the use of constipation therapies. METHODS: We recruited a representative sample of Americans aged 18 years or older who had experienced constipation. Those who met the Rome IV criteria for irritable bowel syndrome and opioid-induced constipation were excluded. The survey included questions on constipation severity, healthcare seeking, and the use of constipation medications. We used multivariable regression methods to adjust for confounders. RESULTS: Overall, 4,702 participants had experienced constipation (24.0% met the Rome IV CIC criteria). Among all respondents with previous constipation, 37.6% discussed their symptoms with a clinician (primary care provider 87.6%, gastroenterologist 26.0%, and urgent care/emergency room physician 7.7%). Age, sex, race/ethnicity, marital status, employment status, having a source of usual care, insurance status, comorbidities, locus of control, and constipation severity were associated with seeking care (P < 0.05). Overall, 47.8% of respondents were taking medication to manage their constipation: over-the-counter medication(s) only, 93.5%; prescription medication(s) only, 1.3%; and both over-the-counter medication(s) and prescription medication(s), 5.2%. DISCUSSION: We found that 3 of 5 Americans with constipation have never discussed their symptoms with a healthcare provider. Furthermore, the use of prescription medications for managing constipation symptoms is low because individuals mainly rely on over-the-counter therapies.

Ear drops for the removal of ear wax.

BACKGROUND: Ear wax (cerumen) is a normal bodily secretion that can become a problem when it obstructs the ear canal. Symptoms attributed to wax (such as deafness and pain) are among the commonest reasons for patients to present to primary care with ear trouble.Wax is part of the ear's self-cleaning mechanism and is usually naturally expelled from the ear canal without causing problems. When this mechanism fails, wax is retained in the canal and may become impacted; interventions to encourage its removal may then be needed. Application of ear drops is one of these methods. Liquids used to remove and soften wax are of several kinds: oil-based compounds (e.g. olive or almond oil); water-based compounds (e.g. sodium bicarbonate or water itself); a combination of the above or non-water, non-oil-based solutions, such as carbamide peroxide (a hydrogen peroxide-urea compound) and glycerol. OBJECTIVES: To assess the effects of ear drops (or sprays) to remove or aid the removal of ear wax in adults and children. SEARCH METHODS: We searched the Cochrane ENT Trials Register; Cochrane Register of Studies; PubMed; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the most recent search was 23 March 2018. SELECTION CRITERIA: Randomised controlled trials (RCTs) in which a 'cerumenolytic' was compared with no treatment, water or saline, an alternative liquid treatment (oil or almond oil) or another 'cerumenolytic' in adults or children with obstructing or impacted ear wax. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. The primary outcomes were 1) the proportion of patients (or ears) with complete clearance of ear wax and 2) adverse effects (discomfort, irritation or pain). Secondary outcomes were: extent of wax clearance; proportion of people (or ears) with relief of symptoms due to wax; proportion of people (or ears) requiring further intervention to remove wax; success of mechanical removal of residual wax following treatment; any other adverse effects recorded and cost. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics. MAIN RESULTS: We included 10 studies, with 623 participants (900 ears). Interventions included: oil-based treatments (triethanolamine polypeptide, almond oil, benzocaine, chlorobutanol), water-based treatments (docusate sodium, carbamide peroxide, phenazone, choline salicylate, urea peroxide, potassium carbonate), other active comparators (e.g. saline or water alone) and no treatment. Nine of the studies were more than 15 years old.The overall risk of bias across the 10 included studies was low or unclear. PRIMARY OUTCOME: proportion of patients (or ears) with complete clearance of ear waxSix studies (360 participants; 491 ears) contributed quantitative data and were included in our meta-analyses.Active treatment versus no treatmentOnly one study addressed this comparison. The proportion of ears with complete clearance of ear wax was higher in the active treatment group (22%) compared with the no treatment group (5%) after five days of treatment (risk ratio (RR) 4.09, 95% confidence interval (CI) 1.00 to 16.80); one study; 117 ears; NNTB = 8) (low-quality evidence).Active treatment versus water or salineWe found no evidence of a difference in the proportion of patients (or ears) with complete clearance of ear wax when the active treatment group was compared to the water or saline group (RR 1.47, 95% CI 0.79 to 2.75; three studies; 213 participants; 257 ears) (low-quality evidence). Two studies applied drops for five days, but one study only applied the drops for 15 minutes. When we excluded this study in a sensitivity analysis it did not change the result.Water or saline versus no treatmentThis comparison was only addressed in the single study cited above (active versus no treatment) and there was no evidence of a difference in the proportion of ears with complete wax clearance when comparing water or saline with no treatment after five days of treatment (RR 4.00, 95% CI 0.91 to 17.62; one study; 76 ears) (low-quality evidence).Active treatment A versus active treatment BSeveral single studies evaluated 'head-to-head' comparisons between two active treatments. We found no evidence to show that one was superior to any other.Subgroup analysis of oil-based active treatments versus non-oil based active treatmentsWe found no evidence of a difference in this outcome when oil-based treatments were compared with non-oil-based active treatments. PRIMARY OUTCOME: adverse effects: discomfort, irritation or painOnly seven studies planned to measure and did report this outcome. Only two (141 participants;176 ears) provided useable data. There was no evidence of a significant difference in the number of adverse effects between the types of ear drops in these two studies. We summarised the remaining five studies narratively. All events were mild and reported in fewer than 30 participants across the seven studies (low-quality evidence).Secondary outcomesThree studies reported 'other' adverse effects (how many studies planned to report these is unclear). The available information was limited and included occasional reports of dizziness, unpleasant smell, tinnitus and hearing loss. No significant differences between groups were reported. There were no emergencies or serious adverse effects reported in any of the 10 studies.There was very limited or no information available on our remaining secondary outcomes. AUTHORS' CONCLUSIONS: Although a number of studies aimed to evaluate whether or not one type of cerumenolytic is more effective than another, there is no high-quality evidence to allow a firm conclusion to be drawn and the answer remains uncertain.A single study suggests that applying ear drops for five days may result in a greater likelihood of complete wax clearance than no treatment at all. However, we cannot conclude whether one type of active treatment is more effective than another and there was no evidence of a difference in efficacy between oil-based and water-based active treatments.There is no evidence to show that using saline or water alone is better or worse than commercially produced cerumenolytics. Equally, there is also no evidence to show that using saline or water alone is better than no treatment.

Polyethylene Glycol 3350 and Docusate Sodium Compared With Docusate Sodium Alone After Urogynecologic Surgery: A Randomized Controlled Trial.

OBJECTIVE: To compare time to first bowel movement and additional gastrointestinal outcomes between women receiving polyethylene glycol 3350 (PEG3350) and docusate sodium and docusate sodium alone after urogynecologic surgery. METHODS: Participants received twice-daily 100 mg docusate sodium and were randomized to daily 1) PEG3350 or 2) inert placebo for 5 days after urogynecologic surgery. They completed bowel diaries, Bristol stool scale, validated Patient Assessment of Constipation Symptom Questionnaire, and Patient Assessment of Constipation Quality-of-Life Questionnaire preoperatively and 1 week after surgery. Our primary outcome was time to first bowel movement after surgery. To detect a 1-day difference in time to first bowel movement (4 compared with 3 days), 63 participants were needed in each group. RESULTS: From September 2012 through March 2015, 145 women were randomized and 131 (90%) analyzed: 66 received PEG3350, and 65 received placebo. Polyethylene glycol 3350 did not significantly reduce time to first bowel movement after surgery compared with placebo (2.77 days [interquartile range 1.86-3.40] compared with 2.92 days [interquartile range 1.85-4.02] P=.25). Women in the PEG3350 group were less likely to take additional laxatives postoperatively, and the PEG3350 group was more adherent to the study drug regimen. Questionnaire scores, fecal incontinence, and urgency were similar between groups. CONCLUSION: In women taking routine docusate sodium after urogynecologic surgery, adding PEG3350 postoperatively did not reduce time to first bowel movement. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT01691742.

Missed Opportunity to Deprescribe: Docusate for Constipation in Medical Inpatients.

BACKGROUND: Hospital admissions provide an opportunity to deprescribe ineffective medications and reduce pill burden. Docusate sodium is a stool softener that is frequently prescribed to treat constipation despite poor evidence for efficacy, thus providing a good target for deprescription. The aims of this study were to characterize rates of use and discontinuation of docusate among internal medicine inpatients, as well as use of other laxatives. METHODS: We conducted a retrospective observational study over 1 year on all patients admitted to internal medicine at 2 urban academic hospitals to determine rates of docusate use. We also evaluated laxative and opioid medication use on a random sample of 500 inpatients who received docusate to characterize patterns of prescription and deprescription. RESULTS: Fifteen percent (1169/7581) of all admitted patients received 1 or more doses of docusate. Among our random sample, 53% (238/452) received docusate before admission, and only 13% (31/238) had docusate deprescribed. Among patients not receiving docusate before admission, 33.2% (71/214) received a new prescription for docusate on discharge. Patients receiving opioids were frequently prescribed no laxatives or given docusate monotherapy (28%, 51/185). CONCLUSIONS: Docusate was frequently prescribed to medical inpatients despite its known ineffectiveness, with low deprescription and high numbers of new prescriptions. Docusate use was common even among patients at high risk of constipation. One third of patients not receiving docusate before admission were prescribed docusate on discharge, potentially exacerbating polypharmacy. Among patients already receiving docusate, 80% had it continued on discharge, indicating significant missed opportunities for deprescribing. Given the availability of effective alternatives, our results suggest that quality-improvement initiatives are needed to promote evidence-based laxative use in hospitalized patients.

Free fatty acid suppositories are as effective as docusate sodium and sorbitol enemas in treating constipation in children.

AIM: A well-documented, clinically proven per rectum treatment for childhood constipation is needed. This phase two clinical trial evaluated the efficacy of suppositories containing free fatty acids (FFA) compared with Klyx docusate sodium and sorbitol enemas. METHODS: A randomised, controlled, single-blind study was undertaken on 77 children aged between one and 17 who presented to an emergency department in Iceland and were diagnosed with constipation. In stage one, 23 patients were randomised to receive lower dose FFA suppositories or Klyx (n = 33). In stage two, 21 different patients were randomised to receive higher dose suppositories and compared with the same Klyx control subjects. RESULTS: The suppositories were effective at bowel emptying in 39% of the group who received the lower FFA doses and 81% of the group receiving higher doses, compared with 88% in the Klyx control group. Symptom relief was obtained in 30% of the group receiving the lower doses and 71% of the group receiving the higher doses, compared with 73% in the control group. CONCLUSION: The higher dose FFA suppositories were as effective as the Klyx enemas with regard to bowel emptying and symptom relief and might provide an important and less invasive alternative for childhood constipation.

Systematic review of stimulant and nonstimulant laxatives for the treatment of functional constipation.

BACKGROUND: Constipation is an uncomfortable and common condition that affects many, irrespective of age. Since 1500 BC and before, health care practitioners have provided treatments and prevention strategies to patients for chronic constipation despite the significant variation in both medical and personal perceptions of the condition. OBJECTIVE: To review relevant research evidence from clinical studies investigating the efficacy and safety of commercially available pharmacological laxatives in Canada, with emphasis on studies adopting the Rome criteria for defining functional constipation. SEARCH METHODS: PubMed, Medline, Embase and Evidence-Based Medicine Reviews databases were searched for blinded or randomized clinical trials and meta-analyses assessing the efficacy of nonstimulant and stimulant laxatives for the treatment of functional constipation. RESULTS: A total of 19 clinical studies and four meta-analyses were retrieved and abstracted regarding study design, participants, interventions and outcomes. The majority of studies focused on polyethylene glycol compared with placebo. Both nonstimulant and stimulant laxatives provided better relief of constipation symptoms than placebo according to both objective and subjective measures. Only one study compared the efficacy of a nonstimulant versus a stimulant laxative, while only two reported changes in quality of life. All studies reported minor side effects due to laxative use, regardless of treatment duration, which ranged from one week to one year. Laxatives were well tolerated by both adults and children.

Efficacy and side-effect profiles of lactulose, docusate sodium, and sennosides compared to PEG in opioid-induced constipation: a systematic review.

UNLABELLED: Opioid-induced constipation (OIC) is a side effect of opioid therapy that can affect quality of life, adherence to treatment, and morbidity and possibly mortality. OBJECTIVES: To investigate whether docusate sodium, sennosides, and lactulose have equal efficacy and side effect profiles compared to PEG in the management of OIC in adults. METHODS: A systematic review was undertaken. Randomized controlled trials of adults taking opioids for cancer or non-cancer pain were considered if they met inclusion criteria. CONCLUSIONS: Statistical pooling was not possible as no studies met inclusion criteria. Large, well-powered, randomized controlled trials are feasible. Standard definitions of OIC would assist with the execution of these studies and contribute to their internal and external validity. Further research is strongly encouraged.

Randomized, double-blind, placebo-controlled trial of oral docusate in the management of constipation in hospice patients.

CONTEXT: The stool softener docusate is widely used in the management of constipation in hospice patients. There is little experimental evidence to support this practice, and no randomized trials have been conducted in the hospice setting. OBJECTIVES: To assess the efficacy of docusate in hospice patients. METHODS: This was a 10-day, prospective, randomized, double-blind, placebo-controlled trial of docusate and sennosides vs. placebo and sennosides in hospice patients in Edmonton, Alberta. Patients were included if they were age 18 years or older, able to take oral medications, did not have a gastrointestinal stoma, and had a Palliative Performance Scale score of 20% or more. The primary outcome measures were stool frequency, volume, and consistency. Secondary outcomes were patient perceptions of bowel movements (difficulty and completeness of evacuation) and bowel-related interventions. RESULTS: A total of 74 patients were randomized into the study (35 to the docusate group and 39 to the placebo group). There were neither significant differences between the groups in stool frequency, volume, or consistency, nor in difficulty or completeness of evacuation. On the Bristol Stool Form Scale, more patients in the placebo group had Type 4 (smooth and soft) and Type 5 (soft blobs) stool, whereas in the docusate group, more had Type 3 (sausage like) and Type 6 (mushy) stool (P=0.01). CONCLUSION: There was no significant benefit of docusate plus sennosides compared with placebo plus sennosides in managing constipation in hospice patients. Docusate use should be considered on an individual basis.

The use of senna with docusate for postoperative constipation after pelvic reconstructive surgery: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: The objective of the study was to compare time to first bowel movement (BM) after surgery in subjects randomized to placebo or senna with docusate. STUDY DESIGN: Ninety-six subjects completed a baseline 7-day bowel diary before and after surgery. After pelvic reconstructive surgery, the subjects were randomized to either placebo (n=45) or senna (8.6 mg) with docusate (50 mg) (n=48). Time to first BM and postoperative use of magnesium citrate were compared. RESULTS: There was a significant difference in the time to first BM in those receiving senna with docusate vs placebo (3.00+/-1.50 vs 4.05+/-1.50 days; P<.002). More subjects in the placebo group needed to use magnesium citrate to initiate a bowel movement (43.6% vs 7.0%; P<.001). CONCLUSION: The use of senna with docusate decreases time to first BM in those undergoing pelvic reconstructive surgery compared with placebo. Subjects using senna with docusate are also significantly less likely to use magnesium citrate.

Constipation in people prescribed opioids.

INTRODUCTION: Constipation is reported in 52% of people with advanced malignancy. This figure rises to 87% in people who are terminally ill and taking opioids. Constipation may be the most common adverse effect of opioids. There is no reason to believe that people with chronic non-malignant disease who take opioids will be any less troubled by this adverse effect. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of: oral laxatives, rectally applied medications, and opioid antagonists for constipation in people prescribed opioids? We searched: Medline, Embase, The Cochrane Library, and other important databases up to August 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). RESULTS: We found 23 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. CONCLUSIONS: In this systematic review we present information relating to the effectiveness and safety of the following interventions: arachis oil enemas, bisacodyl, co-danthrusate/co-danthramer, docusate, glycerol suppositories, ispaghula husk, lactulose, liquid paraffin, macrogols plus electrolyte solutions, magnesium salts, methylcellulose, opioid antagonists, phosphate enemas, senna, sodium citrate micro-enema, and sodium picosulfate.