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1.
J Neonatal Perinatal Med ; 13(4): 495-505, 2020.
Article in English | MEDLINE | ID: mdl-32083593

ABSTRACT

BACKGROUND: Glycerin suppositories are often used to facilitate meconium evacuation in premature infants. The evidence for this practice is inconclusive. The purpose of this study was to assess the feasibility of a multicenter randomized controlled trial on the effectiveness of this treatment strategy. STUDY DESIGN: We conducted an external pilot study for a multicenter randomized controlled trial of premature infants randomized to glycerin suppositories or placebo procedure. Participants were included if they were gestational age of 24 weeks 0 days to 31 weeks 6 days and/or birthweight of 500 to 1500 grams. We excluded infants with life-threatening congenital anomalies, contraindications to receiving suppositories, or signs of clinical instability. Outcomes included cost, recruitment, and treatment-related adverse events. RESULT: A total of 109 were screened, 79 were initially eligible, and 34 consented to participate. Four of these infants were excluded prior to randomization due to thrombocytopenia, 30 were randomized, and 26 reached full enteral feeds. Three infants (10%) experienced rectal bleeding 5 to 43 days after completing study treatments. An anal fissure was noted in two of these patients. There were no cases of rectal perforation but one infant assigned to active treatment developed necrotizing enterocolitis. CONCLUSIONS: Conducting a multicenter randomized controlled trial on the use of glycerin suppositories in premature infants is feasible. Minor modifications to the study protocol are needed to increase participant recruitment and simplify the administration of study treatments.


Subject(s)
Glycerol , Birth Weight , Cathartics/administration & dosage , Cathartics/adverse effects , Cathartics/economics , Clinical Protocols , Enteral Nutrition/methods , Female , Gestational Age , Glycerol/administration & dosage , Glycerol/adverse effects , Glycerol/economics , Humans , Infant, Newborn , Infant, Premature , Male , Meconium , Outcome and Process Assessment, Health Care , Pilot Projects , Suppositories
2.
Clin Gastroenterol Hepatol ; 17(13): 2806-2807, 2019 12.
Article in English | MEDLINE | ID: mdl-30880272

ABSTRACT

High-quality bowel preparation (prep) before colonoscopy is essential for the success of the procedure.1 Bowel preps should be safe, tolerable, efficacious, and allow for visualization of polyps 5 mm or larger.2 Full-volume (4 L) polyethylene glycol-3350 with electrolyte solution (PEG-ELS) has been considered a standard bowel prep regimen, with good safety and efficacy profiles, and is available as a generic.2.


Subject(s)
Cathartics/economics , Drug Costs/trends , Medicare Part D/economics , Citrates/economics , Colonoscopy , Drugs, Generic/economics , Electrolytes/economics , Humans , Organometallic Compounds/economics , Phosphates/economics , Picolines/economics , Polyethylene Glycols/economics , Sulfates/economics , United States
3.
J Med Econ ; 19(4): 356-63, 2016.
Article in English | MEDLINE | ID: mdl-26610148

ABSTRACT

OBJECTIVE: The study aimed to (1) develop a cost model for colonoscopy preparation among patients referred for colonoscopy using split-dose reduced-volume oral sulfate solution (OSS) and generic polyethylene glycol with electrolytes solution (PEG-ELS), (2) examine cost savings associated with OSS vs PEG-ELS, and (3) assess the robustness of the cost model. METHODS: Efficacy of each agent was based on the results of a 541-patient clinical trial comparing OSS to PEG-ELS. Cleansing agent and colonoscopy procedure costs were calculated from OptumHealth Reporting & Insights claims data for 2010-Q12013. In the model, patients' colonoscopies were tracked over a 25 or 35 year time period until the patients reached age 75. The difference per patient per year (PPPY) in total cleansing agent and colonoscopy procedure costs over the time horizon between the OSS and PEG-ELS cohort was calculated. One-way sensitivity analyses were conducted to test the robustness of the cost model. RESULTS: The model showed lower cost for OSS patients over the time horizon. Total PPPY costs were $280.34 for the OSS cohort and $296.36 for the PEG-ELS cohort, resulting in a cost saving of $16.01 PPPY for the OSS cohort. This was due primarily to OSS patients having fewer colonoscopies (OSS: 0.158 vs PEG-ELS: 0.170 PPPY). Over the time horizon, cost savings of $4 763 335 were observed among 10, 000 OSS patients. Cost savings switched from OSS to PEG-ELS cohort in four cases: (1) base-case cost of a completed colonoscopy decreased by 75%, (2) base-case cost of OSS increased to over $143 per usage, (3) all non-completers were lost to follow-up, and (4) OSS bowel preparation quality dropped below PEG-ELS to 70%. CONCLUSIONS: From a payer's perspective, the model showed that the use of OSS as the cleansing agent resulted in potential cost savings compared with PEG-ELS. Cost savings under OSS remained under various sensitivity analyses.


Subject(s)
Cathartics/economics , Colonoscopy/methods , Electrolytes/economics , Polyethylene Glycols/economics , Sulfates/economics , Cathartics/administration & dosage , Electrolytes/administration & dosage , Female , Humans , Male , Models, Econometric , Polyethylene Glycols/administration & dosage , Sulfates/administration & dosage
4.
Dig Dis Sci ; 60(11): 3482-90, 2015 Nov.
Article in English | MEDLINE | ID: mdl-26093612

ABSTRACT

BACKGROUND/AIMS: Adequate bowel preparation is essential to safe and effective inpatient colonoscopy. Predictors of poor inpatient colonoscopy preparation and the economic impacts of inadequate inpatient preparations are not defined. The aims of this study were to (1) determine risk factors for inadequate inpatient bowel preparations, and (2) examine the association between inadequate inpatient bowel preparation and hospital length of stay (LOS) and costs. METHODS: We performed a retrospective cohort study of adult patients undergoing inpatient colonoscopy preparation over 12 months (1/1/2013-12/31/2013). RESULTS: Of 524 identified patients, 22.3% had an inadequate preparation. A multiple logistic regression model identified the following potential predictors of inadequate bowel preparation: lower income (OR 1.11; 95% CI 1.04, 1.22), opiate or tricyclic antidepressant (TCA) use (OR 1.55; 0.98, 2.46), and afternoon colonoscopy (OR 1.66; 1.07, 2.59); as well as American Society of Anesthesiologists (ASA) class ≥3 (OR 1.15; 1.05, 1.25) and symptoms of nausea/vomiting (OR 1.14; 1.04, 1.25) when a fair preparation was considered inadequate. Inadequate bowel preparation was associated with significantly increased hospital LOS (model relative mean estimate 1.25; 95% CI 1.03, 1.51) and hospital costs (estimate 1.31; 1.03, 1.67) when compared to adequate preparations. CONCLUSIONS: The rate of inadequate inpatient bowel preparations is high and associated with a significant increase in hospital LOS and costs. We identified five potential predictors of inadequate inpatient preparation: lower socioeconomic class, opiate/TCA use, afternoon colonoscopies, ASA class ≥3, and pre-preparation nausea/vomiting; these data should guide future initiatives to improve the quality of inpatient bowel preparations.


Subject(s)
Cathartics/administration & dosage , Cathartics/economics , Colonoscopy/economics , Hospital Costs , Length of Stay/economics , Therapeutic Irrigation/economics , Adult , Aged , Analgesics, Opioid/therapeutic use , Antidepressive Agents, Tricyclic/therapeutic use , Appointments and Schedules , Cathartics/adverse effects , Colonoscopy/adverse effects , Colonoscopy/standards , Female , Humans , Inpatients , Linear Models , Logistic Models , Male , Middle Aged , Multivariate Analysis , Nausea/etiology , Odds Ratio , Quality Indicators, Health Care , Retrospective Studies , Risk Factors , Socioeconomic Factors , Therapeutic Irrigation/adverse effects , Therapeutic Irrigation/standards , Time Factors , Vomiting/etiology
5.
Gastroenterol Nurs ; 38(1): 31-41, 2015.
Article in English | MEDLINE | ID: mdl-25636011

ABSTRACT

Colorectal cancer, the third most common cancer in U.S. adults, can be detected early through colonoscopy. Thorough bowel preparation facilitates successful colonoscopy. Effectiveness, tolerability, and costs of 3 bowel preparations were compared in patients undergoing outpatient screening colonoscopy. In this prospective, randomized, single-blind study, comparing three preparation protocols, 209 of 276 consented subjects completed (Protocol [N = 67] = HalfLytely© 1 L × 2 doses and bisacodyl 5 mg delayed release tablets × 2 tablets; Protocol 2 [N = 74] = MiraLAX® 5 tablespoons × 2 doses and bisacodyl 5 mg tablets × 2 tablets; and Protocol 3 [N = 68] = MoviPrep 1 L × 2 doses). Patients completed symptom diaries and a gastroenterologist rated effectiveness. Most subjects were White females, aged 59 years (mean). Protocol 1 was the most effective regimen, but Protocol 2 was the most tolerable and cost-effective. While the three bowel protocol differences were not statistically significant for all outcomes measured, there were clinically meaningful differences. As Protocol 1 was most effective, HalfLytely© and bisacodyl is recommended for patients prior to colonoscopy. For patients who cannot tolerate HalfLytely© or MoviPrep, or with financial concerns, Protocol 2 (MiraLAX® & bisacodyl) is alternatively recommended.


Subject(s)
Cathartics/adverse effects , Cathartics/economics , Colonoscopy/methods , Colorectal Neoplasms/prevention & control , Adult , Aged , Bisacodyl/administration & dosage , Bisacodyl/economics , Cathartics/administration & dosage , Colonoscopy/economics , Cost-Benefit Analysis , Drug Tolerance , Evaluation Studies as Topic , Female , Humans , Male , Middle Aged , Patient Satisfaction/statistics & numerical data , Polyethylene Glycols/administration & dosage , Polyethylene Glycols/economics , Prospective Studies , Single-Blind Method , Treatment Outcome
6.
BMC Health Serv Res ; 14: 92, 2014 Feb 26.
Article in English | MEDLINE | ID: mdl-24572047

ABSTRACT

BACKGROUND: Colorectal cancer is among the leading causes of cancer and cancer-related mortality in the United States. The incidence and mortality associated with CRC can be reduced with preventive screening. Inadequate bowel preparation has been associated with missed adenomas and the need for repeat colonoscopies. METHODS: Separate claims source databases were analyzed to determine the costs associated with colonoscopy in the commercial and Medicare populations. Observed repeat rates for colonoscopy within 4 years of initial screening were also examined. RESULTS: Among the 6 most commonly used billing codes, the average allowed cost for an episode of colonoscopy in 2010 was $2,146 in the commercial population and $1,071 in the Medicare population, with average cost sharing of $334 and $275, respectively. The portion of colonoscopies associated with a biopsy or polyp removal exceeded 50% in the commercial and Medicare populations. Approximately 57% of colonoscopies in the commercial population were associated with claims for a prescription bowel preparation product within 30 days prior to the procedure. Three branded and three generic bowel cleansing products accounted for approximately 75% of the total number of prescription claims for colonoscopy. Given literature reports that up to 25% of patients receive inadequate bowel preparation, the rate of repeat colonoscopy within 4 years of initial screening was lower than expected among patients who were not coded with common clinical reasons for early repeat: benign neoplasm, lesion, or polyp removed at initial screening colonoscopy. CONCLUSIONS: The reported rates of inadequate bowel preparation are 15% to 25%, but the rates of repeat colonoscopy found in our analysis are much lower; this is a risk concern considering the reported, significant miss rate of adenomas secondary to inadequate bowel preparation.


Subject(s)
Colonoscopy/economics , Health Care Costs/statistics & numerical data , Medicare/statistics & numerical data , Cathartics/economics , Cathartics/therapeutic use , Colonoscopy/statistics & numerical data , Cost Sharing/economics , Cost Sharing/statistics & numerical data , Humans , Insurance Claim Review , Insurance, Health/economics , Insurance, Health/statistics & numerical data , Medicare/economics , United States
9.
J Med Econ ; 15(4): 758-65, 2012.
Article in English | MEDLINE | ID: mdl-22364285

ABSTRACT

OBJECTIVE: With the availability of several bowel cleansing agents, physicians and hospitals performing colonoscopies will often base their choice of cleansing agent purely on acquisition cost. Therefore, an easy to use budget impact model has been developed and established as a tool to compare total colon preparation costs between different established bowel cleansing agents. METHODS: The model was programmed in Excel and designed as a questionnaire evaluating information on treatment costs for a range of established bowel cleansing products. The sum of costs is based on National Health Service reference costs for bowel cleansing products. Estimations are made for savings achievable when using a 2-litre polyethylene glycol with ascorbate components solution (PEG+ASC) in place of other bowel cleansing solutions. Test data were entered into the model to confirm validity and sensitivity. The model was then applied to a set of audit cost data from a major hospital colonoscopy unit in the UK. RESULTS: Descriptive analysis of the test data showed that the main cost drivers in the colonoscopy process are the procedure costs and costs for bed days rather than drug acquisition costs, irrespective of the cleansing agent. Audit data from a colonoscopy unit in the UK confirmed the finding with a saving of £107,000 per year in favour of PEG+ASC when compared to sodium picosulphate with magnesium citrate solution (NaPic+MgCit). For every patient group the model calculated overall cost savings. This was irrespective of the higher drug expenditure associated with the use of PEG+ASC for bowel preparation. Savings were mainly realized through reduced costs for repeat colonoscopy procedures and associated costs, such as inpatient length of stay. CONCLUSIONS: The budget impact model demonstrated that the primary cost driver was the procedure cost for colonoscopy. Savings can be realized through the use of PEG+ASC despite higher drug acquisition costs relative to the comparator products. From a global hospital funding perspective, the acquisition costs of bowel preparations should not be used as the primary reason to select the preferred treatment agent, but should be part of the consideration, with an emphasis on the clinical outcome.


Subject(s)
Budgets , Cathartics/economics , Citric Acid/economics , Colonoscopy/economics , Organometallic Compounds/economics , Phosphates/economics , Picolines/economics , Polyethylene Glycols/economics , Cathartics/administration & dosage , Citrates , Citric Acid/administration & dosage , Costs and Cost Analysis/methods , Drug Carriers/administration & dosage , Drug Carriers/economics , Humans , Models, Economic , Organometallic Compounds/administration & dosage , Phosphates/administration & dosage , Picolines/administration & dosage , Polyethylene Glycols/administration & dosage , State Medicine , Surveys and Questionnaires , United Kingdom
10.
Clin J Pain ; 27(6): 508-17, 2011.
Article in English | MEDLINE | ID: mdl-21368666

ABSTRACT

OBJECTIVES: Hospitalized patients often experience adverse events of the gastrointestinal tract due to analgesic treatment. The objectives of this study were to estimate use of medications for treatment of nausea, vomiting, or constipation (NVC medications) after initiation of analgesic treatment, and to compare differences in length of stay and treatment costs between patients who received NVC medications and those who did not. METHODS: This retrospective cohort study used the Premier Perspective data from January 1, 2005 to December 31, 2007 and stratified inpatients into 4 groups based on the first analgesic agent they were given. Patients were observed for 14 days after the first analgesic use until a regimen change, first use of NVC medication, or hospital discharge, whichever occurred first. Data were analyzed using a Cox proportional hazards model and a generalized linear model. RESULTS: This study found that 239,183 (55.1%) of 434,304 patients received NVC medications after analgesic administration. Compared with oral nonopioid analgesics, the risk of using NVC medication was 4.8 times higher for injectable opioid analgesics after controlling for confounders. Patients who received NVC medications were hospitalized 0.26 days longer (P < 0.0001) at an additional cost of $756 per patient compared with patients who did not receive NVC medications (P < 0.0001). DISCUSSION: Use of an analgesic with improved gastrointestinal tolerability may potentially reduce use of NVC medications and hospital resources.


Subject(s)
Analgesics/adverse effects , Antiemetics/therapeutic use , Cathartics/therapeutic use , Gastrointestinal Diseases/chemically induced , Gastrointestinal Diseases/drug therapy , Adolescent , Adult , Aged , Antiemetics/economics , Cathartics/economics , Cohort Studies , Constipation/chemically induced , Constipation/drug therapy , Constipation/economics , Female , Gastrointestinal Diseases/economics , Health Care Costs , Humans , Length of Stay , Male , Middle Aged , Nausea/chemically induced , Nausea/drug therapy , Nausea/economics , Proportional Hazards Models , Retrospective Studies , Vomiting/chemically induced , Vomiting/drug therapy , Vomiting/economics , Young Adult
11.
Dig Dis Sci ; 55(7): 2014-20, 2010 Jul.
Article in English | MEDLINE | ID: mdl-20082217

ABSTRACT

BACKGROUND: Suboptimal bowel preparation prior to colonoscopy is a common occurrence, with a deleterious impact on colonoscopy effectiveness. Established risk factors for suboptimal bowel preparation have been proposed, but social factors, such as socioeconomic status and marital status, have not been investigated. AIMS: The aim of this study was to evaluate sociodemographic factors, including insurance status and marital status, as predictive of suboptimal preparation. METHODS: We analyzed a database of 12,430 consecutive colonoscopies during a 28-month period at Columbia University Medical Center. We collected the following variables: age, gender, indication for colonoscopy, location (inpatient vs. outpatient), race, marital status, and Medicaid status. Preparation quality was recorded and dichotomized as optimal or suboptimal. We employed multivariate regression to determine independent risk factors for suboptimal bowel preparation. RESULTS: Among the 10,921 examinations in which bowel preparation was recorded, suboptimal preparation occurred in 34% of Medicaid patients versus 18% of non-Medicaid patients (P < 0.0001); this remained significant in the multivariate analysis (odds ratio (OR) 1.84, 95% CI 1.61-2.11). Married patients had decreased rates of suboptimal preparation (OR 0.89, 95% CI 0.80-0.98). Other variables associated with suboptimal preparation included increased age (OR per 10 years 1.09, 95% CI 1.05-1.14), male gender (OR 1.44, 95% CI 1.31-1.59), inpatient status (OR 1.51, 95% CI 1.26-1.80), and later time of day (OR 1.89, 95% CI 1.71-2.09). CONCLUSIONS: Unmarried status and Medicaid status are predictive of suboptimal bowel preparation. Future studies are warranted to identify how these social conditions predict bowel preparation quality and to implement interventions to optimize bowel preparation in vulnerable populations.


Subject(s)
Cathartics/administration & dosage , Colonoscopy/methods , Health Knowledge, Attitudes, Practice , Medicaid/economics , Therapeutic Irrigation/standards , Academic Medical Centers , Age Factors , Aged , Aged, 80 and over , Cathartics/economics , Cohort Studies , Colonoscopy/economics , Colorectal Neoplasms/diagnosis , Educational Status , Female , Humans , Inflammatory Bowel Diseases/diagnosis , Male , Middle Aged , Multivariate Analysis , Odds Ratio , Patient Compliance/statistics & numerical data , Predictive Value of Tests , Quality Control , Retrospective Studies , Risk Factors , Single Person , Socioeconomic Factors , Therapeutic Irrigation/economics , Therapeutic Irrigation/trends , United States
12.
Endoscopy ; 41(12): 1038-45, 2009 Dec.
Article in English | MEDLINE | ID: mdl-19967619

ABSTRACT

BACKGROUND AND STUDY AIMS: Comparison of bowel preparation for colonoscopy in children with either Pico-Salax (sodium picosulphate with magnesium citrate) or polyethylene glycol with electrolyte solution (PEG-ELS). PATIENTS AND METHODS: In this investigator-blinded, randomized controlled trial, 83 children (12.5 +/- 3.1 years) requiring elective colonoscopy at a referral hospital were randomly allocated to Pico-Salax (n = 43) or PEG-ELS (n = 40), and an intention-to treat analysis was applied. Pico-Salax was administered in two doses, one the evening before and one on the morning of the procedure. PEG-ELS was administered over 4 hours. Efficacy was scored using the Ottawa scale and other constructs. Tolerability and toxicity were measured by patient and nursing questionnaires and serum biochemistry. RESULTS: 35 of Pico-Salax patients (81 %) were satisfied or very satisfied with the cleanout, compared with 19 (48 %) in the PEG-ELS group (P = 0.001). No differences were found in bowel cleanout effectiveness, as judged by the Ottawa score (P = 0.24), completion rates (P = 0.69), colonoscopy duration (P = 0.59), need for enemas (P = 0.25), or physician's global impression (P = 0.7). Except for one case of mild dehydration in the Pico-Salax group, no clinically significant adverse events were recorded. Serum biochemistry results were similar between groups except for more hypermagnesemia associated with Pico-Salax and hypokalemia with PEG-ELS; neither was clinically significant. CONCLUSION: Children tolerate Pico-Salax better than PEG-ELS for bowel cleanout before colonoscopy. This study did not demonstrate superiority of effectiveness or safety for either regimen.


Subject(s)
Cathartics/administration & dosage , Citric Acid/administration & dosage , Colonoscopy , Magnesium Oxide/administration & dosage , Picolines/administration & dosage , Polyethylene Glycols/administration & dosage , Administration, Oral , Adolescent , Cathartics/adverse effects , Cathartics/economics , Child , Child, Preschool , Citrates , Citric Acid/adverse effects , Citric Acid/economics , Double-Blind Method , Drug Costs , Female , Humans , Magnesium Oxide/adverse effects , Magnesium Oxide/economics , Male , Organometallic Compounds , Patient Satisfaction , Picolines/adverse effects , Picolines/economics , Polyethylene Glycols/adverse effects , Polyethylene Glycols/economics
13.
Health Technol Assess ; 12(13): iii-iv, ix-139, 2008 May.
Article in English | MEDLINE | ID: mdl-18462572

ABSTRACT

OBJECTIVES: To investigate the clinical effectiveness and cost-effectiveness of bulk-forming, stimulant and osmotic laxatives, and also of adding a second type of laxative agent in the treatment of patients whose constipation is not resolved by a single agent. Additionally, to define the meaning of constipation in older people from the perspective of GPs and older patients, and to investigate the use of prescribed and non-prescribed treatments for constipation in older people together with their adherence to prescribed treatments. DESIGN: A multicentre pragmatic, factorial randomised controlled trial with economic evaluation and qualitative study using in-depth interviews and focus groups with older people, GPs and community nurses. SETTING: General practices in north-east England. PARTICIPANTS: People aged 55 years or over with chronic constipation living in private households. INTERVENTIONS: Six stepped-treatment strategies using three classes of laxatives: bulk, stimulant and osmotic preparations, singly and in combination. MAIN OUTCOME MEASURES: The primary outcome was the constipation-specific Patient Assessment of Constipation--Symptoms/Patient Assessment of Constipation--Quality of Life. Secondary outcomes included EuroQoL 5 Dimensions, reported number of bowel movements per week, the presence/absence of the other Rome II criteria for constipation, adverse effects of treatment and relapse rates. RESULTS: Recruitment to the trial was difficult and the trial was closed after recruiting 19 participants. GP participants provided patient-centred definitions that focused on the idea of a change from the norm as defined by the individual patient and 'textbook definitions' that focused on reduced frequency of defecation associated with a range of unpleasant sensations and other clinical symptoms. Nurses' definitions of constipation included both a patient-centred perspective and the description of particular symptoms associated with constipation. Older participants defined constipation in terms of frequency of bowel movements and changes in normal bowel routine. Older participants perceived constipation as follows: linked to specific diseases, medical conditions or health problems; caused by the consumption of specific medications or surgical procedures; caused by diet or eating habits; part of the ageing process; due to not going to the toilet when having the urge to defecate; hereditary; caused by stress or worry; and caused by environmental exposure. GP participants suggested that constipation is due to changes in diet and lifestyle; the physiology and degenerative processes of ageing; and the iatrogenic impact of opiate medications. Nurse participants identified that constipation is linked to decreased mobility, decreased food intake, decreased fluid intake and consumption of certain medications. For many older people their constipation emerged as a problem over a period of time; for some the 'condition' had existed for many years. Self-management of constipation had typically been their first response to the symptoms and continued once professional help had been sought. Older participants had a wide experience of different management strategies and treatments for constipation, and at the time of the study had firm preferences about the laxatives they would use. GP participants recognised the experience and use of laxatives of their patients. They exhibited strong personal preferences for different laxatives, often prescribing them in combination. Nurses were more likely than GPs to treat and prevent constipation using non-laxative measures; these included providing advice on appropriate dietary changes, increasing fluid intake and, if possible, encouraging exercise and mobility. CONCLUSIONS: There is little shared understanding between patients and professionals about 'normal' bowel function with little consensus in general practice of the optimum management strategies for chronic constipation and the most effective strategies to use. Chronic constipation is seen as less important than other conditions prevalent in general practice (e.g. diabetes) because it is not an agreed management target within national frameworks. Consequently, practitioners had little interest in constipation as a research topic. Patient preferences and the absence of patient equipoise formed an enormous barrier to the recruitment of patients in the implementation of this trial. Studies are needed to investigate different methods of recruitment within the constraints of current ethical guidelines on 'opting in' and to identify barriers and facilitators to recruitment to complex trials in general. Patient preference trials and natural cohort observational studies are also needed to investigate the effectiveness or cost-effectiveness of different laxatives and treatment strategies in the management of chronic constipation.


Subject(s)
Constipation/drug therapy , Laxatives/therapeutic use , Aged , Aged, 80 and over , Cathartics/economics , Cathartics/therapeutic use , Chronic Disease , Constipation/economics , Cost-Benefit Analysis , Dietary Fiber/economics , Dietary Fiber/therapeutic use , Female , Humans , Laxatives/economics , Male , Middle Aged , Treatment Outcome
15.
Geriatr Nurs ; 28(2): 104-11, 2007.
Article in English | MEDLINE | ID: mdl-17430744

ABSTRACT

We sought to determine the effect of a natural laxative mixture compared with daily prescribed laxatives on bowel movement frequency in elderly long-term care residents. Secondary endpoints included ease of administration and costs of the natural laxative. A randomized controlled trial comparing the effect of the Beverley-Travis natural laxative mixture to prescribed laxatives was conducted over an 8-week period. Subjects were randomized to treatment and control groups; control subjects continued on regularly prescribed laxatives, and treatment group subjects discontinued prescribed laxatives and received 2 tablespoons of the natural laxative mixture twice a day for the remaining 4-week period. Bowel movement frequency and consistency were collected, and ease of natural laxative administration as well as costs associated with use of the natural or prescribed laxatives were calculated. The study included 45 residents, with 34 completing the 8-week study period (16 treatment group subjects and 18 control subjects). Treatment group subjects had a significant increase in average number of bowel movements from 15.5 to 22.2 (P = .007) following initiation of the natural laxative, and no difference in bowel movement frequency was observed among control subjects (P = NS). The natural laxative mixture was rated as "easy" or "very easy" to administer by 90%-92% of nurses, and cost savings of $103.04 was estimated. The Beverley-Travis natural laxative mixture, given at a dosage of 2 tablespoons twice daily, is easy to use, cost-effective, and more effective than daily prescribed laxatives at producing normal bowel movements.


Subject(s)
Cathartics/therapeutic use , Constipation/prevention & control , Dietary Fiber/therapeutic use , Fruit , Activities of Daily Living , Aged , Aged, 80 and over , Analysis of Variance , Cathartics/chemistry , Cathartics/economics , Clinical Nursing Research , Defecation/drug effects , Dietary Fiber/analysis , Dietary Fiber/economics , Drug Administration Schedule , Drug Costs , Factor Analysis, Statistical , Female , Ficus , Fruit/chemistry , Geriatric Assessment , Humans , Male , Midwestern United States , Pilot Projects , Prunus , Ribes , Skilled Nursing Facilities , Treatment Outcome , Vitis
17.
Gerodontology ; 22(2): 106-8, 2005 Jun.
Article in English | MEDLINE | ID: mdl-15934353

ABSTRACT

BACKGROUND: Chronic constipation is a common and bothersome problem in elderly nursing home patients. Although fibre has a known role in the treatment of constipation, laxatives are still widely used in nursing home patients. OBJECTIVE: To determine whether the addition of a fibre supplement to oral diet can reduce the use of laxatives in a long-term care facility. PARTICIPANTS AND METHODS: Oral diet of 92 nursing home residents (all older than 65) on chronic laxatives (docusate, milk of magnesia with Cascara, psyllium) was supplemented with 'Fiber 7', a natural powder fibre (7 g per meal twice a day). During the next 2.5 years discontinuation of laxatives was attempted. RESULTS: Laxatives were successfully discontinued in 63 of the 92 patients (68.5%, 95% confidence interval 59-78%). The fibre supplement was well tolerated. The cost of care was decreased by dollar 3.5 per patient every month or by dollar 220/month for the 63 patients. CONCLUSIONS: Use of 'Fiber 7' allowed discontinuation of laxatives in 63 of 92 nursing home residents. The fibre supplement was a safe and convenient alternative to laxatives and decreased the cost of medical care.


Subject(s)
Constipation/prevention & control , Dietary Fiber/therapeutic use , Nursing Homes , Aged , Aged, 80 and over , Cathartics/economics , Cathartics/therapeutic use , Chronic Disease , Female , Frail Elderly , Humans , Male , Prospective Studies
18.
J Am Med Dir Assoc ; 6(3 Suppl): S32-4, 2005.
Article in English | MEDLINE | ID: mdl-15890292

ABSTRACT

OBJECTIVE: The objective of this report is to describe a cost-effective strategy for management of constipation in nursing home residents with dementia. DESIGN: We conducted a prospective observational quality improvement study of 41 residents with chronic constipation and receiving an osmotic laxative. Sorbitol was substituted for lactulose. SETTING: The study was conducted at a dementia special care unit at a Veterans Administration hospital. MEASUREMENT: We measured the number and amount of laxative use over a period of 4 weeks that were required to maintain regular bowel function. RESULTS: There was no difference in efficacy of lactulose and sorbitol. Use of additional laxatives was infrequent: Milk of Magnesia on approximately 10% of days/patient, bisacodyl suppository on 2% to 4% of days/patient, and Fleet enema only on 3 occasions. The cost of constipation management using routine administration of sorbitol and as-needed use of other laxatives was 27% to 55% lower than the cost of other constipation management strategies reported in the literature. CONCLUSION: Substitution of sorbitol for lactulose does not change efficacy of the treatment and decreases cost. Regular use of an osmotic laxative avoids the costs and discomforts of rectal laxatives.


Subject(s)
Cathartics/economics , Constipation/drug therapy , Dementia/complications , Drug Costs , Sorbitol/economics , Aged , Aged, 80 and over , Cathartics/therapeutic use , Chronic Disease , Constipation/complications , Cost-Benefit Analysis , Humans , Lactulose/economics , Lactulose/therapeutic use , Male , Middle Aged , Prospective Studies , Sorbitol/therapeutic use , United States , Veterans
19.
Pharmacoeconomics ; 23(5): 461-76, 2005.
Article in English | MEDLINE | ID: mdl-15896098

ABSTRACT

Constipation is a prevalent condition that disproportionately affects women and older adults and leads to self-medication and/or medical consultation. It occurs as a result of functional idiopathic causes or secondarily as a result of a variety of factors including dietary and exercise patterns, adverse effects of medication and disease processes. Constipation is often perceived to be a benign, easily treated condition with short-term treatment being relatively straightforward; however, chronic constipation is associated with mild complications that, left untreated, can develop into more serious bowel complaints (faecal impaction, incontinence and bowel perforations) with further implications for healthcare costs and the patient's health-related quality of life (HR-QOL). This review summarises the evidence of the HR-QOL impact and economic burden of constipation on patients. Relatively few studies have systematically explored the HR-QOL and economic impact of constipation; however, the existing evidence suggests that HR-QOL is lower in patients with constipation than in non-constipated individuals, and treatments for constipation improve HR-QOL. Additionally, constipation represents an economic burden for the patient and healthcare provider. Resource utilisation associated with the diagnosis and management of constipation is a significant cost driver, whereas constipation prevention programmes have demonstrated cost savings.


Subject(s)
Constipation/economics , Quality of Life/psychology , Cathartics/economics , Cathartics/therapeutic use , Constipation/physiopathology , Constipation/psychology , Health Resources/statistics & numerical data , Humans
20.
Scand J Caring Sci ; 19(1): 71-6, 2005 Mar.
Article in English | MEDLINE | ID: mdl-15737169

ABSTRACT

BACKGROUND AND AIMS: Constipation is a common problem in geriatric wards and in the elderly population. Although high-fibre diets can help relieve constipation non-pharmacologically in many patients, traditional laxatives still remain the standard treatment. A fibre supplement in the form of raw bran is not always well tolerated. We wanted to study the effects of a daily consumption of a fruit- and fibre-rich porridge on stool frequency, perceived well-being and the costs for laxatives, when compared with traditional treatment with laxatives, in geriatric patients. METHODS: Twenty patients in secondary geriatric wards (hospital rehabilitation wards) were randomized into an intervention group (porridge group) and a control group (standard diet without porridge) for a 1-week run-in and 2-week study, with registration of clinical data, e.g. medical treatment, laxative consumption, stool frequency and perceived well-being. RESULTS: The patients in the porridge group had a daily defaecation without laxatives on average 76% of the time (10.7/14 days) compared with 23% of the time (3.3/14 days) in the non-porridge group (p = 0.003). The discomfort was less in the porridge group (2.5 vs. 6.5 on a 10-degree visual analogue scale, p = 0.008) when compared with the control group. The cost for laxatives was 93% lower in the intervention group (2.5 vs. 37.5) for the 2-week study. CONCLUSIONS: A fibre-rich porridge was effective, well liked and tolerated and reduced the need for laxatives in geriatric patients. We conclude that a daily fibre-rich meal ought to be included in the treatment strategies of constipation in hospital wards.


Subject(s)
Constipation/prevention & control , Dietary Fiber , Edible Grain , Fruit , Aged , Cathartics/economics , Costs and Cost Analysis , Female , Humans , Male , Sweden
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