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  1. Article ; Online: Cost of Constipation: A New Look With a Focus on New Medications.

    Bielefeldt, Klaus

    Journal of clinical gastroenterology

    2021  Volume 56, Issue 3, Page(s) 249–256

    Abstract: Goal: The study was designed to assess drug costs for constipation therapy and to relate costs to markers of functional status.: Background: Secretagogues have been introduced as new agents for the treatment of constipation. Previously published ... ...

    Abstract Goal: The study was designed to assess drug costs for constipation therapy and to relate costs to markers of functional status.
    Background: Secretagogues have been introduced as new agents for the treatment of constipation. Previously published modeling studies suggested that improved productivity lowers the indirect disease burden and balances the higher drug costs.
    Study: Data were abstracted from the publicly available Medical Expenditure Panel Survey to identify adults with a functional gastrointestinal disorder who received a prescription for laxatives or secretagogues covering >2 days. Demographic data, recorded health care utilization and cost, and markers of functional status were extracted for the years from 2005 to 2017 to determine differences between participants treated with secretagogues or laxatives.
    Results: The cohort of 2006 persons was female predominant [67.8%; age: 56.9 (55.8-57.9) years] and spent $92.89 (75.68-110.10) for medications treating constipation. The use of secretagogues (10.3% of the cohort) was the best independent predictor of constipation treatment costs. Using quality of life measures, perceived limitations in activities or work, and absenteeism, there was no difference between participants receiving laxatives and those taking secretagogues.
    Conclusion: Using survey data designed to be representative of the United States population, the study identified secretagogues as a key cost factor in drug treatment of constipation. The results do not support models suggesting improved role functioning offsets these higher direct expenditures. While prospective comparative studies are needed to more definitively correlate costs with direct or indirect benefits of different agents, limiting the use of more expensive medications to otherwise refractory cases may help to reign in the spiraling health care costs in this country.
    MeSH term(s) Adult ; Constipation/drug therapy ; Female ; Health Expenditures ; Humans ; Laxatives/therapeutic use ; Middle Aged ; Prospective Studies ; Quality of Life ; United States
    Chemical Substances Laxatives
    Language English
    Publishing date 2021-03-09
    Publishing country United States
    Document type Journal Article
    ZDB-ID 448460-5
    ISSN 1539-2031 ; 0192-0790
    ISSN (online) 1539-2031
    ISSN 0192-0790
    DOI 10.1097/MCG.0000000000001514
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  2. Article ; Online: Perceived Barriers to Treatment in Persons Treated for Functional Gastrointestinal Disease with Constipation.

    Bielefeldt, Klaus

    Digestive diseases and sciences

    2020  Volume 66, Issue 3, Page(s) 739–750

    Abstract: Introduction: Despite expanding treatment options, patients with functional gastrointestinal disorders (FGID) frequently express concerns about problems with access to care. We hypothesized that health insurance coverage contributes to the perceived ... ...

    Abstract Introduction: Despite expanding treatment options, patients with functional gastrointestinal disorders (FGID) frequently express concerns about problems with access to care. We hypothesized that health insurance coverage contributes to the perceived problems with care delivery.
    Methods: Using the Medical Expenditure Panel Survey, we examined a cohort of participants defined by the diagnosis code for FGID plus the recorded prescription for laxative therapy. Demographic data, healthcare utilization and cost, insurance coverage, comorbid conditions, and information about provider characteristics were extracted for the years 2005-2015. Age- and sex-matched controls were identified for each year included. Barriers to care were based on responses to questions about inability to receive timely care or medication. Logistic regression was used to identify independent predictors of perceived barriers.
    Results: The cohort was female predominant (67.8%; mean age: 58.8 ± 0.33 years) with 15.4% reporting problems with access to care. Limited insurance coverage was most commonly cited by respondents. Consistent with this result, uninsured persons were significantly more likely to report barriers to care, while the type of insurance for those covered did not independently predict access problems. In addition, comorbidity burden and provider-specific factors, such as available contact options or insufficient explanations, correlated with perceived barriers to care delivery.
    Conclusion: While the study design cannot establish causal links, persons with FGID commonly report access problems, which correlate with lack of health insurance and comorbidities. Providers can influence this perception by offering more flexible office hours and incorporating patient expectations related to treatment explanations and shared decision-making.
    MeSH term(s) Case-Control Studies ; Constipation/complications ; Constipation/economics ; Constipation/therapy ; Female ; Gastrointestinal Diseases/complications ; Gastrointestinal Diseases/economics ; Gastrointestinal Diseases/therapy ; Health Expenditures/statistics & numerical data ; Health Services Accessibility/economics ; Health Services Accessibility/statistics & numerical data ; Humans ; Insurance Coverage/statistics & numerical data ; Logistic Models ; Male ; Middle Aged ; Patient Acceptance of Health Care/psychology ; Patient Acceptance of Health Care/statistics & numerical data ; Perception ; Time-to-Treatment/economics ; Time-to-Treatment/statistics & numerical data
    Language English
    Publishing date 2020-08-20
    Publishing country United States
    Document type Evaluation Study ; Journal Article
    ZDB-ID 304250-9
    ISSN 1573-2568 ; 0163-2116
    ISSN (online) 1573-2568
    ISSN 0163-2116
    DOI 10.1007/s10620-020-06544-4
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  3. Article ; Online: Time Trends in Healthcare Utilization Due to Self-Reported Functional Diseases of the Stomach.

    Bielefeldt, Klaus

    Digestive diseases and sciences

    2020  Volume 65, Issue 10, Page(s) 2824–2833

    Abstract: Introduction: Cohort studies from referral centers suggest an increasing burden of functional gastric disorders, with frequent emergency room (ER) visits, hospitalizations, or absenteeism. We hypothesized that recruitment from tertiary care sites skews ... ...

    Abstract Introduction: Cohort studies from referral centers suggest an increasing burden of functional gastric disorders, with frequent emergency room (ER) visits, hospitalizations, or absenteeism. We hypothesized that recruitment from tertiary care sites skews results and thus investigated the burden of these illnesses, using the population-based data of the Medical Expenditure Panel Survey (MEPS).
    Methods: Using MEPS data for the years 2000-2015, demographic, economic, healthcare-related, and quality-of-life indicators were extracted for adults reporting the diagnosis of functional gastric diseases to assess trends and to compare results with data from all adults surveyed.
    Results: Between 2000 and 2015, 2.7 ± 0.2% of the adults surveyed reported a functional gastric illness. Within the period studied, 28.8 ± 2.8% and 17.9 ± 1.6% of this cohort reported ER visits or hospitalizations, respectively. Only a fraction of these persons attributed the ER visits (22.6 ± 0.9%) or admissions (10.9 ± 0.8%) to the functional gastric disorder. Rates remained stable rates during the period studied. Female sex, measures of physical function, comorbidities, and an income below the poverty line were predictors of healthcare utilization. While utilization was stable over time, annual costs increased by 113.9 ± 16.6% during the study period, outpacing the inflation rate of 37.6%.
    Conclusions: Persons with functional gastric disorders have significant healthcare needs and face increasing costs of care, largely due to coexisting illnesses. While it is important to recognize this impact, the need for emergency care or hospitalizations remained stable and lower than reported for patients seen in tertiary referral centers, providing reassuring information for patients and providers.
    MeSH term(s) Comorbidity ; Emergency Service, Hospital/trends ; Female ; Functional Status ; Health Care Costs/trends ; Health Resources/economics ; Health Resources/trends ; Hospitalization/trends ; Humans ; Male ; Middle Aged ; Quality of Life ; Risk Factors ; Self Report ; Social Determinants of Health/trends ; Stomach Diseases/diagnosis ; Stomach Diseases/economics ; Stomach Diseases/epidemiology ; Stomach Diseases/therapy ; Time Factors ; United States/epidemiology
    Language English
    Publishing date 2020-02-22
    Publishing country United States
    Document type Comparative Study ; Journal Article
    ZDB-ID 304250-9
    ISSN 1573-2568 ; 0163-2116
    ISSN (online) 1573-2568
    ISSN 0163-2116
    DOI 10.1007/s10620-020-06154-0
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  4. Article ; Online: Adverse events of gastric electrical stimulators recorded in the Manufacturer and User Device Experience (MAUDE) Registry.

    Bielefeldt, Klaus

    Autonomic neuroscience : basic & clinical

    2017  Volume 202, Page(s) 40–44

    Abstract: The role of gastric electrical stimulation for patients with refractory symptoms of gastroparesis remains controversial. Open label studies suggest benefit while randomized controlled trials did not demonstrate differences between active and sham ... ...

    Abstract The role of gastric electrical stimulation for patients with refractory symptoms of gastroparesis remains controversial. Open label studies suggest benefit while randomized controlled trials did not demonstrate differences between active and sham intervention. Using a voluntary reporting system of the Federal Drug Administration, we examined the type and frequency of adverse events.
    Methods: We conducted an electronic search of the Manufacturer and User Device Experience (MAUDE) databank using the keyword 'Enterra' for the time between January of 2001 and October of 2015. We abstracted information about the year of stimulator implantation, the year and type of adverse effect, the resulting intervention and outcome if available.
    Results: A total of 1587 entries described adverse effects related the GES. Only 36 of the reports listed perioperative complications. The vast majority described problems that could be classified as patient concerns, local complications, or system failure. The most common problem related lack or loss of efficacy, followed by pain or complications affecting the pocket site. A subset of 801 reports provided information about the time between system implant and registration of concerns, which gradually declined over time. More than one third (35.7%) of the reported adverse events prompted surgical correction.
    Conclusion: The number of voluntarily reported adverse events and the high likelihood of repeated surgical interventions clearly demonstrate the potential downside of gastric electrical stimulation. Physicians considering this intervention will need to carefully weigh these risks and include this information when counseling or consenting patients.
    MeSH term(s) Databases, Factual ; Electric Stimulation Therapy/adverse effects ; Electrodes, Implanted/adverse effects ; Gastroparesis/therapy ; Humans ; Postoperative Complications ; Registries
    Language English
    Publishing date 2017-01
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 2020105-9
    ISSN 1872-7484 ; 1566-0702
    ISSN (online) 1872-7484
    ISSN 1566-0702
    DOI 10.1016/j.autneu.2016.01.003
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  5. Article ; Online: From Harmful Treatment to Secondary Gain: Adverse Event Reporting in Dyspepsia and Gastroparesis.

    Bielefeldt, Klaus

    Digestive diseases and sciences

    2017  Volume 62, Issue 11, Page(s) 2999–3013

    Abstract: Introduction: Medical management of gastroparesis and functional dyspepsia remains difficult with several recent trials showing limited or no benefit. If treatment comes with only marginal improvements, concerns about adverse events become more relevant. ...

    Abstract Introduction: Medical management of gastroparesis and functional dyspepsia remains difficult with several recent trials showing limited or no benefit. If treatment comes with only marginal improvements, concerns about adverse events become more relevant. We therefore examined the type and outcomes of side effects submitted to a public repository.
    Methods: We searched the Federal Adverse Event Reporting System for reports associated with the treatment of dyspepsia or gastroparesis. Demographic data, medications used and implicated, side effects, and outcomes were abstracted for the years 2004-2015.
    Results: Acid-suppressive agents and prokinetics were the most commonly listed medications with a stronger emphasis on prokinetics in gastroparesis. Submissions related to metoclopramide by far exceeded reports about other agents and mostly described tardive dyskinesia or other neurological concerns. They peaked around 2012, driven by submissions through legal workers. Most reports about metoclopramide described short-term use to prevent or treat nausea and vomiting. Concerns about acid-suppressive medications increased over time and spanned a wide spectrum of potential problems, including osteoporosis, worsening renal function, or cardiac events.
    Conclusion: Despite biasing factors, such as pending legal action, the voluntary repository of adverse events provides insight into current medical practice and its associated risk. Knowing about common and uncommon, but potentially serious risks may enable patients and providers to decide on effective and safe management strategies.
    MeSH term(s) Adult ; Adverse Drug Reaction Reporting Systems ; Aged ; Antiemetics/adverse effects ; Databases, Factual ; Deglutition Disorders/diagnosis ; Deglutition Disorders/drug therapy ; Deglutition Disorders/physiopathology ; Dopamine D2 Receptor Antagonists/adverse effects ; Female ; Gastrointestinal Agents/adverse effects ; Gastroparesis/diagnosis ; Gastroparesis/drug therapy ; Gastroparesis/physiopathology ; Humans ; Male ; Metoclopramide/adverse effects ; Middle Aged ; Patient Safety ; Proton Pump Inhibitors/adverse effects ; Risk Assessment ; Risk Factors ; Tardive Dyskinesia/chemically induced ; Time Factors ; Treatment Outcome
    Chemical Substances Antiemetics ; Dopamine D2 Receptor Antagonists ; Gastrointestinal Agents ; Proton Pump Inhibitors ; Metoclopramide (L4YEB44I46)
    Language English
    Publishing date 2017-11
    Publishing country United States
    Document type Journal Article
    ZDB-ID 304250-9
    ISSN 1573-2568 ; 0163-2116
    ISSN (online) 1573-2568
    ISSN 0163-2116
    DOI 10.1007/s10620-017-4633-8
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  6. Article ; Online: Adverse Events After Implantation of a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux.

    Bielefeldt, Klaus

    Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

    2016  Volume 14, Issue 10, Page(s) 1507–1508

    MeSH term(s) Esophageal Sphincter, Lower ; Gastroesophageal Reflux ; Humans ; Magnets
    Language English
    Publishing date 2016
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 2119789-1
    ISSN 1542-7714 ; 1542-3565
    ISSN (online) 1542-7714
    ISSN 1542-3565
    DOI 10.1016/j.cgh.2016.05.003
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  7. Article: Adverse events of sacral neuromodulation for fecal incontinence reported to the federal drug administration.

    Bielefeldt, Klaus

    World journal of gastrointestinal pharmacology and therapeutics

    2016  Volume 7, Issue 2, Page(s) 294–305

    Abstract: Aim: To investigate the nature and severity of AE related to sacral neurostimulation (SNS).: Methods: Based on Pubmed and Embase searches, we identified published trials and case series of SNS for fecal incontinence (FI) and extracted data on adverse ...

    Abstract Aim: To investigate the nature and severity of AE related to sacral neurostimulation (SNS).
    Methods: Based on Pubmed and Embase searches, we identified published trials and case series of SNS for fecal incontinence (FI) and extracted data on adverse events, requiring an active intervention. Those problems were operationally defined as infection, device removal explant or need for lead and/or generator replacement. In addition, we analyzed the Manufacturer and User Device Experience registry of the Federal Drug Administration for the months of August - October of 2015. Events were included if the report specifically mentioned gastrointestinal (GI), bowel and FI as indication and if the narrative did not focus on bladder symptoms. The classification, reporter, the date of the recorded complaint, time between initial implant and report, the type of AE, steps taken and outcome were extracted from the report. In cases of device removal or replacement, we looked for confirmatory comments by healthcare providers or the manufacturer.
    Results: Published studies reported adverse events and reoperation rates for 1954 patients, followed for 27 (1-117) mo. Reoperation rates were 18.6% (14.2-23.9) with device explants accounting for 10.0% (7.8-12.7) of secondary surgeries; rates of device replacement or explant or pocket site and electrode revisions increased with longer follow up. During the period examined, the FDA received 1684 reports of AE related to SNS with FI or GI listed as indication. A total of 652 reports met the inclusion criteria, with 52.7% specifically listing FI. Lack or loss of benefit (48.9%), pain or dysesthesia (27.8%) and complication at the generator implantation site (8.7%) were most commonly listed. Complaints led to secondary surgeries in 29.7% of the AE. Reoperations were performed to explant (38.2%) or replace (46.5%) the device or a lead, or revise the generator pocket (14.6%). Conservative management changes mostly involved changes in stimulation parameters (44.5%), which successfully addressed concerns in 35.2% of cases that included information about treatment results.
    Conclusion: With reoperation rates around 20%, physicians need to fully disclose the high likelihood of complications and secondary interventions and exhaust non-invasive treatments, including transcutaneous stimulation paradigms.
    Language English
    Publishing date 2016-05-03
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2583480-0
    ISSN 2150-5349
    ISSN 2150-5349
    DOI 10.4292/wjgpt.v7.i2.294
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  8. Article ; Online: Ischemic Colitis as a Complication of Medication Use: An Analysis of the Federal Adverse Event Reporting System.

    Bielefeldt, Klaus

    Digestive diseases and sciences

    2016  Volume 61, Issue 9, Page(s) 2655–2665

    Abstract: Background: More than one decade ago, rising cases of ischemic colitis (IC) prompted the Federal Drug Administration to revoke alosetron's approval as treatment of irritable bowel syndrome (IBS). The aim of this study was to identify medical therapies ... ...

    Abstract Background: More than one decade ago, rising cases of ischemic colitis (IC) prompted the Federal Drug Administration to revoke alosetron's approval as treatment of irritable bowel syndrome (IBS). The aim of this study was to identify medical therapies associated with development of IC.
    Methods: The Federal Adverse Event Reporting System was queried for the time between January 2004 and September 2015. We identified reports listing IC as treatment complication and extracted suspected causative and concomitantly administered drugs, indications for their use and outcomes.
    Results: After eliminating duplicates, we found 2811 cases of IC (68.4 % women; 59.4 ± 0.4 years). Patients with IBS accounted for 3.9 % of the cases, mostly attributed to tegaserod or alosetron. Chemotherapeutic and immunosuppressive drugs, sex hormones, and anticoagulants were the most commonly suspected causes. Bisphosphonates, nonsteroidal anti-inflammatory drugs, antipsychotics, triptans, interferon therapy, and laxative use prior to colonoscopy were among the more commonly listed treatments. In 8 %, the adverse event contributed to the patient's death with male sex and older age predicting fatal outcomes.
    Conclusion: Beyond confirming known risks of IC, the results identified several potential culprits of ischemic colitis. This information may not only explain the development of this serious adverse event, but could also guide treatment decisions, cautioning healthcare providers when considering these agents in persons with known risk factors or other drugs that may increase their risk of IC.
    MeSH term(s) Adverse Drug Reaction Reporting Systems ; Age Factors ; Aged ; Anti-Inflammatory Agents, Non-Steroidal/adverse effects ; Anticoagulants/adverse effects ; Antineoplastic Agents/adverse effects ; Antipsychotic Agents/adverse effects ; Autoimmune Diseases/drug therapy ; Bone Density Conservation Agents/adverse effects ; Carbolines/adverse effects ; Colitis, Ischemic/chemically induced ; Colitis, Ischemic/epidemiology ; Colitis, Ischemic/mortality ; Colonoscopy ; Databases, Factual ; Diphosphonates/adverse effects ; Estrogens/adverse effects ; Female ; Gonadal Steroid Hormones/adverse effects ; Humans ; Immunosuppressive Agents/adverse effects ; Indoles/adverse effects ; Interferons/adverse effects ; Irritable Bowel Syndrome/drug therapy ; Laxatives/adverse effects ; Male ; Mental Disorders/drug therapy ; Middle Aged ; Neoplasms/drug therapy ; Osteoporosis/drug therapy ; Preoperative Care ; Serotonin Agents/adverse effects ; Serotonin Antagonists/adverse effects ; Serotonin Receptor Agonists/adverse effects ; Sex Factors ; Tryptamines/adverse effects ; United States/epidemiology
    Chemical Substances Anti-Inflammatory Agents, Non-Steroidal ; Anticoagulants ; Antineoplastic Agents ; Antipsychotic Agents ; Bone Density Conservation Agents ; Carbolines ; Diphosphonates ; Estrogens ; Gonadal Steroid Hormones ; Immunosuppressive Agents ; Indoles ; Laxatives ; Serotonin Agents ; Serotonin Antagonists ; Serotonin Receptor Agonists ; Tryptamines ; alosetron (13Z9HTH115) ; tegaserod (458VC51857) ; Interferons (9008-11-1)
    Language English
    Publishing date 2016-09
    Publishing country United States
    Document type Journal Article
    ZDB-ID 304250-9
    ISSN 1573-2568 ; 0163-2116
    ISSN (online) 1573-2568
    ISSN 0163-2116
    DOI 10.1007/s10620-016-4162-x
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  9. Article ; Online: Bariatric surgery versus intensive medical therapy for diabetes.

    Bielefeldt, Klaus

    The New England journal of medicine

    2014  Volume 371, Issue 7, Page(s) 681–682

    MeSH term(s) Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/surgery ; Female ; Gastrectomy ; Gastric Bypass ; Humans ; Hypoglycemic Agents/therapeutic use ; Male
    Chemical Substances Hypoglycemic Agents
    Language English
    Publishing date 2014-08-14
    Publishing country United States
    Document type Comment ; Letter
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMc1407393#SA4
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  10. Article ; Online: Black bile of melancholy or gallstones of biliary colics: historical perspectives on cholelithiasis.

    Bielefeldt, Klaus

    Digestive diseases and sciences

    2014  Volume 59, Issue 11, Page(s) 2623–2634

    Abstract: Barely 130 years after its first description, cholecystectomies are among the most commonly performed surgeries in the USA. The success of this operation with subsequent technical improvements, such as laparoscopic approaches, caused a paradigm shift in ... ...

    Abstract Barely 130 years after its first description, cholecystectomies are among the most commonly performed surgeries in the USA. The success of this operation with subsequent technical improvements, such as laparoscopic approaches, caused a paradigm shift in the management of gallstone disease. However, symptoms persist in 10-40 % of successfully operated patients. Reviewing monographs, textbooks, and articles published during the last 300 years, several important factors emerge as likely contributors to limited or poor treatment responses. Early on, clinicians recognized that cholelithiasis is quite common and thus often an incidental finding, especially if patients present with vague or atypical symptoms. Consistent with these observations, patients with such atypical symptoms are less likely to benefit from cholecystectomy. Similarly, lasting improvements are more reliably seen in patients with symptoms of presumed biliary origin and documented gallstones compared to individuals without stones, an important point in view of increasing rates of surgery for biliary dyskinesia. While cholelithiasis can cause serious complications, the overall incidence of clinically relevant problems is so low that prophylactic cholecystectomy cannot be justified. This conclusion corresponds to epidemiologic data showing that the rise in elective cholecystectomies decreased hospitalizations due to gallstone disease, but was associated with a higher volume of postoperative complications, ultimately resulting in stable combined mortality due to gallstone disease and its treatment. These trends highlight the tremendous gains in managing gallstone disease, while at the same time reminding us that the tightening rather than expanding indications for cholecystectomy may improve outcomes.
    MeSH term(s) Aging ; Cholecystectomy/history ; Cholecystectomy/methods ; Cholelithiasis/history ; Cholelithiasis/pathology ; Cholelithiasis/surgery ; History, 19th Century ; History, 20th Century ; History, 21st Century ; Humans
    Language English
    Publishing date 2014-08-08
    Publishing country United States
    Document type Historical Article ; Journal Article
    ZDB-ID 304250-9
    ISSN 1573-2568 ; 0163-2116
    ISSN (online) 1573-2568
    ISSN 0163-2116
    DOI 10.1007/s10620-014-3292-2
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