Reviewing the evidence for using continuous subcutaneous metoclopramide and ondansetron to treat nausea & vomiting during pregnancy.

OBJECTIVE: To examine the medical evidence regarding the clinical efficacy and cost-effectiveness of the application of continuous subcutaneous metoclopramide and ondansetron to treat nausea and vomiting during pregnancy. STUDY DESIGN: All of the published peer-reviewed articles on the subject were assembled and assigned a level of evidence based on research design. The search uncovered one level II matched, controlled trial and three level III uncontrolled, retrospective case series published in peer review journals, as well as a book chapter. The book chapter, although not subjected to the peer-review process, is included in this review due to the paucity of other evidence. RESULTS: The matched cohort trial showed that continuous subcutaneous metoclopramide is significantly less-tolerated than continuous subcutaneous ondansetron (31.8% vs. 4.4%; P < 0.001). The four case series reported complete symptom resolution for 63.9% to 75% of the patients. Complications arose in 24.9% to 30.5% of the selected cases that were severe enough to require discontinuation of therapy. Complications included side effects of a worsening of symptoms. All of the trials are retrospective and observational in nature and, therefore, subject to the limitations inherent in the research design. Absent the benefit of meaningful cohort controls, comparative statements effectiveness cannot be substantiated with the available data. CONCLUSION: Randomized, controlled trials of sufficient power are necessary before long-term continuous subcutaneous metoclopramide or ondansetron can be used on a widespread basis to treat nausea and vomiting during pregnancy. Cost approximations in the case series are reported and, when compared to the cost of other methods of treatment previously published in the medical literature, the therapy appears to be cost-prohibitive. However, definitive statements cannot be made regarding cost-effectiveness until clinical efficacy is demonstrated through a sufficiently powered, well-designed, randomized control trial (RCT). Until such time, the therapy should remain experimental and coverage be restricted to intractable hyperemesis gravidarum (HG) that is unresponsive to more-conventional treatment options.

In utero beta 2 adrenergic agonist exposure and adverse neurophysiologic and behavioral outcomes.

Beta 2 adrenergic receptor overstimulation during critical periods of prenatal development can induce a permanent shift in the balance of sympathetic-to-parasympathetic tone. This is a biologically plausible mechanism whereby beta 2 adrenergic agonists can induce functional and behavioral teratogenesis, which explains their association with increases in autism spectrum disorders, psychiatric disorders, poor cognitive, motor function and school performance, and changes in blood pressure in the offspring. The use of beta 2 adrenergic agonists should be limited to proven indications when alternate drugs are ineffective or unavailable; the risks of untreated disease to the mother and fetus are greater than the risk of the beta 2 adrenergic agonist.

Home uterine activity monitoring: an evidence review of its utility in multiple gestations.

OBJECTIVE: To examine the medical evidence regarding the application of home uterine activity monitoring for multiple gestations. STUDY DESIGN: All of the published peer-reviewed articles on the topic were assembled and assigned a level of evidence based on research design. The search uncovered 9 articles, including 3 Level I randomized, controlled trials; 1 level II matched cohort trial; and 5 level III case series. RESULTS: The first 5 trials all showed promising results for home uterine activity monitoring applied to multiple gestations. Ultimately, however, 14 years after the introduction of home uterine activity monitoring, the largest randomized, controlled trial was published, and it demonstrated that pregnancy outcomes were identical for patients with home uterine activity monitoring and patients receiving weekly calls from a nurse. A subsequent National Institute of Child Health and Human Development published trial may provide a clue as to why the large, randomized, controlled trial demonstrated no difference. CONCLUSION: Contractions in multiple gestations are not predictive of preterm birth.

Home uterine activity monitoring: the role of medical evidence.

The current paradigm in obstetrics has shifted toward evidence-based medicine, and yet in clinical practice physicians continue to use interventions for which there exists no credible evidence. This article examines the U.S. Food and Drug Administration (FDA) status of home uterine activity monitoring (HUAM) and the published clinical trials examining HUAM for the management of current preterm labor. The use of HUAM was introduced into clinical practice and heavily marketed without benefit of scientific rigor. Gradually, HUAM use migrated primarily for patients diagnosed (or misdiagnosed) with preterm labor in the current pregnancy who are stabilized and sent home with or without a tocolytic. This clinical intervention has not been cleared by the FDA, has virtually no scientific support, and constitutes a gross deviation from evidence-based medicine. As obstetricians accept the role of medical evidence steering clinical practice, HUAM clearly has no clinical value and therefore should not be used to manage patients outside of a randomized controlled clinical trial.

Nausea and vomiting of pregnancy: cost effective pharmacologic treatments.

Nausea and vomiting of pregnancy (NVP) can range from morning sickness to moderate NVP to hyperemesis gravidarum (HG). If it is left unmanaged, health plans may pay for expensive unproven outpatient therapies that are not necessary for treatment of simple morning sickness or moderate NVP. Meanwhile, patients with serious hyperemesis gravidarum whose treatment is delayed may suffer needlessly, ending up with multiple hospitalizations or emergency room (ER) visits. Two expensive, heavily marketed outpatient therapies with scant supportive evidence in the treatment of NVP have recently emerged and some health plans are providing coverage without a thorough review of the medical evidence or cost implications. Health plans may have an opportunity to save a significant amount and to improve member satisfaction by utilizing evidence-based knowledge of pharmacologic interventions that are driven, in order, by known safety, proven efficacy, and cost effectiveness.

An integrative review of peer support for patients undergoing major limb amputation.

Medical literature is replete with evidence regarding physical rehabilitation of the amputee; however, scant attention has been paid to psychological rehabilitation. The objective was to perform an integrative review of the published medical evidence regarding amputee peer support in the civilian population and provide an evidence-based clinical practice recommendation. This study was based on an exhaustive examination of the civilian amputee peer support medical evidence, bibliographic search, and on the experience of the authors when performing this integrative review. Our search uncovered 10 published peer-reviewed pieces of medical evidence including one level III retrospective case controlled trial, two level IV case series, and seven level V expert opinions. Given the totality of the published evidence, albeit limited, in favor of amputee peer support, an abundance of unpublished anecdotal evidence, virtually no potential risk of harm, and low cost, it seems reasonable to recommend incorporating a preoperative and/or postoperative peer visit in clinical protocols for all patients incurring a major limb amputation.

Removable Rigid Dressings for Postoperative Management of Transtibial Amputations: A Review of Published Evidence.

Forty years of clinical experience and peer-reviewed research studies support the use of nonweight-bearing removable rigid dressings (RRDs) as an effective means of postoperative management of transtibial amputations. We reviewed the published medical evidence regarding the use of RRDs as a postoperative management strategy, culminating in an evidence-based practice recommendation. Published peer-reviewed literature on the topic was searched and classified by level of evidence based on the research design using the scale recommended by the PM&R (level I through V). The search uncovered a total of 15 articles, including 5 level I randomized controlled trials, 6 level III retrospective matched controlled trials, and 4 level V case reports. A number of benefits associated with the application of RRDs compared with soft dressings were reported across these 15 studies. These included faster healing times, reduced limb edema, preparatory contouring of the residual limb in anticipation of prosthetic use, the prevention of knee flexion contractures, and reduced external trauma to the limb. Also described were an increased probability of successful prosthetic use and pain reduction. The RRDs studied permitted regular inspection of surgical wounds with greater ease and consistency of application than traditional soft dressing approaches. Rigid dressings provide all the same benefits of RRDs except ease of wound inspection, therefore rendering them impractical for the 82% of patients receiving an amputation for ischemic disease that are at high risk of developing wound dehiscence. Weight-bearing immediate postoperative prostheses are almost exclusively reserved for use on trauma patients who usually do not show evidence of vascular or neurologic impairment. The inherent risks of falls and inconsistent pressure on the surgical wound have further restricted their use in practice to a limited patient type. The benefits of RRDs compared with soft dressings are universally recognized in the published peer-reviewed medical evidence to be superior to soft dressings. Based on the best-available current published evidence, nonweight-bearing removable rigid dressings should be considered the first treatment choice for the postoperative care of transtibial amputees to optimize outcomes with regard to reductions in injury due to falls, knee flexion contractures, edema, healing time, time to prosthetic fitting, and pain. LEVEL OF EVIDENCE: II.