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For European patent applications filed before 1 April 2009 and international applications entering the European phase before that date, any page fees under Art. 2(2), item 7.2, RFees are part of the fee for grant and printing. Therefore, if only page fees were not paid in due time, the fee for further processing amounts to the flat fee ( Art. 2(1), item 12 RFees, second indent, RFees).http://dev.pb-adcon.de/node/20899 This applies regardless of whether the applicant is informed of the non-performance of procedural acts in one communication or in several communications. In such cases, a fee for further processing is due in respect of each unobserved time limit. For an example, see E?VIII, 3.1.3. RANDY SWARTZ, M.D., University of California, San Diego, School of Medicine, La Jolla PAXTON LONGWELL, M.D., California; Corpus Christi, Texas Am Fam Physician. 2005 Mar 15;71(6):1115-1122. As patients age, vertigo becomes an increasingly common presenting complaint. The most common causes of this condition are benign paroxysmal positional vertigo, acute vestibular neuronitis or labyrinthitis, Meniere’s disease, migraine, and anxiety disorders. Less common causes include vertebrobasilar ischemia and retrocochlear tumors. The distinction between peripheral and central vertigo usually can be made clinically and guides management decisions. Most patients with vertigo do not require extensive diagnostic testing and can be treated in the primary care setting. Benign paroxysmal positional vertigo usually improves with a canalith repositioning procedure. Acute vestibular neuronitis or labyrinthitis improves with initial stabilizing measures and a vestibular suppressant medication, followed by vestibular rehabilitation exercises. Meniere’s disease often responds to the combination of a low-salt diet and diuretics. Vertiginous migraine headaches generally improve with dietary changes, a tricyclic antidepressant, and a beta blocker or calcium channel blocker. Vertigo associated with anxiety usually responds to a selective serotonin reuptake inhibitor. Associated symptoms include nausea, emesis, and diaphoresis. Vertigo should be distinguished from other types of dizziness, such as imbalance (dysequilibrium) and lightheadedness (presyncope). Most cases of vertigo can be diagnosed clinically and managed in the primary care setting. A 18, 19, 20 The modified Epley maneuver also is effective in patients with benign paroxysmal positional vertigo. B 16 Vestibular suppressant medication is recommended for symptom relief in patients with acute vestibular neuronitis. C 6, 7, 8 Vestibular exercises are recommended for more rapid and complete vestibular compensation in patients with acute vestibular neuronitis. B 14 Treatment with a low-salt diet and diuretics is recommended for patients with Meniere’s disease and vertigo. B 13, 30, 31, 32 Selective serotonin reuptake inhibitors can relieve vertigo in patients with anxiety disorders. Because of side effects, slow titration is recommended. See page 1046 for more information. Strength of Recommendations Key clinical recommendation Label References The canalith repositioning procedure (Epley maneuver) is recommended in patients with benign paroxysmal positional vertigo. See page 1046 for more information.In contrast, tumors and ototoxic medications produce slowly progressive unilateral or bilateral lesions. Lesions that progress slowly or processes that affect both vestibular apparatuses equally usually do not result in vertigo.The duration of vertiginous episodes and the presence or absence of auditory symptoms can help narrow the differential diagnosis ( Table 1 ). 1 Psychiatric disorders, motion sickness, serous otitis media, cerumen impaction, herpes zoster, and seizure disorders also can present with dizziness. The neurologic examination should include the Dix-Hallpike maneuver to differentiate peripheral from central vertigo 2, 3 ( Figure 1 and Table 2 3, 4 ). This test consists of a series of two maneuvers: With the patient sitting on the examination table, facing forward, eyes open, the physician turns the patient’s head 45 degrees to the right (A). The physician supports the patient’s head as the patient lies back quickly from a sitting to supine position, ending with the head hanging 20 degrees off the end of the examination table. The patient remains in this position for 30 seconds (B). Then the patient returns to the upright position and is observed for 30 seconds. Next, the maneuver is repeated with the patient’s head turned to the left. A positive test is indicated if any of these maneuvers provide vertigo with or without nystagmus. Figure 1. Dix-Hallpike maneuver (used to diagnose benign paroxysmal positional vertigo). A positive test is indicated if any of these maneuvers provide vertigo with or without nystagmus. Information from references 3 and 4. No laboratory testing is absolutely indicated in the work-up of patients with vertigo. If hearing loss is suspected, complete audiometric testing can help distinguish vestibular pathology from retrocochlear pathology (e.g., acoustic neuroma). Brain imaging is warranted if a tumor or stroke is suspected. The American College of Radiology 5 recommends magnetic resonance imaging with contrast medium when a patient presents with acute vertigo and sensorineural hearing loss. Magnetic resonance angiography can be used to evaluate the vertebrobasilar circulation.Vertigo lasting more than a few days is suggestive of permanent vestibular injury (e.g., stroke), and medications should be stopped to allow the brain to adapt to new vestibular input. Information from references 6 and 7. A wide variety of medications are used to treat vertigo and the frequently concurrent nausea and emesis. These medications exhibit various combinations of acetylcholine, dopamine, and histamine receptor antagonism. The American Gastroenterological Association recommends anticholinergics and antihistamines for the treatment of nausea associated with vertigo or motion sickness. 8 Gamma-aminobutyric acid (GABA) is an inhibitory neurotransmitter in the vestibular system. 6 Benzodiazepines enhance the action of GABA in the central nervous system (CNS) and are effective in relieving vertigo and anxiety. Older patients are at particular risk for side effects of vestibular suppressant medications (e.g., sedation, increased risk of falls, urinary retention). These patients also are more likely to experience drug interactions (i.e., additive effects with other CNS depressants). VESTIBULAR REHABILITATION EXERCISES Vestibular rehabilitation exercises commonly are included in the treatment of vertigo 9, 10 (see patient information handout). These exercises train the brain to use alternative visual and proprioceptive cues to maintain balance and gait. It is necessary for a patient to reexperience vertigo so that the brain can adapt to a new baseline of vestibular function. After acute stabilization of the patient with vertigo, use of vestibular suppressant medications should be minimized to facilitate the brain’s adaptation to new vestibular input. A randomized, controlled trial (RCT) 11 of 143 primary care patients with dizziness and vertigo showed that vestibular rehabilitation exercises improved nystagmus, postural control, movement-provoked dizziness, and subjective indexes of symptoms and distress. Another RCT 12 evaluated the effectiveness of home vestibular rehabilitation in patients with chronic vertigo with a peripheral vestibular etiology. This trial 12 showed a significant reduction of vertigo and an increase in the ability to perform activities of daily living independently. A retrospective case series 13 assessed the efficacy of physical therapy in patients who had vestibular and balance disorders with or without a history of migraine. Both groups showed significant alleviation of dizziness and improvement of balance and gait.Medications generally are not recommended for the treatment of this condition. The vertigo improves with head rotation maneuvers that displace free-moving calcium deposits back to the vestibule. Maneuvers include the canalith repositioning procedure or Epley maneuver 15 and the modified Epley maneuver 16 ( Figure 2 ). The modified Epley maneuver can be performed at home. The physician supports the patient’s head as the patient lies back quickly from a sitting to supine position, ending with the head hanging 20 degrees off the end of the examination table (B). The physician turns the patient’s head 90 degrees to the left side. The patient remains in this position for 30 seconds (C). The physician turns the patient’s head an additional 90 degrees to the left while the patient rotates his or her body 90 degrees in the same direction. The patient remains in this position for 30 seconds (D). The patient sits up on the left side of the examination table. (E) The procedure may be repeated on either side until the patient experiences relief of symptoms. Figure 2. Epley maneuver. The patient sits on the examination table, with eyes open and head turned 45 degrees to the right (A). The patient sits up on the left side of the examination table. (E) The procedure may be repeated on either side until the patient experiences relief of symptoms. Patients may need to remain upright for 24 hours after canalith repositioning to prevent calcium deposits from returning to the semicircular canals, although this measure is not universally recommended. Contraindications to canalith repositioning procedures include severe carotid stenosis, unstable heart disease, and severe neck disease, such as cervical spondylosis with myelopathy or advanced rheumatoid arthritis. 17 Canalith repositioning has been found to be effective in patients with benign paroxysmal positional vertigo. The initial report 15 on the Epley maneuver indicated an 80 percent success rate after a single treatment and a 100 percent success rate with repeated treatments. Two subsequent RCTs 18, 19 reported success rates of 50 to 90 percent. A Cochrane systematic review 20 concluded that the Epley maneuver is a safe treatment that is likely to result in improvement of symptoms and conversion from a positive to negative Dix-Hallpike maneuver. However, the review 20 noted that no long-term assessment was performed in either RCT 18, 19 on the use of the Epley maneuver. A study 16 of 54 patients with benign paroxysmal positional vertigo found that the modified Epley maneuver was effective in resolving vertigo symptoms after one week of treatment. This study, however, has been criticized for inadequate randomization and lack of blinding of outcome assessors (patient self-report of symptoms). 20 One study 21 on the long-term effects of canalith repositioning procedures in patients with benign paroxysmal positional vertigo reported a recurrence rate of about 15 percent per year. Another study 22 reported recurrence rates of 20 percent at 20 months and 37 percent at 60 months. VESTIBULAR NEURONITIS AND LABYRINTHITIS Acute inflammation of the vestibular nerve is a common cause of acute, prolonged vertigo. Associated hearing loss occurs if the labyrinth is involved. The vertigo usually lasts a few days and resolves within several weeks. In this disorder, impaired endolymphatic filtration and excretion in the inner ear leads to distention of the endolymphatic compartment. Treatment lowers endolymphatic pressure. Ablation of the vestibular hair cells with intratympanic injection of gentamicin also may be effective. 26 Surgery usually is reserved for patients with severe, refractory Meniere’s disease. VASCULAR ISCHEMIA The sudden onset of vertigo in a patient with additional neurologic symptoms (e.g., diplopia, dysarthria, dysphagia, ataxia, weakness) suggests the presence of vascular ischemia. Acute vertigo caused by a cerebellar or brainstem stroke is treated with vestibular suppressant medication and minimal head movement for the first day. As soon as tolerated, medication should be tapered, and vestibular rehabilitation exercises should be initiated. 8, 10 Placement of vertebrobasilar stents may be considered in a patient with symptomatic critical vertebral artery stenosis that is refractory to medical management. 27 Rarely, infarction or hemorrhage in the cerebellum or brainstem may present with acute vertigo as the only neurologic symptom. 28 Given the risk of brainstem compression with a large cerebellar stroke, neurosurgical decompression may be indicated. MIGRAINE HEADACHES Epidemiologic evidence shows a strong association between vertigo and migraine. 29 Diagnostic criteria have been proposed to provide a more specific definition of vertiginous migraine. 29 Diagnostic accuracy is important because vertiginous migraine may respond better to migraine treatments than to other interventions. One retrospective review 30 found that migraine treatments were effective in about 90 percent of patients with migraine-associated vertigo. Another retrospective chart review 31 demonstrated that stepwise treatment of migraine-associated dizziness (vertigo or dysequilibrium) resulted in complete or dramatic reduction of symptoms in 58 of 81 patients (72 percent). The stepwise treatment consisted of initiating dietary changes, then adding nortriptyline (Pamelor) if needed, then adding atenolol or a calcium channel blocker if needed and, finally, consultation with a neurologist if needed. A survey 32 of 53 patients with migraine at a university-based headache clinic found that the efficacy of medications in treating migraine-associated dizziness was directly correlated with their ability to alleviate migraines. PSYCHIATRIC DISORDERS Vertigo commonly is associated with anxiety disorders (e.g., panic disorder, generalized anxiety disorder) and, less frequently, depression. 33, 34 Hyperventilation usually occurs and can result in hypocapnia with reversible cerebral vasoconstriction. Hyperventilation and hypocapnia may be accompanied by dyspnea, chest pain, palpitations, or paresthesias. Subclinical vestibular dysfunction has been measured in patients with anxiety disorders or depression, most commonly panic disorder with moderate to severe agoraphobia. 33 Conversely, classic vertigo resulting from more ostensible vestibular pathology usually induces severe anxiety symptoms and thus can be hard to distinguish from a primary anxiety disorder. Vestibular suppressants and benzodiazepines most frequently are used to treat dizziness that is associated with anxiety disorder, but these medications provide only transient or inadequate relief. 34 SSRIs such as citalopram (Celexa), fluoxetine (Prozac), paroxetine (Paxil), and sertraline (Zoloft) may provide better relief. A review 34 of 68 patients from a research database at a university neurotology center evaluated open-label SSRI treatment of dizziness associated with psychiatric symptoms (with or without neurotologic illness). Significant improvement of dizziness occurred in 38 patients (63 percent); however, 15 (25 percent) of the 60 patients experienced intolerable side effects. Nonpharmacologic treatments for anxiety disorders, such as cognitive behavior therapy, may be helpful. A small prospective RCT of vestibular rehabilitation combined with cognitive behavior therapy to reduce anxiety in older patients with dizziness showed that this combination of treatments improved gait speed and dizziness symptoms but did not improve anxiety or depression. 35 PHYSIOLOGIC VERTIGO Motion sickness 9 is attributed to an incongruence in the sensory input from the vestibular, visual, and somato-sensory systems. Motion sickness occurs while riding in a car, boat, or airplane if the vestibular and somato-sensory systems sense movement, but the visual system does not. On the first sensation of motion sickness, efforts should be made to bring vestibular, visual, and somato-sensory input back in congruence. For example, a person on a boat who starts to feel seasick should immediately watch the horizon. Seasickness can be prevented by applying a scopolamine patch (Transderm-Scop) behind one ear at least four hours before boating. 8, 36 Read the full article. Get immediate access, anytime, anywhere. Choose a single article, issue, or full-access subscription. Earn up to 6 CME credits per issue.The Authors show all author info RANDY SWARTZ, M.D., is voluntary associate clinical professor in the Department of Family and Preventive Medicine at the University of California, San Diego, School of Medicine, La Jolla, Calif., and assistant program director at the Scripps Family Practice Residency Program, Chula Vista, Calif. The authors indicate that they do not have any conflicts of interest. Sources of funding: none reported. Members of various family medicine departments develop articles for “Practical Therapeutics.” This article is one in a series coordinated by the Department of Family Medicine and Preventive Medicine at the University of California, San Diego, School of Medicine. Guest editor of the series is Tyson Ikeda, M.D. N Engl J Med.Proc R Soc Med.N Engl J Med. In: Greenberg DA, Aminoff MJ, Simon RP.American College of Radiology. ACR Appropriateness Criteria. Radiology.N Engl J Med.Gastroenterology.Curr Treat Options Neurol.Br J Gen Pract.Otolaryngol Head Neck Surg.Otol Neurotol.Otolaryngol Head Neck Surg.Int J Audiol.Otolaryngol Head Neck Surg.Mayo Clin Proc.Cochrane Database Syst Rev.Otolaryngol Head Neck Surg.A double-blind cross-over placebo-controlled study. ORL J Otorhinolaryngol Relat Spec.Otolaryngol Head Neck Surg.Laryngoscope.J Neurosurg.Laryngoscope.Otol Neurotol.Am J Psychiatry.Otolaryngol Head Neck Surg.Am Fam Physician.A person viewing it online may make one printout of the material and may use that printout only for his or her personal, non-commercial reference. This material may not otherwise be downloaded, copied, printed, stored, transmitted or reproduced in any medium, whether now known or later invented, except as authorized in writing by the AAFP. Contact Get Permissions Sign up for the free AFP email table of contents. Learn More. Abstract Objectives To discuss methods of preservation of treatment fidelity in health behavior change trials conducted in public health contexts. Methods The treatment fidelity framework provided by the NIH’s Behavioral Change Consortium (BCC) ( 1 ) includes five domains of treatment fidelity (Study Design, Training, Delivery, Receipt, and Enactment). A measure of treatment fidelity was previously developed and validated using these categories. Results Strategies for assessment, monitoring, and enhancing treatment fidelity within each of the five treatment fidelity domains are discussed. The previously created measure of treatment fidelity is updated to include additional items on selecting providers, additional confounders, theory testing, and multicultural considerations. Conclusions Implementation of a treatment fidelity plan may require extra staff time and costs. However, the economic and scientific costs of lack of attention to treatment fidelity are far greater than the costs of treatment fidelity implementation. Maintaining high levels of treatment fidelity with flexible adaptation according to setting, provider, and patient is the goal for public health trials. MeSH Keywords: Research design, reproducibility of results, reliability and validity, Treatment fidelity, internal validity, external validity, confounders, contamination Treatment fidelity is the ongoing assessment, monitoring, and enhancement of the reliability and internal validity of a study ( 1 ). Treatment fidelity helps to increase scientific confidence that the changes in the dependent variable (outcome of interest) are due to manipulations of the independent variable (presumed to have an effect on the dependent variable). Treatment fidelity consists of two general components: 1) treatment integrity, the degree to which a treatment is implemented as intended, and 2) treatment differentiation, the degree to which two or more study arms differ along critical dimensions ( 2, 3, 4, 5 ). Conclusive statements about treatment effects cannot be made without attention to treatment fidelity. For example, without assessment of treatment fidelity, significant results may be a function of either an effective intervention or the influence of other unknown factors added into (or omitted from) the intervention. The danger of this is Type 1 error (belief that a treatment effect is significant when it is not) and the potential for dissemination of ineffective treatments. Similarly, if treatment fidelity is not measured and there are non-significant effects, it cannot be known whether these effects are due to an ineffective treatment or to the omission or addition of potentially active or inactive components. The danger of this is Type 2 error (erroneous belief that a treatment effect is non-significant ) and the potential for discarding effective treatments ( 2, 6 ). Thus treatment fidelity enhances both the internal validity (the treatment is delivered as intended) and external validity (the treatment can be replicated and applied in real world settings). Rejection of effective programs or acceptance of ineffective programs due to lack of treatment fidelity has untold costs, both financially and to science. If fidelity is not measured during treatment delivery, increased costs may be incurred when independent labs attempt to replicate the original results but are unable to do so because the components of the treatment as actually delivered are unknown. Further costs are incurred if ineffective treatments are disseminated into standard practice. A scientific cost of inferior treatment fidelity is that investigators may unwittingly try to build their careers on results that have little empirical basis (i.e. positive findings could be due to variables other than those specified in the intervention). The current paper will discuss the assessment, monitoring, and enhancement of treatment fidelity in public health trials, with examples from oral health and other health behavior change studies. Benefits of Treatment Fidelity Treatment fidelity allows for the early detection of errors to prevent protocol deviations from becoming widespread and long lasting, which can potentially affect the study’s ultimate conclusion. Monitoring treatment fidelity early in study implementation increases the fidelity of implementation ( 7 ). High levels of treatment fidelity improve treatment retention and reduce attrition ( 8 ). Treatment fidelity is particularly important for cross-site studies, to ensure that treatments are operationalized (defining what is, and what is not, part of the treatment) in the same way across sites and reducing the possibility of site by treatment interactions ( 9, 10 ). Treatment fidelity facilitates theory testing ( 11, 12 ). High levels of treatment fidelity are associated with changes in the mediating variables (mechanisms of change) hypothesized to be responsible for study outcomes ( 13, 14 ). Interventions that adhere more closely to theory have stronger effects ( 15 ). Simply articulating a theory without monitoring fidelity to the theoretical components is associated with weakened treatment effects ( 16 ). Treatment fidelity implementation should, itself, have treatment fidelity. If one treatment is implemented more purely than another, then treatment condition differences may be due to differences in fidelity, rather than to treatment content.