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Variability plays an obvious role in identifying meclizine 25mg on-line medications xr, measuring meclizine 25mg discount treatment uterine cancer, and report- ing these quality indicators and process-of-care improvements (Goldberg et al buy line meclizine 72210 treatment. For example, patient mix may make it difficult to compare process-of-care measures across multiple hospitals in the same system, cre- 48 the Healthcare Quality Book ating the appearance of variation among facilities in providing these serv- ices. Consequently, some healthcare services administrators are reluctant to utilize quality improvement measures and indicators because they are perceived to be biased toward academic medical research centers or large healthcare organizations, which are not believed to experience broad vari- ation (Miller et al. This is an unfortunate and false assumption, as quality improvement efforts can be and have been successfully applied to small organizations and practices, including single-physician practices (Geyman 1998; Miller et al. Clinical and Operational Issues Implementing best practices, establishing clinical indicators, and measur- ing and interpreting variation all involve considerable effort to create and sustain an environment conducive to sustaining these quality improvement efforts. The ability to collect appropri- ate and accurate data that can be rigorously analyzed requires assiduous planning (Ballard 2003). Patient demographics and physician case mix affect the data to be studied and can arbitrarily skew the conclusions. Organizational Size the size of an organization also affects the ability to disseminate best prac- tices. One group of physicians in a large healthcare delivery system might have developed an effective method to achieve high levels of colorectal can- cer screening (Stroud, Felton, and Spreadbury 2003), but the opportunity to describe, champion, and implement such process redesign across dozens of other groups within the system is much more challenging and typically will require incremental resource commitment. Large organizations tend to have rigid frameworks or bureaucracies; change is slow and requires per- severance and the ability to make clear to skeptics and enthusiasts alike the value of the new procedure in their group and across the system. Small practices may be equally difficult, especially if only one or two physicians or decision makers are involved and they are unwilling or uninterested in pursuing quality improvements. Irrespective of organizational size, there is often a complex matrix of demands for quality improvement and change agents, so simply changing one process in one location will not necessar- ily result in quality improvement, especially throughout an organization. Large organizations also create the potential for multiple layers of quality assessment. The Baylor Health Care System (BHCS), located in the Dallas–Fort Worth area, includes 11 hospitals with 83,000 admissions per V ariation in Medical Practice and Implications for Quality 49 year and 47 primary care and senior centers with more than 500,000 vis- its annually. Consequently, BHCS evaluates its quality improvement efforts at both the hospital level and an outpatient level. Obviously, inpatient and outpatient processes of care differ; quality improvement efforts may be widely applicable for inpatient services at all 11 hospitals, but such process redesigns might not necessarily be applicable to the 47 outpatient clinics and senior centers. Value- based purchasing is increasing, whereby consumers and insurers utilize those healthcare facilities that embrace quality improvement efforts and hence provide better processes of care and, arguably, outcomes. The Joint Commission, CMS, and Medicare have established minimum standard lev- els of quality and linked reimbursement schemes to achieving these goals. Although all healthcare organizations are obligated to meet these stan- dards, a number of hospitals and delivery systems chose to use these stan- dards before they were mandatory or have set higher threshold levels because of the compelling business case to do so. Increasing numbers of healthcare organizations fund these efforts internally, both for inpatients and outpa- tients, because it makes sense to do so in terms of outcomes, patient sat- isfaction, and long-term financial picture (happy patients return for additional care or recommend that friends and relatives use the same services) (Ballard 2003; Leatherman et al. Planning the collection and analysis of suitable data for quality meas- ures requires significant forethought, particularly when considering strate- gies to assess true variation and minimize false variation, and includes using appropriate measures, controlling case mix and other variables, minimiz- ing chance variability, and using high-quality data (Powell, Davies, and Thomson 2003). The initial results of a study that compared generalists to endocri- nologists in providing care to patients with diabetes showed what most people might expect, that specialists provided better care. Adjusting for patient case-mix bias and clustering (physician-level variation) substantially altered the results: there was no difference between generalists and endocri- nologists in providing care to diabetes patients. Studies must be designed with sufficient power and sophistication to account for a variety of con- founding factors and require sufficient numbers of physicians and patients per physician to avoid distorting differences in quality of care between physician groups (Greenfield et al. Another study evaluated the rela- tionship of complication rates of carotid endarectomy to processes of care 50 the Healthcare Quality Book and reported findings similar to the original diabetes survey. Initial analy- sis showed that facilities with high complication rates likely had substan- dard processes of care. By repeating the study at the same location but at a different time, researchers found substantially different complication rates and concluded that the inability, in practice, to estimate complication rates at a high degree of precision is a fundamental difficulty for clinical policy making (Samsa et al. Physicians and administrators alike may challenge results they do not like on the grounds that they con- sider the data suspect because of collection errors or other inaccuracies. Patient socioeconomic status, age, gender, and ethnicity also influence physician profiles in medical prac- tice variation and analysis efforts (Franks and Fiscella 2002). Keys to Successful Implementation and Lessons Learned from Failures Despite the inherent appeal in improving quality, considerable limits and barriers to the successful implementation of quality improvement projects exist. These barriers are subject to or the result of variation in culture, infra- structure, and economic influences across an organization, and overcom- ing them requires a stable infrastructure, sustained funding, and the testing of sequential hypotheses as to how to improve care. Administrative and Physician Views Issues that must be addressed to implement quality improvements include organizational mind-set, administrative and physician worldviews, and patient knowledge and expectations. In one example in a primary care setting, screening for colorectal cancer improved steadily from 47 percent to 86 percent over a two-year period (Stroud, Felton, and Spreadbury 2003). This evolutionary change minimized the barriers of revolutionary change, especially physician and administrator push-back, as well as other personal issues that are difficult to identify and alter (Eisenberg 2002). Success in adjusting culture to embrace quality improvement requires a long view that is sympathetic to V ariation in Medical Practice and Implications for Quality 51 converting daily practice into an environment that adapts accordingly. Many decision makers expect immediate and significant results and are sensitive to short-term variation in results that might suggest the improvements are inappropriate or not cost effective. A monthly drop in screening rates, for example, could be viewed as an indication that the screening protocol is not working and should be modified or abandoned altogether to conserve scarce resources. Then again, the observed decrease could be random vari- ation and no cause for alarm or change (Wheeler 2000). Cultural tolerance to variation and change is a critical issue when considering successful fac- tors to implementing quality improvement efforts, and it can be addressed by systemic adjustments and educational and motivational interventions (Donabedian and Bashur 2003; Palmer, Donabedian, and Povar 1991). Physicians often think in terms of treating disease as it presents within each unique patient rather than in terms of population-based preventive care. As such, physician buy-in is critical to reducing undesired variation or creating new and successful clinical preventive services systems of care (Stroud, Felton, and Spreadbury 2003). The process includes training physi- cian champions and investing in them to serve as models, mentors, and motivators, and it reduces the risk of alienating the key participants in qual- ity improvement efforts. Patient Knowledge Patient education is equally subject to variation in quality of care. Increasingly patients are aware of the status of their healthcare providers in terms of national rankings, public revelations of quality successes (and failures), and participation in reimbursement schemes. Participation in public awareness efforts such as the CMS Public Domain program, which makes variation and processes of care measures available to the public (both consumers and researchers), is another opportunity to educate patients about a healthcare organization and its commitment to quality (CMS 2003b; Hibbard, Stockard, and Tisler 2003; Lamb et al. Organizational Mind-set Organizational infrastructure is an essential component in minimizing vari- ation, disseminating best practices, and supporting a research agenda asso- ciated with quality improvements. Electronic medical records (EMRs), computerized physician order entry systems, and clinical decision support 52 the Healthcare Quality Book tools may reduce errors, allow sharing of specific best practices across large organizations, and enable the widespread automated collection of data to support quality improvement research (Bates and Gawande 2003; Bero et al. Healthcare organizations therefore are addressing the challenge to articulate and implement a long- term strategy to employ EMR resources. Unfortunately, the economic implications of both short- and long-term infrastructure investments under- mine these efforts. Working in an environment that embraces short-term financial gain (in the form of either the quarterly report to stockholders or the report to the chairman of the board), physicians and hospital admin- istrators often face an outright disincentive to invest in an infrastructure that will improve compliance with best practices (Leatherman et al.

Gas- permeable contact lenses were placed in each eye to protect the corneas order meclizine mastercard treatment junctional tachycardia. The retinas were back-refracted onto a tangent screen and the locations of retinal landmarks were recorded on the screen to locate the area centralis (Bishop et al purchase discount meclizine online medicine quetiapine. An acute configuration of the Utah Electrode Array (Cyberkinetics Neurotech- nology Systems buy meclizine once a day 7 medications that can cause incontinence, Inc. An electron micrograph of the UEA and a light micrograph of the implant array system are shown in figure 3. The electrode impedance measured with a 1-kHz, 100-nA, sinusoidal signal ranged between 200 and 400 kW, with the typical impedance around 300 kW. The UEA was implanted to a depth of approximately 1 mm at the junction of the lateral and posterior lateral gyri. Neural activity as well as the state of the visual stimulus was recorded by a 100- channel data acquisition system (Cyberkinetics Neurotechnology Systems, Inc. Further details of the data acquisition system are available elsewhere (Guillory and Normann, 1999). In the experiments described in this chapter, we collected data from both eyes and recorded activity on 98 of the possible 100 electrodes. No data were recorded on the remaining two channels because these two amplifiers had known problems. The array is connected to a connector board by 100, 25-mm- diameter insulated wires. Visual Stimulus All stimuli were provided by a 17-inch computer monitor placed at the approximate visual space representation of the area centralis and 95 cm from the eye. A number of di¤erent visual stimuli were produced by software devel- oped by the authors. The stimuli used to evoke the responses described in this chap- ter were sinusoidal gratings, single drifting bars, and a random checkerboard pattern. In the case of gratings, the spatial and temporal frequencies were approximately 0. Twelve equally spaced orientations were tested between 0 and 330 degrees, where 0 degrees was defined as vertical stripes sweeping to the right and 90 degrees was defined as horizontal stripes sweeping from top to bottom. Each oriented stimulus was presented for 3 s, followed by ap- proximately 3 s of a screen uniformly lit at the background intensity. Three hundred trials were performed, giving twenty-five repeats for each orientation. The orientation for each trial was randomly assigned through a shu¿ing algo- rithm, thereby ensuring that each orientation was tested an equal number of times. The same twelve orientations were tested, but each trial consisted of 64 s of stimulation with a bar, resulting in four passes of the bar, followed by approximately 4 s of a uniformly lit screen at the background inten- sity. Only forty-eight trials were performed, representing four trials at each orienta- tion. Again, the orientation for each trial was selected by a shu¿ing algorithm. Imaging 2-D Neural Activity Patterns 47 the checkerboard pattern consisted of a number of 1:1 Â 1:1-degree squares. Using a pseudorandom number generator, each square was set to one of three inten- sities: white with 15% probability, o¤ with 15% probability, or background with 70% probability. This allowed the entire checkerboard to be shifted both vertically and horizontally by 0. A new checkerboard with a new logical screen o¤set was displayed at a rate of 25 Hz. For all stimuli, the di¤erence between the most intense white and darkest black was selected to give a 50% contrast, with the background intensity set half- way through the intensity range. Data Analysis the optimal orientation was calculated from the drifting sine wave gratings by the method described by Orban (1991). For each orientation tested, a peristimulus time histogram (PSTH) was calculated for the activity recorded on each electrode. The optimal orientation for each multiunit was selected as the orientation giving the largest firing rate for that unit. The recently introduced method of electrophysiological imaging (Diogo et al. In this method, one interpolates activity-level maps for each of the conditions tested; here it was the orientation of a drifting sine wave grating. The condition maps are then combined using the same methods used by the optical imaging community to give a single response map. Their finding that the map of activity for a single condi- tion is relatively smooth supports the validity of interpolating the condition maps. A reverse correlation method was used to estimate the receptive field size and position from the random checkerboard stimulus (Jones and Palmer, 1987; Eckhorn et al. In brief, this method performs a cross-correlation between the occur- rence of a spike and the state of each of the pixels of the computer monitor. Since there is a delay between changing the visual stimulus and the resulting spike, the cross-correlation is typically only examined over a period of 100–20 ms before the spike. After normalization, the result is a three-dimensional array of t-scores, with two of the dimensions representing the vertical and horizontal extent of the computer monitor and the third the latency from the state of the display to a spike. Since the result is presented as a t-score, typically out of a distribution with a very large num- ber of degrees of freedom, the magnitude of the cross-correlation has units of stan- dard deviations. A more complete description of the statistical interpretation of the cross-correlation as well as the spatial and temporal criteria that we apply before accepting a region as being a receptive field are detailed elsewhere (Warren et al. Koulakov In this chapter, we defined the receptive field to be the contiguous region having a magnitude greater than 4. The size of the receptive field was calculated as the area bounded by this region. The location of the receptive field was defined as the center of mass of the region. Both the size and position were cal- culated at the latency having the peak magnitude. Fitting Receptive Fields To analyze the visuotopic organization of the primary visual cortex, we compared the position of the receptive field with fields estimated by an a‰ne coordinate trans- formation of the locations of the electrode array onto its visual space representation. The particular a‰ne transformation provides 5 degrees of freedom: magnification (SFx and SFy), the rotation (y), and translation (OFFa and OFFe). A nonlinear, least-mean-squares minimization method (FMINS function in MATLAB) was used to minimize the di¤erence between the coordinate transform and the measured recep- tive fields. The electrode position (Ex and Ey) was related to the visual space position by the equation Vh SFx cos y SFy sin y Ex OFFa ¼ þ ; Vv ÀSFx sin y SFy cos y Ey OFFe where Vh and Vv are the horizontal and vertical positions of the receptive field in degrees, respectively. We interpreted our results in terms of both linear and confor- mal mapping.

Criteria for treatment include clinical sever- ity buy discount meclizine line medicine cabinet, as judged by the extension and presence of inflammatory lesions order meclizine cheap medications you cant take with grapefruit, and the degree of psycho- PSORIASIS logical distress from the disease order meclizine us medications ending in pam. The aim of treatment is to prevent scarring, limit disease This is a chronic inflammatory disorder charac- duration and reduce psychological stress. Mild terisedbyredscalyareas,whichtendtoaffect acne is usually treated by topical modalities such extensory surfaces of the body and scalp. Its as benzoyl peroxide or tretinoin, while moderate overall prevalence is about 1–3% and males are severity acne is treated by systemic antibiotics or affected more frequently than females. Oral isotretinoin is used varieties have been described including guttate, under specialist supervision for severe unrespon- pustular and erythrodermic psoriasis. There are a number of published 3% of cases it may associate with a peculiar systems for measuring the severity of acne. Significant disability has been docu- These vary from sophisticated systems with up mented with psoriasis. Multifactorial heredity is to 100 potential grades to simple systems with 4 usually considered for disease causation. A specially designed acne disability implies interaction between a genetic predispo- index has also been devised to assess the psycho- sition and environmental factors. Heritability, a logical impact of the disease and disability, and measure that quantifies the overall role of genetic has been found to correlate well with severity as factors, ranges from 0. Acute infections, measured by an objective grading system, even physical trauma, selected medications and psy- if a small group experiences disability which is chological stress are usually viewed as triggers. Sun exposure usually tem- ATOPIC DERMATITIS porarily improves the disease. Typically, this condition is characterised by itch- the lesions are visible and may itch, sting and ing, dry skin and inflammatory lesions especially bleed easily. Patients suffering from short-term suppression of symptoms and long- atopic dermatitis may also develop IgE-mediated term modulation of disease severity, improving allergic diseases such as bronchial asthma or the quality of life with minimal side effects. An overall cumulative preva- Topical agents such as vitamin D derivatives, lence of between 5% and 20% has been suggested dithranol and steroids can be used for short-term by the age of 11. Ultraviolet B phototherapy, clear of significant disease by their mid-teens. Outcomes DERMATOLOGY 215 that matter to the patient include disease suppres- the UK proved to offer advantages over home sion and duration of remission, patient satisfac- treatment. METHODS: ADAPTING STUDY DESIGN TO In the long term, a simple measure such as the SETTING AND DISEASE number of patients reaching complete or nearly complete stable remission appears as the most As for other disciplines, the last few decades relevant outcome variable. LEG ULCERS However, there are indications that the upsurge of clinical research has not been paralleled by a Venous and arterial leg ulcers are recognised refinement in clinical trial methodology and the as the most common chronic wounds in West- quality of randomised control trials (RCTs) in ern populations. A skin ulcer has been defined dermatology falls well below the usually accepted standards. Ulcers persisting for to mention some issues which deserve special 4 weeks or more have been rather arbitrarily attention when designing a randomised clinical classified as chronic ulcers. There is a need tion surveys, the point prevalence of leg ulcers for innovative thinking in dermatology to make ranges from 0. Venous ulcers are the end result of super- not simply ape the scientific design. Arte- RANDOMISATION rial ulceration may be regarded as a multistep process, starting, in general, with a systemic vas- It can be estimated that there are at least cular derangement such as atherosclerosis. The a thousand rare or very rare skin conditions prognosis of leg ulcers is less than satisfactory, where no single randomised trial has been with about one-quarter of subjects not healing in conducted. These conditions are also those which over 2 years and the majority of patients hav- carry a higher burden in terms of physical ing recurrence. The annual incidence the healing time varied according to the dimen- rate of many of them is lower than 1 case sion of the ulcers, their duration and the mobil- per 100 000 and frequently less than 1 case ity of the patient. There are lation, depression and negative self-image have no examples of such an effort. These con- patients in the community, including the lack of ditions include several varieties of eczematous any clinical assessment leading to long periods of dermatitis. One alleged difficulty with mounting riasis lesions, and a maintenance phase, with the randomised clinical trials in dermatology is the main aim of preventing disease relapse. The dif- visibility of skin lesions and the consideration ferent phases are not necessarily well separated that much more than in other areas, patients in time. Long-term disease-modifying strategies self-monitor their disease and may have precon- can be adopted at the same time when a treat- ceptions and preferences about specific treatment ment modality for reaching clearance has been modalities. An example is the treatment of atopic tated by subjective issues and personal feelings. Most ran- As we will consider below, there is a need to edu- domised clinical trials in dermatology use a sim- cate physicians and the public about the value of plified approach to evaluating treatment effects randomised trials to assess interventions in der- and most of them analyse the effect of a single matology. The need to evaluate the attitudes of manoeuvre over a limited time span. One as yet patients and to educate should be clearly con- not fully explored issue is the potential for com- sidered when planning a study and developing bining different treatment approaches in a simul- modalities to obtain an informed consent from taneous or subsequent order. An example als there may be substantial differences in group of such a design would be a randomised clin- sizes that will reduce the precision of the esti- ical trial of the effect of a low-allergen diet mated differences in treatment effect and hence compared with an unrestricted diet in atopic the efficiency of the study. As a consequence, women during pregnancy and breast-feeding on block randomisation may be preferable. On the the subsequent development of atopic disorders other hand, a substantial imbalance may persist in in children where women are randomised to prognostic characteristics, and minimisation can all the possible combinations of restricted and be used to make small groups more similar with unrestricted dietetic measures during the peri- respect to major prognostic variables. The cluster around equal sample it is expected that physicians and patients are sizes may be due to publication bias, failure to subject to strong, though difficult to document, report blocking, or even to the rectification of an hopes and prejudices about the optimal care of unsatisfactory imbalance by adding extra patients skin disorders. Secondly, most outcome measures are For example, at least two phases are usually soft end points involving subjective judgement, considered when treating psoriasis: a clearance which may be influenced to a significant extent phase, which involves a more intensive treatment by the previous knowledge of the treatment DERMATOLOGY 217 adopted. On the other hand, there may be prob- and skin care seem to play a significant role lems with blinding which may be difficult or in the outcome of most skin disorders. It is impossible to solve, like with trials comparing common sense that emollients may improve dry complex procedures such as ultraviolet light radi- skin and wet soaks may help to dry exudat- ation and drug regimens. As a consequence, accessory care rants more attention than it is often given in requires careful standardisation. These variables, observable during priate way (particularly timing and administra- treatment, may in part unblind the trial, even at 18 tion route), non-pharmacological accessory care a subliminal level. This is an issue with the is prone to a larger variability that is affected use of topical retinoids and the associated mild by social and cultural factors among others. As documented in randomised clinical a trial was published examining three different trials of the retinoid derivative tazarotene in pso- therapeutic strategies for psoriasis: oral etretinate riasis, the modalities of application may play a associated with topically applied betamethasone, 20 significant role in tolerability and side effects. The issue of standardisation is also impor- etretinate are responsible for common side effects tant for assessing compliance when the treatment which are reminiscent of vitamin A overdosage, is self-applied by the patient. If indeed there are including dryness of the skin and mucous mem- limitations with such methods as tablet count for branes, while topical steroids commonly produce assessing compliance with systemic agents, the a transitory blanching effect. It is difficult to limitations are even greater when similar methods accept blindness in the trial when there is no addi- are used to monitor the consumption of topical tional information on how blinding was actually agents in the absence of strict rules to define a assured. The amount consumed cannot be rates showed large variations among the differ- monitored if patients are not carefully instructed ent trial arms because of alleged side effects on how to apply the topical agent. This way the second clinicians We have already mentioned that the contents of can be blind to the treatment assigned to the primary care for many skin disorders are impre- patient.

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