By L. Emet. Jamestown College.
Finally order levitra 10mg without prescription erectile dysfunction treatment new york, similar to structural measures generic levitra 10 mg free shipping erectile dysfunction or cheating, use of process measures for assessing quality of care rests on a key assumption: in this case order levitra 20mg line erectile dysfunction mayo, that if the right things are done and are done right, good results for the patient (i. Outcomes Another way quality of care can be assessed is in terms of outcome meas- ures, which seek to capture whether the goals of care were achieved. Some patients do not get better in spite of the best Basic Concepts of Healthcare Quality 35 that medicine can offer, whereas other patients regain full health even though they received inappropriate and potentially harmful care. Nevertheless, the relation between process and outcomes is not random or wholly unpredictable. We know, in particular, that the likelihood that a specific set of clinical activities—a given process—will result in desirable outcomes depends crucially on how efficacious that process has been shown to be. Efficacy A clinical intervention is said to be efficacious if it has been shown to reli- ably produce a given outcome when other, potentially confounding, fac- tors are held constant. The efficacy of a clinical intervention is typically established through formal clinical trials or similarly systematic, controlled studies. Knowledge about efficacy is crucial to making valid judgments about quality of care based on either process or outcome measures. If we know that a given clinical intervention was undertaken in circumstances that match those under which the intervention has been shown to be effi- cacious, we can be confident that the care was appropriate and, to that extent, of good quality. A frequently asked question is whether structure, process, or outcome is the best measure of quality of care. The answer—that none of them is inher- ently better and that all depends on the circumstances (Donabedian 1988a, 2003)—often does not satisfy those who are inclined to believe that out- come measures are the superior measure. After all, they reason, outcomes address the ultimate purpose, the bottom line, of all caregiving: was the condition cured, did the patient get better? As previously mentioned, how- ever, good outcomes can result even when the care (i. The reverse is also possible: although the care was excellent, the outcome was not a good one. Besides the care provided, a number of other factors—most of them, like how frail the patient is, not within the control of clinicians—can affect outcomes and must be accounted for through risk- adjustment calculations that are seldom straightforward (Iezzoni 2003). Ultimately what a particular outcome tells us about quality of care depends crucially on whether the outcome can be attributed to the care provided. In other words, we have to examine the link between the out- come and the antecedent process and determine whether the care provided 36 The Healthcare Quality Book was appropriate—a determination that is made based on what we know about efficacy—and whether it was provided skillfully. Outcomes are there- fore very useful in identifying possible problems of quality (fingering the suspects), but not in ascertaining whether poor quality was actually pro- vided (determining guilt). The latter determination requires delving into the antecedent process of care to establish whether the care provided is actually the likely cause of the observed outcome. Criteria and Standards In practice, to assess quality using structure, process, or outcome measures we need to know what constitutes good structure, good process, or good outcomes. In other words, we need criteria and standards for those aspects of care. Definitions Criteria refer to specific attributes that are the basis for assessing quality. Standards express quantitatively what level the attributes must reach to sat- isfy preexisting expectations about quality. An example unrelated to health- care may help clarify the difference between criteria and standards. The scores are thus one of the criteria by which programs judge the quality of their applicants. However, although two programs may use the same criterion— standardized scores—to evaluate applicants, the programs may differ markedly on their standards: one program may consider applicants accept- able if they have scores above the 50th percentile, whereas scores above the 90th percentile may be the standard of acceptability at the other. Sources A shift in the way criteria and standards are derived has been occurring in the healthcare field. Prior to the 1970s, formally derived criteria and stan- dards for quality-of-care evaluations for the most part relied on consensus opinions of groups of clinicians selected for their clinical knowledge and experience and for the respect they commanded among their colleagues (Donabedian 1982). This approach to formulating criteria took for granted that in their deliberations the experts would incorporate the latest scien- tific knowledge relevant to the topic under consideration, but formal require- ments that they do so seldom existed. It was not until the mid-1970s that the importance of the scientific literature in relation to criteria and standards was highlighted, notably by Basic Concepts of Healthcare Quality 37 TABLE 2. At about the same time, Brook and his col- leagues at RAND were the first to use systematic reviews and evaluations of the scientific literature as the starting point for the deliberations of pan- els charged with defining criteria and standards for studies of quality (Brook et al. This focus on the literature—and especially on the validity of the studies within that literature—was reinforced in the 1990s by the evi- dence-based medicine movement, which seeks to put into practice what the best evidence has to say about what is and is not efficacious under a given set of clinical circumstances (Evidence-Based Medicine Working Group 1992; Sackett et al. Thus, criteria and standards have come to revolve increasingly around the strength and validity of the scientific evi- dence and less on the unaided consensus opinions of experts (Eddy 1996). It must be noted, however, that although estimates vary, efficacy has not been definitely established for at least half of what physicians do in their daily practice (Eddy 1993; Sackett et al. Definitive, efficacy-based assessments of quality are therefore impossible to make about much care clinicians provide. On the other hand, even when we do not know what is 38 The Healthcare Quality Book the right thing to do, we often know what is not the right thing to do (e. Levels When formulating standards, a critical decision that must be made is the level at which the standards should be set: minimal, optimal, achievable, or something in between (Muir Gray 2001). Minimal standards specify what level must be met for quality to be considered acceptable. The impli- cation is that if care does not meet a minimal standard, remedial action is called for. Optimal standards denote the level of quality that can be reached under the best conditions, typically conditions similar to those under which efficacy is determined. Optimal standards are probably most useful as a ref- erence point for setting achievable standards—the level of performance that should be reached by everyone to whom the standards are being applied. One way to define achievable standards is in relation to the level of per- formance of the top quartile of providers of care. The reasoning is that if the top quartile can perform at that level, the other three quartiles should be able to reach it as well (Muir Gray 2001). Since there is no a priori level at which a particular standard ought to be set, a sensible and frequently adopted approach is to choose the level based on why the underlying eval- uation is being conducted in the first place. Using Measurement-Related Concepts How does understanding structure, process, and outcomes; efficacy; and criteria and standards give us insight into quality-of-care measurement issues? The two cases cited at the beginning of this section provide some illustrations. In the first case, minimum standards of quality were specified in terms of nurse staffing levels, a structural measure of quality. The critics are not questioning the choice of measure, nor should they, since structural meas- ures are well suited to detecting lack of capacity to deliver care of accept- able quality. In this case, hospitals that do not meet minimum staffing levels by definition cannot deliver care of acceptable quality (safe care). Put another way, the critics do not challenge nurse staffing levels as a criterion for assessing quality of care. The evidence would have to come from properly controlled studies show- ing that quality of care falls below what can be considered safe levels when Basic Concepts of Healthcare Quality 39 nurse staffing ratios are reduced, holding all else constant. In other words, silencing the critics requires evidence from the kind of studies on which efficacy determinations are based.
However cheap levitra 10mg without a prescription impotence use it or lose it, this effect may be offset by other pharmacokinetic changes of pregnancy order levitra 20mg with amex erectile dysfunction treatment in india. Increased weight (average 25 lb) and body fat Drugs (especially fat-soluble ones) are distributed more widely purchase levitra 10 mg amex erectile dysfunction and diabetes pdf. Drugs that are distrib- uted to fatty tissues tend to linger in the body because they are slowly released from storage sites into the bloodstream. The rate of albumin pro- The decreased capacity for drug binding leaves more free or unbound drug available duction is increased. However, serum levels fall for therapeutic or adverse effects on the mother and for placental transfer to the because of plasma volume expansion. Thus, a given dose of a drug is likely to produce greater effects than it would plasma protein-binding sites are occupied by hor- in the nonpregnant state. Some commonly used drugs with higher unbound mones and other endogenous substances that amounts during pregnancy include dexamethasone (Decadron), diazepam (Valium), increase during pregnancy. Increased renal blood ﬂow and glomerular ﬁltration Increased excretion of drugs by the kidneys, especially those excreted primarily un- rate secondary to increased cardiac output changed in the urine. In late pregnancy, the increased size and weight of the uterus may decrease renal blood ﬂow when the woman assumes a supine position. This may result in decreased excretion and prolonged effects of renally excreted drugs. Drugs enter the brain easily because the blood–brain bar- ﬂuence some aspect of pregnancy. Approximately half of in greater detail and include those used to induce abortion the drug-containing blood is then transported through the um- (abortifacients), drugs used to stop preterm labor (tocolytics), bilical arteries to the placenta, where it reenters the maternal and drugs used during labor and delivery. Thus, the mother can metabolize and excrete some drug molecules for the fetus. MATERNAL–PLACENTAL– FETAL CIRCULATION DRUG EFFECTS ON THE FETUS Drugs ingested by the pregnant woman reach the fetus through The fetus, which is exposed to any drugs circulating in mater- the maternal–placental–fetal circulation, which is completed nal blood, is very sensitive to drug effects because it is small, about the third week after conception. On the maternal side, has few plasma proteins that can bind drug molecules, and has arterial blood pressure carries blood and drugs to the pla- a weak capacity for metabolizing and excreting drugs. In the placenta, maternal and fetal blood are separated drug molecules reach the fetus, they may cause teratogenicity by a few thin layers of tissue over a large surface area. However, since 1984, cental transfer begins approximately the ﬁfth week after con- the Food and Drug Administration (FDA) has required that ception. When drugs are given on a regular schedule, serum new drugs be assigned a risk category (Box 67–1). For drugs taken during the second and amounts are pharmacologically active because the fetus has third trimesters, adverse effects are usually manifested in low levels of serum albumin and thus low levels of drug bind- the neonate (birth to 1 month) or infant (1 month to 1 year) ing. Most are as growth retardation, respiratory problems, infection, or transported to the liver, where they are metabolized. Overall, effects are determined mainly by the type olism occurs slowly because the fetal liver is immature in and amount of drugs, the duration of exposure, and the level quantity and quality of drug-metabolizing enzymes. In addition, Fetal effects of commonly used therapeutic drugs are listed the fetus swallows some amniotic ﬂuid, and some drug mol- in Box 67-2. Effects of nontherapeutic drugs are described in ecules are recirculated. Other drug molecules are transported directly to the heart, Alcohol is contraindicated during pregnancy; no amount which then distributes them to the brain and coronary arter- is considered safe. Heavy intake may cause fetal alcohol CHAPTER 67 DRUG USE DURING PREGNANCY AND LACTATION 967 BOX 67–1 U. Adequate studies in pregnant women demonstrate no risk are no data from human studies. There is evidence of human fetal risk, but the potential adequate studies in pregnant women; or animal studies benefits to the mother may be acceptable despite the show adverse effects, but adequate studies in pregnant potential risk. A potential risk, usually because animal studies have either both have demonstrated fetal abnormalities; the risk of use in not been performed or indicated adverse effects, and there a pregnant woman clearly outweighs any possible beneﬁt. Chronic fetal hypoxia from heavy smoking has been Caffeine is the most commonly ingested nontherapeutic associated with mental retardation and other long-term effects drug during pregnancy. It is present in coffee, tea, cola drinks, on physical and intellectual development. Overall, effects of over-the-counter analgesics, antisleep preparations, and choco- smoking are dose related, with light smoking (<1 pack/day) late. Although ingestion of moderate amounts has not been estimated to increase fetal deaths by 20% and heavy smoking associated with birth defects, spontaneous abortions, preterm (1 or more packs/day) increasing deaths by 35%. In addition, high Cocaine, marijuana, and heroin are illegal drugs of abuse, doses may cause cardiac dysrhythmias in the fetus. Co- Cigarette smoking (nicotine and carbon monoxide inges- caine may cause maternal vasoconstriction, tachycardia, tion) is one of the few preventable causes of perinatal mor- hypertension, cardiac dysrhythmias, and seizures. Effects include may impair fetal growth, impair neurologic development, and increased fetal, neonatal, and infant mortality; decreased birth increase the risk of spontaneous abortion during the ﬁrst and weight and length; shortened gestation; and increased com- second trimesters. During the third trimester, cocaine causes plications of pregnancy (eg, placental abruption, spontaneous increased uterine contractility, vasoconstriction and decreased abortion; preterm delivery). These effects are attributed to de- blood ﬂow in the placenta, fetal tachycardia, and increased risk creased ﬂow of blood and oxygen to the placenta and uterus. These life-threatening Nicotine causes vasoconstriction and decreases blood ﬂow to (text continues on page 970) Conception LMP 14 days Parturition (280 days) 31 days – heart, CNS Classic teratogenic period Palate, ear 71 days Brain growth Internal organ development Figure 67–1 The gestational clock show- ing the classic teratogenic risk assessment. For most drugs, adequate studies have not been done in seem to be safe, although they have not been studied extensively pregnant women and effects on the fetus are unknown. They have shorter half-lives, lower serum con- be used only if potential beneﬁt to the mother justiﬁes potential centrations, and a faster rate of elimination in pregnancy. Adrenergics Aminoglycosides (FDA category D) cross the placenta and Adrenergics are cardiac stimulants that increase rate and force of fetal serum levels may reach 15% to 50% of maternal levels. These drugs are common fetus or neonate have not been reported with other aminoglyco- ingredients in over-the-counter decongestants, cold remedies, and sides, but there is potential harm because the drugs are nephrotoxic appetite suppressants. Oral and parenteral adrenergics may inhibit uterine contractions Clindamycin (Cleocin) should be used only when infection with during labor; cause hypokalemia, hypoglycemia, and pulmonary Bacteroides fragilis is suspected. Erythromycin crosses the placenta to reach fetal Oral albuterol and oral or intravenous terbutaline relax uterine serum levels up to 20% of maternal levels, but no fetal abnormali- muscles and inhibit preterm labor. In animal studies, adverse fetal effects were Analgesics, Opioid reported with clarithromycin and dirithromycin but not with Opioids rapidly cross the placenta and reach the fetus. Clarithromycin is contraindicated if a safer alterna- diction and neonatal withdrawal symptoms result from regular use. Use of codeine during the ﬁrst trimester has been associated with Nitrofurantoin should not be used during late pregnancy be- congenital defects. When given to women in labor, opioids may decrease uterine Sulfonamides should not be used during the last trimester contractility and slow progress toward delivery. They cross the placenta and causes less neonatal respiratory depression than other opioids. If respiratory depression occurs, it can be studies indicate embryotoxicity. Trimethoprim, often given in combination with sulfamethoxa- zole (Bactrim), is contraindicated during the ﬁrst trimester. It Angiotensin-Converting Enzyme (ACE) Inhibitors crosses the placenta to reach levels in fetal serum that are similar to These drugs can cause fetal and neonatal morbidity and death; sev- those in maternal serum.
For example levitra 20mg lowest price erectile dysfunction treatment non prescription, treatments that group which generates the research designs for were designed as non-speciﬁc placebo controls the Centre for Recovery in Severe Psychosis (e levitra 10 mg mastercard erectile dysfunction causes depression. Therefore cheap levitra 20 mg fast delivery erectile dysfunction mayo clinic, the choice of a comparison psychological treatment which changes a key group is extremely important. If psychological factor in the psychological make-up of the therapy is compared to treatment-as-usual (TAU), individual, e. This protocol mainly lation of expectancies had no effect on clinical resulted from the lack of specialist input in the measures, suggesting that at least the anticipa- health services, making it imperative to ration tion of treatment beneﬁt was not inﬂuential in services. In their trial the drug and There is always the danger that the study will the psychological treatment had similar effects at be underpowered to demonstrate an advantage the end of treatment, but psychological treatment of CBT when the non-speciﬁc control group had a more permanent effect and the differences does better than expected. However, CBT may between the two treatments were signiﬁcant at be signiﬁcantly better than TAU, whereas the follow-up. The improvement was predicted by alternative may not give such an advantage. In When the health services have to decide which of other words, the psychological treatment changed several forms of psychological therapy to choose a maintenance factor for the disorder. Furthermore, residual symptoms may be Schizophrenia is most often a chronic relapsing present between episodes of exacerbation. If we take the metaphors from treat- ual positive symptoms at discharge are a risk ments with medication then psychological ther- factor for relapse. It is possible that CBT could have as time passes, although it would not be clear a successful effect on one of these factors but to the research team how this latter improve- fail later when other factors become crucial in the ment came about. This would be shown as how do we explain increases in effect size a successful outcome at post-treatment but a lack post-therapy which cannot be explained merely of durability of gains at follow-up. However, the by the loss to follow-up of those people for usual interpretation of this pattern of results is whom the therapy conferred hardly any beneﬁt that the effect on the disorder was only tempo- at all. Effect size = (Mt − Mc)/SDc The therapeutic protocol adopted for schizo- phrenia with medication is to provide medication where Mt is the mean of the treatment group, intensively at the acute stage that is followed by Mc is the mean of the control group and this is maintenance treatment at lower dose of similar divided by the standard deviation of the control drugs. The mean effect size for the trials studied An alternative mechanism and pattern of by Gould et al. Patients con- ther improvements in other factors to occur, such tinued to improve over the follow-up period as increased social support through the exten- with the combined effect size cited by Gould sion of a support network by increased social et al. These results are encouraging post-treatment and even greater gains at follow- given that schizophrenia is a relapsing condi- up. However, it would appear that CBT was tion where life events and other stressors may not only durable but conferred greater beneﬁts trigger new episodes of illness. However, the COGNITIVE BEHAVIOUR THERAPY 279 interpretation of the results of individual trials should include the number assessed for eligibility has since changed, mainly because the accepted for the trial, reasons for exclusion, who was standards for trials have changed. Several trials randomised and what happened to them prior to that make up this ﬁgure are methodologically ﬁnal assessment and analysis of the trial results. The majority of the current CBT trials do Standards have changed and what was reported not conform to the reporting guidelines as set in papers a number of years ago would have out in here. For some trials the signiﬁcant been adequate and satisfactory for the times. The checklist gives detailed were not randomly allocated to treatment groups. The ﬂow diagram provides readers with However, the current meta-analyses do show a clear picture of the progress of all participants that despite these methodological difﬁculties in the trial, from the time they are referred to there seem to be signiﬁcant changes in overall the trial until the end of their involvement. Items that should be included in reports of randomised trials Heading Subheading Descriptor Title Identify the study as a randomised trial Abstract Use a structured format Introduction State prospectively deﬁned hypothesis, clinical objectives, and planned subgroup or covariate analyses Methods Protocol Describe Planned study population with inclusion or exclusion criteria Planned interventions: their nature, content and timing Primary and secondary outcome measure(s) and the minimum important difference(s), and indicate how the target sample size was estimated Reasons for statistical analyses chosen, and whether these were completed on an intention-to-treat basis Mechanisms for maintaining intervention quality, adherence to protocol and assessment of ﬁdelity Prospectively deﬁned stopping rules (if warranted) Assignment Describe Randomisation (e. Although the type of scientiﬁc COGNITIVE BEHAVIOUR THERAPY 281 evidence does vary, the gold standard for treat- environments, usually by sophisticated university ment outcome is the RCT. Where several trials based research teams, and often involve highly exist they can be considered together through expert therapists. Knowledge concerning evidence- of interest are a reduction in overall psychotic based practice accrues through the accumulating symptoms, reductions in relapse or reduced rates results of efﬁcacy and effectiveness studies. These tri- (a) to ensure that the wealth of research evidence als may also include various control groups and informs clinical practice so that those who are process measures to help understand why the in receipt of treatment will receive the treatment treatments work. An effectiveness trial attempts that is the best available and represents the to more closely resemble the real world of rou- current knowledge base, and (b) to ensure that tine services, inclusion criteria are wider so planning and policy is determined by empirical the sample treated is more heterogeneous and evidence, for those purchasing services to be able includes the atypical patients, and the therapists to make informed choices and for those receiving are recruited from the routine services. This increases accountability may be designed, in which a new treatment is and establishes guidelines for good practice and expected to match the clinical efﬁcacy of an improves the quality of mental health services. These trials have special methodological features There are, however, critics of the colla- that distinguish them from simple comparative tion of data for evidence-based practice. The Cochrane database, for example, provides valuable searches and evaluations of Recruitment Bias randomised control trials with strict criteria for entry. The main criteria for est is the one at the very top that describes those exclusion are the lack of randomisation of the who have been assessed for eligibility. In order participants within the trial and the lack of data to prevent bias in recruitment the best method on all those participants who entered the trial. This ensures that the people who are in the trial do represent those who have the disorder. In TRIALS METHODOLOGY AND AIMS the UK it is largely assumed that those patients Efﬁcacy trials are devised to test whether the ther- with schizophrenia in contact with the services apy has an effect overall on the outcomes of inter- will represent those with the disorder requiring est. Participant recruitment and ﬂow screened all patients who might have a diagno- sample was representative (see Sensky et al. All putative of the trials can be usefully compared, but this candidates following this procedure were inter- information cannot be used as evidence of sample viewed to ascertain whether they satisﬁed the representativeness. This method has been used as a Convenience samples which recruit from clinic gold standard and other trials of CBT have used attenders or, even more problematically, patients the data from Tarrier et al. The referrer may only select COGNITIVE BEHAVIOUR THERAPY 283 those possible participants who they view as Bentall et al. In the treatment of panic criteria (see below), and it was certainly the view disorder, Klein33,34 has argued vigorously that in of one of the authors (TW) that in feasibility stud- comparisons of psychotherapy verses drug, a pill ies of group CBT some patients with diagnoses placebo–drug comparison is necessary to ensure other than schizophrenia, e. This is largely an argument about of schizophrenia or schizoaffective disorder. Cur- how representative or typical any sample is, given rent CBT studies have generally included patients a reliance on convenience samples. The choice of a unlikely that these will have a speciﬁc interac- different system will change the characteristics tion with the outcome from therapy, but as these of the sample. For instance, if people are drawn factors will affect the generalisation of the trial on RDC criteria they will not necessarily be as results it is probably important for the sample to chronic as those fulﬁlling the DSMIV criteria. But ethnicity and cultural mix may potentially Exclusion Criteria affect therapy outcomes. As we know very little about how to target psychological therapy to As well as criteria for inclusion into trials most different cultural groups, it seems reasonable studies also exclude people on the basis of to start investigating a new treatment with a speciﬁc issues. In trials of psychological therapy culturally homogeneous group and in later trials for psychosis one usual criterion is that the modify to accommodate cultural diversity, if people who enter the trial are those whose such modiﬁcation would be a requirement of symptoms have remained despite adequate doses effectiveness in cultural subgroups. The group chosen on this basis is extremely chronic and refractory and provides Diagnosis an extremely stringent test of the efﬁcacy of psychological treatment. In psychological therapies, especially in the ﬁeld A further thorny issue is that of co-morbid of psychosis, there has been a dilemma about substance abuse.
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