Morris Weinberger

A method for assessing drug therapy appropriateness

This study evaluated the reliability of a new medication appropriateness index. Using the index, independent assessments were made of chronic medications taken by 10 ambulatory, elderly male patients by a clinical pharmacist and an internist-geriatrician. Their overall inter-rater agreement for medication appropriateness (ppos) was 0.88, and for medication inappropriateness (pneg) was 0.95; the overall kappa was 0.83. Their intra-rater agreement for ppos was 0.94 overall, for pneg was 0.98 overall while the overall kappa was 0.92. The chronic medications taken by 10 different ambulatory elderly male patients were independently evaluated by two different clinical pharmacists. Their overall inter-rater agreement for ppos was 0.76, and for pneg was 0.93, while the overall kappa was 0.59. This new index provides a reliable method to assess drug therapy appropriateness. Its use may be applicable as a quality of care outcome measure in health services research and in institutional quality assurance programs.

A randomized, controlled trial of a clinical pharmacist intervention to improve inappropriate prescribing in elderly outpatients with polypharmacy

PURPOSE To evaluate the effect of sustained clinical pharmacist interventions involving elderly outpatients with polypharmacy and their primary physicians. PATIENTS AND METHODS Randomized, controlled trial of 208 patients aged 65 years or older with polypharmacy (> or = 5 chronic medications) from a general medicine clinic of a Veterans Affairs Medical Center. A clinical pharmacist met with intervention group patients during all scheduled visits to evaluate their drug regimens and make recommendations to them and their physicians. Outcome measures were prescribing appropriateness, health-related quality of life, adverse drug events, medication compliance and knowledge, number of medications, patient satisfaction, and physician receptivity. RESULTS Inappropriate prescribing scores declined significantly more in the intervention group than in the control group by 3 months (decrease 24% versus 6%, respectively; P = 0.0006) and was sustained at 12 months (decrease 28% versus 5%, respectively; P = 0.0002). There was no difference between groups at closeout in health-related quality of life (P = 0.99). Fewer intervention than control patients (30.2%) versus 40.0%; P = 0.19) experienced adverse drug events. Measures for most other outcomes remained unchanged in both groups. Physicians were receptive to the intervention and enacted changes recommended by the clinical pharmacist more frequently than they enacted changes independently for control patients (55.1% versus 19.8%; P <0.001). CONCLUSIONS This study demonstrates that a clinical pharmacist providing pharmaceutical care for elderly primary care patients can reduce inappropriate prescribing and possibly adverse drug effects without adversely affecting health-related quality of life.

Reminders to physicians from an introspective computer medical record: a two-year randomized trial

We developed a computer-stored medical record system containing a limited set of the total clinical data base--primarily diagnostic studies and treatments. This system responds to its own content according to physician-authored reminder rules. To determine the effect of the reminder messages generated by 1490 rules on physician behavior, we randomly assigned practitioners in a general medicine clinic to study or control groups. The computer found indications for six different actions per patient in 12 467 patients during a 2-year study: 61 study group residents who received computer reminders responded to 49% of these indications; 54 control group residents, to only 29% (p less than 0.0001). Preventive care (occult blood testing, mammographic screening, weight reduction diets, influenza and pneumococcal vaccines) was affected. The intentions of the study group to use a given action for an indication predicted their response to the indications (p less than 0.03, r2 = 0.33). The intentions of the control residents did not.

Salt Sensitivity, Pulse Pressure, and Death in Normal and Hypertensive Humans

Although factors such as age, blood pressure, and its responsiveness to changes in sodium balance and extracellular fluid volume status (salt sensitivity) are associated with an increased risk of end-organ disease and cardiovascular events in hypertensive subjects, no such relationship with mortality has been demonstrated for salt sensitivity in normotensive subjects. We conducted long-term follow-up of 430 normal and 278 hypertensive subjects in whom assessment of salt sensitivity of blood pressure was performed as long as 27 years ago. We ascertained the status of 596 subjects (85% of the total population), 123 (21%) of whom had died. The following initial measurements were significantly (P <0.002) associated with subjects who had died compared with subjects known to be alive: age at study, pulse pressure, systolic, diastolic, and mean arterial pressures, hypertension, salt sensitivity, baseline renin levels, and body mass index (but not body weight). A stepwise logistic regression found the following independent predictors of death (odds ratio, 95% CI): age at initial study (1.08, 1.06 to 1.10), baseline blood pressure (1.03, 1.01 to 1.04), sodium sensitivity (1.73, 1.02 to 2.94), and male gender (1.91, 1.15 to 3.17). When survival curves were examined, normotensive salt-sensitive subjects aged >25 years when initially studied were found to have a cumulative mortality similar to that of hypertensive subjects, whereas salt-resistant normotensive subjects had increased survival (P <0.001). These observations provide unique evidence of a relationship between salt sensitivity and mortality that is independent of elevated blood pressure.

Osteoarthritis: New Insights. Part 2: Treatment Approaches

There is no known cure for osteoarthritis, and the goal of contemporary management of the patient with osteoarthritis remains control of pain and improvement in function and health-related quality of life with avoidance, if possible, of therapeutic toxicity. Recent studies have demonstrated the potential of treatments ranging from newly approved oral medications to nutriceuticals, patient education interventions, and surgery. Increasingly, appropriate treatment of osteoarthritis combines one or more oral agents with exercise and other biomechanical techniques. This article is part 2 of a two-part summary of a National Institutes of Health (NIH) conference, Stepping Away from OA: Prevention of Onset, Progression, and Disability of Osteoarthritis. The conference brought together experts from diverse backgrounds and provided a multidisciplinary and comprehensive summary of recent advances in the prevention of osteoarthritis onset, progression, and disability. For research questions and opportunities identified at the conference, see www.nih.gov/niams/reports/oa/oareport.htm(accessed on 25 May 2000). Systemic and Topical Treatments Dr. Marc C. Hochberg (University of Maryland School of Medicine, Baltimore, Maryland), Dr. Timothy McAlindon (Boston University School of Medicine, Boston, Massachusetts), and Dr. David T. Felson (Boston University School of Medicine): Drug therapy for pain management is most effective when combined with nonpharmacologic strategies (1, 2). In 1995, the American College of Rheumatology issued guidelines for the medical management of osteoarthritis of the hip and knee (2, 3). Since then, several systematic reviews of drug therapy for osteoarthritis have been published (4-6). The following recommendations for systemic and topical treatments (except for glucosamine and chondroitin, which were not evaluated) are derived from updated recommendations of the American College of Rheumatology for the treatment of osteoarthritis. Systemic Treatments Nonopioid Analgesics For many patients with osteoarthritis, the relief of mild to moderate joint pain afforded by the simple analgesic acetaminophen is comparable to that achieved with a nonsteroidal anti-inflammatory drug (NSAID) (7, 8). Accordingly, although acetaminophen fails to adequately relieve pain in many patients, it merits a trial as initial therapy on the basis of its overall cost, efficacy, and toxicity profile (9, 10). The daily dose of acetaminophen should not exceed 4 g. Although it is one of the safest analgesics, acetaminophen can be associated with clinically important adverse events, such as prolongation of the half-life of warfarin (11). At therapeutic doses acetaminophen rarely causes hepatic toxicity, but it should be used cautiously in patients with existing liver disease and avoided in patients with chronic alcohol abuse because of known increased risk in these patients (12-14). Even though acetaminophen was reported to be weakly associated with end-stage renal disease, the Scientific Advisory Committee of the National Kidney Foundation recommended it as the drug of choice for analgesia in patients with impaired renal function (15). Tramadol, a centrally acting oral analgesic, is a synthetic opioid agonist that inhibits reuptake of norepinephrine and serotonin. It has been approved by the U.S. Food and Drug Administration for treatment of moderate to severe pain and can be considered for use in patients in whom acetaminophen therapy has failed and who have contraindications to NSAIDs, including the cyclooxygenase-2 (COX-2)specific inhibitors. Although numerous studies have examined use of tramadol to treat general pain, few controlled studies have examined its use in osteoarthritis. The efficacy of tramadol has been found to be comparable to that of ibuprofen in patients with hip and knee osteoarthritis (16), and it is useful as adjunctive therapy in patients with osteoarthritis whose symptoms were inadequately controlled with NSAIDs (17). Daily doses of tramadol have generally been in the range of 200 to 300 mg given in four divided doses. Side effects are common and include nausea, constipation, and drowsiness. Despite the opioid pharmacology of tramadol, a comprehensive surveillance program has failed to demonstrate significant abuse, and tramadol remains an unscheduled agent. Seizures have been reported as a rare side effect, either at doses above the recommended range or at doses within the recommended range in patients with a history of epilepsy and those taking concomitant medications that lower the seizure threshold. NSAIDs For patients who do not obtain adequate symptom relief with nonopioid analgesics, use of NSAIDs should be considered. The choice between a nonselective NSAID and a COX-2specific inhibitor should be made after evaluation of risk factors, particularly for upper gastrointestinal and renal toxicity. Data from epidemiologic studies show that among persons 65 years of age or older, 20% to 30% of all hospitalizations and deaths due to peptic ulcer disease were attributable to therapy with NSAIDs (18-20). Furthermore, the risk for a catastrophic gastrointestinal event in elderly patients taking NSAIDs is dose dependent (18). Risk factors for upper gastrointestinal bleeding in patients treated with NSAIDs include age 65 years or older, history of peptic ulcer disease or previous upper gastrointestinal bleeding, concomitant use of oral corticosteroids or anticoagulants, and possibly smoking and alcohol consumption (21-23). Risk factors for reversible renal failure in patients with intrinsic renal disease who are treated with NSAIDs include age 65 years or older, hypertension or congestive heart failure, and concomitant use of diuretics and angiotensin-converting enzyme inhibitors (24). Additional considerations involved in a practitioners decision to treat an individual patient with osteoarthritis include existing comorbid conditions and concomitant therapy, as well as the side effects and costs of specific treatments. The options for medical management of the patient with osteoarthritis who is at increased risk for a serious adverse upper gastrointestinal event, such as bleeding, perforation, or obstruction, are use of a COX-2specific inhibitor or a nonselective NSAID with gastroprotective therapy. Two COX-2specific inhibitors, celecoxib and rofecoxib, have been approved by the U.S. Food and Drug Administration for use in patients with osteoarthritis (25, 26). Celecoxib has been found to be more effective than placebo and as effective as naproxen for symptoms in patients with hip or knee osteoarthritis (27-29). Rofecoxib has also been found to be more effective than placebo and is comparable in efficacy to both ibuprofen and diclofenac in patients with hip or knee osteoarthritis (30, 31). Endoscopic studies have shown that celecoxib and rofecoxib are associated with an incidence of gastroduodenal ulcers lower than that of comparator NSAIDs and similar to that of placebo (25). These data suggest an advantageous safety profile compared with nonselective NSAIDs, especially for treatment of high-risk patients (21-23). However, no large long-term studies have been published that were designed to demonstrate differences between COX-2specific inhibitors and nonselective NSAIDs with respect to major gastrointestinal clinical outcomes; such studies are in progress. A further advantage of COX-2specific inhibitors with respect to upper gastrointestinal bleeding is that celecoxib and rofecoxib do not have a clinically significant effect on platelet aggregation or bleeding time. In addition, at doses recommended for treatment of osteoarthritis, these drugs appear to be better tolerated than comparator nonselective NSAIDs, with a lower incidence of dyspepsia and other gastrointestinal side effects. As with nonselective NSAIDs, however, COX-2specific inhibitors can cause renal toxicity. Caution must be exercised, therefore, if these drugs are used in patients with mild to moderate renal insufficiency, and they should not be used in patients with severe renal insufficiency. In addition, celecoxib is contraindicated in patients with a history of allergic reaction to a sulfonamide. The alternative to use of a COX-2specific inhibitor is use of a nonselective NSAID with a gastroprotective agent, an approach endorsed by the American College of Gastroenterology (23). As noted earlier, serious adverse upper gastrointestinal events attributed to NSAIDs in the elderly are dose dependent. Therefore, if nonselective NSAIDs are used, therapy should be begun at low, analgesic doses and increased to full anti-inflammatory doses only if lower doses do not provide adequate relief of symptoms. In a study of 8843 patients with rheumatoid arthritis, misoprostol at a dosage of 200 g four times daily reduced the incidence of serious ulcer complications, including perforation, bleeding, and obstruction, by 51% (32). In a 12-week randomized, double-blind, placebo-controlled endoscopy study, misoprostol at a dosage of 200 g three times per day had comparable efficacy in prevention of both gastric and duodenal ulcers; however, 200 g twice daily conferred significantly less protection against gastric ulcers (33). Side effects, particularly diarrhea and flatulence, may occur with this agent in a dose-dependent manner (33). Alternative approaches to prophylaxis with misoprostol include use of omeprazole or high-dose famotidine, both of which have been shown in carefully conducted endoscopy studies to be effective in treating and preventing NSAID-induced gastropathy (34-37). Histamine-2 blockers in usual doses, however, have not been found to be as effective as misoprostol (36), whereas omeprazole (20 mg/d or 40 mg/d) was as effective as misoprostol (200 g twice daily) in treatment of existing ulcers and was better tolerated and associated with a lower rate of relapse (37). Of note, proton-pump inhibitors have not been approved by the U.S. Food and Dr

Adverse drug events in high risk older outpatients.

OBJECTIVE: To describe the prevalence, types, and consequences of adverse drug events (ADEs) in older outpatients with polypharmacy.

Do Automated Calls with Nurse Follow-up Improve Self-Care and Glycemic Control among Vulnerable Patients with Diabetes?

PURPOSE We sought to evaluate the effect of automated telephone assessment and self-care education calls with nurse follow-up on the management of diabetes. SUBJECTS AND METHODS We enrolled 280 English- or Spanish-speaking adults with diabetes who were using hypoglycemic medications and who were treated in a county health care system. Patients were randomly assigned to usual care or to receive an intervention that consisted of usual care plus bi-weekly automated assessment and self-care education calls with telephone follow-up by a nurse educator. Outcomes measured at 12 months included survey-reported self-care, perceived glycemic control, and symptoms, as well as glycosylated hemoglobin (Hb A1c) and serum glucose levels. RESULTS We collected follow-up data for 89% of enrollees (248 patients). Compared with usual care patients, intervention patients reported more frequent glucose monitoring, foot inspection, and weight monitoring, and fewer problems with medication adherence (all P -0.03). Follow-up Hb A,, levels were 0.3% lower in the intervention group (P = 0.1), and about twice as many intervention patients had Hb A1c levels within the normal range (P = 0.04). Serum glucose levels were 41 mg/dL lower among intervention patients than usual care patients (P = 0.002). Intervention patients also reported better glycemic control (P = 0.005) and fewer diabetic symptoms (P <0.0001 ), including fewer symptoms of hyperglycemia and hypoglycemia. CONCLUSIONS Automated calls with telephone nurse follow-up may be an effective strategy for improving self-care behavior and glycemic control, and for decreasing symptoms among vulnerable patients with diabetes.

A nurse-coordinated intervention for primary care patients with non-insulin-dependent diabetes mellitus: impact on glycemic control and health-related quality of life

AbstractOBJECTIVE: To examine the impact of a nurse-coordinated intervention delivered to patients with non-insulin-dependent diabetes mellitus between office visits to primary care physicians. DESIGN: Randomized, controlled trial. SETTING: Veterans Affairs general medical clinic. PATIENTS: 275 veterans who had NIDDM and were receiving primary care from general internists. INTERVENTION: Nurse-initiated contacts were made by telephone at least monthly to provide patient education (with special emphasis on regimens and significant signs and symptoms of hyperglycemia and hypoglycemia), reinforce compliance with regimens, monitor patients’ health status, facilitate resolution of identified problems, and facilitate access to primary care. MEASUREMENTS: Glycemic control was assessed using glycosylated hemoglobin (GHb) and fasting blood sugar (FBS) levels. Health-related quality of life (HRQOL) was measured with the Medical Outcomes Study SF-36, and diabetes-related symptoms were assessed using patients’ self-reports of signs and symptoms of hyper- and hypoglycemia during the previous month. MAIN RESULTS: At one year, between-group differences favored intervention patients for FBS (174.1 mg/dL vs 193.1 mg/dL, p=0.011) and GHb (10.5% vs 11.1%, p=0.046). Statistically significant differences were not observed for either SF-36 scores (p=0.66) or diabetes-related symptoms (p=0.23). CONCLUSIONS: The intervention, designed to be a pragmatic, low-intensity adjunct to care delivered by physicians, modestly improved glycemic control but not HRQOL or diabetes-related symptoms.

The Role of Antineutrophil Cytoplasmic Antibody (c-ANCA) Testing in the Diagnosis of Wegener Granulomatosis: A Literature Review and Meta-analysis

Wegener granulomatosis is a serious systemic vasculitis that is uniformly fatal if untreated. In 1983, Fauci and colleagues [1] reported their success with a combination of corticosteroid and cyclophosphamide therapy in 85 patients with Wegener granulomatosis. Since then, the recognition among clinicians of Wegener granulomatosis and its expanded clinical spectrum has improved, making early diagnosis and treatment possible. Patients with the classic Wegener triad have necrotizing granulomatous vasculitis of the upper and lower respiratory tract associated with glomerulonephritis; patients with limited Wegener granulomatosis may have vasculitis limited to the respiratory tract [2]. Because of the potential clinical overlap with other diseases, the diagnostic algorithm for patients with suspected Wegener granulomatosis has traditionally included biopsy of the upper airway, lung, or kidney to confirm the diagnosis and to rule out other entities, such as systemic infections and malignancies, that may respond adversely to cyclophosphamide therapy [3]. Antineutrophil cytoplasmic antibody (ANCA), first described in 1982 in patients with systemic vasculitis and glomerulonephritis, has emerged as a new diagnostic tool and marker of disease activity for vasculitis [4, 5]. Originally thought to be a response to arboviral infection, ANCA was later identified as a seromarker for Wegener granulomatosis [4, 6]. It is currently believed that the presence of ANCA is an important factor in the pathogenesis of this disease [5]. Two ANCA patterns may be seen with indirect immunofluorescence of ethanol-fixed neutrophils: a cytoplasmic pattern (c-ANCA) and the artifactual perinuclear pattern (p-ANCA) [7, 8]. The major antigen for c-ANCA is a 29-kd serine protease, known as proteinase 3, which is found within the azurophilic granules of the neutrophil [9]. The major antigen for p-ANCA is myeloperoxidase, a lysosomal enzyme found in neutrophils [7, 10]. Some clinical overlap has been seen, but the two patterns have different disease associations. The c-ANCA pattern has predominantly been associated with Wegener granulomatosis, and p-ANCA has been associated with microscopic polyarteritis, other vasculitides, idiopathic necrotizing and crescentic glomerulonephritis, and other diseases [7, 11-13]. Early studies of c-ANCA in patients with Wegener granulomatosis, especially those with active disease, have been promising. Reported sensitivities and specificities have exceeded 90% [10-12, 14-18]. Because of the morbidity and expense associated with biopsy, c-ANCA has attracted interest as a rapid and noninvasive way to diagnose Wegener granulomatosis. In fact, some investigators advocate immunosuppressive therapy for patients with positive c-ANCA test results and symptoms compatible with Wegener granulomatosis, even in the absence of biopsy results [19-21]. The history of c-ANCA testing appears to mirror the natural history of many new diagnostic tests. Important and early pioneering studies of new tests are typically done in highly selected patients with confirmed disease to determine the tests operating characteristics. However, when the new test is subsequently applied to unselected populations, clinical experience and additional studies often provide a less optimistic picture of its diagnostic power. Several recent reports [22-27] document false-positive c-ANCA test results in patients with tuberculosis, Hodgkin lymphoma, human immunodeficiency virus infection, nasal septal perforation, monoclonal gammopathies, and drug-induced Wegener-like disease. Similarly, additional reports [28, 29] describe negative c-ANCA test results in patients with Wegener granulomatosis, even those with active disease. Given the current enthusiasm for a serologic diagnosis of Wegener granulomatosis, underrecognition of the rate of false-positive c-ANCA test results may lead to inappropriate immunosuppressive therapy in some patients who do not have Wegener granulomatosis. Conversely, underappreciation of the frequency of false-negative c-ANCA test results may delay therapy for patients who have clinical features compatible with Wegener granulomatosis. We did a literature review and meta-analysis to assess the utility of c-ANCA as a diagnostic marker for Wegener granulomatosis overall and in relation to disease activity. Methods As noted above, two ANCA patterns have been described in the literature, and each has separate disease associations. Patients with Wegener granulomatosis often have c-ANCA, whereas p-ANCA is found in patients with various syndromes with and without vasculitis [7, 30, 31]. Because c-ANCA is thought to have a higher test sensitivity than p-ANCA for the diagnosis of Wegener granulomatosis, we focused only on c-ANCA. Search Strategy We could not determine a systematic approach for identifying unpublished data on c-ANCA, and thus we selected only published articles for our literature review. We did a MEDLINE search for English-language studies done in humans and published between 1966 and June 1993. Three searches were done: 1) a textword and registry search for antineutrophil cytoplasmic antibody [ANCA], anticytoplasmic antibody, and antineutrophil antibody; 2) a combination of search terms antibodies, neutrophils and keywords such as pulmonary-renal syndrome, or Wegener granulomatosis, or vasculitis, or glomerulonephritis; and 3) a search using the keyword pulmonary-renal syndrome alone. Using this initial search strategy, we identified 720 citations. Manual examination of the reference lists of included articles and the bibliographies of review articles and standard texts yielded an additional 27 studies, for a total of 747. Article Selection To be included in the analysis, all articles had to pass through a four-stage review (Table 1). First, the titles and abstracts of the 747 articles were independently examined by two reviewers. One reviewer was a rheumatologist, and the other was a health services researcher with a PhD who had experience in the critical appraisal of medical literature. Articles were excluded at this stage if they were not pertinent to the topic (for example, if they addressed antineutrophil antibodies and malignancy) or if they did not present patient-level data (for example, if they were reports of tissue culture experiments). If a cited article did not have a published abstract but appeared to be relevant, or if either reviewer included it, it was retained for further review. Of the original 747 articles, 407 were excluded and 340 were retained for second-level review. Table 1. Summary of the Results of Protocol for Selection of Articles for Meta-analysis In stage 2 of the review process, the complete articles were photocopied and reviewed by a rheumatologist. Articles were excluded if they were case reports (n = 64), reviews (n = 75), or letters to the editor (n = 58), or if they were irrelevant to our topic (n = 81). Sixty-two of the 340 articles remained for potential inclusion. In stage 3, a rheumatologist (JKR) and an investigator with a PhD reviewed the methods section of each article in detail. The methodologic criteria required for inclusion at this stage were specification of the patient selection method and the use of standard reference criteria to define Wegener granulomatosis. For casecontrol and cohort studies, the authors had to have described a systematic method of patient selection (for example, consecutive patients or a random sample based on prespecified criteria) [32]. Thus, case-series studies (such as those defining persons with a common feature nonsystematically without the presence of a control group) were excluded. Authors also had to specify standard reference criteria for establishing Wegener granulomatosis exclusive of the c-ANCA test result. Acceptable reference criteria included the Ear, Nose, Throat, Lung, and Kidney staging system [2], the Fauci criteria [1], and the American College of Rheumatology criteria [33]. The Ear, Nose, Throat, Lung, and Kidney system and the American College of Rheumatology criteria require biopsy confirmation of Wegener granulomatosis, and the Fauci criteria are clinicopathologic in nature. Thirty-nine articles were excluded at this stage for the following reasons: case-series design (n = 24); the method of patient selection was not clearly stated (n = 4); a reference standard was not specified (n = 7); or the article was irrelevant to our review (n = 4). If either reader included an article, it was retained for further review. In stage 4, three physicians each independently read the remaining 23 articles. Articles were excluded at this stage if a 2 2 contingency table, needed to calculate the operating characteristics, could not be constructed from the results (n = 8). Thus, 15 articles remained for detailed review [10, 11, 14, 15, 28, 34-43]. For these 15 articles, 2 2 contingency tables were constructed for patients with and without Wegener granulomatosis compared with patients with and without positive c-ANCA test results. Disagreements between reviewers were resolved by consensus. Definition of Wegener Granulomatosis We included only those studies that specified standard reference criteria for defining Wegener granulomatosis independent of the patients c-ANCA test result [1, 2, 33]. Patients with Wegener granulomatosis can be further divided into two subtypes: those with classic and those with limited disease [2]. In classic Wegener granulomatosis, glomerulonephritis and inflammation of the upper or lower respiratory tract, or both, are present. In limited disease, the kidneys are not involved, but inflammation of the upper or lower respiratory tract, or both, is present. Only 6 of the 15 studies separated patients by subtype. Furthermore, 2 of these 6 studies did not separate the c-ANCA test results by Wegener granulomatosis subtype. Because of these inconsistencies, we considered a single classification (overall Wegener granulomatosis) to repres

A summated score for the medication appropriateness index: development and assessment of clinimetric properties including content validity.

Inappropriate medication prescribing is an important problem in the elderly, but is difficult to measure. As part of a randomized controlled trial to evaluate the effectiveness of a pharmacist intervention among elderly veterans using many medications, we developed the Medication Appropriateness Index (MAI), which uses implicit criteria to measure elements of appropriate prescribing. This paper describes the development and validation of a weighting scheme used to produce a single summated MAI score per medication. Using this weighting scheme, two clinical pharmacists rated 105 medications prescribed to 10 elderly veterans from a general medicine clinic. The summated score demonstrated acceptable reliability (intraclass correlation co-efficient = 0.74). In addition, the summated MAI adequately reflected the putative heterogeneity in prescribing appropriateness among 1644 medications prescribed to 208 elderly veterans in the same general medicine clinic. These data support the content validity of the summated MAI. The MAI appears to be a relatively reliable, valid measure of prescribing appropriateness and may be useful for research studies, quality improvement programs, and patient care.