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The objective was to assess the potential benefits of the routine use of the MOS SF-36 Health Survey (SF-36) in the care of ambulatory patients. The design was a longitudinal, prospective, randomized, controlled study set in the outpatient neurology clinic at the New England Medical Center. There were 163 consecutive patients with epilepsy who had 210 follow-up visits with one of two epileptologists. The patients completed the SF-36 before the patient-physician encounter and the forms were optically scanned. The SF-36 results of the intervention group patients were given to the physicians before the encounter and withheld for control group patients. For intervention group patients, the physicians completed a questionnaire assessing the impact of the SF-36 on the process of care. After the visit, all patients completed a satisfaction questionnaire. The main outcome measures were the physicians' responses to standardized questions about the usefulness of the SF-36 for communication with and management of epilepsy patients and the patients' responses to standardized questions about their satisfaction with care. The physicians indicated that the SF-36 provided new information in 63% of the intervention group encounters. A change in therapy was prompted in 13%. The physicians rated the SF-36 as at least moderately useful for communication in 14% of the encounters and to management in 8%. The lower (indicating worse health status) the patients' SF-36 scale scores, the more useful the SF-36 results were rated by the physicians for communication and management. It was concluded that the routine use of health status measures may enhance patients' care. [ABSTRACT FROM AUTHOR]

This systematic review assessed design characteristics and reporting quality of published randomized clinical trials of spinal cord stimulation (SCS) for treatment of pain in adults and adolescents. The study protocol was registered with PROSPERO (CRD42018090412). Relevant articles were identified by searching the following databases through December 31, 2018: MEDLINE, Embase, WikiStim, The Cochrane Database of Systematic Reviews, and The Cochrane Central Register of Controlled Trials. Forty-six studies were included. Eighty-seven percent of articles identified a pain-related primary outcome. Secondary outcomes included physical functioning, health-related quality of life, and reductions in opioid use. Nineteen of the 46 studies prespecified adverse events as an outcome, with 4 assessing them as a primary outcome. Eleven studies stated that they blinded participants. Of these, only 5 were assessed as being adequately blinded. The number of participants enrolled was generally low (median 38) and study durations were short (median 12 weeks), particularly in studies of angina. Fifteen studies employed an intention-to-treat analysis, of which only seven specified a method to accommodate missing data. Review of these studies identified deficiencies in both reporting and methodology. The review's findings suggest areas for improving the design of future studies and increasing transparency of reporting. PERSPECTIVE: This article presents a systematic review of research methods and reporting quality of randomized clinical trials of SCS for the treatment of various pain complaints. The review identifies deficiencies in both methodology and reporting, which may inform the design of future studies and improve reporting standards., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Differences in payer evaluation and coverage of pharmaceuticals and medical procedures suggest that coverage may differ for medications and procedures independent of their clinical benefit. We hypothesized that coverage for medications is more restricted than corresponding coverage for nonmedication interventions., Methods: We included top-selling medications and highly utilized procedures. For each intervention-indication pair, we classified value in terms of cost-effectiveness (incremental cost per quality-adjusted life-year), as reported by the Tufts Medical Center Cost-Effectiveness Analysis Registry. For each intervention-indication pair and for each of 10 large payers, we classified coverage, when available, as either "more restrictive" or as "not more restrictive," compared with a benchmark. The benchmark reflected the US Food and Drug Administration label information, when available, or pertinent clinical guidelines. We compared coverage policies and the benchmark in terms of step edits and clinical restrictions. Finally, we regressed coverage restrictiveness against intervention type (medication or nonmedication), controlling for value (cost-effectiveness more or less favorable than a designated threshold)., Results: We identified 392 medication and 185 procedure coverage decisions. A total of 26.3% of the medication coverage and 38.4% of the procedure coverage decisions were more restrictive than their corresponding benchmarks. After controlling for value, the odds of being more restrictive were 42% lower for medications than for procedures. Including unfavorable tier placement in the definition of "more restrictive" greatly increased the proportion of medication coverage decisions classified as "more restrictive" and reversed our findings., Conclusions: Therapy access depends on factors other than cost and clinical benefit, suggesting potential health care system inefficiency., (Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

The American College of Clinical Pharmacy charged the Public and Professional Relations Committee to develop a short white paper describing quality measures of clinical pharmacists' patient care services in transitional care settings. Transitional care describes patient movement from one health care setting or service to another. Care transitions are associated with an increased risk of adverse events for patients. Pharmacists play an important role in ensuring that medication errors and adverse events are minimized during these transitions, largely through the reconciliation of medications and assurance of continuity of care. Quality measures are often divided into three domains: structure, process, and outcome. Given the typical nature of the pharmacist's role, process indicators are best suited to evaluate quality clinical pharmacist services. However, process indicators relevant to pharmacists' activities are not yet fully described in the literature. The committee searched available literature describing quality measures that are directly influenced by the pharmacist during care transitions. This white paper describes these process indicators as quality measures of clinical pharmacists' services, identifies the transitional settings and activities to which they are most applicable, and provides the published sources from which indicators were derived. For process indicators that could not be found in published sources, we propose relevant measures that can be adapted for use in a given setting. As pharmacists become more involved in diverse and emerging patient care areas such as transitional care, it will be critical that they use these types of measures to document the quality of new services and reinforce the need for pharmacist participation during transitions of care., (© 2012 Pharmacotherapy Publications, Inc.)

Background: Depression is associated with an increase in the incidence of type 2 diabetes, but the mechanism is unclear. We aimed to study the relationship between depression and glycemic intake in the elderly, and examine whether antidepressant use modified this relationship., Design, Setting and Participants: We evaluated 976 homebound elders in a cross-sectional study. Depression was defined by having a Center for Epidemiological Studies Depression (CES-D) score ≥16. Antidepressant use was documented. Glycemic index (GI), Glycemic load (GL), and fasting blood insulin levels were measured., Results: Depressed elders had slightly higher GI (Mean±SD: 55.8±3.8 vs. 55.1±3.7, P=0.003) and higher insulin levels (Median: 84.0 vs. 74.4pmol/ml, P=0.05) than non-depressed elders. Depressed elders receiving antidepressants, primarily selective serotonin reuptake inhibitors (SSRI), had lower GI (Mean±SD: 55.1±4.7 vs. 56.2±3.4, P=0.002) and GL (Median: 170.3 vs. 6826.3, P=0.03) than those not taking antidepressants. After adjusting for potential confounding variables, GI remained positively associated with depression (β=+0.65, SE=0.28, P=0.02); the logarithm of GL was positively associated with depression (β=+0.33, SE=0.17, P=0.05) and negatively associated with antidepressant use (β=-0.54, SE=0.18, P=0.003)., Conclusions: Prospective studies are needed to examine whether high glycemic intake is a mediating factor between late life depression and the risk of type 2 diabetes., (Copyright © 2011 Elsevier B.V. All rights reserved.)

Background: Low plasma amyloid-beta peptide 42 (Abeta42) is associated with depressive symptoms independently of cardiovascular disease (CVD) in the elderly. It is critical to investigate whether antidepressants modify this relationship., Methods: We evaluated 324 elders without CVD in a cross-sectional study. Depression was evaluated with the Center for Epidemiological Studies Depression (CES-D) scale. Antidepressants were documented. Plasma Abeta40 and Abeta42 were measured., Results: In the absence of CVD, those with depression had lower plasma Abeta42 (median: 13.7 vs. 18.8 pg/mL, p = .003) than those without. Depressed subjects on antidepressant treatment had a lower concentration of plasma Abeta40 (median: 97.8 vs. 133.5 pg/mL, p = .008), but not Abeta42, than those without the treatment. Multivariate logistic regression showed that antidepressant use did not influence the relationship between depression and low plasma Abeta42 (odds ratio = .55; 95% CI = .33, .90; p = .02) after adjusting for confounders, but its use interacted with plasma Abeta40 in the model., Conclusions: Lower concentration of plasma Abeta42 is associated with depression in the absence of CVD that is not related to the antidepressant use by those subjects. Prospective studies are needed to determine whether depression associated with low plasma Abeta42 predicts the onset of Alzheimer's disease.

Objective: To investigate the quality and completeness of clinical and economic data in dossiers submitted by drug companies to a health plan using Academy of Managed Care Pharmacy guidelines (the Format) for formulary submissions., Study Design: We reviewed the quality of economic analyses in dossiers submitted to Premera Blue Cross Health Plan (Mountlake Terrace, Washington; enrollment 1.6 million) between January 2002 and September 2005. For dossiers submitted in 2003, we examined the clinical studies included., Methods: Dossiers were audited with a data collection form to judge the types of clinical studies used to support labeled and off-label indications, and the quality and transparency of economic analyses. We compared economic analyses for high-cost (30-day treatment cost > $1000) versus low-cost products, and for "innovative" versus "me-too" drugs., Results: Evidence to support off-label indications often was included in 2003 dossiers, but the information was less extensive and of poorer quality than data for labeled indications. Of 115 dossiers submitted between 2002 and 2005, 53 (46%) included economic analyses. The economic analyses had low levels of compliance with standards: only 43% performed sensitivity analysis; 38% stated the study perspective; 37% discussed relevant treatment alternatives; 20% stated assumptions clearly; and 18% mentioned caveats to conclusions. Economic analyses of high-cost products and innovative products had higher compliance with recommended practices., Conclusions: Drug companies are submitting dossiers of evidence to formulary committees. Dossiers often included clinical data to support off-label indications, but concerns persist about their quality. About half of dossiers included economic analyses, but these analyses had relatively low levels of compliance with recommended practices.

This paper describes selected scientific principles involved in the design of patient self-administered questionnaires to assess functioning and overall well-being. It gives several examples of successful uses of patient surveys and suggests possibilities for the use of the results by pharmacists in clinical care. The patients' point of view about their health status is important for the decision-making about treatment choices and as a monitoring parameter for effectiveness or toxicities. Pharmacists should approach the creation of new questionnaires or the results from untested questionnaires with caution and respect. The use of results from proven and reliable individual patient surveys will benefit from the evolution of computer adaptive testing. However, the immediate use of individual health status surveys is not discounted, provided that they accompany clinical data in decision processes.

Objective: The reliability, validity, and feasibility of the routine use of a generic health status instrument, the Short-Form-36 Health Survey (SF-36), were examined in a psychiatric outpatient clinic of a general hospital., Methods: The sample comprised 411 patients referred to an outpatient psychiatry department between April 1994 and March 1995. They filled out the SF-36 along with their admission forms. Scores and reports were generated, and the results were returned to the charts and used at weekly clinical conference discussions. Feasibility was evaluated using subjective and objective data on administration of the instrument, its psychometric properties, and costs. Results from the outpatient psychiatry patients were compared with those from patients scheduled for elective surgery and a healthy normative sample., Results: Routine administration of the SF-36 was successfully achieved with minimal resistance from staff and patients. The SF-36 provided reliable and valid data. As predicted, patients with emotional disorders scored lower, indicating more impairment, on scales measuring mental health than did the elective surgery patients and the normative sample. However, the psychiatric patients' scores on the physical health scale were lower than clinicians expected. Compared with the elective surgery patients, the psychiatric patients were less impaired on only the physical functioning and bodily pain scales; no difference was found between the two groups in role functioning due to physical problems., Conclusions: Routine use of the SF-36 in a general hospital psychiatric outpatient clinic was feasible, and the results were reliable, valid, and helpful to clinicians. Psychiatric patients' significantly lower scores in physical health and social and role functioning provided additional information about their difficulties.

A 69-item questionnaire measuring generic functioning and well-being and disease-specific health outcomes was developed and tested using the pre-treatment data from patients with chronic hepatitis C (CHC) participating in two randomized trials of interferon alpha-2b (n = 157). The questionnaire included all eight scales from the SF-36 and measures of nine other generic and disease-specific health concepts. Psychometric tests confirmed the assumptions underlying the construction and scoring of all generic and disease-specific scales. Cross-sectional tests of 'known groups' validity showed that CHC patients scored worse on the generic scales than patients with other chronic conditions and worse than a healthy general population. The generic and disease-specific scale scores were lower in the presence of physical findings of CHC, as hypothesized, but only the physical functioning and bodily pain scales were linked to cirrhosis or extreme alanine aminotransferase (ALT) ratios. This instrument will be useful in studies of health outcome among patients with CHC, a condition whose health burden appears to have been underestimated in studies to date.

Objective: To report the case of a patient with possible paroxetine-induced bruxism that was effectively treated with buspirone., Case Summary: A 20-year-old woman with no active medical conditions besides acne and no history of dental problems was seen in an outpatient psychiatry clinic for the evaluation of ongoing depression. The patient was prescribed paroxetine 10 mg every morning. After 5 days of therapy the patient reported no adverse effects, and the paroxetine dosage was increased to 20 mg every morning. Due to increased somnolence, the dosing schedule was subsequently changed to 20 mg hs. Two months later during a dental visit for a tooth extraction, the dentist noted that the patient's teeth appeared damaged in what he believed to be a pattern consistent with the grinding and clenching of teeth. Prior to this time, dental examinations had not revealed any tooth damage. The patient was thought to have paroxetine-induced bruxism and, based on earlier case reports, was treated with buspirone 5 mg hs. On day 4 of buspirone therapy the patient reported a significant reduction in the extent of gritting, tooth pain, and jaw tenderness., Discussion: The selective serotonin reuptake inhibitors (SSRIs) fluoxetine and sertraline have been associated with bruxism in previous reports. This case suggests paroxetine-induced bruxism. The exact mechanism of SSRI-induced bruxism remains unclear. Many theories have been proposed, including sleep disturbance, serotonergic-mediated inhibition of dopamine manifesting as akathisia, and SSRI-induced anxiety. According to published reports, SSRI-induced bruxism may respond to therapy with buspirone. Consistent with these reports, this patient responded favorably to buspirone therapy., Conclusions: Clinicians should be aware that the potential for paroxetine-induced bruxism exists and that buspirone may be an appropriate therapeutic intervention.

Study Objectives: To examine the feasibility of administering and the psychometric properties of a general health status questionnaire in adults with epilepsy, and to assess the health status of these patients., Design: Prospective, cross-sectional, observational study., Setting: Neurology clinic of a tertiary care medical center., Patients: One hundred forty-eight ambulatory adults with epilepsy., Interventions: Patients completed the SF-36, a general health status questionnaire. Respondent burden and data quality as well as psychometric characteristics were evaluated. Patients' SF-36 scale scores, adjusted for comorbidities, were compared with those of 641 people without chronic conditions with the same sociodemographic characteristics., Measurements and Main Results: Administering the SF-36 to adult outpatients with epilepsy is feasible and results are psychometrically sound. Compared with those who were not ill, patients had significantly (p < 0.001) lower (0 = worst, 100 = best) scores in six of the eight SF-36 domains: general health perceptions (57.7 vs 82.1), mental health (61.3 vs 79.6), vitality (53.5 vs 67.8), role limitations owing to physical (69.6 vs 95.0) and emotional problems (67.2 vs 88.4), and social functioning (75.2 vs 89.9)., Conclusions: Lower SF-36 scores may reflect patients' assessments of the balance among epilepsy, seizures, and antiepileptic drug therapy-related effects. Incorporating health status information into therapeutic decision making may help to attain the ultimate goal of improving patients' health.

Cost analysis, cost containment, and cost reduction are realities in today's health care environment. Discussions of cost must also include an analysis of the consequences of economic decisions so that a balanced perspective can be presented to health care decision makers. The basic principles of pharmacoeconomics can be used to provide information about the cost and consequences of therapy. To ensure a high quality of pharmaceutical care, it will become necessary to use this scientific information to make therapeutic decisions and recommendations.

Health-status measurement is discussed, and a paradigm for the management of patient outcomes is described and applied to a patient case. Challenged not only to eradicate disease but to improve health, today's health-care professionals must examine the structure, process, and outcomes of care to ensure that optimal care is provided. Techniques for measuring outcomes have been developed; important indicators are functional status, general well-being, and the patient's assessment of care. An interdisciplinary team of physicians, social scientists, and public policy experts at The Health Institute, New England Medical Center, Boston, Massachusetts, studies ways of monitoring and improving the quality and efficiency of care. The team, which now includes a pharmacist, is working to develop practical systems of care whose outcomes can be tested in patients at the medical center. The paradigm developed for the management of patient outcomes begins with evaluation based on results of history, physical examination, and diagnostic tests. Problems and goals (therapeutic endpoints) are then defined, and the safest, most effective, and least costly treatment is selected. Treatment is monitored for subjective and objective results and adjusted as necessary. The achievement of each endpoint contributes to improvement of the patient's health. Knowledge of health-status measurement will enable pharmacists to increase their contribution to patients' health.