Systematic Review of Research Methods and Reporting Quality of Randomized Clinical Trials of Spinal Cord Stimulation for Pain.

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.

Optimizing inhaler use by pharmacist-provided education to community-dwelling elderly.

OBJECTIVE: To assess, using a standard observational tool, the ability of patients to demonstrate and maintain proper inhaled medication administration techniques following pharmacist education. DESIGN: Six-month observational study. SETTING: Patients' homes or adult day health center. PARTICIPANTS: Patients in a Program for All-inclusive Care for the Elderly (PACE) prescribed one or more inhaled medications used at least once daily. INTERVENTION: Instruction by on-site clinical pharmacist. MEASUREMENTS: Hickey's Pharmacies Inhaler Technique assessment (score range: 0-20, higher better). RESULTS: Forty-two patients were evaluated at baseline, taught proper techniques for using inhaled medications, assessed immediately following the education, and re-assessed 4-6 weeks later. The mean pre-assessment score was 14 (SD 4.5, range 0-20), the initial post-assessment score increased to 18 (SD 3, range 10-20). The second post-assessment (4-6 weeks later) score mean was 17.7 (SD 3, range 10-20). Both follow-up scores were significantly improved from baseline (p < 0.05). Multivariable analysis indicated the strongest predictors of second post-training score were: score after initial pharmacist training and being subscribed to auto-refill. These characteristics predicted ∼70% of the variance in the second score (p < 0.001). CONCLUSIONS: These results indicate that education by a pharmacist combined with an auto-refill program can improve and sustain appropriate inhaler use by community-dwelling elders in a PACE program. The improved score was maintained 4-6 weeks later indicating a sustained benefit of medication administration education. Optimal inhaler use ensures optimal dosing and supports appropriate inhaler treatment in lieu of oral agents.

Depression and glycemic intake in the homebound elderly.

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 (ß=+0.65, SE=0.28, P=0.02); the logarithm of GL was positively associated with depression (ß=+0.33, SE=0.17, P=0.05) and negatively associated with antidepressant use (ß=-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.

Quality of clinical and economic evidence in dossier formulary submissions.

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.

Depression, antidepressants, and plasma amyloid beta (Beta) peptides in those elderly who do not have cardiovascular disease.

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.

Screening for depressive disorders in patients with skin diseases: a comparison of three screeners.

Despite being common, depression often goes undetected in patients with skin diseases. Our aim was to examine and compare the performance of three depression screeners. We studied dermatological inpatients aged 18-65 years. They completed the questionnaires Primary Care Screener for Affective Disorders (PC-SAD), Patient Health Questionnaire (PHQ) and General Health Questionnaire (GHQ-12) and were administered a standardized psychiatric interview (SCID-I) by a mental health professional, who was unaware of the questionnaire answers. The analysis was performed on 141 patients with complete data (79% of all eligible patients, 89% of all patients who agreed to participate). The prevalence of the main forms of depression, major depressive disorder and dysthymic disorder, was 8.4% and 6.3%, respectively. For major depressive disorder, the sensitivity and specificity of the questionnaires were as follows: PC-SAD, 73% and 88%; PHQ, 55% and 91%; GHQ-12, 73% and 78%. For dysthymic disorder, the sensitivity and specificity were as follows: PC-SAD, 56% and 95%; PHQ, 44% and 90%; GHQ-12, 56% and 76%. The small sample size suggests caution in drawing conclusions about the relative merits of these screeners. Although both the GHQ and the PHQ are short and easily hand scored, the first is a generic screener for psychiatric morbidity that is not specific for depression, while the second displayed modest sensitivity. The PC-SAD, with short average administration time, acceptable sensitivity and high specificity, might be particularly useful in settings where the technology for computer automated scoring is available. Although screening programmes might be useful, they should be supplemented by quality improvement programmes and by the development of consultation-liaison services.

Depression screening instruments made good severity measures in a cross-sectional analysis.

OBJECTIVE: Test equivalence of different survey instruments to diagnose depression and to assess its severity. Where equivalence exists, describe how to convert scores between instruments. STUDY DESIGN: Cross-sectional analysis of six convenience samples consisting of 71 members of a health plan and 107 patients of mental health specialty practices with psychiatric diagnoses were compared using the Beck Depression Inventory (BDI) and one or more of the Primary Care Screener for Affective Disorder, Prime-MD-PHQ, Inventory to Diagnose Depression, the depression subscale of the Psychiatric Diagnostic Screening Questionnaire, and the Mental Health Inventory from the SF-36. RESULTS: Correlations between the screening instruments and the BDI ranged from 0.79 to 0.95 and the sensitivity to depression and the specificity against nondepressive mental health diagnoses was equally good or better. We also describe a method for equating severity scores across instruments and labeling the screener-based severity measures with clinically meaningful descriptions comparable to those used for the BDI. CONCLUSIONS: Screener-based severity measures extensively overlap each other. Good screeners for depression can also be good severity instruments. Exploiting screeners as severity instruments can significantly reduce response burden without sacrificing performance.

The impact of a pharmacist intervention on 6-month outcomes in depressed primary care patients.

The object of the study was to evaluate outcomes of a randomized clinical trial (RCT) of a pharmacist intervention for depressed patients in primary care (PC). We report antidepressant (AD) use and depression severity outcomes at 6-months. The RCT was conducted between 1998 and 2000 in 9 eastern Massachusetts PC practices. We studied 533 patients with major depression and/or dysthymia as determined by a screening test done at the time of a routine PC office visit. The majority of participants had recurrent depressive episodes (63.5% with >/=4 lifetime episodes), and 49.5% were taking AD medications at enrollment. Consultation in person and by telephone was performed by a clinical pharmacist who assisted the primary care practitioner (PCP) and patient in medication choice, dose, and regimen, in accordance with AHCPR depression guidelines. Six-month AD use rates for intervention patients exceeded controls (57.5% vs. 46.2%, P =.03). Furthermore, the intervention was effective in improving AD use rates for patients not on ADs at enrollment (32.3% vs. 10.9%, P =.001). The pharmacist intervention proved equally effective in subgroups traditionally considered difficult to treat: those with chronic depression and dysthymia. Patients taking ADs had better modified Beck Depression Inventory (mBDI) outcomes than patients not taking ADs, (-6.3 points change, vs. -2.8, P =.01) but the outcome differences between intervention and control patients were not statistically significant (17.7 BDI points vs. 19.4 BDI points, P =.16). Pharmacists significantly improved rates of AD use in PC patients, especially for those not on ADs at enrollment, but outcome differences were too small to be statistically significant. Difficult-to-treat subgroups may benefit from pharmacists' care.

Description of a clinical pharmacist intervention administered to primary care patients with depression.

The objective of this article is to provide a detailed description of interactions between patients with depression and pharmacists. Analysis was conducted on patients from the intervention arm (n=268) of an randomized controlled trial that evaluated the impact of a clinical pharmacist on the outcomes for depressed primary care patients from nine metropolitan Boston practices. The main outcome measure was the amount of intervention time spent with patients, physicians, and other activities. Details of the behavioral intervention and a categorization of the activities are offered. Pharmacists reported 978 encounters with 268 patients in 6 months. Eighty percent of patient encounters occurred by telephone. Initial encounters took 45 min if in person and 13.3 min if by telephone. Subsequent encounters followed a similar pattern. Follow-up visits occurred 2.3 times per patient. Physician contact took considerably less time. In total, the pharmacist intervention took 70.3 min per patient over 6 months; 42.2% of encounters involved an activity related to non-antidepressant medication and 85% of encounters involved general support. Other activities (education, advocating antidepressants, and motivating adherence) occurred in at least 50% of encounters. Pharmacists repeated intervention activities in the same category approximately two to three times. Interventions to improve the care of depression in primary care patients must anticipate encountering intense needs for information, personal support, and help negotiating the healthcare system. Research that identifies relationships between the components (active ingredients) of an intervention and the outcomes of care will benefit future intervention strategies and contribute to improved and efficient care.

Antidepressant use: concordance between self-report and claims records.

BACKGROUND: Researchers need valid methods to assess whether patients are taking their antidepressant medications. Two important sources of data on drug exposure are patients' self-reports and pharmacy claims. OBJECTIVE: To compare self-report and claims data for antidepressant exposure. RESEARCH DESIGN: Cross-sectional analysis. SUBJECTS: This study comprised 422 contemporaneous self-report and claims data points obtained from 164 unique patients in a longitudinal depression study in which patients completed up to five surveys during an 18-month period. MEASURES: For the self-report measure, the following question was asked: Do you now take any prescription medicines for depression? Using claims data, patients were considered to be using an antidepressant if they had filled at least one antidepressant prescription in the 90 days before survey dates. RESULTS: Self-report and claims agreed in 85% (358/422) of cases, with a kappa of 0.69. Eighty-eight percent (56/64) of discrepant cases using other study data sources was resolved. Reasons for discrepancies included the use of medications for conditions other than depression (32/64), recent AD discontinuations (6/64), samples usage (3/64), and low-frequency/PRN use (7/64). CONCLUSIONS: Self-report and claims showed good concordance, but they reflect different truths. Self-report identifies medications intended primarily for the treatment of depressive disorders, whereas claims data identify use of medicines with antidepressant effects. Our assessment of discordant cases showed self-report to be more valid than claims to assess current antidepressant use for depression therapy.

Assessing the performance of a new depression screener for primary care (PC-SAD).

As many as 50% of patients with major depression seen in primary care settings are not diagnosed. To facilitate efficient identification of primary care patients with depression, we developed a new patient-administered depression screening instrument (PC-SAD) that produces a DSM-IV diagnosis, and compared its performance to other screeners that yield DSM-IV diagnoses. To assess validity, the diagnostic accuracy of the PC-SAD was compared with the Inventory to Diagnose Depression (IDD) and the PRIME-MD-PHQ (PHQ) in a convenience sample (N = 312) of health plan members, primary care outpatients, and psychiatric patients (with diagnoses). The screeners were compared with each other and with psychiatric diagnoses to assess their relative performance. Disagreement among the three screeners was formally tested using a triangulation approach that incorporates a statistical likelihood model. Of patients diagnosed as depressed using the IDD, 84.2% were also depressed by the PC-SAD (sensitivity). Of patients not diagnosed as depressed by the IDD, 94.7% were not depressed by the PC-SAD (specificity). Using the triangulation method the sensitivities were 87.2% (PC-SAD), 88.4% (IDD), and 60.7% (PHQ). The specificities were 95.0% (PC-SAD), 92.7% (IDD), and 98.3% (PHQ). The performance of the PC-SAD and the IDD was comparable. The PHQ was less sensitive than either of those. The PC-SAD respondent burden strikes a balance between the very short PHQ, and the longer IDD, and has the lowest (easiest) Flesch-Kincaid reading level. Investigators, clinicians, and health plans that want a DSM-IV-based depression screener can choose from among these three instruments, with known tradeoffs in sensitivity, respondent burden, and readability.