ABSTRACT
INTRODUCTION: Preliminary trial data suggest group-delivered acceptance and commitment therapy (ACT) might be effective for smoking cessation. If so, this could offer a viable alternative to mainstream behavioral therapies, such as those grounded in cognitive behavioral therapy (CBT). The goal of the current study was to compare the effectiveness of group-delivered ACT versus group-delivered CBT in a rigorous randomized trial design with long-term follow-up. METHODS: Participants (n = 450) were recruited from the Kaiser Permanente Washington health care system and randomized to either ACT-based group counseling or an attention-matched CBT-based group program. All were prescribed an 8-week course of nicotine patches. The primary outcome was self-reported 30-day point prevalence abstinence at 12 months post-randomization assessed with missing values imputed as smoking. Sensitivity analyses using multiple imputation and complete cases were examined, as were biochemically confirmed and 6-month outcomes. RESULTS: Thirty-day point prevalence abstinence rates at the 12-month follow-up did not differ between study arms in the primary analysis (13.8% ACT vs. 18.1% CBT, adjusted odds ratio = 0.68 [95% CI = 0.35 to 1.27], p = .23) or the sensitivity analyses. CONCLUSIONS: Group-based ACT and CBT had similar long-term quit rates in this methodologically rigorous randomized trial. Group-based ACT is a reasonable alternative to group-based CBT for smoking cessation. IMPLICATIONS: This study compared the effectiveness of group-based ACT with group-based CBT for smoking cessation using a rigorous, large-scale, attention-matched, randomized trial with 1-year follow-up. One-year cessation rates did not differ between group-based ACT and CBT, suggesting ACT-based intervention is a reasonable alternative to CBT-based counseling for smoking cessation. The results add to the nascent but growing literature assessing ACT and other mindfulness-based treatments for smoking cessation.
Subject(s)
Acceptance and Commitment Therapy/methods , Cognitive Behavioral Therapy/methods , Comparative Effectiveness Research/methods , Counseling , Smoking Cessation/methods , Tobacco Smoking/therapy , Tobacco Use Cessation Devices , Female , Humans , Male , Middle Aged , Motivation , Smoking/therapy , Tobacco Smoking/psychologyABSTRACT
INTRODUCTION: Perioperative symptoms such as pain, nausea and anxiety are often inadequately treated. We conducted a pragmatic trial to evaluate the impact of Complementary and Alternative Medicine (CAM) treatments on these symptoms, within the framework of a general surgery department that integrates CAM. METHODS: Patients ≥ 18 years referred to CAM treatments by surgical medical staff were allocated to standard of care with CAM treatment (CAM group) or without, according to patient preference and practitioner availability. CAM treatments included Acupuncture, Reflexology, or Guided Imagery. The primary outcome variable was the change from baseline in symptom severity, measured by Visual Analogue Scale (VAS). Patients and practitioners were asked to report any adverse effects associated with CAM treatments. RESULTS: A total of 1127 patients were enrolled, 916 undergoing 1214 CAM treatments and 211 controls. Socio-demographic characteristics were similar in both groups. Patients in the CAM group had more severe baseline symptoms. Symptom reduction was greater in the CAM group compared with controls, with a mean reduction in pain of -2.17⯱â¯2.4 vs -0.29⯱â¯2 (Pâ¯<â¯0.0001); nausea -1.2⯱â¯2.42 vs -0.3⯱â¯1.94 (Pâ¯<â¯0.0001); and anxiety -2.23⯱â¯2.76 vs -0.03⯱â¯2.54 (Pâ¯<â¯0.0001). Acupuncture was more effective for nausea control. No significant adverse events were reported with any of the CAM therapies. CONCLUSION: CAM treatments provide additional relief to Standard Of Care (SOC) for perioperative symptoms. Larger randomized control trial studies with longer follow-ups are needed to confirm these benefits. The study is registered with clinical trials.gov at (NCT01733771).
Subject(s)
Perioperative Care/methods , Perioperative Period/methods , Acupuncture Therapy/methods , Comparative Effectiveness Research/methods , Complementary Therapies/methods , Female , Humans , Male , Middle Aged , Musculoskeletal Manipulations/methodsABSTRACT
REVIEW QUESTIONS: The questions of this review are.
Subject(s)
Comparative Effectiveness Research/methods , Dietary Supplements/supply & distribution , Vitamin D/analogs & derivatives , Vitamin D/administration & dosage , Administration, Oral , Female , Humans , Male , Non-Randomized Controlled Trials as Topic , Oral Sprays , Randomized Controlled Trials as Topic , Vitamin D/blood , Systematic Reviews as TopicABSTRACT
Modest and even severe vitamin D deficiency is widely prevalent around the world. There is consensus that a good vitamin D status is necessary for bone and general health. Similarly, a better vitamin D status is essential for optimal efficacy of antiresorptive treatments. Supplementation of food with vitamin D or using vitamin D supplements is the most widely used strategy to improve the vitamin status. Cholecalciferol (vitamin D3) and ergocalciferol (vitamin D2) are the most widely used compounds and the relative use of both products depends on historical or practical reasons. Oral intake of calcifediol (25OHD3) rather than vitamin D itself should also be considered for oral supplementation. We reviewed all publications dealing with a comparison of oral cholecalciferol with oral calcifediol as to define the relative efficacy of both compounds for improving the vitamin D status. First, oral calcifediol results in a more rapid increase in serum 25OHD compared to oral cholecalciferol. Second, oral calcifediol is more potent than cholecalciferol, so that lower dosages are needed. Based on the results of nine RCTs comparing physiologic doses of oral cholecalciferol with oral calcifediol, calcifediol was 3.2-fold more potent than oral cholecalciferol. Indeed, when using dosages ≤ 25 µg/day, serum 25OHD increased by 1.5 ± 0.9 nmol/l for each 1 µg cholecalciferol, whereas this was 4.8 ± 1.2 nmol/l for oral calcifediol. Third, oral calcifediol has a higher rate of intestinal absorption and this may have important advantages in case of decreased intestinal absorption capacity due to a variety of diseases. A potential additional advantage of oral calcifediol is a linear dose-response curve, irrespective of baseline serum 25OHD, whereas the rise in serum 25OHD is lower after oral cholecalciferol, when baseline serum 25OHD is higher. Finally, intermittent intake of calcifediol results in fairly stable serum 25OHD compared with greater fluctuations after intermittent oral cholecalciferol.
Subject(s)
Calcifediol/therapeutic use , Cholecalciferol/therapeutic use , Dietary Supplements , Vitamin D Deficiency/drug therapy , Administration, Oral , Calcifediol/administration & dosage , Cholecalciferol/administration & dosage , Comparative Effectiveness Research/methods , Dose-Response Relationship, Drug , Humans , Vitamin D/analogs & derivatives , Vitamin D/blood , Vitamin D Deficiency/bloodABSTRACT
Since 2010, four oral anticoagulants have been approved for marketing in addition to warfarin for treatment of thromboembolic disease. Limited head-to-head data exist comparing these treatments, leaving patients and clinicians with little guidance for selecting a strategy that balances recurrence reduction with bleeding risk. In the dabigatran, apixaban, rivaroxban, edoxaban and warfarin comparative effectiveness research study, we compare all five currently available oral anticoagulant agents for the extended treatment of deep venous thrombosis and pulmonary embolism, as well as no extended treatment, and evaluate whether results differ in specific sub-populations. As our population includes Medicare novel anticoagulant users and large numbers of commercially insured and Medicaid patients, our results will likely be transportable to the majority of US patients experiencing a DVT or pulmonary embolism. CLINICAL TRIALS REGISTRATION: NCT03271450.
Subject(s)
Comparative Effectiveness Research/methods , Dabigatran/therapeutic use , Pyrazoles/therapeutic use , Pyridines/therapeutic use , Pyridones/therapeutic use , Research Design , Rivaroxaban/therapeutic use , Thiazoles/therapeutic use , Warfarin/therapeutic use , Anticoagulants/therapeutic use , Antithrombins/therapeutic use , Factor Xa Inhibitors/therapeutic use , Humans , Pulmonary Embolism/drug therapy , Venous Thrombosis/drug therapyABSTRACT
In recent years, evidence has emerged regarding the effectiveness of osteopathic manipulative treatments (OMT). Despite growing evidence in this field, there is need for appropriate research designs that effectively reflect the person-centred system of care promoted in osteopathy and provide data which can inform policy decisions within the healthcare system. The purpose of this systematic review is to identify, appraise and synthesise the evidence from comparative effectiveness and economic evaluation research involving OMT. A database search was conducted using CINAHL, PubMed, PEDro, AMED, SCOPUS and OSTMED.DR, from their inception to May 2015. Two separate searches were undertaken to identify original research articles encompassing the economic evaluation and comparative effectiveness of OMT. Identified comparative effectives studies were evaluated using the Cochrane risk of bias tool and appraised using the Good Reporting of Comparative Effectiveness (GRACE) principles. Identified economic studies were assessed with the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) guidelines. Sixteen studies reporting the findings of comparative effectiveness (n = 9) and economic evaluation (n = 7) research were included. The comparative effectiveness studies reported outcomes for varied health conditions and the majority (n = 6) demonstrated a high risk of bias. The economic evaluations included a range of analyses and considerable differences in the quality of reporting were evident. Despite some positive findings, published comparative effectiveness and health economic studies in OMT are of insufficient quality and quantity to inform policy and practice. High quality, well-designed, research that aligns with international best practice is greatly needed to build a pragmatic evidence base for OMT.
Subject(s)
Comparative Effectiveness Research/methods , Cost-Benefit Analysis/statistics & numerical data , Economics, Medical/statistics & numerical data , Manipulation, Osteopathic/economics , Manipulation, Osteopathic/methods , Humans , Treatment OutcomeABSTRACT
Insomnia is a prevalent and persistent side effect of cancer, which if left unaddressed, can be unremitting and negatively influence physical and mental well-being. Acupuncture and Cognitive Behavioral Therapy (CBT) are commonly used non-pharmacological treatments that are efficacious for treating insomnia in cancer patients; however, little is known about the comparative effectiveness of these options. The goal of personalized medicine is to determine which treatments are most effective for which individuals, and patient preference for treatment is a particularly important contributor to adherence and outcomes. Here we describe the design of a clinical trial that begins to determine how best to personalize the treatment of insomnia for cancer survivors. This project is a randomized controlled comparative effectiveness trial with a nested qualitative study comparing acupuncture and CBT for insomnia and co-morbid symptoms in a heterogeneous sample of 160 cancer survivors. The primary aim is to determine which treatment is associated with the largest reduction in insomnia severity. The secondary aim is to examine the demographic, clinical, and psychological characteristics that predict and/or moderate treatment effect. Patients will receive ten treatments of acupuncture or 7 sessions of CBT over eight weeks and complete validated patient-reported outcome measures of sleep and co-morbid symptoms at baseline, mid-treatment, post-treatment, and at three-months to assess durability of effect. The results of the proposed study have the potential to improve healthcare outcomes by helping cancer survivors and their caregivers make informed and evidence-based decisions, leading to patient-centered and personalized care for cancer survivors with insomnia.
Subject(s)
Acupuncture Therapy , Cognitive Behavioral Therapy , Neoplasms/complications , Sleep Initiation and Maintenance Disorders/therapy , Adult , Aged , Aged, 80 and over , Clinical Protocols , Comparative Effectiveness Research/methods , Female , Follow-Up Studies , Humans , Male , Middle Aged , Research Design , Sleep Initiation and Maintenance Disorders/etiology , Treatment OutcomeABSTRACT
La amenaza de parto pretérmino (APP) es una urgencia obstétrica que, en ausencia de intervención, desemboca en un parto prematuro. Detener la APP y prolongar la gestación todo lo posible permite trasladar a la gestante a un centro apropiado, administrar los cuidados necesarios y conceder un mayor periodo de maduración al feto, esencial para reducir la morbimortalidad asociada al parto prematuro. El empleo de tocolíticos al inicio de este proceso es esencial. En este artículo se revisa el escenario clínico y la información sobre los tocolíticos actualmente autorizados en España, dos de ellos por vía intravenosa (ritodrina y atosibán) y otro por vía oral (nifedipino solución oral) (AU)
Threatened preterm labour is an urgent obstetric condition leading to a preterm birth in the absence of medical intervention. Intervention must focus on stopping birth progression in order for the patient and the fetus be administered an adequate medical care, providing a temporal window for fetus´ maturation. This medical management is aimed to reduce the morbimortality associated to preterm birth. This manuscript consists of a review of the toclytics of more extended use in our context. Currently, three drugs are authorised as tocolytics in Spain: ritodrine and atosiban (intravenous) and nifedipine (oral solution) (AU)
Subject(s)
Humans , Female , Pregnancy , Tocolysis/methods , Obstetric Labor, Premature/drug therapy , Obstetric Labor, Premature/prevention & control , Nifedipine/therapeutic use , Ritodrine/therapeutic use , Drug-Related Side Effects and Adverse Reactions/epidemiology , Indicators of Morbidity and Mortality , Nifedipine/pharmacokinetics , Comparative Effectiveness Research/methodsABSTRACT
Abstract This study aimed to isolate and evaluate the cellulase activity of cellulolytic bacteria in hot springs of Dehloran, Ilam province, Iran. Water and sludge samples were collected from the hot springs and the bacterial enrichment was performed in a medium containing rice barn and carboxymethyl cellulose (CMC). The cultures were incubated at 50 °C in aerobic conditions. The bacteria were isolated on CMC agar (1%) medium. Cellulase assay of the isolates was measured by the evaluation of endoglucanase enzyme activity, which is also called as carboxymethyl cellulase (CMCase). The isolated thermotolerant bacteria were then identified and optimized for the production of CMCase. Moreover, stabilizing elements of the enzyme were identified with in silico approach. The chosen isolate was identified as Isoptericola variabilis sp. IDAH9. The identified strain produced the most thermostable CMCase at a concentration of 5.6 g/L of ammonium sulfate, 9 g/L CMCase or 12 g/L rice bran, 0/6% Tween-80, and 0.2% sucrose. The produced enzyme showed 80% of the residual activity after 1 h of incubation at 65 °C. In silico data indicated that the remaining residual activity was due to the redundant stabilizing elements in the protein structure. Consequently, I. variabilis can be isolated from the extreme environment and has a thermostable endoglucanase which may be used for various applications after studying them.
Subject(s)
Female , Humans , Male , Middle Aged , Depressive Disorder/epidemiology , Diabetes Mellitus/epidemiology , Forecasting/methods , Health Policy , Mass Screening/legislation & jurisprudence , Artificial Intelligence , Comorbidity , Comparative Effectiveness Research/methods , Decision Support Techniques , Delivery of Health Care, Integrated , Diabetes Complications , Diagnostic and Statistical Manual of Mental Disorders , Depressive Disorder/diagnosis , Depressive Disorder/psychology , Diabetes Mellitus/diagnosis , Diabetes Mellitus/psychology , Logistic Models , Mass Screening/standards , Policy Making , Predictive Value of Tests , Safety-net Providers , Self Care , Surveys and QuestionnairesABSTRACT
INTRODUCTION: Depression is a common but often undiagnosed comorbid condition of people with diabetes. Mass screening can detect undiagnosed depression but may require significant resources and time. The objectives of this study were 1) to develop a clinical forecasting model that predicts comorbid depression among patients with diabetes and 2) to evaluate a model-based screening policy that saves resources and time by screening only patients considered as depressed by the clinical forecasting model. METHODS: We trained and validated 4 machine learning models by using data from 2 safety-net clinical trials; we chose the one with the best overall predictive ability as the ultimate model. We compared model-based policy with alternative policies, including mass screening and partial screening, on the basis of depression history or diabetes severity. RESULTS: Logistic regression had the best overall predictive ability of the 4 models evaluated and was chosen as the ultimate forecasting model. Compared with mass screening, the model-based policy can save approximately 50% to 60% of provider resources and time but will miss identifying about 30% of patients with depression. Partial-screening policy based on depression history alone found only a low rate of depression. Two other heuristic-based partial screening policies identified depression at rates similar to those of the model-based policy but cost more in resources and time. CONCLUSION: The depression prediction model developed in this study has compelling predictive ability. By adopting the model-based depression screening policy, health care providers can use their resources and time better and increase their efficiency in managing their patients with depression.
Subject(s)
Depressive Disorder/epidemiology , Diabetes Mellitus/epidemiology , Forecasting/methods , Health Policy , Mass Screening/legislation & jurisprudence , Artificial Intelligence , Comorbidity , Comparative Effectiveness Research/methods , Decision Support Techniques , Delivery of Health Care, Integrated , Depressive Disorder/diagnosis , Depressive Disorder/psychology , Diabetes Complications , Diabetes Mellitus/diagnosis , Diabetes Mellitus/psychology , Diagnostic and Statistical Manual of Mental Disorders , Female , Humans , Logistic Models , Male , Mass Screening/standards , Middle Aged , Policy Making , Predictive Value of Tests , Safety-net Providers , Self Care , Surveys and QuestionnairesABSTRACT
Las patologías más frecuentes en las consultas urológicas, con una repercusión socioeconómica a nivel mundial muy alta. El cólico nefrítico (CN) es la presentación clínica más frecuente de la litiasis renal y una de las principales urgencias urológicas. El tratamiento farmacológico más utilizado para el control del dolor son los AINEs, seguidos de una amplia gama de fármacos como los opiáceos, anticolinérgicos, analgésicos, etc. Las manipulaciones vertebrales también tienen un efecto analgésico, aunque es necesario estudios que proporcionen una mayor evidencia científica. Objetivos: En esta revisión se pretende analizar las diferentes estrategias terapéuticas sobre el dolor en la LR y valorar la efectividad de los distintos tratamientos. Material y Métodos: Se realizó una revisión sistemática con una muestra de análisis bibliográfico integrado por 25 artículos (n=25) que cumplieron los criterios de selección en dos fases de análisis, lo que supone un 13.02% del total de los artículos encontrados (n=192) y el 43,85% de los artículos que cumplieron los criterios de selección de inclusión y exclusión (n=57). Se usaron las bases de datos Embase.com, Science Direct y PEDro. Como palabras clave principales se usaron «nephrolithiasis», «osteopathic medicine» y «spinal manipulation». Posteriormente se usaron otros términos como «complementary medicine», «chiropractic» y «pharmacology». Resultados: Se analizaron 8 estudios en los que se utilizaron distintas técnicas para el tratamiento del dolor en la LR: AINEs, opiáceos, ansiolíticos, anticolinérgicos, analgésicos, calor, estimulación nerviosa transcutánea (TENS) y manipulaciones vertebrales. Conclusiones: El uso de los AINEs, tanto de manera aislada como en combinación con otros fármacos parece ser el tratamiento farmacológico más eficaz para paliar el dolor. Los opiáceos, tienen como contrapartida efectos adversos no deseados. En cuanto a las terapias físicas el uso del calor local y el TENS son capaces de disminuir el dolor. Las manipulaciones vertebrales son capaces de reducir el dolor a corto plazo, sin los efectos adversos de los fármacos, aunque son necesarios más estudios que demuestren la evidencia (AU)
No disponible
Subject(s)
Nephrolithiasis/complications , Nephrolithiasis/therapy , Pain Management/instrumentation , Pain Management/methods , Cholinergic Antagonists/therapeutic use , Osteopathic Medicine/methods , Manipulation, Osteopathic/instrumentation , Manipulation, Osteopathic/methods , Manipulation, Osteopathic , Evaluation of the Efficacy-Effectiveness of Interventions , Comparative Effectiveness Research/methods , Opioid Peptides/therapeutic use , Analgesics/therapeutic use , Osteopathic Medicine/standards , Osteopathic Medicine/trends , Manipulation, Osteopathic/standards , Manipulation, Osteopathic/trendsABSTRACT
AIM: Explore key factors influencing future expectations for the production of evidence from comparative effectiveness research for drugs in the USA in 2020 and construct three plausible future scenarios. MATERIALS & METHODS: Semistructured key informant interviews and three rounds of modified Delphi with systematic scenario-building methods. RESULTS & CONCLUSION: Most influential key factors were: health delivery system integration; electronic health record development; exploitation of very large databases and mixed data sources; and proactive patient engagement in research. The scenario deemed most likely entailed uneven development of large integrated health systems with pockets of increased provider risk for patient care, enhanced data collection systems, changing incentives to do comparative effectiveness research and new opportunities for evidence generation partnerships.
Subject(s)
Comparative Effectiveness Research/economics , Comparative Effectiveness Research/methods , Drug Discovery/economics , Drug Discovery/methods , Prescription Drugs/economics , Comparative Effectiveness Research/trends , Databases, Factual , Delivery of Health Care , Delphi Technique , Drug Discovery/trends , Electronic Health Records , Humans , Interviews as Topic , Patient Participation , United StatesABSTRACT
Introducción. El uso clínico del mindfulness ha aumentado en los últimos años, y la Mindful Attention Awareness Scale (MAAS) se ha convertido en uno de los instrumentos más empleados para su medida. El objetivo de esta investigación fue analizar la eficacia del entrenamiento en mindfulness y las propiedades psicométricas de las puntuaciones de la MAAS en una muestra clínica mediante el modelo de Rasch. Métodos. Se seleccionaron 199 sujetos con sintomatología ansioso-depresiva. El grupo experimental (n = 103) recibió un entrenamiento grupal en mindfulness y el grupo control (n = 96) un tratamiento ambulatorio convencional con la misma duración. Se analizaron las puntuaciones pre y pos en la MAAS para valorar la eficacia del entrenamiento, las propiedades psicométricas de las puntuaciones y el funcionamiento diferencial de los ítems (DIF) usando el Modelo de Escalas de Calificación (MEC). Resultados. Los ítems 9 y 12 desajustaron, el ítem 9 mostró DIF, y se observaron problemas de traducción al castellano en los ítems 5, 9 y 12. Se decide repetir el análisis eliminándolos. Los resultados de la versión reducida MAAS-12 mostraron valores adecuados en dimensionalidad, ajuste y fiabilidad. Conclusiones. Contrariamente a los resultados de otros trabajos, la MAAS fue sensible al cambio producido por el entrenamiento. La versión habitualmente empleada presenta problemas métricos y de traducción y debe revisarse. La escala MAAS-12 es métricamente mejor que la habitualmente empleada, pero adolece de infrarrepresentación del constructo. Se recomienda construir instrumentos desde una perspectiva teórica coherente, de modo que todas las facetas del atributo se vean representadas (AU)
Introduction. The clinical use of mindfulness has increased recently, and the Mindful Attention Awareness Scale (MAAS) has become one of the most used tools to measure it. The aim of this study was to test the effectiveness of mindfulness training and analyzing the psychometric properties of the MAAS scores in a clinical sample using the Rasch Model. Methods. One hundred and ninety-nine participants with mood-anxiety clinical symptoms were recruited. The experimental group (n = 103) received mindfulness training, and the control group (n = 96) a conventional outpatient treatment for the same duration. The pre-post MAAS scores were analyzed to test the effectiveness of training, the psychometric properties of the scores, and differential item functioning (DIF) using the Rating Scale Model (RSM). Results. Misfit in items 9 and 12, DIF in item 9, and Spanish translation problems in the items 5, 9 and 12 were observed. The repetition of the analysis without these items was decided. Appropriate dimensionality, fit and reliability values were obtained with the short version, MAAS-12. Conclusions. Contrary to previous studies, the MAAS was sensitive to treatment-associated change. However, the commonly used MAAS has some translation and metric problems, and should be revised. MAAS-12 is a better scale than MAAS but suffers from construct under-representation. Constructing tools from a coherent theoretical perspective is suggested, so that all mindfulness facets are represented (AU)
Subject(s)
Humans , Male , Female , Young Adult , Adult , Middle Aged , Psychometrics/methods , Psychometrics/trends , Anxiety/diagnosis , Depression/diagnosis , Depression/psychology , Psychometrics/instrumentation , Psychometrics/organization & administration , Data Analysis/methods , Analysis of Variance , Manifest Anxiety Scale/standards , Comorbidity , Reproducibility of Results/methods , Evaluation of the Efficacy-Effectiveness of Interventions , Comparative Effectiveness Research/methods , Comparative Effectiveness Research/trendsABSTRACT
Comparative effectiveness research (CER) has been regarded as a hot topic in health care recently. Many medicalresearchers currently deem CER as a potential powerful instrument for improving the quality of healthcare and cut medical cost. However, in the past, classic efficacy studies are always focusing on comparing one new intervention with placebo under complete controlled environment. Now CER turns to comparing different interventions directly in real world of routine practice. This article reviewed a series of literature about the design, implementation and analysis of CER in order to give a clue for Chinese medicine researchers in future.
Subject(s)
Comparative Effectiveness Research/methods , Research Design , Humans , Medicine, Chinese Traditional , Statistics as TopicABSTRACT
ETHNOPHARMACOLOGICAL RELEVANCE: In the traditional context, herbs are often used as herbal whole system therapies, however, most clinical trials included highly selected patients and applied standardized treatment protocols with the aim to exclude as much bias as possible. These studies have contributed important information on the efficacy of herbal medicine extracts; however, their results are only marginally helpful to understand the value of herbal medicine and food items in a more traditional usual care context. METHODS: The new development of comparative effectiveness research (CER) will be introduced and synergies with ethnopharmacology will be outlined. RESULTS: CER provides great opportunities for guiding researchers and clinicians in improving management of disease. CER compares two or more health interventions in order to determine which of these options works best for which types of patients in settings that are similar to those in which the intervention will be used in practice. CER uses a broad spectrum of methodologies including randomized pragmatic trials that can also be applied to herbal whole system therapies. Ethnopharmacological research can provide highly relevant information for CER including data on characteristics of typical patients as well as traditional usage including methods of collection, extraction, and preparation. Recommendations for future research on traditional herbal medicine and food items are (1) a systematic cooperation between ethnopharmacology and clinical researchers and (2) a call for more CER on traditional herbal medicines and food items. CONCLUSION: Multiple stakeholders, including ethnopharmacologists, should cooperate to identify relevant study questions as well share their knowledge to determine the optimal placement of a clinical trial in the efficacy-effectiveness-continuum.
Subject(s)
Biomedical Research/methods , Comparative Effectiveness Research/methods , Cooperative Behavior , Diet Therapy , Ethnopharmacology , Interdisciplinary Communication , Plant Preparations/therapeutic use , Research Design , Clinical Trials as Topic , Endpoint Determination , Humans , Phytotherapy , Plants, Medicinal , Treatment OutcomeABSTRACT
Comparative effectiveness research (CER) is intended to address the expressed needs of patients, clinicians, and other stakeholders. Representatives of 54 stakeholder groups with an interest in chronic obstructive pulmonary disease (COPD) participated in workshops convened by the COPD Outcomes-based Network for Clinical Effectiveness and Research Translation (CONCERT) over a 2-year period. Year 1 focused on chronic care and care coordination. Year 2 focused on acute care and transitions in care between healthcare settings. Discussions and provisional voting were conducted via teleconferences and e-mail exchanges before the workshop. Final prioritization votes occurred after in-person discussions at the workshop. We used a modified Delphi approach to facilitate discussions and consensus building. To more easily quantify preferences and to evaluate the internal consistency of rankings, the Analytic Hierarchy Process was incorporated in Year 2. Results of preworkshop and final workshop voting often differed, suggesting that prioritization efforts relying solely on requests for topics from stakeholder groups without in-person discussion may provide different research priorities. Research priorities varied across stakeholder groups, but generally focused on studies to evaluate different approaches to healthcare delivery (e.g., spirometry for diagnosis and treatment, integrated healthcare strategies during transitions in care) rather than head-to-head comparisons of medications. This research agenda may help to inform groups intending to respond to CER funding opportunities in COPD. The methodologies used, detailed in the online supplement, may also help to inform prioritization efforts for CER in other health conditions.
Subject(s)
Comparative Effectiveness Research/methods , Patient Care Management/methods , Pulmonary Disease, Chronic Obstructive/therapy , Acute Disease , Chronic Disease , Delivery of Health Care, Integrated/methods , Humans , Patient Advocacy , Patient-Centered Care/methods , United StatesABSTRACT
In this article, we will focus on how preferences and utilities are measured, including the strengths and limitations of various approaches, discuss their use in estimating quality-adjusted life-years (QALYs) and make some recommendations for further research. Preferences are either measured using direct (visual analog scale, time trade-off or standard gamble) or indirect methods. The most commonly used generic indirect measures include the Quality of Well-Being scale, EuroQol-5 Dimension, Health Utilities Index and Short Form-6 Dimension. Disease-specific preference measures are increasingly being developed and applied in studies as more sensitive measures of health status. Preference-based measures and QALY measurement need to be enhanced, and additional research is needed to improve scientific methods for estimating preferences for health assessment. Given the increased focus on comparative effectiveness research, QALYs have the potential for helping researchers, clinicians, health policy-makers and patients to understand the relative effectiveness of alternative interventions for treating medical conditions.
Subject(s)
Health Policy , Health Status , Quality-Adjusted Life Years , Comparative Effectiveness Research/methods , Cost-Benefit Analysis , Humans , Policy MakingABSTRACT
ObjetivoEvaluar la efectividad de la TN para disminuir el dolor y el consumo de fármacos.DiseñoEstudio de intervención antes-después.EmplazamientoCAP de Llefià en Badalona (Barcelona).Participantes82 pacientes con edades entre 25 y 85 años que presentaban dolor que no remitió después de al menos un mes de evolución.Mediciones principalesSe recogieron datos para la valoración de las variaciones del dolor y sobre el consumo de fármacos antes de la intervención y después a las 2 semanas, 3 meses y 6 meses mediante entrevista personal y para el dolor mediante la escala visual analógica (EVA).ResultadosEVA media preintervención: 7,94 (DE: 1,68), EVA media a las 2 semanas 4,63 (DE: 2,79), a los 3 meses 3,74 (DE: 3,17) y a los 6 meses 3,48 (DE: 3,27) (p<0,001 en las 3 comparaciones, mediante test de Wilcoxon). En cuanto al consumo de fármacos después de la intervención, un 74,4% de los pacientes lo redujeron a las 2 semanas, un 76,8% lo redujeron a los 3 meses y un 80% a los 6 meses.ConclusionesLa TN puede ser eficaz en disminuir el dolor así como el consumo de fármacos. Faltarían ensayos clínicos que lo confirmaran(AU)
ObjectiveTo evaluate the effectiveness of NT in reducing pain and minimising use of analgesics in patients.DesignBefore and after intervention study.SettingLlefià Primary Health Care centre in Badalona (Barcelona).ParticipantsEighty-two patients between the ages of 25 and 85 years old, who suffered pain that did not disappear after a month.Main measurementsData was collected to evaluate any change in pain and the use of analgesics in patients before intervention and then afterwards, at 2 weeks, 3 months and 6 months. This was conducted by means of interviews and use of the Visual Analogue Pain Scale (VAS).ResultsMean VAS pre-treatment: 7.94 (SD: 1.68), mean VAS after two weeks 4.63 (SD: 2.79), after 3 months 3.73 (SD: 3.17), and after 6 months 3.48 (SD: 3,27) (P<.001 in the 3 comparisons, using the Wilcoxon-test for matched data). As regards analgesic use after treatment, 74.4% of patients reduced it after 2 weeks, 76.8% after 3 months and 80% after 6 months.ConclusionsNeural therapy can be effective in reducing pain, as well as the use of analgesics. Further clinical trials would be needed to confirm this assertion(AU)