Evaluation Of Health Care Interventions Research Articles

The Methodological Quality of Randomised Controlled Trials in Plastic Surgery

INTRODUCTION: Randomized controlled trials (RCTs) represent the criterion standard in evaluating healthcare interventions. However, RCTs can yield biased results if they lack methodological rigour, especially where surgical techniques are involved. Surgical RCTs have a number of unique challenges and can be performed poorly. Our objective was to assess the methodological quality of RCTs in Plastic Surgery. METHODS: Medline was searched by an information specialist from 1 January 2009 to 30 June 2011 for the MESH heading “Surgery, Plastic” with limitations for English language, human studies and randomized controlled trials. Results were then manually searched for relevant RCTs involving surgical techniques. The papers were then scored out of seven using the authors own extended version of the Linde Internal Validity Scale (ELIVS). Secondary scoring was then performed and discrepancies resolved by consensus. RESULTS: 57 papers involving 3,878 patients across 16 countries met the inclusion criteria from a manual search of 254 papers retrieved from Medline. The median ELIVS score was 3.0 with a mean of 3.2 (range 1.0-6.5). Compliance was poorest with items related to: use of intention to treat analysis (4%), blinding of patients (23%) and the handling and reporting of patient withdrawals (25%). There was no link between journal ELIVS score and 2010 impact factor or number of authors (Spearman rho correlations 0.14 and 0.27 respectively). Multicentre trials had a higher average ELIVS score than single centre ones (3.6 vs 2.7) although this did not reach significance. There was no correlation between the volume of RCTs performed in a particular country and methodological quality. CONCLUSION: The methodological quality of RCTs in Plastic Surgery is poor, as in other surgical specialties. Further education on trial methodology is advocated, especially the value of intention to treat analysis.

The quality of reporting in randomised controlled trials in plastic surgery

The quality of reporting in randomised controlled trials in plastic surgery

Orthopaedic Trial Networks

Randomized controlled trials (RCTs) are considered the most robust design for evaluating health care interventions. However, it is difficult to acquire funding for RCTs, and they are complex to set up. Threats to their successful conduct and impact on clinical practice, particularly in surgical trials, include problems with recruitment, notably in terms of clinical equipoise and patient acceptability. Historically, RCTs are less common in surgical specialties, and their contribution to the orthopaedic literature remains small. Orthopaedic networks, such as orthopaedic associations, specialist societies, travel fellowships, and clinical research networks, provide an opportunity to meet the challenges of promoting RCTs in orthopaedic clinical practice. This can include identifying important research questions to help prioritize funding; educating and training surgeons in the design and practice of RCTs; helping to promote and coordinate RCTs; and disseminating the findings of RCTs. Orthopaedic trial networks should be encouraged to promote a research culture in which RCTs are feasible and to ensure that scarce resources utilized to support their funding are used most efficiently and to best effect. In particular, the use of networks is encouraged to support the conduct of RCTs in achieving patient recruitment, which is crucial in providing the evidence base to inform orthopaedic practice. Furthermore, to improve generalizability, acceptance of study findings and communication between orthopaedic surgeons, as well as international collaboration in trials, should be part of the strategy for the future.

Can self-report questionnaires create illness cognitions in middle-aged men?

To examine the effect of questionnaire context on self-reported illness cognition. A single-item measure of the perceived impact of lower urinary tract symptoms (LUTS) was embedded twice in a questionnaire battery completed by community-dwelling middle-aged males (N = 1,790). The impact measure was placed in two distinct questionnaire contexts; at the end of a general somatic symptoms questionnaire, and following an illness-specific symptoms questionnaire. The order of the two questionnaire contexts was counterbalanced in a random subsample. An established single-item measure of the perceived impact of LUTS. Concordance between the two single-item measures was moderate. Scores on a single-item measure of impact were significantly lower when assessed immediately following the completion of a LUTS-specific questionnaire than when assessed following the completion of a general symptoms questionnaire. There was no evidence of order effects. The observed effect was moderated by the severity of LUTS such that the difference in perceived impact scores between contexts (where general symptoms context > illness-specific context) increased as urinary symptoms increased. Questionnaire context systematically influenced responses on self-report measures of illness impact. The magnitude of the context effect was largest in the highest quintile of LUTS severity, a difference of 0.5 on a scale with a range of 3. These findings may have implications for situations where patient reported outcome measures are used to evaluate health care interventions or inform treatment decisions.

Economics and resourcing of complex healthcare systems

With rapid increases in healthcare spending over recent years, health economic evaluation might be thought to be increasing in importance to decision-makers. Such evaluations are designed to inform the efficient management of healthcare resources. However, research into health policy decisions often report, at best, moderate use of economic evaluation information, especially at the local level of administration. Little attention seems to have been given to the question of why economic evaluations have been underused and why they may yield different results in different contexts. There are many barriers to applying economic evaluations in situations which combine complexity with uncertainty. These barriers call for innovative and creative responses to economic evaluation of healthcare interventions. One response is to view economic evaluations in the context of complex adaptive systems theory. Such theory offers a conceptual framework that takes into account contextual factors, multiple input and output, multiple perspectives and uncertainty involved in healthcare interventions. This article illustrates how complexity theory can enrich and broaden policy-makers' understanding of why economic evaluations have not always been as successful as health economists would have hoped. It argues for health economists to emphasise contextual knowledge and relativist understanding of decision contexts rather than seeking more technically sound evidence-based reviews including economic evaluations.

Policy Implications of Adjusting Randomized Trial Data for Economic Evaluations

Although the randomized controlled trial (RCT) is widely considered the most reliable method for evaluation of health care interventions, challenges to both internal and external validity exist. Thus, the efficacy of an intervention in a trial setting does not necessarily represent the real-world performance that decision makers seek to inform comparative effectiveness studies and economic evaluations. Using data from the ASCUS-LSIL Triage Study (ALTS), we performed a simplified economic evaluation of age-based management strategies to detect cervical intraepithelial neoplasia grade 3 (CIN3) among women who were referred to the study with low-grade squamous intraepithelial lesions (LSIL). We used data from the trial itself to adjust for 1) potential lead time bias and random error that led to variation in the observed prevalence of CIN3 by study arm and 2) potential ascertainment bias among providers in the most aggressive management arm. We found that using unadjusted RCT data may result in counterintuitive cost-effectiveness results when random error and/or bias are present. Following adjustment, the rank order of management strategies changed for 2 of the 3 age groups we considered. Decision analysts need to examine study design, available trial data, and cost-effectiveness results closely in order to detect evidence of potential bias. Adjustment for random error and bias in RCTs may yield different policy conclusions relative to unadjusted trial data.

The ‘how’ of cost-effectiveness analysis for care pathways is not straightforward

Introduction: As health-care payers are faced with the need to allocate finite resources to maximize the health and wellbeing of the population, interest in the economic evaluation of health-care interventions has risen over the past decades. Although we have become aware of the growing importance of economic issues in medicine, economic evaluations in care pathways have remained up to now rather limited.Even if we agree with the author that there is an urgent need for economic evaluations in health service interventions, we fear that this paper contains methodological flaws which may mislead the reader of the journal, as well as potential users of economic evaluations.

PHP79 What Are the Research Priorities in the Spanish National Health System? A Comparison of Economic Evaluations of Health Care Interventions and Public-Funded Research

PHP79 What Are the Research Priorities in the Spanish National Health System? A Comparison of Economic Evaluations of Health Care Interventions and Public-Funded Research

PRM11 Learning Effect in Economic Evaluations of Health Care Interventions

PRM11 Learning Effect in Economic Evaluations of Health Care Interventions

PRM21 Validating a Multi-Criteria Decision Analysis (MCDA) Framework for Health Care Decision Making

OBJECTIVES: When evaluating healthcare interventions, decision-makers are increasingly asked to consider multiple criteria to support their decision. The MCDA-based EVIDEM framework was developed to support this process. It includes a simple weight elicitation technique, designed to be easily applicable by a broad range of users. The objective of this study was to compare the EVIDEM technique with more traditional techniques. METHODS: An online questionnaire was developed comparing the EVIDEM technique with four alternative techniques including AHP, best/worst scaling, ranking and point-allocation. A convenience sample of 60 Dutch and Canadian students were asked to fill out the questionnaires as if they were sitting in an advisory committee for reimbursement/prioritization of healthcare interventions. They were asked to provide weights for 14 criteria using two techniques, and to provide feedback on ease of use and clarity of concepts of the different techniques. RESULTS: Results based on the first 30 responses show that EVIDEM is easy to understand and takes little time to complete, three minutes on average. Criteria weights derived using the EVIDEM technique and best/worst scaling are divergent. Comparing the rank order of criteria respondents gave using these two techniques; there is more resemblance in rank order of criteria weighted with the EVIDEM technique. Compared to AHP/ranking/point-allocation, EVIDEM takes less time to complete but is only preferred by 33% of decision-makers. AHP/ranking and point allocation were often described as clearer and more reflective of the respondents’ opinion. CONCLUSIONS: The simple technique is proposed as a starting point for users wishing to adapt the EVIDEM framework to their own context. Other techniques may be preferred and their impact on the MCDA value estimate generated by applying the framework is being explored. This project is part of a large collaborative work that includes developing and validating this framework to facilitate sound and efficient MCDA-applications.

Cannabinoids for treatment of chronic non‐cancer pain; a systematic review of randomized trials

Effective therapeutic options for patients living with chronic pain are limited. The pain relieving effect of cannabinoids remains unclear. A systematic review of randomized controlled trials (RCTs) examining cannabinoids in the treatment of chronic non-cancer pain was conducted according to the PRISMA statement update on the QUORUM guidelines for reporting systematic reviews that evaluate health care interventions. Cannabinoids studied included smoked cannabis, oromucosal extracts of cannabis based medicine, nabilone, dronabinol and a novel THC analogue. Chronic non-cancer pain conditions included neuropathic pain, fibromyalgia, rheumatoid arthritis, and mixed chronic pain. Overall the quality of trials was excellent. Fifteen of the eighteen trials that met the inclusion criteria demonstrated a significant analgesic effect of cannabinoid as compared with placebo and several reported significant improvements in sleep. There were no serious adverse effects. Adverse effects most commonly reported were generally well tolerated, mild to moderate in severity and led to withdrawal from the studies in only a few cases. Overall there is evidence that cannabinoids are safe and modestly effective in neuropathic pain with preliminary evidence of efficacy in fibromyalgia and rheumatoid arthritis. The context of the need for additional treatments for chronic pain is reviewed. Further large studies of longer duration examining specific cannabinoids in homogeneous populations are required.

Response to Letter Regarding Article, “Drug-Eluting or Bare Metal Stents for the Treatment of Saphenous Vein Graft Disease: A Bayesian Meta-Analysis”

HomeCirculation: Cardiovascular InterventionsVol. 4, No. 2Response to Letter Regarding Article, “Drug-Eluting or Bare Metal Stents for the Treatment of Saphenous Vein Graft Disease: A Bayesian Meta-Analysis” Free AccessReplyPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessReplyPDF/EPUBResponse to Letter Regarding Article, “Drug-Eluting or Bare Metal Stents for the Treatment of Saphenous Vein Graft Disease: A Bayesian Meta-Analysis” Jean-Michel Paradis, MD, Olivier F. Bertrand, MD, PhD, Robert DeLarochellière, MD, Jean-Pierre Déry, MD, MHS, Éric Larose, DVM, MD, Josep Rodés-Cabau, MD and Stéphane Rinfret, MD, SM Patrick Bélisle, MSc and Lawrence Joseph, PhD Jean-Michel ParadisJean-Michel Paradis Search for more papers by this author , Olivier F. BertrandOlivier F. Bertrand Search for more papers by this author , Robert DeLarochellièreRobert DeLarochellière Search for more papers by this author , Jean-Pierre DéryJean-Pierre Déry Search for more papers by this author , Éric LaroseÉric Larose Search for more papers by this author , Josep Rodés-CabauJosep Rodés-Cabau Search for more papers by this author and Stéphane RinfretStéphane Rinfret Search for more papers by this author Patrick BélislePatrick Bélisle Search for more papers by this author and Lawrence JosephLawrence Joseph Search for more papers by this author Originally published1 Apr 2011https://doi.org/10.1161/CIRCINTERVENTIONS.111.961581Circulation: Cardiovascular Interventions. 2011;4:e15As pointed out by Hakeem et al, other meta-analyses have been published recently on the use of drug-eluting versus bare metal stents in saphenous vein grafts. Because the data on which they are founded are available to researchers worldwide, meta-analyses are certainly more prone to redundancy than original research. However, we still believe that our meta-analysis differed slightly from other reviews because it was the first to use a bayesian hierarchical random-effects model. Moreover, at the time of our literature search, the number of patients collected in our meta-analysis was the highest ever reported. Finally, our work included new data from contemporary studies, including, for example, the STENT registry.1We agree with Hakeem et al on the fact that there is a need for a facility that will assume a prospective registration of protocols for systematic reviews and meta-analyses of studies evaluating health care interventions. This kind of centralized open registry would consequently provide more transparency throughout the publication process, from protocol redaction to revelation of potential bias. This would also avoid superfluous duplication. In fact, a simple, free, web-based, easily searchable platform would be beneficial to inform medical researcher on ongoing reviews and meta-analyses. Thus, we support initiatives like the PRISMA statement,2 which will probably lead to a more efficient use of the finite research funding and to an improvement of the overall quality of systematic reviews and meta-analyses.Jean-Michel Paradis, MDOlivier F. Bertrand, MD, PhDRobert DeLarochellière, MDJean-Pierre Déry, MD, MHSÉric Larose, DVM, MDJosep Rodés-Cabau, MDStéphane Rinfret, MD, SM Institut universitaire de cardiologie et de pneumologie de Québec (Quebec Heart and Lung Institute) Quebec City, CanadaPatrick Bélisle, MScLawrence Joseph, PhD McGill University Health Center Montreal, CanadaDisclosuresNone.

Using a business model approach and marketing techniques for recruitment to clinical trials.

Randomised controlled trials (RCTs) are generally regarded as the gold standard for evaluating health care interventions. The level of uncertainty around a trial's estimate of effect is, however, frequently linked to how successful the trial has been in recruiting and retaining participants. As recruitment is often slower or more difficult than expected, with many trials failing to reach their target sample size within the timescale and funding originally envisaged, the results are often less reliable than they could have been. The high number of trials that require an extension to the recruitment period in order to reach the required sample size potentially delays the introduction of more effective therapies into routine clinical practice. Moreover, it may result in less research being undertaken as resources are redirected to extending existing trials rather than funding additional studies.Poor recruitment to publicly-funded RCTs has been much debated but there remains remarkably little clear evidence as to why many trials fail to recruit well, which recruitment methods work, in which populations and settings and for what type of intervention. One proposed solution to improving recruitment and retention is to adopt methodology from the business world to inform and structure trial management techniques.We review what is known about interventions to improve recruitment to trials. We describe a proposed business approach to trials and discuss the implementation of using a business model, using insights gained from three case studies.

Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: A systematic review

Objective The most reliable evidence for evaluating healthcare interventions comes from well-designed and conducted randomized controlled trials (RCTs). The extent to which published RCTs reflect the efficacy of interventions, however, depends on the completeness and accuracy of published results. The Consolidated Standards of Reporting Trials statement, initially developed in 1996, provides guidelines intended to improve the transparency of published RCT reports. A policy of the International Committee of Medical Journal Editors, initiated in 2005, requires clinical trials published in member journals to be registered in publicly accessible registries prior to patient enrollment. The objective of this study was to assess the clarity of outcome reporting, proportion of registered trials, and adequacy of outcome registration in RCTs published in top behavioral health journals. Methods Eligible studies were primary or secondary reports of RCTs published in Annals of Behavioral Medicine, Health Psychology, Journal of Psychosomatic Research, and Psychosomatic Medicine from January 2008 to September 2009. Data were extracted for each study on adequacy of outcome reporting and registration. Results Of 63 articles reviewed, only 25 (39.7%) had adequately declared primary or secondary outcomes, whereas 38 (60.3%) had multiple primary outcomes or did not define outcomes. Only 13 studies (20.6%) were registered. Only 1 study registered sufficiently precise outcome information to compare with published outcomes, and registered and published outcomes were discrepant in that study. Conclusion Greater attention to outcome reporting and trial registration by researchers, peer reviewers, and journal editors will increase the likelihood that effective behavioral health interventions are readily identified and made available to patients.

PHP132 VALUE OF MULTI-CRITERIA DECISION ANALYSIS IN EARLY ASSESSMENT OF MEDICAL DIAGNOSTIC DEVICES

OBJECTIVES: Multicriteria decision analytic (MCDA) techniques are a powerful tool in evaluating health care interventions where multiple, often competing, factors need to be considered. The analytic hierarchy process (AHP) is one such technique. We have applied AHP to evaluate medical diagnostic technologies as to support product development and market access. The main objective of this study is to show feasibility of AHP in terms of applicability and outcome. We therefore have studied the expected performance of the Photoacoustic Mammoscope (PAM), a new imaging device for detection of breast cancer based on photoacoustic imaging. METHODS: Before starting the study we defined different diagnostic and screening scenarios for the PAM including criteria that are important in the acceptance of the device. We finally defined four strategies including mammography, ultrasound and MRI imaging. The Analytic Hierarchy Process (AHP) analysis was then used to identify the relative importance of evaluation criteria, and to identify the relative performance of four different breast cancer imaging techniques. RESULTS: According to the expert panel the most important criterion in the design of a diagnostic breast imaging device is sensitivity (overall weight was 54%). Factors that mainly determine the performance on sensitivity are the visualization of mass margins, mass shape and vascularization. Second most important criterion was safety. CONCLUSIONS: From an early assessment of photoacoustic imaging it may be concluded that the potential clinical performance justifies further development and implementation of PAM. However, further research on the use of AHP in medical product development is required. We present and discuss some ideas to further integrate clinical evidence into MCDA using Bayesian techniques as well as sensitivity analyses on the model inputs.

Validity and responsiveness of the EQ-5D in assessing and valuing health status in patients with anxiety disorders.

BackgroundThe EQ-5D is a generic questionnaire which generates a health profile as well as index scores for health-related quality of life that may be used in cost-utility analysis.Aims of the studyTo examine validity and responsiveness of the EQ-5D in patients with anxiety disorders.Methods389 patients with anxiety disorders completed the EQ-5D at baseline and 6-month follow-up. Subjective measures of quality of life (WHOQOL-BREF) and psychopathology (BAI, BDI-II, BSQ, ACQ, MI) were used for comparison. Validity was analyzed by assessing associations between EQ-5D scores and related other scores. Responsiveness was analyzed by calculating effect sizes of differences in scores between baseline and follow-up for 3 groups indicating more, constant or less anxiety. Meaningful difference scores for shifting to less or more anxiety were derived by means of regression analysis.Results88.4% of respondents reported problems in at least one of the EQ-5D dimension at baseline; the mean EQ VAS score was 63.8. The EQ-5D dimension most consistently associated with the measures used for comparison was 'anxiety/depression'. EQ VAS and EQ-5D index scores were highly correlated (|r|>0.5) with scores of the WHOQOL-BREF dimensions 'physical', 'mental' and 'overall' as well as BAI and BDI-II. The EQ-5D index tended to be the most responsive score. Standardized meaningful difference scores were not significantly different between EQ VAS, EQ-5D index and measures used for comparison.ConclusionsThe EQ-5D seems to be reasonably valid and moderately responsive in patients with anxiety disorders. The EQ-5D index may be suitable for calculating QALYs in economic evaluation of health care interventions for patients with anxiety disorders.Trial registrationCurrent Controlled Trials ISRCTN15716049

Evidence-Based Medicine and Hospital Reform: Tracing Origins Back to Florence Nightingale

The use of reliable evidence to evaluate health care interventions has gained strong support within the medical community and in the field of plastic surgery in particular. Evidence-based medicine aims to improve health care and reduce costs through the use of sound clinical evidence in evaluating treatments, procedures, and outcomes. The field is hardly new, however, and most trace its origins back to the work of Cochrane in the 1970s and Sackett in the 1990s. Though she wouldn't know it, Florence Nightingale was applying the concepts of evidence-based reform to the medical profession more than a century before. She used medical statistics to reveal the nature of infection in hospitals and on the battlefield. Moreover, Nightingale marshaled data and evidence to establish guidelines for health care reform. Tracing the origins of evidence-based medicine back to Nightingale underscores how critical this movement is to improving the quality and effectiveness of patient care today.

Using clinical databases to evaluate healthcare interventions

The aim of this study was to test the feasibility of conducting rigorous, nonrandomized studies (NRSs) of healthcare interventions using existing clinical databases in terms of the following: recruiting a large representative sample of hospitals, identifying eligible cases, matching cases to controls to achieve similar baseline characteristics, making meaningful comparisons of outcomes, and carrying out subgroup analyses. Data were extracted from the Intensive Care National Audit & Research Centre's Case Mix Programme Database to investigate the impact of management with a pulmonary artery catheter (PAC) in intensive care unit (ICU) patients. Participating ICUs were invited to collect additional data for the analysis. Patients managed with a PAC were matched to control patients on their propensity score. Hospital mortality was then compared between the two groups. Of 117 eligible ICUs, 68 (58 percent) agreed to participate, of which 57 (84 percent) collected additional data. Although a slightly higher proportion of larger ICUs in university hospitals participated, the patient case-mix was similar to that in nonparticipating ICUs. Almost all patients managed with a PAC (98 percent) were successfully matched to patients managed without a PAC. The two groups were similar for baseline characteristics. However, hospital mortality was worse for PAC patients than for non-PAC patients (odds ratio, 1.28; 95 percent confidence interval, 1.06-1.55). Subgroup analysis suggested that the impact of management with a PAC was modified by severity of illness. Rigorous NRSs are feasible if they are based on data from high-quality clinical databases. However, the reliability of estimated treatment effects from such studies requires further investigation.

The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration

Systematic reviews and meta-analyses are essential to summarize evidence relating to efficacy and safetyof health care interventions accurately and reliably. The clarity and transparency of these reports, however,is not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, andother users. Since the development of the QUOROM (QUality Of Reporting Of Meta-analysis) Statement—areporting guideline published in 1999—there have been several conceptual, methodological, and practicaladvances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews ofpublished systematic reviews have found that key information about these studies is often poorly reported.Realizing these issues, an international group that included experienced authors and methodologistsdeveloped PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) as an evolution ofthe original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health careinterventions. The PRISMA Statement consists of a 27-item checklist and a four-phase flow diagram. Thechecklist includes items deemed essential for transparent reporting of a systematic review. In thisExplanation and Elaboration document, we explain the meaning and rationale for each checklist item. Foreach item, we include an example of good reporting and, where possible, references to relevant empiricalstudies and methodological literature. The PRISMA Statement, this document, and the associated Web site(http://www. prisma-statement.org/) should be helpful resources to improve reporting of systematicreviews and meta-analyses.

Archie Cochrane and His Vision for Evidence-Based Medicine

Archibald (Archie) Cochrane's most influential mark on health care was his 1971 publication, Effectiveness and Efficiency. This book strongly criticized the lack of reliable evidence behind many of the commonly accepted health care interventions at the time. His criticisms spurred rigorous evaluations of health care interventions and highlighted the need for evidence in medicine. His call for a collection of systematic reviews led to the creation of The Cochrane Collaboration. Archie Cochrane was a visionary person who helped lay down much of the foundation for evidence-based medicine. This article introduces evidence-based medicine to plastic surgery by tracing its history to the seminal efforts by Archie Cochrane.