Pragmatic-Explanatory Continuum Indicator Summary Research Articles

Applying the Pragmatic-Explanatory Continuum Indicator Summary Model in a Primary Care-Based Lifestyle Intervention Trial.

The majority of adults in the U.S. can be classified as overweight or obese (68%), putting them at risk for Type 2 diabetes, cardiovascular diseases, and other adverse health outcomes. The U.S. Preventive Services Task Force recommends that providers offer or refer obese adults to intensive, multicomponent lifestyle interventions. However, there is a critical need for interventions that have been shown to be pragmatic and effective among diverse populations, scalable across different clinical settings and systems, and sustainable over time. The Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) tool can be used to assess the degree to which trials of behavioral lifestyle interventions provide evidence to support this need. We used our recently completed trial, Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care (E-LITE), as a case study and assessed the domains of PRECIS to explore the degree to which we felt it achieved its intended pragmatic design (completed in December 2014). Overall, the systematic assessment using the PRECIS tool revealed that the E-LITE trial design was very pragmatic in nature. Its results and the subsequent adoption of the intervention into actual practice also suggest high potential for implementation of primary care interventions.

Evaluating Feasible and Referable Behavioral Counseling Interventions.

The U.S. Preventive Services Task Force (USPTF) recognizes that behaviors have a major impact on health and well-being. Currently, the USPSTF has 11 behavioral counseling intervention (BCI) recommendations. These BCIs can be delivered in a primary care setting or patients can be referred to other clinical or community programs. Unfortunately, many recommended BCIs are infrequently and ineffectually delivered, suggesting that more evidence is needed to understand which BCIs are feasible and referable. In response, the USPSTF convened an expert forum in 2013 to inform the evaluation of BCI feasibility. This manuscript reports on findings from the forum and proposes that researchers use several frameworks to help clinicians and the USPSTF evaluate which BCIs work under usual conditions. A key recommendation for BCI researchers is to use frameworks whose components can support dissemination and implementation efforts. These frameworks include the Template for Intervention Description and Replication (TIDieR), which helps describe the essential components of an intervention, and pragmatic frameworks like Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) or Pragmatic-Explanatory Continuum Indicator Summary (PRECIS), which help to report study design elements and outcomes. These frameworks can both guide the design of more-feasible BCIs and produce clearer feasibility evidence. Critical evidence gaps include a better understanding of which patients will benefit from a BCI, how flexible interventions can be without compromising effectiveness, required clinician expertise, necessary intervention intensity and follow-up, impact of patient and clinician intervention adherence, optimal conditions for BCI delivery, and how new care models will influence BCI feasibility.

Perspectives in Implementing a Primary Care-Based Intervention to Reduce Alcohol Misuse.

In 2013, the U.S. Preventive Services Task Force (USPSTF) recommended screening followed by brief behavioral counseling to reduce alcohol misuse. Our study, Options Regarding Consumption of Alcohol (ORCA), was one of the studies included in an evidence review that comprised 23 RCTs. ORCA was designed to test whether a primary care-based intervention would reduce alcohol misuse among patients who screened positive for risky or hazardous drinking. Data collection occurred between 1995 and 1999; data analysis was conducted in 2000-2002. Study design and implementation built from a behavioral counseling research paradigm with four components: (1) population-based screening; (2) centralized delivery of intervention components; (3) involvement of primary care practitioners to motivate and reinforce behavior change; and (4) personalization of intervention components. In this paper, we assess the study features using the Pragmatic-Explanatory Continuum Indicator Summary Model domains. As a randomized trial, the study included some explanatory features (e.g., standardized follow-up surveys administered by study personnel); however, several aspects of the study were highly pragmatic. Practicable recruitment and training of providers, embedding population-based screening in pre-visit surveys, and keeping the delivery of the primary care intervention components consistent with the tempo and competing priorities of practice are three key features that contributed to the study's success and relevance to the USPSTF.

Using the Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) model in clinical research: Application to refine a practice-based research network (PBRN) study.

Pragmatic clinical trials (PCTs) are increasingly recommended to evaluate interventions in real-world conditions. Although PCTs share a common approach of evaluating variables from actual clinical practice, multiple characteristics can differ. These differences affect interpretation of the trial. The Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) model was developed in 2009 by the CONSORT Work Group on Pragmatic Trials, published by Thorpe et al, to aid in trial design. PRECIS provides clarity about the generalizability and applicability of a trial by depicting multiple study characteristics. We recently completed a National Institutes of Health-sponsored pilot study examining health-related outcomes for 2 complementary therapies for chronic low back pain in patients referred by primary care providers in the Kentucky Ambulatory Network. In preparation for a larger study, we sought to characterize the pragmatic features of the study to aid in our design decisions. The purpose of this article is to introduce clinical researchers to the PRECIS model while demonstrating its application to refine a practice based research network study. We designed an exercise using an audience response system integrated with a Works in Progress presentation to experienced researchers at the University of Kentucky to examine our study methodologies of parameters suggested by the PRECIS model. The exercise went smoothly and participants remained engaged throughout. The study received an overall summary score of 30.17 (scale of 0 to 48; a higher score indicates a more pragmatic approach), with component scores that differentiate design components of the study. A polar chart is presented to depict the pragmatism of the overall study methodology across each of these components. The study was not as pragmatic as expected. The exercise results seem to be useful in identifying necessary refinements to the study methodology that may benefit future study design and increase generalizability. Readers can identify how the PRECIS model may be used to provide clarity and transparency for proposed or existing studies and may wish to replicate our exercise in planning their own studies.

PRM32 - How Well the Pragmatic Randomized Controls in Joint Replacement Field: Results from Precis, Consort and Iom Tools' Assessment

Evidence from real world are important for patients care. Pragmatic randomized control trial (PRCT) as one of the research methods of Comparative Effectiveness Research (CER) is used in many medical fields recently. This study aims to assess design and reporting qualities of PRCTs published in joint replacement fields. We searched the Medline, Embase, CENTRAL to February 2014 and the reference lists of retrieved studies to identify the full-report pragmatic randomized trials in English that compared Total Hip Replacement (THR) or Total Knee Replacement (TKR) with a conventional treatment. Three reviewers independently assess the quality of PRCTs by using the pragmatic-explanatory continuum indicator summary (PRECIS) tool, CONSORT statement guidelines and the six CER defining characteristics of the Institute of Medicine (IOM). We screened 55 potentially eligible abstracts and identified 6 full-text PRCTs of joint replacement fields. Finally 3 trials with 4,152 patients were assessed. Three reviewers scored the 3 trials based on PRECIS tool (39.5 vs 44 vs 36); CONSORT statement guidelines (36.5 vs 39 vs 37.5); IOM defining characteristics of CER (26.5 vs 29 vs 29). All 3 trials reported the clinical, economic and patient-centered outcomes. The Knee Arthroplasty Trial with 10 years’ follow-up was scored the highest and considered to be more closer to the real world than other two trials as it was conducted in 2352 patients from 34 UK centers and 116 surgeons in the study could adjusted their treatments based on individual patients’ characteristics. PRCT is different from standard RCT in many aspects. The number of PRCT in joint replacement field is limited and the quality need to be improved. PRECIS, CONSORT guidelines are useful for researchers in designing and reporting the PRCT.

Do randomized controlled nursing trials have a pragmatic or explanatory attitude? Findings from the Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) tool exercise.

Randomized controlled trials (RCTs) may be categorized as either effectiveness trials or efficacy trials, which may be categorized by the Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) tool. However, no data regarding the application of the PRECIS tool in a cluster of RCTs belonging to a specific discipline such as nursing are available. The principal aim of this study was to assess the prevailing nature (pragmatic vs. explanatory) of a cluster of clinical nursing RCTs. Evaluating the suitability of the PRECIS in the analysis of nursing RCTs was the secondary aim. All nursing RCTs published in 2010 were identified through a systematic review and extracted in full-text form. An explanatory-pragmatic (E-P) group consisting of 11 researchers trained in the use of the PRECIS tool evaluated each RCT in terms of 10 domains, respectively scored on a scale ranging from 5 (pragmatic) to 1 (explanatory). The E-P group further scored the feasibility of the PRECIS tool using a numerical rating scale (0 = not at all, 10 = entirely feasible). Along the pragmatic-explanatory continuum, assuming 50 as the highest degree of pragmatism and 10 as the highest degree of explanatory, the evaluation of nursing RCTs returned an average of 31.1 (median = 31, SD = 7.18, range = 13-44). On the pragmatic-explanatory continuum, the evaluated nursing RCTs tended to be pragmatic, which seems to be consistent with the purposes of the nursing discipline. The feasibility of the PRECIS tool in the evaluation of nursing trials as perceived by the E-P Group was, on average, 7.09 (SD = 1.09, 95% CI [6.35, 7.82]). Applying the PRECIS tool is perceived to be highly feasible in the critical appraisal of a cluster of RCTs in a specific discipline such as nursing.

How pragmatic is it? Lessons learned using PRECIS and RE-AIM for determining pragmatic characteristics of research.

BackgroundThe need for high-quality evidence that is applicable in real-world, routine settings continues to increase. Pragmatic trials are designed to evaluate the effectiveness of interventions in real-world settings, whereas explanatory trials aim to test whether an intervention works under optimal situations. There is a continuum between explanatory and pragmatic trials. Most trials have aspects of both, making it challenging to label and categorize a trial and to evaluate its potential for translation into practice.MethodsWe summarize our experience applying the Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) combined with external validity items based on the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to three studies to provide a more robust and comprehensive assessment of trial characteristics related to translation of research. We summarize lessons learned using domains from the combined frameworks for use in study planning, evaluating specific studies, and reviewing the literature and make recommendations for future use.ResultsA variety of coders can be trained to use the PRECIS and RE-AIM domains. These domains can also be used for diverse purposes, content areas, and study types, but are not without challenges. Both PRECIS and RE-AIM domains required modification in two of the three studies to evaluate and rate domains specific to study type. Lessons learned involved: dedicating enough time for training activities related to the domains; use of reviewers with a range of familiarity with specific study protocols; how to best adapt ratings that reflect complex study designs; and differences of opinion regarding the value of creating a composite score for these criteria.ConclusionsCombining both frameworks can specifically help identify where and how a study is and is not pragmatic. Using both PRECIS and RE-AIM allows for standard reporting of key study characteristics related to pragmatism and translation. Such measures should be used more consistently to help plan more pragmatic studies, evaluate progress, increase transparency of reporting, and integrate literature to facilitate translation of research into practice and policy.Electronic supplementary materialThe online version of this article (doi:10.1186/s13012-014-0096-x) contains supplementary material, which is available to authorized users.

Technology-assisted weight loss interventions in primary care: a systematic review.

The US Preventive Services Task Force recommends screening for and treating obesity. However, there are many barriers to successfully treating obesity in primary care (PC). Technology-assisted weight loss interventions offer novel ways of improving treatment, but trials are overwhelmingly conducted outside of PC and may not translate well into this setting. We conducted a systematic review of technology-assisted weight loss interventions specifically tested in PC settings. We searched the literature from January 2000 to March 2014. (1) Randomized controlled trial; (2) trials that utilized the Internet, personal computer, and/or mobile device; and (3) occurred in an ambulatory PC setting. We applied the Cochrane Effective Practice and Organization of Care (EPOC) and Delphi criteria to assess bias and the Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) criteria to assess pragmatism (whether trials occurred in the real world versus under ideal circumstances). Given heterogeneity, results were not pooled quantitatively. Sixteen trials met inclusion criteria. Twelve (75 %) interventions achieved weight loss (range: 0.08 kg - 5.4 kg) compared to controls, while 5-45 % of patients lost at least 5 % of baseline weight. Trial duration and attrition ranged from 3-36 months and 6-80 %, respectively. Ten (63 %) studies reported results after at least 1 year of follow-up. Interventions used various forms of personnel, technology modalities, and behavior change elements; trials most frequently utilized medical doctors (MDs) (44 %), web-based applications (63 %), and self-monitoring (81 %), respectively. Interventions that included clinician-guiding software or feedback from personnel appeared to promote more weight loss than fully automated interventions. Only two (13 %) studies used publically available technologies. Many studies had fair pragmatism scores (mean: 2.8/4), despite occurring in primary care. Compared to usual care, technology-assisted interventions in the PC setting help patients achieve weight loss, offering evidence-based options to PC providers. However, best practices remain undetermined. Despite occurring in PC, studies often fall short in utilizing pragmatic methodology and rarely provide publically available technology. Longitudinal, pragmatic, interdisciplinary, and open-source interventions are needed.

A Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) Examination of a Recent Study of Massage and Relaxation Therapy Effectiveness

A Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) Examination of a Recent Study of Massage and Relaxation Therapy Effectiveness

Behavioral counseling research and evidence-based practice recommendations: U.S. Preventive Services Task Force perspectives.

The U.S. Preventive Services Task Force (USPSTF) makes recommendations on which preventive services to routinely incorporate into primary care for specific populations. Behavioral counseling interventions are preventive services designed to help persons engage in healthy behaviors and limit unhealthy ones. The USPSTF's evaluation of behavioral counseling interventions asks 2 primary questions: Do interventions in the clinical setting influence persons to change their behavior, and does changing health behavior improve health outcomes with minimal harms?This article discusses challenges encountered by the USPSTF in aggregating the behavioral counseling intervention literature to develop guidelines. The challenges relate broadly to study populations, intervention protocols, assessment of outcomes, and linking behavior changes to health outcomes. Recommendations to address these challenges include use of the PRECIS (Pragmatic-Explanatory Continuum Indicator Summary) tool as a guide for the development of feasible, replicable, and generalizable behavioral counseling interventions; improved reporting of study methods and results; consensus measures for key behavioral outcomes; and use of existing data sets to link behavior change and clinical outcomes.

A systematic review of eHealth cancer prevention and control interventions: new technology, same methods and designs?

There has been a recent surge of eHealth programs in cancer and other content areas, but few reviews have focused on the methodologies and designs employed in these studies. We conducted a systematic review of studies on eHealth interventions on cancer prevention and control published between 2001 and 2010 applying the Pragmatic Explanatory Continuum Indicator Summary (PRECIS) criteria and external validity components from the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework. We identified 113 studies that focused on cancer prevention and control of eHealth interventions. Most studies fell midway along the explanatory/pragmatic trial continuum, but few reported on various practical feasibility criteria for translation. Despite vast interest in cancer eHealth and the applied nature of this field, few studies considered key external validity issues. There is a need for use of alternative pragmatic study designs and transparent reporting of external validity components to produce more rapid and generalizable results.

Designing a valid randomized pragmatic primary care implementation trial: the my own health report (MOHR) project.

BackgroundThere is a pressing need for greater attention to patient-centered health behavior and psychosocial issues in primary care, and for practical tools, study designs and results of clinical and policy relevance. Our goal is to design a scientifically rigorous and valid pragmatic trial to test whether primary care practices can systematically implement the collection of patient-reported information and provide patients needed advice, goal setting, and counseling in response.MethodsThis manuscript reports on the iterative design of the My Own Health Report (MOHR) study, a cluster randomized delayed intervention trial. Nine pairs of diverse primary care practices will be randomized to early or delayed intervention four months later. The intervention consists of fielding the MOHR assessment – addresses 10 domains of health behaviors and psychosocial issues – and subsequent provision of needed counseling and support for patients presenting for wellness or chronic care. As a pragmatic participatory trial, stakeholder groups including practice partners and patients have been engaged throughout the study design to account for local resources and characteristics. Participatory tasks include identifying MOHR assessment content, refining the study design, providing input on outcomes measures, and designing the implementation workflow. Study outcomes include the intervention reach (percent of patients offered and completing the MOHR assessment), effectiveness (patients reporting being asked about topics, setting change goals, and receiving assistance in early versus delayed intervention practices), contextual factors influencing outcomes, and intervention costs.DiscussionThe MOHR study shows how a participatory design can be used to promote the consistent collection and use of patient-reported health behavior and psychosocial assessments in a broad range of primary care settings. While pragmatic in nature, the study design will allow valid comparisons to answer the posed research question, and findings will be broadly generalizable to a range of primary care settings. Per the pragmatic explanatory continuum indicator summary (PRECIS) framework, the study design is substantially more pragmatic than other published trials. The methods and findings should be of interest to researchers, practitioners, and policy makers attempting to make healthcare more patient-centered and relevant.Trial registrationClinicaltrials.gov: NCT01825746

Generalizing the Findings From Group Dynamics–Based Physical Activity Research to Practice Settings

The general purpose of this secondary analysis of a prior systematic review was to determine the degree to which group dynamics-based physical activity interventions align with research processes and outcomes that are more likely to facilitate the translation of research into practice. To accomplish this, a systematic search was conducted within Science Citation Index Expanded, Social Sciences Citation Index, Arts and Humanities Citation Index, and MEDLINE databases to identify articles published prior to 2010 that used at least one group dynamics-based strategy (e.g., group interaction, group goal setting) in physical activity promotion. These 17 intervention studies were identified and coded based on the reach, effectiveness, adoption, implementation, maintenance framework and Pragmatic-Explanatory Continuum Indicator Summary (for trial design characteristics). Reporting was infrequent for external validity factors (i.e., representativeness, adoption, cost, maintenance) but more frequent for internal validity factors (e.g., inclusion criteria). Intervention costs were not reported. Studies were more likely to be pragmatic (i.e., designed to determine the effects of an intervention under the usual conditions in which it will be applied) in areas of participant compliance and practitioner adherence and explanatory (i.e., designed to determine the effects of an intervention under ideal conditions) and in areas of practitioner expertise and flexibility of intervention protocol. While a number of these interventions were tested in more pragmatic settings, external validity factors were still underreported.

The value of the pragmatic-explanatory continuum indicator summary wheel in an ongoing study: the bullous pemphigoid steroids and tetracyclines study

BackgroundThe Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) tool is intended to be used in the design phase of trials to help investigative teams design trials in-line with their purpose. Our team applied this tool to an ongoing trial (BLISTER) to determine whether the initial suggestion among some team members that the trial could be described as largely pragmatic was the consensus.MethodsEach of the six members of the BLISTER trial team was sent a blank PRECIS wheel to independently complete. The results obtained were averaged and plotted on a single PRECIS wheel to illustrate the degree of pragmatism of the trial.ResultsThe trial team found that the design of the trial was closest to the pragmatic end of the pragmatic-explanatory continuum. The strongest consensus was found on the ‘flexibility of the comparison intervention’ and ‘practitioner adherence’ domains (SD = 13). The trial team appeared to disagree most on the ‘eligibility criteria’ (SD = 35) and ‘participant compliance’ (SD = 31) domains, although the large standard deviations were a result of a single outlier in the two domains.ConclusionThe PRECIS tool can be used to retrospectively determine the pragmatism of a trial provided enough expertise and information on the trial is available. Illustrating the design of a trial on the PRECIS wheel can help research users more easily identify studies of interest. We hope our recommendations for applying this useful tool will encourage others to consider using it when designing, conducting and reporting studies.Trial registrationCurrent Controlled Trials http://www.controlled-trials.com/ISRCTN13704604

How Well Do Randomized Trials Inform Decision Making: Systematic Review Using Comparative Effectiveness Research Measures on Acupuncture for Back Pain

BackgroundFor Comparative Effectiveness Research (CER) there is a need to develop scales for appraisal of available clinical research. Aims were to 1) test the feasibility of applying the pragmatic-explanatory continuum indicator summary tool and the six CER defining characteristics of the Institute of Medicine to RCTs of acupuncture for treatment of low back pain, and 2) evaluate the extent to which the evidence from these RCTs is relevant to clinical and health policy decision making.MethodsWe searched Medline, the AcuTrials™ Database to February 2011 and reference lists and included full-report randomized trials in English that compared needle acupuncture with a conventional treatment in adults with non-specific acute and/or chronic low back pain and restricted to those with ≥30 patients in the acupuncture group. Papers were evaluated by 5 raters.Principal FindingsFrom 119 abstracts, 44 full-text publications were screened and 10 trials (4,901 patients) were evaluated. Due to missing information and initial difficulties in operationalizing the scoring items, the first scoring revealed inter-rater and inter-item variance (intraclass correlations 0.02–0.60), which improved after consensus discussions to 0.20–1.00. The 10 trials were found to cover the efficacy-effectiveness continuum; those with more flexible acupuncture and no placebo control scored closer to effectiveness.ConclusionBoth instruments proved useful, but need further development. In addition, CONSORT guidelines for reporting pragmatic trials should be expanded. Most studies in this review already reflect the movement towards CER and similar approaches can be taken to evaluate comparative effectiveness relevance of RCTs for other treatments.

Quantifying the unquantifiable

Applicability has been described as ‘‘inferences about the extent to which a causal relationship holds over variations in persons, settings, treatments, and outcomes’’ [1,2]. Consequently, to determine the applicability of any research result to a population of interest in a given setting, one has to take two aspects into consideration: first, whether, and to what extent, differences in patient characteristics, settings, treatments, and outcomes are present between a given body of evidence and a population of interest and second, whether existing differences can act as effect modifiers and have the potential to alter or even reverse the magnitude of an observed treatment effect. The first step, assessing differences in patient characteristics, settings, treatments, and outcomes, sounds straightforward but is, in reality, often hampered by lack of reporting [3]. The second step, determining the potential impact of differences on the magnitude of a treatment effect, is even more challenging. Such an assessment is frequently fraught with unknown factors such as the extent of effect modification caused by specific differences in patient characteristics, interventions, and so forth. In reality, assessments of applicability, therefore, often become a matter of assumptions and subjective judgments. In this issue of the journal, Koppenaal et al. [4] propose an adaptation of the Pragmatic-Explanatory Continuum Indicator Summary tool to be used to grade the applicability of systematic reviews of trials. The idea is intriguing because unless conclusions of systematic reviews are both valid and applicable to broader patient populations in realworld settings, decisions based on such systematic reviews may be flawed. Devising an applicability score that could complement the grading of the strength of a body of evidence would be a useful feature for users of systematic reviews. But is it possible to quantify and rate the applicability of an entire body of evidence in a systematic review? I am

Applying the PRECIS criteria to describe three effectiveness trials of weight loss in obese patients with comorbid conditions.

To characterize Practice-Based Opportunities for Weight Reduction (POWER) trials along the pragmatic-explanatory continuum. The POWER trials consist of three individual studies that target obesity treatment in primary care settings. Using the PRagmatic Explanatory Continuum Indicator Summary (PRECIS) criteria, nine reviewers independently scored each trial. Average and median ratings, inter-rater reliability, and relationships to additional ratings of the extent to which study designs were explanatory (i.e., efficacy) versus pragmatic (i.e., practical) and related to external validity were determined. One trial was consistently rated as being significantly more pragmatic than the others (R(2) =0.43, p< .001), although all three were in the moderate range on the PRECIS scales. Ratings varied across PRECIS dimensions, being most pragmatic on comparison condition and primary outcome. Raters, although undergoing training and using identical definitions, scored their own study as more pragmatic than the other studies/interventions. These results highlight the need for more comprehensive reporting on PRECIS and related criteria for research translation. The PRECIS criteria provide a richer understanding of the POWER studies. It is not clear whether the original criteria are sufficient to provide a comprehensive profile.

Pragmatic vs explanatory trials: the Pragmascope tool to help measure differences in protocols of mental health randomized controlled trials

In the pragmatic-explanatory continuum, a randomized controlled trial (RCT) can at one extreme investigate whether a treatment could work in ideal circumstances (explanatory), or at the other extreme, whether it would work in everyday practice (pragmatic). How explanatory or pragmatic a study is can have implications for clinicians, policy makers, patients, researchers, funding bodies, and the public. There is an increasing need for studies to be open and pragmatic; however, explanatory trials are also needed. The previously developed Pragmatic-explanatory continuum indicator summary (PRECIS) was adapted into the Pragmascope tool to assist mental health researchers in designing RCTs, taking the pragmatic-explanatory continuum into account. Ten mental health trial protocols were randomly chosen and scored using the tool by three independent raters. Their results were compared for consistency and the tool was found to be reliable and practical. This preliminary work suggests that evaluating different domains of an RCT at the protocol level is useful, and suggests that using the Pragmascope tool presented here might be a practical way of doing this.

Alternative approaches to tuberculosis treatment evaluation: the role of pragmatic trials [State of the art series. Operational research. Number 4 in the series

Clinical trials are sometimes classified as being explanatory or pragmatic, although they are rarely reported in that way. Explanatory trials may seek to investigate the efficacy of new treatments by imposing strict limitations on many aspects of trial design, including, for example, recruiting only those patients who are most likely to respond. In contrast, the objective of pragmatic trials is to assess whether treatments work in conditions more appropriate to routine practice. This dichotomy is, however, over-simplistic; there is usually a continuum, which is a consequence of there being many areas of trial design that can vary between the extremities of the explanatory and pragmatic approaches. The PRECIS (pragmatic-explanatory continuum indicator summary) wheel based on 10 domains, which include inclusion criteria, flexibility of delivery of the intervention and intensity of follow-up, has been proposed as a way of enabling researchers to assess the extent to which the trials they are designing could be considered explanatory or pragmatic. In this article, we consider how the PRECIS tool can be applied to trials of tuberculosis treatment. In view of the well-recognised delay in getting results from well-conducted clinical trials into practice, we would suggest that if more pragmatic trials were to be conducted, physicians would better understand the implications of the results for their own practice and be more ready to adopt new treatments.

Alternative approaches to tuberculosis treatment evaluation: the role of pragmatic trials

Clinical trials are sometimes classified as being explanatory or pragmatic, although they are rarely reported in that way. Explanatory trials may seek to investigate the efficacy of new treatments by imposing strict limitations on many aspects of trial design, including, for example, recruiting only those patients who are most likely to respond. In contrast, the objective of pragmatic trials is to assess whether treatments work in conditions more appropriate to routine practice. This dichotomy is, however, over-simplistic; there is usually a continuum, which is a consequence of there being many areas of trial design that can vary between the extremities of the explanatory and pragmatic approaches. The PRECIS (pragmatic-explanatory continuum indicator summary) wheel based on 10 domains, which include inclusion criteria, flexibility of delivery of the intervention and intensity of follow-up, has been proposed as a way of enabling researchers to assess the extent to which the trials they are designing could be considered explanatory or pragmatic. In this article, we consider how the PRECIS tool can be applied to trials of tuberculosis treatment. In view of the well-recognised delay in getting results from well-conducted clinical trials into practice, we would suggest that if more pragmatic trials were to be conducted, physicians would better understand the implications of the results for their own practice and be more ready to adopt new treatments.