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Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research
Open accessAbstract
The management of many health disorders often entails a sequential, individualized approach whereby treatment is adapted and readapted over time in response to the specific needs and evolving status of the individual. Adaptive interventions provide one way to operationalize the strategies (e.g., continue, augment, switch, step-down) leading to individualized sequences of treatment. Often, a wide variety of critical questions must be answered when developing a high-quality adaptive intervention. Yet, there is often insufficient empirical evidence or theoretical basis to address these questions. The Sequential Multiple Assignment Randomized Trial (SMART)-a type of research design-was developed explicitly for the purpose of building optimal adaptive interventions by providing answers to such questions. Despite increasing popularity, SMARTs remain relatively new to intervention scientists. This manuscript provides an introduction to adaptive interventions and SMARTs. We discuss SMART design considerations, including common primary and secondary aims. For illustration, we discuss the development of an adaptive intervention for optimizing weight loss among adult individuals who are overweight.
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36 Not checked yet · 29 Own interpretation · 26 No basis given · 4 Own method · 1 Supported · 1 Supported so far
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“factorial designs (along with other approaches) are often used in the optimization stage of MOST to develop more potent interventions [65,67]”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
What the sources say
- Not checked yetcites [65] Chakraborty B, Collins LM, Strecher V, et al. Developing multicomponent interventions using fractional factorial designs. Stat Med. 2009; 28: 2687-2708. source
- Supportedcites [67] Collins LM, Chakraborty B, Murphy SA, et al. Comparison of a phased experimental approach and a single randomized clinical trial for developing multicomponent behavioral interventions. Clin Trials. 2009; 6(1): 5-15. source
The Methods section (page not provided) uses a fractional factorial experiment in the phased approach’s screening phase to select intervention components, and describes a factorial experiment as one option in its refining phase. The Background (page not provided) describes screening and refining as steps intended to optimize multicomponent interventions. Together, these passages support the cited point that factorial designs are used in this optimization process, alongside other approaches. (LLM, conf=0.86)
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“in terms of second-stage treatment offerings, nonresponders are underrepresented in the data; this underrepresentation occurs by design.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Analysis associated with the embedded adaptive interventions aim
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“the four AIs in Table 2 employ this intermediate tailoring variable as the sole tailoring variable.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Embedded adaptive interventions aim
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“Therefore, assuming a within-person correlation of 0.50 in longitudinal weight, and a study drop-out rate of 10 %, a total sample size of at least N=122 (i.e., 61 in group A+B+C vs 61 in group D+E+F) would be needed in order to detect a medium effect size [58] (Cohen's d=0.5) with at least 85 % power and type-I error of 5 %.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SAMPLE SIZE CONSIDERATIONS
What the sources say
- Not checked yetcites [58] Forman EM, Hoffman KL, McGrath KB, et al. A comparison of acceptance- and control-based strategies for coping with food cravings: an analog study. Behav Res Ther. 2007; 45(10): 2372-2386. source
hedgedn = 122- Asserted: passes — The authors put it forward as true.
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“Assuming a nonresponse rate of 0.60 to initial IBT, and keeping all other assumptions the same as above, would require a total sample size of at least N=204=122/0.6;that is, 204/2=102 in group A+B+C vs 102 in group D+E+F, which implies 102×0.6=61 in group B+E vs 61 in group C+F.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SAMPLE SIZE CONSIDERATIONS
hedgedn = 204- Asserted: passes — The authors put it forward as true.
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“To account for this imbalance (i.e., to account for the underrepresentation of nonresponders), weighted regression is employed, whereby nonresponders are assigned a weight of 4 and responders are assigned a weight of 2.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Analysis associated with the embedded adaptive interventions aim
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“Comparing the mean outcomes between the four AIs can be done using all of the data in one regression analysis.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Analysis associated with the embedded adaptive interventions aim
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“The weights are inversely proportional to the probability of being offered a particular treatment sequence.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Analysis associated with the embedded adaptive interventions aim
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“Further, research suggests that it may be possible to identify such individuals early, i.e., during treatment [16].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Abstract
What the sources say
- Not checked yetcites [16] Nackers LM, Ross KM, Perri MG. The association between rate of initial weight loss and long-term success in obesity treatment: does slow and steady win the race? Int J Behav Med. 2010; 17(3): 161-167. source
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“Data analyses associated with the aim to develop a more deeply-tailored AI are akin to, but go beyond, standard moderator analysis [69][70][71][72].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Analysis associated with the embedded adaptive interventions aim
What the sources say
- Not checked yetcites [69][70][71]
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In the paper
“Due to the cost of meal replacements (MR) and the cost and availability of trained ACT psychotherapists, it would not be feasible from a public health, costeffectiveness point of view, to provide all adult individuals who are overweight with IBT+MR or with ACT from the start.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SEQUENTIAL MULTIPLE ASSIGNMENT RANDOMIZED TRIALS
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- Rests on an assumption: Meal replacements and trained ACT psychotherapists are costly or limited in availability.
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In the paper
“The statistical foundation for the weightingand-replication method is found in the work by Orellana, Rotnitzky, and Robins [33,34,68].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Analysis associated with the embedded adaptive interventions aim
What the sources say
- Not checked yetcites [33] Orellana L, Rotnitzky A, Robins JM. Dynamic regime marginal structural mean models for estimation of optimal dynamic treatment regimes, Part I: Main Content. Int J Biostat. 2010; 6(2): Article No. 8. source
- Not checked yetcites [34] Orellana L, Rotnitzky A, Robins JM. Dynamic regime marginal structural mean models for estimation of optimal dynamic treatment regimes, part ii: proofs of results. Int J Biostat. 2010;6(2):Article No. 9. source
- Not checked yetcites [68] Robins JM, Orellana L, Rotnitzky A. Estimation and extrapolation in optimal treatment and testing strategies. Stat Med. 2008; 27: 4678-4721. source
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“Due to the waxing and waning course of many chronic disorders such as obesity [3], for example, a treatment that demonstrates short-term weight loss for an individual may not lead to weight loss in the long-term even if the individual remains on the same treatment (within-person heterogeneity; [4]).”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Abstract
What the sources say
- Not checked yetcites [3] Middleton KM, Patidar SM, Perri MG. The impact of extended care on the long-term maintenance of weight loss: a systematic review and meta-analysis. Obes Rev. 2012; 13(6): 509-517. source
- Not checked yetcites [4] Butryn ML, Webb V, Wadden TA. Behavioral treatment of obesity. Psychiatric Clin North Am. 2011; 34(4): 841-859. source
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In the paper
“Previous research also suggests the promise of ACT for managing or losing weight (Table 2) [58][59][60][61][62].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SEQUENTIAL MULTIPLE ASSIGNMENT RANDOMIZED TRIALS
What the sources say
- Not checked yetcites [58][59][60][61][62]
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In the paper
“a SMART is a form of a factorial experimental design [17].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > OVERVIEW OF DATA ANALYSES FOR THE COMMON SCIENTIFIC AIMS IN A SMART
What the sources say
- Not checked yetcites [17] Murphy SA, Bingham D. Screening experiments for developing dynamic treatment regimes. J Am Stat Assoc. 2009; 184: 391-408. source
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In the paper
“This type of sequential decision-making is necessary when there is high level of individual heterogeneity in response to treatment.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Abstract
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“Standard longitudinal data analysis methods, such as linear mixed models (LMM [64]; also known as mixed-effect, random effects, hierarchical linear, or growth curve models) are used to address the two main effect aims.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > OVERVIEW OF DATA ANALYSES FOR THE COMMON SCIENTIFIC AIMS IN A SMART
What the sources say
- Not checked yetcites [64] Verbeke G, Molenberghs G. Linear Mixed Models for Longitudinal Data. New York: Springer; 2001.
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“An example of an early precursor to the SMART is the Clinical Antipsychotics Trial of Intervention Effectiveness (CATIE) [54] in chronic schizophrenia.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SEQUENTIAL MULTIPLE ASSIGNMENT RANDOMIZED TRIALS
What the sources say
- Not checked yetcites [54] Lieberman JA, Stroup TS, McEvoy JP, et al. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005; 353: 1209-1223. source
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In the paper
“The management of many health disorders, such as obesity, substance use, or depression, often entails a sequential, individualized approach whereby treatment (e.g., behavioral or medical interventions, or a combination) is adapted and readapted over time in response to the specific needs and evolving status of the individual [1,2].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Abstract
What the sources say
- Not checked yetcites [1] Murphy SA, Lynch KG, Olsin D, et al. Developing adaptive treatment strategies in substance abuse research. Drug Alcohol Depend. 2007; 88(2): S24-S30. source
- Not checked yetcites [2] Lavori PW, Dawson R. Adaptive treatment strategies in chronic disease. Annu Rev Med. 2008; 59: 443p-453p. source
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In the paper
“However, unlike the standard regression analyses (e.g., LMM) associated with the main effect aims, this analysis requires a small adjustment involving weighting and replication.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Analysis associated with the embedded adaptive interventions aim
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In the paper
“As with IBT in the first-stage, there is an evidence base for IBT+MR [5,56,57] and ACT [58][59][60][61][62] as second-stage treatment options for weight loss.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SEQUENTIAL MULTIPLE ASSIGNMENT RANDOMIZED TRIALS
What the sources say
- Not checked yetcites [5] Rock CL, Flatt SW, Sherwood NE, et al. Effect of a free prepared meal and incentivized weight loss program on weight loss and weight loss maintenance in obese and overweight women: a randomized controlled trial. JAMA. 2010; 304(16): 1803-1810. source
- Not checked yetcites [56] Wing RR, Jeffery RW, Burton LR, et al. Food provision vs structured meal plans in the behavioral treatment of obesity. Int J Obes Relat Metab Disord. 1996; 20(1): 56-62.
- Not checked yetcites [57] Heymsfield SB, van Mierlo CA, van der Knaap HC, et al. Weight management using a meal replacement strategy: meta and pooling analysis from six studies. Int J Obes Relat Metab Disord. 2003; 27(5): 537-549. source
- Not checked yetcites [58][59][60][61][62]
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In the paper
“Indeed, what works for one individual, may not work (or may, in fact, be iatrogenic) for another.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Abstract
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In the paper
“IBT augmented with MR (IBT+MR) may, therefore, permit nonresponding individuals to focus their time and efforts on physical activity and experience the benefits of proper nutrition.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SEQUENTIAL MULTIPLE ASSIGNMENT RANDOMIZED TRIALS
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- Rests on an assumption: Meal replacements are effective for weight loss partly because they remove the need to decide what food to prepare and the time and effort to prepare it, and they provide a clear method for portion control and reduced energy intake.
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In the paper
“Both approaches permit stratified random allocation; this is used to control potential bias due to chance imbalances in treatment groups on key prognostic factors.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
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In the paper
“SMART is a type of factorial design [17]”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
What the sources say
- Not checked yetcites [17] Murphy SA, Bingham D. Screening experiments for developing dynamic treatment regimes. J Am Stat Assoc. 2009; 184: 391-408. source
plain- Asserted: passes — The authors put it forward as true.
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In the paper
“Following Oetting et al. [63], a total sample size of at least N= 154 is required in order to correctly identify the best embedded AI with at least 95 % probability.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SAMPLE SIZE CONSIDERATIONS
What the sources say
- Not checked yetcites [63] Oetting AI, Levy JA, Weiss RD, et al. Statistical Methodology for a SMART Design in the development of adaptive treatment strategies. In: Shrout PE, Keyes KM, Ornstein K, eds. Causality and Psychopathology: Finding the Determinants of Disorders and their Cures. Arlington: American Psychiatric Publishing, Inc; 2011: 179-205.
plainn = 154- Asserted: passes — The authors put it forward as true.
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In the paper
“Stratifying the second-stage randomization on intermediate outcomes is not possible with up-front randomization to the embedded AIs;”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
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“As with any randomized trial, the key to avoiding this type of bias in a SMART is to make a clear distinction between the measures used for treatment (e.g., tailoring variables) versus the outcomes used for research [80].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
What the sources say
- Not checked yetcites [80] Almirall D, Compton SN, Gunlicks-Stoessel M, et al. Preparing for a sequential multiple assignment randomized trial for developing an adaptive treatment strategy: designing a SMART pilot study. Stat Med. 2012; 31(17): 1887-1902. source
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“SMART studies are not necessarily “adaptive trial designs” in the sense that in adaptive trial designs, the clinical trial can be altered during the course of the trial (e.g., minimum required sample size is recalculated, or a treatment arm is abandoned) as data is gathered during the conduct of the trial [82].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
What the sources say
- Not checked yetcites [82] Berry SM, Carlin BP, Lee JJ, et al. Bayesian adaptive methods for clinical trials. Boca Raton: CRC Press; 2011.
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In the paper
“Apart from the important practical matter of which type of duration decision makes the most sense in clinical practice, the investigator's decision to design the SMART as in Fig. 2 vs the variation in Fig. 3 also has scientific implications.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SAMPLE SIZE CONSIDERATIONS
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In the paper
“SMARTs are part of the Multiphase Optimization Strategy (MOST; [66]), a framework for constructing effective multicomponent behavioral interventions.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
What the sources say
- Not checked yetcites [66] Collins LM, Baker TB, Mermelstein RJ, et al. The multiphase optimization strategy for engineering effective tobacco use interventions. Ann Behav Med. 2011; 41: 208-226. source
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In the paper
“SMART designs differ significantly from standard randomized clinical trials (RCT) in terms of their overarching aim.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
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In the paper
“Note that a nonresponse rate lower than 0.6 would result in a larger total N.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SAMPLE SIZE CONSIDERATIONS
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In the paper
“SMARTs also differ from other experimental designs in that randomizations may be restricted based on an intermediate response/nonresponse to earlier treatment; e.g., second-stage randomization to ACT vs IBT+MR in Fig. 2 occurs only for nonresponders to IBT.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
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In the paper
“SMART designs can help address these critical questions empirically, using experimental design principles, prior to evaluation.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
plaindirect- Asserted: passes — The authors put it forward as true.
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- Rests on an assumption: Many investigators lack sufficient empirical evidence or theoretical basis to form a high-quality adaptive intervention.
- Rests on an assumption: Investigators often face important open questions about optimal adaptive intervention design, such as the best first-stage treatment.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The end result of a SMART is a proposal for an optimal AI, e.g., such as the more deeply-tailored AI in Fig. 1b.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
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“it would be less cost-effective-both in terms of actual dollars spent and, importantly, the value of the scientific information gained”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
What the sources say
- Not checked yetcites [1] Murphy SA, Lynch KG, Olsin D, et al. Developing adaptive treatment strategies in substance abuse research. Drug Alcohol Depend. 2007; 88(2): S24-S30. source
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In the paper
“These regression models often help unpack the effects of interventions because they can be used to help explain for whom treatment effects are stronger vs weaker.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Analysis associated with the embedded adaptive interventions aim
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“the randomizations in a SMART are aimed at permitting unbiased comparisons between treatment components (or their levels) at each decision stage in the development of an AI.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
What the sources say
- Not checked yetcites [75] Piantadosi S. Clinical Trials: A Methodologic Perspective. 2nd ed. Hoboken: Wiley; 2005. source
plaindirect- Asserted: passes — The authors put it forward as true.
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- Load-bearing: passes — The paper’s conclusions depend on it.
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A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The latter design is less suitable for shedding light on such interesting expectancy effects of initial IBT duration.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SAMPLE SIZE CONSIDERATIONS
plain- Asserted: passes — The authors put it forward as true.
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- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“just as randomization is aimed at permitting an unbiased comparison (i.e., free of alternative explanations due to confounding or treatment selection bias [75]) between the experimental treatment and a control conditions in an RCT or between different levels of treatment components in a factorial design”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
What the sources say
- Not checked yetcites [75] Piantadosi S. Clinical Trials: A Methodologic Perspective. 2nd ed. Hoboken: Wiley; 2005. source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“The aim of this study was not to construct an adaptive intervention; rather, the aim was to evaluate the above-described intervention.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
What the sources say
- Not checked yetcites [44] Jakicic JM, Tate DF, Lang W, et al. Effect of a stepped-care intervention approach on weight loss in adults. JAMA. 2012; 307(24): 2617-2626. source
plain- Asserted: passes — The authors put it forward as true.
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- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Thus, the latter design offers additional opportunities for using data to inform the decision to provide 5 vs 10 weeks of initial IBT.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SAMPLE SIZE CONSIDERATIONS
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“a SMART differs from other experimental designs (such as RCTs and factorial designs) in that randomizations occur repeatedly over time.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
plain- Asserted: passes — The authors put it forward as true.
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In the paper
“using a SMART to construct the best AI prior to evaluating it in an RCT is consistent with the resource management principle of MOST, which states that “available research resources must be managed strategically so as to gain the most information [to] move science forward fastest” [66].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
What the sources say
- Not checked yetcites [66] Collins LM, Baker TB, Mermelstein RJ, et al. The multiphase optimization strategy for engineering effective tobacco use interventions. Ann Behav Med. 2011; 41: 208-226. source
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
In the paper
“As is well known, the minimum sample size for any experimental trial is dictated by the primary aim for that trial [75].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SAMPLE SIZE CONSIDERATIONS
What the sources say
- Not checked yetcites [75] Piantadosi S. Clinical Trials: A Methodologic Perspective. 2nd ed. Hoboken: Wiley; 2005. source
boosteddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Yet, because this analysis is among nonresponders, the sample size calculations need to take into account the rate of nonresponse to IBT as follows.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SAMPLE SIZE CONSIDERATIONS
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“This step ensures that the evaluation of first-stage tailoring variables (the third step, below) incorporates the effect of having made the optimal future treatment decision (IBT+MR vs ACT) for each individual.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > "Q-Learning
plaindirect- Asserted: passes — The authors put it forward as true.
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- Probably not a substantial claim. 34
- It may state two separate claims as one. 20
Every source the paper cites for this claim was checked and supports it.
In the paper
“Different SMART designs are suitable for addressing different types of scientific questions [21,23].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SAMPLE SIZE CONSIDERATIONS
What the sources say
- Supportedcites [21] Nahum-Shani I, Qian M, Almirall D, et al. Experimental design and primary data analysis methods for comparing adaptive interventions. Psychol Methods. 2012; 17(4): 457-477. source
The “Other Types of SMART Designs” section describes designs that differ in how intermediate outcomes and prior treatment determine re-randomization, and says investigators choose design features based on scientific evidence and ethical considerations. The “Sequential Multiple Assignment Randomized Trial” section identifies several kinds of research questions SMART data can address. Together, these passages support the paraphrase; page numbers are unavailable in our copy. (LLM, conf=0.90)
- Supportedcites [23] Lei H, Nahum-Shani I, Lynch K, et al. A “SMART” design for building individualized treatment sequences. Annu Rev Clin Psychol. 2012; 8: 21-48. source
The “Comparison of SMART Studies” section says SMART designs vary in the primary research questions they are sized to address. It gives examples focused on first-stage options, second-stage options, and embedded adaptive interventions (page not supplied). (LLM, conf=0.93)
plaincorrelational- Asserted: passes — The authors put it forward as true.
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Probably not a substantial claim. The paper’s conclusions may not depend on it.
- Supported
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“these four AIs do not (i) individualize initial IBT duration (first-stage treatment), and they (ii) do not take advantage of additional heterogeneity within the nonresponders to further individualize the choice of IBT+MR vs ACT.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Embedded adaptive interventions aim
plain- Asserted: passes — The authors put it forward as true.
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- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“by design-i.e., nonresponders are randomized twice whereas responders are randomized only once-nonresponders would have a 1/4 chance of following the sequence of treatments they were offered, whereas responders would have a 1/2 chance of following the sequence of treatments they were offered.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Analysis associated with the embedded adaptive interventions aim
hedgeddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“These two AIs, for example, represent the two most distinct AIs in this SMART in terms of first-stage treatment duration and second-stage treatment (i.e., an augment versus a switch)”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Embedded adaptive interventions aim
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“An interesting variation of the SMART shown in Fig. 2 centers on whether the decision to provide 5 vs 10 weeks of initial IBT occurs at baseline or whether this decision occurs at some point after initial IBT (but prior to 10 weeks).”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SAMPLE SIZE CONSIDERATIONS
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
None of the sources cited for this claim have been checked yet.
In the paper
“In addition, not all individuals will respond or adhere to the weight loss treatment to the same degree, have the same side effect profile (e.g., in the case of weight loss medications), or respond within the same time-frame, to any given treatment or package of treatments (between-persons heterogeneity; [5,6].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Abstract
What the sources say
- Not checked yetcites [5] Rock CL, Flatt SW, Sherwood NE, et al. Effect of a free prepared meal and incentivized weight loss program on weight loss and weight loss maintenance in obese and overweight women: a randomized controlled trial. JAMA. 2010; 304(16): 1803-1810. source
- Not checked yetcites [6] Jeffrey RW, Drewnowski A, Epstein LH, et al. Long-term maintenance of weight loss: current status. Health Psychol. 2000; 19(1): 5-16. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Since the example SMART experimentally”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Embedded adaptive interventions aim
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“Once the mean outcome and standard error is estimated for each of the embedded AIs, it is possible to conduct a hypothesis test to compare any two (or more) of the embedded AIs, or identify the AI leading to the greatest estimated weight loss [63].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Analysis associated with the embedded adaptive interventions aim
What the sources say
- Not checked yetcites [63] Oetting AI, Levy JA, Weiss RD, et al. Statistical Methodology for a SMART Design in the development of adaptive treatment strategies. In: Shrout PE, Keyes KM, Ornstein K, eds. Causality and Psychopathology: Finding the Determinants of Disorders and their Cures. Arlington: American Psychiatric Publishing, Inc; 2011: 179-205.
hedgeddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Although ACT may not produce superior weight losses on average compared to more traditional interventions, ACT may be particularly effective for certain types of individuals, specifically, those who experience higher levels of negative affect, and may, therefore, be a suitable second-stage treatment option for nonresponders.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SEQUENTIAL MULTIPLE ASSIGNMENT RANDOMIZED TRIALS
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“For example, SMART has been used in oncology to develop medication algorithms to treat prostate cancer [36,52,53].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SEQUENTIAL MULTIPLE ASSIGNMENT RANDOMIZED TRIALS
What the sources say
- Not checked yetcites [36] Wang L, Rotnitzky A, Lin X, et al. Evaluation of viable dynamic treatment regimes in a sequentially randomized trial of advanced prostate cancer. J Am Stat Assoc. 2012; 107(498): 493-508. source
- Not checked yetcites [52] Thall P, Logothetis C, Pagliaro L, et al. Adaptive therapy for androgen-independent prostate cancer: a randomized selection trial of four regimens. J Natl Cancer Inst. 2007; 99(21): 1613-1622. source
- Not checked yetcites [53] Almirall D, Lizotte D, Murphy SA. SMART design issues and the consideration of opposing outcomes. J Am Stat Assoc. 2012; 107(498): 509-512. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Note that the AIs themselves do not involve randomization.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Embedded adaptive interventions aim
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
None of the sources cited for this claim have been checked yet.
In the paper
“Despite the general success of interventions such as IBT (and others [7,[10][11][12][13][14]), a significant number of individuals do not lose a clinically significant amount of weight (for example, ≥7 % weight loss in a 26week period (~6 months) [15]) or meet their targeted goals for weight loss.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Abstract
What the sources say
- Not checked yetcites [7,[10][11][12][13][14]
- Not checked yetcites [15] Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002; 346: 393-403. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“That is, such a comparison permits investigators to examine whether it is better to be more stringent about achieving response during IBT and, if not responsive, augment IBT versus whether it is better to be less stringent about achieving response during IBT and, if still not responsive, give up on IBT and try an alternative.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Embedded adaptive interventions aim
plainconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“This analysis compares change in weight loss between all nonresponders randomly assigned to augmented IBT+MR (subgroups B+E) versus all nonresponders randomly assigned to switch to ACT (subgroups C + F).”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > OVERVIEW OF DATA ANALYSES FOR THE COMMON SCIENTIFIC AIMS IN A SMART
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“In this example, the 5 lbs cutoff is based on previous research [16], which is corroborated by clinical experience, suggesting that weight loss of less than 5 lbs during the first 5 weeks of behavioral therapy treatment is associated with longer-term insufficient weight loss (<5-10 % of body weight at the end of 26 weeks), thereby indicating a need for subsequent (changes or”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > ADAPTIVE INTERVENTIONS
What the sources say
- Not checked yetcites [16] Nackers LM, Ross KM, Perri MG. The association between rate of initial weight loss and long-term success in obesity treatment: does slow and steady win the race? Int J Behav Med. 2010; 17(3): 161-167. source
hedgedcorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“The optimization aim is less confirmatory (more hypothesis generating)-it is akin to the aim of identifying moderators in a standard RCT.For this reason, the optimization aim is rarely chosen as primary; in a SMART, investigators often choose the optimization aim as a third aim.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > COMMON SCIENTIFIC AIMS IN A SMART
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Among these, the primary aim in a SMART is often one of the main effect aims or embedded AIs aim.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > COMMON SCIENTIFIC AIMS IN A SMART
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“responders to initial short duration IBT (subgroup A; see Table 2 and Fig. 2) are consistent with AIs # 1 (A+B) and # 2 (A+C); and, similarly, responders to initial long duration IBT (subgroup D) are consistent with AIs # 3 (D+E) and # 4 (D+F).”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Analysis associated with the embedded adaptive interventions aim
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“Across a wide-range of the behavioral and clinical sciences, a wide variety of SMART designs has been conducted, or is currently being conducted, to build adaptive interventions.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SEQUENTIAL MULTIPLE ASSIGNMENT RANDOMIZED TRIALS
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“Lei et al. [23] describe the rationale and scientific questions addressed by four different SMART studies either recently completed or underway in autism, attention-deficit/hyperactivity disorder (ADHD), and for various substance use disorders.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SEQUENTIAL MULTIPLE ASSIGNMENT RANDOMIZED TRIALS
What the sources say
- Not checked yetcites [23] Lei H, Nahum-Shani I, Lynch K, et al. A “SMART” design for building individualized treatment sequences. Annu Rev Clin Psychol. 2012; 8: 21-48. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“Developed explicitly for the purpose of building empirically supported adaptive interventions, they are meant to complement the use of theoretical models and expert clinical consensus for developing optimal adaptive interventions [21][22][23].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Abstract
What the sources say
- Not checked yetcites [21][22][23]
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“This is a single factor (initial IBT duration) analysis where the factor has two levels (short vs long duration).This analysis is identical to the analysis used to analyze data arising from a two-arm, longitudinal randomized clinical trial (RCT).”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > OVERVIEW OF DATA ANALYSES FOR THE COMMON SCIENTIFIC AIMS IN A SMART
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“In weight loss research, the primary outcome is often weight loss, and secondary outcomes may include quality of life or cost-effectiveness outcomes.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > COMMON SCIENTIFIC AIMS IN A SMART
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
In the paper
“A growing body of literature suggests that ACT may be useful for managing or losing weight [48][49][50].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > ADAPTIVE INTERVENTIONS
What the sources say
- Not checked yetcites [48][49][50]
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Since this operationalization of the aim seeks to identify the best performing AI, it differs from the first operationalization, which aims to compare two (or more) AIs using a statistical hypothesis test.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Embedded adaptive interventions aim
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“This is often the case for many chronic disorders, conditions for which there is no widely effective treatment, or conditions for which there are widely effective treatments but they are burdensome, costly, or carry side effects.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Abstract
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: fails — The paper may give no reason why it holds.
Probably not a substantial claim. The paper may give no reason why it holds. It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“This examination would be part of the optimization aim analysis.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SAMPLE SIZE CONSIDERATIONS
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“AIs, which SMARTs aim to construct, are multicomponent interventions (e.g., different components may be provided at different time points to different individuals);”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Such analyses are often also used with RCT data to determine whether the identified moderators are also baseline tailoring variables.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > Analysis associated with the embedded adaptive interventions aim
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Above, we have identified two types of aims that often serve as primary aims in a SMART: main effect aims and the embedded AIs aim.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SAMPLE SIZE CONSIDERATIONS
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Indeed, the ideas in this manuscript extend readily to this type of application, and within or between any phases/sequences of care.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
plain- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may be too vague to check against evidence. The paper’s conclusions may not depend on it.
In the paper
“Misconceptions about SMART also arise when the term “adaptive design” is used to describe SMARTs because the phrase is not sufficiently precise [81].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
What the sources say
- Not checked yetcites [81] The Methodology Center. are adaptive interventions Bayesian? Available at http://methodology.psu.edu/eresources/ask/sp11 . Accessibility verified December 31, 2013.
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“is a data analysis method useful for optimizing the AI while exploring candidate tailoring variables [22].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > "Q-Learning
What the sources say
- Not checked yetcites [22] Nahum-Shani I, Qian M, Almirall D, et al. Q-Learning: a data analysis method for constructing adaptive interventions. Psychol Methods. 2013; 2012; 17(4): 478–94.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The purpose of this final regression is to examine candidate baseline tailoring variables (e.g., emotional/binge eating or level of severity at baseline) of first-stage treatment while taking into account the fact that a future optimal decision has been made.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > "Q-Learning
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“To avoid information bias, these measures would not be used to address the research aims.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“On the other hand, since in the latter design the decision concerning 5 vs 10 weeks of initial IBT occurs at week 5, this permits greater opportunity for developing a more deeply-tailored AI.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SAMPLE SIZE CONSIDERATIONS
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“this is used to control potential bias due to chance imbalances in treatment groups on key prognostic factors.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“After these decisions were made, the investigators evaluated this adaptive intervention versus a standard behavioral weight loss intervention using a 2-arm RCT.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
What the sources say
- Not checked yetcites [44] Jakicic JM, Tate DF, Lang W, et al. Effect of a stepped-care intervention approach on weight loss in adults. JAMA. 2012; 307(24): 2617-2626. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Whereas the overarching aim of a SMART is to construct a high-quality adaptive intervention based on data, the overarching aim of an RCT is to evaluate an already-developed intervention versus a suitable control.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“SMART studies are used to develop “adaptive interventions”.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“That is, an RCT is highly useful when investigators already have the theoretical basis and empirical evidence necessary for constructing the best/optimal adaptive intervention, and they wish to test the effectiveness of this already-developed AI by comparing it to a suitable control.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
boosted- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Q-Learning is essentially a generalization of moderated regression analysis to multiple stages of treatment.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > "Q-Learning
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“yet such stratification is particularly attractive when nonadherence in the first-stage (to IBT) may be prognostic of outcomes to the second-stage treatments.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Such an analysis may, indeed, require large sample sizes; however, as we have discussed, such an analysis does not correspond to any of the primary aims described above.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SAMPLE SIZE CONSIDERATIONS
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“In developing this AI prior to study, decisions were made (i) about the total number of decision stages, including when and how often they would occur (i.e., there was a step every 3 months over 18 months), (ii) to use one tailoring variable (i.e., weight loss), (iii) about the treatment options (i.e., group sessions, behavioral lessons, 1 vs 2 sessions of telephone counseling, individual sessions”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
What the sources say
- Not checked yetcites [44] Jakicic JM, Tate DF, Lang W, et al. Effect of a stepped-care intervention approach on weight loss in adults. JAMA. 2012; 307(24): 2617-2626. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Note that the first-stage treatment decision (5 vs 10 weeks initial treatment duration) may also serve as a tailoring variable for the decision to augment with IBT+MR vs switch to ACT.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > "Q-Learning
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“An alternative, potentially less conservative approach, is to calculate the sample size to contrast two (or more) embedded adaptive interventions by simulation experiment [78].”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SAMPLE SIZE CONSIDERATIONS
What the sources say
- Not checked yetcites [78] Buyze J, Rompaye BV, Goetghebeur E. Designing a sequentially randomized study with adherence enhancing interventions for diabetic patients. Stat Med. 2010; 29: 1114-1126. source
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“the former approach only allows stratified random allocation based on baseline prognostic factors, whereas in the latter approach randomizations can make use of a wider variety of prognostic factors.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“A common misconception is that SMARTs require prohibitively large sample sizes.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SAMPLE SIZE CONSIDERATIONS
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
The paper relies on this without support.
Meal replacements are effective for weight loss partly because they remove the need to decide what food to prepare and the time and effort to prepare it, and they provide a clear method for portion control and reduced energy intake.
“MR is effective for weight loss, in part, because it alleviates the need for decision-making regarding what food(s) to prepare as well as the time and effort needed to prepare the food.It provides a clear and unambiguous method for obtaining portion control and accompanying reduction in energy intake.”
The paper relies on this without support.
Meal replacements and trained ACT psychotherapists are costly or limited in availability.
“Due to the cost of meal replacements (MR) and the cost and availability of trained ACT psychotherapists”
The paper relies on this without support.
ACT requires a time commitment from the individual that may be burdensome.
“Furthermore, ACT requires a time commitment on the part of the individual, which may be burdensome.”
The paper relies on this without support.
A subset of people may do well enough over time with IBT by itself.
“These perspectives are important since some proportion of individuals might benefit adequately in the longterm from IBT alone.”
The paper relies on this without support.
Creating a high-quality adaptive intervention usually demands answers to many critical questions, yet empirical evidence or theoretical grounding for those answers is frequently lacking.
“Often, a wide variety of critical questions must be answered when developing a highquality adaptive intervention.Yet, there is often insufficient empirical evidence or theoretical basis to address these questions.”
The paper relies on this without support.
Many behavioral intervention scientists are still unfamiliar with SMARTs.
“Despite their increasing popularity due to their real-world clinical appeal, and their fit in research aimed at developing high-quality adaptive interventions, SMARTs remain relatively new to many behavioral intervention scientists.”
The paper relies on this without support.
Most healthy dieting and weight-loss programs include IBT.
“IBT is incorporated in most healthy dieting and weight loss interventions.”
The paper relies on this without support.
Many investigators lack sufficient empirical evidence or theoretical basis to form a high-quality adaptive intervention.
“in many other cases investigators have insufficient empirical evidence or theoretical basis to form a high-quality adaptive intervention.”
The paper relies on this without support.
Investigators often face important open questions about optimal adaptive intervention design, such as the best first-stage treatment.
“investigators often confront important open questions such as “What is the best first-stage treatment?””
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“The adaptive intervention that a SMART design produces can be incorporated into clinical practice more naturally and seamlessly than the findings of a fixed-intervention study [53, 54, 62].”
From A Sequential Multiple Assignment Randomized Trial (SMART) study of medication and CBT sequencing in the treatment of pediatric anxiety disorders (2021) · cites this paper as [54]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“That analysis, however, does not correspond with our primary aims and hypotheses, which are tested as two main effects and their interaction, and which require a sample size considerably smaller than for a 6-way ANCOVA [54].”
From A Sequential Multiple Assignment Randomized Trial (SMART) study of medication and CBT sequencing in the treatment of pediatric anxiety disorders (2021) · cites this paper as [54]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“The experimental approaches used for optimization include full or fractional factorial experiments 38, 39, the sequential multiple-assignment randomized trial (SMART), 40 and system identification techniques 41, 42.”
From Evaluating Digital Health Interventions (2016) · cites this paper as [42]
The cited source says what the claim attributes to it.
In the citing paper
“making them ideal for developing an adaptive intervention that optimizes outcomes based on patient treatment history [51–54].”
From A Sequential Multiple Assignment Randomized Trial (SMART) study of medication and CBT sequencing in the treatment of pediatric anxiety disorders (2021) · cites this paper as [54]
The cited source says what the claim attributes to it.
In the citing paper
“Findings of the sequential randomization aspect of the SMART design during treatment can inform clinician decisions about treatment sequencing based on the individual patient’s response to the intervention currently in use, further supporting personalized treatment [53, 54].”
From A Sequential Multiple Assignment Randomized Trial (SMART) study of medication and CBT sequencing in the treatment of pediatric anxiety disorders (2021) · cites this paper as [54]
The cited source says what the claim attributes to it.
In the citing paper
“SMART designs are commonly but incorrectly assumed to require prohibitively large sample sizes [54].”
From A Sequential Multiple Assignment Randomized Trial (SMART) study of medication and CBT sequencing in the treatment of pediatric anxiety disorders (2021) · cites this paper as [54]
In the citing paper
“These methods are designed to optimize intervention components with regard to dose and sequencing and to test which intervention components can be used alone or in combination.”
From A Research Agenda for Advancing Non-pharmacological Management of Chronic Musculoskeletal Pain: Findings from a VHA State-of-the-art Conference (2018) · cites this paper as [33]
In the citing paper
“innovative trial designs 31 that allow rigorous, systematic ways of testing a combination of approaches within a single trial including the multiphase optimization strategy and the sequential multiple assignment randomized trial. 32,33”
From A Research Agenda for Advancing Non-pharmacological Management of Chronic Musculoskeletal Pain: Findings from a VHA State-of-the-art Conference (2018) · cites this paper as [33]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Rated minor: it would not touch a result — a value no result rests on, a p-value that stays on the same side of the significance level, or a conflict that is clerical, resolved elsewhere in the paper, or outside its own findings.
In the paper
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > DISCUSSION
“This is a variation of the example SMART in Fig.3in which the decision to provide 5 vs 10 weeks of initial IBT occurs at the end of 5 weeks on IBT instead of at baseline.”
§ Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research > SAMPLE SIZE CONSIDERATIONS
“The design in Fig. 2 supposes that the decision of 5 vs 10 weeks occurs at baseline; and consistent with this consideration, all participants are randomized at baseline to 5 vs 10 weeks duration of IBT.”
Citations
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Statistical Power Analysis for the Behavioral Sciences
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Statistical power analysis for the behavioral sciences
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Statistical Power Analysis for the Behavioral Sciences (2nd ed.).
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Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin
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“Despite the general success of interventions such as IBT (and others [7, 10–14]), a significant number of individuals do not lose a clinically significant amount of weight (for example, ≥7 % weight loss in a 26week period (~6 months) [15]) or meet their targeted goals for weight loss.”
BackgroundAcceptance and commitment therapy: model, processes and outcomes
Hayes, S. C., Luoma, J. B., Bond, F. W., Masuda, A., & Lillis, J. (2006) · Behaviour Research and Therapy · doi:10.1016/j.brat.2005.06.006 · Cited by 6,587 · cited 1×
“ACT is a psychotherapeutic approach focusing on acceptance and mindfulness strategies for promoting health behavior change [47].”
BackgroundEffectiveness of Antipsychotic Drugs in Patients with Chronic Schizophrenia
Lieberman, J. A., Stroup, T. S., McEvoy, J. P., Swartz, M. S., Rosenheck, R. A., Perkins, D. O., Keefe, R. S. E., Davis, S. M., Davis, C. E., Lebowitz, B. D., et al. (2005) · New England Journal of Medicine · doi:10.1056/nejmoa051688 · Cited by 5,892
Linear Mixed Models for Longitudinal Data
Verbeke, G. (1997) · Lecture Notes in Statistics · doi:10.1007/978-1-4612-2294-1_3 · Cited by 3,506
Linear Mixed Models for Longitudinal Data
Molenberghs, G., & Verbeke, G. N. (2000) · Springer series in statistics · doi:10.1007/978-1-4419-0300-6 · Cited by 2,681
Mediators and Moderators of Treatment Effects in Randomized Clinical Trials
Kraemer, H. C., Wilson, G. T., Fairburn, C. G., & Agras, W. S. (2002) · Archives of General Psychiatry · doi:10.1001/archpsyc.59.10.877 · Cited by 2,562 · cited 1×
“Data analyses associated with the aim to develop a more deeply-tailored AI are akin to, but go beyond, standard moderator analysis [69–72].”
MethodThe Diabetes Prevention Program (DPP)
The Diabetes Prevention Program (DPP) Research Group (2002) · Diabetes Care · doi:10.2337/diacare.25.12.2165 · Cited by 1,938
Research works printed but not linked: 1
- Lillis J, Hayes SC, Bunting K, et al. Teaching acceptance and mindfulness to improve the lives of the obese: a preliminary test of a theoretical model. Ann Behav Med. 2009; 37(1): 58-69. · DOI · Paper page
Cited by
Sorted by citations
Evaluating Digital Health Interventions
Murray, E., Hekler, E. B., Andersson, G., Collins, L. M., Doherty, A., Hollis, C., Rivera, D. E., West, R., & Wyatt, J. C. (2016) · American Journal of Preventive Medicine · doi:10.1016/j.amepre.2016.06.008 · Cited by 847
Hollis, C., Falconer, C. J., Martin, J. L., Whittington, C., Stockton, S., Glazebrook, C., & Davies, E. B. (2017) · Journal of Child Psychology and Psychiatry · doi:10.1111/jcpp.12663 · Cited by 846
Skivington, K., Matthews, L., Simpson, S. A., Craig, P., Baird, J., Blazeby, J. M., Boyd, K., Craig, N. J., French, D., McIntosh, E., et al. (2021) · Health Technology Assessment · doi:10.3310/hta25570 · Cited by 585
Burke, L. E., Ma, J., Azar, K. M. J., Bennett, G. G., Peterson, E. D., Zheng, Y., Riley, W., Stephens, J., Shah, S. H., Suffoletto, B., et al. (2015) · Circulation · doi:10.1161/cir.0000000000000232 · Cited by 516
“answers within a shorter time frame than the conventional 5-year clinical trial when testing a delivery mode that will become obsolete before the end of the trial.(88) • Finally, we need to capitalize on the currently available technologies that permit collection and transmission of data in real time to better learn a…”
BackgroundMiaskowski, C. A., Barsevick, A. M., Berger, A. M., Casagrande, R. J., Grady, P. A., Jacobsen, P. B., Kutner, J. S., Patrick, D. L., Zimmerman, L. M., Xiao, C., et al. (2016) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djw253 · Cited by 507
Metadata
- Authors
- Almirall, D., Nahum-Shani, I., Sherwood, N. E., & Murphy, S. A.
- Affiliations
- University of Michigan (US)
- HealthPartners (US)
- Corresponding author
- Almirall, Daniel
- Venue
- Translational Behavioral Medicine
- Publisher
- Oxford University Press (OUP)
- Published
- 2014-05-06
- Volume
- 4
- Issue
- 3
- Pages
- 260-274
- ISSN
- 1613-9860 (ISSN-L)
- 1869-6716
- PMC
- PMC4167891
- OpenAlex
- W1986546901
- Cited by
- 453
- References
- 88
- Citations by year
- 2026: 35 · 2025: 50 · 2024: 49 · 2023: 37 · 2022: 49 · 2021: 44 · 2020: 45 · 2019: 47 · 2018: 26 · 2017: 27 · 2016: 30 · 2015: 11 · 2014: 2
- FWCI
- 24.67
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Translational Behavioral Medicine (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health
- National Institute of Mental Health (RC4MH092722, R03MH097954)
- National Institute on Drug Abuse (P50DA010075)
- National Institute of Diabetes and Digestive and Kidney Diseases (P30DK050456, P30DK092924)
- National Institute of Biomedical Imaging and Bioengineering (U54EB020404)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Keywords
- adaptive interventions, sequential multiple assignment randomized trial, smart design, weight loss, overweight adults, personalized treatment, intervention development
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
A language model drew the claims from the paper on 2026-10-06, under version 3 of the claim definition (model deepseek-v4.1-flash, prompt extract-v3).
A second model labelled each claim on 2026-10-06 (model jev-1.13-20260917, definition revision gold-guideline-v0.2).
Cited sources are checked with a language model’s help (gpt-6-sol).
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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