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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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“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
Strength:hedged· not yet calibratedn = 122Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesThe 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.
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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
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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
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIn the paper
“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]
Strength:plain· not yet calibratedCausal:correlational· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesA 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
“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
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes- Rests on an assumption: Meal replacements and trained ACT psychotherapists are costly or limited in availability.
- It may state two separate claims as one. 20
- Probably not a substantial claim. 34
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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
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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
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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
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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
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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
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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
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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.
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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
“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
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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
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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
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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
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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
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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
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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
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
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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
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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
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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
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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
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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
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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]
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
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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
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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
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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]
Strength:hedged· not yet calibratedCausal:conditional· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
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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
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“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
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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
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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
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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
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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
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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
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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.
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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.
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
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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
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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
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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
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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
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably 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
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably 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
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably 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
Strength:boosted· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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
“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
- Not checked yetcites [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
- 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
Strength:plain· not yet calibratedCausal:correlational· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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
Strength:hedged· not yet calibratedCausal:conditional· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt 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
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt 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
Strength:hedged· not yet calibratedCausal:conditional· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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
Strength:hedged· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt 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
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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
“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
“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]
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.
Figure 3 caption identifies itself as the baseline-randomization design
MinorThe caption calls Figure 3 a variation of the design in Figure 3, with the duration decision moved from baseline to week 5. The body instead identifies Figure 2 as the baseline-randomization design and Figure 3 as its variation.
“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.”
“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.”
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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 [69–72].”
MethodThe Diabetes Prevention Program (DPP)
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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).
Statistics and arithmetic are recomputed, not judged.
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