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SPECIAL SECTION on RCTRACK Clinical Research

Recommendations for Reporting on Rehabilitation Interventions

Whyte, John MD, PhD; Dijkers, Marcel P. PhD; Fasoli, Susan E. ScD, OTR/L; Ferraro, Mary PhD, OTR/L; Katz, Leanna W. OTD, OTR/L; Norton, Sarah CCC-SLP; Parent, Eric PhD; Pinto, Shanti M. MD; Sisto, Sue Ann PhD; Van Stan, Jarrad H. PhD, CCC-SLP; Wengerd, Lauren PhD, OTR/L

Author Information
American Journal of Physical Medicine & Rehabilitation: January 2021 - Volume 100 - Issue 1 - p 5-16
doi: 10.1097/PHM.0000000000001581

Abstract

BACKGROUND

 Clear reporting on a rehabilitation intervention or treatment under investigation is critical for interpreting study results. (Hereafter, “treatment” and “intervention” are used interchangeably to indicate a clinical action intended to address a rehabilitation need.) A report of null results might reflect an ineffective treatment, or alternatively: inadequate delivery of the intervention, selection of study participants who cannot reasonably be expected to benefit from it, use of outcome measures insensitive to the intervention’s effects, and others. The importance of a clear intervention description persists beyond the demonstration of efficacy and effectiveness: it allows ongoing dissemination and implementation of the intervention in clinical practice. Rehabilitation practitioners cannot be expected to implement evidence-based interventions without an adequate understanding of what the intervention entails.1 In recent years, inadequate reporting of the “active ingredients” in clinical trials of rehabilitation interventions or the specific elements of the intervention thought to facilitate patient change2,3 has been recognized as a significant barrier to implementation of evidence-based interventions1,4,5—a phenomenon known as the “black box” of rehabilitation.6

This article reflects the efforts of a work group contributing to a larger effort, to develop reporting guidelines for randomized controlled trials, tailored to the field of rehabilitation—the Randomized Controlled Trials Rehabilitation Checklist.7 The goal of this work group was to review randomized controlled trial reporting guidelines from diverse fields to identify content that might improve the reporting of the treatment intervention under study in rehabilitation trials. The group’s efforts were organized through the American Congress of Rehabilitation Medicine’s Rehabilitation Treatment Specification Networking Group.8 Group members conducted a scoping review, exploring how previously published reporting guidelines across diverse healthcare fields had recommended reporting on experimental treatments, and identified content that could improve the reporting of rehabilitation interventions in clinical trials. The group worked to organize those recommendations into general themes and unique recommendations.

METHODS

The group took a sample of 151 reporting guidelines listed on the Enhancing the Quality and Transparency of Health Research Website9 within the category of randomized controlled trials, as well as four other prominent guidelines not yet listed there.10–13 (See Appendix A, Supplemental Digital Content 1, http://links.lww.com/PHM/B120, for a complete list of guidelines reviewed.) The task force members then applied a three-phase method, summarized in Figure 1. They extracted treatment reporting themes from the guidelines and mapped them onto individual items from the Template for Intervention Description and Replication (TIDieR) reporting guideline (included among the 151 above). TIDieR was used as a frame of reference because of its focus on intervention description.14 The group met by teleconference approximately twice per month over 6 mos to develop the protocol and to discuss progress and results.

FIGURE 1
FIGURE 1:
The three phases the task force used in its methodology and workflow for the scoping review.

The boundaries between some of the 12 TIDieR items are vague (e.g., What—Materials vs. WhatProcedures), as are the boundaries between whether a guideline item was similar to or expanded upon a TIDieR item. Specifically counting the number of guidelines that mirrored TIDieR content, extended it, or added novel concepts would have required operationally defining the boundaries between those categories, assessing reliability across raters in the assignment of content to the categories, and (likely) adjudicating disagreements. The purpose of this scoping review was to identify relevant content that could be used to develop useful recommendations, rather than to rigorously quantify the relative frequency of different themes in the literature. For this reason, only qualitative statements of the frequency with which particular themes were encountered and illustrative examples of a content theme are provided.

RESULTS AND RECOMMENDATIONS

Findings for the sample of guidelines with treatment-relevant content are summarized below, in relation to each TIDieR item. Early in the synthesis phase, the authors identified a pattern that pertained to 9 of the 12 TIDieR items. This overarching pattern is discussed below, after the first item to which it pertains. After each item or group of items (including the themes unrelated to TIDieR items), the implications for potential improvements to TIDieR’s item descriptors for the field of rehabilitation are discussed. The specific recommendations are provided in Table 1, where the recommended reporting items are shown in bold. Further subcategories to facilitate complete reporting appear below each item. The TIDieR item(s) from which the reporting recommendation was modified is noted, where applicable.

TABLE 1 - Recommendations to improve the reporting on rehabilitation treatments
1. Provide a name for the treatment.
 • Avoid names based on treatment goal (e.g., memory remediation, gait training).
 • Use names based on MoA only when substantial evidence supports MoA.
2. Describe the goal of a study (e.g., proof of concept, feasibility, efficacy, etc.) in the context of the existing knowledge. (TIDieR 2)
 • State the gap in or extension from previous literature that the study intends to address.
 • Stakeholder involvement contributing to defining the importance of the problem and acceptability of the treatment should be reported under this item.
{Overarching Recommendations}
3. Identify the theory(ies) underlying each treatment component, including:
 • the number of separate treatment components included in the treatment
 • the treatment target, ingredients (see no. 4 for details), and known or hypothesized MoA(s) for each treatment component
 • for treatment components that rely on patient/client volitional behavior, identify the clinician words and actions (volition ingredients) intended to ensure treatment task performance (volition targets)
4. Identify the active ingredients important for each treatment component, considering the following types of treatment attributes where theoretically relevant:
 • Describe any physical or informational materials used with patients in the intervention. (TIDieR 3)
  ○ Provide information on where the materials can be accessed (e.g., online appendix, URL).
  ○ When reporting any treatment equipment or technology used, beyond identifying the product model, investigators should identify the attribute(s) or feature(s) of the product thought to be associated with the treatment effect.
 • Describe each of the procedures, activities, and/or processes used in the intervention (TIDieR 4), considering:
  ○ Procedures to stress/adapt organ system functions
  ○ Procedures to provide opportunities to practice
  ○ Procedures to impart or facilitate reprocessing of information to modify knowledge, attitudes, beliefs, motivation
 • Describe the characteristics of treating staff. (TIDieR 5)
  ○ Identify the relevant characteristics of the clinicians providing the study treatment, considering the following factors as relevant:
   ▪ patient engagement (e.g., demographic and cultural characteristics in relation to study participants)
   ▪ the provider’s treatment delivery skills (e.g., education, credentials, licensing/certification; specific skill training for the study; verification of skill acquisition)
   ▪ the provider’s commitment to treatment delivery as assigned (how treatment providers were recruited, how they were assigned to treatment conditions, number of patients treated by each provider, consistency of provider-patient treatment assignments)
 • Describe the physical and social context of the treatment. (TIDieR 6, 7)
  ○ Report factors such as the modes of delivery (e.g., face to face, internet, or telephone), individual or group treatment, type(s) of location(s), necessary infrastructure, in light of their relevance to these dimensions:
   ▪ Access for the patient (e.g., location with respect to transportation availability and cost)
   ▪ Availability of necessary infrastructure (e.g., physical therapy in a hospital gymnasium vs. in the patient’s home)
   ▪ Level of experience/specialization of the overarching program (e.g., specialized brain injury program vs. mixed community outpatient program)
   ▪ Generalizability to other patient populations (recruitment in a tertiary referral center vs. community practice)
   ▪ Elements of the delivery mode that are novel should also be specified in greater detail
   ▪ Where relevant, infrastructure required to replicate the study should be distinguished from infrastructure required to deliver the treatment in an ongoing fashion
 • Describe the dosing/intensity of the treatment. (TIDieR 8)
  ○ Define the dose or intensity of the active ingredients addressing each target, using the most quantitative units available for measuring them. Consider different reporting schemes for ingredients used in treatments of:
   ▪ Organ functions (predominantly quantities of matter or energy)
   ▪ Skills and habits (predominantly number and schedule of practice repetitions)
   ▪ Representations (predominantly “key information bits” and methods of delivery)
 • Describe methods for individualizing treatment, where relevant. (TIDieR 9)
  ○ Define methods or algorithms for tailoring the treatment to the individual at the outset of treatment and over time.
   ▪ (If the treatment component is volitional) Describe the patient factors or assessments used to plan the delivery of instructional/motivational ingredients and how those ingredients are to be adjusted in response to the assessments.
   ▪ (For all treatment components) Describe the patient factors or assessments used to plan the delivery of the active ingredients for each target and how those ingredients will be adjusted for each target in response to the assessments.
 • Describe any methods used to optimize the consistent delivery of the active ingredients. (TIDieR 11)
  ○ Describe any actions (including specific investigator training, treatment supervision with feedback, structured workbooks/treatment guides, etc.) used to optimize delivery of the active ingredients for each treatment target (treatment fidelity).
   ▪ Report separately on methods to promote fidelity in delivering instructional and motivational ingredients vs. fidelity in delivering ingredients intrinsic to the treatment’s effect.
 • Describe any measurement tools and methods used to assess consistency of the delivery of the active ingredients. (TIDieR 12)
  ○ Describe, for each treatment component:
   ▪ The method(s) of assessing treatment fidelity and measures or tools used
   ▪ The results of those assessments
   ▪ Whether results were provided to clinicians and/or patients as feedback
   ▪ Distinguish, in reporting, the methods and results related to fidelity for instructional and motivational ingredients vs. ingredients intrinsic to the treatment’s effect
{Additional Recommendations}
5. Describe the costs of treatment (where relevant).
 • Treatment costs should be reported when the study goal is implementation/effectiveness.
 • Costs should be reported in terms of “necessary resources” (e.g., hours of specific personnel) to allow for regional and temporal differences.
6. Describe the factors relevant to study and/or treatment implementation.
 • In early-phase clinical trials, it is sufficient to report on any implementation barriers and facilitators related to study conduct and how they were addressed.
 • In the dissemination/implementation phases of research, key dimensions that may be predicted to affect broad implementation should be reported, considering the following categories as relevant:
  ○ Staff training required
  ○ Necessary infrastructure, equipment, costs
  ○ Compatibility with clinician and family beliefs/attitudes
  ○ Ease of integration of the treatment into routine clinical workflow
  ○ Regulatory constraints (e.g., licensing, billing and documentation issues)

Guideline Themes Related to TIDieR Items

TIDieR 1: Brief Name—Provide the Name or a Phrase That Describes the Intervention

Few of the guidelines reviewed mentioned the need to name the treatment, perhaps because it is self-evident. “Describes” in this item can refer to the ingredients themselves (e.g., “aspirin”) or the intervention as applied in a particular context (analogous to two distinct treatments, “aspirin for prevention of heart attack” and “aspirin to reduce pain”). Alternatively, the name may describe the problem the treatment addresses (e.g., “gait [disorder] training”) or the active ingredients contained in the treatment (e.g., “repetitive practice of walking using parallel bars”). The few guidelines that addressed naming did not provide rules or criteria to determine when a treatment name is sufficient to “describe” the intervention, although several examples were used, such as the drug name or herbal product name,15 the name of a defined public health program,16 or an intervention using a specific conceptual framework (e.g., “cognitive behavior therapy”). A few guidelines recommend naming the intervention based on the problem being treated—something that occurs commonly in rehabilitation (e.g., “memory remediation”).2

At the simplest level, an arbitrary name that is linked to a well-defined set of ingredients is sufficient to support replication and communication (“I give most of my patients Treatment #482”). If the treatment name is to convey intrinsic meaning, it would be most useful to follow the drug analogy, where the generic and class names of some drugs (e.g., “statins” and “beta-blockers”) reflect related mechanisms of action (MoAs) and thus help the practitioner recognize when members of the class can be applied. Names based on the problem being treated (“memory remediation,” “gait training”) cloud the picture by potentially combining mechanistically distinct treatments under one label, despite likely differences in efficacy. Instead, it is probably better to use names closer to “progressive resistance exercises” than to “strength training,” closer to “behavioral activation therapy” than to “depression therapy.” However, there are many examples of rehabilitation treatments that are named for hypothesized MoAs that have not been empirically supported, and this naming runs the risk of promoting misapplication. Thus, mechanism-based names should be reserved for treatments with well-supported mechanisms.

TIDieR 2: Why—Describe Any Rationale, Theory, or Goal of the Elements Essential to the Intervention

The reviewed guidelines addressed several themes related to the study purpose. The study rationale, referring to the reason the study was conducted (i.e., to advance the knowledge in a specific way), was requested by most. Scientific background, referring to previous work that paved the way for the current study, and specific aims or a priori hypotheses were requested by a minority of the guidelines. The one universal suggestion was to explicitly note what about the current study is new or different from previous research. Many of the guidelines also requested that the treatment rationale—the expectation of treatment efficacy—be provided. None of the guidelines went beyond TIDieR in specifying how this information should be reported.

The treatment rationale, or treatment theory, is critically relevant to many aspects of treatment reporting. Consequently, the lack of guidance about whether and how this theory should be reported has far-reaching implications. It is critical to report in a well-defined and quantifiable way the active ingredients of an intervention that are associated with its clinical impact. It is these ingredients that must be present for replication, but absent or reduced in any control or comparator treatment. However, the attributes relevant to treatment efficacy and effectiveness vary enormously across treatments, particularly in rehabilitation where treatment goals can range from tendon lengthening to return to work. Consequently, the number of characteristics that could be reported to specify a treatment is infinite. Factors such as the hair color of the therapist are normally not included, presumably because these are judged unlikely to have effects on the treatment outcome and therefore to be irrelevant to the theory of how the treatment works. Given this, how should a guideline prioritize reporting the treatment theory in a manner that identifies the active ingredients of treatment and facilitates replication and dissemination?

The authors of this review recommend reporting treatment theory in the manner provided in the Manual of Rehabilitation Treatment Specification.8 Treatment theory is a statement of the active ingredients of a treatment, the target of treatment (the functional change expected as a direct result of the ingredients), and the known or hypothesized MoA that links them.2 This requires the investigator to consider how many distinct targets the treatment is addressing (e.g., treatment of depression using antidepressant medication may have distinct targets such as “enhanced knowledge of when/how to take the medicine,” “increased ability to take the medication as directed,” and “improved mood,” with distinct ingredients applied to each). Most targets also require what the Rehabilitation Treatment Specification System17 calls volition ingredients—ingredients administered by the clinician to elicit the patient’s willingness to receive or to “self-administer” the ingredients that bring about change in the functional target (e.g., improved mood). These two classes of ingredients may be clearly separable (the medication improving mood and the clinician’s words facilitating willingness to take it) or partially overlapping (knowledge of when to take the medication and willingness to develop that knowledge). Such a theory also defines the appropriate proximal outcomes of the treatment (i.e., measurable targets predicted to be changed).

An Overarching Pattern Relevant to Multiple TIDieR Items: Applying Treatment Theory to Reporting on an Experimental Treatment

Nine of the 12 subsequent TIDieR items deal with reporting on various attributes of the intervention for which treatment theory is relevant. Review of the content of the reporting guidelines revealed that about half did not address one or more TIDieR items at all. Among those that were relevant to TIDieR, a tradeoff was noted between the breadth of the guideline’s scope and the specificity of the guideline’s recommendations, captured by the following general approaches.

Approach 1: “Report all the information that would be necessary to…” (e.g., “…replicate the treatment”). This approach was found in many guidelines that sought to provide guidance for broad areas of research, including CONSORT.18 Even TIDieR’s reporting recommendations provide relatively general guidance (e.g., item 8, “When and How Much,” provides no guidance about units of measurement). This reporting approach allows the investigator to decide which elements of the treatment are relevant to report but does not tell him/her how to decide. In particular, it provides no explicit linkage between treatment theory and what must be reported. The obvious downside of this open-ended approach is that the reader has no basis to determine whether relevant treatment variables have been omitted. As discussed above (“TIDieR 2: Why—Describe Any Rationale, Theory, or Goal of the Elements Essential to the Intervention” section), it is the treatment theory that defines which ingredients are active and, hence, what should be reported and what need not be. Each clinical trial may support or refute the underlying treatment theory, and the understanding of the treatment’s active ingredients may evolve.19

Approach 2: “Report specific listed categories of information.” Some guidelines recommended reporting the demographics of clinicians providing treatment, the geographic setting where treatment is provided, or whether it was individual or group treatment. But are these always critical attributes of a treatment? The authors are not aware of any empirical process to determine the largest confounds or moderators affecting treatment results that should be reported for every study, nor does it seem likely that the same factors are equally relevant across all types of treatment. For example, reporting the credentials of a practitioner may be critical for very technical interventions, whereas the cultural match between practitioner and client may be more vital for certain psychosocial interventions. Aside from what to report is the question of how to report. Although some notion of amount, dose, or treatment intensity may be relevant to almost all interventions, the relevant metric for reporting those parameters differs greatly across treatments (e.g., units of energy for heat, load, and repetitions for resistance exercises). Also, the spacing of treatment sessions may be critically important for one kind of intervention and irrelevant for another.

This second approach, requiring an explicit fixed list of items to be reported, risks authors’ reporting treatment attributes that are irrelevant and failing to report others that are germane to a particular treatment and is likely to result in a relatively long list of required items. On the other hand, it provides much more explicit guidance for what must be reported and allows more objective review of whether the demands of reporting guidelines have been met.20

As noted earlier in this section, guidelines with a broad scope took the investigator-defined tactic (approach 1), whereas those addressing circumscribed domains of research proposed reporting more operationalized lists of treatment attributes (approach 2) that were either consensus based or empirically validated. Table 2 provides examples that illustrate this pattern. The left column lists the nine theory-related TIDieR items, which are relatively general (approach 1), reflecting TIDieR’s broad application to “intervention reporting.” On the right side are examples of how more circumscribed guidelines further operationalized these concepts (approach 2). The relative homogeneity within these treatment research domains and, in some cases, a greater understanding of the active ingredients allow more specific identification of the factors that are relevant to report.

TABLE 2 - Content from circumscribed guidelines in relation to TIDieR items
TIDieR Item and Content Examples of More Specific Recommendations and Sample References
3. WHAT—Materials: Describe any physical or informational materials used in the intervention, including those provided to participants or used in intervention delivery or in training of intervention providers. Provide information on where the materials can be accessed (e.g., online appendix, URL). Treatments using biologic materials: anatomical source, methods of harvesting and processing, storage environment (temperature, light, time from collection to patient use), methods of activation and delivery, delivery equipment used21
Drugs and herbal interventions: product name, processing method, source, quality control, dosage form, concentration, route of administration, names of the parts of the substances used in a mixture, needle type (diameter, length, and manufacturer, or material)15,22
Computer-based interventions: type and manufacturer, model, year produced, description of software and hardware, open-source status, details of any modifications made to publicly available software23
4. WHAT—Procedures: Describe each of the procedures, activities, and/or processes used in the intervention, including any enabling or support activities Complex interventions: number of components, sequence of components/activities, whether each treatment component was active or discretionary, if behavior change techniques were used in intervention (and if so, a detailed description)13
Physical interventions:
 • Electrical stimulation: duration, frequency, measured current, placement of electrodes on the body, size and geometry of electrodes, voltage amplitude24,25
• Whole-body vibration: vibration frequency (Hertz), peak acceleration, peak-to-peak displacement (millimeters), type of footwear worn during treatment, body posture during treatment26
• Acupuncture, dry needling: number and depth of needle insertions, name/type of needle used, response sought (e.g., muscle twitch), needle stimulation (manual vs. electrical), retention time27
5. WHO PROVIDED: For each category of intervention provider (e.g., psychologist, nursing assistant), describe their expertise, background and any specific training given Provider demographics
Psychosocial interventions
 • Age, sex, education level, socioeconomic status, ethnic and cultural background28
• Information about key personnel supporting the intervention implementation29
Mobile health interventions
• Name and affiliations of the developers, sponsors, and owners30
Provider background
Mobile health interventions
• Credentials of the developers, sponsors, and owners; expertise of those providing assistance30
Herbal and homeopathic interventions
• Description of previous experience and training15,31; school of homeopathy31
6. HOW: Describe the modes of delivery (e.g., face to face or by some other mechanism, such as Internet or telephone) of the intervention and whether it was provided individually or in a group. Psychosocial interventions: composition of treatment groups (degree of similarity of severity and context)16
Remote interventions: Web-based or not, synchronous or asynchronous, human vs. avatar facilitator23,32
Exercise interventions: degree of supervision33
7. WHERE: Describe the type(s) of location(s) where the intervention occurred, including any necessary infrastructure or relevant features Complex interventions: physical location or setting (e.g., inpatient hospital, school, home, community, geographic scope)34; relevant contextual factors (financial, social, or organizational features and clinical settings)13; social, economic, and policy context impacting replication and dissemination29; factors related to the generalization of findings to other settings (clinical traditions, health service organization, available resources)35 Mobile health interventions: infrastructure required (e.g., health informatics/privacy officer personnel, access to electricity/power, connectivity)23
8. WHEN and HOW MUCH: Describe the number of times the intervention was delivered and over what period of time, including the number of sessions, their schedule, and their duration, intensity or dose Exercise interventions: detailed description of exercises (e.g., sets, repetitions, duration, intensity); progression rules for individual exercises, including home program; avoid simply referring to developer-named protocol36
Low-level laser therapy/photomedicine: beam spot size at target (cm2), irradiance at target (mW/cm2), exposure duration (seconds), radiant exposure (J/cm2), radiant energy (J), number of points irradiated, area irradiated (cm2), application technique, number and frequency of treatment sessions total radiant energy (J)37
Mobile health interventions: frequency of mobile communication, mode of delivery of intervention (e.g., SMS, face to face, interactive voice response), timing and duration over which delivery occurred23
Educational interventions: posting of the actual materials, duration, circumstances (learning environment, extent and intensity of direct interactions with educators, other environmental parameters), medium used, kind and extent of institutional or other support for learners38
9. TAILORING: Whether the intervention was planned to be personalized, titrated, or adapted, then describe what, why, when, and how Drug/herbal interventions: genetic variations, physical variations such as body mass index, drug titration plans, drug dosing by weight or other metabolic factors, drug dose changes in response to adverse events or treatment response15,39
Exercise interventions: baseline strength differences relevant to exercise, exercise intensity changes in response to rising strength or endurance (also known as progression parameters, addressed in guidelines such as the Consensus on Exercise Reporting Template)33,36
Psychosocial interventions: cognitive, psychologic, or social differences; cultural differences; preferences (e.g., in choice of music therapy activities)40,41
11. HOW WELL—Planned: If intervention adherence or fidelity was assessed, describe how and by whom, and if any strategies were used to maintain or improve fidelity, describe them Study-specific training
Drug/herbal interventions: training protocols used for providers, system  for providers to determine correct dosage15
Exercise interventions: assessment of delivery fidelity during training as a  criterion to begin treatment, predefined markers of success in obtaining overall exercise compliance36
Complex interventions: training provided in delivering the intervention, as well as whether (and how) their level of competence was assessed42
Public health interventions: investigator training, treatment manual,43 building assessment of fidelity into trial protocol, activities to increase adherence (e.g., incentives such as bus fare, food stamps),16 address barriers to adherence (e.g., location, group or individual attributes, and/or structural, economic, and social aspects)
12. HOW WELL—Actual: If intervention adherence or fidelity was assessed, describe the extent to which the intervention was delivered as planned Exercise interventions: adherence to delivery of intervention (did the clinician provide the assigned treatment?) and receipt of the intervention (did the patient pay attention, understand treatment requirements, and perform as prescribed?)33 Complex interventions: study-specific fidelity measures required, since no fidelity framework is ideal for all situations42; description of assessment tools used; tables to illustrate fidelity assessment44; external factors during study that influenced delivery of intervention45; video or audio-taping intervention to ensure consistent administration; group meetings to discuss protocol issues and adapt/modify if needed12; method used and results regarding whether participants understood and/or followed treatment recommendations (e.g., complete homework assignments, practice activities, etc.)23
Mobile health interventions: qualitative focus group results, measures of participant engagement, technological challenges encountered23
Educational interventions: in-depth interviews, self-report methods, checklists, behavioral observations, competency checks29

The recommendation of the authors of this review for addressing the tension between these two approaches is similar across these nine TIDieR items. It avoids a strategy of requiring extensive reporting on specific treatment attributes (approach 2). This is done partly because of the reporting burden given the diversity of rehabilitation interventions and also given the worry that more important study-specific attributes might be omitted or lost in the process. Moreover, to the extent that global scores of “reporting completeness” are used as indicators of evidence strength,20,46,47 the inclusion of many study-irrelevant items distorts the meaning of that score. Equally important, however, is the question of how useful it is for an investigator to report attributes that he/she believes are irrelevant and, therefore, have not been considered in the study design. Should the next investigator strive equally to mirror relevant and irrelevant attributes to replicate the treatment’s effects? Can other investigators “discover” overlooked active ingredients by analyzing the reported (but supposedly irrelevant) attributes? The former seems inefficient and the latter may suffer from the fact that the original investigator did not design the study to allow rigorous assessment of “extraneous” variables. There is something ironic about trying to analyze variables that have not been accounted for in the study design, when much of the emphasis of reporting guidelines is on documenting rigorous experimental control.

Although the recommended theory-driven reporting approach allows considerable discretion of the investigator, particularly early in a line of research, three strategies can enhance reporting specificity beyond the guidance provided by TIDieR:

  1. Explicitly stating the treatment theory(ies) as mentioned above (Table 1, item 3): this does not guarantee that the theories are “true,” but it allows reviewers to examine whether all treatment components have been accounted for and whether the logic tying the treatment ingredients to the measured outcomes is plausible. It also facilitates direct comparison of competing treatment theories.
  2. Including in the reporting guideline relevant subcategories, similar to those found in TIDieR, which can be used to prompt complete reporting where theoretically relevant (see the subcategories under bolded items in Table 1): This minimizes the inadvertent omission of important content, without mandating reporting on any specific item.
  3. Refining reporting requirements in circumscribed research domains over time: As lines of rehabilitation treatment research advance, there is an opportunity to develop more tailored reporting requirements for that domain, based on expert consensus and empirical investigation, similar to many of the examples in the right-hand column of Table 2. That is, groups of investigators and clinicians can develop domain-specific guideline extensions that provide specific operationalization of the items to be reported. As the evidence in a certain domain demonstrates that particular dimensions of treatment (e.g., training level of the practitioner, schedule of the practice trials) are related to the outcome, whereas others thought to be important have no apparent impact, specific reporting requirements can be revised.

TIDieR 3: What—Materials

This TIDieR item is the first of those related to the overarching theme discussed in the previous section. Most reporting guidelines requested information about treatment materials in very general terms, although some distinguished between materials used with patients and those used to support treatment staff. When guidance more specific than found in TIDieR was provided, it was because the guideline addressed a particular domain of treatment where the relevant materials can be more easily defined, as suggested above (e.g., Refs.21,48). Specific reporting of treatment materials is captured under the “Overarching Recommendations” in Table 1. In the case of treatment equipment and technology, this approach requires the investigator to supplement information about brand and model number (the delivery vehicle) with the attribute(s) of the device that constitute active ingredients (e.g., “voice output functionality” or “adjustable rate scanning system”).

TIDieR 4: What—Procedures

Among the guidelines reviewed, four themes related to this TIDieR item were identified. Most recommended (1) specification of intervention ingredients and methods. More specific reporting guidance related to this theme came from guidelines addressing more circumscribed areas of treatment (e.g., Refs.24,26). Fewer guidelines addressed the three other subthemes: (2) specific parameters for material and equipment use; (3) how interventions were standardized, including procedures for training interventionists and ensuring/monitoring fidelity; or (4) study management procedures.

Recommendations: The first three themes are captured in the authors’ overarching recommendations, which suggests considering the treatment group (organ function, skills/habits, representations) in which the treatment component falls, because this structures the nature of the relevant procedures. The last of these themes is not directly pertinent to treatment reporting.

TIDieR 5: Who Provided

Although only a minority of guidelines addressed the reporting of who delivered the intervention, almost all of these requested specific details regarding those providing the intervention. Five separate themes were identified: (1) number of providers (e.g., Refs.30,44), (2) allocation of providers to the different intervention groups, (3) provider demographics (e.g., Refs.11,28), (4) their previous experience or credentials (e.g., Refs.31,43,49), and (5) additional training given them for administering the study treatment. Themes 3–5 were the most commonly requested. The first two themes were addressed less commonly and are not directly relevant to treatment reporting in most cases.

Among these themes, recommendations on reporting demographic and cultural provider attributes varied the most across research areas (see Table 2). It is likely that attributes of the treatment provider are relevant to the outcome of most treatments. It is also likely that the most important provider attributes vary considerably across treatments and across patient groups, depending on technical and effort requirements, cultural aspects of the treatment, and patient attitudes, personalities, or cultures. Pending more formal consensus-based recommendations, it may be most realistic to identify categories of provider attributes that frequently are relevant and ask the investigator to select those most pertinent to the study, as shown in the authors’ overarching recommendations.

TIDieR 6: How

Approximately half of the reviewed guidelines mentioned specifying individual or group therapy (with group size) (e.g., Refs.11,43,50). A few emphasized the importance of reporting delivery modality (e.g., in person, online, telephone, telehealth, etc.) (e.g., Refs.23,51). Very few of these provided more specific guidance than contained in the TIDieR item. As in other areas, the theoretically relevant aspects of the delivery mode, along with those in the “TIDieR 7: Where” section, are addressed in the authors’ overarching recommendation.

TIDieR 7: Where

Of the guidelines that included language regarding where the intervention occurred, most provided general recommendations aligned with TIDieR to report the physical location or setting where the treatment was delivered (e.g., inpatient hospital, school, home, community, geographic scope) (e.g., Ref.34). Specific requirements were found in guidelines for more circumscribed areas of research (e.g., Refs.13,29). Note that although these broad setting categories may be relevant, the aspects of context that are most relevant to outcome vary greatly from treatment to treatment. The topics of “HOW” and “WHERE” were combined into “physical and social context,” which are addressed in the “Overarching Recommendations” in Table 1 with subcategories that can elicit study-relevant information.

TIDieR 8: When and How Much

Most guidelines mentioned the notion of “quantity” in some way. However, most did so superficially, because of the trade-off between the specificity and breadth. More circumscribed guidelines provided added guidance about how to specify the construct of “quantity” (e.g., J/cm2 of radiant energy; schedule and repetitions of learning trials) (e.g., Refs.36,37).

Where the known or hypothesized active ingredients can be measured directly (e.g., radiation, drugs), the treatment should be reported in the units known to be relevant. When one cannot measure the active ingredients directly (e.g., amount of heat energy delivered to a deep muscle), one should specify their best surrogate (e.g., output parameters of the heat delivery vehicle).8 The Rehabilitation Treatment Specification System provides distinct dose specification guidance for each of its three broad treatment groups—those that induce changes in organ function, in skills and habits, and in mental representations (knowledge, attitudes, beliefs, emotions).2

TIDieR 9: Tailoring

Most of the guidelines requested that planned variations in treatment be reported. Like TIDieR, they simply made a general statement that any tailoring should be adequately described. As before, the recommendations for reporting treatment tailoring seem to be most specific in areas where the active ingredients of the treatment are already clearly known (e.g., exercise, various drugs) (e.g., Refs.33,39), and therefore, the relevant tailoring dimension (i.e., the intensity or duration of the exercise or the milligrams of the drug) and/or the patient factors that should guide tailoring of that active ingredient (e.g., baseline level of strength or endurance; genetic factors affecting drug clearance) can be identified. Useful reporting should address specific patient characteristics that guide tailoring as well as the active ingredients that may be modified as planned to respond to patient status or change. Where it is possible to independently tailor different treatment components (e.g., amount of motivational coaching vs. intensity of exercise), this should be specified.

TIDieR 10: Modifications—If the Intervention Was Modified During the Course of the Study, Describe the Changes (What, Why, When, and How)

A minority of the guidelines addressed the need to report modifications initiated during the intervention, and it was sometimes ambiguous whether researchers were being asked to report modifications of the treatment itself or modifications of the study design. The guidance was nonspecific, likely reflecting the possibility of many kinds of changes to interventions or study conduct for many different reasons. Individual guidelines suggested that reports should make clear whether the change occurred after the trial was already underway, whether the change was planned or unplanned, why the change(s) was/were made, and the specific nature of the change(s). Some guidelines recommended that defined “versions” of the protocol be saved so that such changes can be reconstructed.18

This TIDieR item deals primarily with wholesale changes in aspects of the study that might affect interpretation of the results. If those changes are in the treatment itself, treatment theory and the authors’ overarching recommendations are relevant to reporting on each version of the treatment.

TIDieR 11: How Well—Planned and TIDieR 12: How Well—Actual

These last two TIDieR items reflect efforts to (1) optimize treatment fidelity (effective clinician delivery of the protocol-described treatment) and adherence (effective patient engagement with the treatment) and (2) efforts to measure the fidelity of and adherence to the treatment actually administered. A minority of the guidelines acknowledged the need to report a plan for optimizing treatment fidelity/adherence or reporting on actual fidelity, and did so with general statements (e.g., Ref.15). Some aspects of planning for effective clinician delivery are also addressed in relation to TIDieR item 5 “Who” (background and training of the clinicians delivering the treatment). Guideline recommendations for measuring fidelity and adherence were similarly broad, with the most detailed recommendations coming from guidelines related to delivering complex interventions, where it was noted that such plans and measures must be study specific.42 Both optimizing and measuring treatment adherence are addressed by the authors’ overarching recommendations.

Guideline Recommendations Unrelated to TIDieR

During review of the 155 guidelines, suggestions potentially useful to rehabilitation treatment reporting that were not related to any TIDieR items were also gathered. These recommendations are provided at the end of Table 1.

Stakeholder Involvement

A number of guidelines requested that stakeholder involvement in the development of the treatment and/or study design be reported (e.g., Refs.52,53). These guidelines focused on the type of stakeholder (e.g., patient, caregiver, policy maker, etc.) (e.g., Refs.53,54) and the phase of involvement (e.g., selecting study topic, study design, interpretation of findings, etc.).53 Some also requested a report of the number of stakeholders, their demographics, what role they played, and what methods were used to elicit their feedback.53,55 Stakeholder involvement generally intends to ensure that treatment is crafted around a need experienced by patients and that the treatment is likely to be accepted by the clinicians who must administer it and the patients who will receive it. Thus, reporting on stakeholder involvement is of particular importance when the need for or the acceptability of the treatment by providers and patients is unclear. Reporting stakeholder involvement may aid in the interpretation of failures of enrollment or adherence but is less relevant to the question of the efficacy of the treatment in a well-designed and successfully completed study. Thus, the recommendations contained here focus on reporting stakeholder involvement in shaping the aims of the study, particularly when the need for or acceptability of the intervention may be less clear (Table 1, item 2).

Cost of the Intervention

The cost of an intervention was requested by a minority of guidelines (e.g., Refs.56) and is clearly relevant to the implementation of treatments in clinical practice. Thus, it is useful to report the costs of treatment materials/ingredients, personnel time, and other fixed budget items, as well as any end-user fees relevant to adherence.32,57 However, it should be kept in mind that the cost of a newly designed treatment may be quite different from that of a refined and streamlined version. Costs of treatment are increasingly relevant to report when the treatment nears implementation stages, for example, along the lines of the National Institute on Disability, Independent Living, and Rehabilitation Research’s research framework’s stages: intervention development, intervention efficacy, and scale-up evaluation,58 and the authors of this scoping review recommend deferring cost reporting to later research phases.

Necessary Infrastructure

Several guidelines requested reporting on the infrastructure necessary to deliver the treatment, but the definition of infrastructure to be reported varied considerably.23,54 For example, no guideline requested that available furniture, lighting, beds, or staff education infrastructure be reported, but some did suggest that computer networks and privacy firewalls be reported (for Web-based interventions),54 suggesting that the aspects of infrastructure that should be reported are those that are less ubiquitous or routine. Also note that “Environmental and contextual factors” (TIDieR 7: Where) overlaps with the construct of infrastructure. Therapeutically active aspects of the environment are addressed by the authors’ overarching recommendations. Uncommon or nonstandard aspects of infrastructure necessary for delivering the treatment should specifically be noted.

Implementation Barriers and Facilitators

A number of guidelines requested information on facilitators of, and barriers to, implementation (e.g., Refs.23,29). Some guidelines addressed reporting on implementation science strategies (e.g., studies comparing different approaches to facilitating adoption of a new treatment) (e.g., Refs.23,32), whereas others focused on reporting on constraints relevant to scaling the intervention.23,29 Just as the reporting on early-phase treatment research should facilitate the replication and extension of the study of efficacy and effectiveness, the reporting on late-phase treatment research should facilitate the implementation of that treatment in clinical practice. Moreover, earlier phases of treatment research may face “mini-implementation” challenges. For example, recruiting research patients with a given problem from within a clinic may require changing habitual clinician referral behavior; providing an experimental treatment to a patient who is receiving additional rehabilitation treatments may require coordination with other providers to avoid resistance. Consequently, the authors recommend reporting, in late-stage research, on facilitators and barriers that are likely to be encountered in attempted implementation. In earlier phases of research, factors that may affect the ability to implement replication of the research should be articulated.

DISCUSSION

Rehabilitation is a highly diverse field, using an equally diverse set of ingredients by which to facilitate functional change. Treatments involve physical and biologic processes leading to changes in organ and tissue function, experiential learning processes resulting in behavioral adaptations and changes in skills and habits, and cognitive processes leading to changes in knowledge, attitudes, beliefs, and motivation. It is challenging to develop a finite and operationalized set of reporting requirements that define the important ingredients and attributes across such a diverse set of treatments. Moreover, the understanding of whether and how these treatments work is continually evolving, so what is relevant to know and report about them today may alter tomorrow.

The authors of this review believe that the concept of treatment theory provides a unifying structure to sharpen the specification of rehabilitation interventions. Although this approach does not dictate whether a specific treatment attribute should or should not be reported, it does provide the framework for determining which attributes are reportable and requires the investigator to decompose the treatment into mechanistically distinct components, each with a defined treatment target and a corresponding set of known or hypothesized active ingredients intended to change that target. In Table 3, the authors offer a template to help structure reporting in this way. Although articulating an early or crude treatment theory may not guarantee that all active ingredients have been correctly specified or reported, a theory-driven approach structures the issues that an investigator must consider when developing and reporting on a treatment protocol. In addition, it allows grant and manuscript reviewers, rehabilitation scientists, and clinicians to examine the plausibility of the treatment rationale and to demand more extensive reporting where they find gaps. Importantly, this approach allows the treatment theory itself to be debated, so that each step of clinical research delivers not only an empirical result but also a refinement of the understanding of why, how, and for whom a treatment works. As domains of treatment research develop, reporting recommendations such as the ones proposed here can be supplemented with more operationalized expert consensus-based guidelines. Indeed, in some areas, it may already be possible to provide more specific recommendations than what is offered here.

TABLE 3 - Template to structure rehabilitation treatment reporting
Treatment name
Study goal(s)
Intervention components
Component 1 Component 2 Component 3 Component N
Component name
Supply in light of the treatment theory
 Component MoA
 Component target
 Component active ingredients
  • Materials
  • Procedures
  • Dosing/intensity
  • Individualization of treatment
  • Methods to optimize fidelity
  • Methods to assess fidelity
Characteristics of treating staff
Treatment context
Treatment costs
Implementation (study: early phase; treatment: late phase)

Designing research and reporting research protocols within a framework of treatment theory will facilitate the critical review of emerging evidence. One might argue that articulating the theory is no longer essential for delivering an intervention once its ingredients have been fully operationalized on the basis of previous research. Even then, however, the underlying theory may help guide patient selection by a clinician, or, for complex interventions, the differential application of separable components of the intervention.

Although treatment theory, in principle, sorts active from inactive ingredients, in early phases of research, the investigator may have a more graded “degree of certainty” about ingredients, ranging from those believed to be “definitely active” (as in key theoretical elements) to “definitely inactive” (as in the color of the room), with a gray zone of things in between that “might be active” (e.g., personal characteristics of the clinician). What should be his/her “threshold” for reporting a treatment attribute? This ultimately comes down to a debate that is beyond the scope of this discussion: Which research strategy ultimately delivers evidence of effectiveness more efficiently:

  • Retrospective analysis of reported items, which were not of key interest to the investigator or incorporated into the design, to discover unforeseen active ingredients; or
  • Overt debate of treatment theories among investigators, leading to follow-up studies explicitly designed to test variables omitted from a prior study?

CONCLUSION

Developing a highly specific set of guidelines for reporting on rehabilitation interventions is a challenging task owing to the diversity of the field. The authors of this review use the framework of treatment theory to structure the reporting on rehabilitation treatments, and propose a set of categories and subcategories of treatment attributes to help ensure complete reporting. This group’s recommendations will need to be combined with those of Randomized Controlled Trials Rehabilitation Checklist’s work groups focused on other dimensions of rehabilitation trial reporting, to arrive at a consensus-based randomized controlled trial reporting guideline for the field, but following the treatment reporting items can aid the interpretation of many other research designs. The authors recommend that the consensus process also consider a means by which, as circumscribed areas of rehabilitation research develop, expert consensus groups may develop more specific operationalized reporting guidelines for those domains, organized around coalescing bodies of treatment theory.

ACKNOWLEDGMENTS

The authors would like to acknowledge Stefano Negrini for helpful consultation during the project period, and Mary Czerniak for assistance with preparation of the manuscript.

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                  Keywords:

                  Rehabilitation; Physical and Medical Rehabilitation; Therapy; Randomized Controlled Trial; Guideline [Publication Type]; Guidelines as Topic; Review Literature as Topic; Review [Publication Type]; Medical Writing

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