Recommendations for Reporting on Rehabilitation Interventions

[Pages:42]American Journal of Physical Medicine & Rehabilitation Articles Ahead of Print DOI: 10.1097/PHM.0000000000001581

Recommendations for Reporting on Rehabilitation Interventions

John Whyte1, Marcel Dijkers2, Susan E. Fasoli3, Mary Ferraro1, Leanna W. Katz4, Sarah Norton5, Eric Parent6, Shanti M. Pinto7, Sue Ann Sisto8, Jarrad H. Van Stan3,9,

Lauren Wengerd10

D 1 Moss Rehabilitation Research Institute, Einstein Healthcare Network, Elkins Park, PA

2 Wayne State University, Department of Physical Medicine and Rehabilitation, Detroit, MI

E 3 MGH Institute of Health Professions, Boston, MA T 4 Spaulding Rehabilitation Hospital, Department of Occupational Therapy; Boston University,

Sargent College of Health and Rehabilitation Sciences, Department of Occupational Therapy,

P Boston, MA

5 Scripps Memorial Hospital, Department of Neurological Rehabilitation, Encinitas, CA

E 6 Department of Physical Therapy, University of Alberta, Edmonton, AB, Canada

7 Department of Physical Medicine and Rehabilitation, Carolinas Rehabilitation, Charlotte, NC

C 8 School of Public Health and Health Professions, Department of Rehabilitation Science,

University at Buffalo, Buffalo, NY

C 9 Harvard Medical School, Massachusetts General Hospital, Boston, MA A 10 The Ohio State University, School of Health and Rehabilitation Sciences, Division of

Occupational Therapy, Columbus, OH

2nd through 11th authors are listed alphabetically.

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Corresponding Author: John Whyte, MD, PhD Moss Rehabilitation Research Institute 50 Township Line Rd. Elkins Park PA 19027 (ph) 215-663-6872 (fax) 215-663-6113

D (email) johnwhyte@ E Funding: No funding was received for the work or writing of this manuscript. T Acknowledgments: The authors would like to acknowledge Stefano Negrini for helpful P consultation during the project period, and Mary Czerniak for assistance with preparation of the

manuscript.

E Prior presentations: The results of this review were presented at the RCTrack Consensus ACC Conference, Orlando, FL, March 3-4, 2020

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Abstract

Clear reporting on rehabilitation treatments is critical for interpreting and replicating study results, and for translating treatment research into clinical practice. This article reports the recommendations of a working group on improved reporting on rehabilitation treatments. These recommendations are intended to be combined with the efforts of other working groups, through a consensus process, to arrive at a reporting guideline for randomized controlled trials (RCTs) in

D physical medicine and rehabilitation (RCTrack). The work group conducted a scoping review of

156 diverse guidelines for RCT reporting, to identify themes that might be usefully applied to the

E field of rehabilitation. Themes were developed by identifying content that might improve or

enhance existing items from the Template for Intervention Description and Replication

T (TIDieR). Guidelines addressing broad research domains tended to define reporting items P generally, from the investigator`s perspective of relevance, whereas those addressing more

circumscribed domains provided more specific and operationalized items. Rehabilitation is a

E diverse field, but a clear description of the treatment`s separable components, along with distinct

treatment theories for each, can improve reporting of relevant information. Over time, expert

C consensus groups should develop more specific guideline extensions for circumscribed research AC domains, around coalescing bodies of treatment theory.

Key Words: 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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1. Background Clear reporting on a rehabilitation intervention or treatment under investigation is critical

for interpreting study results. (Hereafter, we use treatment and intervention 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, etc. The importance of a clear

D intervention description persists beyond the demonstration of efficacy and effectiveness: it

allows ongoing dissemination and implementation of the intervention in clinical practice.

E Rehabilitation practitioners cannot be expected to implement evidence-based interventions

without an adequate understanding of what the intervention entails1. In recent years, inadequate

T reporting of the active ingredients` in clinical trials of rehabilitation interventions, or the specific P 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

E as the black box of rehabilitation. 6 C This article reflects the efforts of a work group contributing to a larger effort, to develop

reporting guidelines for randomized controlled trials (RCTs), tailored to the field of

C rehabilitation -- the Randomized Controlled Trials Rehabilitation Checklist (RCTrack).7 The A goal of this work group was to review RCT 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 (ACRM) Rehabilitation Treatment Specification Networking Group.8

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Group members conducted a scoping review, exploring how previously published reporting guidelines across diverse healthcare fields had recommended reporting on experimental treatments, and identify 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.

2. Methods

D The group took a sample of 151 reporting guidelines listed on the Enhancing the Quality

and Transparency of Health Research (EQUATOR) website9 within the category of RCTs, as

E well as 4 other prominent guidelines not yet listed on EQUATOR.10-13 (See Appendix A,

Supplemental Digital Content 1, , for a complete list of

T guidelines reviewed.) The task force members then applied a 3-phase method, summarized in P 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)

E 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

C approximately twice per month over six months to develop the protocol and to discuss progress

and results.

AC [Figure 1 about here]

The boundaries between some of the 12 TIDieR items are vague (for example, What ? Materials vs. What ? Procedures), as are the boundaries between whether a guideline item was

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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, we provide only qualitative statements of the frequency

D with which particular themes were encountered and illustrative examples of a content theme. E 3. Results & Recommendations

Findings for the sample of guidelines with treatment-relevant content are summarized

T below, in relation to each TIDieR item. Early in the synthesis phase, the authors identified a P 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

E 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

C 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

AC which the reporting recommendation was modified is noted, where applicable.

[Table 1 about here]

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3.1 Guideline Themes Related to TIDieR items 3.1.1 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,

D 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

E 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, though several

T examples were used such as the drug name or herbal product name,15 the name of a defined P 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

E the problem being treated ? something that occurs commonly in rehabilitation (e.g., memory

remediation).2

C At the simplest level, an arbitrary name that is linked to a well-defined set of ingredients C is sufficient to support replication and communication. (I give most of my patients Treatment A #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, betablockers) 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,

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(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.

D 3.1.2 TIDieR 2 WHY: Describe any rationale, theory, or goal of the elements essential to E the intervention.

The reviewed guidelines addressed several themes related to the study purpose. The study

T rationale, referring to the reason the study was conducted (i.e., to advance the knowledge in a P specific way), was requested by a majority. Scientific background, referring to prior work that

paved the way for the current study, and specific aims or a priori hypotheses were requested by a

E minority of the guidelines. The one universal suggestion was to explicitly note what about the

current study is new or different from prior research. Many of the guidelines also requested that

C 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.

AC 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

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