Reporting on Interventions: Issues and Guidelines for Rehabilitation Researchers

Accepted Manuscript Reporting on interventions: issues and guidelines for rehabilitation researchers Marcel Dijkers, PhD PII:

S0003-9993(15)00093-3

DOI:

10.1016/j.apmr.2015.01.017

Reference:

YAPMR 56094

To appear in:

ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION

Received Date: 14 October 2014 Revised Date:

23 December 2014

Accepted Date: 18 January 2015

Please cite this article as: Dijkers M, Reporting on interventions: issues and guidelines for rehabilitation researchers, ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION (2015), doi: 10.1016/ j.apmr.2015.01.017. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Running head: Reporting on interventions

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Marcel Dijkers, PhD1

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Reporting on interventions: issues and guidelines for rehabilitation researchers

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Department of Rehabilitation Medicine, Icahn School of Medicine at Mount Sinai, New York,

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Correspondence regarding this paper should be addressed to: Marcel Dijkers Ph.D., FACRM

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Department of Rehabilitation Medicine, Box 1240, Icahn School of Medicine at Mount Sinai,

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One Gustave L. Levy Place, New York NY 10029. Telephone 00-1-212-659-8587 (B) or 00-1-

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718-549-2038 (H); fax 00-1-212-348-5901. Electronic mail may be sent to

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[email protected].

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This work was supported, in part, by cooperative agreement H133A080053 between Mount Sinai

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School of Medicine and the National Institute on Disability and Rehabilitation Research, Office

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of Special Education Services, Department of Education.

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I certify that no party having a direct interest in the results of the research supporting this article

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has or will confer a benefit on me or on any organization with which I am associated AND, if

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applicable, I certify that all financial and material support for this research (e.g, NIH or NHS

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grants) and work are clearly identified in the title page of the manuscript. There are no conflicts

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of interest to report.

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Reprints will not be available from the author.

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Thanks to Mary Ferraro PhD OTR/L, Tessa Hart PhD, Andy Packel PT NCS, John Whyte MD

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PhD, and Jeanne Zanca PhD MPT for feedback on an outline for and an advanced draft of this

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article.

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Reporting on interventions: issues and guidelines for rehabilitation researchers

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Abstract

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Observers commonly note the poor reporting of research, including rehabilitation research. The

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CONSORT checklist (supplemented by the CONSORT extension for non-pharmacologic

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interventions) has been published for improving the reporting of intervention research. However,

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the items on these checklists are considered to be inadequate to guide authors as to which

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information to include when reporting on the intervention(s) studied, and TIDieR (Template for

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Intervention Description and Replication), JARS (Journal Article Reporting Standards) and the

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checklist of the Western Journal of Nursing Research are recommended to rehabilitation

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researchers. The Rehabilitation Treatment Taxonomy framework is recommended as a

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conceptual scheme to assist authors in thinking through the linkages between intervention

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ingredients, targets of treatment, and the mechanisms of action linking the two.

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Recommendations are made for prospective authors and journal editors who desire to see

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improved reporting of interventions.

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Key words: Rehabilitation; Guidelines as topic; Publishing; Peer review, research; Intervention

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studies

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Abbreviations

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ADL

activity of daily living

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APA

American Psychological Association

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CONSORT

Consolidated Standards of Reporting Trials

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CONSORT-NPT

CONSORT for nonpharmacologic treatments

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JARS

Journal Article Reporting Standards

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RCT

randomized controlled trial

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RTT

Rehabilitation Treatment Taxonomy

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TIDieR

Template for Intervention Description and Replication

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Reporting on interventions: issues and guidelines for rehabilitation researchers

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Poor reporting of health care research, including information on interventions

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In 2012, van Heugten and colleagues published a systematic review in which they

assessed how many of the primary studies of cognitive rehabilitation after acquired brain injury

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published between 1980 and 2010 provided adequate information on the content of the

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intervention.1 For the 95 studies identified, the total number of treatment hours was known for

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83%, the number of weeks of treatment for 93%, and the number of hours per week for 82%.

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This was planned and/or actual numbers; the actual hours, weeks, or hours per week were

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available in 23% or less. Whether treatment was given individually, in groups or in both formats

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was unknown for 33%; use of homework assignments was not reported for 75%, and

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involvement of caregivers not for 77%. Even the setting in which treatment was offered was

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missing in 17% of 95 papers, as was information on the necessary experience, knowledge or

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skills of the staff - in 100%. The authors noted that in many studies the “outcome measures are

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all described in high detail while the intervention is only described in very general terms”1 p 663

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(confirming an observation made 10 years earlier in a broader study of intervention reporting in

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rehabilitation research2), and that a “detailed description of the differences between control and

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experimental treatments was not available in any report”.1 p 663

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If fairly superficial information like the number of hours of treatment is not available in

rehabilitation intervention research reports, it is not surprising that a recent review of aphasia

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treatment studies reported that based on the treatment description in the article or in related

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publications, only 50% of 149 studies could be replicated.3

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Careful and complete description of interventions used in research in rehabilitation and other

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domains of health care is needed for a number of reasons. Such description is the basis for

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replication of the research by other researchers, synthesis by systematic reviewers and guideline

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developers, and most importantly, implementation by clinicians in their practice. We researchers

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have been trained to include in our manuscripts many details on the psychometrics of the

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dependent variables, and editors and peer reviewers do not hesitate to return a manuscript to its

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authors if that information is lacking. But the independent variable gets much less attention –

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both its nature and theoretical linkage to the outcomes, and its careful implementation (fidelity)

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and measurement. When in rehabilitation and other intervention research a comparator treatment

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is used, it tends to get even less attention, as if ‘usual care’ is a standardized entity which every

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reader knows intimately.

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Unfortunately, rehabilitation researchers are not alone in their dereliction of duty: missing

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information in the description of treatment, especially nonpharmacologic treatment, has been

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reported widely.4-13 One review of the degree to which interventions described in the journal

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Evidence Based Medicine were replicable in primary care general practice judged that only 65%

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had been described adequately to allow replication.14

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“Reporting of health research is, in general, bad”.15 p. 1 That is a judgment shared by

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many editors, systematic reviewers, and others who have had reason to look critically at the

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quality of biomedical and health services research reporting. This is not an esthetic issue, but an

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economic and ethical one. Research that is not reported completely and with carefully written

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information on its strengths, weaknesses and implications for patient care, policy and future

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research constitutes a waste of resources. The waste may be of the time, interest and efforts of

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the patients and other individuals who volunteered to be research subjects, of the grant funds of

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the government agency or foundation that supported the work, or of the time and dedication of

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peer reviewers and editors who through feedback on manuscripts try to salvage what they can.16,

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minor risks, but then not publishing that research in a format that is useful, constitutes an ethical

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problem.

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Asking subjects to volunteer their time for research, sometimes research that brings more than

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Checklists as a solution?

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While medical journal editors always have complained about poor writing by authors,

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and have published articles on ‘how to write a paper’ (of which type PubMed contained a few

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hundred as of mid-2014), the grumbling became more widespread and serious when systematic

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reviewers tried to extract information from published empirical papers, and discovered that in

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many instances crucial information on study design, nature of the intervention, the patients

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involved and their outcomes was missing, or was written with so much ambiguity that it might as

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well have been missing. Out of the circle of evidence-based medicine, with its emphasis on proof

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produced by systematic experimentation and observation and the need to synthesize evidence in

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a systematic review, also came one suggested solution: reporting checklists. The first one

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published was Consolidated Standards of Reporting Trials (CONSORT),18 which offers a list of

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items that should be in a report on a clinical trial. CONSORT (as well as its specialized additions

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and other reporting guidelines) also offers a table with the reportable items and a box next each

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one where authors, if the journal they are submitting to demands such, can note on what pages or

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lines of their manuscript they provide the information required. A number of studies have shown

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that endorsement of CONSORT by a journal indeed results in improvement of its articles

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(measured, generally, as compliance with CONSORT items), whether that is demonstrated by

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comparison of papers published before vs. after CONSORT endorsement, or comparison of

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articles in journals endorsing CONSORT with those printed in similar journals (same area of

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medicine or nursing, same focus, etc.) not (yet) endorsing it.19 However, a recent systematic

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review of studies investigating reporting improvements as a consequence of endorsement of

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other reporting guidelines concluded that evidence for their benefit was not (yet) available.15 A

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“systematic scoping review of adherence to reporting guidelines in health care literature” found

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that 43 of 50 reviews found “suboptimal levels of adherence to reporting guidelines”20 p 169

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The editors of Archives of Physical Medicine and Rehabilitation recently published an editorial in which they announced that this journal (along with about 30 other rehabilitation

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journals) had decided to “take a more aggressive stance on the use of reporting guidelines”21 p. 415

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and would make the use of reporting guidelines obligatory, beginning with submissions in 2015.

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A later change in the “author information pack” for the journal22 specified that a completed

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checklist was required as part of submission, and like the editorial named what can be called the

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‘big 5’: CONSORT (for trials), STROBE (for observational studies),23 STARD (for diagnostic

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studies),24 CARE (for case reports)25, and PRISMA (for systematic reviews).26 A reference to the

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EQUATOR website,27 as an “excellent resource for key reporting guidelines, checklists, and

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flow diagrams” p. 8 suggests that authors are at liberty to select other ones. Unfortunately, without

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further specification, the simple instruction “use a reporting guideline” may result in a tower of

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Babel situation: as of December 14, 2014, EQUATOR listed no less than 225 guidelines,

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differentiable by research design, topic area, and probably many other factors.

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Even if the big 5 are accepted (or turned into the big 10 that on the EQUATOR website are designated ‘key reporting guidelines’27) there is a remaining problem for rehabilitation

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journals, stemming from the fact that the big 5 were created by and for medical researchers, with

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the randomized controlled trial (RCT) of a placebo-controlled medication as the paradigmatic

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case. Medication interventions are easy to describe: with drug name, route, titration scheme, dose

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and duration all information has been supplied that another physician needs for prescribing. But

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rehabilitation interventions are different; they mostly consist of teaching patients new motor

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behaviors, activities of daily living (ADLs) and other skills. Both the “content” of those

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behaviors and of “cognitive/affective representations”28 (new attitudes, knowledge and values)

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and the methods used to teach them to patients are crucial to adequately describing these

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treatments, the latter sometimes even more so than the former. There are other, “simpler”

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interventions used by rehabilitation clinicians, for instance assistive technology, but as long as

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they are not standardized (commercially available) entities, stating that the intervention consisted

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of giving the patient, for instance, a reciprocal gait orthosis is of limited value. Even then we

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would expect the author to emphasize that how the therapist taught the patient to use that

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reciprocal gait orthosis was crucial to successful restoration of mobility. And the description of a

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training program in such a way that another clinician can replicate it is no easy matter.2, 28

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The group that developed CONSORT has realized that this guideline was insufficient for describing many, if not all, instances of research on surgical interventions, public health

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activities, rehabilitation, behavioral medicine and a number of other healthcare areas, and created

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an extension for CONSORT named CONSORT for Randomized Trials of Non-pharmacologic

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Treatment, and known as CONSORT-NPT. It consists of extensions to 8 of the 22 CONSORT

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items, and a single new item: “Implementation of intervention: Details of the experimental

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treatment and comparator as they were implemented” (Table 1). This new item joins extensions

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for the old item 4: “Interventions: Precise details of the interventions intended for each group and

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how and when they were actually administered” (Table 1). That this extension of CONSORT

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may be unsatisfactory for some types of research may be suggested by the fact that still another

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group is working on yet another CONSORT extension, CONSORT-SPI, where SPI stands for

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social and psychological interventions.29

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The latter development should remind one that adequate description of what now commonly is called a “complex intervention”30 has been the topic of scholarship before the

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publication of CONSORT’s NPT extension, although these efforts to offer guidance to authors

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describing an intervention may not have resulted in a neat checklist that can be submitted to a

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journal along with one’s manuscript. However, a bulleted list of items, preferably accompanied

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by a description of the items and examples of how to describe interventions, may go far in

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helping prospective authors. Unfortunately, many of these lists offer little beyond “describe who,

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where, when, using what equipment or materials”. An unsystematic search found a number of

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such lists.1, 31-37 A few that go beyond a simple listing but offer detailed guidance for a particular

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journal or area of research have also been published.38-43 Three efforts that would appear to be

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especially useful to rehabilitation researchers may be noted.

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Three checklists to assist in rehabilitation intervention reporting

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An American Psychological Association (APA) Publications and Communications Board

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Working Group on Journal Article Reporting Standards in 2008 published “recommendations on

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information that should be included in manuscripts submitted to APA journals”.44 p 839 The

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working group created a document containing what have become known as the Journal Article

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Reporting Standards (JARS) which were desired “in anticipation of the impending revision” p 839

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of the Publication Manual of the APA, a style manual that is authoritative for manuscripts

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submitted to dozens of APA journals and hundreds of non-APA psychology and social science

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journals. As far as can be determined, these JARS never became requirements (except for one

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non-psychology journal45), and in the new 2010 edition of the Publication Manual they are

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relegated to an appendix, which receives minimal referencing elsewhere in this lengthy

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document.46 The JARS provide a table (see table 2) that describes in quite some detail what

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authors ought to write about their experimental manipulation or intervention. (There are

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additional tables with standards for the description of other components of a study, which all are

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quite extensive too).

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Conn, a nursing researcher and editor of the Western Journal of Nursing Research has

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published on the deficiencies of intervention reporting in the nursing literature,9, 42, 47, 48 and

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created a checklist for proper reporting (Table 3) that was stated to become “content requirement

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for interventions research reports submitted for publication”.48 p. 428 (The journal’s website under

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“Manuscript requirement” now asks authors to please use CONSORT, and refers to the checklist

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in connection with a request to provide “extensive details regarding any intervention”.49) This list

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is noticeable for the emphasis on the conceptual framework that provides the constructs and

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theory for any intervention, and on the cultural relevance of interventions.

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The most recent and detailed proposal for an interventions reporting guideline was made

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by a group of authors of whom several had contributed to CONSORT and others in the big 5:

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TIDieR, or Template for Intervention Description and Replication.50 TIDieR consists of 12

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items, offered in the form of a checklist that assists authors to describe the why, what, who, how,

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where and how much of interventions and of their comparators, if those are used in a study

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(Table 4). Unlike the two other lists, TIDieR is accompanied by the ‘explanation and

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elaboration’ that many of the checklists among the big 10 have received, with descriptions of

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what should be reported and examples of good reporting. This guideline is too new to know if it

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is used, and whether its use improves reporting.

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If one maps the items of these three lists to the CONSORT (original and CONSORT-

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NPT) checklist, it becomes clear that they differ in coverage, even if one considers only their

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correspondence to the CONSORT items addressing the interventions (which in most studies

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involve both the experimental and the comparator treatment): plans for, delivery of, and

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interpretation of the effects of the treatment: 3, 4, 4A-C, 11B, 13, 15, 20, 21 (Table 1). It might

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be proper for any researcher planning a study and writing up the results of a completed

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investigation to consult all four checklists, and consider the applicability of their joint items to a

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complete report of what was done.

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The Rehabilitation Treatment Taxonomy framework, and its role in reporting

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Another observation is that in none of the checklists (or their description and elaboration

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in the articles that originally presented them) the issue of the treatment ingredients as they relate

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to the outcomes receives much attention. All authors or author groups appear to consider

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describing the “content” of the intervention that was used unproblematic. They presumably

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would specify that the “content” of an intervention to teach a stroke patient ADLs consists of

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demonstrating each ADL, and then having the patient practice each one in some systematic way

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until a minimum standard of competence has been achieved. Adding setting, discipline of the

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therapist, and amount of time presumably would complete the intervention description.

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However, the conceptual framework of the RTT (Rehabilitation Treatment Taxonomy)

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published in this journal in early 201428, 51, 52 suggests that a distinction must be made between

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the target of a (rehabilitation) treatment, which is a measurable aspect of the patient’s

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functioning that is directly changed by the treatment and is functionally relevant, and the aims of

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treatment that may or may not result from the change in the target, depending on the causal

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network of factors linking targets to aims.52 (Figure 1). The ingredients are the observable and

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measurable actions (words, demonstrations, visual feedback, etc.) delivered by a therapist, or the

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devices, informative documents, chemicals or forms of energy selected and delivered by this

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clinician, because she (or the investigator who employs her as a research clinician) has a

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treatment theory that holds that these specific ingredients have the potential to change the target

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selected, through distinct mechanisms of action. The targets are considered to fall into one of

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four domains: tissue properties, organ functions, skilled performances (ADLs, walking, etc.) and

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cognitive and affective presentations (knowledge, beliefs, values, etc.).28 Unfortunately, the RTT

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framework as it exists does not include guidelines, let alone operational steps, for identifying and

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specifying the targets, ingredients and mechanisms of action. However, funding from the

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Patients-Centered Outcomes Research Institute just approved will support a project to try and

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bring clarity to these issues.

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Specification of the ingredients that are combined in a particular treatment and their link to the target or targets selected is considered one of the major challenges in creating an RTT.51 In

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all treatments that have as their target a skilled performance, actually performing the skill in

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question is an essential ingredient and repeated rehearsal of the skill is an important dosing

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parameter; therefore, one would need to count the number of repetitions to quantify dose of this

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particular ingredient. Given the burden of doing so in many situations,53 a proxy such as “patient

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active time”54 or accelerometry55 may be a considered. Similarly, ingredients delivered to help

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get the patient into “set,” such as goal setting, other manipulations of motivation, and various

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types of instructions, as well as feedback accompanying or following the performance, are likely

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active ingredients in any skilled performance treatment. Here, the details are qualitative as well

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as quantitative, and we are less certain about how to define and enumerate these. For instance,

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feedback may be positive or corrective, concurrent or terminal, intermittent or continuous, visual

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or verbal, external or magnifications of internal, just to name a few possible variations. Certainly,

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for most rehabilitation treatments “hours of treatment” appears to be an inadequate way of

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measuring dose as it is almost certain that these latter types of ingredients are not delivered in a

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fixed ratio to minutes elapsed.

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This observation should not be understood to mean that henceforth every rehabilitation

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treatment researcher needs to start budgeting half his grant money for development and

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implementation of a way of reliably measuring “dose”; however, it is time to stop assuming that

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any and all dosage can be reliably quantified by counting sessions or minutes of treatment. It

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behooves us to start considering in our intervention research (1) what specific aspect of the

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patient’s (client’s, subject’s) functioning are we trying to change; (2) what ingredients can be

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used to bring about that change, and what is the known or hypothesized mechanism of action that

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connects those ingredients to the target; (3) what is the best available way to quantify the dosage

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of ingredients the subjects in this research should be receiving and actually are receiving. Any

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attempt to report one or more of these will eventually help us to get a better handle on

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“rehabilitation interventions”.

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Conclusion and recommendations

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In order to improve our research and research reporting, we rehabilitation

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researchers ought to pay more attention to a number of issues, specifically the ingredients of the

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treatment, and how they are known or hypothesized to be linked by mechanisms of action to the

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outcomes (‘targets’, in RTT terminology) we aim to change. Even if we do not have a good

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notion of the active ingredients, and the mechanisms of action are incompletely known or only

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hypothesized, trying to specify what we know is helpful to the development of our science and

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practice, and eventually the quality of our services. In this era of evidence-based practice, it is

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more important than ever to build the evidence base of rehabilitation. In doing so, offering proof

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that something works is insufficient. If practitioners have no detailed information on how they

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can implement what research shows to be effective, the research might as well not been done.

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Even worse, payers of care might take the same stance, and reject claims for reimbursement

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because evidence that a treatment is effective is missing.

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The checklists provided in this paper can be helpful to developers of research proposals in specifying what treatments will be delivered and how they will be measured, and to authors

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who, when all data have been analyzed, set out to inform others of their findings. The list of

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items in CONSORT (and even in CONSORT-NPT) was developed primarily for the benefit of

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systematic reviewers, and as such is insufficient to guide complete reporting, especially for non-

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drug research. Adding in a flexible manner the TIDieR, JARS and Western Journal of Nursing

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Research checklists will guarantee that the CONSORT standards are satisfied, but that in

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addition much detail is provided for users of clinical research reports other than systematic

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reviewers.

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While CONSORT clearly is predicated on RCTs being the sole legitimate research design

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to produce dependable evidence, we must acknowledge that many other designs are used by

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rehabilitation researchers, because it is too early for a RCT,56, 57 it is unethical to perform a RCT,

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or the researchers lack funds for a group-controlled investigation. Some of those designs are

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covered in other checklists among the big 5 or 10 – CARE, STROBE, SPIRIT58 and even

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STARD. To the degree that these other checklists call for a description of a diagnostic,

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rehabilitative, curative or preventive intervention, consulting the three intervention checklists

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highlighted here will be beneficial. Consultation of the RTT conceptual framework may assist in

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thinking through the nature of the treatment in terms of its ingredients and their link to targets of

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the intervention and additional aims ‘downstream’ from it.

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Prospective authors without doubt will have one major concern with the recommendation

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to provide more detail on interventions: where will they find the space when journal editors limit

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them to 5,000, 3,000 or even fewer words? The obvious answer is: digital supplemental content –

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either on the journal’s website, or on the website of their institution or some other entity that is

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unlikely to discontinue the platform used. It would not be unreasonable for editors to require

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more and better summary information on one’s intervention, with maybe a general guideline as

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to the number of words that should be dedicated to this topic in the text. The supplemental digital

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content can be used to provide detail, in principle unlimited detail. In fact, it would not be

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unreasonable for a journal to require that the entire trial protocol and intervention manual be

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posted, along with whatever handouts were given to subjects and all other documents used in or

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describing the intervention. The precedent exists – Implementation Science and Addiction now

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require that relevant documents are made available in permanent records.5 This ‘pull’ by editors

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may be needed in addition to the ‘push’ of researchers wanting to do a better job of reporting.

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This push apparently is not very strong yet – one study of RCT intervention research published

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in the online Health Technology Assessment Journal, which has no word count cap and publishes

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papers that on average tally 50,000 words, found that 69% of papers did not have a complete

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description of the intervention, with only 27% of the RCTs with psychological interventions

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deemed to have a complete description.33

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It will not have escaped the reader that the CONSORT-NPT statement asks for

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“description of the experimental treatment, comparator, care providers, centers, and blinding

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status” in the abstract. Clearly, providing information that is even somewhat complete is very

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hard given the number of words most journals allow for abstracts (with Archives of Physical

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Medicine and Rehabilitation among the stingier ones with a cap of 275 words for its structural

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abstracts). It is not surprising that the one review focusing on the adequacy of reporting in

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abstracts found that in terms of the CONSORT and CONSORT-NPT extension, active

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ingredients were reported adequately more often for pharmacologic than for non-pharmacologic

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interventions.59 To the degree that they value informative abstracts, journal editors may want to

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allow longer abstracts, and provide better guidelines as to what should be provided under the

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structured abstract heading ‘Intervention’.

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There is much that all involved in the process of publishing rehabilitation intervention

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research – authors, peer reviewers, editors – can do to improve the finished product offered to

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readers. More extensive and informative descriptions of interventions and comparators is high on

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the list of steps with a large payoff. Authors do not have to wait for recommendations or

342

requirements by editors – they can start with their next paper.

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EP

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17

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Accessed 12/14/2014.

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standardizing evaluation reports of web-based and mobile health interventions. J Med Internet

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47. Conn VS. Nursing intervention research. West J Nurs Res. 2005;27(3):249-251.

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48. Conn VS. Unpacking the black box: Countering the problem of inadequate intervention descriptions in research reports. West J Nurs Res. 2012;34(4):427-433.

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53. Kimberley TJ, Samargia S, Moore LG, Shakya JK, Lang CE. Comparison of amounts and types of practice during rehabilitation for traumatic brain injury and stroke. J Rehabil Res

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54. Host HH, Lang CE, Hildebrand MW, et al. Patient active time during therapy sessions in

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postacute rehabilitation: Development and validation of a new measure. Phys Occup Ther

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Geriatr. 2014;32(2):169-178.

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23

55. Choquette S, Hamel M, Boissy P. Accelerometer-based wireless body area network to

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estimate intensity of therapy in post-acute rehabilitation. J Neuroengineering Rehabil.

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2008;5:20.

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developmental approach. Arch Phys Med Rehabil. 2012;93(8):S101-S110.

57. Whyte J, Gordon W, Rothi LJ. A phased developmental approach to neurorehabilitation research: The science of knowledge building. Arch Phys Med Rehabil. 2009;90(11 Suppl):S3-

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10.

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58. Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: Defining standard

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protocol items for clinical trials. Ann Intern Med. 2013;158(3):200-207. 59. McCleary N, Duncan EM, Stewart F, Francis JJ. Active ingredients are reported more often

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for pharmacologic than non-pharmacologic interventions: An illustrative review of reporting

489

practices in titles and abstracts. Trials. 2013;14:146-6215-14-146.

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ACCEPTED MANUSCRIPT Reporting on interventions 490

24

Figure legends

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Figure 1. Conceptual framework of the Rehabilitation Treatment Taxonomy at a glance.

RI PT

492

493

SC

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Reproduced, with permission, from Dijkers MP, Hart T, Whyte J, Zanca JM, Packel A,

496

Tsaousides T. Rehabilitation treatment taxonomy: implications and continuations. Arch Phys

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Med Rehabil. 2014 Jan;95(1 Suppl):S45-54.e2. Abbreviation: AT, assistive technology.

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Table 1. The CONSORT checklist (original, and the additional items for non-pharmacologic interventions), and how items on the

1

CONSORT description

SC

Title and

Item

JARS

TIDieR

Conn

item(s)

item(s)

item(s)

How participants were allocated to interventions (e.g., “random

1

M AN U

Section

RI PT

JARS, TIDieR and Conn reporting lists apply.

allocation,” “randomized,” or “randomly assigned”). In the abstract,

abstract

description of the experimental treatment, comparator, care providers,

Introduction 2

Scientific background and explanation of rationale.

3

Eligibility criteria for participants and the settings and locations where

Methods

2

3-8

5, 7

22, 23,

AC C

Participants

EP

Background

TE D

centers, and blinding status.

Interventions

4

the data were collected. When applicable, eligibility criteria for centers

25, 26,

and those performing the interventions.

37-39

Precise details of the interventions intended for each group and how

1a, 1b,

3, 4, 6-8

9-21

ACCEPTED MANUSCRIPT

and when they were actually administered. Precise details of both the

1d-f

4A

RI PT

experimental treatment and comparator. Description of the different components of the interventions and, when

1a

4, 9

9-21

1g

11

33

12

39

applicable, descriptions of the procedure for tailoring the interventions

SC

to individual participants.

Details of how the interventions were standardized.

4C

Details of how adherence of care providers with the protocol was assessed or enhanced.

M AN U

4B

5

Specific objectives and hypotheses.

Outcomes

6

Clearly defined primary and secondary outcome measures and, when

TE D

Objectives

applicable, any methods used to enhance the quality of measurements

7

How sample size was determined and, when applicable, explanation of

AC C

Sample size

EP

(e.g., multiple observations, training of assessors).

any interim analyses and stopping rules. When applicable, details of whether and how the clustering by care providers or centers was addressed.

2

ACCEPTED MANUSCRIPT

Randomization-

8

Method used to generate the random allocation sequence, including details of any restriction (e.g., blocking, stratification). When

generation

applicable, how care providers were allocated to each trial group.

Allocation

9

Method used to implement the random allocation sequence (e.g.,

numbered containers or central telephone), clarifying whether the

SC

concealment

RI PT

sequence

Implementation

10

M AN U

sequence was concealed until interventions were assigned.

Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups.

11A

(masking)

Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment.

TE D

Blinding

Whether or not those administering co-interventions were blinded to

If blinded, method of blinding and description of the similarity of

AC C

11B

EP

group assignment.

interventions Statistical methods

12

Statistical methods used to compare groups for primary outcome(s); methods for additional analyses, such as subgroup analyses and

7

ACCEPTED MANUSCRIPT

adjusted analyses. When applicable, details of whether and how the

RI PT

clustering by care providers or centers was addressed. Results Participant flow

13

Flow of participants through each stage (a diagram is strongly

1c3, 3, 4

SC

recommended)—specifically, for each group, report the numbers of

M AN U

participants randomly assigned, receiving intended treatment, completing the study protocol, and analyzed for the primary outcome; describe protocol deviations from study as planned, together with reasons. The number of care providers or centers performing the

TE D

intervention in each group and the number of patients treated by each care provider or in each center.

Details of the experimental treatment and comparator as they were

intervention

item. implemented.

EP

New

AC C

Implementation of

Recruitment

14

Dates defining the periods of recruitment and follow-up.

Baseline data

15

Baseline demographic and clinical characteristics of each group. When applicable, a description of care providers (case volume, qualification,

5

1c1, 6

10

35, 36

ACCEPTED MANUSCRIPT

expertise, etc.) and centers (volume) in each group. 16

Number of participants (denominator) in each group included in each

RI PT

Numbers analyzed

analysis and whether analysis was by “intention-to-treat”; state the results in absolute numbers when feasible (e.g., 10/20, not 50%).

estimation

For each primary and secondary outcome, a summary of results for

SC

17

each group and the estimated effect size and its precision (e.g., 95%

M AN U

Outcomes and

confidence interval). Ancillary analyses

18

Address multiplicity by reporting any other analyses performed,

TE D

including subgroup analyses and adjusted analyses, indicating those prespecified and those exploratory

All important adverse events or side effects in each intervention group.

20

Interpretation of the results, taking into account study hypotheses,

Discussion Interpretation

EP

19

AC C

Adverse events

sources of potential bias or imprecision, and the dangers associated with multiplicity of analyses and outcomes. In addition, take into account the choice of the comparator, lack of or partial blinding, and

8

9, 10

ACCEPTED MANUSCRIPT

Generalizability

21

RI PT

unequal expertise of care providers or centers in each group.

Generalizability (external validity) of the trial findings.

11, 12

SC

Generalizability (external validity) of the trial findings according to

the intervention, comparators, patients, and care providers and centers

Overall evidence

22

M AN U

involved in the trial.

General interpretation of the results in the context of current evidence.

TE D

Note: Descriptions in italics are part of the CONSORT-NPT Checklist; the remainder is part of the original (“standard”) CONSORT checklist. Reproduced, with permission, from Isabelle Boutron, et al. “Extending the CONSORT Statement to Randomized Trials of

AC C

EP

Nonpharmacologic Treatment: Explanation and Elaboration”. Ann Intern Med. 2008 148:295-309.

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Table 2. JARS reporting standards for studies with an experimental manipulation or intervention Paper section and

RI PT

Item number and description topic METHOD

1. Details of the interventions or experimental manipulations intended for each study condition,

SC

Experimental

including control groups, and how and when manipulations or interventions were actually

interventions

administered, specifically including:

M AN U

manipulations or

a. Content of the interventions or specific experimental manipulations 1. Summary or paraphrasing of instructions, unless they are unusual or compose the experimental

TE D

manipulation, in which case they may be presented verbatim b. Method of intervention or manipulation delivery

EP

1. Description of apparatus and materials used and their function in the experiment

AC C

a. Specialized equipment by model and supplier c. Deliverer: who delivered the manipulations or interventions 1. Level of professional training 2. Level of training in specific interventions or manipulations

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3. Number of deliverers and, in the case of interventions, the M, SD, and range of number of

RI PT

individuals/units treated by each d. Setting: where the manipulations or interventions occurred

e. Exposure quantity and duration: how many sessions, episodes, or events intended to be delivered, how

SC

long they were intended to last

M AN U

f. Time span: how long it took to deliver the intervention or manipulation to each unit g. Activities to increase compliance or adherence (e.g., incentives) h. Use of language other than English and the translation method 2. Unit of delivery: How participants were grouped during delivery

and analysis

a. Description of the smallest unit that was analyzed (and in the case of experiments, that was randomly

TE D

Units of delivery

classes)

EP

assigned to conditions) to assess manipulation or intervention effects (e.g., individuals, work groups,

AC C

b. If the unit of analysis differed from the unit of delivery, description of the analytical method used to account for this (e.g., adjusting the standard error estimates by the design effect or using multilevel analysis) RESULTS

ACCEPTED MANUSCRIPT

Participant flow

3. Total number of groups (if intervention was administered at the group level) and the number of

RI PT

participants assigned to each group: a. Number of participants who did not complete the experiment or crossed over to other conditions, explain

b. Number of participants used in primary analyses

SC

why

M AN U

4. Flow of participants through each stage of the study

5. Evidence on whether the treatment was delivered as intended

Baseline data

6. Baseline demographic and clinical characteristics of each group

Statistics and data

7. Whether the analysis was by intent-to-treat, complier average causal effect, other or multiple ways

and side effects DISCUSSION

8. All important adverse events or side effects in each intervention group

EP

Adverse events

9. Discussion of results taking into account the mechanism by which the manipulation or intervention

AC C

analysis

TE D

Treatment fidelity

was intended to work (causal pathways) or alternative mechanisms 10. If an intervention is involved, discussion of the success of and barriers to implementing the intervention, fidelity of implementation

ACCEPTED MANUSCRIPT

11. Generalizability (external validity) of the findings, taking into account:

b. How, what outcomes were measured c. Length of follow-up

SC

d. Incentives

RI PT

a. The characteristics of the intervention

M AN U

e. Compliance rates

12. The “clinical or practical significance” of outcomes and the basis for these interpretations

TE D

Note: Reproduced, with permission, from APA Publications and Communications Board Working Group on Journal Article Reporting Standards “Reporting Standards for Research in Psychology: Why Do We Need Them? What Might They Be?” Am Psychol.

AC C

EP

2008;63(9):839-851. Numbering has been added.

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Table 3. Western Journal of Nursing Research checklist for reporting of interventions

Person(s) responsible for developing original intervention with full citation to publications/sources

intervention

Conceptual framework

2

Description of modifications to previously developed intervention

3

Conceptual framework name and/or description

4

Developer of conceptual framework, if applicable (cite original sources over secondary

on which intervention is based

RI PT

1

Examples of details to include

SC

Previously developed

Item

M AN U

Component

sources)

Modifications to the original conceptual framework for this project

6

Specific links between conceptual model key constructs and intervention attributes

7

Any conceptual framework suggested intervention components not included in the tested

EP

TE D

5

8

AC C

intervention

Conceptual model-specific mediating constructs or moderating variables measured in this study

Intervention

9

Specific details of what treatment subjects’ received when they received the intervention

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components

10

Descriptive information about any materials provided to subjects, for example, readability of

11

RI PT

print content Nonspecific intervention components, that is, intervention active factors/components that are not specified or suggested by the conceptual framework that differ between treatment and

“Common” factors, that is, those usually found in most nursing intervention studies such as

M AN U

12

SC

control subjects

therapeutic relationships that differ between treatment and control subjects 13

Any intervention or attention provided to control or comparison subjects to clarify active components of the intervention

14

Provide rationale and description of delivery timing

delivery

15

Identify if the intervention was delivered in relationship to some index event such as

TE D

Timing of intervention

16 17 18 19

Total number of doses

AC C

Intervention dose

EP

following medical procedure or diagnosis

Strength of dose, that is, the amount/volume/duration per individual dose Dose frequency, that is, time elapsed between doses Treatment duration, that is, minutes, hours, days, weeks, or months over which the entire

ACCEPTED MANUSCRIPT

intervention was delivered

21

Mediated, for example, telephone, surface mail, email, Internet, DVD

22

Target: person or social unit (e.g., family) that will be potentially affected by the

RI PT

Face-to-face

intervention

recipient 23

SC

Intervention target and

20

Recipient: individuals who receive the intervention; interventions often are delivered

M AN U

Mode of delivery

directly to patients, but in some cases health care providers or families receive an intervention intended to benefit someone besides the recipient Description of any compensation such as gifts or honoraria intervention targets/recipients

TE D

24

receive to participate in the study 25

Physical setting: for example, home, diabetes clinic, inpatient hospital room

26

Social setting: individual, family, researcher formed groups or existing groups such as

EP

Delivery setting

27

AC C

coworkers or church members Researcher-created groups should include information on group size and how groups were

formed

Cultural relevance

28

Recruitment strategies to attract individuals from specific cultural/ethnic groups that might

ACCEPTED MANUSCRIPT

influence sample responsiveness to the intervention Indication of shared ethnicity/cultural traits between interventionists and target group

30

Literature used to design culturally relevant interventions

31

Participation of target group in intervention development, for example, focus groups during

RI PT

29

Description of culturally relevant aspects of intervention, for example, patient education in

M AN U

32

SC

design phase

participants’ native language Intervention variations

33

Standardized interventions identical for all participants

34

Interventions with planned variations: a. Targeted interventions, that is, interventions matched to group characteristics, such as

EP

different interventions for women vs. men b. Tailored interventions, that is, interventions matched to individual characteristics

AC C

individual attributes

TE D

related to group or

b1. Basis of tailoring b2. Decision points for tailoring b3. Strategies to ensure content validity

ACCEPTED MANUSCRIPT

36

Discussion of unplanned deviations in content and dose

37

Personal attributes relevant to the study such as age, gender, ethnicity

38

Professional attributes, including profession, credentials, and formal education

39

Intervention delivery competence

M AN U

a. Interventionist training

RI PT

Discussion of treatment fidelity

SC

Interventionist

35

b. Verification of competency

Note: Reproduced, with permission, from Conn VS “Unpacking the black box: countering the problem of inadequate

AC C

EP

TE D

intervention descriptions in research reports.” West J Nurs Res. 2012;34(4):427-433. Numbering has been added.

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Table 4. TIDieR reporting checklist for intervention studies Item Description

RI PT

Mnemonic

1

Provide the name or a phrase that describes the intervention.

Why

2

Describe any rationale, theory, or goal of the elements essential to the intervention.

What

3

Materials: Describe any physical or informational materials used in the intervention, including those provided

SC

Brief name

M AN U

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). What

4

Procedures: Describe each of the procedures, activities, and/or processes used in the intervention, including

5

provided How

For each category of intervention provider (e.g. psychologist, nursing assistant), describe their expertise, background and any specific training given.

6

Describe the modes of delivery (e.g. face-to-face or by some other mechanism, such as internet or telephone)

EP

Who

TE D

any enabling or support activities.

Where

7

AC C

of the intervention and whether it was provided individually or in a group. Describe the type(s) of location(s) where the intervention occurred, including any necessary infrastructure or relevant features. When and

8

Describe the number of times the intervention was delivered and over what period of time including the

ACCEPTED MANUSCRIPT

Tailoring

number of sessions, their schedule, and their duration, intensity or dose. 9

If the intervention was planned to be personalised, titrated or adapted, then describe what, why, when, and

RI PT

how much

how. Modifications

10

If the intervention was modified during the course of the study, describe the changes (what, why, when, and

11

planned How well:

used to maintain or improve fidelity, describe them. 12

If intervention adherence or fidelity was assessed, describe the extent to which the intervention was delivered as planned.

TE D

actual

If intervention adherence or fidelity was assessed, describe how and by whom, and if any strategies were

M AN U

How well:

SC

how).

Note: Reproduced, with permission, from Hoffman TC et al. “Better reporting of interventions: template for intervention description

AC C

EP

and replication (TIDieR) checklist and guide.” BMJ. 2014;348:g1687.

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Factor C

Factor D

Mechanism of Action

Object (

Target1

Target2)

Enablement/Disablement theory: direct and indirect effects (positive or negative, at a “higher or “lower” level) of changes in one aspect of a patient’s functioning

SC

Ingredient(s)

Factor B

RI PT

Treatment Theory: (hypothesized) linkages between components of the tripartite structure

Factor A

TE D

M AN U

Processes by which the essential ingredients induce change in the object of treatment

AC C

EP

Observable measurable actions, chemicals, devices, or forms of energy that are selected or delivered by the clinician. Includes active ingredients that are considered essential (defining a particular treatment and distinguishing it from other treatments) as well as other active ingredients that moderate treatment effects but may be common to multiple treatments. Appended to ingredient codes there may be optional codes to designate: 1. skill/cognitive-affective representation domain 2. deficit being compensated by AT, etc. 3. exercises assigned in “homework”

Measurable aspects of the treatment recipient’s functioning or personal factors that are predicted to be DIRECTLY changed by the treatment and are functionally relevant. Objects are grouped in four domains: 1. structural tissue properties 2. organ functions 3. skilled performances 4. cognitive/affective representations