CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update etc.

[Dolphin]

These are the guidelines about how you should report randomised controlled trials.

Most of us here won't be reporting on our own trials but it can be interesting to read how trials should be reported and hence how trials shouldn't be reported.


Free full text: http://annals.org/aim/article/26332...ogic-treatments-2017-update-consort-extension

Ann Intern Med. 2017 Jul 4;167(1):40-47. doi: 10.7326/M17-0046. Epub 2017 Jun 20.
CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts.
Boutron I1, Altman DG1, Moher D1, Schulz KF1, Ravaud P1; CONSORT NPT Group.
Author information

Abstract

Incomplete and inadequate reporting is an avoidable waste that reduces the usefulness of research.

The CONSORT (Consolidated Standards of Reporting Trials) Statement is an evidence-based reporting guideline that aims to improve research transparency and reduce waste.

In 2008, the CONSORT Group developed an extension to the original statement that addressed methodological issues specific to trials of nonpharmacologic treatments (NPTs), such as surgery, rehabilitation, or psychotherapy.

This article describes an update of that extension and presents an extension for reporting abstracts of NPT trials.

To develop these materials, the authors reviewed pertinent literature published up to July 2016; surveyed authors of NPT trials; and conducted a consensus meeting with editors, trialists, and methodologists.

Changes to the CONSORT Statement extension for NPT trials include wording modifications to improve readers' understanding and the addition of 3 new items.

These items address whether and how adherence of participants to interventions is assessed or enhanced, description of attempts to limit bias if blinding is not possible, and specification of the delay between randomization and initiation of the intervention.

The CONSORT extension for abstracts of NPT trials includes 2 new items that were not specified in the original CONSORT Statement for abstracts.

The first addresses reporting of eligibility criteria for centers where the intervention is performed and for care providers.

The second addresses reporting of important changes to the intervention versus what was planned.

Both the updated CONSORT extension for NPT trials and the CONSORT extension for NPT trial abstracts should help authors, editors, and peer reviewers improve the transparency of NPT trial reports.

PMID: 28630973

DOI: 10.7326/M17-0046
[Indexed for MEDLINE]

 

[Dolphin]

Updating the CONSORT NPT Extension

[..]

Items 11a and 11b, related to blinding, were modified because they were incorporated into the 2010 CONSORT Statement. Three new items were added to account for the difficulties in replicating NPTs, the frequent lack of blinding, and the risk for a differential delay between randomization and initiation of the intervention. These items are dedicated to whether and how adherence of participants to interventions is assessed or enhanced (item 5d), the description of any attempts to limit bias if blinding is not possible (item 11c), and the delay between randomization and initiation of the intervention (item 13c).

Specific Methodological Issues Considered in the Update to the CONSORT NPT Extension

Complexity of NPTs. Nonpharmacologic treatments frequently involve multicomponent interventions delivered by multiple care providers, and each component or provider may influence the success of the overall intervention (20). Nonpharmacologic treatments are difficult to describe and standardize, and the “active ingredients” are sometimes difficult to disentangle (21). Furthermore, the intervention that is actually administered may differ substantially from the one that was planned.

To account for these issues, the updated CONSORT NPT extension recommends providing a description of the components of the intervention and, when applicable, a description of the procedure for tailoring the intervention to individual participants (item 5a) in the methods section. We also recommend describing whether and how the interventions were standardized (item 5b), whether and how adherence of care providers to the protocol was assessed or enhanced (item 5c), and whether and how adherence of participants to interventions was assessed or enhanced (item 5d).

Adherence has not been discussed in some ME/CFS trials. I think it may have improved in recent years, though it is often simply how many appointments a participant attended. Sometimes therapists are asked to rate the adherence of participants to the intervention. But detailed examination and reporting of exercise logs for example doesn't usually if ever get mentioned.

 

[Dolphin]

Difficulties of Blinding.

Blinding of patients and care providers is frequently impossible in trials assessing NPTs and often relies on complex methods when it is possible (9, 31). Some of these methods rely on blinding other care providers who do not perform the intervention but who will care for the patients after the intervention. To account for this, item 11a was modified slightly.

If blinding is not possible in a trial, the updated CONSORT NPT extension recommends reporting this information explicitly and providing a description of any attempts to limit bias, such as collection of data by an independent researcher (item 11c). Furthermore, the authors are advised to discuss the limitations related to the lack of blinding when relevant (item 20).

A lack of blinding in a lot of ME/CFS trials rarely gets mentioned. Also blinded assessors are rarely used as I recall.

 

[Dolphin]

Finally, the updated checklist is consistent with reporting guidelines that were developed after publication of the 2008 CONSORT extension for NPTs, particularly the TIDieR checklist for better reporting of interventions (22).

22. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: Template for Intervention Description and Replication (TIDieR) checklist and guide. BMJ. 2014; 348:g1687. [PMID: 24609605] doi:10.1136/bmj.g1687

I'm not sure I was previously aware of this TIDieR checklist.

 

[Dolphin]

We hope the 2017 update of the CONSORT NPT extension improves the reporting of RCTs. The guidelines are not intended to deter authors from publishing imperfect trials—the perfect trial being difficult to achieve—but to ensure transparency and a coherent approach to testing and reporting trials of complex interventions.

I would also add that just because a paper adheres well to the CONSORT guidelines, doesn't mean that the results of the trial itself are necessarily very strong. For example an nonblinded trial based solely on subjective outcome measures could adhere well to CONSORT guidelines.

 

[Dolphin]

Appendix Table 3. Extended CONSORT Checklist of Information to Include When Reporting RCTs Assessing NPTs, With

Examples for 2 Types of Interventions*
CONSORT Item and Extension for NPT Trials Examples for RCTs

Assessing Participative Interventions†

Item 5d
Details of whether and how adherence of participants to interventions was assessed or enhanced

Participative interventions:

“Therapists detailed the content of all treatment sessions in a standardised log book and clinical records. Every therapist received at least one quality-control assessment per intervention type, and all records were reviewed to ascertain attendance and for documentary evidence of assessment, and of progression or regression of exercises. We defined patient compliance with the intervention as attendance at all face-to-face sessions with the therapist. Participants kept a diary record of exercise completion.” (50)

“Treatment fidelity was facilitated through standardized training, manuals of operation, and clinical documentation forms that were monitored weekly by research staff.” (54)

 

[Dolphin]

I'm not sure how much this point relates to CONSORT but it is interesting to hear talk of "patient preferences". This is something that tends to be neglected in systems offering CBT and GET for ME/CFS. Discussing "patient preferences" might be a way to challenge the offering of CBT and GET and basically nothing else.

Item 5a
Description of the different components of the interventions and, when applicable, description of the procedure for tailoring
the interventions to individual participants

“The intervention protocols were developed and tested in previous pilot studies. Both interventions were intended to be pragmatic in nature (for example, modified to patient presentation and needs) and were informed by commonly recommended clinical practices, patient preferences, and promising research evidence.” (54)

 

[Dolphin]

Nothing particularly amazingly new here but I find it interesting to hear examples of how blinding is dealt with

Blinding Item 11a

Standard CONSORT description

If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how

Extension for NPT trials

If done, who was blinded after assignment to interventions (for example, participants, care providers, those administering co-interventions, those assessing outcomes) and how

Surgery and procedures: “The operating surgeon could not be blind in the trial and, as the Kirschner wires protrude on the back of the wrist and the locking plate require an incision, nor could the patient. All staff involved in checking, entering, and analysing questionnaire responses, however, were blind to allocation” (67)

Participative interventions:

“Participants were blinded to trial hypothesis. They were informed that the study aimed to compare two computer-assisted interventions in patients admitted to EDs, but they were not informed of all the research hypotheses. Furthermore, to limit bias, the data collection was standardized and performed by phone by independent and trained research assistants, who were blinded to the treatment allocation.” (68)

“Using the standard double-blinding procedures employed in medication research is not feasible or desirable in psychotherapy research. Therapists need to be aware of which treatment they are delivering, and patients need to know as well. Blinded assessment is the gold standard in psychotherapy trials. Using centralized phone assessment for the primary outcome in this trial enhances blinding because assessors are not physically located where patients are receiving treatment, which offers an additional layer of protection from accidental unblinding. For secondary outcomes, the Site Coordinator collects patient self-report questionnaires by providing folders containing the questionnaire measures to participants and then collecting these folders from participants after completion.” (66)

Item 11c
Extension for NPT trials If blinding was not possible, description of any attempts to limit bias

Surgery and procedures:

“A blinded health professional performed outcome assessments at the primary end point (6 months). Before assessments, opaque ankle bandages were applied to obscure the ankle. (. . .) The assessments at 6 weeks were not blinded because the assessor needed knowledge of postoperative instructions for weight bearing and movement. It was not possible to mask the surgeons or participants because of the nature of the interventions, nor was it possible to mask the radiograph assessors.” (52)

Participative interventions:

“Blinding was not feasible in this study. However, independent research staff rather than the treating physician performed outcome assessments.” (69)

 

[Dolphin]

I find it interesting to see these issues discussed.

Appendix Table 5.

Allocation of Care Providers to Each Trial Group Allocation Across Group

In NPT trials where care providers could perform the intervention in both groups, the allocation of care providers to each trial group raises specific issues. Several situations are possible, all having advantages and drawbacks.

Care providers deliver the intervention in both groups. In this situation, care providers may have to administer an intervention they are less confident with or expert in. Consequently, there is a risk for:

Low adherence to the protocol

Contamination (i.e., participants randomly assigned in 1 group inadvertently receive the intervention [or some component of the intervention] that is allocated to the other group) (82). Contamination may underestimate treatment effect estimates and reduce the study power.

Differential expertise bias (i.e., a disproportionate number of patients treated by an expert care provider in 1 group compared with the other group).

Care providers could be randomly assigned to perform the intervention in 1 group.

Care providers may be randomly assigned to an intervention they are not expert in or are less committed to. This situation would increase the risk for low adherence and contamination.

Care providers could perform only the intervention they prefer or are expert in. Such choice is also called an “expertise-based randomized controlled trial” (83, 84). This design has several advantages. It should reduce the risk for contamination, take into account the learning curve and avoid the risk for differential expertise bias, and facilitate participation of care providers and patients. However, it also raises feasibility issues and questions the applicability of the trial results (85, 86).

Allocation Within Group

In some NPT trials, the care providers can perform the intervention in only 1 group (e.g., surgery vs. drug or surgery vs. physiotherapy). The allocation of care providers within groups is frequently determined by logistical considerations. However, in some situations, care providers could be randomly assigned among a pool of eligible care providers.

NPT = nonpharmacologic treatment.