Guideline for Reporting Interventions on SMT: Reporting Criteria List
Written by Editor   
Monday, February 06, 2017 08:29 AM

News Bite:  This study represents a large group of representatives throughout the field of SMT, defines a (minimal) criteria list for reporting trials of SMT. In the end, this encompasses 24 items clustered in 5 domains. This effort represents the first guideline for reporting items to be included in trials of SMT.  A better description of SMT will make it possible for clinicians to better interpret results and determine to what extent a study may influence their clinical practice. Such a guideline also makes it possible to better interpret and compare results across trials. 

A randomized controlled trial (RCT) is considered the most robust design to study the effectiveness of treatments. Accurate reporting of RCTs is important for critical appraisal of study validity, adequate interpretation of the results, and for optimal implementation of the findings in clinical practice. In that regard, the CONsolidated Standard Of Reporting Trials Statement (CONSORT) was designed to improve the reporting of trials and has been modified for nonpharmacologic trials. A checklist to evaluate a report of a nonpharmacological trial (CLEAR NPT) was developed using consensus. 

Many RCT reports often lack crucial details about the intervention. To best interpret the results of individual studies, it is important to have more detailed information about the “who, what, when, and where” of the intervention, especially given that interventions are typically tailored to meet individual needs

Development of a criteria list for the reporting of interventions has been undertaken for a variety of conservative interventions, including acupuncture and homeopathy for musculoskeletal complaints but no item list for reporting spinal manipulative therapy (SMT) has yet been developed. Creating such a list seems essential given the fact that many different techniques are used in SMT.  The specific characteristics of the application of SMT techniques are critical to adequate interpretation of the outcomes of RCTs and make them applicable to clinical practice. Therefore, CIRCLe SMT (Consensus on Interventions Reporting Criteria List for Spinal Manipulative Therapy) aims to develop a minimum set of items for the description of SMT in RCTs by obtaining consensus via a Delphi procedure among experts in the field of SMT. 

In September 2011, the project team formed a steering committee that was responsible for the construction of the list of items, selection of participants, construction of the Delphi questionnaires, analysis of the responses of the participants, and handling the feedback from the participants after each round.

In a pilot study, participants with various clinical backgrounds were invited to evaluate these items and to formulate additional items to ensure that all potentially relevant items would be included in the initial draft of the criteria list.  To ensure content validity, a large number of international experts from different disciplines were invited to participate.

To be able to replicate the trial or implement the performed treatment in clinical practice, the fullest possible description of the underlying concepts that are the basis for the therapeutic constructs should be stated, including references to literature and to documents pertaining to the trial. This list includes:

Type of Practitioner(s)

Spinal manipulative therapy is characterized by different conceptions and styles/types. The overall styles, types, or approach on which the treatment is based should be described to contextualize the trial within the range of current clinical practices.

Years in Practice

To clarify potential variations and expertise bias and to help improve the applicability of the results, it is informative to report the years of practice of the care providers involved in the trial.

Special Training of the Practitioner(s) for the Trial

It is necessary to describe whether participating care providers received any specific training for the trial.

Settings of the SMT Intervention (eg, Primary, Secondary, Tertiary Care)

To be clinically useful, the result should be relevant to a definable group of patients in a particular clinical setting (ie, they must be externally valid). There needs to be a description of where the treatment was delivered, even if in general terms (ie, in private practices or in a hospital setting).

Standardization of the Interventions

Spinal manipulative therapy could be defined as a complex intervention, as there are several interacting components both independently and interdependently. A highly specific protocol would provide a word-for-word, session-by-session script for the therapist to follow with every patient. A flexible treatment protocol would provide a general framework within which to operate but would not constrain the selection of specific activities or topics. Both treatment protocols are possible; therefore, the treatment protocol should be adequately described.

Description of the Frequency of Treatment Sessions to Be Modified if the Protocol Allows

The planned number and frequency of treatments should be clearly documented. Deviations from the protocol during the study should be described in the Results section, including, where relevant, the reasons for this deviation.

Criteria for Tailoring the Interventions to Individual Patients

Describing the details of the process of tailoring the treatment for individual patients is necessary for enabling replication, whereby the algorithm might be done as a figure, flowchart, or a table rather than as text. It is important to use relevant standardized terminology (eg, items of our list) in the study protocol to facilitate documentation of the interventions and to determine the amount of individualization in the intervention.

Criteria for Treatments to Be Discontinued

Criteria for discontinuation of therapy should be preset. These criteria may depend on the symptoms of the patient or the complaint’s course.

Method of Assessment of Adherence to the Protocol

Assessing treatment adherence is essential to appraising the feasibility and reproducibility of the intervention in clinical practice. Therefore, the method of assessment of adherence to the protocol should be described.

Direction of Force of the Technique

The direction in which the therapist applies the force should be described using standard anatomical and biomechanical terminology.

Velocity of the Technique

The velocity should be recorded in general terms (eg, slow or fast).

Thrust Technique (Name/System)

A description of whether or not a thrust technique is used should be given (including name or system), as well as the position in which the restricted barrier is provided.

Number of Treated Motion Segments/Joints

The number of treated motion segments of the spine should be described. If the number varies among patients, the mean and range should be reported.

Number of Repetitions of the Technique

The number of repetitions of each applied technique should be mentioned by mean and range.

Level of Treated Motion Segments/Joints

When the study is on a specific level (eg, C0-C1 or L5-S1), the level should be specified with the description of how the segments were localized.

Number of Treated Regions

It is suggested that the number of treated regions, at least the subregions (eg, upper, middle, and lower cervical regions), be described.

Patient's Position

A description of the position of the patient should be included (eg, supine, prone, side-lying). This includes any prepositioning of a region of the body, such as positioning the patient in rotation or side bending.

Additional Techniques/Interventions

A clear and detailed description of all additional components, whether carried out by the practitioner or the patient, should be reported so that the factors that might be responsible for any change observed are made known. Additional techniques and interventions refer to, for example, exercises, acupuncture, auxiliary techniques, prescribed self-treatment (including medication usage), and (lifestyle) advice provided by the practitioner. These additions should be described in detail so that readers are well informed about the package of treatment. If appropriate, guidelines or recommendations on reporting of interventions or techniques should be followed, such as for exercises or acupuncture.  

Treatment Period and the Follow-up Period

Both the treatment period and the follow-up period should be clearly described.

Treatment Frequency per Week or Month

The frequency of treatment should be accurately described, for example, if participants have been treated twice a week for the first 2 weeks and then once a week for an additional 4 weeks.

Treatment Dosage

Therapy dose can be described in terms of time spent in therapy or in terms of effort expended, or both. Description of time includes minutes per session, sessions per day or week, and number of days or weeks.

Number of Treatments of the Intervention

The mean and range should be reported if there is variation among the participants. The frequency and duration of sessions should be described, with mean and range if there are differences among the participants.

Number of Care Providers Performing the Intervention

To describe the potential clustering of practitioners and centers, which is essential for accurate statistical analyses, the number of care providers for each trial arm should be documented in detail.

This is the first study to develop a criteria list for the reporting of SMT, which may to serve as an extension of the CONSORT Statement. A similar extension exists for nonpharmacologic interventions; however, a list specific to SMT is lacking.  SMT is not one entity but, rather, represents a broad description of an intervention. A better description of SMT will make it possible for clinicians to better interpret results and determine to what extent this may influence their clinical practice. Such a guideline also makes it possible to better interpret and compare results across trials. This study represents a large group of representatives throughout the field of SMT, defines a (minimal) criteria list for reporting trials of SMT. In the end, this encompasses 24 items clustered in 5 domains. This effort represents the first guideline for reporting items to be included in trials of SMT. 

Authors of clinical trials in the field of manipulation-based therapy and mobilization-based therapy should use the recommendations presented in this report, together with the items from the CONSORT Statement, with the extension for nonpharmaceutical trials. Spinal manipulative therapy is, in general, a complex intervention with a large number of interacting components. For example, the biomechanical parameters in patients may change with the patients’ physical characteristics, clinical condition, and clinical progress. Thus, each related item on the list should be described in as detailed a manner as possible.