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Chiropractor interaction and treatment equivalence in a pilot randomized controlled trial: an observational analysis of clinical encounter video-recordings.

Salsbury SA, DeVocht JW, Hondras MA, Seidman MB, Stanford CM, Goertz CM - Chiropr Man Therap (2014)

Bottom Line: Chiropractic care is a complex health intervention composed of both treatment effects and non-specific, or placebo, effects.Active participants received more directions (63 vs. 58) and adjusting instrument thrusts (41.5 vs. 23) in the procedural domain and more optimistic (2.5 vs. 0) or neutral (7.5 vs. 5) outcome statements in the treatment effectiveness domain.Following the first treatment, 82% of active and 11% of sham participants correctly identified their treatment group.

View Article: PubMed Central - PubMed

Affiliation: Palmer College of Chiropractic, Palmer Center for Chiropractic Research, 741 Brady Street, Davenport, IA 52803 USA.

ABSTRACT

Background: Chiropractic care is a complex health intervention composed of both treatment effects and non-specific, or placebo, effects. While doctor-patient interactions are a component of the non-specific effects of chiropractic, these effects are not evaluated in most clinical trials. This study aimed to: 1) develop an instrument to assess practitioner-patient interactions; 2) determine the equivalence of a chiropractor's verbal interactions and treatment delivery for participants allocated to active or sham chiropractic groups; and 3) describe the perceptions of a treatment-masked evaluator and study participants regarding treatment group assignment.

Methods: We conducted an observational analysis of digital video-recordings derived from study visits conducted during a pilot randomized trial of conservative therapies for temporomandibular pain. A theory-based, iterative process developed the 13-item Chiropractor Interaction and Treatment Equivalence Instrument. A trained evaluator masked to treatment assignment coded video-recordings of clinical encounters between one chiropractor and multiple visits of 26 participants allocated to active or sham chiropractic treatment groups. Non-parametric statistics were calculated.

Results: The trial ran from January 2010 to October 2011. We analyzed 111 complete video-recordings (54 active, 57 sham). Chiropractor interactions differed between the treatment groups in 7 categories. Active participants received more interactions with clinical information (8 vs. 4) or explanations (3.5 vs. 1) than sham participants within the therapeutic domain. Active participants received more directions (63 vs. 58) and adjusting instrument thrusts (41.5 vs. 23) in the procedural domain and more optimistic (2.5 vs. 0) or neutral (7.5 vs. 5) outcome statements in the treatment effectiveness domain. Active participants recorded longer visit durations (13.5 vs. 10 minutes). The evaluator correctly identified 61% of active care video-recordings as active treatments but categorized only 31% of the sham treatments correctly. Following the first treatment, 82% of active and 11% of sham participants correctly identified their treatment group. At 2-months, 93% of active and 42% of sham participants correctly identified their group assignment.

Conclusions: Our findings show the feasibility of evaluating doctor-patient interactions in chiropractic clinical trials using video-recordings and standardized instrumentation. Clinical trial design and clinician training protocols should improve and assess the equivalence of doctor-patient interactions between treatment groups.

Trial registration: This trial was registered in ClinicalTrials.gov as NCT01021306 on 24 November 2009.

No MeSH data available.


Chiropractor Interaction and Treatment Equivalence Instrument (CITE-I).
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Related In: Results  -  Collection

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Fig1: Chiropractor Interaction and Treatment Equivalence Instrument (CITE-I).

Mentions: The team members reviewed and accepted the Chiropractor Interaction and Treatment Equivalence Instrument (CITE-I) for use in the interaction equivalence study. This version of the CITE-I included 5 domains with 13 variables. The affective domain consisted of 2 socio-emotional variables [49,54] categorizing the clinician’s verbal interactions as social/humor or name use. The therapeutic domain included 3 instrumental variables [49,54]: clinical information, explanations, and logistics. The procedural domain consisted of 3 variables addressing treatment implementation and fidelity [55] including adherence, delivery, and dose: directions, cautions, and Activator clicks, or the sound produced by the adjusting instrument. The treatment effectiveness domain categorized optimistic, pessimistic and neutral statements about health or treatment outcomes [31]. Lastly, the encounter context domain tabulated the duration of the treatment encounter as an additional measure of dose, as well as any unclear statements made by the clinician that the video evaluator could not definitively place into another category. The CITE-I also included a field to denote how much of the participant’s body position was on the video and a notes field to record additional details of the interaction context, blinding issues, etc. The final item on the CITE-I asks the video evaluator to denote which study treatment he believed the participant to have received (active, placebo/sham or not sure). Figure 1 presents the CITE-I instrument including variable definitions and examples.Figure 1


Chiropractor interaction and treatment equivalence in a pilot randomized controlled trial: an observational analysis of clinical encounter video-recordings.

Salsbury SA, DeVocht JW, Hondras MA, Seidman MB, Stanford CM, Goertz CM - Chiropr Man Therap (2014)

Chiropractor Interaction and Treatment Equivalence Instrument (CITE-I).
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4255952&req=5

Fig1: Chiropractor Interaction and Treatment Equivalence Instrument (CITE-I).
Mentions: The team members reviewed and accepted the Chiropractor Interaction and Treatment Equivalence Instrument (CITE-I) for use in the interaction equivalence study. This version of the CITE-I included 5 domains with 13 variables. The affective domain consisted of 2 socio-emotional variables [49,54] categorizing the clinician’s verbal interactions as social/humor or name use. The therapeutic domain included 3 instrumental variables [49,54]: clinical information, explanations, and logistics. The procedural domain consisted of 3 variables addressing treatment implementation and fidelity [55] including adherence, delivery, and dose: directions, cautions, and Activator clicks, or the sound produced by the adjusting instrument. The treatment effectiveness domain categorized optimistic, pessimistic and neutral statements about health or treatment outcomes [31]. Lastly, the encounter context domain tabulated the duration of the treatment encounter as an additional measure of dose, as well as any unclear statements made by the clinician that the video evaluator could not definitively place into another category. The CITE-I also included a field to denote how much of the participant’s body position was on the video and a notes field to record additional details of the interaction context, blinding issues, etc. The final item on the CITE-I asks the video evaluator to denote which study treatment he believed the participant to have received (active, placebo/sham or not sure). Figure 1 presents the CITE-I instrument including variable definitions and examples.Figure 1

Bottom Line: Chiropractic care is a complex health intervention composed of both treatment effects and non-specific, or placebo, effects.Active participants received more directions (63 vs. 58) and adjusting instrument thrusts (41.5 vs. 23) in the procedural domain and more optimistic (2.5 vs. 0) or neutral (7.5 vs. 5) outcome statements in the treatment effectiveness domain.Following the first treatment, 82% of active and 11% of sham participants correctly identified their treatment group.

View Article: PubMed Central - PubMed

Affiliation: Palmer College of Chiropractic, Palmer Center for Chiropractic Research, 741 Brady Street, Davenport, IA 52803 USA.

ABSTRACT

Background: Chiropractic care is a complex health intervention composed of both treatment effects and non-specific, or placebo, effects. While doctor-patient interactions are a component of the non-specific effects of chiropractic, these effects are not evaluated in most clinical trials. This study aimed to: 1) develop an instrument to assess practitioner-patient interactions; 2) determine the equivalence of a chiropractor's verbal interactions and treatment delivery for participants allocated to active or sham chiropractic groups; and 3) describe the perceptions of a treatment-masked evaluator and study participants regarding treatment group assignment.

Methods: We conducted an observational analysis of digital video-recordings derived from study visits conducted during a pilot randomized trial of conservative therapies for temporomandibular pain. A theory-based, iterative process developed the 13-item Chiropractor Interaction and Treatment Equivalence Instrument. A trained evaluator masked to treatment assignment coded video-recordings of clinical encounters between one chiropractor and multiple visits of 26 participants allocated to active or sham chiropractic treatment groups. Non-parametric statistics were calculated.

Results: The trial ran from January 2010 to October 2011. We analyzed 111 complete video-recordings (54 active, 57 sham). Chiropractor interactions differed between the treatment groups in 7 categories. Active participants received more interactions with clinical information (8 vs. 4) or explanations (3.5 vs. 1) than sham participants within the therapeutic domain. Active participants received more directions (63 vs. 58) and adjusting instrument thrusts (41.5 vs. 23) in the procedural domain and more optimistic (2.5 vs. 0) or neutral (7.5 vs. 5) outcome statements in the treatment effectiveness domain. Active participants recorded longer visit durations (13.5 vs. 10 minutes). The evaluator correctly identified 61% of active care video-recordings as active treatments but categorized only 31% of the sham treatments correctly. Following the first treatment, 82% of active and 11% of sham participants correctly identified their treatment group. At 2-months, 93% of active and 42% of sham participants correctly identified their group assignment.

Conclusions: Our findings show the feasibility of evaluating doctor-patient interactions in chiropractic clinical trials using video-recordings and standardized instrumentation. Clinical trial design and clinician training protocols should improve and assess the equivalence of doctor-patient interactions between treatment groups.

Trial registration: This trial was registered in ClinicalTrials.gov as NCT01021306 on 24 November 2009.

No MeSH data available.