Consideration of treatment fidelity to improve manual therapy research

Karas, Steve; Plankis, L.

doi:10.1080/10669817.2015.1135555

Cited by 10 publications

(11 citation statements)

References 41 publications

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“…Third, adherence to psychological therapy and medication and fidelity to CBCM were suboptimal. These challenges are common in psychotherapy trials . The very low adherence to fluoxetine (26.8%) led to insufficient power, though its timing (6 months postbaseline) may have been too delayed to protect against transition to psychosis .…”

Section: Discussionmentioning

confidence: 99%

A Sequential Adaptive Intervention Strategy Targeting Remission and Functional Recovery in Young People at Ultrahigh Risk of Psychosis

McGorry,

Mei,

Amminger

et al. 2023

JAMA Psychiatry

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ImportanceClinical trials have not established the optimal type, sequence, and duration of interventions for people at ultrahigh risk of psychosis.ObjectiveTo determine the effectiveness of a sequential and adaptive intervention strategy for individuals at ultrahigh risk of psychosis.Design, Setting, and ParticipantsThe Staged Treatment in Early Psychosis (STEP) sequential multiple assignment randomized trial took place within the clinical program at Orygen, Melbourne, Australia. Individuals aged 12 to 25 years who were seeking treatment and met criteria for ultrahigh risk of psychosis according to the Comprehensive Assessment of At-Risk Mental States were recruited between April 2016 and January 2019. Of 1343 individuals considered, 342 were recruited.InterventionsStep 1: 6 weeks of support and problem solving (SPS); step 2: 20 weeks of cognitive-behavioral case management (CBCM) vs SPS; and step 3: 26 weeks of CBCM with fluoxetine vs CBCM with placebo with an embedded fast-fail option of ω-3 fatty acids or low-dose antipsychotic medication. Individuals who did not remit progressed through these steps; those who remitted received SPS or monitoring for up to 12 months.Main Outcomes and MeasuresGlobal Functioning: Social and Role scales (primary outcome), Brief Psychiatric Rating Scale, Scale for the Assessment of Negative Symptoms, Montgomery-Åsberg Depression Rating Scale, quality of life, transition to psychosis, and remission and relapse rates.ResultsThe sample comprised 342 participants (198 female; mean [SD] age, 17.7 [3.1] years). Remission rates, reflecting sustained symptomatic and functional improvement, were 8.5%, 10.3%, and 11.4% at steps 1, 2, and 3, respectively. A total of 27.2% met remission criteria at any step. Relapse rates among those who remitted did not significantly differ between SPS and monitoring (step 1: 65.1% vs 58.3%; step 2: 37.7% vs 47.5%). There was no significant difference in functioning, symptoms, and transition rates between SPS and CBCM and between CBCM with fluoxetine and CBCM with placebo. Twelve-month transition rates to psychosis were 13.5% (entire sample), 3.3% (those who ever remitted), and 17.4% (those with no remission).Conclusions and RelevanceIn this sequential multiple assignment randomized trial, transition rates to psychosis were moderate, and remission rates were lower than expected, partly reflecting the ambitious criteria set and challenges with real-world treatment fidelity and adherence. While all groups showed mild to moderate functional and symptomatic improvement, this was typically short of remission. While further adaptive trials that address these challenges are needed, findings confirm substantial and sustained morbidity and reveal relatively poor responsiveness to existing treatments.Trial RegistrationClinicalTrials.gov Identifier: NCT02751632

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Section: Discussionmentioning

confidence: 99%

A Sequential Adaptive Intervention Strategy Targeting Remission and Functional Recovery in Young People at Ultrahigh Risk of Psychosis

McGorry,

Mei,

Amminger

et al. 2023

JAMA Psychiatry

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“…Methods to maximise treatment fidelity in RCTs for physiotherapy interventions are highly variable and often poorly reported [164,165,166,167,168,169]. The STOPS trial employed a range of evidence-based methods [170] to enhance treatment fidelity including: specification regarding the treatment program design (140 page clinical manual with full detail on all aspects of individualised treatment); 16 hours of standardised practitioner training; review of practitioner treatment and practitioner feedback during the RCT (by way of study researchers reviewing the clinical notes followed by verbal feedback and group-based monthly case reviews); and evaluation of the participant’s perspective/understanding of the treatment provided (qualitative exit interviews).…”

Section: Discussionmentioning

confidence: 99%

The Evolving Case Supporting Individualised Physiotherapy for Low Back Pain

Ford

Hahne

Surkitt

et al. 2019

JCM

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Low-back pain (LBP) is one of the most burdensome health problems in the world. Guidelines recommend simple treatments such as advice that may result in suboptimal outcomes, particularly when applied to people with complex biopsychosocial barriers to recovery. Individualised physiotherapy has the potential of being more effective for people with LBP; however, there is limited evidence supporting this approach. A series of studies supporting the mechanisms underpinning and effectiveness of the Specific Treatment of Problems of the Spine (STOPS) approach to individualised physiotherapy have been published. The clinical and research implications of these findings are presented and discussed. Treatment based on the STOPS approach should also be considered as an approach to individualised physiotherapy in people with LBP.

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“…Data regarding fidelity are currently limited, especially for SMT, but fidelity is often not reported on in related fields [ 37 ] and health researchers appear to have poor knowledge or understanding of the concept [ 38 ]. In 2016, Karas and Plankis [ 39 ] made recommendations about how treatment fidelity can be implemented in manual therapy research. Methods to this end include standardising treatment dosages (e.g., time, repetitions, grade, force), as well as interactions between researchers and participants [ 39 ].…”

Section: Main Textmentioning

confidence: 99%

Waste not, want not: call to action for spinal manipulative therapy researchers

Aspinall,

Nim,

Hartvigsen

et al. 2024

Chiropr Man Therap

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Background Research waste is defined as research outcomes with no or minimal societal benefits. It is a widespread problem in the healthcare field. Four primary sources of research waste have been defined: (1) irrelevant or low priority research questions, (2) poor design or methodology, (3) lack of publication, and (4) biased or inadequate reporting. This commentary, which was developed by a multidisciplinary group of researchers with spinal manipulative therapy (SMT) research expertise, discusses waste in SMT research and provides suggestions to improve future research. Main text This commentary examines common sources of waste in SMT research, focusing on design and methodological issues, by drawing on prior research and examples from clinical and mechanistic SMT studies. Clinical research is dominated by small studies and studies with a high risk of bias. This problem is compounded by systematic reviews that pool heterogenous data from varying populations, settings, and application of SMT. Research focusing on the mechanisms of SMT often fails to address the clinical relevance of mechanisms, relies on very short follow-up periods, and has inadequate control for contextual factors. Conclusions This call to action is directed to researchers in the field of SMT. It is critical that the SMT research community act to improve the way research is designed, conducted, and disseminated. We present specific key action points and resources, which should enhance the quality and usefulness of future SMT research.

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Consideration of treatment fidelity to improve manual therapy research

Cited by 10 publications

References 41 publications

A Sequential Adaptive Intervention Strategy Targeting Remission and Functional Recovery in Young People at Ultrahigh Risk of Psychosis

A Sequential Adaptive Intervention Strategy Targeting Remission and Functional Recovery in Young People at Ultrahigh Risk of Psychosis

The Evolving Case Supporting Individualised Physiotherapy for Low Back Pain

Waste not, want not: call to action for spinal manipulative therapy researchers

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