Trials on therapist-delivered treatments (for illnesses or symptoms that don't have biomarkers yet) that used objective outcomes as primary endpoints

[Caroline Struthers]

Just parking that here -- not checked if this is on the thread about Placebos and/or in the Tack/Struthers/Tuller paper about blinding, just stumbled across that reference in Faulkner (2016) :

Kamper SJ, Apeldoorn AT, Chiarotto A, Smeets RJ, Ostelo RWJG, Guzman J & van Tulder MW (2014) Multidisciplinary biopsychosocial rehabilitation for chronic low back pain. Cochrane Database of Systematic Reviews CD000963. http://www.ncbi.nlm.nih.gov/pubmed/25180773

Faulkner (2016):

Brilliant - I will take a look at that. I could even use the same search strategy (for biopsychosocial rehab interventions) from that review to find other Cochrane reviews of biopsychosocial interventions for other conditions. Maybe there won't be that many...

 

[Midnattsol]

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[MSEsperanza]

I'm afraid there are a few more examples of trials that applied objective outcomes, but the trial design is bad for other reasons:

Sandler, C; Llloyd, A Barry, B (2016), Fatigue Exacerbation by Interval or Continuous Exercise in Chronic Fatigue Syndrome, Medicine & Science in Sports & Exercise: October 2016 - Volume 48 - Issue 10 - p 1875–1885
doi: 10.1249/MSS.0000000000000983 / https://journals.lww.com/acsm-msse/...Exacerbation_by_Interval_or_Continuous.3.aspx

A similiar study by almost the same authors: https://www.s4me.info/threads/auton...ep-after-physical-or-cognitive-challenge.239/

And another one:

Cvejic E, Lloyd AR, Vollmer-Conna U. (2016), Neurocognitive improvements after best-practice intervention for chronic fatigue syndrome: Preliminary evidence of divergence between objective indices and subjective perceptions. Comprehensive Psychiatry. 2016 Apr 30;66:166-75. https://www.sciencedirect.com/science/article/abs/pii/S0010440X15302492

 

[MSEsperanza]

Ganslev CA, Storebø OJ, Callesen HE, Ruddy R, Søgaard U. Psychosocial interventions for conversion and dissociative disorders in adults. Cochrane Database Syst Rev. 2020 Jul 17;7(7):CD005331. doi: 10.1002/14651858.CD005331.pub3. PMID: 32681745; PMCID: PMC7388313.

https://pubmed.ncbi.nlm.nih.gov/32681745/

Haven't read this meta-analysis yet, and actually don't think it fulfills the criteria of this thread's title?

It seems in the abstract they forget to say how they measured reduction in physical signs (primary endpoint) but at least they honestly acknowledged some weaknesses of the trials -- even in their conclusion.

Abstract quoted here.

Authors' conclusions: The results of the meta-analysis and reporting of single studies suggest there is lack of evidence regarding the effects of any psychosocial intervention on conversion and dissociative disorders in adults. It is not possible to draw any conclusions about potential benefits or harms from the included studies.

From the abstract: "None of the studies reported results on adverse effects. In the studies reporting on level of functioning and quality of life at end of treatment the effects ranged from small to no effect."

Forum thread here.

Am I wrong, or are scandinavian psychologists more and more critical of the doxa?

 

[rvallee]

there is lack of evidence regarding the effects of any psychosocial intervention on conversion and dissociative disorders in adults

What's even more amazing is that it's literally the "effectiveness" of "psychosocial interventions" on those conditions that is cited as evidence for why they are psychosocial, e.g. PACE is commonly cited as having "proved" that ME is psychological since a psychosocial intervention is effective. It's literally the main basis for the concept of conversion disorder, that having been shown that it's effective to treat them psychosocially, it means that they are.

But in Freudland requirements are optional, rules are meant to be broken and nothing matters.

 

[MSEsperanza]

Not a trial but perhaps useful for a confrontation both with the negligence of the issue with using subjective outcomes in (unblindable) therapist-delivered treatments and with the feasibility of using objective outcomes:

Patel KV, Amtmann D, Jensen MP, Smith SM, Veasley C, Turk DC. Clinical outcome assessment in clinical trials of chronic pain treatments. Pain Rep. 2021 Jan 21;6(1):e784. doi: 10.1097/PR9.0000000000000784. PMID: 33521482; PMCID: PMC7837993.


Abstract

Clinical outcome assessments (COAs) measure outcomes that are meaningful to patients in clinical trials and are critical for determining whether a treatment is effective.

The objectives of this study are to (1) describe the different types of COAs and provide an overview of key considerations for evaluating COAs, (2) review COAs and other outcome measures for chronic pain treatments that are recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) or other expert groups, and (3) review advances in understanding pain-related COAs that are relevant to clinical trials.

The authors reviewed relevant articles, chapters, and guidance documents from the European Medicines Agency and U.S. Food and Drug Administration. Since the original core set of outcome measures were recommended by IMMPACT 14 years ago, several new advancements and publications relevant to the measurement or interpretation of COAs for chronic pain trials have emerged, presenting new research opportunities.

Despite progress in the quality of measurement of several outcome domains for clinical trials of chronic pain, there remain some measurement challenges that require further methodological investigation.


https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7837993/

Open Access

This paper I think is interesting with regard to the discrepancy in the research on useful outcome measures for pain compared to the research on outcome measures for fatigue or even PEM.

Does not actually tackle the subjective-endpoints-alone-in-unblined-trials issue but discusses advantages and disadvantages of different types of outcome measures, and also shortcomings in reporting of adverse events.

Also has a paragraph on accelerometers.