Systematic Review of Primary Outcome Measurements for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) in RCTs: 2020, Do-Young Kim et al

Sly Saint

Sly Saint

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Systematic Review of Primary Outcome
Measurements for Chronic Fatigue
Syndrome/Myalgic Encephalomyelitis (CFS/ME) in
Randomized Controlled Trials

Abstract
Background: Due to its unknown etiology, the objective diagnosis and therapeutics of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) are still challenging. Generally, the patient-reported outcome (PRO) is the major strategy driving treatment response because the patient is the most important judge of whether changes are meaningful.

Methods: In order to determine the overall characteristics of the main outcome measurement applied in clinical trials for CFS/ME, we systematically surveyed the literature using two electronic databases, PubMed and the Cochrane Library, throughout June 2020. We analyzed randomized controlled trials (RCTs) for CFS/ME focusing especially on main measurements.

Results: Fifty-two RCTs out of a total 540 searched were selected according to eligibility criteria. Thirty-one RCTs (59.6%) used single primary outcome and others adapted ≥2 kinds of measurements. In total, 15 PRO-derived tools were adapted (50 RCTs; 96.2%) along with two behavioral measurements for adolescents (4 RCTs; 7.7%). The 36-item Short Form Health Survey (SF-36; 16 RCTs), Checklist Individual Strength (CIS; 14 RCTs), and Chalder Fatigue Questionnaire (CFQ; 11 RCTs) were most frequently used as the main outcomes.

Since the first RCT in 1996, Clinical Global Impression (CGI) and SF-36 have been dominantly used each in the first and following decade (26.1% and 28.6%, respectively), while both CIS and Multidimensional Fatigue Inventory (MFI) have been the preferred instruments (21.4% each) in recent years (2016 to 2020).

Conclusions: This review comprehensively provides the choice pattern of the assessment tools for interventions in RCTs for CFS/ME. Our data would be helpful practically in the design of clinical studies for CFS/ME-related therapeutic development.
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https://www.mdpi.com/2077-0383/9/11/3463

eta:
Recently, the PACE trial, a large-scale clinical study of cognitive behavior therapy (CBT) and graded-exercise therapy (GET), was reported to be effective for CFS/ME [7].

There is however a fair amount of controversy surrounding this PACE trial, likely due to the debates regarding its efficacy and criticisms by researchers and patients due to judgments of restoration as well as side effects [8].

On the other hand, the absence of objective biomarkers of CFS/ME raises a problem for the actual diagnosis of this illness. In addition, clinical evaluations of treatment responses are also dependent on self-reported assessments of symptom severity, leading to potential trouble during the investigation of new therapeutics [9]. Accordingly, methodologically well-designed tools to assess the valuable responses of treatments for CFS/ME are very important.
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Some interesting sections:
Among the 17 tools used in the 52 RCTs, only two behavioral measurements (school attendance rate and the number of steps per day) were adopted in four RCTs that enrolled only adolescent participants

Unlike the CFQ-11, the MFI and CIS adopt both positive and negative questions and measure PEM-related symptoms such as “I am tired very quickly or easily”, which is focused on as one of the recently established hallmark symptoms of CFS/ME

Most measurement tools (including CFS/ME-specific instruments) have non-CFS/ME-specific questionnaires, such as “I feel tired” or “I feel weak”, which are frequently complained of among general populations

responders to the CFQ-11 will obtain high scores due to comparisons with “usual” or “last well-state”. Because most CFS patients have experienced many years of the disease with fluctuating symptoms, assessment methods involving comparisons to “usual” can hardly reflect not only deterioration in status but also treatment response [2]. Thus, some studies have adopted a modified CFQ-11 as a 10-point Likert scale (from 0 points for healthy conditions to 9 points for the worst status) in RCTs for drug development related to CFS/ME
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