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Introduction: The multi-system symptoms accompanying acute and post-treatment Lyme disease syndrome pose a challenge for time-limited assessment. The General Symptom Questionnaire (GSQ-30) was developed to fill the need for a brief patient-reported measure of multi-system symptom burden. In this study we assess the psychometric properties and sensi...
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Citations
... The quality of life on the SF-36 scale for individuals with persistent symptoms enrolling in an NIH trial was lower than for individuals with diabetes and heart disease. Individuals with PTLDS were worse than individuals with traumatic brain injury (TBI), depression, and Erythema Migrans (EM) using a Multi-System Symptom Burden (MSSB) Scale [10]. ...
... We used the General Symptom Questionnaire-30 (GSQ-30) [10] to contrast the symptom burden between groups. The GSQ-30 is a brief self-report scale designed to assess the MSSB in Lyme disease. ...
... The GSQ-30 is a brief self-report scale designed to assess the MSSB in Lyme disease. The MSSB is a validated measure of pain/fatigue, neuropsychiatric, neurological, and viral-like symptoms [10]. The GSQ-30 asks "How much have you been bothered by any of the following?" ...
Individuals with Lyme disease can be very symptomatic. This survey compares the burden of illness for individuals with a history of Lyme disease (HLD) with individuals with a HLD who have either contracted COVID-19 or who have taken the COVID-19 vaccine. The findings describe the relative symptom burden among these three groups using a cross-sectional descriptive survey investigating the burden of Lyme disease in a pandemic. The survey includes the General Symptom Questionnaire-30 (GSQ-30), a brief self-report scale designed to assess the symptom burden in Lyme disease (LD). The results of this survey show that the overall burden of illness among individuals with HLD is not significantly different after contracting COVID-19 or after COVID-19 vaccination. A new survey will be needed to better understand why one in five individuals with a HLD reported long COVID after contracting COVID-19. These results should help clinicians and their patients to discuss the consequences of contracting a COVID-19 infection or being vaccinated against COVID-19.
... Patients often have problems with memory and attention [31], or their sleep is affected by pain, fatigue, anxiety and other symptoms [28]. Appeal symptoms have a negative impact on their memory, emotional processing and learning [9,28], which has seriously affected the daily life of patients. ...
... We performed a meta-analysis of BDI scores in the two studies [8,16] using a random-effects model, which showed no statistically significant difference in BDI scores after treatment compared with placebo [SMD = 0.18, 95%CI (− 0.48, 0.83), P = 0.598 > 0.05]. Although studies have shown that the degree of depression of patients will increase with the aggravation of PTLD symptoms, the degree of depression of patients can hardly be alleviated with the alleviation or disappearance of symptoms due to long-term suffering [9], and the common symptoms of PTLD will lead to sleep disorders [28], which will undoubtedly bring different degrees of depression risk to patients. ...
Background
At present, the pathogenesis of post-treatment Lyme disease (PTLDS) is not clear, so the treatment scheme of PTLDS, especially antibiotic treatment, is still controversial. This study aims to evaluate the efficacy of antibiotics in the treatment of PTLDS using network meta-analysis (NMA).
Methods
Following PRISMA guidelines, a systematic literature search was conducted on randomized controlled trials in PubMed, EMBASE, Web of Science and Cochrane Library (the literature was published from database inception through December 16, 2022). Using random effect model and fixed effect model. STATA17.0 software was used to evaluate the quality and heterogeneity of the included research literature.
Results
The system included 4 randomized controlled trials (485 subjects). The network meta-analysis showed that ceftriaxone had better results than placebo [Mean = 0.87, 95% CI (0.02, 1.71)] and doxycycline [Mean = 1.01, 95% CI (0.03, 1.98)] in FSS scale scores. There was no statistical difference in FSS scale scores of other drugs after treatment. In terms of FSS score results, Ceftriaxone was the best intervention according to the SUCRA value of each treatment (97.7). The analysis of outcome indicators such as Beck Depression Inventory (BDI), Mental-health Scale and Physical-functioning scale showed that there was no statistically significant difference between the antibiotic group and placebo group.
Conclusion
Ceftriaxone treatment may be the best choice for antibiotic treatment of PTLD, which provides useful guidance for antibiotic treatment of PTLD in the future.
... Secondary outcomes were assessed at baseline, week 4, and week 8 of the study. Multisystem symptom burden over the past two weeks was assessed using the General Symptom Questionnaire-30 [47], in which a higher score indicates higher multisystem symptom burden. Depression, anxiety, sleep disturbance, physical function, and social activities over the past week were assessed using PROMIS measures, in which higher scores indicate more of the construct measured: Depression Short Form 6A v.1.0 ...
... These data suggest that the GSQ-30 should be considered in future PTLDS studies as a primary outcome to assess treatment response. While a prior validation study confirmed the sensitivity of the GSQ-30 to detect change among patients with acute Lyme disease [47], this study suggests the GSQ-30 may also be sensitive in detecting change among patients persistent symptoms after treated Lyme disease. ...
This study examined the adherence to and the potential benefit of Kundalini yoga (KY) for post-treatment Lyme disease syndrome (PTLDS). Participants were randomly assigned to 8 weeks of a KY small-group intervention or a waitlist control (WLC). Adherence was measured as attendance at KY group sessions. Primary outcomes assessed pain, pain interference, fatigue, and global health. Secondary outcomes assessed multisystem symptom burden, mood, sleep, physical and social functioning, cognition, and mindfulness. Linear mixed models were used to test changes in outcomes over time as a function of group assignment; intercepts for participants were modeled as random effects. Although the target sample size was 40 participants, the study concluded with 29 participants due to recruitment challenges. No KY participants dropped out of the study, and participants attended 75% of group sessions on average, but WLC retention was poor (57%). Regarding primary outcomes, there was no significant interaction between group and time. Regarding secondary outcomes, there was a significant interaction between group and time for multisystem symptom burden (p < 0.05) and cognition (p < 0.01); KY participants reported improved multisystem symptom burden and cognition over the course of the study compared to WLC participants. To enhance recruitment and retention, future trials may consider expanding geographic access and including supportive procedures for WLC participants. This preliminary study supports the need for a larger study to determine if KY reduces multisystem symptom burden and enhances cognition among people with PTLDS.
... The purpose of the study was explained, and they were asked to consent to a telephone questionnaire. We used a modified version of a previously validated general symptom questionnaire (GSQ-30) to assess multi-system symptom burden among patients with post-treatment Lyme disease syndrome [6]. It is easy to administer and strongly correlates with the functional impairment among patients with multisystem disease. ...
... Although the analyses and the measure differed, results from our EFA were generally consistent with those from a recent study with some participant sample overlap, which aimed to validate the General Symptom Questionnaire-30 (GSQ-30) in PTLD. 30 One noticeable difference was that fatigue loaded with the musculoskeletal pain factor in the GSQ-30 study rather than with cognitive symptoms, as it did in the current study. This suggests that fatigue in PTLD could arise from multiple sources including pain, the central nervous system, or muscle weakness. ...
... It is important to clarify that symptom severity in the current study is relative to this study sample of participants with PTLD and not the general population; we have previously shown a higher symptom burden in a subset of this sample of patients with PTLD compared with non-Lyme infected controls. 8 Similar to our previous GSQ-30 study, 30 we conclude that morbidity in this population can exist above and beyond the effects of mood-related symptoms. Indeed, in our EFA analysis an independent 'Mood-Related' factor was formed whose symptoms failed to load with other core symptoms of PTLD such as fatigue, pain and cognitive difficulty. ...
Objectives
To identify underlying subgroups with distinct symptom profiles, and to characterise and compare these subgroups across a range of demographic, clinical and psychosocial factors, within a heterogeneous group of patients with well-defined post-treatment Lyme disease (PTLD).
Design
A clinical case series of patents.
Setting
Participants were recruited from a single-site, Lyme disease referral clinic patient population and were evaluated by physical exam, clinical laboratory testing and standardised questionnaires.
Participants
Two hundred and twelve participants met study criteria for PTLD, with medical record-confirmed prior Lyme disease as well as current symptoms and functional impact.
Results
Exploratory factor analysis classified 30 self-reported symptoms into 6 factors: ‘Fatigue Cognitive’, ‘Ocular Disequilibrium’, ‘Infection-Type’, ‘Mood-Related’, ‘Musculoskeletal Pain’ and ‘Neurologic’. A final latent profile analysis was conducted using ‘Fatigue Cognitive’, ‘Musculoskeletal Pain’ and ‘Mood-Related’ factor-based scores, which produced three emergent symptom profiles, and participants were classified into corresponding subgroups with 59.0%, 18.9% and 22.2% of the sample, respectively. Compared with the other two groups, subgroup 1 had similarly low levels across all factors relative to the sample as a whole, and reported lower rates of disability (1.6% vs 10.0%, 12.8%; q=0.126, 0.035) and higher self-efficacy (median: 7.5 vs 6.0, 5.3; q=0.068,<0.001). Subgroup 2 had the highest ‘Musculoskeletal Pain’ factor-based scores (q≤0.001). Subgroup 3 was characterised overall by higher symptom factor-based scores, and reported higher depression (q≤0.001).
Conclusions
This analysis identified six symptom factors and three potentially clinically relevant subgroups among patients with well-characterised PTLD. We found that these subgroups were differentiated not only by symptom phenotype, but also by a range of other factors. This may serve as an initial step towards engaging with the symptom heterogeneity that has long been observed among patients with this condition.
... An IRB-approved clinical trial headed by Brian Fallon, M.D., M.P.H. at Columbia University's Lyme and Tick-Borne Diseases Research Center is examining disulfiram as a test of symptom reduction among patients with previously treated Lyme disease [35]. The serial laboratory assessments and serial formal patient self-rating scales such as the General Symptom Questionnaire-30 (GSQ-30) [36] in the research protocol will provide more objective results. Additional studies, including multicenter, double-blind trials with comparator drug arms using serial patients rating scales, direct detection methods, and biomarkers could provide more objective, quantifiable and robust data. ...
A total of 71 patients with Lyme disease were identified for analysis in whom treatment with disulfiram was initiated between 15 March 2017 and 15 March 2020. Four patients were lost to follow-up, leaving 67 evaluable patients. Our retrospective review found patients to fall into a “high-dose” group (≥4 mg/kg/day) and a “low-dose” group (<4 mg/kg/day). In total, 62 of 67 (92.5%) patients treated with disulfiram were able to endorse a net benefit of the treatment with regard to their symptoms. Moreover, 12 of 33 (36.4%) patients who completed one or two courses of “high-dose” therapy enjoyed an “enduring remission”, defined as remaining clinically well for ≥6 months without further anti-infective treatment. The most common adverse reactions from disulfiram treatment in the high-dose group were fatigue (66.7%), psychiatric symptoms (48.5%), peripheral neuropathy (27.3%), and mild to moderate elevation of liver enzymes (15.2%). We observed that although patients on high dose experienced a higher risk for adverse reactions than those on a low dose, high-dose patients were significantly more likely to achieve enduring remission.
... SRHS is part of the CDC Healthy Days measure as well as a survey item in the 36-Item Short Form Survey (SF-36) and is measured annually in the Behavioral Risk Factor Surveillance System (BRFSS) survey [20,21]. Both symptom severity and reported percentage of improvement from baseline illness have been used in varying forms in clinical trials of Lyme disease [17,[22][23][24]. These scales are used to measure health quality descriptively as well as to measure treatment outcomes. ...
... Compared to the general population and patients with other chronic diseases, CLD patients report significantly lower health quality status, more bad mental and physical health days, a significant symptom disease burden, and greater activity limitations [5,23,30,31]. They also report impairment in their ability to work, increased utilization of healthcare services, and greater out-of-pocket medical costs, and, as noted in Table 1, they also report high rates of disability [5,32,33]. ...
... Symptom severity scales are widely used in many diseases as outcome measures and a number of different symptom scales have been used in persistent Lyme disease trials. A recently published symptom severity questionnaire for "Post Treatment Lyme Disease" was validated against the SRHS and other widely used PROs [23]. Other studies have demonstrated that severity of symptoms is a defining feature of CLD and identified fatigue as the most commonly reported severe symptom [5,10]. ...
There is considerable uncertainty regarding treatment of Lyme disease patients who do not respond fully to initial short-term antibiotic therapy. Choosing the best treatment approach and duration remains challenging because treatment response among these patients varies: some patients improve with treatment while others do not. A previous study examined treatment response variation in a sample of over 3500 patients enrolled in the MyLymeData patient registry developed by LymeDisease.org (San Ramon, CA, USA). That study used a validated Global Rating of Change (GROC) scale to identify three treatment response subgroups among Lyme disease patients who remained ill: nonresponders, low responders, and high responders. The present study first characterizes the health status, symptom severity, and percentage of treatment response across these three patient subgroups together with a fourth subgroup, patients who identify as well. We then employed machine learning techniques across these subgroups to determine features most closely associated with improved patient outcomes, and we used traditional statistical techniques to examine how these features relate to treatment response of the four groups. High treatment response was most closely associated with (1) the use of antibiotics or a combination of antibiotics and alternative treatments, (2) longer duration of treatment, and (3) oversight by a clinician whose practice focused on the treatment of tick-borne diseases.
... A recent study in France showed that 43 of 824 patients (5.22%) with polymorphic signs and symptoms and suspected tick-borne illness were PCR positive for B. miyamotoi (5). Studies in North America using the GlpQ assay among patients with presumed tick-borne infection have revealed antibody seropositivity rates ranging from 3 to 21% Northeast (11), Canada (12), and California (13). ...
... Patients rated their symptoms using the General Symptom Questionnaire-30 (GSQ-30), a measure specifically developed to assess multisystem symptom burden in patients with early Lyme disease and post-treatment Lyme disease syndrome (12). Patients also completed the Beck Depression Inventory-II, Cognitive Failures Questionnaire, Fatigue Severity Scale, Epworth Sleepiness Scale, McGill VAS Pain Scale, and Zung Anxiety Scale. ...
Eighty-two patients seeking consultation for long-term sequalae after suspected tick-borne illness were consecutively tested for Borrelia miyamotoi antibodies using a recombinant glycerophosphodiester phosphodiesterase (GlpQ) enzyme immunoassay. Twenty-one of the 82 patients (26%) tested positive on the GlpQ IgG ELISA. Nearly all of the patients (98%) had no prior B. miyamotoi testing, indicating that clinicians rarely test for this emerging tick-borne pathogen. Compared to patients who solely tested positive for Lyme disease antibodies, patients with B. miyamotoi antibodies presented with significantly more sleepiness and pain. A prospective study is needed to ascertain the relationship between the presence of B. miyamotoi antibodies and persistent symptoms.
... Furthermore, a pilot study used [ 11 C]DPA-713 PET imaging to study cerebral glial activation and found that several brain regions had higher [ 11 C]DPA-713 binding in patients with PTLDS than in healthy controls (12). In addition to these biomarkers, Fallon et al. (69) developed a survey, the General Symptom Questionnaire-30 (GSQ-30), to assess symptom burden and changes; patients with PTLDS reported higher GSQ-30 scores before treatment and maintained these scores until 6 months posttreatment. The GSQ-30 could be a powerful tool to accompany biomarkers like the gut microbiome in PTLDS. ...
Lyme disease is the most common vector-borne disease in the United States, with an estimated incidence of 300,000 infections annually. Antibiotic intervention cures Lyme disease in the majority of cases; however, 10 to 20% of patients develop posttreatment Lyme disease syndrome (PTLDS), a debilitating condition characterized by chronic fatigue, pain, and cognitive difficulties. The underlying mechanism responsible for PTLDS symptoms, as well as a reliable diagnostic tool, has remained elusive. We reasoned that the gut microbiome may play an important role in PTLDS given that the symptoms overlap considerably with conditions in which a dysbiotic microbiome has been observed, including mood, cognition, and autoimmune disorders. Analysis of sequencing data from a rigorously curated cohort of patients with PTLDS revealed a gut microbiome signature distinct from that of healthy control subjects, as well as from that of intensive care unit (ICU) patients. Notably, microbiome sequencing data alone were indicative of PTLDS, which presents a potential, novel diagnostic tool for PTLDS.
IMPORTANCE Most patients with acute Lyme disease are cured with antibiotic intervention, but 10 to 20% endure debilitating symptoms such as fatigue, neurological complications, and myalgias after treatment, a condition known as posttreatment Lyme disease syndrome (PTLDS). The etiology of PTLDS is not understood, and objective diagnostic tools are lacking. PTLDS symptoms overlap several diseases in which patients exhibit alterations in their microbiome. We found that patients with PTLDS have a distinct microbiome signature, allowing for an accurate classification of over 80% of analyzed cases. The signature is characterized by an increase in Blautia , a decrease in Bacteroides , and other changes. Importantly, this signature supports the validity of PTLDS and is the first potential biological diagnostic tool for the disease.
... Patients also indicated whether any of the symptoms impaired their work, social, or family functioning, and if yes, which symptom was the most impairing. The GSQ-30 has shown excellent validity and internal consistency (57). The Sheehan Disability Scale (SDS) was also administered at the same time. ...
Context: Persistent fatigue, pain, and neurocognitive impairment are common in individuals following treatment for Lyme borreliosis (LB). Poor sleep, depression, visual disturbance, and sensory neuropathies have also been reported. The cause of these symptoms is unclear, and widely accepted effective treatment strategies are lacking. Objectives: To identify symptom clusters in people with persistent symptoms previously treated for LB and to examine the relationship between symptom severity and perceived disability. Methods: This was a retrospective chart review of individuals with a history of treatment of LB referred to The Dean Center for Tick-Borne Illness at Spaulding Rehabilitation Hospital between 2015 and 2018 (n = 270) because of persistent symptoms. Symptoms and functional impairment were collected using the General Symptom Questionnaire-30 (GSQ-30), and the Sheehan Disability Scale. Clinical tests were conducted to evaluate for tick-borne co-infections and to rule out medical disorders that could mimic LB symptomatology. Exploratory factor analysis was performed to identify symptom clusters. Results: Five symptom clusters were identified. Each cluster was assigned a name to reflect the possible underlying etiology and was based on the majority of the symptoms in the cluster: the neuropathy symptom cluster, sleep-fatigue symptom cluster, migraine symptom cluster, cognitive symptom cluster, and mood symptom cluster. Symptom severity for each symptom cluster was positively associated with global functional impairment (p < 0.001). Conclusion: Identifying the interrelationship between symptoms in post-treatment LB in a cluster can aid in the identification of the etiological basis of these symptoms and could lead to more effective symptom management strategies. Key Message: This article describes symptom clusters in individuals with a history of Lyme borreliosis. Five clusters were identified: sleep-fatigue, neuropathy, migraine-like, cognition, and mood clusters. Identifying the interrelationship between symptoms in each of the identified clusters could aid in more effective symptom management through identifying triggering symptoms or an underlying etiology.
