T219. REAL LIFE FUNCTIONING IN 22Q11 DELETION SYNDROME (DS) IN COMPARISON TO SCHIZOPHRENIA SUBJECTS: STUDY ON PSYCHOSES VULNERABILITY FACTORS. DATA FROM THE MULTICENTER STUDY OF THE ITALIAN NETWORK FOR RESEARCH ON PSYCHOSES

Abstract Background 22q11DS is the most common microdeletion with an incidence of 1:4000 live births. It is considered a genetic biological model for psychosis vulnerability: 25–28% of 22q11DS adults is affected by a psychotic disorder. Few data are available regarding functioning in 22q11DS. Our aim was to test the hypothesis that functioning is similar in 22q11DS psychotic and non-psychotic patients, and idiopathic schizophrenic subjects. We expected also a correlation between negative symptoms and functioning. Methods Data come from Italian Network for Research on Psychoses for the Schizophrenic (SCZ, N=252) and Control groups (HC, N=110). 22q11DS psychotic (22q11DS_SCZ, N=21) and non-psychotic patients (22q11DS, N=23) were enrolled at Policlinico Umberto I, in Rome. The SLOF scale (Specific Levels of Functioning) and the Brief Negative Symptom Scale interview (BNSS) were employed. Results The Global Functioning was significantly different between all groups but not between 22q11DS groups and SCZ. The multivariate analysis of variance showed the higher effect size for the Interpersonal Functioning, in which differences resulted significant between all groups, except for the comparison between 22q11DS-SCZ and SCZ. Differences between groups in BNSS were significant except for the post-hoc 22q11DS-SCZ vs SCZ. Global and Interpersonal Functioning showed a significant negative correlation with BNSS scores in the three clinical groups. Discussion 22q11DS-SCZ showed a severe deficit in Interpersonal Functioning, similar to that of idiopathic schizophrenia. 22q11DS showed a deficit in Interpersonal Functioning respect to control group, but less severe than psychotic groups. Our data suggest a common impairment shared among the clinical groups, that may be the functional correlate of an underlying neurobiological mechanism.

Download Full-text

Efficacy and safety of Jie-du-qing-nao granules for first-episode schizophrenics: study protocol for a randomized controlled trial

10.21203/rs.3.rs-22794/v1 ◽

2020 ◽

Author(s):

Ziyan Li ◽

Yanzhe Ning ◽

Pei Chen ◽

Yi Zhang ◽

Dongqing Yin ◽

...

Keyword(s):

Negative Symptoms ◽

Complete Blood Count ◽

Controlled Trial ◽

First Episode ◽

Control Group ◽

Study Group ◽

Efficacy And Safety ◽

Clinical Trial Registry ◽

Symptom Scale ◽

Double Blind

Abstract BackgroundAt present, the focus and difficulty of schizophrenia (SCZ) treatment is to improve cognitive function and negative symptoms. Jie-du-qing-nao granules(JQG) , a traditional Chinese medicine(TCM) prescription , has a good clinical effectiveness in enhancing the cognition and negative symptoms of patients with SCZ. However, its clear effectiveness and safety have not been adequately supported by clinical studies. The main objective of this study is to explore the efficacy and safety of JQG for first-episode schizophrenics.Methods/designThis trial is a prospective, randomized, single-centered, parallel-controlled clinical study with double-blind design. A total of 96 eligible participants will be randomly assigned to either the study group or the control group in a ratio of 1:1. Participants allocated to the study group will receive JQG and aripiprazole, control group will receive placebo and aripiprazole. The treatment course will last 12 weeks, with follow-up every 4 weeks. Outcome measurements include Positive and Negative Syndrome Scale (PANSS), self face test , MATRICS Consensus Cognitive Battery (MCCB), TNFα, IL-6, IL-1β, BDNF, vital signs, complete blood count, liver and kidney function tests, urinalysis, and electrocardiograph. Adverse reactions will be evaluated using the Treatment Emergent Symptom Scale (TESS).DiscussionThis study will provide evidence for the efficacy and safety of JQG as a complementary approach, which can be initiated following with antipsychotics therapy. Trial registration Chinese Clinical Trial Registry, ID: ChiCTR1900028250 . Registered on December 16, 2019, http://www.chictr.org.cn/edit.aspx?pid=41880&htm=4 .

Download Full-text

Amygdala volume in a population with special educational needs at high risk of schizophrenia

Psychological Medicine ◽

10.1017/s0033291709990870 ◽

2009 ◽

Vol 40 (6) ◽

pp. 945-954 ◽

Cited By ~ 11

Author(s):

K. A. Welch ◽

A. C. Stanfield ◽

T. W. Moorhead ◽

K. Haga ◽

D. C. G. Owens ◽

...

Keyword(s):

Negative Symptoms ◽

Learning Disabled ◽

Significant Negative Correlation ◽

Elevated Risk ◽

Control Group ◽

Special Educational Needs ◽

Extended Phenotype ◽

Educational Assistance ◽

Amygdala Volume ◽

The Relationship

BackgroundThe mildly learning disabled population has a three-fold elevated risk for schizophrenia. It has been proposed that in some individuals this cognitive limitation is a pre-psychotic manifestation of early onset schizophrenia. We examined clinical and neuroanatomical measures of a putative extended phenotype of schizophrenia in an adolescent population receiving special educational assistance. We predicted that people with intellectual impairment and schizotypal features would exhibit amygdala volume reduction as one of the neuroanatomical abnormalities associated with schizophrenia.MethodAssessment by clinical interview, neuropsychological assessment and magnetic resonance imaging scanning was carried out in 28 intellectually impaired individuals identified as being at elevated risk of schizophrenia due to the presence of schizotypal traits, 39 intellectually impaired controls and 29 non-intellectually impaired controls. Amygdala volume was compared in these three groups and the relationship between symptomatology and amygdala volume investigated.ResultsRight amygdala volume was significantly increased in the elevated risk group compared with the intellectually impaired controls (p=0.05). A significant negative correlation was seen between left amygdala volume and severity of negative symptoms within this group (p<0.05), but not in either control group.ConclusionsIntellectually impaired subjects judged to be at elevated risk of schizophrenia on the basis of clinical assessment exhibit structural imaging findings which distinguish them from the generality of learning disabled subjects. Within this population reduced amygdala volume may be associated with negative-type symptoms and be part of an extended phenotype that reflects particularly elevated risk and/or early manifestations of the development of psychosis.

Download Full-text

Evaluation of paliperidone on social function in patients with chronic schizophrenia

General Psychiatry ◽

10.1136/gpsych-2018-000011 ◽

2018 ◽

Vol 31 (2) ◽

pp. e000011

Author(s):

Yan Gu ◽

Hong Peng ◽

Jingjing Dai ◽

Hui Gao ◽

Xianghong Yang ◽

...

Keyword(s):

Interaction Effect ◽

Negative Symptoms ◽

Chronic Schizophrenia ◽

Social Function ◽

Time Effect ◽

Control Group ◽

Positive Symptoms ◽

Symptom Scale ◽

Grouping Effect ◽

The Difference

BackgroundThe impairment of social function is widespread in the patients with chronic schizophrenia, which seriously affects family, life and work conditions.AimsThe main purpose of this study was to investigate the efficacy of paliperidone in the treatment of social function in chronic schizophrenia.MethodsA total of 81 patients who met the standard criteria for schizophrenia and long-term hospitalised inpatients were randomly divided into the treatment group and normal control group following a 1- year prospective follow-up study. The reatment group (41 cases) used paliperidone extended-release tablets for reducing dosage, as appropriate, based on the original treatment strategy; and the control group (40 cases) used the former drugs. All patients were assessed using the Positive and Negative Symptom Scales (PANSS), and the Treatment Emergent Symptom Scale (TESS) was used to assess adverse drug reactions. The Hospitalised Psychiatric Patients’ Social Functions Rating Scale (SSPI) was used to assess social function of participants before and after 8 weeks, 6 months and 1 year of treatment.ResultsAt baseline there were no significant differences between the two groups in age, duration of illness, educational background and dosage of antipsychotic drugs (converted into chlorpromazine equivalency). There was statistically significant difference in PANSS positive symptoms by interaction effect (Fgroup×time=18.24, df=3237, p<0.001) and time effect (Ftime=21.66, df=3, p<0.01) and the difference in PANSS positive symptoms by grouping effect (Fgroup=0.68, df=1, p=0.41) was not statistically significant. The difference of grouping effect of PANSS negative symptoms (Fgroup=9.93, df=1, p=0.002), time effect (Ftime=279.15, df=3, p<0.001) and interaction effect (Fgroup×time=279.15, df=3237, p<0.001) were statistically significant. There were statistically significant differences in the grouping effect (Fgroup=6.59, df=1, p=0.012), time effect (Ftime=152.97, df=3, p<0.001) and interaction effect (Fgroup×time=148.82, df=3237, p<0.001) of PANSS general pathological symptoms, the same as the total score of the PANSS, which showed large differences in grouping effect (Fgroup=7.04, df=1, p=0.001), time effect (Ftime=210.78, df=3, p<0.001) and interaction effect (Fgroup×time=205.20, df=3237, p<0.01). We found in the total SSPI score, grouping effect (Fgroup=31.70, df=1, p<0.001), time effect (Ftime=161.84, df=3, p<0.001) and interaction effect (Fgroup×time=132.74, df=3237, p<0.001) were demonstrated to be significantly different. Even though adverse reactions occurred 7 times in the treatment group and 44 times in the control group based on the Treatment Emergent Symptom Scale (TESS), incidence rate was significantly lower than that of the control group (χ²=18.854, p<0.001).ConclusionPaliperidone can safely and effectively improve negative symptoms and social function in patients with chronic schizophrenia.

Download Full-text

Neurophysiological correlates of negative symptom domains in patients with schizophrenia

European Psychiatry ◽

10.1016/j.eurpsy.2016.01.687 ◽

2016 ◽

Vol 33 (S1) ◽

pp. s265-s265

Author(s):

A. Vignapiano ◽

V. Montefusco ◽

G.M. Plescia ◽

G. Di Lorenzo ◽

C. Niolu ◽

...

Keyword(s):

Negative Symptom ◽

Negative Symptoms ◽

Negative Impact ◽

Real Life ◽

Event Related Potentials ◽

Central Feature ◽

Symptom Scale ◽

Symptom Domains ◽

Related Potentials ◽

Competing Interest

IntroductionNegative symptoms have long been recognized as a central feature of schizophrenia, which limit recovery, having a strong negative impact on real-life functioning. External validators of the negative symptoms domains might help refining hypotheses on their pathophysiological basis.AimsThe objective of this study was to evaluate, in the context of the multicenter study of the Italian Network for Research on Psychoses, the relationships between auditory event-related potentials (ERPs) components and negative symptom domains in patients with schizophrenia (SCZ).MethodsWe examined ERPs recorded during an auditory odd-ball task in 115 chronic stabilized SCZ (78% on second-generation antipsychotics) and 62 matched healthy controls (HC). Negative symptoms were assessed using the Brief Negative Symptom Scale.ResultsOur main findings included significant N100 and P3b amplitude reductions in SCZ compared to HC. P3b amplitude did not correlate with any negative symptom domain, while N100 amplitude correlated with both anhedonia and avolition domains.ConclusionsAvolition and anhedonia, often clustering in the same factor, are related to abnormalities of early components of the ERPs correlated with perceptual and automatic attention processes. None of the negative symptom domains is associated with abnormalities of the later stages indexed by P3 amplitude.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Download Full-text

Symptomatic remission in psychosis and real-life functioning

The British Journal of Psychiatry ◽

10.1192/bjp.bp.111.104414 ◽

2012 ◽

Vol 201 (3) ◽

pp. 215-220 ◽

Cited By ~ 44

Author(s):

M. Oorschot ◽

T. Lataster ◽

V. Thewissen ◽

M. Lardinois ◽

J. van Os ◽

...

Keyword(s):

Negative Symptoms ◽

Real Life ◽

Mood States ◽

Control Group ◽

Symptom Reduction ◽

Partial Recovery ◽

Schizophrenia Spectrum Disorders ◽

Remission Criteria ◽

Functional Outcome Measures ◽

Symptomatic Remission

BackgroundIn 2005 Andreasen proposed criteria for remission in schizophrenia. It is unclear whether these criteria reflect symptom reduction and improved social functioning in daily life.AimsTo investigate whether criteria for symptomatic remission reflect symptom reduction and improved functioning in real life, comparing patients meeting remission criteria, patients not meeting these criteria and healthy controls.MethodThe Experience Sampling Method (ESM), a structured diary technique, was used to explore real-life symptoms and functioning in 177 patients with (remitted and non-remitted) schizophrenia spectrum disorders and 148 controls.ResultsOf 177 patients, 70 met criteria for symptomatic remission. These patients reported significantly fewer positive and negative symptoms and better mood states compared with patients not in remission. Furthermore, patients in remission spent more time in goal-directed activities and had less preference for being alone when they were with others. However, the patient groups did not differ on time spent in social company and doing nothing, and both the remission and non-remission groups had lower scores on functional outcome measures compared with the control group.ConclusionsThe study provides an ecological validation for the symptomatic remission criteria, showing that patients who met the criteria reported fewer positive symptoms, better mood states and partial recovery of reward experience compared with those not in remission. However, remission status was not related to functional recovery, suggesting that the current focus on symptomatic remission may reflect an overly restricted goal.

Download Full-text

Negative Psychotic Symptoms in 22q11.2 Deletion and Their Association with Neuropsychological Profile

European Psychiatry ◽

10.1016/j.eurpsy.2017.01.2210 ◽

2017 ◽

Vol 41 (S1) ◽

pp. S221-S221

Author(s):

M. Pontillo ◽

A. Lin ◽

M. Armando ◽

D. Menghini ◽

G. Alvares ◽

...

Keyword(s):

Negative Symptoms ◽

Verbal Response ◽

Deletion Syndrome ◽

Psychotic Symptoms ◽

Healthy Controls ◽

Role Functioning ◽

Schizophrenia Spectrum Disorders ◽

Global Functioning ◽

22Q11.2 Deletion ◽

Neuropsychological Profile

22q11.2 deletion syndrome (22q11.2 DS) is associated with a markedly elevated risk for schizophrenia spectrum disorders. The role of negative symptoms in the pathogenesis of schizophrenia in this population and their link to role, social and cognitive functioning is still unclear. Aims of this study were investigate the association between negative symptoms, social and role functioning and neurocognitive performance in the sample of individuals with 22q11.2DS and compare them to healthy controls. The study was conducted on a sample of 60 individuals with 22q11.2DS (mean age = 14.8; SD = 4.8) and 56 healthy control (HC) participants (mean age = 13.8; SD = 5.4). Individuals with 22q11DS and high level of negative symptoms showed significantly higher level of impairment in several neurocognitive domain (i.e. visuospatial abilities, verbal response inhibition) compared with individuals with 22q11DS and low level of negative symptoms and healthy controls. They showed also lower global functioning, specifically role functioning and not social functioning. Negative symptoms are frequent in 22q11.2DS and are associated with specific cognitive deficit and low role functioning. These results suggest that negative symptoms should be considered an important target in the assessment of risk of conversion to full-blown psychosis and in planning of psychological interventions for this population.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Download Full-text

The broad autism phenotype in real-life: clinical and functional correlates of autism spectrum symptoms and rumination among parents of patients with autism spectrum disorder

CNS Spectrums ◽

10.1017/s1092852919001615 ◽

2019 ◽

Vol 25 (6) ◽

pp. 765-773 ◽

Cited By ~ 4

Author(s):

Barbara Carpita ◽

Claudia Carmassi ◽

Sara Calderoni ◽

Dario Muti ◽

Alessia Muscarella ◽

...

Keyword(s):

Autism Spectrum Disorder ◽

Psychiatric Disorders ◽

Real Life ◽

Autistic Traits ◽

Significant Negative Correlation ◽

Autism Spectrum ◽

Spectrum Disorder ◽

Response Scale ◽

Global Functioning ◽

History Of

AbstractObjectiveIncreasing literature reported higher rates of psychiatric disorders in parents of children with autism spectrum disorder (ASD), as well as of autistic-like features in social and cognitive functioning. However, little attention has been paid to the association between autistic traits (AT) and global functioning in this population. The aim of the present work was to investigate clinical and functional correlates of AT among parents of ASD children, with a specific focus on ruminative thinking.MethodsOne hundred and twenty parents of ASD children were assessed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the Adult Autism Subthreshold Spectrum (AdAS Spectrum), the Ruminative Response Scale (RRS), the Social and Occupational Functioning Assessment Scale (SOFAS).ResultsSubjects with at least 1 psychiatric disorder (39.2%) showed significantly higher AdAS Spectrum and RRS scores. Subjects with a history of school difficulties and with language development alterations scored significantly higher on specific AdAS Spectrum domains. A significant negative correlation was found between SOFAS and AdAS Spectrum scores, as well as between SOFAS and RRS scores. AdAS Spectrum nonverbal communication domain score was identified has a statistically predictive variable for the presence of psychiatric disorders and lower SOFAS scores. Finally, we found a significant indirect effect of AdAS total score on SOFAS score, which was fully mediated by RRS total score.ConclusionsAT in parents of ASD children seem to be associated with a higher vulnerability toward psychopathology and with a lower global functioning. Ruminative thinking may play a role in the relationship between AT and functional outcome.

Download Full-text

The Pattern of Ventricular Remodeling Influences the Level of Oxidative Stress in Heart Failure Patients

Revista de Chimie ◽

10.37358/rc.17.7.5705 ◽

2017 ◽

Vol 68 (7) ◽

pp. 1506-1511

Author(s):

Cerasela Mihaela Goidescu ◽

Anca Daniela Farcas ◽

Florin Petru Anton ◽

Luminita Animarie Vida Simiti

Keyword(s):

Oxidative Stress ◽

Heart Failure ◽

Ventricular Remodeling ◽

Clinical Laboratory ◽

Left Ventricular ◽

Control Group ◽

Reactive Protein ◽

Lv Mass ◽

Few Data

Oxidative stress (OS) is increased in chronic diseases, including cardiovascular (CV), but there are few data on its effects on the heart and vessels. The isoprostanes (IsoP) are bioactive compounds, with 8-iso-PGF25a being the most representative in vivo marker of OS. They correlate with the severity of heart failure (HF), but because data regarding OS levels in different types of HF are scarce, our study was aimed to evaluate it by assessing the urinary levels of 8-iso-PGF2aand its correlations with various biomarkers and parameters. Our prospective study included 53 consecutive patients with HF secondary to ischemic heart disease or dilative cardiomyopathy, divided according to the type of HF (acute, chronic decompensated or chronic compensated HF). The control group included 13 hypertensive patients, effectively treated. They underwent clinical, laboratory - serum NT-proBNP, creatinine, uric acid, lipids, C reactive protein (CRP) and urinary 8-iso-PGF2a and echocardiographic assessment. HF patients, regardless the type of HF, had higher 8-iso-PGF2a than controls (267.32pg/�mol vs. 19.82pg/�mol, p[0.001). The IsoP level was directly correlated with ejection fraction (EF) (r=-0.31, p=0.01) and NT-proBNP level (r=0.29, p=0.019). The relative wall thickness (RWT) was negatively correlated with IsoP (r=-0.55, p[0.001). Also 8-iso-PGF25a was higher by 213.59pg/�mol in the eccentric left ventricular (LV) hypertrophy subgroup comparing with the concentric subgroup (p=0.014), and the subgroups with severe mitral regurgitation (MR) and moderate/severe pulmonary hypertension (PAH) had the highest 8-iso-PGF2a levels. Male sex, severe MR, moderate/severe PAH, high LV mass and low RWT values were predictive for high OS level in HF patients.Eccentric cardiac remodeling, MR severity and PAH severity are independent predictors of OS in HF patients.

Download Full-text

Pediatric Residents and Interns in an Italian Hospital Perform Improved Bibliographic Searches when Assisted by a Biomedical Librarian

Evidence Based Library and Information Practice ◽

10.18438/b88321 ◽

2013 ◽

Vol 8 (1) ◽

pp. 76

Author(s):

Mathew Stone

Keyword(s):

Teaching Hospital ◽

Assessment Tool ◽

Controlled Trial ◽

Intervention Group ◽

Real Life ◽

Boolean Logic ◽

Bibliographic Databases ◽

Control Group ◽

Pediatric Residents ◽

Clinical Scenarios

A Review of: Gardois, P., Calabrese, R., Colombi, N., Lingua, C., Longo, F., Villanacci, M., Miniero, R., & Piga, A. (2011). Effectiveness of bibliographic searches performed by paediatric residents and interns assisted by librarian. A randomised controlled trial. Health Information and Libraries Journal, 28(4), 273-284. doi: 10.1111/j.1471-1842.2011.00957.x Objective – To establish whether the assistance of an experienced biomedical librarian delivers an improvement in the searching of bibliographic databases as performed by medical residents and interns. Design – Randomized controlled trial. Setting – The pediatrics department of a large Italian teaching hospital. Subjects – 18 pediatric residents and interns. Methods – 23 residents and interns from the pediatrics department of a large Italian teaching hospital were invited to participate in this study, of which 18 agreed. Subjects were then randomized into two groups and asked to spend between 30 and 90 minutes searching bibliographic databases for evidence to answer a real-life clinical question which was randomly allocated to them. Each member of the intervention group was provided with an experienced biomedical librarian to provide assistance throughout the search session. The control group received no assistance. The outcome of the search was then measured using an assessment tool adapted for the purpose of this study from the Fresno test of competence in evidence based medicine. This adapted assessment tool rated the “global success” of the search and included criteria such as appropriate question formulation, number of PICO terms translated into search terms, use of Boolean logic, use of subject headings, use of filters, use of limits, and the percentage of citations retrieved that matched a gold standard set of citations found in a prior search by two librarians (who were not involved in assisting the subjects) together with an expert clinician. Main Results – The intervention group scored a median average of 73.6 points out of a possible 100, compared with the control group which scored 50.4. The difference of 23.2 points in favour of the librarian assisted group was a statistically significant result (p value = 0.013) with a 95% confidence interval of between 4.8 and 33.2. Conclusion – This study presents credible evidence that assistance provided by an experienced biomedical librarian improves the quality of the bibliographic database searches performed by residents and interns using real-life clinical scenarios.

Download Full-text

Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00788-1 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Laura Williams ◽

Charlotte L. Hall ◽

Sue Brown ◽

Boliang Guo ◽

Marilyn James ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Young People ◽

Controlled Trial ◽

Medication Management ◽

Control Group ◽

Global Functioning ◽

Children And Young People ◽

Link Type ◽

Randomised Controlled

Abstract Background Medication for attention deficit hyperactivity disorder (ADHD) should be closely monitored to ensure optimisation. There is growing interest in using computerised assessments of ADHD symptoms to support medication monitoring. The aim of this study was to assess the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate the efficacy of one such computerised assessment, the Quantified Behavior (Qb) Test, as part of medication management for ADHD. Methods This feasibility multi-site RCT conducted in child and adolescent mental health and community paediatric settings recruited participants aged 6–15 years diagnosed with ADHD starting stimulant medication. Participants were randomised into one of two arms: experimental (QbTest protocol) where participants completed a QbTest at baseline and two follow-up QbTests on medication (2–4 weeks and 8–10 weeks later) and control where participants received treatment as usual, including at least two follow-up consultations. Measures of parent, teacher, and clinician-rated symptoms and global functioning were completed at each time point. Clinicians recorded treatment decision-making and health economic measures were obtained. Data were analysed using multi-level modelling and participants (children and parents) and clinicians were interviewed about their experiences, resulting data were thematically analysed. Results Forty-four children and young people were randomised. Completion of study outcome measures by care-givers and teachers ranged from 52 to 78% at baseline to 47–65% at follow-up. Participants reported the questionnaires to be useful to complete. SNAP-IV inattention scores showed greater reduction in the intervention than the control group (− 5.85, 95% CI − 10.33, − 1.36,). Engagement with the intervention ranged from 100% at baseline, to 78% follow-up 1 and 57% follow-up 2. However, only 37% of QbTests were conducted in the correct time period. Interview data highlighted that the objectivity of the QbTest was appreciated by clinicians and parents. Clinicians commented that the additional time and resources required meant that it is not feasible to use QbTest for all cases. Conclusion The trial design and protocol appear to be feasible and acceptable but could be improved by modifying QbTest time periods and the method of data collection. With these changes, the protocol may be appropriate for a full trial. Adding QbTest may improve symptom outcome as measured by SNAP-IV. Trial registration ClinicalTrials.gov, NCT03368573, prospectively registered, 11th December 2017, and ISRCTN, ISRCTN69461593, retrospectively registered, 10th April 2018

Download Full-text