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      Adverse events and deterioration reported by participants in the PACE trial of therapies for chronic fatigue syndrome

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          Abstract

          Objective

          Adverse events (AEs) are health related events, reported by participants in clinical trials. We describe AEs in the PACE trial of treatments for chronic fatigue syndrome (CFS) and baseline characteristics associated with them.

          Methods

          AEs were recorded on three occasions over one year in 641 participants. We compared the numbers and nature of AEs between treatment arms of specialist medical care (SMC) alone, or SMC supplemented by adaptive pacing therapy (APT), cognitive behaviour therapy (CBT) or graded exercise therapy (GET). We examined associations with baseline measures by binary logistic regression analyses, and compared the proportions of participants who deteriorated by clinically important amounts.

          Results

          Serious adverse events and reactions were infrequent. Non-serious adverse events were common; the median (quartiles) number was 4 (2, 8) per participant, with no significant differences between treatments ( P = .47). A greater number of NSAEs were associated with recruitment centre, and baseline physical symptom count, body mass index, and depressive disorder. Physical function deteriorated in 39 (25%) participants after APT, 15 (9%) after CBT, 18 (11%) after GET, and 28 (18%) after SMC ( P < .001), with no significant differences in worsening fatigue.

          Conclusions

          The numbers of adverse events did not differ significantly between trial treatments, but physical deterioration occurred most often after APT. The reporting of non-serious adverse events may reflect the nature of the illness rather than the effect of treatments. Differences between centres suggest that both standardisation of ascertainment methods and training are important when collecting adverse event data.

          Highlights

          • This study shows the distribution of adverse events in a trial of treatments for CFS.

          • Non-serious adverse events were common, but no difference between treatments.

          • Non-serious adverse events were more related to ill different than treatments.

          • Deterioration in physical function was more likely after adaptive pacing therapy.

          • Differences between centres may be related to different ascertainment methods.

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          Most cited references34

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          The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection.

          A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. The survey was constructed for self-administration by persons 14 years of age and older, and for administration by a trained interviewer in person or by telephone. The history of the development of the SF-36, the origin of specific items, and the logic underlying their selection are summarized. The content and features of the SF-36 are compared with the 20-item Medical Outcomes Study short-form.
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            The Patient Health Questionnaire Somatic, Anxiety, and Depressive Symptom Scales: a systematic review.

            Depression, anxiety and somatization are the most common mental disorders in primary care as well as medical specialty populations; each is present in at least 5-10% of patients and frequently comorbid with one another. An efficient means for measuring and monitoring all three conditions would be desirable. Evidence regarding the psychometric and pragmatic characteristics of the Patient Health Questionnaire (PHQ)-9 depression, generalized anxiety disorder (GAD)-7 anxiety and PHQ-15 somatic symptom scales are synthesized from two sources: (1) four multisite cross-sectional studies (three conducted in primary care and one in obstetric-gynecology practices) comprising 9740 patients, and (2) key studies from the literature that have studied these scales. The PHQ-9 and its abbreviated eight-item (PHQ-8) and two-item (PHQ-2) versions have good sensitivity and specificity for detecting depressive disorders. Likewise, the GAD-7 and its abbreviated two-item (GAD-2) version have good operating characteristics for detecting generalized anxiety, panic, social anxiety and post-traumatic stress disorder. The optimal cutpoint is > or = 10 on the parent scales (PHQ-9 and GAD-7) and > or = 3 on the ultra-brief versions (PHQ-2 and GAD-2). The PHQ-15 is equal or superior to other brief measures for assessing somatic symptoms and screening for somatoform disorders. Cutpoints of 5, 10 and 15 represent mild, moderate and severe symptom levels on all three scales. Sensitivity to change is well-established for the PHQ-9 and emerging albeit not yet definitive for the GAD-7 and PHQ-15. The PHQ-9, GAD-7 and PHQ-15 are brief well-validated measures for detecting and monitoring depression, anxiety and somatization. Copyright 2010. Published by Elsevier Inc.
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              The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms.

              Somatization is prevalent in primary care and is associated with substantial functional impairment and healthcare utilization. However, instruments for identifying and monitoring somatic symptoms are few in number and not widely used. Therefore, we examined the validity of a brief measure of the severity of somatic symptoms. The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-15 comprises 15 somatic symptoms from the PHQ, each symptom scored from 0 ("not bothered at all") to 2 ("bothered a lot"). The PHQ-15 was administered to 6000 patients in eight general internal medicine and family practice clinics and seven obstetrics-gynecology clinics. Outcomes included functional status as assessed by the 20-item Short-Form General Health Survey (SF-20), self-reported sick days and clinic visits, and symptom-related difficulty. As PHQ-15 somatic symptom severity increased, there was a substantial stepwise decrement in functional status on all six SF-20 subscales. Also, symptom-related difficulty, sick days, and healthcare utilization increased. PHQ-15 scores of 5, 10, 15, represented cutoff points for low, medium, and high somatic symptom severity, respectively. Somatic and depressive symptom severity had differential effects on outcomes. Results were similar in the primary care and obstetrics-gynecology samples. The PHQ-15 is a brief, self-administered questionnaire that may be useful in screening for somatization and in monitoring somatic symptom severity in clinical practice and research.
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                Author and article information

                Contributors
                Journal
                J Psychosom Res
                J Psychosom Res
                Journal of Psychosomatic Research
                Pergamon Press
                0022-3999
                1879-1360
                1 July 2014
                July 2014
                : 77
                : 1
                : 20-26
                Affiliations
                [a ]East London Foundation NHS Trust, London, UK
                [b ]MRC Clinical Trials Unit at UCL, London, UK
                [c ]Biostatistics Department, Institute of Psychiatry, King's College London, UK
                [d ]Psychological Medicine Research, Department of Psychiatry, University of Oxford, Oxford, UK
                [e ]Nuffield Department of Medicine, University of Oxford, UK
                [f ]Academic Department of Psychological Medicine, King's College London, UK
                [g ]Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK
                Author notes
                [* ]Corresponding author at: Department of Psychological Medicine, St Bartholomew's Hospital, London EC1A 7BE, UK. Tel.: + 44 203 465 5974. p.d.white@ 123456qmul.ac.uk
                Article
                S0022-3999(14)00188-3
                10.1016/j.jpsychores.2014.04.002
                4065570
                24913337
                2b4568bd-53b9-4875-8a1f-66b32c6b7aeb
                © 2013 The Authors

                This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/3.0/).

                History
                : 22 November 2013
                : 31 March 2014
                : 8 April 2014
                Categories
                Article

                Clinical Psychology & Psychiatry
                adverse events,body mass index,chronic fatigue syndrome,depression,medically unexplained symptoms

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