Role of Patient-Reported Outcome Measures in the Assessment of Central Nervous System Agents

2013 ◽  
Vol 47 (5) ◽  
pp. 613-618 ◽  
Author(s):  
Ari Gnanasakthy ◽  
Carla DeMuro ◽  
Marci Clark ◽  
Margaret Mordin ◽  
Simu Thomas
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Outcome Measures ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Patient Reported ◽  
Central Nervous System Agents

scholarly journals Improved Central Nervous System Symptoms in People with HIV without Objective Neuropsychiatric Complaints Switching from Efavirenz to Rilpivirine Containing cART

2019 ◽  
Vol 9 (8) ◽  
pp. 195 ◽  
Author(s):  
Vera ◽  
Bracchi ◽  
Alagaratnam ◽  
Lwanga ◽  
Fox ◽  
...  
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Tenofovir Disoproxil Fumarate ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
People Living With Hiv ◽  
White Ethnicity ◽  
Patient Reported ◽  
Switching Therapy ◽  
Living With Hiv

Objective: Occult central nervous system (CNS) symptoms not recognized by people living with HIV (PLWH) receiving efavirenz or their clinicians could occur and impact people’s quality of life. The aim of this study was to determine whether CNS parameters improve in PLWH when switching from efavirenz to rilpivirine. Methods: PLWH receiving tenofovir disoproxil fumarate, emtricitabine, efavirenz (Atripla™) with undetectable HIV RNA, and no CNS symptoms were switched cART to tenofovir disoproxil fumarate, emtricitabine, rilpivirine (Eviplera™). CNS parameters including sleep, anxiety, and depressive symptoms were evaluated using patient-reported outcome measures at baseline, 4, 12, and 24 weeks after switching therapy. A median CNS score was derived from the sum of CNS toxicities of all the grades collected in the study questionnaires. Cognitive function was assessed using a computerized test battery. Results: Of 41 participants, median age was 47 years, Interquartile range (IQR) 31, 92% were male and 80% were of white ethnicity. A significant reduction in total CNS score (10 to 7) was observed at 4 weeks (p = 0.028), but not thereafter. Significant improvements in sleep and anxiety were observed 4, 12 and 24 weeks after switching therapy (p < 0.05). No significant change in global cognitive scores was observed. Conclusions: Switching from efavirenz to rilpivirine based regimens in virologically suppressed PLWH without perceived CNS symptoms was well tolerated and slightly improved overall CNS symptoms.

scholarly journals Systematic review of the evidence on orthotic devices for the management of knee instability related to neuromuscular and central nervous system disorders

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e015927 ◽  
Author(s):  
Catriona McDaid ◽  
Debra Fayter ◽  
Alison Booth ◽  
Joanne O'Connor ◽  
Rocio Rodriguez-Lopez ◽  
...  
Keyword(s):  
Systematic Review ◽  
Central Nervous System ◽  
Nervous System ◽  
Outcome Measures ◽  
Patient Reported Outcome Measures ◽  
Neuromuscular Disorder ◽  
Knee Instability ◽  
Walking Ability ◽  
Orthotic Devices ◽  
Patient Reported

ObjectivesTo assess the effectiveness of orthotic devices for the management of instability of the knee in adults with a neuromuscular disorder or central nervous system disorder.DesignA systematic review of primary studies.SettingCommunity.ParticipantsAdults with a neuromuscular disorder or central nervous system disorder and impaired walking ability due to instability of the knee.InterventionsOrthoses with the clinical aim of controlling knee instability, for example, knee-ankle-foot orthoses, ankle-foot orthoses and knee orthoses or mixed design with no restrictions in design or material.Primary and secondary outcome measuresCondition-specific or generic patient-reported outcome measures assessing function, disability, independence, activities of daily living, quality of life or psychosocial outcomes; pain; walking ability; functional assessments; biomechanical analysis; adverse effects; usage; patient satisfaction and the acceptability of a device; and resource utilisation data.ResultsTwenty-one studies including 478 patients were included. Orthotic devices were evaluated in patients with postpolio syndrome, poststroke syndrome, inclusion body myositis and spinal cord injury. The review included 2 randomised controlled trials (RCTs), 3 non-randomised controlled studies and 16 case series. Most were small, single-centre studies with only 6 of 21 following patients for 1 year or longer. They met between one and five of nine quality criteria and reported methods and results poorly. They mainly assessed outcomes related to gait analysis and energy consumption with limited use of standardised, validated, patient-reported outcome measures. There was an absence of evidence on outcomes of direct importance to patients such as reduction in pain and falls.ConclusionsThere is a need for high-quality research, particularly RCTs, of orthotic devices for knee instability related to neuromuscular and central nervous system conditions. This research should address outcomes important to patients. There may also be value in developing a national registry.Registration number systematic reviewPROSPERO (CRD42014010180).

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