primary outcome:
Aquatic exercise training for fibromyalgia
Until recently, there was no consensus on outcomes to guide research on the effectiveness of interventions for fibromyalgia. In 2004, a group of clinicians, researchers, and patients, under the auspices of the Outcome Measures in Rheumatology group (OMERACT) initiative, set about to improve outcome measurement in fibromyalgia through a data‐driven interactive consensus process used previously for other rheumatic diseases (Mease 2009). Over the course of the next five years, patient focus groups (Arnold 2008), patient and clinician Delphi exercises (Mease 2008), a systematic literature review and analysis of outcomes used in fibromyalgia intervention trials (Carville 2008), and analyses of psychometric properties of outcomes (i.e., face, construct, content, and criterion validity in fibromyalgia) (Choy 2009a) were conducted. Based on these efforts, OMERACT has recommended the following core set of outcomes for inclusion in all fibromyalgia clinical trials: pain, fatigue, multidimensional function, tenderness, and quality of sleep (Choy 2009; Mease 2009). OMERACT designated two additional outcomes, depression and dyscognition, as important but not core, and placed anxiety, morning stiffness, imaging, and biomarkers on the agenda for further research (Choy 2009).In this review, we have extracted data for 24 outcomes, which include all the outcomes considered to be important by OMERACT (Choy 2009). We categorized the 24 outcomes into four main categories: wellness, fibromyalgia symptoms, physical fitness, and safety and acceptability. In the wellness category, we extracted six outcomes: multidimensional function, patient‐rated global, clinician‐rated global, self reported physical function, self efficacy, and mental health. In the symptom category of outcomes, we extracted data for eight symptoms experienced by individuals with fibromyalgia: pain, fatigue, sleep disturbance, stiffness, tenderness, depression, anxiety, and dyscognition. In the physical fitness category we extracted six outcomes associated with physiological adaptation to exercise training: muscle strength, muscle endurance, muscle power, muscle/joint flexibility, maximum cardiorespiratory function, and submaximal cardiorespiratory function. The Cochrane Handbook for Systematic Reviews of Interventions states (in Section 5.4.3): "It is important that Cochrane reviews include information about the undesirable as well as desirable outcomes of the interventions examined ... at least one undesirable outcome should be defined as a major outcome measure" (O'Connor 2011). With this in mind, we conceptualized the final category of outcomes as safety and acceptance of exercise training. This category consists of three outcomes associated with possible harms ‐ injuries, exacerbations of fibromyalgia, or other adverse effects; while another outcome, withdrawal rates, served as a proxy for lack of acceptability of exercise training.When an included study used more than one instrument to measure a particular outcome, we selected the data for extraction based on the following criteria: a) the frequency of use of the instruments in the fibromyalgia literature (e.g., the Fibromyalgia Impact Questionnaire or FIQ is a disease‐specific instrument commonly used in this literature), and b) documented evidence supporting the psychometric properties of the instrument (e.g., validity, reliability, sensitivity, measurement properties) used in similar populations.1. Outcomes representing wellness:This category of outcomes relates to generalized health or functioning. Tools used to measure outcomes in this category included both broad‐spectrum indices designed to capture an array of tasks or characteristics to yield a single summary score (e.g., SF‐36), and single‐item tests on which the respondent is asked to rate their status in an area of health using a single‐item scale (e.g., a visual analog scale ‐ VAS) on which the respondent places a mark on a 10 cm line between worst health on one end and best health on the other.2. Outcomes representing fibromyalgia symptoms:This category of outcomes includes eight symptoms associated with fibromyalgia.3. Outcomes representing physical fitness:This category, consisting of six outcomes, is associated with physiological adaptation to exercise training. There are several facets to physical fitness including: cardiovascular function (maximal capacity and submaximal endurance), body composition, muscle strength, muscle endurance, flexibility, agility, co‐ordination, balance, power, reaction time, and speed (ACSM 2009a). Given the nature of the intervention, outcomes reflecting physical fitness are highly relevant.4. Outcomes representing safety and acceptabilityWe used four outcomes grouped into two categories to represent safety (i.e., adverse events, injuries, exacerbations) and acceptability (i.e., withdrawals). We recorded qualitative descriptions of any adverse events, injuries, exacerbations of pain, and/or other fibromyalgia symptoms. We also extracted withdrawals as a proxy for acceptability of interventions.