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      Validity and reliability of a new, short symptom rating scale in patients with persistent atrial fibrillation

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          Abstract

          Background

          Symptoms related to atrial fibrillation and their impact on health-related quality of life (HRQoL) are often evaluated in clinical trials. However, there remains a need for a properly validated instrument. We aimed to develop and validate a short symptoms scale for patients with AF.

          Methods

          One hundred and eleven patients with a variety of symptoms related to AF were scheduled for DC cardioversion. The mean age was 67.1 ± 12.1 years, and 80% were men. The patients completed the new symptoms scale, the Toronto Symptoms Check List (SCL) and the generic Short Form 36 (SF-36) the day before the planned DC cardioversion. Compliance was excellent, with only 1 of 666 answers missing.

          Results

          One item, 'limitations in working capability', was deleted because of a low numerical response rate, as many of the patients were retired. The internal consistency reliability of the remaining six items was 0.81 (Cronbach's α). Patients scored highest in the items of 'dyspnoea on exertion', 'limitations in daily life due to AF' and 'fatigue due to AF', with scores of 4.5, 3.3 and 4.5, respectively. There was a good correlation to all relevant SF-36 domains and to the relevant questions of the SCL. The Rasch analyses showed that the items are unidimensional and that they are clearly separated and cover an adequate range. Test-retest reliability was performed in patients who failed DC and was adequate for three of six items, >0.70.

          Conclusion

          The psychometric characteristics of the new short symptoms scale were found to have satisfactory reliability and validity.

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          Most cited references25

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          Quality of life in patients with atrial fibrillation: a systematic review.

          The impact of atrial fibrillation (AF) on patients' quality of life (QoL) has yet to be fully elucidated in a systematic manner. This article examines QoL in "general" patients with AF as well as the effects that rate and/or rhythm-control interventions have on QoL. Patients with AF have significantly poorer QoL compared with healthy controls, the general population, and other patients with coronary heart disease. Studies examining rate or rhythm-control strategies alone demonstrate improved QoL after intervention. Three of the four large randomized control trials (STAF, PIAF, RACE) comparing rate versus rhythm control demonstrated a greater improvement in QoL in patients receiving rate control. However, the AFFIRM trial revealed a similar improvement in QoL for both rate and rhythm-control groups. The data, although frequently compromised by various methodologic weaknesses, suggest that patients with AF have impaired QoL, and that QoL can be significantly improved through rate or rhythm-control strategies.
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            Relationships between sinus rhythm, treatment, and survival in the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) Study.

            The AFFIRM Study showed that treatment of patients with atrial fibrillation and a high risk for stroke or death with a rhythm-control strategy offered no survival advantage over a rate-control strategy in an intention-to-treat analysis. This article reports an "on-treatment" analysis of the relationship of survival to cardiac rhythm and treatment as they changed over time. Modeling techniques were used to determine the relationships among survival, baseline clinical variables, and time-dependent variables. The following baseline variables were significantly associated with an increased risk of death: increasing age, coronary artery disease, congestive heart failure, diabetes, stroke or transient ischemic attack, smoking, left ventricular dysfunction, and mitral regurgitation. Among the time-dependent variables, the presence of sinus rhythm (SR) was associated with a lower risk of death, as was warfarin use. Antiarrhythmic drugs (AADs) were associated with increased mortality only after adjustment for the presence of SR. Consistent with the original intention-to-treat analysis, AADs were no longer associated with mortality when SR was removed from the model. Warfarin use improves survival. SR is either an important determinant of survival or a marker for other factors associated with survival that were not recorded, determined, or included in the survival model. Currently available AADs are not associated with improved survival, which suggests that any beneficial antiarrhythmic effects of AADs are offset by their adverse effects. If an effective method for maintaining SR with fewer adverse effects were available, it might be beneficial.
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              Quality of life improves with treatment in the Canadian Trial of Atrial Fibrillation.

              The impact of atrial fibrillation (AF) and its treatment on health-related quality of life (QOL) is not well understood. We assessed QOL in patients with symptomatic AF participating in the Canadian Trial of Atrial Fibrillation. Self-report QOL questionnaires including the Short-Form-36 (SF-36), symptom checklist (SCL) and AF Severity Scale (AFSS) were completed at baseline and 3, and 12 months after randomization. The study group was aged 65 +/- 10 years and 59% were male. By design, 50% of patients were randomized to amiodarone (n = 132), 25% to sotalol (n = 66), and 25% to propafenone (n = 66). Most patients had normal left ventricular function (89%). Physical (41.9 +/- 9.3 to 43.7 +/- 9.2, P =.001) and mental health (47.5 +/- 10.5 to 49.0 +/- 9.8, P =.023) summary measures from the SF-36 improved significantly from baseline to 3 months. Arrhythmia symptom frequency and severity (SCL) also improved markedly from baseline to 3 months (symptom frequency 20.4 +/- 9.4 to 16.2 +/- 9.5 and symptom severity 16.7 +/- 8.2 to 12.9 +/- 7.4, both P <.001). QOL improvements were not significantly different among the groups randomized to amiodarone, sotalol, or propafenone. However, patients with no symptomatic recurrences of AF had higher scores at 3 months on measures of global well-being than those with recurrences in the first 3 months (7.4 +/- 1.8 vs 6.9 +/- 1.8, P <.05). There were no significant QOL changes from the 3 to 12 month assessment. In patients with symptomatic AF, QOL improves after treatment, independent of the specific drug used for treatment. This is especially true for patients in whom treatment prevents AF recurrence.
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                Author and article information

                Journal
                Health Qual Life Outcomes
                Health and Quality of Life Outcomes
                BioMed Central
                1477-7525
                2009
                15 July 2009
                : 7
                : 65
                Affiliations
                [1 ]Division of Cardiology, Sahlgrenska University Hospital, Göteborg, Sweden
                [2 ]AstraZeneca HEOR R&D, Mölndal, Sweden
                [3 ]Sahlgrenska Academy at Sahlgrenska University Hospital, Göteborg, Sweden
                Article
                1477-7525-7-65
                10.1186/1477-7525-7-65
                2717073
                19604399
                7abab599-096d-4ce8-8d49-496d95951a0b
                Copyright © 2009 Härdén et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 24 February 2008
                : 15 July 2009
                Categories
                Research

                Health & Social care
                Health & Social care

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