RESUMO
OBJECTIVE: To explore whether using a single matched or composite outcome might affect the results of previous randomized controlled trials (RCTs) testing exercise for non-specific low back pain (NSLBP). The first objective was to explore whether a single matched outcome generated greater standardized mean differences (SMDs) when compared with the original unmatched primary outcome SMD. The second objective was to explore whether a composite measure, composed of matched outcomes, generated a greater SMD when compared with the original primary outcome SMD. DESIGN: We conducted exploratory secondary analyses of data. SETTING: Seven RCTs were included, of which 2 were based in the USA (University research clinic, Veterans Affairs medical center) and the UK (primary care clinics, nonmedical centers). One each were based in Norway (clinics), Brazil (primary care), and Japan (outpatient clinics). PARTICIPANTS: The first analysis comprised 1) 5 RCTs (n=1033) that used an unmatched primary outcome but included (some) matched outcomes as secondary outcomes, and the second analysis comprised 2) 4 RCTs (n=864) that included multiple matched outcomes by developing composite outcomes (N=1897). INTERVENTION: Exercise compared with no exercise. MAIN OUTCOME MEASURES: The composite consisted of standardized averaged matched outcomes. All analyses replicated the RCTs' primary outcome analyses. RESULTS: Of 5 RCTs, 3 had greater SMDs with matched outcomes (pooled effect SMD 0.30 [95% confidence interval {CI} 0.04, 0.56], P=.02) compared with an unmatched primary outcome (pooled effect SMD 0.19 [95% CI -0.03, 0.40] P=.09). Of 4 composite outcome analyses, 3 RCTs had greater SMDs in the composite outcome (pooled effect SMD 0.28 [95% CI 0.05, 0.51] P=.02) compared with the primary outcome (pooled effect SMD 0.24 [95% CI -0.04, 0.53] P=.10). CONCLUSIONS: These exploratory analyses suggest that using an outcome matched to exercise treatment targets in NSLBP RCTs may produce greater SMDs than an unmatched primary outcome. Composite outcomes could offer a meaningful way of investigating superiority of exercise than single domain outcomes.
Assuntos
Dor Lombar , Humanos , Dor Lombar/terapia , Exercício Físico , Brasil , Japão , Noruega , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Previous studies measuring the health-related quality of life (HRQoL) of individuals with dengue focused on treatment seeking populations. However, the vast majority of global dengue cases are unlikely to be detected by health systems. Representative measurements of HRQoL should therefore include patients with disease not likely to trigger treatment-seeking behavior. This study based in Iquitos, Peru used the Quality of Wellbeing Scale-Self Administered, a survey that enquires about not only physical health, but also psychological health, self-care, mobility, and usual social activities, and rates HRQoL between 0 (death) and 1 (optimum function), to evaluate the impact of dengue on HRQoL. In order to enroll treatment and non treatment-seeking participants, three modalities of participant recruitment were used. In addition to clinic and community-based febrile surveillance, a contact-cluster methodology was also employed to identify infected individuals less likely to seek treatment. We measured changes in HRQoL and identified common areas of health impairment in 73 virologically confirmed dengue cases at 3 time points during the participant's illness; the early-acute (days 0-6 post symptom onset), late-acute (days 7-20), and convalescent illness phases (days 21 +). Participants reported HRQoL related impairments at significantly higher frequency during the early-acute versus convalescent illness phase (Fisher's exact: P<0.01). There was substantial heterogeneity in scores during each illness phase with median scores in the early-acute, late-acute and convalescent phases of 0.56 (IQR: 0.41-0.64), 0.70 (IQR: 0.57-0.94), and 1 (IQR: 0.80-1.00), respectively. In all illness phases participants recruited in clinics had on average the lowest HRQoL scores where as those recruited in the contact clusters had the highest. Only 1 individual who was recruited in the contact-clusters had no reduction in HRQoL score during their illness. These data illustrate that dengue should be considered as a disease that may have significant implications for not only physical health but also psychological health and social functioning. The impact of dengue on the HRQoL of non-treatment-seeking individuals, although lower than the impact among treatment-seeking individuals, is not necessarily trivial.