METHODS: This study, which involved the caregivers of schizophrenia patients from a hospital in Kuala Lumpur, Malaysia, was comprised of three parts, namely in-depth interviews, a pilot study, and the validation of the developed questionnaire, known as Caregiver Cope (CgCopeTM).
RESULTS: Part A originally consisted of eight themes, and it was later modified to seven themes with four items each after discussions with some experts. Part B initially had 28 items derived from the seven themes in Part A, which were then reduced to six components after a factor analysis. Part C of the questionnaire consisted of 19 items, with six components (Distraction, Caring for patient, Venting, Religion, Recreation, and Social support) having a moderate to high reliability ranging from a Cronbach's alpha coefficient of 0.54 to 0.82. A factor analysis showed that the six factors of coping accounted for 62.36% of the total variance.
CONCLUSION: The CgCOPETM questionnaire is suitable for use among caregivers of schizophrenia patients. There is a need to further validate the instrument among caregivers of other patient populations.
METHODS: We assessed the use of composite outcomes in neonatal RCTs included in Cochrane Neonatal reviews published till November 2017. Two authors reviewed the components of the composite outcomes to compare their patient importance and computed the ratios of effect sizes and event rates between the components, with an a priori threshold of 1.5, indicating a substantial difference. Descriptive statistics were presented.
RESULTS: We extracted 7,766 outcomes in 2,134 RCTs in 312 systematic reviews. Among them, 55 composite outcomes (0.7%) were identified in 46 RCTs. The vast majority (92.7%) of composite outcomes had 2 components, with death being the most common component (included 51 times [92.7%]). The components in nearly three-quarters of the composite outcomes (n = 40 [72.7%]) had different patient importance, while the effect sizes and event rates differed substantially between the components in 27 (49.1%) and 35 (63.6%) outcomes, respectively, with up to 43-fold difference in the event rates observed.
CONCLUSIONS: The majority of composite outcomes in neonatal RCTs had different patient importance with contrasting effect sizes and event rates between the components. In patient communication, clinicians should highlight individual components, rather than the composites, with explanation on the relationship between the components, to avoid misleading impression on the effect of the intervention. Future trials should report the estimates of all individual components alongside the composite outcomes presented.