Question (Q). Q1: Is the Hypothesis/aim/objective clearly described? Q2: Are the main outcomes to be measured clearly described in the Introduction or Methods section? Q3: Are the characteristics of the participants included in the study clearly described? Q4: Are the interventions of interest clearly described? Q5: Are the distribution of principal confounders, in each group of subjects to be compared, clearly described? Q6: Are the main findings of the study clearly described? Q7: Does the study provide estimates of random variability in the data for the main outcomes? Q8: Have all the important adverse events, that may be a consequence of the intervention, been reported? Q9: Have the characteristics of patients lost to follow-up been described? Q10: Have actual probability values been reported for the main outcomes except where the probability value is less than 0.001? Q11: Were the subjects asked to participate in the study representative of the entire population from which they were recruited? Q12: Were those subjects who were prepared to participate representative of the entire population from which they were recruited? Q13: Were the staff, place, and facilities where the patients were treated, representative of the treatment the majority of patients receive? Q14: Was an attempt made to blind study subjects to the intervention they have received? Q15: Was an attempt made to blind those measuring the main outcomes of the intervention? Q16: If any of the results of the study were based on 'data dredging', was this made clear? Q17: In trials and cohort studies, do the analysis adjust for different lengths of follow-up of patients, or in case-control studies, in the time period between intervention and outcome the same for cases and controls? Q18: Were the statistical tests used to assess the main outcomes appropriate? Q19: Was the compliance with the interventions reliable? Q20: Were the main outcome measures used accurate (valid and reliable)? Q21: Were the patients in different intervention groups (trials and cohort studies) or were the cases and controls (case-control studies) recruited from the same population? Q22: Were the study subjects in different intervention groups (trials and cohort studies) or were the cases and controls (case-control studies) recruited over the same period of time? Q23: Were study subjects randomized to intervention groups? Q24: Was the randomized intervention assignment concealed from both patient and health care staff until was complete and irrevocable? Q25: Was there adequate adjustment for confounding in the analysis from which the main findings were drawn? Q26: Were losses of patients to follow-up taken into account? Q27. Did the study have sufficient power to detect a clinically important effect where the probability value for a difference being due to chance is less than 5%? |