Form B-1. Inclusion form for the effectiveness of different methods of toilet training for bowel and bladder control

Transcription

1 Form B-1. Inclusion form for the effectiveness of different methods of toilet training for bowel and bladder control Form B-2. Assessment of methodology for non-randomized controlled trials for the effectiveness of different methods of toilet training for bowel and bladder control Form B-3. Assessment of methodology for controlled trials for the effectiveness of different methods of toilet training for bowel and bladder control Form B-4. Data extraction for the effectiveness of different methods of toilet training for bowel and bladder control B-26

2 Form B-1. Inclusion form for the effectiveness of different methods of toilet training for bowel and bladder control Reviewer: Date: Reference Number: TOPIC, include if either: [ ] Examining at least one method used to toilet train DESIGN, include if any of the following: [ ] Randomized clinical trial [ ] Controlled clinical trial [ ] Prospective cohort [ ] Retrospective cohort [ ] Case-series of at least 5 children [ ] Cross-sectional PARTICIPANTS, include if: Infants, toddlers, or children who do not have enuresis or encopresis and: [ ] Are normally developed [ ] Have special needs, such as physical co-mortibidities, neuro-muscular, cognitive, and/or behavioral disabilities INTERVENTION, include if there is at least one of the following toilet training methods: [ ] Azrin and Foxx [ ] Child-oriented [ ] Operant conditioning [ ] Behavioral therapy [ ] Infant assisted toileting [ ] Other: OUTCOMES, include if there is at least one of the following quantified, objective outcomes: [ ] Success or failure in achieving bowel control [ ] Success or failure in achieving bladder control [ ] Time required to complete toilet training [ ] Other: [ ] Adverse events (e.g.: enuresis, encopresis, stool withholding, stool toileting refusal) B-27

3 FINAL DECISION: [ ] INCLUDE (meets all of the above inclusion criteria) [ ] EXCLUDE [ ] CAN T TELL If disagreement between reviewers, final outcome: [ ] INCLUDED [ ] EXCLUDED Check box if study provides useful background information B-28

4 Form B-2. Assessment of methodology for non-randomized controlled trials for the effectiveness of different methods of toilet training for bowel and bladder control Reporting 1. Is the hypothesis/aim/objective of the study clearly described? This question refers to a clear statement of the objective, i.e. to measure the effectiveness of x in population y with respect to z, even if x, y and z are not clearly described (see questions 2, 3 and 4). 2. Are the main outcomes to be measured clearly described in the Introduction or Methods section? If the main outcomes are first mentioned in the Results section, the question should be answered no. In case-control studies the case definition should be considered the outcome. 3. Are the characteristics of the patients included in the study clearly described in the Introduction or Methods section? In cohort studies and trials, inclusion and or exclusion criteria should be given. In case-control studies, a case definition and the source for controls should be given. 4. Are the interventions of interest clearly described in the Introduction or Methods section? Treatments and placebo (where relevant) that are to be compared should be clearly described. B-29

5 5. Are the distributions of principal confounders in each group of subjects to be compared clearly described? A list of principal confounders is provided. Yes 2 Partially 1 6. Are the main findings of the study clearly described? Simple outcome data (including denominators and numerators) should be reported for all major findings so that the reader can check the major analyses and conclusions. This question does not cover statistical tests, which are considered below. 7. Does the study provide estimates of the random variability in the data for the main outcomes? In non-normally distributed data the inter-quartile range of results should be reported. In normally distributed data the standard error, standard deviation or confidence intervals should be reported. If the distribution of the data is not described, it must be assumed that the estimates used were appropriate and the question should be answered yes. 8. Have all important adverse events that may be a consequence of the intervention been reported? This should be answered yes if the study demonstrates that there was a comprehensive attempt to measure adverse events. (A list of possible adverse events is provided). B-30

6 9. Have the characteristics of patients lost to followup been described? This should be answered yes where there were no losses to followup or where losses to followup were so small that findings would be unaffected by their inclusion. This should be answered no where a study does no report the number of patients lost to followup. 10. Have 95% CIs and/or actual probability values been reported (e.g rather than <0.05) for the main outcomes except where the probability value is less than (both CI and p value, either CI or p value, neither)? External validity 11. Were the subjects asked to participate in the study representative of the entire population from which they were recruited? The study must identify the source population for patients and describe how the patients were selected. Patients would be representative if they comprised the entire source population, an unselected sample of consecutive patients, or a random sample. Random sampling is only feasible where a list of all members of the relevant population exists. Where a study does not report the proportion of the source population from which the patients are derived, the question should be answered as unable to determine. 12. Were those subjects who were prepared to participate representative of the entire population from which they were recruited? The proportion of those asked who agreed should be stated. Validation that the sample was representative would include demonstrating that the distribution of the main confounding factors was the same in the study sample and the source population. B-31

7 13. Were the staff, places, and facilities where the patients were treated, representative of the treatment the majority of patients receive? For the study to be answered yes the study should demonstrate that the intervention was representative of that in use in the source population. The question should be answered no if, for example, the intervention was undertaken in a specialist center unrepresentative of the hospitals most of the source population would attend. Internal validity bias 14. Was an attempt made to blind study subjects to the intervention they have received? For studies where the patients would have no way of knowing which intervention they received, this should be answered yes. 15. Was an attempt made to blind those measuring the main outcomes of the intervention? 16. If any of the results of the study were based on data dredging, was this made clear? Any analyses that had not been planned at the outset of the study should be clearly indicated. If no retrospective unplanned subgroup analyses were reported, then answer yes. B-32

8 17. In trials and cohort studies, do the analyses adjust for different lengths of followup of patients, or in case-control studies, is the time period between the intervention and outcome the same for cases and controls? Where followup was the same for all study patients that answer should be yes. If different lengths of followup were adjusted for by, for example, survival analysis the answer should be yes. Studies where differences in followup are ignored should be answered no. 18. Were the statistical tests used to assess the main outcomes appropriate? The statistical techniques used must be appropriate to the data. For example non-parametric methods should be used for small sample sizes. Where little statistical analysis has been undertaken but where there is no evidence of bias, the question should be answered yes. If the distribution of the data (normal or not) is not described it must be assumed that the estimates used were appropriate and the question should be answered yes. 19. Was compliance with the interventions reliable? Where there was non compliance with the allocated treatment or where there was contamination of one group, the question should be answered no. For studies where the effect of any misclassification was likely to bias any association to the null, the question should be answered yes. 20. Were the main outcome measures used accurate (valid and reliable)? For studies where the outcome measured are clearly described, the question should be answered yes. For studies which refer to other work or that demonstrates the outcome measures are accurate, the question should be answered as yes. B-33

9 Internal validity confounding (selection bias) 21. 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? For example, patients for all comparison groups should be selected from the same hospital. The question should be answered unable to determine for cohort and case-control studies where there is no information concerning the source of patients included in the study. 22. Were 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? For a study which does not specify the time period over which patients were recruited, the question should be answered as unable to determine. 23. Were the subjects randomized to intervention groups? Studies which state that subjects were randomized should be answered yes except where method of randomization would not ensure random allocation. For example alternate allocation would score no because it is predictable. B-34

10 24. Was the randomized intervention assignment concealed from both patients and health care staff until recruitment was complete and irrevocable? All non-randomized studies should be answered no. If assignment was concealed from patients but not from staff, it should be answered no. 25. Was there adequate adjustment for confounding in the analyses from which the main findings were drawn? This question should be answered no for trials if: the main conclusions of the study were based on analyses of treatment rather than intention to treat; the distribution of known confounders in the different treatment groups was not described; or the distribution of known confounders different between the treatment groups but was not taken into account in the analyses. In non-randomized studies if the effect of the main confounders was not investigated or confounding was demonstrated but no adjustment was made in the final analyses the question should be answered as no. 26. Were losses to patients to followup take into account? (yes, no, unable to determine) If the numbers of patients lost to followup are not reported, the question should be answered as unable to determine. If the proportion lost to followup was too small to affect the main findings, the question should be answered yes. B-35

11 Power 27. Was a power calculation reported for the primary outcome? 28. Did the study have sufficient power to detect a clinically important effect where the probability value for a difference being due to chance in less than 5%? B-36

12 Form B-3. Assessment of methodology for controlled trials for the effectiveness of different methods of toilet training for bowel and bladder control JADAD SCORE: circle the appropriate response and total for the final Jadad score Randomization: 1. Was the study described as being randomized? 1 = Yes 0 = No 2. Was the method of randomization appropriate? 1 = Yes 0 = No 3. Was the method of randomization inadequate? -1 = Yes 0 = No Double Blindedness: 4. Was the study described as double-blind? 1 = Yes 0 = No 5. Was the method of double-blinding appropriate? 1 = Yes 0 = No 6. Was the method of double-blinding inadequate? -1 = Yes 0 = No Withdrawals: 7. Was there an adequate description of withdrawals? 1 = Yes 0 = No Total Score: CONCEALMENT OF ALLOCATION: was the method used to conceal the randomization list [ ] adequate [ ] inadequate [ ] unclear B-37

13 Form B-4. Data extraction form for the effectiveness of different methods of toilet training for bowel and bladder control Study Characteristics First author: Title: Journal citation: Year published: Country(ies) where conducted: Funding: Private industry Government Internal Foundation Other NR Study design: RCT/CCT Single cohort Multiple cohort Case-control Other Data collection: Prospective Retrospective Can t tell Subject source Community(ies) Clinic practice Recruitment Random Consecutive All eligible Special care facility Convenience Special selection (restricted) NR Other Time frame NR Description of children (inclusion criteria) Normal Physically challenged Hirschprung s Spina bifida Other Mentally challenged Autism ADHD Mix of conditions Other NR Readiness screening Other inclusion criteria: Cultural background: B-38

14 Toilet training intervention Azrin & Foxx Azrin & Foxx modified Operant conditioning Child-oriented Behavioral therapy Other method described in text Positive reinforcement used: yes no NR Negative reinforcement used: yes no NR External signalling device used: yes no NR Special toileting equipment needed: yes no NR Special room needed: yes no NR Training objective Daytime bladder control Nighttime bladder control Both day and nighttime bladder control Both bladder and bowel control anytime Self-directed toileting Daytime bowel control Nighttime bowel control Both day and nighttime bowel control Improved control Toileting when prompted Patient Flow 1. Initial number selected/screened/eligible: n= NR 2. Total agreed to participate: n= 3. Exclusions: Yes n= No Unclear NR Reasons: 4. Withdrawals/dropouts/refusals: Yes n= No Unclear NR Reasons: 5. Number who completed the study: n= 6. Describe comparison group(s) if included: Data Collection Questionnaire Interview Clinical review Chart review Can t tell Baseline Characteristics Please indicate the statistic (%, SD, SEM, range, AND the units) Group A: Group B: N N All N Males (n, %) Age: mean; SD chronological age social age Culture/religion/racial breakdown B-39

15 IQ or VSMS score Position in family 1 st child Age TT begun 2 nd or later SES Baseline bladder function Baseline bowel function Other Other Definition of Success: NR Primary Trainer(s): NA NR Parents Were parents trained prior to implementation? Yes No NR Other care givers Were care givers trained prior to implementation? Yes No NR Intervention: Toilet training program Drug therapy Other Describe drug therapy or other : Describe toilet training program: Number of phases: Duration of phases: Duration of TT program: Baseline performance recorded: Yes No Frequency of diaper/pant (accident) checks: Frequency of toileting: Tracking method in place (i.e.: chart or home visit) Yes No B-40

16 Results Reported: Bladder Bowel Both NR For all outcomes specify the units reported in e.g. % change, absolute numbers, incidence/time, etc. Time of measure Change from baseline bladder Group A: N Group B: N All N bowel both Mean # successes bladder bowel both Mean # accidents bladder Success rate bowel both Failure rate Adverse events Additional Comments B-41