Abstract
The Frazier Free Water Protocol was developed with the aim of providing patients with dysphagia an option to consume thin (i.e. unthickened) water in-between mealtimes. A systematic review was conducted of research published in peer-reviewed journals. An electronic search of the EMBASE, CINAHL and MEDLINE databases was completed up to July 2016. A total of 8 studies were identified for inclusion: 5 randomised controlled trials, 2 cohort studies with matched cases and 1 single group pre-post intervention prospective study. A total of 215 rehabilitation inpatients and 30 acute patients with oropharyngeal dysphagia who required thickened fluids or were to remain ‘nil by mouth’, as determined by bedside swallow assessment and/or videofluoroscopy/fiberoptic endoscopic evaluation of swallowing, were included. Meta-analyses of the data from the rehabilitation studies revealed (1) low-quality evidence that implementing the protocol did not result in increased odds of having lung complications and (2) low-quality evidence that fluid intake may increase. Patients’ perceptions of swallow-related quality of life appeared to improve. This review has found that when the protocol is closely adhered to and patients are carefully selected using strict exclusion criteria, including an evaluation of their cognition and mobility, adult rehabilitation inpatients with dysphagia to thin fluids can be offered the choice of implementing the Free Water Protocol. Further research is required to determine if the Free Water Protocol can be implemented in settings other than inpatient rehabilitation.
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Appendices
Appendix 1
Search Terms and Keywords
Dysphag*, deglutition, aspiration, laryngeal penetration, swallow*, thickened fluid*, thick fluid*, thickened drink*, thick drink*, modified fluid*, modified drink*, nil by mouth, nil oral, NBM, water protocol*, liquid protocol*, fluid protocol*, regular fluid*, thin liquid*, free liquid*, regular liquid*, risk feed*, frazier*, frasier*, free fluid*, free water, thin fluid*, water, sip*, risk*, benefit*, positiv*, negativ*, outcome*, effectiv*, advantag*, disadvantag*, quality of life, chest infection*, respiratory tract infection*, LRTI, URTI, RTI, mortality rate*, rate* of mortality, complian*, compl*, cost*, satisf*, IV fluid*, intravenous fluid*.
Appendix 2
Downs and black quality assessment | Karagiannis et al. [46] | Carlaw et al. [50] | Garon et al. [49] | Karagiannis et al. [47] | Frey et al. [53] | Murray et al. [51] | Pooyania et al. [52] | Bernard et al. [54] |
|---|---|---|---|---|---|---|---|---|
1. Is the hypothesis/aim/objective of the study clearly described? | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
2. Are outcomes to be measured clearly described in Intro/Methods? | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
3. Are patient characteristics clearly described? | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
4. Are the interventions of interest clearly described? | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
5. Are the distributions of principal confounders in each group of subjects to be compared clearly described? | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 1 |
6. Are the main findings of the study clearly described? | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 |
7. Does the study provide estimates of the random variability in the data for the main outcomes? | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 0 |
8. Have all important adverse events that may be a consequence of the intervention been reported? | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
9. Have the characteristics of patients lost to follow-up been described? | 1 | 1 | 0 | 1 | 0 | 1 | 1 | 1 |
10. Have actual probability values been reported for the main outcomes except where the probability values is less that 0.001? | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 0 |
11. Were the subjects asked to participate in the study representative of the entire population from which they were recruited? | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 1 |
12. Were those subjects who were prepared to participate representative of the entire population from which they were recruited? | 0 | 1 | 1 | 1 | 1 | 1 | 0 | 0 |
13. Were the staff, places and facilities where the patients were treated, representative of the treatment the majority of patients receive? | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
14. Was an attempt made to blind study subjects to the intervention they have received? | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
15. Was an attempt made to blind those measuring the main outcomes of the intervention? | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
16. If any of the results of the study were based on ‘data dredging’, was this made clear? | 1 | 1 | 1 | 1 | 0 | 1 | 0 | 0 |
17. In trials and cohort studies, do the analysis adjust for different lengths of follow-up of patients of in case–control studies is the time period between the intervention and outcome the same for cases and controls? | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
18. Were the statistical tests used to assess the main outcomes appropriate? | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 |
19. Was compliance with the intervention reliable? | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
20. Were the main outcome measures used accurate (valid and reliable)? (were they clearly described?) | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 0 |
21. Were the patients in different intervention groups (trials and cohorts) or were the cases and controls (case–control studies) recruited from the same population? | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
22. Were study subjects in different intervention groups (trials and cohort studies) or were the case and controls (case–control studies) recruited over the same period of time? | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 0 |
23. Were subjects randomised to intervention groups? | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 0 |
24. Was the randomised intervention assignment concealed from both parties and health care staff until recruitment was complete and irrevocable? | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
25. Was there adequate adjustment for confounding in the analyses from which the main findings were drawn? | 1 | 1 | 0 | 1 | 1 | 1 | 0 | 0 |
26. Were losses of patients to follow-up taken into account? | 1 | 1 | 0 | 1 | 0 | 1 | 1 | 1 |
27. 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%? | 5 | 5 | 3 | 3 | 3 | 5 | 1 | 0 |
Score | 29 | 28 | 23 | 25 | 18 | 28 | 23 | 13 |
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Gillman, A., Winkler, R. & Taylor, N.F. Implementing the Free Water Protocol does not Result in Aspiration Pneumonia in Carefully Selected Patients with Dysphagia: A Systematic Review. Dysphagia 32, 345–361 (2017). https://doi.org/10.1007/s00455-016-9761-3
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DOI: https://doi.org/10.1007/s00455-016-9761-3