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Evidence reviews for the clinical and cost-effectiveness of interventions to support oral hygiene for adults after a stroke
Evidence review J
NICE Guideline, No. 236
1. Oral hygiene interventions
1.1. Review question
In people after stroke, what is the clinical and cost effectiveness of interventions to improve oral hygiene?
1.1.1. Introduction
Dryness of the mouth is very uncomfortable, can be embarrassing, and the presence of secretions and debris in the mouth and pharynx can cause distress and lead to feelings of choking. Poor oral hygiene is associated with an increased risk of respiratory tract infections and therefore is an important risk factor for aspiration pneumonia after a stroke. Additionally, poor oral hygiene can result in a reduced oral intake and contribute to malnutrition and dehydration.
Maintaining good oral hygiene can be difficult for some people after a stroke because of cognitive issues, plus weakness to limbs or face. This review aims to compare the effectiveness of different methods for maintaining good oral hygiene in people after a stroke.
1.1.2. Summary of the protocol
Table 1
PICO characteristics of review question.
For full details see the review protocol in Appendix A.
1.1.3. Methods and process
This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual. Methods specific to this review question are described in the review protocol in Appendix A and the methods document.
Declarations of interest were recorded according to NICE’s conflicts of interest policy.
1.1.4. Effectiveness evidence
1.1.4.1. Included studies
Nine randomised controlled trial studies (from thirteen papers) were included in the review;2, 4, 5, 8, 9, 11–13, 16 these are summarised in Table 2 below. Evidence from these studies is summarised in the clinical evidence summary below (Table 3).
These studies reported the following comparisons:
- Oral hygiene intervention (three times a day) compared to usual care16
- Oral hygiene intervention (four times a day or more) compared to usual care9
The following comparisons were not included in the protocol, but were included as the committee agreed they were relevant for their decision making:
- Oral hygiene intervention (twice a day with additional treatment twice a week) compared to oral hygiene intervention (twice a day)13
- Oral hygiene intervention (twice a day with additional treatment twice a week) compared to usual care13
No relevant clinical studies comparing the following were identified:
- Hourly oral care compared to usual care
- Any oral hygiene intervention compared to placebo/sham procedures
- Any oral hygiene intervention compared to each other (except for oral health interventions [twice a day with additional treatment twice a week] compared to oral health interventions [twice a day])
Studies included people after ischaemic and haemorrhagic strokes (including people after subarachnoid haemorrhage). The severity of the stroke was mostly not reported, but when reported was of moderate severity (or NIHSS 5–14). Some studies included participants with dysphagia at baseline4, 5, 9 while other studies did not discuss the inclusion of people with dysphagia. Some only included people who were nil-by-mouth at baseline4, 12, while others included a mixture of people who were and were not nil-by-mouth 5, excluded people who were nil by mouth 13 or did not discuss the inclusion of people who were nil-by-mouth.
The type of intervention varied, with the majority of interventions being a combination of various interventions (including tooth brushing [with or without an electrical toothbrush], tongue brushing, oral swabbing, flossing, mouthwash, education and professional cleaning).
There was limited evidence for most outcomes. Some outcomes were not reported in any of the included studies, including:
- Person/participant and carer generic health-related quality of life
- Stroke outcome (modified Rankin scale)
- Presence of denture-induced stomatitis
- Re-admission
- Stroke-specific Patient-Reported Outcome Measures (including stroke-specific quality of life measures)
See also the study selection flow chart in Appendix C, study evidence tables in Appendix D, forest plots in Appendix E and GRADE tables in Appendix F.
Indirectness
Some evidence was considered as indirect. The reasons for this included:
- Intervention indirectness – in Chen 20194 the amount of treatment provided was less frequent than the smallest category provided in the protocol (care was provided three times a week rather than once a day). In this case the study was considered as indirect but included in the oral hygiene intervention (once a day) category.
- Outcome indirectness
- In Kim 201411 length of hospital stay was reported as length of intensive care unit admission only. As the person may have been in hospital for longer than this, the outcome was considered an indirect measure.
These outcomes were included in the analysis but downgraded in the GRADE analysis.
Meta-analysis
In the majority of cases there was insufficient evidence to form meta-analyses for outcomes. Where meta-analysis was possible there was no inconsistency seen.
Kim 201411 reported presence of oral disease (oral candidiasis) in two different methods: presence on the tongue and presence in saliva. When compared to other studies reporting the same outcome, it was decided to meta-analyse the outcome measuring presence on the tongue as this was most likely to complement the data from the other study. The outcome reporting presence in saliva was reported separately for completeness.
1.1.4.2. Excluded studies
A Cochrane review, Campbell 20203 was identified but was not included in this review. This was excluded as it included oral hygiene assessment as an intervention, while this shall be analysed in a separate review question. Additionally, it did not include the stratifications for the interventions that the committee decided were relevant and included outcomes that the committee did not think were relevant. Instead, the studies included in the Cochrane review were checked for inclusion in this review.
See the excluded studies list in Appendix J.
1.1.5. Summary of studies included in the effectiveness evidence
Table 2
Summary of studies included in the evidence review.
See Appendix D for full evidence tables.
1.1.6. Summary of the effectiveness evidence
1.1.6.1. Oral hygiene intervention (once a day) compared to usual care
Table 3
Clinical evidence summary: oral hygiene intervention (once a day) compared to usual care.
1.1.6.2. Oral hygiene intervention (twice a day) compared to usual care
Table 4
Clinical evidence summary: oral hygiene intervention (twice a day) compared to usual care.
1.1.6.3. Oral hygiene intervention (three times a day) compared to usual care
Table 5
Clinical evidence summary: oral hygiene intervention (three times a day) compared to usual care.
1.1.6.4. Oral hygiene intervention (four times a day or more) compared to usual care
Table 6
Clinical evidence summary: oral hygiene intervention (four times a day or more) compared to usual care.
1.1.6.5. Oral hygiene intervention (twice a day with additional treatment twice a week) compared to oral hygiene intervention (twice a day)
Table 7
Clinical evidence summary: oral hygiene intervention (twice a day with additional treatment twice a week) compared to oral hygiene intervention (twice a day).
1.1.6.6. Oral hygiene intervention (twice a day with additional treatment twice a week) compared to usual care
Table 8
Clinical evidence summary: oral hygiene intervention (twice a day with additional treatment twice a week) compared to usual care.
See Appendix F for full GRADE tables.
1.1.7. Economic evidence
1.1.7.1. Included studies
No health economic studies were included.
1.1.7.2. Excluded studies
No relevant health economic studies were excluded due to assessment of limited applicability or methodological limitations.
See also the health economic study selection flow chart in Appendix G
1.1.8. Summary of included economic evidence
No health economic studies were included in this review.
1.1.9. Economic model
New cost-effectiveness analysis was not prioritised in this area.
1.1.10. Unit costs
Oral hygiene interventions may require additional resource use over usual care. In the studies included in the clinical review this varied (see Table 1 for details) and could be due to:
- Different health care professionals undertaking mouth care (for example, a nurse rather than a nursing assistant).
- Increased health care professional time required to undertake mouth care.
- Additional or different consuables (such as electric instead of standard toothbrushes, modified toothbrushes to aid handling, different toothpaste, mouth wash, dental floss, mouth gel and other hygiene related equipment).
- Additional training costs.
Relevant unit costs are provided below to aid consideration of cost effectiveness.
Table 9
Unit costs of health care professionals who may be involved in delivering oral hygiene interventions.
If an intervention reduces clinical events (such as pneumonia) this may result in cost savings due to treatment costs avoided, reduced length of stay (if already in hospital) or reduced readmission (if discharged).
1.1.11. Evidence statements
Effectiveness/Qualitative
Economic
No relevant economic evaluations were identified.
1.1.12. The committee's discussion and interpretation of the evidence
1.1.12.1. The outcomes that matter most
The committee included the following outcomes: mortality, person/participant and carer generic health-related quality of life, occurrence of pneumonia, stroke outcome (modified Rankin scale), requirement for enteral feeding support, oral health outcome scales, dysphagia severity, presence of oral disease (including gingivitis, oral candidiasis and denture-induced stomatitis), length of hospital stay, readmission and stroke-specific patient-reported outcome measures (including stroke-specific quality of life measures). All outcomes were considered equally important for decision making and therefore have all been rated as critical. Mortality, occurrence of pneumonia and presence of oral disease were considered important as direct markers of the consequence of poor oral hygiene for people after a stroke. Requirement for enteral feeding support and dysphagia severity was selected as important areas that could be improved by oral hygiene intervention that would have significant benefits for the person. The committee chose to not investigate the rates of dental plaque, as they did not consider this to be critically important for their decision making. The committee chose to investigate these outcomes up to 3 months, as they considered that any improvements would likely be seen before this point and any changes afterwards may be attributable to other factors.
There was limited evidence for most outcomes. Some outcomes were not reported in any of the included studies, including:
- Person/participant and carer generic health-related quality of life
- Stroke outcome (modified Rankin scale)
- Presence of denture-induced stomatitis
- Readmission
- Stroke-specific Patient-Reported Outcome Measures
The committee concluded that while this produced an element of uncertainty, they could still form recommendations based on the information available.
1.1.12.2. The quality of the evidence
Nine randomised controlled trial studies were included in the review. Evidence was available for the following comparisons:
- Oral hygiene intervention (once a day) compared to usual care – 3 studies
- Oral hygiene intervention (twice a day) compared to usual care – 4 studies
- Oral hygiene intervention (three times a day) compared to usual care – 1 study
- Oral hygiene intervention (four times a day) compared to usual care – 1 study
Two additional comparisons, which were not explicitly stated in the protocol, were reported for the committee to consider while making decisions.
- Oral hygiene intervention (twice a day with additional treatment twice a week) compared to oral hygiene intervention (twice a day)
- Oral hygiene intervention (twice a day with additional treatment twice a week) compared to usual care
There were no studies discussing hourly oral care, and different daily frequencies of oral hygiene care were not compared to each other.
The evidence varied from moderate to very low quality, with the majority being of very low quality. Outcomes were commonly downgraded for risk of bias and imprecision. In most cases, it was not possible to conduct a meta-analysis on outcomes as there was limited outcome data reported by the studies. Furthermore, with small sample sizes in the majority of studies, very severe imprecision was seen in most outcomes. Risk of bias was commonly due to bias arising from the randomisation process and bias due to missing outcome data. The quality of some outcomes was further reduced due to indirectness. This included intervention indirectness (where the amount of treatment provided was less than the minimum time category) and outcome indirectness. Where meta-analysis was possible, no inconsistency was seen.
The type of oral hygiene intervention varied between studies. This included interventions where more minimal changes were implemented (such as using an electric toothbrush) and where more substantial changes were made (including professional cleaning). Most commonly, the intervention was a combination of multiple techniques (including tooth brushing [with or without an electrical toothbrush], tongue brushing, oral swabbing, flossing, mouthwash, education and professional cleaning).
The usual care provided varied between studies. This varied from manual toothbrushing with commercial toothpaste, to toothbrushing and sponge stick cleaning, to both of these and mouthwash and lip care. In the case of the trial where an antimicrobial oral gel was used, a placebo oral gel was used in the usual care group. The committee acknowledged this heterogeneity when examining the studies and took this into account when considering the effects of each trial.
The committee concluded that the evidence was of a sufficient quality to make recommendations. They acknowledged the small sample sizes which had an effect on the precision. They noted that 2 of the studies were conducted in stroke units, while others were conducted in neurological intensive care units and rehabilitation wards. Only 1 study was completed in the United Kingdom but the committee agreed that the interventions described could be applied to the NHS and most would be available now, although additional resource would be required for the more intense oral hygiene regimens described.
1.1.12.3. Benefits and harms
1.1.12.3.1. Key uncertainties
The committee noted that there was no evidence for some outcomes, in particular for health-related quality of life. However, the patient and carer representatives were unanimous in emphasising the negative impact of inadequate mouthcare on quality of life, and each had experience of poor practice in this area. They reflected that mouth discomfort would have a significant effect on their ability to participate in other aspects of rehabilitation and would influence their mood throughout the day. It would also affect their ability to taste, and so influence their oral intake adding a further barrier to effective care.
The committee discussed the effect on pneumonia. It is commonly believed that poor mouthcare influences rates of pneumonia. While some comparisons showed evidence of this, in others there was no evidence that rates of pneumonia were affected by oral hygiene measures. In at least 1 of these studies pneumonia rates were surprisingly low in both arms (no cases), raising questions about the ascertainment methods for pneumonia. Of the 2 other studies showing a reduction in pneumonia rates, 1 was in a population admitted to ICU and so only reflected a subset of the stroke population. People in ICU will have a higher rate of pneumonia than the general stroke population. The other was in acute stroke assessment units and looked at the use of an oral gel 4 times daily in addition to usual care. Overall, the committee agreed that the link between oral health and pneumonia was well accepted, but this review provided only weak evidence that oral health care interventions reduce the incidence.
The committee discussed the effect on mortality. They would have predicted that a reduction in mortality from improved mouth care would be mediated by a reduction in pneumonia, but this is not apparent in some of the studies in this review. This may be because of a failure to report pneumonia consistently, but the committee also reflected that other mechanisms may be relevant, including the effect of good oral hygiene on hydration and nutrition.
There was no evidence investigating oral hygiene interventions completed hourly. The committee noted that this is an important area for people with significant swallowing problems who may require extra support to prevent aspiration. While some studies included participants who were nil-by-mouth who were provided with less frequent interventions, there are people who may require more frequent intervention.
The committee considered whether they could identify the key elements of an oral hygiene care package, but the interventions used were different in each study and it was not possible to do this with confidence. They acknowledged the importance of assessing the individual needs of the person after a stroke. Some people may require more intense care than others, including the use of an electric toothbrush, chlorhexidine mouthwash and suctioning, but this may not be appropriate for all people (for example: people who bite down on their toothbrush may find it harder to use an electric toothbrush, people with sensory differences may find the intensity of some procedures uncomfortable). A person-centred approach should be taken for all interventions and mouth care should be adapted to the needs of the person.
There were no studies comparing different frequencies of oral care to each other, and some evidence of benefit at each of the frequencies described by the studies. The committee decided that providing oral care at least twice a day was important, noting that basic dental advice is that teeth should be cleaned a minimum of 2 times per day.
1.1.12.3.2. Oral hygiene intervention (once a day)
The results showed that, when compared to usual care, there were clinically important benefits from oral hygiene interventions (once a day) for mortality, requirement of enteral feeding support, oral health outcome scales, presence of oral disease (gingivitis only) and length of hospital stay. However, there was no clinically important difference seen in dysphagia severity and presence of oral disease (oral candidiasis only). These outcomes were reported in small studies, with the majority having approximately 30 participants in each study arm. Most outcomes were of very low quality due to risk of bias, imprecision and indirectness.
The committee acknowledged that the interventions included in the evidence for this comparison was unlikely to be the only oral care provided to participants. In 2 cases, the oral hygiene intervention was of high intensity, including professional cleaning in one case, and a combination of suctioning, oral swabbing, toothbrushing, flossing and interdental brushes, being performed 30 minutes prior to swallow training in the other. The latter comparison was downgraded for indirectness as this care was only provided three times a week specifically before swallowing training. They reflected that common guidance is to at least complete tooth brushing with a fluoride-containing toothpaste twice a day and providing care less frequently than this is unlikely to be rigorous enough to maintain oral health. However, more intense care may be required less frequently than this dependent on the needs of the person.
1.1.12.3.3. Oral hygiene intervention (twice a day)
The results showed that, when compared to usual care, there were clinically important benefits from oral hygiene interventions (twice a day) for mortality, requiring enteral feeding support and oral health outcome scales. However, there was no clinically important difference seen in occurrence of pneumonia, dysphagia severity and presence of oral disease (gingivitis). These outcomes were reported in small studies, with the majority having approximately 35 participants in each study arm. Most outcomes were of very low quality, due to risk of bias, imprecision and indirectness.
One study discussed adding an additional intervention three times a week to an intervention twice a day. This showed no clinically important difference to the oral hygiene intervention completed twice a day.
The committee considered this evidence as important for showing the benefit of oral hygiene interventions. They noted that the interventions used were more intense than those regularly offered to people in current practice, including: electric toothbrushing, chlorhexidine mouthwash, flossing, tongue cleaning and lip balm. Each package included education and training for either the person after a stroke, healthcare staff or caregivers to ensure the tools were being used appropriately. While this is more intense than usual care, they also noted that the usual care provided in the studies may be more intense than that currently provided. Expert patient and healthcare staff experience reflected that in some cases oral health care may not be provided twice a day and people may not receive the mouthcare that they require. Given the effect on mortality seen in the evidence, the committee members agreed that regular mouthcare was important to help prevent death as well as a range of additional benefits for quality of life that were not captured in this evidence.
The committee noted that there was an inconsistency in the results for mortality and pneumonia in this comparison. The mortality outcome (including one study) showed a clinically important benefit (leading to 60 fewer deaths per 1000 people), while the occurrence of pneumonia outcome showed no clinically important difference with zero pneumonia events in both study arms. The committee reflected that they would expect the rate of pneumonia to be higher than this in people after stroke (they would expect 20–30% of people after stroke to develop pneumonia). On looking at the evidence, they noted that the Kuo 2016 study, which was included in the mortality outcome, did not report the occurrence of pneumonia. Therefore, it was unclear as to whether these events were linked to pneumonia. The committee discussed that other causes may prevent deaths in people receiving oral hygiene interventions after stroke.
1.1.12.3.4. Oral hygiene intervention (three times a day)
The results showed that, when compared to usual care, there were clinically important benefits from oral hygiene interventions (three times a day) for mortality and occurrence of pneumonia. The outcomes were reported in one study, including approximately 40 participants in each study arm. The outcomes were of very low quality due to risk of bias and imprecision.
There was only 1 study included in the evidence for this comparison. This study looked specifically at oral swabbing with chlorhexidine mouthwash for people in an intensive care unit. The committee noted that a minority of stroke victims are admitted to intensive care and had reservations about the applicability of this study to usual practice.
1.1.12.3.5. Oral hygiene intervention (four times a day)
The results showed that, when compared to usual care, there were clinically important benefits from oral hygiene interventions (4 times a day) for mortality and occurrence of pneumonia. These outcomes were reported in 1 study, including a larger number of participants (approximately 100 in each study arm). The outcomes ranged from moderate (for occurrence of pneumonia) and low quality (for mortality) due to imprecision.
The committee noted the benefits seen in this one study included in the evidence for this outcome. This study was conducted in England in a group of acute stroke assessment units and was considered directly applicable to NHS practice. They noted that oral gels including antibacterial and antifungal properties may be helpful for people after a stroke to prevent infections. They concluded that this should be assessed based on the needs of the person after a stroke.
1.1.12.3.6. Weighing up the benefits and harms
Weighing up the benefits and the absence of harms from the evidence, and from their committee consensus, it was agreed that oral hygiene should be assessed using standard national or local protocols (such as Mouthcare Matters) to ensure that mouthcare is considered for all people. All people should be encouraged to protect their oral health by brushing their teeth and gums, using an electric or battery-powered toothbrush if needed and using mouthwash and dental gel as needed, at least twice a day. Other measures may be necessary and these can be advised by appropriately trained staff. This may include increased frequency of care (for example: for people at risk of aspiration). Finally, they recommended that people who are suitably trained should deliver or supervise mouth care for people who are not able to do this on their own at this time, acknowledging that not all people may be able to look after their mouth care after a stroke. The committee wanted to emphasise the importance of care being provided at least twice a day, but that more frequent mouthcare may be beneficial and care should be provided as frequently as the person requires.
1.1.12.4. Cost effectiveness and resource use
No relevant health economic analyses were identified for this review; therefore, unit costs were presented to aid committee consideration of cost-effectiveness.
As described above, the studies included in the clinical review varied in terms of the oral hygiene interventions being assessed but would all involve some additional resource use over usual care. It was also noted that usual care comparator in the studies may be more than is current usual NHS practice. Additional costs could relate to different or additional consumables (such as electric toothbrushes or oral gels), the healthcare professionals who delivered the mouth care to patients, the additional staff time required to provide mouth care, and whether training was provided to staff or family members. Four of the 9 studies had a nurse deliver the intervention and the committee noted that mouth care is often delivered by the nursing team in practice, although in some committee members’ experience potentially any member of the stroke rehabilitation team could currently be responsible for providing care.
The clinical evidence suggested there may be reductions in oral health problems and pneumonia, and this could potentially result in cost savings due to treatment costs avoided.
The committee discussed that the potential mortality benefit seen in the clinical evidence could result in gains of quality-adjusted life years. The committee also highlighted the potential for quality of life improvements from people simply receiving sufficient oral hygiene treatment. Some members noted that inadequate oral care left stroke patients feeling discomfort, embarrassment and low confidence which can deter them from engaging in therapy. Poor mouth care hinders speech and language therapists from providing treatment to patients as well. These benefits are difficult to formally assess due to the lack of quality of life data from the clinical review.
The committee took the uncertainties in cost effectiveness into consideration when making recommendations. They agreed that the potential health benefits of improved oral hygiene were likely to justify additional resource use. It was also noted that twice daily mouthcare is the national standard for oral hygiene and should be facilitated as part of the essential requirements of care.
The committee agreed it was difficult to judge whether there was likely to be a substantial resource impact from the recommendations due to a number of uncertainties including a lack of information about what mouth care is currently being provided to stroke patients, difficulties estimating the number of people where additional intervention would be required and uncertainty about what downstream cost savings might be realisable. The committee noted that the number of people who require assistance with mouthcare after stroke was likely to be a fairly large proportion of the stroke population as it will include people who experience a range of issues such as dysphagia, sensory loss, lack of balance, limited upper limb function and those who are nil-by-mouth. The committee agreed that current practice is variable, and patients often report a lack of support for mouth care. However, it was also highlighted that there is an existing NHS initiative (Mouth Care Matters) that aims to improve mouth care in hospitals including for those requiring assistance. There could be a significant resource impact if interventions such as electric toothbrushes were routinely provided for all stroke patients due to their cost, however, the committee recommended that use of such interventions should be based on individual assessment of need and so would not be applicable to the entire stroke population. The committee noted that mouth care training should already be available to healthcare professionals involved in delivering it. Appropriate training to family members or carers may incur additional resource use to the NHS as this is beyond current practice for some areas in the UK. The committee highlighted that training is important to ensure that effective oral hygiene is being offered and to prevent complications.
1.1.12.5. Other factors the committe took into account
The committee acknowledged the importance of empowering the person after stroke to complete mouth care themselves as far as they can, to support their return to independence. Adjustments may be needed to help the person to do this. Where this is not possible, caregivers should work with the person to complete mouth care. The committee noted that a holistic approach is needed for this, as people may be unable to complete oral care for a variety of reasons (for example: memory problems, visual neglect, physical difficulties in using a sink, sensory sensitivities).
The committee noted that a variety of healthcare professionals and other individuals may be involved in providing mouthcare. This included:
- Healthcare assistants
- Nurses
- Family members/carers
- Speech and language therapists
- Physiotherapists
- Occupational therapists
- Doctors
- Dentists and dental hygienists
- Volunteers
They noted that anyone providing help with mouth care should have the appropriate training to complete the task. This is particularly important for people with dysphagia and people who are nil-by-mouth, as extra considerations may need to be taken to ensure mouth care is provided safely.
The effect of poor oral care on the work of professionals was discussed. Speech and language therapists on the committee explained that they would require someone to have had good mouth care before completing swallowing assessments, as if this is not achieved then it may lead to poorer outcomes. When this is not completed beforehand, they may not be able to do swallowing assessments on that day, which can have an effect on providing holistic rehabilitation care and supporting discharge from hospital care.
The committee noted that currently recording of mouth care in healthcare services is not consistent across the country. Given the potential impact mouth care interventions could have, they would encourage that consistent monitoring is used by services and that this could be an important area for auditing in the future.
Mouth care is considered in other NICE guidance, including NG48: Oral health for adults in care homes. This includes the consideration of assessment of mouth care. The committee took this into consideration when making the recommendation about assessment of oral hygiene. Ultimately they agreed that any national or local protocol that is agreed as acceptable would be relevant to use, as they noted that some are currently used (such as Mouthcare Matters), and that use of these protocols may be useful for ensuring continuity of practice.
The previous version of this guidance from 2013 included the following guidance:
1.7.3 Ensure that effective mouth care is given to people with difficulty swallowing after stroke, in order to decrease the risk of aspiration pneumonia.
The committee considered the new recommendation to contain this information and provide clearer guidance to help support people with difficulty swallowing after stroke.
1.1.13. Recommendations supported by this evidence review
This evidence review supports recommendations 1.10.1 to 1.10.3.
1.1.14. References
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- 2.
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Appendices
Appendix A. Review protocols
Review protocol for the clinical and cost-effectiveness of interventions for oral hygiene (PDF, 234K)
Review protocol for health economic literature review (PDF, 142K)
Appendix B. Literature search strategies
B.1. Clinical search literature search strategy
Searches were constructed using a PICO framework where population (P) terms were combined with Intervention (I) and in some cases Comparison (C) terms. Outcomes (O) are rarely used in search strategies as these concepts may not be indexed or described in the title or abstract and are therefore difficult to retrieve. Search filters were applied to the search where appropriate.
Download PDF (188K)
B.2. Health Economics literature search strategy
Health economic evidence was identified by conducting searches using terms for a broad Stroke Rehabilitation population. The following databases were searched: NHS Economic Evaluation Database (NHS EED - this ceased to be updated after 31st March 2015), Health Technology Assessment database (HTA - this ceased to be updated from 31st March 2018) and The International Network of Agencies for Health Technology Assessment (INAHTA). Searches for recent evidence were run on Medline and Embase from 2014 onwards for health economics, and all years for quality-of-life studies. Additional searches were run in CINAHL and PsycInfo looking for health economic evidence.
Download PDF (191K)
Appendix C. Effectiveness evidence study selection
Download PDF (249K)
Appendix D. Effectiveness evidence
Ab Malik, 2018 (PDF, 95K)
Ab Malik, 2018 (PDF, 216K)
Chen, 2019 (PDF, 285K)
Chipps, 2014 (PDF, 256K)
Dai, 2017 (PDF, 206K)
Dai, 2017 (PDF, 236K)
Dai, 2019 (PDF, 178K)
Gosney, 2006 (PDF, 209K)
Kim, 2014 (PDF, 283K)
Kuo, 2016 (PDF, 209K)
Lam, 2013 (PDF, 177K)
Lam, 2013 (PDF, 255K)
Yuan, 2020 (PDF, 211K)
Appendix E. Forest plots
E.1. Oral hygiene intervention (once a day) compared to usual care
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E.2. Oral hygiene intervention (twice a day) compared to usual care
Download PDF (160K)
E.3. Oral hygiene intervention (three times a day) compared to usual care
Download PDF (153K)
E.4. Oral hygiene intervention (four times a day or more) compared to usual care
Download PDF (119K)
E.5. Oral hygiene intervention (twice a day with additional treatment twice a week) compared to oral hygiene intervention (twice a day)
Download PDF (148K)
E.6. Oral hygiene intervention (twice a day with additional treatment twice a week) compared to usual care
Download PDF (145K)
Appendix F. GRADE tables
F.1. Oral hygiene intervention (once a day) compared to usual care
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F.2. Oral hygiene intervention (twice a day) compared to usual care
Download PDF (202K)
F.3. Oral hygiene intervention (three times a day) compared to usual care
Download PDF (175K)
F.4. Oral hygiene intervention (four times a day or more) compared to usual care
Download PDF (175K)
F.5. Oral hygiene intervention (twice a day with additional treatment twice a week) compared to Oral hygiene intervention (twice a day)
Download PDF (190K)
F.6. Oral hygiene intervention (twice a day with additional treatment twice a week) compared to usual care
Download PDF (180K)
Appendix G. Economic evidence study selection
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Appendix H. Economic evidence tables
No health economic studies were included in this review.
Appendix I. Health economic model
New cost-effectiveness analysis was not prioritised in this area.
Appendix J. Excluded studies
Clinical studies
Table 18Studies excluded from the clinical review
| Study | Code [Reason] |
|---|---|
| 'Ö, Ä, ö2, Lakhyung et al (2011) Effect of Saengmaeg-san Extract on Xerostomia in Stroke Patients: A Double-Blind Randomized Controlled Study. The Journal of Internal Korean Medicine 32: 542–549 | - Study not reported in English |
| Ab Malik N., Mohamad Yatim S., Lam O. L. et al (2017) Effectiveness of a Web-Based Health Education Program to Promote Oral Hygiene Care Among Stroke Survivors: Randomized Controlled Trial. Journal of Medical Internet Research 19(3): e87 [PMC free article: PMC5392212] [PubMed: 28363880] |
- Population not relevant to this review protocol Investigating effects purely on the healthcare professionals, not the stroke survivors |
| Brady M. C., Stott D. J., Norrie J. et al (2011) Developing and evaluating the implementation of a complex intervention: using mixed methods to inform the design of a randomised controlled trial of an Oral healthcare intervention after stroke. Trials [Electronic Resource] 12: 168 [PMC free article: PMC3155479] [PubMed: 21729277] |
- Study design not relevant to this review protocol Non-comparative study |
| Brady M. C., Stott D. J., Weir C. J. et al (2020) A pragmatic, multi-centered, stepped wedge, cluster randomized controlled trial pilot of the clinical and cost effectiveness of a complex Stroke Oral healthCare intervention pLan Evaluation II (SOCLE II) compared with usual Oral healthcare in stroke wards. International Journal of Stroke 15(3): 318–323 [PMC free article: PMC7153219] [PubMed: 31564241] |
- Population not relevant to this review protocol Is conducted on a stroke ward but not with stroke patients only. The overall diagnosis rate was 74.8%. Therefore, >20% didn’t have a stroke. |
| Brady M. C., Stott D., Weir C. J. et al (2015) Clinical and cost effectiveness of enhanced Oral healthcare in stroke care settings (SOCLE II): a pilot, stepped wedge, cluster randomized, controlled trial protocol. International Journal of Stroke 10(6): 979–84 [PubMed: 26079661] |
- Population not relevant to this review protocol Protocol for a different study that was excluded as it was conducted on a stroke ward but not with stroke patients only. The overall diagnosis rate was 74.8%. Therefore, >20% didn’t have a stroke. |
| Brady M., Furlanetto D., Hunter R. V. et al (2006) Staff-led interventions for improving Oral hygiene in patients following stroke. Cochrane Database of Systematic Reviews: cd003864 [PubMed: 17054189] | - More recent systematic review included that covers the same topic |
| Campbell P., Bain B., Furlanetto D. L. C. et al (2020) Interventions for improving Oral health in people after stroke. Cochrane Database of Systematic Reviews [PMC free article: PMC8106870] [PubMed: 33314046] |
- Cochrane review - included interventions in the pooled analysis that are not included in our analysis (assessment techniques), included outcomes that the committee did not think were relevant for their analysis, included studies with a smaller proportion of participants with stroke than 80% (as aareed in the protocol for this guideline) References checked |
| Dai R., Lam O. L. T., Lo E. C. M. et al (2017) Oral health-related quality of life in patients with stroke: a randomized clinical trial of Oral hygiene care during outpatient rehabilitation. Scientific Reports 7(1): 7632 [PMC free article: PMC5550442] [PubMed: 28794410] | - Data not reported in an extractable format or a format that can be analysed |
| Dai R., Lam O. L., Lo E. C. et al (2015) A systematic review and meta-analysis of clinical, microbiological, and behavioural aspects of Oral health among patients with stroke. Journal of Dentistry 43(2): 171–80 [PubMed: 24960298] |
- Comparator in study does not match that specified in this review protocol Compares people who had a stroke with people who did not looking at their Oral health care behaviours and status |
| Edwards M. (2008) Staff training improved Oral hygiene in patients following stroke. Evidence-Based Dentistry 9(3): 73 [PubMed: 18927563] |
- Study design not relevant to this review protocol Commentary on a systematic review |
| Fields L. B. (2008) Oral care intervention to reduce incidence of ventilator-associated pneumonia in the neurologic intensive care unit. Journal of Neuroscience Nursing 40(5): 291–8 [PubMed: 18856250] |
- Study design not relevant to this review protocol Started as a randomised control trial, but then finished early due to positive response. They did not report results in a way that we could extract. |
| Frenkel H.; Harvey I.; Needs K. (2002) Oral health care education and its effect on caregivers' knowledge and attitudes: a randomised controlled trial. Community Dent Oral Epidemiol 30(2): 91–100 [PubMed: 12000349] |
- Population not relevant to this review protocol <80% of participants had a stroke. |
| Frenkel H.; Harvey I.; Newcombe R. G. (2001) Improving Oral health in institutionalised elderly people by educating caregivers: a randomised controlled trial. Community Dent Oral Epidemiol 29(4): 289–97 [PubMed: 11515643] | - Population not relevant to this review protocol |
| Juthani-Mehta M., Van Ness P. H., McGloin J. et al (2015) A cluster-randomized controlled trial of a multicomponent intervention protocol for pneumonia prevention among nursing home elders. Clin Infect Dis 60(6): 849–57 [PMC free article: PMC4415071] [PubMed: 25520333] | - Population not relevant to this review protocol |
| Kelly T. (2010) Review of the evidence to support Oral hygiene in stroke patients. Nursing Standard 24(37): 35–8 [PubMed: 20533667] | - Review article but not a systematic review |
| Kim E. K., Park E. Y., Sa Gong J. W. et al (2017) Lasting effect of an Oral hygiene care program for patients with stroke during in-hospital rehabilitation: a randomized single-center clinical trial. Disability & Rehabilitation 39(22): 2324–2329 [PubMed: 27628624] |
- Data not reported in an extractable format or a format that can be analysed Discusses number of people who had systemic infection and recurrence of stroke together, while if reported separately may be able to use systemic infection to discuss pneumonia. |
| Kobayashi K., Ryu M., Izumi S. et al (2017) Effect of Oral cleaning using mouthwash and a mouth moisturizing gel on bacterial number and moisture level of the tongue surface of older adults requiring nursing care. Geriatr Gerontol Int 17(1): 116–121 [PubMed: 26711466] | - Data not reported in an extractable format or a format that can be analysed |
| Kuo Y. W., Yen M., Fetzer S. et al (2015) Effect of family caregiver Oral care training on stroke survivor Oral and respiratory health in Taiwan: a randomised controlled trial. Community Dental Health 32(3): 137–42 [PubMed: 26513847] | - Data not reported in an extractable format or a format that can be analysed |
| Lam O. L. T. and McGrath C. P. J. (2010) A clinical trial on the effect of chlorhexidine mouth rinse and assisted tooth brushing on the health condition and quality of life of elderly stroke patients. |
- Full text paper not available Trial registry record |
| Lyons M., Smith C., Boaden E. et al (2018) Oral care after stroke: Where are we now?. European Stroke Journal 3(4): 347–354 [PMC free article: PMC6571511] [PubMed: 31236482] |
- Review article but not a systematic review Narrative review, references checked |
| McMillan A. S. (2006) A randomized clinical trial on the effect of chlorhexidine mouth rinse and assisted tooth brushing on the health condition and quality of life of elderly stroke patients. |
- Full text paper not available Trial registry record |
| Poohkam J., Meemak J., Sukhanthaman M. et al (2021) The effectiveness of an aspiration pneumonia prevention program in acute ischemic stroke patients. Stroke 52(suppl1) | - Conference abstract |
| Seguin P., Laviolle B., Dahyot-Fizelier C. et al (2014) Effect of oropharyngeal povidone-iodine preventive Oral care on ventilator-associated pneumonia in severely brain-injured or cerebral hemorrhage patients: a multicenter, randomized controlled trial. Critical Care Medicine 42(1): 1–8 [PubMed: 24105456] | - Population not relevant to this review protocol |
| Smith C., Lightbody C., Sandom F. et al (2022) CHLORHEXIDINE OR TOOTHPASTE, MANUAL OR POWERED BRUSHING TO PREVENT PNEUMONIA COMPLICATING STROKE (CHOSEN): A 2X2 FACTORIAL RANDOMISED CONTROLLED FEASIBILITY TRIAL. European Stroke Journal 7(1suppl): 150–151 | - Conference abstract |
| Wu J., Dai Y., Lo E. C. M. et al (2020) Using metagenomic analysis to assess the effectiveness of Oral health promotion interventions in reducing risk for pneumonia among patients with stroke in acute phase: study protocol for a randomized controlled trial. Trials [Electronic Resource] 21(1): 634 [PMC free article: PMC7350693] [PubMed: 32650814] | - Protocol only |
Health Economic studies
Published health economic studies that met the inclusion criteria (relevant population, comparators, economic study design, published 2006 or later and not from non-OECD country or USA) but that were excluded following appraisal of applicability and methodological quality are listed below. See the health economic protocol for more details.
Table 19Studies excluded from the health economic review
| Reference | Reason for exclusion |
|---|---|
| None |
Final version
Evidence reviews underpinning recommendations 1.10.1 to 1.10.3
These evidence reviews were developed by NICE
Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.
NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.
- Review Technology for maintaining oral care after stroke: considerations for patient-centered practice.[Disabil Rehabil Assist Technol...]Review Technology for maintaining oral care after stroke: considerations for patient-centered practice.Gurgel-Juarez N, Egan M, Wiseman M, Finestone H, Flowers HL. Disabil Rehabil Assist Technol. 2022 Nov; 17(8):916-926. Epub 2020 Sep 29.
- Effectiveness of professional oral health care intervention on the oral health of residents with dementia in residential aged care facilities: a systematic review protocol.[JBI Database System Rev Implem...]Effectiveness of professional oral health care intervention on the oral health of residents with dementia in residential aged care facilities: a systematic review protocol.Yi Mohammadi JJ, Franks K, Hines S. JBI Database System Rev Implement Rep. 2015 Oct; 13(10):110-22.
- Randomized clinical trial of oral health promotion interventions among patients following stroke.[Arch Phys Med Rehabil. 2013]Randomized clinical trial of oral health promotion interventions among patients following stroke.Lam OL, McMillan AS, Samaranayake LP, Li LS, McGrath C. Arch Phys Med Rehabil. 2013 Mar; 94(3):435-43. Epub 2012 Nov 2.
- The effect of a daily application of a 0.05% chlorhexidine oral rinse solution on the incidence of aspiration pneumonia in nursing home residents: a multicenter study.[BMC Geriatr. 2017]The effect of a daily application of a 0.05% chlorhexidine oral rinse solution on the incidence of aspiration pneumonia in nursing home residents: a multicenter study.Hollaar VRY, van der Putten GJ, van der Maarel-Wierink CD, Bronkhorst EM, de Swart BJM, Creugers NHJ. BMC Geriatr. 2017 Jun 19; 17(1):128. Epub 2017 Jun 19.
- Review Oral health disparities in older adults: oral bacteria, inflammation, and aspiration pneumonia.[Dent Clin North Am. 2014]Review Oral health disparities in older adults: oral bacteria, inflammation, and aspiration pneumonia.Scannapieco FA, Shay K. Dent Clin North Am. 2014 Oct; 58(4):771-82. Epub 2014 Jul 22.
- Evidence reviews for the clinical and cost-effectiveness of interventions to sup...Evidence reviews for the clinical and cost-effectiveness of interventions to support oral hygiene for adults after a stroke
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