| Study | Risk of Bias Assessment |
|---|---|
| Ancoli- Israel, 20031 | Moderate - Patient blinding unclear; staff/outcome assessors not blinded, staff reported preconceptions of what each treatment group would do for the patients; analysis methods do not mention attrition, but period is short so possibly little. |
| Baillon, 20042 | High - High performance, detection, and attrition bias. |
| Baker, 20033 | Moderate - Fidelity issues, also different organizational contexts across countries, high attrition. |
| Ballard, 20024 | Moderate - Randomization at facility level but study does not account for facility differences. |
| Beck, 20025 | Moderate - Attrition not equal in groups. |
| Burns, 2011 | Moderate - High attrition at posttreatment; not corrected for multiple comparisons. |
| Burns, 20096 | Low |
| Camberg, 19997 | Moderate - Intervention not implemented as directed; instruments not validated for agitation; staff reporting may introduce bias. |
| Clark, 19988 | High - Blinding unclear; only valid data presented in line graphs; other data combines from crossover groups; attrition and missing data unclear. |
| Cohen-Mansfield, 20129 | Moderate - Selection bias; unclear performance bias; potential detection bias. |
| Cohen-Mansfield, 200710 | High - Partial randomization; baseline characteristics not similar regarding age; no mention of blinding of participants, interventionists, manuals, power analysis, attrition, or handling of missing data; outcome assessors not blinded; co-interventions not similar. |
| Cooke, 201011 | Low |
| Deponte, 200712 | High - Selection and randomization unclear; high performance bias; blinding and fidelity unclear; incomplete data not handled appropriately; underpowered. |
| Dowling, 200713 | Moderate - Performance and detection bias unclear; high attrition. |
| Fu, 201314 | Moderate - Mid intervention they had 5 dropouts that withdrew consent because they wanted to be sure they were in experimental group--they were dropped so ITT model not completely used. |
| Fuji, 200815 | Moderate - Performance bias may be an issue; they did the aroma therapy 3 times a day, an hour after meals; no placebo control. |
| Garland, 200716 | High - Unclear randomization method and baseline characteristics; no mention of fidelity checks, manuals, outcome assessors, power and attrition; high risk of reporting bias; crossover study, unclear if patients were observed for all outcomes or only those which the patient primarily displayed; unsure if 2-day washout is appropriately long enough, assessors not completely blinded (seemed to guess which treatment the participant had); many excluded participants seemingly after randomization; not ITT analysis. |
| Gerdner, 200017 | High - Unclear randomization method, no mention of blinding of participants, interventionists, fidelity checks, manuals and outcome assessors; no mention of power analysis or handling of missing data; crossover study, unblinded outcome assessor (RA who did assessment was also there while the music was playing); possibly unbalanced groups at baseline (no demographic table, but mention 2 of 16 demographic variables significantly different); low attrition; not ITT analysis. |
| Hatakeyama, 201018 | High - Small sample size; selective recruitment unclear randomization, blinding, attrition, fidelity. |
| Hawranik, 200819 | Moderate - Selection bias, small sample size, diffusion, definition of intervention, fidelity unclear. |
| Hicks-Moore, 200820 | High - Randomization and allocation methods unclear, unblinded, power calculation not reported, attrition unclear. |
| Houser, 201421 | High - Unclear randomization method; small study sample (no power analysis); no mention of blinding of participants, interventionists, fidelity checks, manuals and outcome assessors; no mention of handling of missing data. |
| Hozumi, 199622 | Moderate - Participants seemingly blinded, unclear about outcomes assessors; attrition unclear; missing data unclear. |
| Hutson, 201423 | Moderate - Unclear if participants in control group received treatment, unblinded, underpowered at randomization. |
| Ito, 200724 | Moderate - Participants and staff not blinded; high attrition and MNAR obvious from group comparisons; not ITT analysis; high possibility for bias for how data is presented for primary and secondary analysis purposes. |
| Janata, 201225 | High - Unblinded, power calculation not reported, most results reported via graphs. |
| Jablonski, 200526 | High - Selection bias; performance bias actual implementation of intervention, fidelity checks, hard to know what exactly was done for the intervention. |
| Kolanowski, 200127 | High – Randomization methods not described, patients served as their own controls, small sample size, power calculation not reported. |
| Kolanowski, 200528 | Moderate - Crossover study; outcome assessors blinded; only selected certain behaviors by patient; did not assess all behaviors; fidelity checks appropriate; study design and analysis very confusing since A, B, and C treatments are individualized; multiple comparisons correction unclear but unlikely and many comparisons were made, not ITT analysis. |
| Kolanowski, 201129 | Moderate - Baseline differences among groups. |
| Kovach, 200430 | Moderate - Performance bias; nurses sometimes didn't implement if they were too busy; had to change schedules several times, groups unequal at baseline; high attrition. |
| Landi, 200431 | High - Authors call this a case control study but mention randomization; blinding unclear; little description of intervention, no mention of attrition or missingness; bar graphs only for outcomes. |
| Lawton, 199832 | High - About 50% attrition rate, missing data not appropriately handled, outcome assessors not blinded; fidelity and power unclear. |
| Lichenberg, 200533 | Moderate -Assessor not blinded—an outside geriatric neuropsychologist; attrition not reported. |
| Lin, 200734 | Moderate - Non-random sampling, issues with design (assumes no changes in condition), staff were not blinded to outcomes. |
| Lin, 200935 | Low |
| Lin, 201136 | Moderate - Some issues with selection bias and contamination (in the same facility); blinding unclear; low attrition; likely not ITT analysis, but unclear; did not appear to correct for multiple comparisons. |
| Low, 201337 | Moderate - Theory-base unclear, unclear if manualized, outcome assessor blinding compromised. |
| Lyketsos, 199938 | Moderate - High attrition, not clear about how these patients were selected (and small sample size), whether sample was appropriate (did not report concerns with sleep/wake cycles), concerned about diffusion, not clear if staff were trained differently, etc. |
| Mariko, 201539 | High - Randomization and allocation methods not described, standardization of intervention unclear, missing data handling unclear. |
| Maseda, 2014 | Moderate - Unblinded outcome assessor, power calculation not reported, all results reported via graphs. |
| McCallion, 1999a40 | Moderate - Unclear regarding method of randomization and study may be under powered, unbalanced on two baseline measures one being length of stay which may mean there are unobserved disease severity variables impacting results. |
| McGilton, 200341 | High – Issues with selection bias, unclear intervention intensity and fidelity to treatment, small sample size. |
| Milev, 200842 | High - No ITT analysis; mostly unblinded; low attrition, but small population; unbalanced groups at baseline; selection bias, contamination, power issues, inadequate randomization. -Incomplete data not handled appropriately; lack of blinding of outcome assessors. |
| Moyle, 2014 | Moderate - Some detection bias (underpowered, multiple comparisons not corrected for) |
| Narme, 201443 | High - Selection bias (only native French speakers, those without musical expertise, etc.); diffusion issues in same NH; attrition issues, small sample size, no usual care control group; very high attrition; assessors blinded; blinding of participants unclear; not ITT analysis. |
| Raglio, 201044 | Moderate - High attrition issues, differences across experimental and control groups, inadequate controls in statistical models. |
| Remington, 200245 | Moderate - Issues with detection bias, questions about whether this was the right sample (residents all had low scores for agitation). |
| Ridder, 201346 | High – Unblinded; some baseline differences; paired RCT; say ITT analysis, but then say they exclude missing data from main analysis. |
| Robichaud, 199447 | Moderate - Issues with selection bias, sample size, diffusion across institutions, concerns about fidelity of the program; some baseline differences between groups; second assessment unblended; participant blinding unclear; ITT analysis; low attrition. |
| Rodriguez-Mansilla, 201348 | Moderate - Self designed instruments not validated. |
| Rolland, 200749 | Moderate - Only assessor blinded; low attrition; not ITT analysis for outcomes we are interested in here. |
| Sakamoto, 201350 | Moderate - Not enough information about selection of patients, short followup, power issues; participant blinding unclear; assessors blinded; corrected for multiple comparisons; attrition unclear. |
| Sloane, 200451 | High - Group-randomized trial; participant blinding unclear; assessors blinded; analyses combined treatment groups (person-centered vs. towel were separate time periods in two groups, seemingly combined for analysis); baseline differences for important characteristics; corrected for multiple comparisons; attrition unclear. |
| Smallwood, 200152 | High - Study does not have enough power to detect a difference; the allocation of subjects is poorly described; differences between controls and intervention group; participant blinding unclear; outcome assessors and aromatherapist blinded; attrition unclear; analysis methods not described. |
| Staal, 200753 | High - Selection bias, low sample size, differences between exp. and control groups; participant blinding unclear; nurse assessors unblinded; reported significant group differences at baseline; attrition unclear. |
| Sung, 200654 | High - Low attrition, but not ITT analysis; researchers blinded, outcome assessors not blinded. |
| Sung, 201255 | High - No blinding; single facility; tool for measuring anxiety has poor validity; low attrition, but not ITT analysis; not blinded. |
| Svansdottir, 200656 | High - Authors refer to it as a case-control study, but it appears to be RCT; little information about analysis, but not ITT analysis according to tables; Attrition under 20%; outcome assessors blinded; blinding of intervention staff and patients unclear. |
| Telenius, 201557 | Moderate - Multiple comparisons not corrected for; some details of standardization and fidelity to intervention unclear. |
| Van de Winckel, 200458 | High - Practitioner not blinded; behavior assessors blinded to treatment; cognition assessor not blinded (same person who delivered intervention); low attrition. |
| Van der Ploegg, 201359 | Moderate - Control intervention same number of one-on-one therapy time; unclear if outcomes assessors blinded; underpowered; odd selection of instruments for agitation trial. |
| Van Haitsma, 201560 | Moderate – Randomization methods unclear, blinding methods unclear, unclear if outcome measures validated, power calculation not reported. |
| Vink, 201361 | Moderate - Nurses who took patients to activities were those who completed outcomes instruments; not ITT analysis; attrition okay, but excluded a lot of people from analysis. |
| Woods, 200562 | Moderate - Blinded patients and assessors, not research assistants who performed intervention; questionable assignment of research assistants to intervention and placebo groups. |
| Woods, 200963 | High – Blinded; dropped one participant from the study and analysis due to problem behaviors; did not correct for multiple comparisons, yet many time points shown; did not seem to present results for each measure collected. |
| Yang, 201564 | Moderate - Randomization and allocation methods not described, investigators not blinded, moderate level of attrition. |
NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.