Background
Methods
Search methodology
Field | Key words | |
---|---|---|
Title | (sleep$ adj2 (disrupt$ or disturb$ or impair$ or interrupt$ or depriv$ or lack or poor or problem$)) | |
OR | Title | (sleep$ adj2 (quality or quantity or duration or time$ or timing or pattern$ or rhythm$ or promotion or hygiene or efficiency or cycle$ or onset or health$ or hour$ or phase$ or support or help or initiat$)) |
OR | Title | insomnia$ |
OR | Title | circadian |
OR | Title | (sleep$ adj5 “biological clock$”) |
AND | All Text | (hospital$ or inpatient$ or institutional$ or “intensive care” or ward$ or hospice$ or “nursing home$” or “assisted living” or palliative or “end of life” or “end-of-life” or terminal or “health facilit$” or “residential facilit$” or icu or “critical care”) |
Inclusion | Exclusion |
---|---|
English-language articles | Articles with only partial content in English |
Intervention studies published in peer-reviewed journals | Dissertations, presentation/poster abstracts, brief reports in letters to the editors, editorials/commentaries, literature reviews, or meta-analyses |
Non-pharmacological interventions, including food supplements and melatonin, conducted within or outside the United States | Pharmacological interventions, models of care (e.g., palliative care team), or respiratory interventions |
Experimental or quasi-experimental design | Single case studies or cross-sectional design |
Adult participants, including those with dementia | Participants being treated for a medical sleep disorder or those with a psychiatric disorder such as depression, schizophrenia, or addiction disorder |
Any setting, including hospitals, long-term care settings (nursing homes, assisted-living facilities, or group homes), in-patient hospice or other institutional settings, or simulated hospital environments | Community settings including those involving interventions from home caregivers, outpatient clinics, dialysis centers, or adult foster homes, as well as psychiatric in-patient facilities |
Nighttime sleep as a subjective (self-reported) or objective outcome (primary or secondary) | Sleep not measured with tool |
Study selection, data extraction, and analysis
Results
First author, Year | Design, Number of groups, and Study type | Setting (number of facilities), Number of participants, Mean age, % male, and Inclusion/exclusion criteria | Description of intervention | Effect (positive, mixed, none, or negative), Measurement of sleep, Main finding(s) |
---|---|---|---|---|
Clinical care practices (n = 3) | ||||
Kim, 2016 [73] | Quasi-experimental pre-post intervention with 3 groups (intervention, comparison with placebo of 36.5 ° C water and control) | Nursing home (n = 1), N = 30, mean age 85.9, 20% men | Adjust core body temperature: 30 min of warm (40 ° C) foot baths in the evening daily for 4 weeks | None; Actigraphy; No significant differences in total sleep amount, efficiency, or latency among the 3 groups |
O’Rourke, 2001 [25] | Quasi-experimental pre-post intervention without comparison | Assisted-living facility (n = 2), N = 18, mean age 84.5, 22% men, with incontinence | Minimize clinical disruptions: 15 consecutive days alternating every 5 days between usual nighttime rounds and non-disruptive nighttime care | Positive; 24-h monitoring at 30-min intervals; Significant improvement in total nighttime sleep by 30 min (p = 0.01) |
Matthews, 1996 [41] | Quasi-experimental pre-post intervention without comparison group | Nursing home (n = 1), N = 33, mean age 84.2, 36.3% men, with dementia | Individualize care: Four 4-week phases of changes in staff behavior from task-oriented to individualized (client-centered) care | None; Sleep subscale of Dementia Mood Assessment Scale; Nighttime sleep did not change significantly |
Mind-body practices (n = 3) | ||||
Chen, 2010 [22] | Quasi-experimental pre-post intervention with comparison | Assisted-living facility (n = 2), N = 55, mean age 75.4, 47.3% men | Relaxation techniques: 70-min sessions of Silver Hatha Yoga (adapted for older population) 3 times per week for 6 months | Positive; Pittsburgh Sleep Quality Index; Overall sleep quality significantly improved, and sleep disturbances and daytime dysfunction decreased significantly (p = 0.05) |
Örsal, 2014 [58] | Quasi-experimental pre-post intervention with comparison | Nursing home (n = 1), N = 64, mean age 75.8, 57.8% men | Relaxation techniques: Progressive muscle relaxation exercises each night between 9 pm and 12 MN (for a total of 30 min/week) each night × 7 days | Positive; Pittsburgh Sleep Quality Index; Quality of sleep improved significantly (p = 0.000) |
El Kady, 2012 [50] | Quasi-experimental pre-post intervention without comparison | Nursing home (n = 4), N = 210, mean age 72.2, 46.2% men, with sleep problems | Cognitive-behavioral therapy: Four 30-min sessions of cognitive behavioral sleep therapy using sleep hygiene education and stimulus control techniques | Positive; Pittsburgh Sleep Quality Index; Statistically higher improvement in sleep quality (percentage of poor sleepers decreased from 63.3 to 46.2%) |
Social and physical stimulation (n = 11) | ||||
Kuck, 2014 [51] | RCT clustered by nursing home | Nursing home (n = 20), N = 85, mean age 83.9, 75.5% men, with sleep problems | Combination (social/physical): 2 days per week of both two 45-min sessions of social activity and two sessions of physical exercise (balance & muscle strengthening) for 8 weeks | Mixed Actigraphy & Insomnia Severity Index; No improvement by actigraphy measures in the intervention group but subjective sleep quality increased post intervention (p = 0.04) |
Lorenz, 2012 [55] | RCT, 4 groups (3 intervention and 1 control) | Nursing home (n = 13), N = 193, mean age 81.4, 36% men | Combination (social/physical): 3 intervention groups of exercise (3 days physical resistance training and 2 days walking per week), individualized social activity (1 h per day 5 days per week), or both for 7 weeks | None; Polysomnography; No relationship between change in everyday function (from interventions) and change in sleep parameters |
Richards, 2011 [26] | RCT, 4 groups (3 intervention and 1 control) | Nursing home (n = 10) and assisted-living centers (3), N = 165, mean age 81.8, 39.9% men | Combination (social/physical): 3 intervention groups of exercise (3 days physical resistance training and 2 days walking per week), individualized social activity (1 h per day 5 days per week), or both for 7 weeks | Positive; Polysomnography; Group receiving both treatments showed a significantly greater increase in total nocturnal sleep time and sleep efficiency over the control condition, but the exercise and social activity alone groups did not |
Richards, 2001 [42] | Quasi-experimental pre-post intervention without comparison | Nursing home (n = 1), N = 5, mean age 76.2, 100% men, with dementia | Social and cognitive activity: 15–30 min of individualized activity for 1 to 2 h per day for 3 days | Positive; Actigraphy; Percent of nocturnal time asleep significantly increased (p < 0.01) |
Richards, 2005 [43] | RCT | Nursing home (n = 7), N = 139, mean age 79, 51.8% men, with dementia | Social and cognitive activity: 1–2 h of individualized social activity for 21 days | Mixed; Actigraphy; Significantly reduced minutes to sleep onset, significantly reduced minutes awake, and increased sleep among those with baseline poor sleep but not for total group; sleep efficiency not improved |
Thodberg, 2015 [46] | Quasi-experimental pre-post intervention (dog visit) with comparison (robot seal or toy cat) | Nursing home (n = 4), N = 100, mean age 85.5, with dementia | Social and cognitive activity: 10-min biweekly visits by an “animal” (dog, robot seal, or toy cat) for 6 weeks | Mixed; Actigraphy; Sleep duration increased in the third week for the dog group compared to the robot seal or toy cat (p = 0.01); no effects were found in the sixth week or after the visit period had ended |
Alessi, 1995 [33] | Quasi-experimental pre-post intervention with comparison | Nursing home (n = 7), N = 65, mean age 84.8, 85% men, with urinary incontinence or physically restrained | Physical exercises: Exercises (transfers, walking, and rowing) performed every 2 h (8 am-4 pm) 5 days a week for 9 weeks | None; Actigraphy; No significant improvement in nighttime or daytime sleep |
Chen, 2015 [57] | RCT (clustered by nursing home) | Nursing home (n = 10), N = 127, mean age 79.2, 50.9% men, wheelchair bound | Physical exercises: 40-min elastic-band exercises (in wheelchair) 3 times per week for 6 months | Positive; Pittsburgh Sleep Quality Index; Intervention group had significantly longer sleep duration at 3 and 6 months and overall better sleep quality at 6 months |
Eggermont, 2010 [67] | RCT | Nursing home (n = 19), N = 79, mean age 84.3, 20.3% men, with dementia | Physical exercises: Five 30-min walking sessions per week for 6 weeks (total of 30 sessions) | None; Actigraphy; No significant improvement in nighttime restlessness, sleep efficiency, number of waking bouts, or daytime activity |
Taboonpong, 2010 [32] | Quasi-experimental pre-post intervention with comparison | Elderly residential center (n = 2), N = 50, 58% men | Physical exercises: Tai Chi exercise at least 3 times a week for 22 min for 12 weeks | Positive; Pittsburgh Sleep Quality Index; Significant improvement in sleep quality (p < 0.01) |
Lee, 2008 [23] | Quasi-experimental pre-post intervention without comparison | Assisted-living facility (n = 1), N = 23, with dementia | Physical activity: Indoor gardening twice daily for 4 weeks | Positive; 24-h sleep diary; Significant improvement in wake after sleep onset, nocturnal sleep time, and sleep efficiency |
Complementary health practices (n = 12) | ||||
Soden, 2004 [29] | RCT (3 groups: aromatherapy and massage, massage, or control) | Assisted-living facility (n = 3), N = 42, 24% men | Combination (touch and aromatherapy): Massage with lavender oil and/or massage with inert oil, each for 30 min for four weeks | Mixed; Verran and Snyder-Halpern Sleep Scale; Statistically significant improvement in the massage (p = 0.02) and combined massage (p = 0.03) groups but not for the aromatherapy and massage group only |
Gehrman, 2009 [68] | RCT | Nursing home (n = 1), N = 41, mean age 82.9, 31.7% men; with dementia | Oral supplement: Melatonin (8.5 mg immediate release and 1.5 mg sustained release) administered at 10 pm for 10 consecutive nights | None; Actigraphy; No significant differences between the groups for nighttime or daytime sleep |
Rondanelli, 2011 [28] | RCT | Assisted-living facility (n = 1), N = 43, mean age 78.3, with insomnia | Oral supplement: Melatonin (5 mg) plus dietary supplement (magnesium 225 mg and zinc 11.25 mg) every day for 8 weeks | Positive; Pittsburgh Sleep Quality Index; Significantly better sleep (p < 0.001) |
Valtonen, 2005 [47] | Quasi-experimental pre-post intervention with comparison, crossover design (3 groups: 2 intervention and 1 control) | Nursing home (n = 2), N = 81, mean age 82.8, 21% men, mild cognitive impairment | Oral supplement: 8 weeks of melatonin-rich (5–20 mg/day) milk then 8 weeks of normal milk (and conversely for the other intervention group) | Mixed; Sleep questionnaire; In one intervention group, sleep quality, morning activity, and evening activity all increased significantly (p < 0.001) when milk was consumed in the evening |
Braun, 1986 [62] | Quasi-experimental pre-post intervention without comparison | Nursing home (n = 1), N = 6, mean age 85, 0% men | Touch: 5 min of talking and 5 min of therapeutic touch 6 in. above the solar plexus | Positive; Visser’s Sleep Quality Assessment; Improved sleep quality |
Chen, 1999 [21] | RCT | Nursing home (n = 1), N = 84, mean age 79, 61.9% men | Touch: 15 min of acupressure, consisting of 5 min of finger massage and 10 min of acupoint massage between 1 pm and 10 pm 5 days per week for 3 weeks | Positive; Pittsburgh Sleep Quality Index; Significantly more positive sleep including quality, latency, duration, efficiency; reduced disturbances of sleep; and frequencies of nocturnal awakening and night wakeful time. |
Harris, 2012 [69] | RCT | Nursing home (n = 4), N = 40, mean age 86, 22.5% men, with dementia | Touch: 3-min slow-stroke back massage at bedtime for 2 nights | None; Actigraphy; No significant increase in minutes of nighttime sleep |
Nelson, 2010 [74] | RCT | Nursing home (n = 4), N = 28, mean age 69.5, 57.1% men | Touch: 15-min massage to head, neck shoulders, and back between 8 pm and 10 pm every night and 7 days | None; Observed 3 participants asleep following the intervention |
Reza, 2010 [59] | RCT (3 groups: intervention, sham, and control) | Nursing home (n = 1), N = 77, mean age 75.2, 53.2% men | Touch: 3 sessions of acupressure (hands, head, ears, and feet) per week for 4 weeks | Positive; Pittsburgh Sleep Quality Index; Compared to controls, the acupressure group had significantly positive subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep sufficiency, and reduced sleep disturbance. No differences between the sham and control groups. |
Simoncini, 2015 [60] | Quasi-experimental pre-post intervention without comparison | Nursing home (n = 2), N = 129, mean age 82.7 | Touch: Daily acupressure of 8 h continuously on the HT7 acupoint with a patch device for 8 weeks | Positive. Pittsburgh Sleep Quality Index; Significant improvement in ability to fall asleep and quality of sleep |
Sun, 2010 [30] | RCT | Assisted-living facility (n = 2), N = 50, mean age 70.48, 64% men, with insomnia | Touch: 5 s of acupressure on HT7 acupoint of both wrists followed by 1-s rest repeated for 5-min before bedtime for 5 weeks | Positive; Athens Insomnia Scale-Taiwan Form; Significant improvement in sleep at 6 weeks post-intervention (p = 0.002) |
Van Someren, 1998 [48] | RCT | Nursing home (n = 1), N = 14, mean age 84, 7.1% men, with early dementia | Touch: TENS (transcutaneous electrical nerve stimulation) between the shoulder blades for 30 min per day between 4 pm and 6 pm, 5 days a week for 6 weeks | Positive; Actigraphy; Post-treatment mean was significantly higher in the treatment group than both the pretreatment mean (p = 0.03) and the follow up mean (p = 0.03) |
Environmental intervention (n = 14) | ||||
Ancuelle, 2015 [56] | Quasi-experimental pre-post intervention without comparison | Nursing home (n = 1), N = 38, mean age 78.4, 44.7% men, with musculoskeletal pain | Ergonomic adjustment: 4 weeks of medium-firm mattress use | None. Pittsburg Sleep Quality Index and subsample with actigraphy. Sleep not significantly improved (p = 0.245). |
Akyar, 2013 [49] | Quasi-experimental pre-post intervention without comparison | Nursing home (n = 1): N = 24, mean age 80, 33.3% men, with poor sleep quality | Increased light: 30 min of morning bright light (10,000 lx) for 30 days | Positive; Pittsburg Sleep Quality Index; Immediately and 4 weeks post-intervention, there was significant improvement on all sleep outcomes (p < 0.001) |
Ancoli-Israel, 2002 [36] | RCT, 3 intervention groups (morning v. evening light) v. sleep restriction or comparison | Nursing homes (n = 2), N = 77, mean age 85.7, 24.7% men with dementia | Increased light: Bright light box (2500 lx) from 5:30 pm to 7:30 pm or 9:30 am to 11 am or daytime sleep restriction comparison with dim (50 lx) red light from 5:30 pm-7:30 pm for 10 days | None; Actigraphy; No improvements in nighttime sleep or daytime alertness in any of the treatment groups. (Note: Daytime restriction is comparison group.) |
Ancoli-Israel, 2003 [35] | RCT, 3 groups (intervention of daytime or evening bright light with comparison of dim red light) | Nursing home (n = 2), N = 92, mean age 82.3, 31.5% men, with late-stage Alzheimer’s disease | Increased light: Either morning or evening bright light box (2500 lx) compared with morning dim (< 300 lx) red light for 10 days | Mixed; Actigraphy; Duration of maximum sleep bout significantly increased from 64.9 min to 88.4 min in the morning and evening bright light group. However, there was no effect on total sleep time or on night or day wake time. |
Burns, 2009 [37] | RCT | Nursing home (n = 2), N = 48, mean age 83.5, 33% male; with dementia & agitation | Increased light: 2-h (10 am to 12 pm) bright light therapy (10,000 lx) for 2 weeks | None; Actigraphy; Mean duration of nocturnal sleep improved but not significantly |
Calkins, 2007 [38] | RCT | Nursing home (n = 3), N = 17, 11.8% men, with dementia | Increased light: Outdoor daylight exposure for 30 min for 2 weeks | None; Actigraphy and Pittsburgh Sleep Quality Index; No significant improvement in sleep |
Castor, 1991 [63] | Quasi-experimental pre-post intervention without comparison | Nursing home (n = 1), N = 12, mean age 70, 100% men | Increased light: Twice daily exposure (1 h in morning and 1 h in afternoon) to sunlight for 1 week | Positive; Nursing Assessment of Sleep; Significant improvement in uninterrupted sleep (p = 0.003) and mean sleep hours per 24 h (p = 0.052), as well as a decrease in night wake hours (p = 0.007) |
Dowling, 2005 [40] | RCT | Assisted-living Facility (n = 2), N = 46, mean age 84, 22% men, with severe dementia | Increased light: 1 h of bright morning light (9:30 am to 10:30 am; 2500 lx) 5 days per week for 10 weeks | None; Actigraphy; No significant improvement in nighttime sleep efficiency, sleep time, wake time, or number of awakenings |
Fetveit, 2003 [61] | Quasi-experimental pre-post intervention without comparison | Nursing home (n = 1), N = 11, mean age 86.1, 9.1% men, with dementia | Increased light: 2 h of morning (8 am to 11 am; 6000–8000 lx) bright light per day for 2 weeks | Positive; Actigraphy; Waking time within nighttime sleep reduced by 2 h and sleep efficiency improved from 73 to 86% |
Fetveit, 2004 [64] | Quasi-experimental pre-post intervention without comparison | Nursing home (n = 1), N = 11, mean age 86.1, 9.1% men, with dementia | Increased light: 2 h of bright morning light (6000–8000 lx) per day for 2 weeks | Mixed; Actigraphy; Sleep efficiency remained higher than baseline for 4 weeks and sleep onset latency remained significantly reduced for 12 weeks |
Figueiro, 2014 [53] | Quasi-experimental pre-post intervention without comparison | Nursing home (n = 1), N = 14, mean age 86.9, 37.7% men, with dementia | Increased light: 4 weeks of blush-white lighting (luminaires) in residents’ rooms with timer (from waking until 6 pm) for 4 weeks | Mixed; Daysimeter; Significant improvement in sleep efficiency (80 to 84%, p = 0.03) and sleep time (431 min to 460 min, p = 0.03) but not in sleep latency |
Koyama, 1999 [71] | Quasi-experimental pre-post intervention without comparison | Nursing home (n = 2), N = 6, with dementia | Increased light: 1 or 2 h of late morning bright light (4000 lx) | None; sleep observation diary; Nighttime sleep maintained in 3 participants |
Lyketsos, 1999 [24] | RCT | Assisted-living facility (n = 1), N = 8, mean age 80.8, 6.7% men, with dementia and agitated behaviors | Increased light: 1 h of morning bright light (10,000 lx) therapy for 4 weeks | Positive; sleep observation log, 8 pm-8 am; Statistically significant improvement in sleep duration from 6.4 h to 8.1 h (p < 0.05) |
Wu, 2015 [31] | Quasi-experimental pre-post intervention with comparison (clustered by unit) | Assisted Living Facility (n = 1) N = 65, mean age 80, 57.1% men | Increased light: 30 min of morning (9:30 am–10 am) bright light (10,000 lx) therapy 3 times per week for 4 weeks | Mixed; sleep diary; Significant decrease in sleep disruptions in the experimental group from week 1 to week 4 (p = 0.02) but no significant difference between treatment and control groups |
Environment | CHP | SPS | CCP | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
First author, Year) | Design, Number of groups, and type | Setting (number of facilities), Number of participants, Mean age, % Male, Inclusion/exclusion criteria | Description of intervention | Effect (positive, mixed, none, or negative), Measurement of sleep, Main finding(s) | Light | Noise | Melatonin | Physical activity | Individual care | Less disruptions | Mange Sleep wake |
Alessi, 1999 [34] | RCT | Nursing home (n = 1); N = 29, mean age 88.3, 10% male, with incontinence | Daytime physical activity and nighttime program to decrease noise and decrease sleep-disruptive nursing care practices 5 days per week for 14 weeks | Positive; Actigraphy; Nighttime sleep increased from 51.7 to 62.5% (p = 0.045) | X | X | X | ||||
Alessi, 2005 [65] | RCT | Nursing home (n = 4): N = 118, mean age 86.8, 45% men | Efforts to decrease daytime in-bed time, provide daily sunlight exposure for at least 30 min, increase physical activity, structure bedtime routines, and decrease nighttime noise and light for 5 consecutive days and nights | Mixed; Actigraphy; Modest decrease in nighttime awakenings (p = 0.04) but no effect on % of nighttime sleep or number of nighttime awakenings | X | X | X | X | X | ||
Connel, 2007 [39] | RCT | Nursing home (n = 1), N = 20, mean age 79.7, 95% male, with dementia | 1 h of group outdoor structured activity for 10 days (compared with indoor structured activity) | Positive; Actigraphy; Maximum sleep duration increased and total sleep minutes significantly increased | X | X | |||||
Dowling, 2008 [66] | RCT | Nursing home (n = 2), N = 50, mean age 86, 14% men, with dementia | Melatonin 5 mg & 1 h of morning bright light (≥ 2500 lx) for 5 mid-week days per week for 10 weeks | None; Actigraphy; No significant impact on sleep | X | X | |||||
Gammack, 2009 [72] | RCT | Nursing homes (n = 1), N = 24, mean age 79.5, 37.5% men, without dementia | 60-min outdoor morning (between 7 am-12 pm) light and structured recreational activity for 21 days | None; Medical Outcome Study Sleep Scale; No differences in sleep scores between treatment and controls | X | X | |||||
Ito, 2001 [70] | Quasi-experimental pre-post intervention with comparison (bright light only) | Nursing home, N = 28, mean age 78.3, 42.9% men, with Alzheimer’s disease | Daily Vitamin B12 (1.5 mg for 2 weeks then 3.0 mg for 2 weeks) and 2-h morning (9 am–11 am) bright light (3000 lx) therapy for 4 weeks | None; Actigraphy; No significant improvement in nighttime sleep outcomes | X | X | |||||
Martin, 2007 [52] | RCT | Nursing home (n = 4) N = 118, mean age 87.05, 78% men, with sleep disruption | Exposure to outdoor bright light (at least 20,000 lx), efforts to keep residents out of bed during the day, bedtime routine, efforts to decrease nighttime noise and light, and structured physical activity for 10 min to 15 min 3 times per day for 5 days | None; Actigraphy; Significant change only in the active phase of the rest/activity rhythms. Not able to significantly reduce nighttime noise and light. | X | X | X | ||||
Ouslander, 2006 [54] | RCT, clustered by facility | Nursing home (n = 8), N = 160, mean age 83.2, 25% men | Daytime activities, keep residents out of bed, evening bright light, consistent bedtime routine, nighttime care routines to minimize disruption, and strategies to reduce nighttime noise for 17 days | None; Actigraphy and polysomnography; No improvement in nighttime sleep | X | X | X | X | X | ||
Riemersma-Van Der Lek, 2008 [27] | RCT, clustered by facility with 4 groups (bright light, melatonin, combination, or none) | Assisted-living facilities (n = 12), N = 189, mean age 85.8, 10% men, with dementia | Whole-day bright light (10,000 lx) and 2.5 mg melatonin for a mean of 15 months | Positive; Actigraphy; Combined treatment (light and melatonin) significantly ameliorated nocturnal restlessness, reduced awakenings, and increased sleep efficiency. Melatonin shortened sleep onset latency and increased sleep duration. | X | X | |||||
Schnelle, 1998 [44] | Quasi-experimental pre-post intervention with comparison | Nursing home (n = 4), N = 92, mean age 87.3, 19% men, with incontinence | Individualized nighttime incontinence care (every 2 or 4 h and when awake) and minimized sleep disruption for 5 nights | Positive; Actigraphy; Significant reduction in awakenings due to light and sound (p < 0.001) | X | X | X | X | |||
Schnelle, 1999 [45] | RCT | Nursing home (n = 8), N = 267, mean age 83.95, 82% men, with incontinence | Individualized nighttime incontinence care (every 2 or 4 h and when awake) and noise abatement and staff feedback to reduce noise for 5 nights | Mixed; Actigraphy; Significant reduction in sleep awakenings with noise and light abatement but not in % sleep or sleep duration. Significant reductions in light events but not noise. | X | X | X | X |
Sites and participants
Measures
Quality assessment
Low Risk | High Risk | Unclear | Not Applicable | |
---|---|---|---|---|
Random sequence generation | 11 | 4 | 15 | 0 |
Allocation concealment | 11 | 4 | 15 | 0 |
Blinding of participants and personnel | 8 | 9 | 13 | 0 |
Blinding of outcome assessment | 21 | 2 | 7 | 0 |
Incomplete outcome data (2–6 weeks) | 19 | 5 | 6 | 0 |
Incomplete outcome data (> 6 weeks) | 7 | 0 | 1 | 22 |
Selective reporting | 28 | 0 | 2 | 0 |
Criteria | Yes | No |
---|---|---|
1. Are the aims and objectives of the study clearly stated? | 24 | 0 |
2. Are the hypotheses and research questions clearly specified? | 24 | 0 |
3. Are the dependent and independent variables clearly stated? | 23 | 1 |
4. Have the variables been adequately operationalized? | 23 | 1 |
5. Is the design of the study adequately described? | 24 | 0 |
6. Are the research methods appropriate? | 22 | 2 |
7. Were the instruments used appropriate and adequately tested for reliability and validity? | 16 | 8 |
8. Is there an adequate description of the source of the sample, inclusion and exclusion criteria, response rates, and (in the case of longitudinal research and post-test in experiments) sample attrition? | 20 | 4 |
9. Was the statistical power of the study to detect or reject differences (types I and II error) discussed critically? | 5 | 19 |
10. Are ethical considerations presented? | 5 | 19 |
11. Was the study piloted? | 11 | 13 |
12. Were the statistical analyses appropriate and adequate? | 22 | 2 |
13. Are the results clear and adequately reported? | 23 | 1 |
14. Does the discussion of the results report them in the light of the hypotheses of the study and other relevant literature? | 22 | 2 |
15. Are the limitations of the research and its design presented? | 20 | 4 |
16. Does the discussion generalize and draw conclusion beyond the limits of the data and number and type of people studied? | 11 | 13 |
17. Can the findings be generalized to other relevant population and time periods? | 21 | 3 |
18. Are the implications-practical or theoretical-of the research discussed? | 12 | 12 |
19. Who was the sponsor of the study, and was there a conflict of interest? | 11 | 2 (11 NI) |