Husebo BS, Ballard C, Sandvik R, et al. Efficacy of treating pain to reduce behavioural disturbances in residents of nursing homes with dementia: cluster randomised clinical trial. BMJ 343:d4065

Department of Public Health and Primary Health Care, University of Bergen, 5020 Bergen, Norway.
BMJ (online) (Impact Factor: 17.45). 07/2011; 343(jul15 1):d4065. DOI: 10.1136/bmj.d4065
Source: PubMed


To determine whether a systematic approach to the treatment of pain can reduce agitation in people with moderate to severe dementia living in nursing homes.
Cluster randomised controlled trial.
60 clusters (single independent nursing home units) in 18 nursing homes within five municipalities of western Norway.
352 residents with moderate to severe dementia and clinically significant behavioural disturbances randomised to a stepwise protocol for the treatment of pain for eight weeks with additional follow-up four weeks after the end of treatment (33 clusters; n = 175) or to usual treatment (control, 27 clusters; n = 177).
Participants in the intervention group received individual daily treatment of pain for eight weeks according to the stepwise protocol, with paracetamol (acetaminophen), morphine, buprenorphine transdermal patch, or pregabaline. The control group received usual treatment and care.
Primary outcome measure was agitation (scores on Cohen-Mansfield agitation inventory). Secondary outcome measures were aggression (scores on neuropsychiatric inventory-nursing home version), pain (scores on mobilisation-observation-behaviour-intensity-dementia-2), activities of daily living, and cognition (mini-mental state examination).
Agitation was significantly reduced in the intervention group compared with control group after eight weeks (repeated measures analysis of covariance adjusting for baseline score, P < 0.001): the average reduction in scores for agitation was 17% (treatment effect estimate -7.0, 95% confidence interval -3.7 to -10.3). Treatment of pain was also significantly beneficial for the overall severity of neuropsychiatric symptoms (-9.0, -5.5 to -12.6) and pain (-1.3, -0.8 to -1.7), but the groups did not differ significantly for activities of daily living or cognition.
A systematic approach to the management of pain significantly reduced agitation in residents of nursing homes with moderate to severe dementia. Effective management of pain can play an important part in the treatment of agitation and could reduce the number of unnecessary prescriptions for psychotropic drugs in this population. Trial registration NCT01021696 and Norwegian Medicines Agency EudraCTnr 2008-007490-20.

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Available from: Bettina Sandgathe Husebø, Oct 10, 2015
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    • "These medications are often used to control challenging behaviours demonstrated by PWD, when symptoms such as these may actually result from untreated pain (Geda & Rummans 1999, Gibson & Helme 2000). Treatment with simple analgesia, such as paracetamol, has been shown to reduce agitation in PWD (Elliott & Horgas 2009, Husebo et al. 2011). While the associations between pain and depression among older people and those with dementia are well known (Hadjistavropoulos et al. 2008, Snow et al. 2009, Zwakhalen et al. 2009), there is a lack of consistent or conclusive data on other patient-or caregiver-related factors that are associated with, or predict, the presence of pain in PWD (M€ antyselk€ a et al. 2004, Shega et al. 2004, Zwakhalen et al. 2009, Eritz & Hadjistavropoulos 2011). "
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    ABSTRACT: Few pain studies have made community-dwelling people with dementia (PWD) their focus. The aim of this study was to determine the prevalence of pain among this patient population and to explore medication use. Moreover, we sought to investigate patient and caregiver variables associated with the presence of pain. Community-dwelling PWD and their caregivers were recruited between May 2009 and July 2012 from outpatient memory clinics in Northern Ireland to take part in a face-to-face structured interview with a researcher. Patients' cognitive status and presence of depression were established. A full medication history was taken. Both patients and caregivers were asked to rate patients' pain, at the time of the interview and on an average day, using a 7-point verbal descriptor scale. From the 206 patients who were eligible to take part, 75 patient-caregiver dyads participated in the study (participation rate = 36.4%). The majority of patients (92.0%) had dementia classed as mild or moderate. Pain was commonly reported among the sample, with 57.3% of patients and 70.7% of caregivers reporting patient pain on an average day. Significant differences were found between patients' and caregivers' reports of pain. Two-fifths of patients (40.0%) were prescribed analgesia. Antipsychotic, hypnotic and anxiolytic drug use was low, whereas antidepressant drugs were prescribed more commonly. Presence of pain was unaffected by dementia severity; however, the use of prescribed analgesic medication was a significant predictor of the presence of pain in these patients, whether reported by the patient or their caregiver 'right now' or 'on an average day' (P < 0.001). Patient and caregiver recruitment was challenging, and remains a barrier to research in this area in the future. © 2015 John Wiley & Sons Ltd.
    Health & Social Care in the Community 02/2015; DOI:10.1111/hsc.12204 · 1.15 Impact Factor
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    • "The SPTP followed the latest recommendations of the American Geriatric Society (AGS) Panel for pharmacological management of persistent pain in older adults (AGS Panel on Persistent Pain in Older Persons, 2009) and is described in our previous publication (Husebo et al., 2011). All patients assigned to the treatment group were investigated individually by the responsible team, which consisted of the NH physician, the patient's primary caregiver, a pain therapist (B.S.H.) and a research assistant (R.K.S.). "
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    ABSTRACT: Background Pain is frequent and distressing in people with dementia, but no randomized controlled trials have evaluated the effect of analgesic treatment on pain intensity as a key outcome.Methods Three hundred fifty-two people with dementia and significant agitation from 60 nursing home units were included in this study. These units, representing 18 nursing homes in western Norway, were randomized to a stepwise protocol of treating pain (SPTP) or usual care. The SPTP group received acetaminophen, morphine, buprenorphine transdermal patch and pregabalin for 8 weeks, with a 4-week washout period. Medications were governed by the SPTP and each participant's existing prescriptions. We obtained pain intensity scores from 327 patients (intervention n = 164, control n = 163) at five time points assessed by the primary outcome measure, Mobilization-Observation-Behaviour-Intensity-Dementia-2 (MOBID-2) Pain Scale. The secondary outcome was activities of daily living (ADL). We used a linear intercept mixed model in a two-way repeated measures configuration to assess change over time and between groups.ResultsThe SPTP conferred significant benefit in MOBID-2 scores compared with the control group [average treatment effect (ATE) −1.388; p < 0.001] at week 8, and MOBID-2 scores worsened during the washout period (ATE = −0.701; p = 0.022). Examining different analgesic treatments, benefit was conferred to patients receiving acetaminophen compared with the controls at week 2 (ATE = −0.663; p = 0.010), continuing to increase until week 8 (ATE = −1.297; p < 0.001). Although there were no overall improvements in ADL, an increase was seen in the group receiving acetaminophen (ATE = +1.0; p = 0.022).Conclusion Pain medication significantly improved pain in the intervention group, with indications that acetaminophen also improved ADL function.
    European journal of pain (London, England) 11/2014; 18(10). DOI:10.1002/ejp.523 · 2.93 Impact Factor
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    • "The association between MOBID-2 pain scale and CMAI was, as expected, moderately and confirmed our hypothesis. Pain behaviour certainly includes elements of behavioural disturbances in patients with dementia, and earlier findings demonstrated reductions in agitation and aggression by systematic pain management in patients with dementia (Husebo et al., 2011b). Especially, verbal agitation behaviours, such as complaining or negativism, and physical nonaggressive behaviour, such as pacing and restlessness, responded to this treatment (Husebo et al., 2013). "
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    ABSTRACT: Background Mobilization-Observation-Behavior-Intensity-Dementia-2 (MOBID-2) pain scale is a staff-administered pain tool for patients with dementia. This study explores MOBID-2's test–retest reliability, measurement error and responsiveness to change.Methods Analyses are based upon data from a cluster randomized trial including 352 patients with advanced dementia from 18 Norwegian nursing homes. Test–retest reliability between baseline and week 2 (n = 163), and weeks 2 and 4 (n = 159) was examined in patients not expected to change (controls), using intraclass correlation coefficient (ICC2.1), standard error of measurement (SEM) and smallest detectable change (SDC). Responsiveness was examined by testing six priori-formulated hypotheses about the association between change scores on MOBID-2 and other outcome measures.ResultsICCs of the total MOBID-2 scores were 0.81 (0–2 weeks) and 0.85 (2–4 weeks). SEM and SDC were 1.9 and 3.1 (0–2 weeks) and 1.4 and 2.3 (2–4 weeks), respectively. Five out of six hypotheses were confirmed: MOBID-2 discriminated (p < 0.001) between change in patients with and without a stepwise protocol for treatment of pain (SPTP). Moderate association (r = 0.35) was demonstrated with Cohen-Mansfield Agitation Inventory, and no association with Mini-Mental State Examination, Functional Assessment Staging and Activity of Daily Living. Expected associations between change scores of MOBID-2 and Neuropsychiatric Inventory – Nursing Home version were not confirmed.Conclusion The SEM and SDC in connection with the MOBID-2 pain scale indicate that the instrument is responsive to a decrease in pain after a SPTP. Satisfactory test–retest reliability across test periods was demonstrated. Change scores ≥ 3 on total and subscales are clinically relevant and are beyond measurement error.
    European journal of pain (London, England) 11/2014; 18(10). DOI:10.1002/ejp.507 · 2.93 Impact Factor
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