Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Impact of Pain on Behavioural Disturbances in Patients With Moderate and Severe Dementia. A Cluster Randomized Trial
Brief Summary: In nursing homes (NHs) 80% of the patients have dementia, between 60%-80% exhibit behavioural disturbances (BPSD), and more than 60% have pain. Both pain and BPSD is more common in those with severe dementia. Since older persons with dementia have less communicative skills, suffer from more pain and exhibit more agitation, pain may be a contributing factor in these patients. More than 40% of patients with BPSD are treated with neuroleptics despite described side-effects. There is an urgent need to investigate the impact of individual pain management on BPSD in patients with dementia.

It was hypothesized that

* pain increase BPSD in patients with dementia
* individual pain treatment decrease BPSD in patients with dementia


Options:
A: Inclusion Criteria:

* Aged 65 and older
* Residing in the NHs for at least 4 weeks
* Dementia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (American Psychiatric Association 1994), FAST score \> 4 (Hughes 1982).
* Clinically relevant BPSD, operationally defined as CMAI score ≥ 39 or higher or/and at least one week history of agitation or aggression (Koss 1997).
* Written, informed consent provided by the participant (if they have capacity) or assent (if they do not have capacity) and a written proxy informed consent from a legally authorized representative empowered to make health-related decisions for the potential study participant.

Exclusion Criteria:

* Clinician responsible for care, or study clinician considers that the patient suffers from any physical condition, which would make participation in the trial distressing or likely to increase suffering
* Advanced severe medical disease/disorder with expected survival less than 6 months or that could interfere with participation
* Psychosis or other severe mental disorder prior to dementia diagnosis;
* Severe aggression (≥8) on item 3 of the NPI subscale, with aggression as the predominant symptom
* Schizophrenia, schizoaffective disorder and bipolar disorder
* Uncontrolled epilepsy
* Severe liver impairment
* Renal failure, as measured by or equivalent to an estimated creatinine clearance of \< 50mL/min/1.73m,
* Severe injury or anaemia (Hb \< 8.5 mmol/l), comatose state, current enrolment in another experimental protocol.
* Known allergy or adverse reaction to Paracetamol, Morphine ret, Buprenorphine plaster or pregabalin
B: Inclusion Criteria:

* long-term nursing home residents,
* 65 years and older,
* with moderate or greater pain in the week prior to screening,
* residing in a participating facility,
* who consent to participate (or whose surrogate decisionmaker consents to participation)

Exclusion Criteria:

* short-term stay patients,
* persons less than 65 years,
* residents on hospice
C: Inclusion Criteria:

* Patients residing in long term nursing home units for at least 4 weeks prior to study
* Diagnosed with probable or possible dementia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), FAST score \> 4
* Diagnosed with depression ≥ 4 week duration as measured by CSDD ≥ 8
* Written, informed consent provided by the participant (if they have capacity) or assent (if they do not have capacity) and a written proxy informed consent from a legally authorized representative empowered to make health-related decisions for the potential study participant

Exclusion Criteria:

* The patient is contra-indicated to study drugs of pain treatment, in another trial, or had no carer.
* Participants are ineligible if they are clinical critical (e.g. suicide risk)
* Clinician responsible for care, or study clinician considers that the patient suffers from any physical condition, which would make participation in the trial distressing or likely to increase suffering
* Advanced severe medical disease/disorder with expected survival less than 6 months or that could interfere with participation
* Psychosis or other severe mental disorder prior to dementia diagnosis
* Severe aggression (≥8) on item 3 of the NPI subscale, with aggression as the predominant symptom
* Schizophrenia, schizoaffective disorder and bipolar disorder
* Uncontrolled epilepsy
* Severe liver impairment
* Renal failure
* Severe injury or anaemia (Hb \< 8.5 mmol/l), comatose state, current enrolment in another experimental protocol
* Known allergy or adverse reaction to paracetamol or buprenorphine transdermal patch
* Advanced severe medical disease with expected survival of less than six months, severe psychiatric or neurological disorder.
* Patients with diseases that make it impossible to follow the research schedule are excluded
D: Inclusion Criteria:

* Age 60 or older
* Diagnosis of dementia derived from the resident's medical chart at the facility or from an attending physician, as based on DSM-IV criteria and the Report of the NINCDS-ADRDA
* Resident of the facility for at least three weeks so that nursing staff members know the resident well enough to accurately assess him or her
* Identified by nursing staff to exhibit either verbal agitation or physical non-aggressive agitation at least several times a day

Exclusion Criteria:

* Lifelong diagnosis of schizophrenia
* Bipolar disorder diagnosed prior to onset of dementia
* Diagnosis of premorbid mental retardation
* Judged by direct-care nursing staff to have a life expectancy of less than 3 months
* Expected to leave the nursing home (either to enter the hospital or to go home) within the next 4 months
* Agitation manifested less than 6 times a day

Answer: A