Trends in quality of care and dying perceived by family caregivers of nursing home residents with dementia 2005-2019.

BACKGROUND: Dementia palliative care is increasingly subject of research and practice improvement initiatives. AIM: To assess any changes over time in the evaluation of quality of care and quality of dying with dementia by family caregivers. DESIGN: Combined analysis of eight studies with bereaved family caregivers' evaluations 2005-2019. SETTING/PARTICIPANTS: Family caregivers of nursing home residents with dementia in the Netherlands (n = 1189) completed the End-of-Life in Dementia Satisfaction With Care (EOLD-SWC; quality of care) and Comfort Assessment in Dying (EOLD-CAD, four subscales; quality of dying) instruments. Changes in scores over time were analysed using mixed models with random effects for season and facility and adjustment for demographics, prospective design and urbanised region. RESULTS: The mean total EOLD-SWC score was 33.40 (SD 5.08) and increased by 0.148 points per year (95% CI, 0.052-0.244; adjusted 0.170 points 95% CI, 0.055-0.258). The mean total EOLD-CAD score was 30.80 (SD 5.76) and, unadjusted, there was a trend of decreasing quality of dying over time of -0.175 points (95% CI, -0.291 to -0.058) per year increment. With adjustment, the trend was not significant (-0.070 EOLD-CAD total score points, 95% CI, -0.205 to 0.065) and only the EOLD-CAD subscale 'Well being' decreased. CONCLUSION: We identified divergent trends over 14 years of increased quality of care, while quality of dying did not increase and well-being in dying decreased. Further research is needed on what well-being in dying means to family. Quality improvement requires continued efforts to treat symptoms in dying with dementia.

Field-testing the Euro-MCD Instrument: Experienced outcomes of moral case deliberation.

BACKGROUND: Moral case deliberation is a form of clinical ethics support to help healthcare professionals in dealing with ethically difficult situations. There is a lack of evidence about what outcomes healthcare professionals experience in daily practice after moral case deliberations. The Euro-MCD Instrument was developed to measure outcomes, based on the literature, a Delphi panel, and content validity testing. To examine relevance of items and adequateness of domains, a field study is needed. AIM: To describe experienced outcomes after participating in a series of moral case deliberations, both during sessions and in daily practice, and to explore correlations between items to further validate the Euro-MCD Instrument. METHODS: In Sweden, the Netherlands, and Norway, healthcare institutions that planned a series of moral case deliberations were invited. Closed responses were quantitatively analyzed. The factor structure of the instrument was tested using exploratory factor analyses. ETHICAL CONSIDERATIONS: The study was approved in Sweden by a review board. In Norway and the Netherlands, data services and review boards were informed about the study. RESULTS: The Euro-MCD Instrument was completed by 443 and 247 healthcare professionals after four and eight moral case deliberations, respectively. They experienced especially outcomes related to a better collaboration with co-workers and outcomes about individual moral reflexivity and attitude, both during sessions and in daily practice. Outcomes were experienced to a higher extent during sessions than in daily practice. The factor structure revealed four domains of outcomes, which did not confirm the six Euro-MCD domains. CONCLUSION: Field-testing the Euro-MCD Instrument showed the most frequently experienced outcomes and which outcomes correlated with each other. When revising the instrument, domains should be reconsidered, combined with theory about underlying concepts. In the future, a feasible and valid instrument will be presented to get insight into how moral case deliberation supports and improves healthcare.

Pain assessment in impaired cognition: observer agreement in a long-term care setting in patients with dementia.

Aim: To study the application of the meta-tool Pain Assessment in Impaired Cognition (PAIC) in a clinical setting in patients with moderate to severe dementia. Materials & methods: Observational study in five Dutch nursing homes, where residents were observed by nurses or nurse-assistants during rest and movement. Prevalence and observer agreement of individual items were examined. Results: An observer agreement of ≥70% was found for most items of the body movement domain and vocalization domain, although prevalence of these behaviors was low (especially during rest). Items of the facial expression domain had a percentage agreement <70%, especially during movement, but with high prevalence of behaviors. Conclusion: The pain assessment in impaired cognition items show promising interobserver and intraobserver agreement in a clinical setting.

Important outcomes of moral case deliberation: a Euro-MCD field survey of healthcare professionals' priorities.

BACKGROUND: There is a lack of empirical research regarding the outcomes of such clinical ethics support methods as moral case deliberation (MCD). Empirical research in how healthcare professionals perceive potential outcomes is needed in order to evaluate the value and effectiveness of ethics support; and help to design future outcomes research. The aim was to use the European Moral Case Deliberation Outcome Instrument (Euro-MCD) instrument to examine the importance of various MCD outcomes, according to healthcare professionals, prior to participation. METHODS: A North European field survey among healthcare professionals drawn from 73 workplaces in a variety of healthcare settings in the Netherlands, Norway and Sweden. The Euro-MCD instrument was used. RESULTS: All outcomes regarding the domains of moral reflexivity, moral attitude, emotional support, collaboration, impact at organisational level and concrete results, were perceived as very or quite important by 76%-97% of the 703 respondents. Outcomes regarding collaboration and concrete results were perceived as most important. Outcomes assessed as least important were mostly about moral attitude. 'Better interactions with patient/family' emerged as a new domain from the qualitative analysis. Dutch respondents perceived most of the outcomes as significantly less important than the Scandinavians, especially regarding emotional support. Furthermore, men, those who were younger, and physician-respondents scored most of the outcomes as statistically significantly less important compared with the other respondents. CONCLUSIONS: The findings indicate a need for a broad instrument such as the Euro-MCD. Outcomes related to better interactions between professionals and patients must also be included in the future. The empirical findings raise the normative question of whether outcomes that were perceived as less important, such as moral reflexivity and moral attitude outcomes, should still be included. In the future, a combination of empirical findings (practice) and normative reflection (theories) will contribute to the revision of the instrument.

Pain Assessment in Impaired Cognition (PAIC): content validity of the Dutch version of a new and universal tool to measure pain in dementia.

OBJECTIVES: Detection and measurement of pain in persons with dementia by using observational pain measurement tools is essential. However, the evidence for the psychometric properties of existing observational tools remains limited. Therefore, a new meta-tool has been developed: Pain Assessment in Impaired Cognition (PAIC), as a collaborative EU action. The aim is to describe the translation procedure and content validity of the Dutch version of the PAIC. METHODS: Translation of the PAIC into Dutch followed the forward-backward approach of the Guidelines for Establishing Cultural Equivalence of Instruments. A questionnaire survey was administered to clinical nursing home experts (20 physicians and 20 nurses) to determine whether the PAIC items are indicative of pain and whether items are specific for pain or for other disorders (anxiety disorder, delirium, dementia, or depression). To quantify content validity, mean scores per item were calculated. RESULTS: Eleven items were indicative of pain, for example, "frowning," "freezing," and "groaning." Fifteen items were considered to be pain-specific, for example, "frowning," "curling up," and "complaining." There were discrepancies between the notion of pain characteristics according to nurses and physicians, especially in the facial expressions domain. DISCUSSION: Within the body movement domain, PAIC items correspond well with the clinical experience of the physicians and nurses. However, items in the facial expressions and vocalizations domains need further study with respect to item reduction. Also, differences were revealed in the notion of pain characteristics between physicians and nurses, suggesting the need for more interdisciplinary education on pain in dementia.

Passive imputation and parcel summaries are both valid to handle missing items in studies with many multi-item scales.

Previous studies showed that missing data in multi-item scales can best be handled by multiple imputation of item scores. However, when many scales are used, the number of items will become too large for the imputation model to reliably estimate imputations. A solution is to use passive imputation or a parcel summary score that combine and consequently reduce the number of variables in the imputation model. The performance of these methods was evaluated in a simulation study and illustrated in an example. Passive imputation, which updated scale scores from imputed items, and parcel summary scores that use the average over available item scores were compared to using all items simultaneously, imputing total scores of scales and complete-case analysis. Scale scores and coefficient estimates from linear regression were compared to "true" parameters on bias and precision. Passive imputation and using parcel summaries showed smaller bias and more precision than imputing total scores and complete-case analyses. Passive imputation or using parcel summary scores are valid missing data solutions in studies that include many multi-item scales.

Traction for low-back pain with or without sciatica.

BACKGROUND: Traction has been used to treat low-back pain (LBP), often in combination with other treatments. We included both manual and machine-delivered traction in this review. This is an update of a Cochrane review first published in 1995, and previously updated in 2006. OBJECTIVES: To assess the effects of traction compared to placebo, sham traction, reference treatments and no treatment in people with LBP. SEARCH METHODS: We searched the Cochrane Back Review Group Specialized Register, the Cochrane Central Register of Controlled Trials (2012, Issue 8), MEDLINE (January 2006 to August 2012), EMBASE (January 2006 to August 2012), CINAHL (January 2006 to August 2012), and reference lists of articles and personal files. The review authors are not aware of any important new randomized controlled trial (RCTs) on this topic since the date of the last search. SELECTION CRITERIA: RCTs involving traction to treat acute (less than four weeks' duration), subacute (four to 12 weeks' duration) or chronic (more than 12 weeks' duration) non-specific LBP with or without sciatica. DATA COLLECTION AND ANALYSIS: Two review authors independently performed study selection, risk of bias assessment and data extraction. As there were insufficient data for statistical pooling, we performed a descriptive analysis. We did not find any case series that identified adverse effects, therefore we evaluated adverse effects that were reported in the included studies. MAIN RESULTS: We included 32 RCTs involving 2762 participants in this review. We considered 16 trials, representing 57% of all participants, to have a low risk of bias based on the Cochrane Back Review Group's 'Risk of bias' tool.For people with mixed symptom patterns (acute, subacute and chronic LBP with and without sciatica), there was low- to moderate-quality evidence that traction may make little or no difference in pain intensity, functional status, global improvement or return to work when compared to placebo, sham traction or no treatment. Similarly, when comparing the combination of physiotherapy plus traction with physiotherapy alone or when comparing traction with other treatments, there was very-low- to moderate-quality evidence that traction may make little or no difference in pain intensity, functional status or global improvement.For people with LBP with sciatica and acute, subacute or chronic pain, there was low- to moderate-quality evidence that traction probably has no impact on pain intensity, functional status or global improvement. This was true when traction was compared with controls and other treatments, as well as when the combination of traction plus physiotherapy was compared with physiotherapy alone. No studies reported the effect of traction on return to work.For chronic LBP without sciatica, there was moderate-quality evidence that traction probably makes little or no difference in pain intensity when compared with sham treatment. No studies reported on the effect of traction on functional status, global improvement or return to work.Adverse effects were reported in seven of the 32 studies. These included increased pain, aggravation of neurological signs and subsequent surgery. Four studies reported that there were no adverse effects. The remaining studies did not mention adverse effects. AUTHORS' CONCLUSIONS: These findings indicate that traction, either alone or in combination with other treatments, has little or no impact on pain intensity, functional status, global improvement and return to work among people with LBP. There is only limited-quality evidence from studies with small sample sizes and moderate to high risk of bias. The effects shown by these studies are small and are not clinically relevant. Implications for practice To date, the use of traction as treatment for non-specific LBP cannot be motivated by the best available evidence. These conclusions are applicable to both manual and mechanical traction. Implications for research Only new, large, high-quality studies may change the point estimate and its accuracy, but it should be noted that such change may not necessarily favour traction. Therefore, little priority should be given to new studies on the effect of traction treatment alone or as part of a package.

Systematic review: do patient expectations influence treatment outcomes in total knee and total hip arthroplasty?

OBJECTIVE: This systematic review aims to summarise all the available evidence related to the association between pre-operative patient expectations (outcome expectations, process expectations and self efficacy expectations) and 5 different treatment outcomes (overall improvement, pain, function, stiffness and satisfaction) in patients with total knee or total hip arthroplasty at three different follow-op periods (>6 weeks; >6 weeks- ≤6 months; >6 months). METHODS: English and Dutch language articles were identified through PubMed, EMBASE.com, PsycINFO, CINAHL and The Cochrane Library from inception to September 2012. Articles assessing the association between pre-operative patient expectations and treatment outcomes for TKA/THA in either adjusted or unadjusted analysis were included. Two reviewers, working independently, determined eligibility, rated methodological quality and extracted data on study design, population, expectation measurements, outcome measurements and strength of the associations. Methodological quality was rated by the same reviewers on a 19 item scale. The scores on the quality assessment were taken into account when drawing final conclusions. RESULTS: The search strategy generated 2252 unique references, 18 articles met inclusion criteria. Scores on the methodological quality assessment ranged between 6% and 79%. Great variety was seen in definitions and measurement methods of expectations. No significant associations were found between patient expectations and overall improvement, satisfaction and stiffness. Both significant positive and non-significant associations were found for the association between expectations and pain and function. CONCLUSIONS: There was no consistency in the association between patients' pre-operative expectations and treatment outcomes for TKA and THA indentified in this systematic review. There exists a need for a sound theoretical framework underlying the construct of 'patient expectations' and consistent use of valid measurement instruments to measure that construct in order to facilitate future research synthesis.

Predictors for persistent neuropathic pain--a Delphi survey.

BACKGROUND: Chronic neuropathic pain has a major effect on quality of life. In order to prevent neuropathic pain from becoming chronic and improve neuropathic pain care, it is important to identify predictors associated with the persistence of neuropathic pain. OBJECTIVE: To identify potential predictors associated with the persistence of neuropathic pain. STUDY DESIGN: A 2-round Delphi study. SETTING: University Medical Center and Pain Management Research Center. METHODS: A 2-round Delphi study was conducted among 17 experts in the field of neuropathic pain. Selection of the panel was based on the citation index ranking for neuropathic pain-related research and/or membership in the neuropathic pain special interest group of the International Association for the Study of Pain (IASP), complemented with experts with demonstrated field knowledge.Potential predictors were categorized according to the International Classification of Functioning, Disability and Health model. Participants were asked to identify important predictors, suggest new predictors, and grade the importance on a 0-10 scale. For the second round, predictors were considered important if the median score was ≥ 7 and the interquartile range (IQR) ≤ 3. RESULTS: In the first round, 20 predictors were selected and 58 were added by the experts (patient characteristics [15], environmental factors [25], functions & structure [4], participation & health related quality of life [14]). In the second round, 12 predictors were considered important (patient characteristics [4; e.g., depression, pain catastrophizing], environmental factors [surgery as treatment for neuropathic pain], functions & structure [6; e.g., allodynia, duration of the complaints], participation & trait anxiety/depression as a part of health related quality of life). Presence of depression and pain catastrophizing were considered the most important predictors for chronic neuropathic pain (median ≥ 8; IQR ≤ 2). LIMITATIONS: The study design did not include plenary discussion among the experts. The meaning of the individual topics used in this study could have been subject to interpretation bias. CONCLUSIONS: Overall, psychological factors and factors related to sensory disturbances were considered important predictors for persistence of neuropathic pain. Activity related factors and previously received paramedical and alternative treatment were considered to be less important. The list of possible predictors obtained by this study may serve as a basis for development of a clinical prediction rule for chronic neuropathic pain.

The COSMIN checklist for evaluating the methodological quality of studies on measurement properties: a clarification of its content.

BACKGROUND: The COSMIN checklist (COnsensus-based Standards for the selection of health status Measurement INstruments) was developed in an international Delphi study to evaluate the methodological quality of studies on measurement properties of health-related patient reported outcomes (HR-PROs). In this paper, we explain our choices for the design requirements and preferred statistical methods for which no evidence is available in the literature or on which the Delphi panel members had substantial discussion. METHODS: The issues described in this paper are a reflection of the Delphi process in which 43 panel members participated. RESULTS: The topics discussed are internal consistency (relevance for reflective and formative models, and distinction with unidimensionality), content validity (judging relevance and comprehensiveness), hypotheses testing as an aspect of construct validity (specificity of hypotheses), criterion validity (relevance for PROs), and responsiveness (concept and relation to validity, and (in) appropriate measures). CONCLUSIONS: We expect that this paper will contribute to a better understanding of the rationale behind the items, thereby enhancing the acceptance and use of the COSMIN checklist.

Physical examination for lumbar radiculopathy due to disc herniation in patients with low-back pain.

BACKGROUND: Low-back pain with leg pain (sciatica) may be caused by a herniated intervertebral disc exerting pressure on the nerve root. Most patients will respond to conservative treatment, but in carefully selected patients, surgical discectomy may provide faster relief of symptoms. Primary care clinicians use patient history and physical examination to evaluate the likelihood of disc herniation and select patients for further imaging and possible surgery. OBJECTIVES: (1) To assess the performance of tests performed during physical examination (alone or in combination) to identify radiculopathy due to lower lumbar disc herniation in patients with low-back pain and sciatica;(2) To assess the influence of sources of heterogeneity on diagnostic performance. SEARCH STRATEGY: We searched electronic databases for primary studies: PubMed (includes MEDLINE), EMBASE, and CINAHL, and (systematic) reviews: PubMed and Medion (all from earliest until 30 April 2008), and checked references of retrieved articles. SELECTION CRITERIA: We considered studies if they compared the results of tests performed during physical examination on patients with back pain with those of diagnostic imaging (MRI, CT, myelography) or findings at surgery. DATA COLLECTION AND ANALYSIS: Two review authors assessed the quality of each publication with the QUADAS tool, and extracted details on patient and study design characteristics, index tests and reference standard, and the diagnostic two-by-two table. We presented information on sensitivities and specificities with 95% confidence intervals (95% CI) for all aspects of physical examination. Pooled estimates of sensitivity and specificity were computed for subsets of studies showing sufficient clinical and statistical homogeneity. MAIN RESULTS: We included 16 cohort studies (median N = 126, range 71 to 2504) and three case control studies (38 to100 cases). Only one study was carried out in a primary care population. When used in isolation, diagnostic performance of most physical tests (scoliosis, paresis or muscle weakness, muscle wasting, impaired reflexes, sensory deficits) was poor. Some tests (forward flexion, hyper-extension test, and slump test) performed slightly better, but the number of studies was small. In the one primary care study, most tests showed higher specificity and lower sensitivity compared to other settings.Most studies assessed the Straight Leg Raising (SLR) test. In surgical populations, characterized by a high prevalence of disc herniation (58% to 98%), the SLR showed high sensitivity (pooled estimate 0.92, 95% CI: 0.87 to 0.95) with widely varying specificity (0.10 to 1.00, pooled estimate 0.28, 95% CI: 0.18 to 0.40). Results of studies using imaging showed more heterogeneity and poorer sensitivity. The crossed SLR showed high specificity (pooled estimate 0.90, 95% CI: 0.85 to 0.94) with consistently low sensitivity (pooled estimate 0.28, 95% CI: 0.22 to 0.35).Combining positive test results increased the specificity of physical tests, but few studies presented data on test combinations. AUTHORS' CONCLUSIONS: When used in isolation, current evidence indicates poor diagnostic performance of most physical tests used to identify lumbar disc herniation. However, most findings arise from surgical populations and may not apply to primary care or non-selected populations. Better performance may be obtained when tests are combined.

Injection therapy for subacute and chronic low-back pain.

BACKGROUND: The effectiveness of injection therapy for low-back pain is still debatable. Heterogeneity of target tissue, pharmacological agent and dosage generally found in randomized controlled trials (RCTs) points to the need for clinically valid comparisons in a literature synthesis. OBJECTIVES: To determine if injection therapy is more effective than placebo or other treatments for patients with subacute or chronic low-back pain. SEARCH STRATEGY: We updated the search of the earlier systematic review and searched the Cochrane Central Register of Controlled Trials, MEDLINE and EMBASE databases from January 1999 to March 2007 for relevant trials reported in English, French, German, Dutch and Nordic languages. We also screened references from trials identified. SELECTION CRITERIA: RCTs on the effects of injection therapy involving epidural, facet or local sites for subacute or chronic low-back pain were included. Studies which compared the effects of intradiscal injections, prolotherapy or Ozone therapy with other treatments, were excluded unless injection therapy with another pharmaceutical agent (no placebo treatment) was part of one of the treatment arms. Studies about injections in sacroiliac joints and studies evaluating the effects of epidural steroids for radicular pain were also excluded. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the quality of the trials. If study data were clinically and statistically too heterogeneous to perform a meta-analysis, we used a best evidence synthesis to summarize the results. The evidence was classified into five levels (strong, moderate, limited, conflicting or no evidence), taking into account the methodological quality of the studies. MAIN RESULTS: 18 trials (1179 participants) were included in this updated review. The injection sites varied from epidural sites and facet joints (i.e. intra-articular injections, peri-articular injections and nerve blocks) to local sites (i.e. tender- and trigger points). The drugs that were studied consisted of corticosteroids, local anesthetics and a variety of other drugs. The methodological quality of the trials was limited with 10 out of 18 trials rated as having a high methodological quality. Statistical pooling was not possible due to clinical heterogeneity in the trials. Overall, the results indicated that there is no strong evidence for or against the use of any type of injection therapy. AUTHORS' CONCLUSIONS: There is insufficient evidence to support the use of injection therapy in subacute and chronic low-back pain. However, it cannot be ruled out that specific subgroups of patients may respond to a specific type of injection therapy.