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Abstract: Many studies report a female predominance in the prevalence of chronic musculoskeletal pain (CMP) but the mechanisms explaining these sex differences are poorly understood. Data from a random postal questionnaire survey in the Dutch general population were used to examine whether sex differences in the prevalences of CMP are due to sex differences in the distribution of known potential risk factors for CMP (exposure model) and/or to the different importance of risk factors for CMP (i.e. show different strength of association) in men and women (vulnerability model). In the present analyses, 909 men and 1178 women aged 25–65 were included. CMP was defined as pain lasting longer than 3 months and was assessed for 10 anatomical locations (neck, shoulder, higher back, elbow, wrist/hand, lower back, hip, knee, ankle, foot). Sex differences in CMP could not be explained by a different distribution of age, educational level, smoking status, overweight, physical activity, and pain catastrophizing. Having no paid job was associated with CMP, explaining part of the sex differences, but its role seems complex. Risk factors with a sex-specific association were: overweight (all pain locations) and older age (lower extremities) – both having only an effect among women – and pain catastrophizing (upper extremities), which was stronger associated with CMP among men than among women. In conclusion, sex differences in prevalence of CMP may partly be explained by sex differences in vulnerability to risk factors for CMP. Future research towards sex-specific identification of risk factors for CMP is warranted. Eventually this may lead to sex-specific prevention and management of CMP. [Copyright &y& Elsevier]

Summary: Objective: To assess the construct validity of the DynaPort®KneeTest (KneeTest), which is a performance-based test to assess functioning of patients with knee osteoarthritis (OA). Scores on the KneeTest (KneeScore) were compared with observations of physical therapists of the patients'' functional disability. The reliability of these observations was also assessed. Method: Twelve physical therapists received identical video tapes showing the performance of 33 patients on the KneeTest. Each physical therapist rated the functional disability of each patient, performing the 23 activities of the KneeTest, on 23 Visual Analogue Scales (VASactivity). The 23 VASactivity scores were averaged into a VASaverage score. At the end of the test, an overall rating for the general performance of the patient was given on a VASoverall. Inter-observer Reliability was assessed for the VASactivity scores, VASaverage, and the VASoverall. Results: Inter-observer reliability of the VASaverage was higher (ICC 0.85, 95% CI 0.74–0.92) than the VASoverall (ICC 0.65, 95% CI 0.51–0.77). The correlation between the KneeScore and the VASaverage, averaged over the 12 physiotherapists, was 0.86. Conclusion: The construct validity of the KneeTest was supported by the strong correlation with the ratings of the patients'' disability by physical therapists. Given these findings and the high test–retest reliability of the KneeTest that was found in our previous study, we conclude that the KneeTest is a valid measure for assessing functioning in orthopedic and physical therapy research in patients with knee-OA before and after total knee replacement. Longitudinal validity has to be evaluated yet. [Copyright &y& Elsevier]

Objective: To describe the design of a randomized controlled trial (RCT), including a cost-effectiveness analysis, comparing high-intensity and low-intensity back schools with usual care in occupational health care. Design: RCT and cost-effectiveness analysis. Study Population: Employees sick-listed for a period of 3 to 6 weeks because of nonspecific low back pain. Interventions: High-intensity back school treatment consists of a training program based on the principles of cognitive- behavioral therapy. Low-intensity back school treatment is comparable to the original Swedish Back School. Usual care is provided by the occupational physician according to the Dutch guidelines for the occupational health treatment of patients with low back pain. Outcome Measures: Primary outcome measures are return to work, pain intensity, functional status, and general improvement. Secondary outcome measures are kinesiophobia and pain coping. The cost-effectiveness analysis includes the direct and indirect costs. The outcome measures are assessed before randomization and 3, 6, and 12 months after randomization. Conclusion: RCTs of different methodological quality have been conducted to examine the effectiveness of back schools in occupational health care. The large variation in type, content, and intensity of back schools has led to conflicting evidence. Therefore, 2 different forms of back schools are compared. Moreover, this is the first RCT to include a cost- effectiveness analysis comparing low-intensity and high-intensity back schools with usual care in occupational health care. [ABSTRACT FROM AUTHOR]

The increased attention for quality of life (QOL) as an outcome measure has led to the development of numerous questionnaires to assess this construct in the field of ophthalmology. This article presents a systematic review on QOL questionnaires for people with vision impairments. We systematically searched and selected the literature. Furthermore, a rating list with descriptive aspects (e.g. target population) and psychometric aspects (e.g. reproducibility) was developed. The 31 questionnaires that were included in the review were rated on the basis of criteria stated in this rating list. The questionnaires were mostly targeted at cataract patients or visually impaired persons in general. Only a few of the questionnaires demonstrated sufficient psychometric quality. A recent development is the (re-)evaluation of questionnaires with Rasch analysis. This is one of the most important issues to which future research in this field should be directed. [ABSTRACT FROM AUTHOR]

Presents letters to the editors commenting on articles previously published in the periodical 'Annals of Internal Medicine.' Effects of three therapies for neck pain; Subgroup variation in diagnostic test evaluation; Postmenopausal hormone replacement therapy; Screening for postmenopausal osteoporosis.

To assess the cultural competence (CC) of GP trainees and GP trainers. Design and setting: A cross-sectional survey study was conducted at the GP Training Institute of Amsterdam UMC. We included 92 GP trainees and 186 GP trainers. We measured the three domains of cultural competency: 1) knowledge, 2) culturally competent attitudes and 3) culturally competent skills. Regression models were used to identify factors associated with levels of CC. Participants rated their self-perceived CC at the beginning and end of the survey, and the correlation between self-perceived and measured CC was assessed. Approximately 94% of the GP trainees and 81% of the GP trainers scored low on knowledge; 45% and 42%, respectively, scored low on culturally competent attitudes. The level of culturally competent skills was moderate (54.3%) or low (48.4%) for most GP trainees and GP trainers. The year of residency and the GP training institute were significantly associated with one or more (sub-)domains of CC in GP trainees. Having >10% migrant patients and experience as a GP trainer were positively associated with one or more (sub-) domains of cultural competence in GP trainers. The correlation between measured and self-perceived CC was positive overall but very weak (Spearman correlation coefficient ranging from −0.1–0.3). The level of cultural competence was low in both groups, especially in the knowledge scores. Cultural competence increased with experience and exposure to an ethnically diverse patient population. Our study highlights the need for cultural competence training in the GP training curricula. General practitioner (GP) trainees find cross-cultural consultations stressful due to a self-perceived lack of cultural competence (CC). The level of CC in general practice is as yet unknown. On average, the level of CC was low for the majority of GP trainees and GP trainers, especially for the scores on knowledge. CC increased with experience and exposure to an ethnically diverse patient population. GP trainees and trainers perceived a lack of covered education on various topics related to the care of migrants. Our study highlights the need for cultural competence training in the GP training curricula. [ABSTRACT FROM AUTHOR]

Background: The Pelvic Floor Distress Inventory-20 is used to evaluate symptoms and treatment effects in women with pelvic floor disorders. To interpret changes in the scores of this inventory, information is needed about what patients and clinicians perceive as the minimal important (meaningful) change. Although this change in the inventory score has been investigated previously in women who have undergone pelvic floor surgery, the results could not be generalized to women with milder symptoms (ie, lower scores) who often require only conservative treatment.Objective: We aimed to estimate the minimal important change in the Pelvic Floor Distress Inventory-20 that was needed to demonstrate clinical improvement in women who qualify for conservative pelvic floor treatment.Study Design: The data of 214 women aged ≥55 years were used. All participants were from 2 randomized controlled trials that compared conservative prolapse treatments in primary care in The Netherlands. The degree of prolapse was assessed with the use of the Pelvic Organ Prolapse Quantification system; participants completed the Pelvic Floor Distress Inventory-20 at baseline and at 12 months, with a global perception of improvement question at 12 months. To assess both the patient perspective and the clinical perspective, 2 anchors were assessed: (1) the global perception of improvement was considered the anchor for the patients' perspective, and (2) the difference in the degree of prolapse was considered the anchor for the clinical perspective. Provided that the anchors were correlated by at least 0.3 to the Pelvic Floor Distress Inventory-20 change scores, we estimated the following minimal important changes: (1) the optimal cutoff-point of the receiver operating characteristics curve that discriminates between women with and without improvement in the global perception of improvement scale and (2) the mean Pelvic Floor Distress Inventory-20 change score of participants who improved 1 assessment stage. We then calculated the smallest detectable change to check whether the minimal important change was larger than the measurement error of the questionnaire.Results: Using the global perception of improvement as the anchor, we found a minimal important change for improvement of 13.5 points (95% confidence interval, 6.2-20.9). The Pelvic Organ Prolapse Quantification change scores correlated poorly to the Pelvic Floor Distress Inventory-20 change scores and therefore could not be used as an anchor. The smallest detectable change at the group level was 5.5 points. Thus, the minimal important change was larger than the smallest detectable change at the group level.Conclusion: In women with relatively mild pelvic floor symptoms, an improvement of 13.5 points (or a 23% reduction) in the Pelvic Floor Distress Inventory-20 score can be considered clinically relevant. This minimal important change can be used for clinical trial planning and evaluation of treatment effects in women whose condition is considered suitable for conservative treatment. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented about the efficacy of spinal cord stimulation and physical therapy in treating chronic reflex sympathetic dystrophy.

Transepidermal water loss (TEWL) is a physiological characteristic to measure the efficiency of the skin barrier. The aim was to investigate the reliability of the Tewameter TM300 for the assessment of TEWL (g/m2/h) in burn scars. Also the relation between TEWL scar values and scar quality parameters was investigated. Three different study areas (scar, healthy adjacent and contralateral skin) were assessed in 55 adult patients. The intra- and inter-observer reliability were tested using the intra-class correlation coefficient (ICC) and the standard error of measurement (SEM). The inter-observer reliability for the three areas was excellent with ICC values between 0.85 and 0.94. SEM values were between 1.76 and 3.97g/m2/h. Bland-Altman plots showed relatively wide LoA values for scar and healthy skin. Mean TEWL scar values were significantly higher than healthy skin (p<0.001). Significant correlations were found between TEWL hypertrophic scar values and erythema (r=0.60, p=0.001) and a negative correlation for weeks after burn (r=-0.61, p=0.001). TEWL values were significantly different between 3 and 6 months and 3 and 12 months old scars (respectively p=0.021 and p=0.002). To evaluate the skin barrier function over time as a measure for scar maturation, Tewameter TM300 measurements have to be performed according to strict and standardized protocols. [ABSTRACT FROM AUTHOR]

Objectives To describe observations of suffering in patients with dementia from the diagnosis of pneumonia until cure or death. Design Prospective observational study between January 2012 and May 2014. Setting Dutch nursing homes (32). Participants Nursing home patients with dementia and pneumonia (n = 193). Measurements Independent observers performed observations of patients with dementia scheduled 13 times within the 15 days following diagnosis of pneumonia; twice daily in the first 2 days– to observe discomfort (Discomfort Scale–Dementia of Alzheimer Type; range 0–27), comfort (End Of Life in Dementia-Comfort Assessment in Dying; range 14–42), pain (Pain Assessment in Advanced Dementia; range 0–10), and dyspnea (Respiratory Distress Observation Scale; range 0–16). Results Observational data were obtained for 208 cases of pneumonia in 193 patients. In 71.2% of cases, patients received 1 or more treatments to relieve symptoms such as antipyretics, opioids, or oxygen; 89.4% received antibiotics. Discomfort was highest 1 day after diagnosis [mean Discomfort Scale-Dementia of Alzheimer Type score 8.1 (standard deviation, SD 5.8)], then declined, and stabilized around day 10 [mean 4.5 (SD 4.1)], or increased in the days preceding death. Observed pain and dyspnea followed a comparable pattern. Discomfort patterns did not differ much between cases treated with and without antibiotics. Conclusions Pneumonia in patients with dementia involved elevated levels of suffering during 10 days following diagnosis and in the days preceding death. Overall observed discomfort was low compared with prior Dutch studies, and the number of treatments to relieve symptoms was higher. Future studies should examine whether symptoms of pneumonia can be relieved even more, and what treatments are the most effective. [ABSTRACT FROM AUTHOR]

Abstract: Despite the importance of palliative care and quality of life (QoL) as an outcome measure, little research evaluated the QoL instruments that are used in end-of-life situations. We evaluated the content of and domains measured by QoL instruments that are suitable for use in palliative care and how the domain of spirituality was operationalized in these instruments. We conducted two literature reviews. One identified the domains that are most important for the QoL of incurably ill patients and resulted in a framework of QoL domains. The other review identified 29 instruments measuring (at least one domain of) QoL that are appropriate for use in palliative care. Most of the instruments covered only one or two QoL domains, and none of the instruments covered all QoL domains included in the framework. Among the 29 instruments, 15 included items on spirituality. We also categorized the spirituality items contained in the instruments into the spirituality aspects in the framework. Most spirituality items concerned the meaning or purpose of life. This study provides information about the domains included in QoL instruments that are suitable for use in palliative care and provides insights into the differences in content, which can be helpful when choosing an instrument for use in palliative care. [ABSTRACT FROM AUTHOR]

Several countries offer HPV self-sampling for screening non-attendees. It is assumed that screening attendees also prefer self-sampling to clinician-based sampling, however, little research has been conducted with respect to this. Women participating in the IMPROVE-study were randomised (1:1) to self- or clinician-collected HPV testing, and HPV-positive women were retested using the other collection method. Three different questionnaires were sent out among a subset of participating women: Q1) HPV-positive women from both study groups were asked about their experiences with self-sampling and clinician-based sampling (n = 497); Q2) HPV-negative women from the self-sampling group were asked about their experiences with self-sampling (n = 2366); and Q3) HPV-negative women in the clinician-collection group were asked about their experiences with clinician-based sampling (n = 2092). Response rates ranged from 71.6 to 79.4%. Women reported significantly lower levels of shame, nervousness, discomfort and pain during self-sampling compared to clinician-based sampling. However, trust in correct sampling was significantly higher during clinician-based sampling. The majority of women in group Q1 preferred self-sampling (76.5%) to clinician-based sampling (11.9%) in future screening, while 11.6% of women reported to have no preference for either method. To conclude, women from a regular screening population have a positive attitude towards self-sampling but express some concerns with respect to accuracy. The majority prefers self-sampling to clinician-based sampling in future screening. Based on these results, a screening approach where women can choose for either self-sampling or clinician-based sampling seems highly justifiable. [ABSTRACT FROM AUTHOR]

Head and neck squamous cell carcinoma (HNSCC) is typically regarded as a disease of elderly people. However, increasing numbers of patients worldwide with HNSCC at younger age (defined as <45 years old) have been reported in recent years. To assess geographical variations and trends worldwide in incidence of oral and oropharyngeal cancer in young patients, a systematic review was conducted in PubMed and Google scholar databases from 1975 to June 2016. Seventy-eight studies were selected for further study. Nineteen population-based studies on incidence rate were available from 13 countries, showing a prominent increase over time except for the Netherlands. A notable rise of oral (mobile) tongue cancer among white women and oropharyngeal cancer in white men was observed. Data suggest that cancer in young patients may be a distinct clinical entity and characterised by different aetiology and pathogenesis. Additionally, the relative proportion of oral and oropharyngeal cancer in young patients to total incidence revealed a significant difference between estimates from North America (5.5%) and both Africa (17.2%) and Middle East (14.5%). It is concluded that (i) a rising trend in oral and oropharynx cancers is observed in young patients worldwide; (ii) incidence studies should properly define outcomes in age cohorts and use a consensus cut-off for young patients; (iii) more population-based studies should be performed in non-Western regions to get accurate global measures of incidence for these cancers in young subpopulations and (iv) there is an urge to identify new aetiological factors in these young patients. [ABSTRACT FROM AUTHOR]

Objectives: To review the methodology of interobserver variability studies; including current practice and quality of conducting and reporting studies. Methods: Interobserver variability studies between January 2019 and January 2020 were included; extracted data comprised of study characteristics, populations, variability measures, key results, and conclusions. Risk of bias was assessed using the COSMIN tool for assessing reliability and measurement error. Results: Seventy‐nine full‐text studies were included covering various imaging tests and clinical areas. The median number of patients was 47 (IQR:23–88), and observers were 4 (IQR:2–7), with sample size justified in 12 (15%) studies. Most studies used static images (n = 75, 95%), where all observers interpreted images for all patients (n = 67, 85%). Intraclass correlation coefficients (ICC) (n = 41, 52%), Kappa (κ) statistics (n = 31, 39%) and percentage agreement (n = 15, 19%) were most commonly used. Interpretation of variability estimates often did not correspond with study conclusions. The COSMIN risk of bias tool gave a very good/adequate rating for 52 studies (66%) including any studies that used variability measures listed in the tool. For studies using static images, some study design standards were not applicable and did not contribute to the overall rating. Conclusions: Interobserver variability studies have diverse study designs and methods, the impact of which requires further evaluation. Sample size for patients and observers was often small without justification. Most studies report ICC and κ values, which did not always coincide with the study conclusion. High ratings were assigned to many studies using the COSMIN risk of bias tool, with certain standards scored 'not applicable' when static images were used. Advances in knowledge: The sample size for both patients and observers was often small without justification. For most studies, observers interpreted static images and did not evaluate the process of acquiring the imaging test, meaning it was not possible to assess many COSMIN risk of bias standards for studies with this design. Most studies reported intraclass correlation coefficient and κ statistics; study conclusions often did not correspond with results. [ABSTRACT FROM AUTHOR]

Objective The aim of this study was to describe the process of advance care planning (ACP) and to explore factors related to the timing and content of ACP in nursing home patients with dementia, as perceived by family, physicians, and nurses. Design A qualitative descriptive study. Methods A total of 65 in-depth qualitative interviews were held with families, on-staff elderly care physicians, and nurses of 26 patients with dementia who died in the Dutch End Of Life in Dementia (DEOLD) study. Interviews were coded and analyzed to find themes. Results Family, nurses, and physicians of all patients indicated they had multiple contact moments during nursing home stay in which care goals and treatment decisions were discussed. Nearly all interviewees indicated that physicians took the initiative for these ACP discussions. Care goals discussed and established during nursing home stay and the terminology to describe care goals varied between facilities. Regardless of care goals and other factors, cardiopulmonary resuscitation (CPR) and hospitalization were always discussed in advance with family and commonly resulted in a do-not-resuscitate (DNR) and a do-not-hospitalize (DNH) order. The timing of care planning discussions about other specific treatments or conditions and the content of treatment decisions varied. The factors that emerged from the interviews as related to ACP were general strategies that guided physicians in initiating ACP discussions, patient's condition, wishes expressed by patient or family, family's willingness, family involvement, continuity of communication, consensus with or within family, and general nursing home policy. Two influential underlying strategies guided physicians in initiating ACP discussions: (1) wait for a reason to initiate discussions, such as a change in health condition and (2) take initiative to discuss possible treatments (actively, including describing scenarios). Conclusions ACP is a multifactorial process, which may lean on professional caregivers' guidance. The most acute decisions are covered in advance, but a responsive as well as a proactive style is seen with other treatment decisions. Further research is needed to increase understanding of whether and how the physicians' strategies affect care processes and outcomes. [ABSTRACT FROM AUTHOR]

Context Although dying peacefully is considered an important outcome of high-quality palliative care, large-scale quantitative research on dying peacefully and the factors associated with a peaceful death is lacking. Objectives To gain insight into how many residents with dementia in long-term care facilities die peacefully, according to their relatives, and whether that assessment is correlated with observed physical and psychological distress. Methods This was a retrospective cross-sectional study of deceased nursing home residents in a representative sample of long-term care facilities in Flanders, Belgium (2010). Structured post-mortem questionnaires were completed by relatives of the resident, who were asked to what extent they agreed that the resident “appeared to be at peace” during the dying process. Spearman correlation coefficients gave the correlations between physical and psychological distress (as measured using the Symptom Management at the End of Life with Dementia and Comfort Assessment in Dying at the End of Life with Dementia scales) and dying peacefully (as measured using the Quality of Dying in Long Term Care instrument). Results The sample comprised 92 relatives of deceased residents with dementia. In 54% of cases, relatives indicated that the resident died peacefully. Weak-to-moderate correlations (0.2–0.57) were found between dying peacefully and physical distress in the last week of life. Regarding psychological distress, weak-to-moderate correlations were found for both the last week (0.33–0.44) and last month of life (0.28–0.47). Conclusion Only half of the residents with dementia died peacefully as perceived by their relatives. Relatives' assessment of whether death was peaceful is related to both physical and psychological distress. Further qualitative research is recommended to gain more in-depth insights into the aspects on which relatives base their judgment of dying peacefully. [ABSTRACT FROM AUTHOR]

Objectives: Previous studies show that missing values in multi-item questionnaires can best be handled at item score level. The aim of this study was to demonstrate two novel methods for dealing with incomplete item scores in outcome variables in longitudinal studies. The performance of these methods was previously examined in a simulation study. The two methods incorporate item information at the background when simultaneously the study outcomes are estimated. Study Design and Setting: The investigated methods include the item scores or a summary of a parcel of available item scores as auxiliary variables while using the total score of the multi-item questionnaire as the main focus of the analysis in a latent growth model. That way the items help estimating the incomplete information of the total scores. The methods are demonstrated in two empirical data sets. Results: Including the item information results in more precise outcomes in terms of regression coefficient estimates and standard errors, compared with not including item information in the analysis. Conclusion: The inclusion of a parcel summary is an efficient method that does not overcomplicate longitudinal growth estimates. Therefore, it is recommended in situations where multi-item questionnaires are used as outcome measure in longitudinal clinical studies with incomplete scores because of missing item scores. [ABSTRACT FROM AUTHOR]

Background Perforator-based flaps have become indispensable in the treatment of burn scars. Pre-operative perforator mapping is often performed by use of the hand held Doppler device, partly due to its convenience and the low costs. We expected to find sufficient evidence in literature to support the use of the device, however available literature showed a distinct lack of clinimetric studies that adequately tested the reliability. Methods To assess reliability, perforator locations were mapped independently by two clinicians using an 8 MHz Doppler device. In healthy volunteers the elbow region or the peri-umbilical region were randomly chosen to be the measurement areas of predefined squares (7 cm × 7 cm). Subsequently, the perforators within the area were mapped with Duplex to establish the validity by means of the positive predictive value. Results 20 volunteers were included. The hand held Doppler technique showed moderate reliability with a mean Dice coefficient of 0.56. Also, poor validity was found expressed by a mean positive predictive value of 55%. Conclusions Surprisingly, this study has shown that performance of the hand held Doppler device was moderate. The Doppler should not be used alone for the detection of perforators. [ABSTRACT FROM AUTHOR]

Abstract: Rationale: Malnutrition screening among nursing home residents is often performed with tools developed for use among older subjects, and sometimes with tools designed for an adult population. Only a few tools have been designed specifically for the nursing home setting. This systematic review assesses the criterion and predictive validity of malnutrition screening tools used in nursing homes. Methods: The databases MEDLINE, CINAHL, and EMBASE were searched on January 30, 2013, for manuscripts including search terms for malnutrition, screening or assessment tools, and setting. Articles were eligible for inclusion if they expressed criterion validity (how well can a tool assess nutritional status) or predictive validity (how well can a tool predict clinical outcome) of malnutrition screening tools in a nursing home population. Included were articles that had been published in the English, German, French, Dutch, Spanish, or Portuguese language. Results: The search yielded 8313 references. Of these, 24 met the inclusion criteria and were available; 2 extra manuscripts were retrieved by reference checking. Twenty tools were identified. Seventeen studies reported on criterion validity, and 9 on predictive validity. Four of the tools had been designed specifically for use in long term care. None of the tools, not even the ones specifically designed for the nursing home setting, performed (on average) better than “fair” in either assessing the residents' nutritional status or in predicting malnutrition-related outcomes. Conclusion: The use of existing screening tools for the nursing home population carries limitations, as none performs better than “fair” in assessing nutritional status or in predicting outcome. Also, no superior tool can be pointed out. This systematic review implies that further considerations regarding malnutrition screening among nursing home residents are required. [Copyright &y& Elsevier]

Abstract: Context: More people are surviving into old age, and chronic diseases tend to become more common with age. Ill health and disability can lead to concerns about loss of personal dignity. Objectives: To investigate whether health status affects the perceptions of factors influencing personal dignity at the end of life, and the relationship between those perceptions and sociodemographic characteristics. Methods: A subsample (n =2282) of a large advance directives cohort study was used. Three different health status groups (good, moderate, and poor) were defined based on the Euroqol-5D and a question on whether they had an illness. For each health status group, we calculated the percentage of respondents who indicated the extent to which the items of the Patient Dignity Inventory would influence their dignity as (very) large. Logistic regression analyses were used to investigate the associations between the perceptions of factors influencing personal dignity and sociodemographics. Results: The percentage of respondents who indicated the factors as having a (very) large influence on dignity at the end of life were not significantly different for the three health status groups, except for three physical items on symptoms, roles, and routines. Those items were significantly more influential on dignity for people with a poor health status. Gender, old age, having a partner, and having a belief or religion that is important to one''s life were associated with an understanding of factors influential to dignity. Conclusion: Health status seems only to affect the perceptions of physical factors maintaining dignity at the end of life. This might suggest that the understanding of dignity will not substantially change as health status changes and may support starting advance care planning early. [Copyright &y& Elsevier]

Abstract: Objectives: To compare available instruments and investigate which best measure the quality of end-of-life care (QOC) and quality of dying (QOD) in long term care settings, in terms of validity, reliability, and feasibility. Design: Family and professional caregivers of long term care decedents completed postdeath interviews and questionnaires between November 2007 and April 2009. Setting: Nursing home and residential care/assisted living settings in the United States and the Netherlands. Participants: Two hundred and sixty four families of decedents with (48%) and without (52%) dementia in the United States, and 70 families and 103 professional caregivers of decedents with dementia in the Netherlands. Measurements: Ten instruments to evaluate the QOC and QOD in long term care, an additional overall assessment of QOC/QOD, and an assessment of the perception of the relevance and ease of use of each instrument. Criteria for validity, reliability, and feasibility were set forth for good, intermediate, and poor performance. Results: None of the instruments scored positively on all criteria. In both countries, of the QOC instruments, the End-of-Life in Dementia-Satisfaction With Care (EOLD-SWC) best met the criteria, followed by the Family Assessment of Treatment at the End-of-Life Short Version, the Family Perception of Care Scale, and Family Perception of Physician-Family Caregiver Communication. Of the QOD instruments, the End-of-Life in Dementia–Comfort Assessment at Dying (EOLD-CAD) and Mini-Suffering State Examination (MSSE) met more of the criteria than others. The EOLD-CAD performed better on content and construct validity than the MSSE. The MSSE performed better on feasibility. Conclusion: We recommend the EOLD-SWC to measure QOC, and the EOLD-CAD and MSSE to measure QOD in populations with dementia and in mixed long term care populations of nursing home or residential care home/assisted living residents, because they performed best in both countries. Use of the same instruments allows for comparison of the results between studies. [Copyright &y& Elsevier]

Abstract: Context: Long-term care (LTC) settings have become a significant site for end-of-life care; consequently, instruments that assess the quality of dying and care may be useful in these settings. Objectives: To evaluate the content of available measurement instruments to assess the quality of dying and care when dying. Methods: Qualitative content analysis to categorize items as structure of care, process of care, satisfaction with health care (the first three representing quality of care and its evaluation), quality of dying, or patient factors. Results: Instruments that measure mostly quality of care and its evaluation are the Family Perception of Physician-Family Caregiver Communication, End-of-Life in Dementia (EOLD) Satisfaction With Care, Family Perception of Care Scale, Toolkit of Instruments to Measure End-of-Life Care after-death bereaved family member interview (nursing home version), and the Family Assessment of Treatment at the End-of-Life Short version. Instruments measuring quality of dying are the EOLD-Comfort Assessment in Dying, EOLD-Symptom Management, Mini-Suffering State Examination, and Palliative Care Outcome Scale. The Quality of Dying in Long-Term Care measures care and dying. The Minimum Data Set-Palliative Care measures mostly dying and patient factors. The instruments differ in dementia specificity, time of administration, and respondent. Conclusion: Instruments that assess quality when dying differ in several ways and most do not measure a single construct, which is relevant to guiding and evaluating care. Comparing psychometric properties and usefulness of instruments that measure similar constructs is the next step in determining which are best suited for use in LTC. [Copyright &y& Elsevier]

Abstract: Background context: The recovery of patients with chronic low back pain (LBP) is slow. Furthermore, it is recently proposed that chronic LBP needs a prognostic approach to determine who will develop clinically significant back pain. Therefore, it is imperative to identify prognostic factors that are mostly seen in chronic LBP patients at an early stage. This may give clinicians tailored advice to prevent chronicity or may refer to a specific intervention. Purpose: To investigate the contribution of demographic, work, clinical, and psychosocial variables, including new prognostic variables as changes in pain intensity and disability status, on the development of chronic LBP. Study design/setting: Prospective cohort data by merging data from three randomized trials (secondary analyses). Patient sample: Workers (n=628) on sick leave because of subacute nonspecific LBP. Outcome measures: Chronic LBP for longer than 6 months (functional measure). Methods: Potential prognostic variables were demographic, work, clinical, and psychosocial characteristics (self-report measures). We also included as prognostic variables a clinically relevant change in pain intensity and disability status. For the selection of variables and prognostic models, bootstrapping techniques were used in combination with multivariable logistic regression. The explained variance and discrimination were used to evaluate the clinical performance of the models. Results: The variables most strongly related to chronic LBP were as follows: no clinically relevant change in pain intensity and in disability status in the first 3 months, a higher pain intensity score at baseline, and a higher score for kinesiophobia. This prognostic model had a bootstrap-corrected explained variance of 37% and a discriminative ability (c index) of 0.80. Conclusions: Clinical-, work-, and psychosocial-related variables contribute to the development of chronic LBP. The most promising variables are a clinically relevant decrease in pain intensity and in disability status in the first 3 months. These variables are relevant for clinicians to advise their patients with respect to preventive measures or treatment strategies. [Copyright &y& Elsevier]

Abstract: Objective: Lack of consensus on taxonomy, terminology, and definitions has led to confusion about which measurement properties are relevant and which concepts they represent. The aim was to clarify and standardize terminology and definitions of measurement properties by reaching consensus among a group of experts and to develop a taxonomy of measurement properties relevant for evaluating health instruments. Study Design and Setting: An international Delphi study with four written rounds was performed. Participating experts had a background in epidemiology, statistics, psychology, and clinical medicine. The panel was asked to rate their (dis)agreement about proposals on a five-point scale. Consensus was considered to be reached when at least 67% of the panel agreed. Results: Of 91 invited experts, 57 agreed to participate and 43 actually participated. Consensus was reached on positions of measurement properties in the taxonomy (68–84%), terminology (74–88%, except for structural validity [56%]), and definitions of measurement properties (68–88%). The panel extensively discussed the positions of internal consistency and responsiveness in the taxonomy, the terms “reliability” and “structural validity,” and the definitions of internal consistency and reliability. Conclusions: Consensus on taxonomy, terminology, and definitions of measurement properties was reached. Hopefully, this will lead to a more uniform use of terms and definitions in the literature on measurement properties. [Copyright &y& Elsevier]

Objective: There is no consensus on the best method to determine the minimal important change (MIC) of patient-reported outcomes. Recent publications recommend the use of multiple methods. Our aim was to assess whether different methods lead to consistent values for the MIC.Study Design and Setting: We used two commonly used anchor-based methods and three commonly used distribution-based methods to determine the MIC of the subscales: pain and physical functioning of the Western Ontario and McMaster University Osteoarthritis Index questionnaire in five different studies involving patients with hip or knee complaints. We repeated the anchor-based methods using relative change scores, to adjust for baseline scores.Results: We found large variation in MIC values by the same method across studies and across different methods within studies. We consider it unlikely that this variation can be explained by differences between disease groups, disease severity, or lengths of follow-up. The variation persisted when using relative change scores. It was not possible to conclude whether this variation is because of true differences in MIC values between populations or to conceptual and methodological problems of the MIC methods.Conclusion: To better disentangle these two possible explanations, the MIC methodology should be improved and standardized. In the meantime, caution is needed when interpreting and using published MIC values. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To evaluate the inter-rater agreement of the record review process of the Dutch Adverse Event study, which we aimed to improve by the involvement of two independent physician reviewers per record instead of one including a consensus procedure in case of disagreement. Methods: The inter-rater agreement within pairs of physicians (independent review between physician A+B) and between pairs of physicians (independent review between physician A+B and C+D) was measured to evaluate the record review process with two physicians including a consensus procedure, with 4,272 and 119 records, respectively. Results: The inter-rater agreement within pairs of physicians was substantial for the determination of adverse events (AEs) with a kappa of 0.64 (95% confidence interval [CI]: 0.61, 0.68). The inter-rater agreement between pairs of physicians was fair for the determination of AEs with a kappa of 0.25 (95% CI: 0.05, 0.45). Conclusion: A record review process with two physicians per record including a consensus procedure to assess AEs is not more reliable than a record review process with one physician. Retrospective estimates of incidence of AEs from record review studies should be interpreted with caution. Improvement of the method is necessary for monitoring incidence of AEs over time at a national level. [Copyright &y& Elsevier]

Abstract: Objective: To provide a practical example showing how to relate measurement error to minimal important change (MIC) to estimate sample sizes required for detecting important changes in research, and to determine the usefulness of patient-reported outcomes (PROs) in daily clinical practice. Study Design and Setting: The standard error of measurement (SEM) can be calculated as a parameter of measurement error. MIC can be determined by taking the mean change in score on the questionnaire in the subgroup of patients that reported to be “a little better” or “better” on a global rating scale minus the mean change in score in the subgroup of patients that reported to be “not changed.” Based on SEM and MIC, formulas are presented that can be used to estimate sample sizes and to determine whether the questionnaire can be used to monitor changes in individual patients in daily clinical practice. Results: A fully worked-out example is presented, using Western Ontario and McMaster University Osteoarthritis Index data from a cohort of patients undergoing hip or knee replacement. Conclusion: We strongly recommend investigators to present the SEM and MIC of PROs and use these to estimate sample sizes for research and to determine the usefulness of these outcomes in daily clinical practice. [Copyright &y& Elsevier]

Abstract: Objectives: Recently, an increasing number of systematic reviews have been published in which the measurement properties of health status questionnaires are compared. For a meaningful comparison, quality criteria for measurement properties are needed. Our aim was to develop quality criteria for design, methods, and outcomes of studies on the development and evaluation of health status questionnaires. Study Design and Setting: Quality criteria for content validity, internal consistency, criterion validity, construct validity, reproducibility, longitudinal validity, responsiveness, floor and ceiling effects, and interpretability were derived from existing guidelines and consensus within our research group. Results: For each measurement property a criterion was defined for a positive, negative, or indeterminate rating, depending on the design, methods, and outcomes of the validation study. Conclusion: Our criteria make a substantial contribution toward defining explicit quality criteria for measurement properties of health status questionnaires. Our criteria can be used in systematic reviews of health status questionnaires, to detect shortcomings and gaps in knowledge of measurement properties, and to design validation studies. The future challenge will be to refine and complete the criteria and to reach broad consensus, especially on quality criteria for good measurement properties. [Copyright &y& Elsevier]

Abstract: Background and Objectives: To test the hypothesis that self-reported physical functioning is more influenced by pain than performance-based physical functioning. Methods: 163 knee-osteoarthritis patients completed the performance-based DynaPort® KneeTest (DPKT), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and SF-36 (self-report measures of pain and physical functioning) before, 3, 6, and 12 months after knee replacement. Results: Correlations between (two) self-reported measures of functioning and (two) pain measures were higher (0.57–0.74) than correlations between the performance-based measure of functioning and the two pain measures (0.20 and 0.26). In factor analysis, WOMAC and SF-36 pain and physical functioning subscores loaded on the first factor (eigenvalue 3.2), while DPKT KneeScore2 loaded on the second factor (eigenvalue 0.92). Before surgery, correlations between performance-based and self-reported physical functioning were higher in patients with less pain (0.43) compared to patients with more pain (0.17), for the WOMAC (as expected), but not for the SF-36. After surgery, when the pain had diminished, the correlations between performance-based and self-reported physical functioning were higher, especially for the WOMAC. Conclusions: Our hypothesis was convincingly supported by the results of the WOMAC, and somewhat less by the results of the SF-36. We consider this as evidence for a lack of content validity of the WOMAC. [Copyright &y& Elsevier]

Context: There is need for tools to help detect pain or lack of comfort in persons unable to communicate. However, pain and (dis)comfort tools have not been compared, and it is unclear to what extent they discriminate between pain and other possible sources of discomfort, or even if items differ.Objectives: To map and compare items in tools that assess pain and the broader notion of discomfort or comfort in people with severe dementia or at the end of life.Methods: Using qualitative content analysis with six classifications, we categorized each item of four thoroughly tested observational pain tools (Pain Assessment in Advanced Dementia [PAINAD], Pain Assessment Checklist for Seniors with Limited Ability to Communicate [PACSLAC], Doloplus-2, and draft Pain Assessment in Impaired Cognition [PAIC]), and four discomfort tools (including distress, comfort, and quality of life in severe dementia or at the end of life; Discomfort Scale-Dementia Alzheimer Type [DS-DAT], Disability Distress Assessment Tool [DisDAT], End-of-Life in Dementia-Comfort Assessment in Dying with Dementia [EOLD-CAD], and Quality of Life in Late-Stage Dementia [QUALID] scale). We calculated median proportions to compare distributions of categories of pain and discomfort tools.Results: We found that, despite variable content across tools, items from pain and discomfort tools overlapped considerably. For example, positive elements such as smiling and spiritual items were more often included in discomfort tools but were not unique to these. Pain tools comprised more "mostly descriptive" (median 0.63 vs. 0.44) and fewer "highly subjective" items (0.06 vs. 0.18); some used time inconsistently, mixing present and past observations.Conclusion: This analysis may inform a more rigorous theoretical underpinning and (re)development of pain and discomfort tools and calls for empirical testing of a broad item pool for sensitivity and specificity in detecting and discriminating pain from other sources of discomfort. [ABSTRACT FROM AUTHOR]

Abstract: Objective: The study investigated the test–retest reliability and construct validity of the Global Perceived Effect (GPE) scale in patients with musculoskeletal disorders. Study Design and Setting: Data from seven clinical studies including 861 subjects were used for the analyses. Repeat measures taken at the same attendance and from attendances separated by 24 hours were compared to estimate test–retest reliability. Construct validity was evaluated by examining relationships between pre, post, and change scores in pain and disability measures with GPE measures. Results: Intraclass correlation coefficient values of 0.90–0.99 indicate excellent reproducibility of the GPE scale. In all but one data set, change scores on pain and disability measures correlated well (r =0.40–0.74) with GPE; however, post scores nearly always correlated even more strongly (r =0.58–0.84), and pre scores showed much weaker association (r =0.00–0.28). Pre scores accounted for only a small amount of additional R 2 when added to regression models including post score. Conclusions: Test–retest reliability of the GPE is excellent. GPE ratings are strongly influenced by current status, with the effect more obvious as transition time lengthens. This result questions whether transition ratings truly reflect change, or rather just current state. This finding also has implications for the use of GPE ratings as an external criterion of change in clinimetric studies. [Copyright &y& Elsevier]

Background: Chronic reflex sympathetic dystrophy (also called the complex regional pain syndrome) is a painful, disabling disorder for which there is no proven treatment. In observational studies, spinal cord stimulation has reduced the pain associated with the disorder. Methods: We performed a randomized trial involving patients who had had reflex sympathetic dystrophy for at least six months. Thirty-six patients were assigned to receive treatment with spinal cord stimulation plus physical therapy, and 18 were assigned to receive physical therapy alone. The spinal cord stimulator was implanted only if a test stimulation was successful. We assessed the intensity of pain (on a visual-analogue scale from 0 cm [no pain] to 10 cm [very severe pain]), the global perceived effect (on a scale from 1 [worst ever] to 7 [best ever]), functional status, and the health-related quality of life. Results: The test stimulation of the spinal cord was successful in 24 patients; the other 12 patients did not receive implanted stimulators. In an intention-to-treat analysis, the group assigned to receive spinal cord stimulation plus physical therapy had a mean reduction of 2.4 cm in the intensity of pain at six months, as compared with an increase of 0.2 cm in the group assigned to receive physical therapy alone (P<0.001 for the comparison between the two groups). In addition, the proportion of patients with a score of 6 (“much improved”) for the global perceived effect was much higher in the spinal cord stimulation group than in the control group (39 percent vs. 6 percent, P=0.01). There was no clinically important improvement in functional status. The health-related quality of life improved only in the 24 patients who actually underwent implantation of a spinal cord stimulator. Six of the 24 patients had complications that required additional procedures, including removal of the device in 1 patient. Conclusions: In carefully selected patients with chronic reflex sympathetic dystrophy, electrical stimulation of the spinal cord can reduce pain and improve health-related quality of life. (N Engl J Med 2000;343:618-24.) [ABSTRACT FROM AUTHOR]