Psychometric validation of PROM instruments.

The aim was to provide an overview of the different statistical methods for validation of patient-reported outcome measures, ranging from simple statistical methods available in all software packages to advanced statistical models that require specialized software. A non-technical summary of classical test theory (CTT) and modern test theory (MTT) is provided. Specifically, confirmatory factor analysis, item response theory, and Rasch analysis is outlined. One CTT and three MTT methods were used to validate the two subscales (Symptoms and Quality of Life) from the Knee Injury and Osteoarthritis Outcome Score (KOOS). For each methodology, two analyses were considered: (i) a unidimensional analysis ignoring the pre-specified dimensionality, and (ii) a two-dimensional analysis using the pre-specified dimensionality. While CTT did not adequately address central issues regarding the validity of the KOOS subscales, the three MTT methods yielded very similar results. In conclusion, MTT methods offer analysis of all relevant properties related to the validity of patient-reported outcome measures, while this is not the case for CTT. Claims about sufficient validity based on CTT methods are inadequate and should not be trusted.

What is a PROM and why do we need it?

The purpose of this article was to introduce the reader to the nature of patient-reported outcome measures (PROMs) and pitfalls in their use. PROMs collect subjective information directly from the patient regarding specific or general conditions and add to clinical and functional outcomes, and turn unmeasurable subjective qualities into quantitative measures. PROMs are questionnaires consisting of items: questions or statements with predefined response options. The items in an adequate PROM have been developed by involvement of patients with the condition in focus, and the PROM has been validated for these patients using suitable statistical methods. An adequate well-targeted PROM is more responsive than an inadequate PROM. Unfortunately, many studies use inadequate PROMs as outcomes. The methods used to generate PROMs should be described as thoroughly as those used to develop any other types of measurement instruments, and the choice of PROM should always be explained and thereby justified. If the PROM used is not adequate, the consequences for the interpretation of the results should be discussed. In many cases, an adequate PROM does not exist. If the best available PROM is chosen, there are methods to validate the adequacy of the chosen PROM, which make an interpretation of the study results possible.

The DISABKIDS generic and diabetes-specific modules are valid but not directly comparable between Denmark, Sweden, and Norway.

BACKGROUND/OBJECTIVES: Government guidance promote benchmarking comparing quality of care including both clinical values and patient reported outcome measures in young persons with type 1 diabetes. The aim was to test if the Nordic DISABKIDS health-related quality of life (HrQoL) modules were construct valid and measurement comparable within the three Nordic countries. METHODS: Data from three DISABKIDS validation studies in Sweden, Denmark, and Norway were compared using Rasch and the graphical log-linear Rasch modeling. Monte Carlo methods were used to estimate reliability coefficient and target was defined as the point with the lowest SE of the mean. Self-report data were available from 99 Danish (8-18 years), 103 Norwegian (7-19 years), and 131 Swedish (8-18 years) young people. RESULTS: For the DISABKIDS higher scores on most subscales were noted in the Norwegian population. The Swedish sample had a significantly higher score on the "Diabetes treatment" subscale and scores closer to optimal target than the other countries. For each country, construct validity and sensitivity were acceptable when accounting for differential item function (DIF) and local dependency (LD). Less LD and DIF were found if only Denmark and Norway were included. The combined model was reliable; however, some differences were noted in the scale translations relating to the stem and response alternatives, which could explain the discrepancies. CONCLUSION: The Nordic versions of the DISABKIDS questionnaires measures valid and reliable HrQoL both within and between countries when adjusted for DIF and LD. Adjusting the Likert scales to the same respond categories may improve comparability.

Assessment of cognitive ability at conscription for the Danish army: Is a single total score sufficient?

Børge Priens Prøve (BPP) was developed for the Danish Army by psychologist Børge Prien in the 1950s, as a test of general cognitive ability for use at conscription for the Danish armed forces. The final BPP (1957) had four subtests; a Raven-like matrix subtest, and three subtests measuring verbal, numerical, and visuospatial ability. The BPP is a speeded test counting the number of correct responses within 45 minutes. Thus, we consider the BPP as a measure of "cognitive efficiency" rather than a pure measure of cognitive ability. The BPP is still in use.Using techniques available in 1960, Rasch concluded that the matrices and numerical tests appeared to satisfy the requirements of the Rasch (Probabilistic models for some intelligence and attainment tests, Danish Institute for Educational Research, Copenhagen; 1960) model, while the verbal and visuospatial tests did not. Since then, there have been, to our knowledge, no published studies of the psychometric scaling properties of the BPP, partly because the practice of the Danish draft board has been to record only the total score. We examine these properties by analysis of data from two cohorts (n = 9,491), using the Leunbach (A probabilistic measurement model for assessing whether two tests measure the same personal factor. The Danish Institute of Educational, Copenhagen, Denmark; 1976) model to assess whether the sum of the four subtests provides a statistically sufficient measure of a common latent trait. Since we found only weak evidence against fit to the Leunbach model, we claim that this warrants the use of a summarized total BPP score. We examined whether BPP subscales suffered from differential test functioning (DTF) relative to samples. Weak, and for practical purposes too weak, DTF was suggested for one subscale.

Test equating sleep scales: applying the Leunbach's model.

BACKGROUND: In most cases, the total scores from different instruments assessing the same construct are not directly comparable, but must be equated. In this study we aimed to illustrate a novel test equating methodology applied to sleep functions, a domain in which few score comparability studies exist. METHODS: Eight scales from two cross-sectional self-report studies were considered, and one scale was common to both studies. The International Classification of Functioning, Disability and Health (ICF) was used to establish content comparability. Direct (common persons) and indirect (common item) equating was assessed by means of Leunbach's model, which equates the scores of two scales depending on the same person parameter, taking into account several tests of fit and the Standard Error of Equating (SEE). RESULTS: All items were linked to the body functions category b134 of the ICF, which corresponds to 'Sleep functions'. The scales were classified into three sleep aspects: four scales were assessing mainly sleep disturbance, one quality of sleep, and three impact of sleep on daily life. Of 16 direct equated pairs, 15 could be equated according to Leunbach's model, and of 12 indirect equated pairs, 8 could be equated. Raw score conversion tables between each of these 23 equated pairs are provided. The SEE was higher for indirect than for direct equating. Pairs measuring the same sleep aspect did not show better fit indices than pairs from different aspects. The instruments mapped to a higher order concept of sleep functions. CONCLUSION: Leunbach's equating model has been successfully applied to a functioning domain little explored in test equating. This novel methodology, together with the ICF, enables comparison of clinical outcomes and research results, and facilitates communication among clinicians.

Assessment of family functioning in families with a child diagnosed with type 1 diabetes: Validation and clinical relevance of the general functioning subscale of the McMaster family assessment device.

BACKGROUND: Type 1 diabetes (T1D) can have a negative effect on family functioning, which is associated with deterioration in metabolic control. Therefore, a valid tool for assessing family functioning is clinically relevant. We assessed the quality and validity of the Danish general functioning (GF) subscale of the family assessment device (FAD). Additionally, we investigated GF scores among adolescents with T1D and their parents and the relationship between family functioning and background variables, including metabolic control. METHODS: All Danish families with a child diagnosed with T1D (N = 1997) were invited to participate in a web-based survey. In total, 616 adolescents (aged 12-17 years) and 1035 parents (of children aged 2-17 years) responded. The quality and validity of measurements made using the GF subscale were assessed using the Rasch model and graphical log-linear Rasch models (GLLRMs). Differences among GF responses were also assessed using GLLRMs. The relationships between GF scores and background variables were examined by multivariate analyses. RESULTS: A dichotomized version of the GF subscale provided essentially valid measures of family functioning. Furthermore, the GF subscale measured family functioning most accurately in families with worse family functioning than in our population. To accurately characterize family functioning, it is important to take both parent's and adolescent's perceptions into account. Family functioning was associated with glycated hemoglobin (HbA1c) levels, and discrepancies in family functioning were associated with higher HbA1c levels. CONCLUSIONS: A dichotomized GF subscale is useful for assessment of family functioning. Parent's and adolescent's scores should be kept separate. Family functioning is associated with HbA1c levels.

A Danish version of self-efficacy in diabetes self-management: A valid and reliable questionnaire affected by age and sex.

BACKGROUND: Managing the chronic illness type 1 diabetes (T1D) is extremely demanding, especially during adolescence. Self-efficacy is belief in one's own capabilities and this is crucial for diabetes management. Having a valid method for measuring self-efficacy is important. OBJECTIVE: Our aims were to psychometrically validate a Danish version of the self-efficacy in diabetes management (SEDM) questionnaire, and to examine the relationship between background variables and self-efficacy. METHODS: All Danish adolescents with T1D (n = 1075) were invited to participate in our study. In total, 689 agreed to participate and 602 completed the study. Data were collected using a web-based survey. All participants were asked to provide a blood sample for HbA1c measurement. Graphical log-linear Rasch modeling (GLLRM) was used to validate the questionnaire and its reliability was assessed using Monte Carlo simulation. RESULTS: We found the questionnaire to be valid and reliable, but it had a dual structure that suggested a need for 2 separate subscales. One subscale related to practical (SEDM1) and the other to emotional (SEDM2) aspects of diabetes management. Both subscales were targeted toward adolescents with lower self-efficacy and were associated with HbA1c. SEDM1 was influenced by treatment modality and age. In SEDM2 we found an interaction between age and sex. CONCLUSION: The Danish version of the SEDM questionnaire should be divided into two parts, each with a valid and reliable subscale for self-efficacy measurement. The relationship between self-efficacy and age seems to differ between boys and girls.

Item analysis using Rasch models confirms that the Danish versions of the DISABKIDS® chronic-generic and diabetes-specific modules are valid and reliable.

BACKGROUND: Type 1 Diabetes (T1D) has a negative impact on psychological and overall well-being. Screening for Health-related Quality of Life (HrQoL) and addressing HrQoL issues in the clinic leads to improved well-being and metabolic outcomes. The aim of this study was to translate the generic and diabetes-specific validated multinational DISABKIDS® questionnaires into Danish, and then determine their validity and reliability. METHODS: The questionnaires were translated using a validated translation procedure and completed by 99 children and adolescents from our diabetes-department; all diagnosed with T1D and were aged between 8 and 18 years old. The Rasch and the graphical log linear Rasch model (GLLRM) were used to determine validity. Monte Carlo methods and Cronbach's α were used to confirm reliability. RESULTS: The data did not fit a pure Rasch model but did fit a GLLRM when item six in the independence scale is excluded. The six subscales measure different aspects of HrQoL indicating that all the subscales are necessary. The questionnaire shows local dependency between items and differential item functioning (DIF). Therefore age, gender, and glycated hemoglobin (HbA1c) levels must be taken into account when comparing HrQoL between groups. CONCLUSIONS: The Danish versions of the DISABKIDS® chronic-generic and diabetes-specific modules provide valid and objective measurements with adequate reliability. These Danish versions are useful tools for evaluating HrQoL in Danish patients with T1D. However, guidelines on how to manage DIF and local independence will be required, and item six should be rephrased.

Utilisation of psychiatrists and psychologists in private practice among non-Western labour immigrants, immigrants from refugee-generating countries and ethnic Danes: the role of mental health status.

PURPOSE: The stressful migration process has been associated with higher vulnerability for mental health problems, implying a greater need for mental healthcare among immigrants compared with native-born. Our objective was to investigate whether potential differences in the use of psychiatrists and psychologists in labour immigrants, immigrants from refugee-generating countries (RGC), and ethnic Danes could be fully explained by mental health status. METHODS: We conducted a nationwide survey in 2007 with 3,573 individuals aged 18-66 comprising ethnic Danes, labour immigrants (Pakistan and Turkey), and immigrants from RGC (Iran, Iraq, Lebanon, and Somalia). Survey data was linked to healthcare utilisation registries. Using Poisson regression, contacts with private practising psychiatrists and psychologists were estimated. Analyses were adjusted for socioeconomic factors and mental health status. RESULTS: Overall, 2.2 % among ethnic Danes, 1.4 % among labour immigrants and 6.5 % among immigrants from RGC consulted a psychiatrist or psychologist. In adjusted analyses, for psychiatrists, compared with ethnic Danes, labour-immigrant women (multiplicative effect = 1.78), and immigrant women from RGC (multiplicative effect = 2.49) had increased use, while labour-immigrant men had decreased use (multiplicative effect = 0.03). For psychologists, immigrant men from RGC had increased use (multiplicative effect = 2.96), while labour-immigrant women had decreased use (multiplicative effect = 0.27) compared with ethnic Danes. CONCLUSIONS: Mental health status had a somewhat explanatory effect on the use of psychiatrists and psychologists. These selected parts of the Danish mental healthcare system seem responsive to health needs across different population groups, particularly for immigrants from RGC. Yet more attention should be given to non-Western labour immigrants to meet their mental health needs.

Differential item functioning analysis by applying multiple comparison procedures.

Analysis within a Rasch measurement framework aims at development of valid and objective test score. One requirement of both validity and objectivity is that items do not show evidence of differential item functioning (DIF). A number of procedures exist for the assessment of DIF including those based on analysis of contingency tables by Mantel-Haenszel tests and partial gamma coefficients. The aim of this paper is to illustrate Multiple Comparison Procedures (MCP) for analysis of DIF relative to a variable defining a very large number of groups, with an unclear ordering with respect to the DIF effect. We propose a single step procedure controlling the false discovery rate for DIF detection. The procedure applies for both dichotomous and polytomous items. In addition to providing evidence against a hypothesis of no DIF, the procedure also provides information on subset of groups that are homogeneous with respect to the DIF effect. A stepwise MCP procedure for this purpose is also introduced.

Altered pain perception in children with chronic tension-type headache: is this a sign of central sensitisation?

AIM: The aim of this article is to investigate if children (7-17 years) with frequent episodic tension-type headache (FETTH) or chronic TTH (CTTH) have an altered pain perception compared to healthy controls. METHODS: We applied a pressure of five increasing intensities to m. trapezius and m. temporalis with a Somedic Algometer II. Visual analogue scale-score was rated and area under the curve (AUC) calculated. An average AUC in each person was used as an outcome variable in further univariate multiple linear regression analysis because factor analysis showed that AUC represents only one dimension underlying both muscles. RESULTS: Participants included 22 children with FETTH, 36 children with CTTH and 57 controls. The CTTH group had a significantly higher AUC compared to the control group ( P < 0.001). The FETTH group represented an intermediate state. AUC did not change with increasing age, headache years, headache intensity, headache frequency or sex. CONCLUSION: Children with CTTH show significantly increased pain sensitivity in a range of pressures compared to the FETTH group and the controls. Since AUC in m. trapezius and m. temporalis represents only one general latent tenderness, it might indicate that the altered pain perception is mainly due to central sensitisation.

Measuring child and adolescent well-being in Denmark: Validation and norming of the Danish KIDSCREEN-10 child/adolescent version in a national representative sample of school pupils in grades five through eight.

KIDSCREEN-10 is a generic instrument for measuring global health-related quality of life among 8-18-year-old children and adolescents. This study examines the criterion-related construct validity and psychometric properties of the Danish language version of the KIDSCREEN-10 using Rasch models. A further aim was to construct Danish norms based on the resulting person parameter estimates from the Rasch models. Data consists of a nationally representative cross-sectional survey of 8171 children in the 5th to 8th grade of primary school in Denmark. No adequate fit to the Rasch model or a graphical loglinear Rasch model could be established for the KIDSCREEN-10 in the full sample of children (n = 8171). Results based on analyses with increasing samples sizes showed that even with the smallest sample item 3 (Kid3) of the KIDSCREEN-10 did not fit the Rasch model. After elimination of Kid3, substantial local dependence and differential item functioning relative to gender and grade level was still present. Already with a sample size of 630 fit to the Rasch model or a graphical loglinear Rasch model adjusting for local dependence and differential item functioning was not established. Therefore, generation of Danish norms was not realizable, as this requires valid sum scores and estimates of the person parameters for an adequate number of cases. Thus, the Danish language version of the child/adolescent self-report KIDSCREEN-10 questionnaire cannot be recommended for use in population-level studies. Neither can use in small sample be recommended as adjustment for differential item functioning and local dependence is ambiguous.

In Ischemic Heart Disease, Reduced Sensitivity to Pressure at the Sternum Accompanies Lower Mortality after Five Years: Evidence from a Randomized Controlled Trial.

Background: Autonomic nervous system dysfunction (ANSD) is associated with negative prognosis of ischemic heart disease (IHD). Elevated periosteal pressure sensitivity (PPS) at the sternum relates to ANSD and sympathetic hyperactivity. Two previous observational case-control studies of the effect of reduction of PPS suggested lower all-cause mortality from IHD and stroke. We now used a specific daily, adjunct, non-pharmacological program of reduction of elevated PPS to test the hypothetical association between the intervention and reduced all-cause mortality in patients with stable IHD in a randomized controlled trial (RCT). Methods: We completed active (n = 106) and passive interventions (n = 107) and compared the five-year mortalities. We also compared the five-year individual all-cause mortality of each participant to approximately 35.000 members of the general population of Denmark. Pooling the mortality data from the active group of the RCT with the two preliminary studies, we registered the mortality following active intervention of 1.168 person-years, compared to 40 million person-years of the pooled general population. Results: We recorded fewer deaths of the active RCT intervention group than of the corresponding control group from the general population (p = 0.01), as well as of the passive RCT intervention group (p = 0.035). The meta-analysis of the three studies together demonstrated reduced 4.2-year all-cause mortality of 60% (p = 0.007). Conclusions: The test of the hypothetical effect of an intervention aimed at the attenuation of ANSD accompanied by a lowered PPS revealed reduced all-cause mortality in patients with stable IHD.

Is there equity in use of healthcare services among immigrants, their descendents, and ethnic Danes?

BACKGROUND: Legislation in Denmark explicitly states the right to equal access to healthcare. Nevertheless, inequities may exist; accordingly evidence is needed. Our objective was to investigate whether differences in healthcare utilisation in immigrants, their descendents, and ethnic Danes could be explained by health status, socioeconomic factors, and integration. METHODS: We conducted a nationwide survey in 2007 with 4952 individuals aged 18-66 comprising ethnic Danes; immigrants from the former Yugoslavia, Iran, Iraq, Lebanon, Pakistan, Somalia, Turkey; and Turkish and Pakistani descendents. Data were linked to registries on healthcare utilisation. Using Poisson regression models, contacts to hospital, emergency room (ER), general practitioner (GP), specialist in private practice, and dentist were estimated. Analyses were adjusted for health symptoms, sociodemographic factors, and proxies of integration. RESULTS: In adjusted analyses, immigrants and their descendents had increased use of ER (multiplicative effect 1.19-5.02 dependent on immigrant and descendent group) and less frequent contact to dentist (multiplicative effect 0.04-0.80 dependent on the group). For hospitalisation, GP, and specialist doctor, physical health symptoms had positive but different explanatory effects within groups; however, most immigrant and descendent groups had increased use of services compared with that of ethnic Danes. Socioeconomic factors and integration had no systematic effect on the use in the different groups. CONCLUSIONS: The Danish healthcare system seems responsive to health across different population groups. We found no systematic pattern of inequity in use of free-of-charge healthcare services, but for dentists, who require co-payment, we found inequity among immigrants and descendents compared with ethnic Danes.

Conditional pairwise person parameter estimates in Rasch models.

Conditional pairwise estimates parameters in Rasch models separate inference on item parameters from inference on person parameters. Pairwise item parameter estimates are consistent when sample size approaches infinity, but adds an extra random error to estimation compared to conditional maximum likelihood estimates. Pairwise estimates of person parameters are easily calculated, but can rarely be assumed to be consistent since the number of items is often small and the properties of the estimates generally unknown. This note gives results from a study of conditional pairwise estimation of person parameters and suggests a modification of the estimate that takes care of some of the error.

The Early Functional Abilities-revised may bridge the gap between the disorder of consciousness and the functional independence scales: evidence from Rasch analysis.

BACKGROUND: There is a tremendous clinical and research need to bridge the gap between disorder of consciousness and functional independence scales with a single unidimensional measure in people with acquired brain injury. AIM: To calibrate an essentially unidimensional subset of items from the Italian Early Functional Abilities (EFA), demonstrating internal construct validity and sufficient reliability for individual patient measurement. DESIGN: Multicenter observational cross-sectional study. SETTING: Inpatients from 11 different Italian Rehabilitation centers. POPULATION: Three hundred sixty-two adult patients with a disorder of consciousness due to an acquired brain injury. METHODS: The Italian version of EFA was administered to the sample and then submitted to Mokken analysis, Confirmatory Factor Analysis, Rasch analysis, Confirmatory Bifactor Analysis, and external construct validity. RESULTS: According to Mokken Analysis (all item scalability coefficients Hj positive; all item-pair scalability coefficients Hij >0.3; scale coefficient H=0.762), and Confirmatory Factor Analysis (RMSEA=0.081; SRMR=0.048; CFI=0.995; TLI=0.995), the Italian EFA showed a sufficient preliminary unidimensionality. Within Rasch Analysis, a final 12-item solution for the EFA (EFA-R) was calibrated. EFA-R is "essentially unidimensional" according to the following requirements: 1) analysis of residual correlations which supported item essential local independence; 2) a robust correlation between item subtests (rho=0.950); 3) only 2.1% of cases with significant difference between person parameter estimates by different subscales; 4) an explained common variance equal to 0.916 obtained from a final Confirmatory Bifactor Analysis. It also satisfied invariance requirement (unconditional χ220=9.81; P=0.457, conditional class-interval based χ235=33.1; P=0.557), and monotonicity. The reliability (Person Separation Index=0.887) was adequate for person measurements. A practical raw-score-to-measure conversion table based on the EFA-R calibration was devised. Finally, EFA-R strongly correlated with Coma Recovery Scale-Revised (rho=0.922) and motor FIM™ (rho=0.808). CONCLUSIONS: EFA-R is an essentially unidimensional subset of 12 items with adequate internal construct validity and sufficient reliability for individual patient measurement under the Rasch Model Theory framework. CLINICAL REHABILITATION IMPACT: EFA-R has the potential to measure people's functional abilities whose consciousness is improving despite ongoing severe motor-functional impairments during the early stages of rehabilitation. It provides "a measurement bridge" between the disorder of consciousness and the functional independence scales in patients with severe acquired brain injury.

No difference between alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients: a randomized crossover trial.

Alfacalcidol and paricalcitol are vitamin D analogs used for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease, but have known dose-dependent side effects that cause hypercalcemia and hyperphosphatemia. In this investigator-initiated multicenter randomized clinical trial, we originally intended two crossover study periods with a washout interval in 86 chronic hemodialysis patients. These patients received increasing intravenous doses of either alfacalcidol or paricalcitol for 16 weeks, until parathyroid hormone was adequately suppressed or calcium or phosphate levels reached an upper threshold. Unfortunately, due to a period effect, only the initial 16-week intervention period for 80 patients was statistically analyzed. The proportion of patients achieving a 30% decrease in parathyroid hormone levels over the last four weeks of study was statistically indistinguishable between the two groups. Paricalcitol was more efficient at correcting low than high baseline parathyroid hormone levels, whereas alfacalcidol was equally effective at all levels. There were no differences in the incidence of hypercalcemia and hyperphosphatemia. Thus, alfacalcidol and paricalcitol were equally effective in the suppression of secondary hyperparathyroidism in hemodialysis patients while calcium and phosphorus were kept in the desired range.

No evidence of a clinically important effect of adding local infusion analgesia administrated through a catheter in pain treatment after total hip arthroplasty.

BACKGROUND AND PURPOSE: Postoperative analgesia after primary total hip arthroplasty (THA) using opioids is associated with troublesome side effects such as nausea and dizziness, and epidural analgesic means delayed mobilization. Thus, local infiltration analgesia (LIA) during surgery prolonged with local infusion analgesia (LINFA) into the soft tissue in the hip region through a catheter in the first postoperative days has gained major interest in THA fast-track settings within a short period of time. LIA at the time of surgery is a validated treatment. We investigated the additional effect of giving postoperative LINFA after THA in patients already having LIA during surgery. PATIENTS AND METHODS: 60 consecutive patients undergoing non-cemented THA were randomized into two groups in a double-blind and controlled study. During surgery, all patients received standardized pain treatment with LIA. Postoperatively, they were treated either with a solution of Ropivacain, Ketorolac, and Adrenaline (LINFA group) or placebo (placebo group) administered through a catheter to the hip 10 and 22 h after surgery. Pain score, opioid consumption, and length of stay (LOS) were evaluated. RESULTS: After adjustment for multiple testing, there was no statistically significant postoperative difference between the LINFA group and the placebo group regarding pain and tiredness. We found some evidence of a short-term effect on nausea and vomiting. Opioid consumption and length of stay were similar in the two groups. INTERPRETATION: We found some evidence of a short-term effect of LINFA on nausea and vomiting, but no evidence of an effect on postoperative pain and tiredness. Thus, LINFA cannot be recommended as a standard pain treatment in patients with THA.

Reducing the item number to obtain same-length self-assessment scales: a systematic approach using result of graphical loglinear Rasch modeling.

The Revised Danish Learning Styles Inventory (R-D-LSI) (Nielsen 2005), which is an adaptation of Sternberg-Wagner Thinking Styles Inventory (Sternberg, 1997), comprises 14 subscales, each measuring a separate learning style. Of these 14 subscales, 9 are eight items long and 5 are seven items long. For self-assessment, self-scoring and self-interpretational purposes it is deemed prudent that subscales measuring comparable constructs are of the same item length. Consequently, in order to obtain a self-assessment version of the R-D-LSI with an equal number of items in each subscale, a systematic approach to item reduction based on results of graphical loglinear Rasch modeling (GLLRM) was designed. This approach was then used to reduce the number of items in the subscales of the R-D-LSI which had an item-length of more than seven items, thereby obtaining the Danish Self-Assessment Learning Styles Inventory (D-SA-LSI) comprising 14 subscales each with an item length of seven. The systematic approach to item reduction based on results of GLLRM will be presented and exemplified by its application to the R-D-LSI.

Reduction of Pressure Pain Sensitivity as Novel Non-pharmacological Therapeutic Approach to Type 2 Diabetes: A Randomized Trial.

BACKGROUND: Autonomic nervous system dysfunction (ANSD) is known to affect glucose metabolism in the mammalian body. Tradition holds that glucose homeostasis is regulated by the peripheral nervous system, and contemporary therapeutic intervention reflects this convention. OBJECTIVES: The present study tested the role of cerebral regulation of ANSD as consequence of novel understanding of glucose metabolism and treatment target in type 2 diabetes (T2D), suggested by the claim that the pressure pain sensitivity (PPS) of the chest bone periosteum may be a measure of cerebral ANSD. DESIGN: In a randomized controlled trial of 144 patients with T2D, we tested the claim that 6 months of this treatment would reduce PPS and improve peripheral glucose metabolism. RESULTS: In the active treatment group, mean glycated hemoglobin A1c (HbA1c) declined from 53.8 to 50.5 mmol/mol (intragroup p = 0.001), compared with the change from 53.8 to 53.4 mmol/mol in the control group, with the same level of diabetes treatment but not receiving the active treatment (between group p = 0.036). Mean PPS declined from 76.6 to 56.1 units (p < 0.001) in the active treatment group and from 77.5 to 72.8 units (p = 0.02; between group p < 0.001) in the control group. Changes of PPS and HbA1c were correlated (r = 0.37; p < 0.001). CONCLUSION: We conclude that the proposed approach to treatment of T2D is a potential supplement to conventional therapy. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov (NCT03576430).