Early stress during NICU stay and parent-reported health-related quality of life after extremely preterm birth: an exploratory study with possible targets for early intervention.

Introduction: The association between neonatal intensive care unit (NICU) related stress in preterm infants and their health-related quality of life (HRQoL) in the first year following preterm birth remains unexplored. Understanding this association is crucial for enhancing preventive and supportive measures for infants and parents within and beyond the NICU. Methods: From a single center observational cohort study, we included infants with gestational ages below 30 weeks and/or birth weights under 1,000 grams. HRQoL was quantified using the Infant Quality of Life Instrument (IQI) at 3-, 6-, 9- and 12-months corrected age, covering seven domains. NICU stress was quantified using the Neonatal Infant Stressor Scale (NISS) for the first week of life. We performed Spearman's correlation analyses to test this association. Results: Of the 45 included infants, the IQI was completed for 27 (60%) at 3, 15 (33%) at 6, 14 (31%) at 9 and 15 (33%) at 12 months. The HRQoL sum scores were related to neonatal stress at 9 and 12 months (ρ = 0.643 and 0.591, p = 0.013 and p = 0.019, respectively) but not at 3 and 6 months (ρ = -0.001 and -0.077 respectively, p > 0.05). Higher NICU stress tended to be associated with more respiratory and mood problems throughout the first year. Discussion: From a parental perspective on infant HRQoL, extremely preterm infants with higher stress exposure show more problems in the second half-year of life, mainly breathing and possibly mood-related problems. This knowledge may help improve our neonatal care, both during NICU stay and in follow-up clinics, by implementing targeted interventions.

Different Frameworks, Similar Results? Head-to-Head Comparison of the Generic Preference-Based Health-Outcome Measures CS-Base and EQ-5D-5L.

OBJECTIVE: We compared two generic, preference-based health-outcome measures: the novel patient-centered Château-Santé Base (CS-Base), entailing a multi-attribute preference response framework, and the widely used EQ-5D-5L, regarding effects of different measurement frameworks and different descriptive systems. METHODS: We conducted a cross-sectional study using a random sample of patients (3019 reached, 1988 included) in the USA with various health conditions. The CS-Base (12 attributes, each with four levels), EQ-5D-5L and the 5D-4L (an ad hoc, multi-attribute preference response-based measure that includes five attributes similar to the EQ-5D-5L, but with four levels) were used as health-outcome measures. We compared the proportions of problems reported on health attributes, statistical robustness and face validity of coefficients, attribute importance, differentiation between health states based on health-state values obtained with these measures, and user experience. RESULTS: All the CS-Base and 5D-4L coefficients had logical orders and significant differences from the reference level (p < 0.001). Substantial differences were observed in the CS-Base and 5D-4L coefficients between all levels on all attributes, while subtle differences were seen in those of the EQ-5D-5L. Attribute importance of usual (daily) activities were lowest or second lowest in all the three health-outcome measures. Attributes with the highest importance in the CS-Base, 5D-4L, and EQ-5D-5L were respectively mobility, anxiety/depression, and pain/discomfort. Four attributes are similar between the CS-Base and EQ-5D-5L, eight are exclusive to CS-Base. Of the eight, vision and hearing had the highest importance. Health-state values showed a smoother distribution with minimal discontinuity in the CS-Base and EQ-5D-5L than in the 5D-4L. In user experience evaluation, both CS-Base and the 5D-4L showed mean scores above 50 (indicating positive evaluation) in terms of the description of health and ease of understanding. CONCLUSIONS: This study demonstrated that CS-Base and 5D-4L, which are grounded in the multi-attribute preference response framework, produced statistically robust coefficients, with better face validity than those for the EQ-5D-5L. CS-Base and the EQ-5D-5L outperformed the 5D-4L in differentiating between health states. Notwithstanding differences in content, measurement frameworks, and estimated coefficients, the computed health-state values were similar between CS-Base and EQ-5D-5L.

From simple to even simpler, but not too simple: a head-to-head comparison of the Better-Worse and Drop-Down methods for measuring patient health status.

BACKGROUND: We recently developed a novel, preference-based method (Better-Worse, BW) for measuring health status, expressed as a single metric value. We have since expanded it by developing the Drop-Down (DD) method. This article presents a head-to-head comparison of these two methods. We explored user feasibility, interpretability and statistics of the estimated coefficients, and distribution of the computed health-state values. METHODS: We conducted a cross-sectional online survey among patients with various diseases in the USA. The BW and DD methods were applied in the two arms of the study, albeit in reverse order. In both arms, patients first performed a descriptive task (Task 1) to rate their own health status according to the 12 items (each with 4 levels) in the CS-Base health-outcome instrument. They then performed Task 2, in which they expressed preferences for health states by the two methods. We then estimated coefficients for all levels of each item using logistic regression and used these to compute values for health states. RESULTS: Our total sample comprised 1,972 patients. Completion time was < 2 min for both methods. Both methods were scored as easy to perform. All DD coefficients were highly significant from the reference level (P < 0.001). For BW, however, only the second-level coefficient of "Cognition" was significantly different (P = 0.026). All DD coefficients were more precise with narrower confidence intervals than those of the BW method. CONCLUSIONS: Both the BW and DD are novel methods that are easy to apply. The DD method outperformed the BW method in terms of the precision of produced coefficients. Due to its task, it is free from a specific distorting factor that was observed for the BW method.

Validity and reliability of the adapted Dutch version of the Brace Questionnaire (BrQ).

BACKGROUND AND PURPOSE: The Brace Questionnaire (BrQ) is a disease-specific health-related quality of life (HRQOL) instrument for measuring perceived health status of scoliosis patients undergoing brace treatment. The purpose of this study is to evaluate the validity and reliability of a translated and culturally adapted Dutch version of the BrQ. PATIENTS AND METHODS: The original Greek BrQ was translated into Dutch and a cross-cultural adaptation and validation processes were conducted. Subsequently, 80 adolescent idiopathic scoliosis (AIS) patients undergoing active brace treatment were included from 4 scoliosis centers to evaluate the validity and reliability of the Dutch version of the BrQ. The questionnaire's floor and ceiling effects, internal consistency, and test-retest reliability were assessed. Concurrent validity was evaluated by comparing the BrQ with the revised Scoliosis Research Society 22-item questionnaire (SRS-22r) scores. RESULTS: The mean total BrQ score was 75.9 (standard deviation [SD] 11.3) and the mean domain scores varied between 3.4 (SD 0.9) and 4.2 (SD 0.7) for the domains "vitality" and "bodily pain," respectively. There were no floor and ceiling effects for the total BrQ score. The BrQ showed satisfactory internal consistency in most subdomains with a Cronbach's α ranging between 0.35 for the domain "general health perception" and 0.89 for the domain "self-esteem and aesthetics." Excellent test-retest reproducibility was observed for the total BrQ score (ICC 0.91), and the BrQ was successfully validated against the SRS-22r. CONCLUSION: The translated and culturally adapted Dutch version of the BrQ is a valid and reliable HRQOL instrument for AIS patients undergoing brace treatment.

Health Status of US Patients With One or More Health Conditions: Using a Novel Electronic Patient-reported Outcome Measure Producing Single Metric Measures.

BACKGROUND: Most existing research studying health status impacted by morbidity has focused on a specific health condition, and most instruments used for measuring health status are neither patient-centered nor preference-based. This study aims to report on the health status of patients impacted by one or more health conditions, measured by a patient-centered and preference-based electronic patient-reported outcome measure. METHODS: A cross-sectional study was conducted among patients with one or more health conditions in the United States. A novel generic, patient-centered, and preference-based electronic patient-reported outcome measure: Château Santé-Base, was used to measure health status. Individual health state was expressed as a single metric number (value). We compared these health-state values between sociodemographic subgroups, between separate conditions, between groups with or without comorbidity, and between different combinations of multimorbidity. RESULTS: The total sample comprised 3913 patients. Multimorbidity was present in 62% of the patients. The most prevalent health conditions were pain (50%), fatigue/sleep problems (40%), mental health problems (28%), respiratory diseases (22%), and diabetes (18%). The highest (best) and lowest health-state values were observed in patients with diabetes and mental health problems. Among combinations of multimorbidity, the lowest values were observed when mental health problems were involved, the second lowest values were observed when fatigue/sleep problems and respiratory diseases coexisted. CONCLUSIONS: This study compared health status across various single, and multiple (multimorbidity and comorbidity) health conditions directly, based on single metric health-state values. The insights are valuable in clinical practice and policy-making.

Lifestyle factors related to prevalent chronic disease multimorbidity: A population-based cross-sectional study.

BACKGROUND: Multimorbidity is associated with poor quality of life, polypharmacy, health care costs and mortality, with those affected potentially benefitting from a healthy lifestyle. We assessed a comprehensive set of lifestyle factors in relation to multimorbidity with major chronic diseases. METHODS: This cross-sectional study utilised baseline data for adults from the prospective Lifelines Cohort in the north of the Netherlands (N = 79,345). We defined multimorbidity as the co-existence of two or more chronic diseases (i.e. cardiovascular disease, cancer, respiratory disease, type 2 diabetes) and evaluated factors in six lifestyle domains (nutrition, physical (in)activity, substance abuse, sleep, stress, relationships) among groups by the number of chronic diseases (≥2, 1, 0). Multinomial logistic regression models were created, adjusted for appropriate confounders, and odds ratios (OR) with 95% confidence intervals (95%CI) were reported. RESULTS: 3,712 participants had multimorbidity (4.7%, age 53.5 ± 12.5 years), and this group tended to have less healthy lifestyles. Compared to those without chronic diseases, those with multimorbidity reported physical inactivity more often (OR, 1.15; 95%CI, 1.06-1.25; not significant for one condition), chronic stress (OR, 2.14; 95%CI, 1.92-2.38) and inadequate sleep (OR, 1.70; 95%CI, 1.41-2.06); as expected, they more often watched television (OR, 1.70; 95%CI, 1.42-2.04) and currently smoked (OR, 1.91; 95%CI, 1.73-2.11), but they also had lower alcohol intakes (OR, 0.66; 95%CI, 0.59-0.74). CONCLUSIONS: Chronic stress and poor sleep, in addition to physical inactivity and smoking, are lifestyle factors of great concern in patients with multimorbidity.

Economic evaluation of upper limb prostheses in the Netherlands including the cost-effectiveness of multi-grip versus standard myoelectric hand prostheses.

PURPOSE: To investigate the costs, quality of life, and user experiences associated with upper limb prosthesis use, and to evaluate the cost-effectiveness of multi-grip compared to standard myoelectric hand prostheses (MHPs/SHPs). MATERIALS AND METHODS: The EQ-5D-5L to assess the quality of life, the patient-reported outcome measure to assess the preferred usage features of upper limb prosthesis (PUF-ULP), and a cost questionnaire (societal perspective) were completed by 242 prosthesis users (57% men; mean age = 58 years). Incremental cost-utility and cost-effectiveness ratios (ICUR/ICER) with respectively the EQ-5D-5L and PUF-ULP were calculated to compare MHPs with SHPs. Statistical uncertainty was estimated using bootstrapping. Netherlands Trial Registry number: NL7682. RESULTS: The mean yearly total costs related to prosthesis use of MHPs (€54 112) and SHPs (€23 501) were higher compared to prostheses with tools/accessories (€11 977), body-powered (€11 298), and cosmetic/passive prostheses (€10 132). EQ-5D-5L and PUF-ULP scores did not differ between prosthesis types. ICUR was €-728 833 per quality-adjusted life year; ICER was €-187 798 per PUF-ULP point gained. CONCLUSIONS: Myoelectric prostheses, especially MHPs, were most expensive compared to other prostheses, while no differences in quality of life and user experiences were apparent. MHPs were not cost-effective compared to SHPs. When prescribing MHPs, careful consideration of advantages over SHPs is recommended.

Myoelectric upper limb prostheses, especially the multi-grip hands, were more expensive than all other types of upper limb prostheses.Health-related quality of life and user experiences were comparable in users of different types of upper limb prostheses.Acquisition costs mainly explained the differences in costs related to upper limb prosthesis use.Prescription of multi-grip hand prostheses should be considered carefully, since these are not cost-effective compared to standard myoelectric hand prostheses.

What really matters: a patient-centered instrument to evaluate health-related quality of life in cardiovascular disease.

AIMS: Patient-reported outcome measures (PROMs) to assess health-related quality of life (HRQoL) are increasingly used to guide decision-making in cardiovascular care. However, many of the existing PROMs are developed with limited patient involvement and overlook personal health preferences. We aim to develop a cardiovascular disease (CVD)-specific patient-centred preference-based PROM to assess and monitor HRQoL in CVD patients. METHODS AND RESULTS: A mixed-methods study consisting of several phases was conducted to identify important health items: (i) a scoping literature review, (ii) first- and second-round expert group meetings, (iii) interviews with CVD patients, and (iv) an online survey asking CVD patients to indicate from a large set those health items that are considered the most important. The literature review, expert group meetings, and patient interviews resulted in a list of 55 items potentially important to CVD patients. In total, 666 CVD patients responded to the survey. The following nine items were considered the most important by CVD patients: mobility, activities, self-reliance, fatigue, shortness of breath, chest pain, palpitations, anxiety/worrying, and sexual limitations. An electronic preference-based PROM consisting of these nine items was developed within a cloud-based environment for clinical implementation. CONCLUSION: Nine items considered the most important for health by CVD patients were identified and included in a new preference-based patient-centred PROM. This new CVD-specific PROM can be easily implemented using the electronic application and has the potential to improve quality of care for CVD patients.

Towards assessing the preferred usage features of upper limb prostheses: most important items regarding prosthesis use in people with major unilateral upper limb absence-a Dutch national survey.

PURPOSE: To determine which items regarding prosthesis use were considered most important by adults with major unilateral upper limb absence (ULA) and to develop a patient-reported outcome measure to assess the preferred usage features of upper limb prostheses: PUF-ULP. MATERIALS AND METHODS: Based on a qualitative meta-synthesis combined with input from patients and clinicians a graphical diagram of 79 items related to prosthesis use was developed. Adults with ULA (N = 358; mean age = 55.4 ± 16.5 years; 52.0% male/40.8% female/7.3% unknown) selected their top-10 of most important items from this diagram. This study is registered in the Netherlands Trial Register: NL7682. RESULTS: Most selected items were "wearing comfort" (54.0% of cases), "grabbing, picking up, and holding" (34.3%), and "weight" (31.4%). All subpopulations (i.e. age, sex, origin of ULA, level of ULA, and prosthesis type), except multi-grip myoelectric hand prosthesis users (MHP), selected "wearing comfort" most. Nine items were included in the PUF-ULP: "wearing comfort," "functionality," "independence," "work, hobby, and household," "user-friendly," "life-like appearance," "phantom limb pain," "overuse complaints," and "reliability." CONCLUSIONS: All prosthesis users, except MHP-users, considered wearing comfort most important, which might be of interest for future research and industry. The PUF-ULP can be used to reflect the match between users and their prostheses.IMPLICATIONS FOR REHABILITATIONAll persons with upper limb absence, except multi-grip myoelectric hand prosthesis users, considered "wearing comfort" most important regarding prosthesis use, which highlights that prosthesis wearing comfort deserves more attention in future research to increase the value placed by the user on their upper limb prosthesis.Regarding prosthesis use, men considered "ease of control" more important compared to the overall population, while women considered "independence," "household," "life-like appearance," "overuse complaints," and "anonymity" more important.Persons with a mono- or multi-grip myoelectric upper limb prosthesis rated function-related items as more important compared to the overall population, while persons with a passive/cosmetic prosthesis rated comfort-related and appearance-related items as more important.The newly developed measurement tool, also called the PUF-ULP, provides a single score that represents the match between the user and their upper limb prosthesis.

Exploring patient satisfaction after operative and nonoperative treatment for midshaft clavicle fractures: a focus group analysis.

BACKGROUND: There is no consensus on the optimal treatment for displaced midshaft clavicle fractures. Several studies indicate superior patient satisfaction in favour of operative reconstruction. It is unknown what drives superior satisfaction in this treatment group. The aim of this study was to explore patient satisfaction and identify contributors to patient satisfaction after operative and nonoperative treatment for displaced midshaft clavicle fractures in adults using a focus group approach. METHODS: Four face-to-face and two web-based focus groups were hosted. A total of 24 participants who were treated nonoperatively (n = 14) or operatively (n = 10) agreed to participate. Participants were selected using purposive sampling, ensuring variation in gender, age, treatment complications and outcomes. A question script was developed to systematically explore patient expectations, attitudes and satisfaction with different dimensions of care. All focus groups were voice-recorded and transcribed at verbatim. Thematic analysis was conducted on all face-to-face and web-based transcripts. RESULTS: The main emerging themes across treatment groups were; need for more information, functional recovery, speed of recovery and patient-doctor interaction. There was no difference in themes observed between operative and nonoperative focus groups. The lack of information was the most important complaint in dissatisfied patients. CONCLUSION: Our study shows that informing patients about their injury, treatment options and expectations for recovery is paramount for overall patient satisfaction after treatment for a displaced midshaft clavicle fracture. LEVEL OF EVIDENCE: Level III, focus group study.

Value judgment of new medical treatments: Societal and patient perspectives to inform priority setting in The Netherlands.

BACKGROUND: In many countries, medical interventions are reimbursed on the basis of recommendations made by advisory boards and committees that apply multiple criteria in their assessment procedures. Given the diversity of these criteria, it is difficult to find common ground to determine what information is required for setting priorities. OBJECTIVE: To investigate whether society and patients share the same interests and views concerning healthcare priorities. METHODS: We applied a framework of discrete choice models in which respondents were presented with judgmental tasks to elicit their preferences. They were asked to choose between two hypothetical scenarios of patients receiving a new treatment. The scenarios graphically presented treatment outcomes and patient characteristics. Responses were collected through an online survey administered among respondents from the general population (N = 1,253) and patients (N = 1,389) and were analyzed using conditional logit and mixed logit models. RESULTS: The respondents' preferences regarding new medical treatments revealed that they attached the most relative importance to additional survival years, age at treatment, initial health condition, and the cause of disease. Minor differences in the relative importance assigned to three criteria: age at treatment, initial health, and cause of disease were found between the general population and patient samples. Health scenarios in which patients had higher initial health-related quality of life (i.e., a lower burden of disease) were favored over those in which patients' initial health-related quality of life was lower. CONCLUSIONS: Overall, respondents within the general population expressed preferences that were similar to those of the patients. Therefore, priority-setting studies that are based on the perspectives of the general population may be useful for informing decisions on reimbursement and other types of priority-setting processes in health care. Incorporating the preferences of the general population may simultaneously increase public acceptance of these decisions.

An overview of the time trade-off method: concept, foundation, and the evaluation of distorting factors in putting a value on health.

INTRODUCTION: Preference-based instruments measuring health status express the value of specific health states in a single number. One method used is time trade-off (TTO). Health-status values are key elements in calculating quality-adjusted life years (QALYs) and are pertinent for resource allocation. Since they are used in economic evaluations of healthcare, searching for a theoretical foundation of TTO in economics is justified. AREA COVERED: This paper provides an overview of TTO, including its relation to economic theory, and discusses biases and distortions, compiled from recent and older research. Inconsistencies between TTO and random utility theory were detected; The TTO is confounded by time preferences and by respondents' life expectancies. TTO is cognitively challenging, therefore guidance during the interviews is needed, producing interview effects. TTO does not measure one thing at a time, nor are the values independent of other states that are being valued in the same task. That is, TTO does not exhibit theoretical measurement properties such as unidimensionality and the invariance principle. EXPERT OPINION: We conclude that the TTO may be a pragmatic method of eliciting health state values, but the limitations in regard to measurement theory and practical elicitation problems makes it prone to inconsistencies and arbitrariness.

Health items with a novel patient-centered approach provided information for preference-based transplant outcome measure.

OBJECTIVES: Patient-reported outcome measures (PROMs) are widely applied to assess perceived health status. To date, no transplant-specific PROM is available for generating a single, standardized score regarding the health status of transplant recipients. The objective of this study is to generate health items for a new patient-centered PROM for organ recipients: the Transplant PROM (TXP). STUDY DESIGN AND SETTING: A five-phase, mixed-method approach was applied to identify and select the health items: scoping literature review, expert meetings, focus-group meetings with organ recipients, a special judgmental task within an online survey, and expert meetings for final selection of health items. RESULTS: Based on a previously published scoping literature review, a first round of expert meetings, and a total of four focus-group meetings with kidney, lung, and liver transplant recipients (N = 18), a list of 83 relevant health items relating to post-transplant life was selected. In an online survey, 183 transplant recipients selected the 10 most important health items from this list. After evaluating the frequency of selected health items and combining items that assess closely related or similar concepts in the second round of expert meetings, nine health items were chosen to be included in TXP: fatigue, skin, worry/anxiety, self-reliance, activities, weight, sexuality, stooling, and memory/concentration. CONCLUSION: The nine TXP health items reflect the most prominent issues transplant recipients experience. The TXP can be administered by means of a mobile phone app.

Assessing the Preferences for Criteria in Multi-Criteria Decision Analysis in Treatments for Rare Diseases.

Background: Increasingly, multi-criteria decision analysis has gained importance as a method by which to assess the value of orphan drugs. However, very little attention has been given to the weight (relative preferences) of the individual criteria used in a framework. Aims: This study sought to gain an understanding of the preferential weights that should be allocated in a multi-criteria decision analysis framework for orphan drugs, from a multi-stakeholder perspective. Method: Using key MCDA criteria for orphan drugs reported in the literature, we developed an interactive web-based survey tool to capture preferences for different criteria from a general stakeholder sample who were requested to assign weights from a reimbursement perspective. Each criterion could be assigned a weight on a sliding scale from 0 to 100% as long as the sum of all the criteria was 100%. We subsequently used the interactive tool with an expert focus group, followed up with a group discussion regarding each criterion and their perspectives on the weight that each criterion should be allocated when assessing an orphan drug. The expert focus group participants were then able to adjust their weights, if the group discussion had changed their perspectives. Results: The interactive tool was completed by 120 general stakeholder sample from a wide range of countries and professional backgrounds and an expert focus group of ten members. The results showed the differences in perspectives on the importance of criteria. Both groups considered Treatment efficacy to be the most important criterion. The general stakeholder sample weighted Treatment safety at 12.03% compared to the expert focus group's average of 20%. The results also demonstrated the value of the group discussion, which provided additional insights into the perspectives on the importance of criteria in assessing orphan drugs. Conclusion: This study aimed to contribute to the important aspect of preferences for different criteria in MCDA. This study sheds light on the important aspect of the preferences of the different criteria. All respondents agreed on the relative importance of Treatment efficacy and Treatment safety, criteria that are captured in conventional cost-effectiveness studies, but they also expressed the view that in addition to those, several disease-related and drug-related criteria should be included in MCDA frameworks for assessing orphan drugs.

A two-step procedure to generate utilities for the Infant health-related Quality of life Instrument (IQI).

BACKGROUND: Because of a lack of preference-based health-related quality of life (HRQoL) instruments suitable for infants aged 0-12 months, we previously developed the Infant QoL Instrument (IQI). The present study aimed to generate an algorithm to estimate utilities for the IQI. METHODS: Via an online survey, respondents from the general population and primary caregivers from China-Hong Kong, the UK, and the USA were presented 10 discrete choice scenarios based on the IQI classification system. An additional sample of respondents from the general population were also asked if they considered the examined health states to be worse than death. Coefficients for the IQI item levels were obtained with a conditional logit model based on the responses of the primary caregivers for IQI states only. These coefficients were then normalized using the rank-ordered logit model based on the responses from the general population who assessed "death" as a choice option. In this way, the values were rescaled from full health (1.0) to death (0.0), and consequently, they became suitable for the computation of quality-adjusted life years. RESULTS: The total sample consisted of 1409 members of the general population and 1229 primary caregivers. Results indicated that, out of the 7 IQI items ("sleeping," "feeding," "breathing," "stooling/poo," "mood," "skin," and "interaction"), "breathing" had the highest impact on the HRQoL of infants. Moreover, except for "stooling," all item levels were statistically significant. The general population sample considered none of the health states as worse than death. The utility value for the worst health state was 0.015 (State 4444444). CONCLUSIONS: The IQI is the first generic instrument to assess overall HRQoL in 0-1-year-old infants by providing values and utilities. Using discrete choice experiments, we demonstrated that it is possible to derive utilities of infant health states. The next step will be to collect IQI values in a clinical population of infants and to compare these values with those of other instruments.

Comparing the EQ-5D-3 L and EQ-5D-5 L: studying measurement and scores in Indonesian type 2 diabetes mellitus patients.

BACKGROUND: The EuroQoL five-dimensional instrument (EQ-5D) is the favoured preference-based instrument to measure health-related quality of life (HRQoL) in several countries. Two versions of the EQ-5D are available: the 3-level version (EQ-5D-3 L) and the 5-level version (EQ-5D-5 L). This study aims to compare specific measurement properties and scoring of the EQ-5D-3 L (3 L) and EQ-5D-5 L (5 L) in Indonesian type 2 diabetes mellitus (T2DM) outpatients. METHODS: A survey was conducted in a hospital and two primary healthcare centres on Sulawesi Island. Participants were asked to complete the two versions of the EQ-5D instruments. The 3 L and 5 L were compared in terms of distribution and ceiling, discriminative power and test-retest reliability. To determine the consistency of the participants' answers, we checked the redistribution pattern, i.e., the consistency of a participant's scores in both versions. RESULTS: A total of 198 T2DM outpatients (mean age 59.90 ± 11.06) completed the 3 L and 5 L surveys. A total of 46 health states for 3 L and 90 health states for 5 L were reported. The '11121' health state was reported most often: 17% in the 3 L and 13% in the 5 L. The results suggested a lower ceiling effect for 5 L (11%) than for 3 L (15%). Regarding redistribution, only 6.1% of responses were found to be inconsistent in this study. The 5 L had higher discriminative power than the 3 L version. Reliability as reflected by the index score was 0.64 for 3 L and 0.74 for 5 L. Pain/discomfort was the dimension mostly affected, whereas the self-care dimension was the least affected. CONCLUSIONS: This study suggests that the 5 L-version of the EQ-5D instrument performs better than the 3 L-version in T2DM outpatients in Indonesia, regarding measurement and scoring properties. As such, our study supports the use of the 5 L as the preferred health-related quality of life measurement tool. We did not do a trial but this study was approved by the Medical Ethics Committee of Universitas Gadjah Mada Yogyakarta, Indonesia (document number KE/FK/1188/EC, 12 November 2014, amended 16 March 2015).

'Diabetes is a gift from god' a qualitative study coping with diabetes distress by Indonesian outpatients.

BACKGROUND: More than two-thirds of patients diagnosed with type 2 diabetes mellitus (T2DM) in Indonesia encounter medical-related problems connected to routine self-management of medication and the social stigma related to T2DM. The current study aims to explore distress and coping strategies in Indonesian T2DM outpatients in a Primary Healthcare Centre (PHC) in Surabaya, East Java, Indonesia. METHODS: We conducted a qualitative study using two different data collection methods: focus group discussions and in-depth interviews. The guideline of interviews and discussions were developed based on seventeen questions derived from the DDS17 Bahasa Indonesia (a Bahasa Indonesia version of the Diabetes Distress Scale questionnaire), which covered physician distress domain, emotional burden domain, regimen distress domain and interpersonal distress domain. RESULTS: The majority of the 43 participants were females and aged 50 or older. Our study discovered two main themes: internal and external diabetes distress and coping strategies. Internal diabetes distress consists of disease burden, fatigue due to T2DM, fatigue not due to T2DM, emotional burden (fear, anxiety, etc.) and lack of knowledge. Internal coping strategies comprised spirituality, positive attitude, acceptance and getting more information about T2DM. External diabetes distress was evoked by distress concerning healthcare services, diet, routine medication, monthly blood sugar checks, interpersonal distress (family) and financial concern. External coping strategies included healthcare support, traditional medicine, vigilance, self-management, social and family support and obtaining information about health insurance. CONCLUSION: Our study shows that for Indonesian T2DM-patients, spirituality and acceptance are the most common coping mechanisms for reducing DD. Furthermore, our study revealed an overall positive attitude towards dealing with T2DM as well as a need for more information about T2DM and potential coping strategies. Finally, an important finding of ours relates to differences in DD between males and females, potential DD associated with health services provision and the specific challenges faced by housewives with T2DM.

Valuing Health Status in the First Year of Life: The Infant Health-Related Quality of Life Instrument.

OBJECTIVES: Efforts to evaluate HRQoL and calculate quality-adjusted life years (QALYs) for infants less than 12 months of age are hampered by the lack of preference-based HRQoL instruments for this group. To fill this gap, we developed the Infant Quality of life Instrument (IQI), which is administered through a mobile application. This article explains how weights were derived for the 4 levels of each health item. METHODS: The IQI includes 7 health items: sleeping, feeding, breathing, stooling/poo, mood, skin, and interaction. In an online survey, respondents from the general population (n = 1409) and primary caregivers (n = 1229) from China, the United Kingdom, and the United States were presented with 10 discrete choice scenarios. Coefficients for the item levels were obtained with a conditional logit model. RESULTS: The highest coefficients were found for sleeping, feeding, and breathing. All coefficients for these items were negative and logically ordered, meaning that more extreme levels were less preferred. Stooling, mood, skin, and interaction showed some irregularities in the ordering of coefficients. Results for caregivers and the general population were about the same. CONCLUSIONS: The IQI is the first generic instrument to assess overall HRQoL in infants up to 1 year of age. It is short and easy to administer through a mobile application. We demonstrated how to derive values for infant health states with a discrete choice methodology. Our next step will be to normalize these values into utilities ranging from 0 (dead) to 1 (best health state) and to collect IQI values in a clinical population.

Patient-Centered Item Selection for a New Preference-Based Generic Health Status Instrument: CS-Base.

OBJECTIVES: To develop patient-centered health content for a novel generic instrument (Château Santé Base [CS-Base]) that is suitable to generate values for health status. METHODS: Candidate items were drawn from existing health frameworks of generic health status instruments and placed in a diagram (HealthFANTM, Zeist, the Netherlands). Through an online survey, patients with a wide range of diseases were asked to select the 9 items that were most important to them. The importance of the items for the whole study group was determined by means of frequency distributions. RESULTS: After handling duplicates and overlap, the remaining set of 47 items was placed in the HealthFAN. Among the 2256 Dutch patients who started the survey, the most common diagnoses were neck and back pain, diabetes, and asthma/chronic obstructive pulmonary disease. The 5 health items mentioned most frequently as most important were pain, personal relationships, fatigue, memory, and vision. Hearing and vision, anxiety and depression, and independence and self-esteem seemed highly intertwined, so we chose to pair these items. CONCLUSIONS: A total of 12 health items were included in CS-Base. Its content is largely based on patient input and enables classification of patients' health status. CS-Base can be administered by means of an app on a mobile phone, which makes it a convenient and attractive tool for patients and researchers.