Measuring Quality of Life in Hidradenitis Suppurativa: Development and Validation of a Disease-specific Patient-reported Outcome Measure for Practice and Research.

Hidradenitis suppurativa is a chronic disease that disrupts patients' physical and psychological well-being. A disease-specific measure was developed and validated for assessing health-related quality of life in hidradenitis suppurativa. After qualitative item development, the quality of life in hidradenitis suppurativa instrument was tested in 101 patients, applying convergent measures and a usability questionnaire. Descriptive and validation-specific analyses were conducted. There was no ceiling, but moderate floor effects (scores between 0 and 3.13 on a scale of 0-4). Few missing values were observed (21 of 23 items < 5%). Internal consistency was satisfying: 2 subscales with 6 and 16 items were identified (Cronbach's alpha=0.95 and 0.88). The quality of life in hidradenitis suppurativa instrument correlated significantly with all convergent criteria (including change in convergent patient-reported outcomes; p < 0.05) except for Hurley stage (p = 0.490). In conclusion, the quality of life in hidradenitis suppurativa questionnaire is an internally consistent, valid, responsive, and usable instrument to assess quality of life in patients with hidradenitis suppurativa.

Measurement Properties of Patient-Reported Outcome Measures for Pruritus: An Updated Systematic Review.

This systematic review aims to provide an update on measurement properties of patient-reported outcome measures for pruritus. A Medline literature search was conducted to update the systematic review published in this journal in 2017 and to identify new validation studies published between October 2015 and July 2019. The methodological quality of validation studies was assessed on the basis of the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist, and the measurement properties of patient-reported outcome measures were evaluated. A total of 19 new studies were included and added to the 22 studies identified in the previously published review. Evidence from all the 41 studies evaluating 38 different measures was summarized. Outcome measures were mapped to one of three constructs where possible: pruritus intensity, pruritus severity, pruritus-specific health-related QOL. COSMIN rating revealed mixed results, with deficiencies in the methodological quality of many studies across all constructs. The most appropriate pruritus severity measure was the Itch Severity Scale. ItchyQoL and the disease-specific Uremic Pruritus in Dialysis Scale achieved the most promising results considering the construct pruritus-specific health-related QOL. For pruritus intensity, nine measures performed similarly well.

Determining the Minimal Important Difference for the Wound-QoL Questionnaire.

BACKGROUND: The questionnaire for the quality of life with chronic wounds (Wound-QoL) is a valid and reliable instrument to determine the disease-specific health-related QoL of patients with chronic wounds. For the interpretation of HRQoL scores, it is additionally important to know which differences in scores are considered meaningful. The minimal important difference (MID) is defined as a change in HRQoL that a patient would consider meaningful, such that the patient would judge a treatment to be beneficial and worthy of repeating. OBJECTIVE: To interpret changes in the Wound-QoL scores and draw conclusions regarding the relevance of detected changes; the purpose of this study was to estimate the MID of the Wound-QoL global score and its subscales for patients with chronic wounds. PATIENTS AND METHODS: Patients completed the Wound-QoL before and four to six weeks after treatment and additionally gave a global rating of wound status change after treatment. The global rating of change served as an anchor question. MIDs were calculated based on an anchor-based and a distribution-based method. RESULTS: In total, 227 patients participated in the study. The mean age of the study population was 66.9 (± 12.7) median was 69.5, and 51.5% of the patients were female. MIDs for the Wound-QoL global score ranged from 0.47 to 0.52, proposing an overall estimation of 0.50. CONCLUSION: The results can be used to measure and interpret changes in wound-specific QoL over time.

Challenges and lessons learned from using anchoring vignettes to explore quality of life response behavior.

PURPOSE: Asking patients to rate health-related quality of life (HRQoL) of hypothetical individuals described in anchoring vignettes has been proposed to enhance knowledge on how patients understand and respond to HRQoL questionnaires. In this article, we describe the development of anchoring vignettes and explore their utility for measuring response shift in patients' self-reports of HRQoL. METHODS: We conducted an explorative mixed-methods study. One hundred patients with multiple sclerosis or psoriasis participated in two interviews at intervals of 3-6 months. During both interviews, patients assessed HRQoL of 16 hypothetical individuals on the SF-12 questionnaire (two vignettes for each of the eight domains of the SF-12). In addition to these quantitative ratings, we used the think-aloud method to explore changes in patients' verbalization of their decision processes during vignette ratings. RESULTS: Agreement of vignette ratings at baseline and follow-up was low (ICCs < 0.55). In addition, paired sample t-tests revealed no significant directional mean changes in vignette ratings. Thus, ratings changed non-directionally, neither confirming retest reliability nor a systematic change of assessment. Furthermore, patients' verbalization of their decision processes did not indicate whether or not the assessment strategy of individual patients had changed. CONCLUSIONS: Patients' ratings of anchoring vignettes fluctuate non-directionally over time. The think-aloud method appears not to be informative in exploring whether these fluctuations are due to changes in the individual decision process. Overall, vignettes might not be an appropriate approach to explore response shift, at least with regard to the specific target population and the use of the SF-12.

Recall of health-related quality of life: how does memory affect the SF-6D in patients with psoriasis or multiple sclerosis? A prospective observational study in Germany.

OBJECTIVE: This study aimed to quantify recall bias in the measurement of health-related quality of life (HRQoL), that is, the extent to which recollection is impaired and leads to distorted judgements. DESIGN: Prospective observational study. SETTING AND PARTICIPANTS: One hundred patients with two paradigmatic chronic diseases (50 with multiple sclerosis and 50 with psoriasis) were recruited at two outpatient clinics. METHODS AND OUTCOME MEASURES: Patients completed the online version of the 12-Item Short Form Survey (SF-12) repeatedly for 28 consecutive days: (1) daily, considering the past 24 hours; (2) weekly, considering the past 7 days; and (3) on the last day of data collection, considering the past 4 weeks. SF-12 scores for all three measurement approaches were subsequently converted into preference-based utility indices (Short-Form Six-Dimension). Agreement of the three indices was analysed on group and individual patient levels. RESULTS: The mean age of participants was 40.3 years (±12.0), and 63% were female. The utility index based on daily recall (0.74±0.13) was more positive than indices based on a weekly (0.70±0.13, p<0.001) or a monthly (0.70±0.14, p<0.001) recall. While agreement of measurement approaches was high on group level (intraclass correlation coefficient>0.85), it was lower for the subgroup of patients experiencing high variability of HRQoL over time. Bland-Altman plots revealed considerable differences on individual patient level. CONCLUSIONS: On the group level, retrospective overestimation and underestimation of HRQoL almost cancelled out one another and recall bias was relatively small. Therefore, a 4-week recall period could be appropriate when group-level data are used for research or economic evaluations. In contrast, recall bias can be considerable on the individual patient level and may thus impact decision-making in clinical practice. TRIAL REGISTRATION NUMBER: VfD_RECALL_16_003837.

Towards patients' understanding of health-related quality of life-a mixed-method study in psoriasis and multiple sclerosis.

PURPOSE: Patients' individual understanding of health-related quality of life (HRQoL) varies widely, making the measurement of this complex and subjective construct challenging. Anchoring vignettes, i.e., descriptions of fictive patients may provide insights into patients' individual questionnaire reference frames, assessment processes, and understanding of HRQoL. This study analyzes how patients assess HRQoL of vignettes. METHODS: This exploratory mixed-method study included 100 patients with a chronic disease (50 multiple sclerosis (MS); 50 psoriasis). Sixteen vignettes, two for each domain of the SF-12v2, were developed based on literature recommendations and pretested in a convenience sample of seven healthy individuals. Patients assessed their own HRQoL and HRQoL of the vignettes on the SF-12v2. In semi-structured interviews, they justified their assessments. We quantitatively analyzed associations of vignette assessments with individual characteristics using linear regression models and qualitatively analyzed assessment justifications. RESULTS: Patients' age and disease were significant (p < 0.05) predictors for ten and seven vignette assessments, respectively. Older patients assessed vignettes being less extreme; patients diagnosed with MS rated them more positively. Overall, adjusted R2 values ranged from 0.033 to 0.172. Qualitatively, most of the ratings were based on the evaluation of symptoms or impairments in daily life. Fewer participants ranked different dimensions of HRQoL in a personal hierarchy or assumed impairments beyond the vignette description. CONCLUSIONS: The understanding of HRQoL may vary substantially and is associated with individual characteristics, individual assessment strategies, and probably other intrinsic factors as explained variance was quite low. Therefore, usage of generic instruments only allows for limited comparison across groups.

Long-term use of benzodiazepines and Z drugs: a qualitative study of patients' and healthcare professionals' perceptions and possible levers for change.

BACKGROUND: Although long-term use of benzodiazepines (BZDs) and Z drugs is associated with various side effects, they remain popular among the older population. Possible reasons for this phenomenon could be ineffective ways of transmitting information on the health risks associated with long-term use, and communication gaps between patients and healthcare professionals. AIM: The aim was to investigate the views of patients, physicians, nurses, and pharmacists regarding long-term BZD and Z drug use. DESIGN & SETTING: The qualitative study design used focus group interviews with physicians, pharmacists, and nurses in Hamburg. Patient interviews were conducted in Lippstadt, Germany. METHOD: The interviews were audiotaped with each participant's permission, transcribed, and thematically analysed using a software program for qualitative research (MAXQDA). RESULTS: The data from the four focus groups consisting of 28 participants were analysed. Patients indicated lack of knowledge about risks and side effects, difficult access to alternatives, and fears of ceasing drug use without professional support. Although the physicians were reported to be cautious about prescribing BZDs and Z drugs, the psychosocial problems of older patients are often considered to be complex and treatment knowledge, experience, and resources are frequently unsatisfactory. Nurses described that when BZDs were prescribed, they did not feel it was their responsibility to evaluate their effects. Pharmacists were reported to be strongly ambivalent in informing patients about the risks, which may contradict the prescription advice provided by the physician. CONCLUSION: Patients, physicians, nurses, and pharmacists reported differences in the perception of long-term BZD and Z drug use. Nevertheless, all of the participants described lack of information and expressed the need for greater communication exchange.

Measuring Patient Needs and Benefits in Dermatology using the Patient Benefit Index 2.0: A Validation Study.

This study investigated the validity and feasibility of the Patient Benefit Index 2.0 (PBI 2.0), a short instrument to assess patient-relevant treatment benefit. In a cross-sectional study, patients with skin diseases completed the PBI 2.0 alongside instruments on quality of life and disease-specific PBI long versions to assess convergent validity. Feasibility questions appraise comprehensibility, completeness, length, and readability. Data from a longitudinal study were used to explore responsiveness and test-retest reliability. Most patients rated the PBI 2.0 easy to understand, complete, legible, and not too long. The amount of missing values was overall low. In all groups, except for vitiligo, correlation analyses indicated good convergent validity of PBI 2.0. Responsiveness of the PBI 2.0 could not be clearly confirmed. Retest-reliability achieved satisfactory results. Thus, the PBI 2.0 may be a suitable instrument for its use in different skin diseases. Its broad applicability allows for comparisons across diagnosis groups.

Patient-centered care interventions to reduce the inappropriate prescription and use of benzodiazepines and z-drugs: a systematic review.

BACKGROUND: Benzodiazepines (BZDs) and z-drugs are effective drugs, but they are prescribed excessively worldwide. International guidelines recommend a maximum treatment duration of 4 weeks. Although these drugs are effective in the short-term, long-term BZD therapy is associated with considerable adverse effects, the development of tolerance and, finally, addiction. However, there are different interventions in terms of patient-centered care that aim to reduce the use of BZDs and z-drugs as well as assist health care professionals (HCPs) in preventing the inappropriate prescription of BZDs. AIM: The aim of this systematic review was to identify interventions that promote patient-centered treatments for inappropriate BZD and z-drug use and to analyze their effectiveness in reducing the inappropriate use of these drugs. METHODS: To identify relevant studies, the PubMed, EMBASE, PsycINFO, Psyndex, and Cochrane Library databases were searched. Studies with controlled designs focusing on adult patients were included. Trials with chronically or mentally ill patients were excluded if long-term BZD and z-drug use was indicated. Study extraction was performed based on the Cochrane Form for study extraction. To assess the quality of the studies, we used a tool based on the Cochrane Collaboration's tool for assessing the risk of bias in randomized trials. RESULTS: We identified 7,068 studies and selected 20 for systematic review. Nine interventions focused on patients, nine on HCPs, and two on both patients and HCPs. Intervention types ranged from simple to multifaceted. Patient-centered interventions that provided patient information effectively increased the appropriate use of BZDs. The educational approaches for HCPs that aimed to achieve appropriate prescription reported inconsistent results. The methods that combined informing patients and HCPs led to a significant reduction in BZD use. CONCLUSIONS: This is the first review of studies focused on patient-centered approaches to reducing the inappropriate prescription and use of BZDs and z-drugs. The patient-centered dimension of patient information was responsible for a decrease in BZD and z-drug consumption. Further, in some studies, the patient-centered dimensions responsible for reducing the prescription and use of BZDs and z-drugs were the clinician's essential characteristics and clinician-patient communication.

Psychometric properties of the German version of Observer OPTION5.

BACKGROUND: In order to conduct studies on shared decision-making (SDM) and to implement SDM in routine practice, psychometrically tested measures are needed. The development of the short 5-item version of the OPTION scale (Observer OPTION5) allows to assess SDM from an observer perspective. Observer OPTION5 is so far only available in English and Dutch. The aim of this study was to translate the Observer OPTION5 rating scale into German and to test its psychometric properties. METHODS: The German Observer OPTION5 was tested in a secondary data analysis of audio-recordings of patient-physician-consultations (N = 79) in German primary care practices. Demographic data were analysed using descriptive statistics. To assess inter- and intra-rater reliability, intraclass correlation coefficients (ICCs) were calculated. For assessing concurrent validity, a correlation (Spearman's Rho) of the sum score of Observer OPTION5 and Observer OPTION12 was calculated. RESULTS: The consultations dealt with decisions regarding type 2 diabetes (N = 31), chronic back pain (N = 23), depression (N = 20), and other diseases (N = 5). Analysis of inter-rater reliability yielded an ICC of 0.82 for the sum score; across the five single items ICCs ranged between 0.45 and 0.77. For the intra-rater reliability an ICC of 0.83 was observed for the total score; across the five single items ICCs ranged between 0.45 and 0.86. The Observer OPTION5 had a mean total score of 11.84 (SD = 11.92) and the Observer OPTION12 had a mean total score of 10.3 (SD = 7.9), both on a potential range of 0 to 100. The correlation between the total scores of Observer OPTION5 and Observer OPTION12 was r = 0.47 (p = 0.01). CONCLUSIONS: The results regarding inter- and intra-rater reliability were excellent on the total score level. Observer OPTION5 showed moderate concurrent validity using Observer OPTON12. The results are generally comparable to the results of the original English version of Observer OPTION5. The German version of Observer OPTION5 can be used in research and evaluation of clinical practice. Nevertheless, further testing is adviced.

Shared decision-making in physical therapy: A cross-sectional study on physiotherapists' knowledge, attitudes and self-reported use.

OBJECTIVE: This study aimed a) to investigate knowledge, attitudes, and self-reported use of shared decision-making (SDM) among physiotherapists in Germany, b) to explore their association with demographic characteristics, and c) to assess barriers to the implementation of SDM. METHODS: We assessed above mentioned domains using an online survey. Two-level logistic regression models were used to examine factors associated with knowledge, attitudes and self-reported use of SDM. RESULTS: 60.5% of a total sample of 357 participants reported to have had no knowledge on SDM before participating in the survey. Attitudes towards SDM were mostly positive, half of all participants expressed a preference for SDM. About two thirds of all participants reported to use a rather paternalistic approach in routine care. Knowledge, attitudes, and self-reported use of SDM were associated with several demographic characteristics. CONCLUSION: SDM was perceived as an appropriate concept in physiotherapy. However, missing knowledge and limited self-reported use of SDM in routine care on the one hand and positive attitudes towards SDM on the other hand indicate a need for action. PRACTICE IMPLICATIONS: In order to emphasize the use of SDM in physiotherapy efforts need to be undertaken in research, clinical practice and health policy.

Vorvida: study protocol of a randomized controlled trial testing the effectiveness of Internet-based self-help program for the reduction of alcohol consumption for adults.

BACKGROUND: Problem drinking is an important global health concern, causing premature mortality and morbidity. Only few problem drinkers seek professional care, unfortunately, because of multiple barriers such as insufficient change motivation, fear of stigmatization or limited access to care. The aim of this study will be to examine the effectiveness of a novel Internet intervention termed Vorvida, which was developed based on established cognitive-behavioral therapy techniques with the aim of reducing problematic alcohol consumption. METHODS/DESIGN: A two-arm randomized control trial (RCT) will be conducted to determine whether using Vorvida results in greater reductions in self-reported problem drinking, compared with a care-as-usual/waitlist (CAU/WL) control group. There will be a baseline assessment (t0) and follow-up assessments after three (t1) and six months (t2). Inclusion criteria will be: minimum age of 18, an average consumption of alcohol >24/12 g (men/women) per day and an AUDIT-C score ≥ 3, as well as informed consent. Participants will be randomly assigned to the intervention or control condition at a ratio of 1:1. Recruitment, informed consent, randomization and assessment will be Internet-based. Primary outcome will be change in self-reported alcohol consumption between t0 and t1. Secondary outcomes will be self-reported drinking behavior, expectancies of effects of alcohol use, abstinence and relapse tendencies, self-efficacy and motivation to change. DISCUSSION: This study is expected to establish the extent to which a novel Internet intervention could contribute to reducing problem drinking among adults with mild to severe alcohol use disorders who may or may not seek or access a traditional treatments. Potentially, this program could be an effective and efficient tool to help reduce problem drinking on a population level because a great number of users can be reached simultaneously without adding burden to treating clinicians. TRIAL REGISTRATION: German Clinical Trial Registration (DRKS): DRKS00006104. Registered 14 April 2014.