scholarly journals Additional assessment of Acute Cystitis Symptom Score questionnaire for patient-reported outcome measure in female patients with acute uncomplicated cystitis: part II

2019 ◽  
Vol 38 (8) ◽  
pp. 1977-1988 ◽  
Author(s):  
J. F. Alidjanov ◽  
K. G. Naber ◽  
A. Pilatz ◽  
A. Radzhabov ◽  
M. Zamuddinov ◽  
...  
Keyword(s):  
Clinical Cure ◽  
Missing Values ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Summary Score ◽  
Acute Cystitis ◽  
Female Patients ◽  
Patient Reported ◽  
Acute Uncomplicated Cystitis ◽  
Uncomplicated Cystitis

Abstract Purpose Since symptomatic, non-antibiotic therapy has become an alternative approach to treat acute cystitis (AC) in women, suitable patient-reported outcome measures (PROM) are urgently needed. The aim of this part II of a larger non-interventional, case–control study was the additional assessment of the ACSS as a suitable PROM. Methods Data from 134 female patients with diagnosed acute uncomplicated cystitis were included in the current analysis with (1) a summary score of “Typical” domain of 6 and more; (2) at least one follow-up evaluation after the baseline visit; (3) no missing values in the ACSS questionnaire data. Six different predefined thresholds based on the scoring of the ACSS items were evaluated to define “clinical cure”, also considering the draft FDA and EMA guidelines. Results Of the six different thresholds tested, a summary score of the five typical symptoms of 5 and lower with no symptom more than 1 (mild), without visible blood in urine, with or without including QoL issues was favoured, which partially also could be adapted to the draft FDA and EMA guidelines. The overall patient’s clinical assessment (“Dynamic” domain) alone was not sensitive enough for a suitable PROM. Conclusions Scoring of the severity of symptoms is needed not only for diagnosis, but also for PROM to define “clinical cure” of any intervention, which could be combined with QoL issues. Results of the study demonstrated that the ACSS questionnaire has the potential to be used as a suitable PROM and should further be tested in prospective clinical studies.

scholarly journals Validation of the American English Acute Cystitis Symptom Score

Antibiotics ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. 929
Author(s):  
Jakhongir F. Alidjanov ◽  
Kurt G. Naber ◽  
Adrian Pilatz ◽  
Florian M. Wagenlehner
Keyword(s):  
Symptom Score ◽  
Clinical Success ◽  
American English ◽  
Clinical Success Rate ◽  
Acute Cystitis ◽  
Sum Score ◽  
Patient Reported ◽  
Acute Uncomplicated Cystitis ◽  
Uncomplicated Cystitis ◽  
Self Reporting Questionnaire

The diagnosis of acute uncomplicated cystitis (UC) is usually based on clinical symptoms. The study aims to develop and validate the American-English Acute Cystitis Symptom Score (ACSS), a self-reporting questionnaire for diagnosis and patient-reported outcome in women with acute uncomplicated cystitis (UC). After certified translation into American-English and cognitive assessment, the clinical validation of the ACSS was performed embedded in a US phase-II trial. 167 female patients with typical symptoms of UC were included in the study following US Food and Drug Administration (FDA) guidance. At Day 1 (diagnosis), the mean (SD) sum score of the six ACSS typical symptoms reached 10.60 (2.51). Of 100 patients followed-up last time on Day 5 or 6 (End-of-treatment, EoT), 91 patients showed clinical success according to the favored ACSS criteria (sum score of typical symptoms 0.98 (1.94)). There was no correlation between the severity of symptoms on Day 1 or between clinical success rate at EoT and level of bacteriuria on Day 1. The American-English ACSS showed high predictive ability and responsiveness and excellent levels of reliability and validity. It can now be recommended as the new master version in clinical and epidemiological studies, in clinical practice, or for self-diagnosis of women with symptoms of UC.

scholarly journals Development of social contact and loneliness measures with validation in social prescribing

2021 ◽  
Vol 10 (2) ◽  
pp. e001306
Author(s):  
Tim Benson ◽  
Helen Seers ◽  
Nicola Webb ◽  
Philippa McMahon
Keyword(s):  
Construct Validation ◽  
Secondary Analysis ◽  
Social Contact ◽  
Well Being ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Summary Score ◽  
Social Prescribing ◽  
Patient Reported ◽  
Before And After

AimsThis paper describes two patient-reported measures of social contact and loneliness, which are closely related concepts. The first measure (R-Outcomes Social Contact measure) was developed from scratch, based on customer needs and literature review. It covers emotional and social aspects using positive terms. The second measure (R-Outcomes Loneliness measure) is adapted from the GSS Loneliness Harmonised Standard. Both measures are patient-reported outcome measures, based on patients’ own perception of how they feel.MethodThis development started in 2016 in response to customers’ requests to measure social contact/loneliness for patients in social prescribing projects.Both measures are compared with three other loneliness measures (the GSS Loneliness Harmonised Standard, De Jong Gierveld and Campaign to End Loneliness). Both measures are short (36 and 21 words, respectively). Mean improvement is reported as a positive number on a 0–100 scale (where high is good).We tested the psychometric performance and construct validity of the R-Outcomes Social Contact measure using secondary analysis of anonymised data collected before and after social prescribing interventions in one part of Southern England.ResultsIn the validation study, 728 responses, collected during 2019–2020, were analysed. 90% were over 70 years old and 62% women. Cronbach’s α=0.76, which suggests that it is appropriate to use a single summary score. Mean Social Contact scores before and after social prescribing intervention were 59.9 (before) and 66.7 (after, p<0.001).Exploratory factor analysis shows that measures for social contact, health status, health confidence, patient experience, personal well-being, medication adherence and social determinants of health are correlated but distinct factors. Construct validation shows that the results are consistent with nine hypotheses, based on the loneliness literature.ConclusionThe R-Outcomes Social Contact measure has good psychometric and construct validation results in a population referred to social prescribing. It is complementary to other R-Outcomes measures.

Optimizing electronic capture of patient-reported outcome measures in oncology clinical trials: lessons learned from a qualitative study

2020 ◽  
Vol 9 (17) ◽  
pp. 1195-1204
Author(s):  
Florence D Mowlem ◽  
Brad Sanderson ◽  
Jill V Platko ◽  
Bill Byrom
Keyword(s):  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Lessons Learned ◽  
Structured Interviews ◽  
Patient Reported ◽  
Oncology Clinical Trials ◽  
Anticancer Treatment ◽  
Fit For Purpose ◽  
The Impact ◽  
Electronic Implementation

Aim: To understand the impact of anticancer treatment on oncology patients’ ability to use electronic solutions for completing patient-reported outcomes (ePRO). Materials & methods: Semi-structured interviews were conducted with seven individuals who had experienced a cancer diagnosis and treatment. Results: Participants reported that the following would impact the ability to interact with an ePRO solution: peripheral neuropathy of the hands (4/7), fatigue and/or concentration and memory issues (6/7), where they are in a treatment cycle (5/7). Approaches to improve usability included: larger, well-spaced buttons to deal with finger numbness, the ability to pause a survey and complete at a later point and presenting the recall period with every question to reduce reliance on memory. Conclusion: Symptoms associated with cancers and anticancer treatments can impact the use of technologies. The recommendations for optimizing the electronic implementation of patient-reported outcome instruments in this population provides the potential to improve data quality in oncology trials and places patient needs at the forefront to ensure ‘fit-for-purpose’ solutions.

Impact of Depression on Patient-Reported Outcome Measures After Lumbar Spine Decompression

Spine ◽  
2018 ◽  
Vol 43 (6) ◽  
pp. 434-439 ◽  
Author(s):  
Robert K. Merrill ◽  
Lukas P. Zebala ◽  
Colleen Peters ◽  
Sheeraz A. Qureshi ◽  
Steven J. McAnany
Keyword(s):  
Lumbar Spine ◽  
Outcome Measures ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Patient Reported

scholarly journals The effects of competition and bundled payment on patient reported outcome measures after hip replacement surgery

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Fanny Goude ◽  
Sverre A. C. Kittelsen ◽  
Henrik Malchau ◽  
Maziar Mohaddes ◽  
Clas Rehnberg
Keyword(s):  
Hip Replacement ◽  
Health Gain ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Economic Incentives ◽  
Bundled Payment ◽  
Treatment Groups ◽  
Replacement Surgery ◽  
Hip Replacement Surgery ◽  
Patient Reported

Abstract Background Competition-promoting reforms and economic incentives are increasingly being introduced worldwide to improve the performance of healthcare delivery. This study considers such a reform which was initiated in 2009 for elective hip replacement surgery in Stockholm, Sweden. The reform involved patient choice of provider, free establishment of new providers and a bundled payment model. The study aimed to examine its effects on hip replacement surgery quality as captured by patient reported outcome measures (PROMs) of health gain (as indicated by the EQ-5D index and a visual analogue scale (VAS)), pain reduction (VAS) and patient satisfaction (VAS) one and six years after the surgery. Methods Using patient-level data collected from multiple national registers, we applied a quasi-experimental research design. Data were collected for elective primary total hip replacements that were carried out between 2008 and 2012, and contain information on patient demography, the surgery and PROMs at baseline and at one- and six-years follow-up. In total, 36,627 observations were included in the analysis. First, entropy balancing was applied in order to reduce differences in observable characteristics between treatment groups. Second, difference-in-difference analyses were conducted to eliminate unobserved time-invariant differences between treatment groups and to estimate the causal treatment effects. Results The entropy balancing was successful in creating balance in all covariates between treatment groups. No significant effects of the reform were found on any of the included PROMs at one- and six-years follow-up. The sensitivity analyses showed that the results were robust. Conclusions Competition and bundled payment had no effects on the quality of hip replacement surgery as captured by post-surgery PROMs of health gain, pain reduction and patient satisfaction. The study provides important insights to the limited knowledge on the effects of competition and economic incentives on PROMs.

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