Evaluation of a short instrument for measuring health-related quality of life in oncological patients in routine care (HELP-6): an observational study

Purpose Patient-reported outcomes have not been sufficiently implemented into the routine care of cancer patients because the existing instruments are often too long and complex or not cancer-specific. The aim of this study is the determination of psychometric properties and item reduction of a newly developed health-related quality of life (HrQoL) questionnaire for use in oncological clinical routines. Methods This observational study with a repeated measurements design included oncological inpatients and outpatients. A total of 630 patients participated at the first point of measurement and 404 at the second point of measurement. To evaluate the instrument, we conducted hierarchical confirmative factor analyses and for further validation correlated the resulting factors with standardized and validated HrQoL measurements. Test–retest reliability and responsiveness to change were tested. Results The developed questionnaire “HELP-6” (“Hamburg Inventory for Measuring Quality of Life in Oncological Patients”) has a six-factor structure and has moderate-to-good convergent validity (r= −0.25 –−0.68). Test–retest reliability was moderate-to-good (r =0.56−0.81, p < 0.001). Indications for responsiveness to change were found for three dimensions. The final version of the questionnaire HELP-6 has six dimensions with one item each. Conclusion With the HELP-6 instrument for measuring HrQoL in cancer patients, we provide a short and practical patient-reported outcome instrument. Though responsiveness to change could not be confirmed for all dimensions in this study, the HELP-6 includes time-efficient completion and evaluation and is informative in relevant HrQoL dimensions of cancer patients. Therefore, the HELP-6 poses an important addition to inpatient and outpatient routine cancer care. Trial registration This study was registered at Open Science Framework (https://osf.io/y7xce/), on 9 June 2018.

[1]  H. Schulz,et al.  Identification and Determination of Dimensions of Health-Related Quality of Life for Cancer Patients in Routine Care – A Qualitative Study , 2022, Frontiers in Psychology.

[2]  M. Morita,et al.  Health-related quality of life after esophagectomy in patients with esophageal cancer , 2021, Esophagus.

[3]  C. Weinberg,et al.  Health‐related quality of life outcomes among breast cancer survivors , 2020, Cancer.

[4]  Nikki G. Lobczowski,et al.  Using cognitive interviews and think-aloud protocols to understand thought processes. , 2020, Currents in pharmacy teaching & learning.

[5]  P. Butow,et al.  A review of the barriers to using Patient‐Reported Outcomes (PROs) and Patient‐Reported Outcome Measures (PROMs) in routine cancer care , 2020, Journal of medical radiation sciences.

[6]  C. Bokemeyer,et al.  Development of a Short Instrument for Measuring Health-Related Quality of Life in Oncological Patients for Clinical Use: Protocol for an Observational Study , 2020, JMIR research protocols.

[7]  L. Barbera,et al.  Feasibility of implementing a cervix cancer–specific patient-reported outcome measure in routine ambulatory clinics , 2020, Supportive Care in Cancer.

[8]  P. Butow,et al.  Using patient‐reported outcomes (PROs) and patient‐reported outcome measures (PROMs) in routine head and neck cancer care: What do health professionals perceive as barriers and facilitators? , 2020, Journal of medical imaging and radiation oncology.

[9]  J. Braithwaite,et al.  What are the attitudes of health professionals regarding patient reported outcome measures (PROMs) in oncology practice? A mixed-method synthesis of the qualitative evidence , 2020, BMC health services research.

[10]  C. Bokemeyer,et al.  Implementation analysis of patient reported outcomes (PROs) in oncological routine care: an observational study protocol , 2020, Health and Quality of Life Outcomes.

[11]  E. Eng,et al.  The role of patient-physician relationship on health-related quality of life and pain in cancer patients , 2019, Supportive Care in Cancer.

[12]  F. Dekker,et al.  Patient-reported outcome measures: selection of a valid questionnaire for routine symptom assessment in patients with advanced chronic kidney disease – a four-phase mixed methods study , 2019, BMC Nephrology.

[13]  Hester F. Lingsma,et al.  Implementing Patient-Reported Outcome Measures in Clinical Breast Cancer Care: A Systematic Review. , 2019, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[14]  Cara C. Lewis,et al.  Implementing Measurement-Based Care in Behavioral Health: A Review , 2019, JAMA psychiatry.

[15]  C. McHorney,et al.  Exploring the implementation of patient-reported outcome measures in cancer care: need for more real-world evidence results in the peer reviewed literature , 2018, Journal of Patient-Reported Outcomes.

[16]  M. Meeus,et al.  Screening of physical distress in breast cancer survivors: Concurrent validity of the Distress Thermometer and Problem List , 2018, European journal of cancer care.

[17]  Neil W. Wagle Implementing Patient-Reported Outcome Measures , 2017 .

[18]  G. Ehninger,et al.  Cancer patients’ control preferences in decision making and associations with patient-reported outcomes: a prospective study in an outpatient cancer center , 2017, Supportive Care in Cancer.

[19]  J. Griggs,et al.  Implementing a Method for Evaluating Patient-Reported Outcomes Associated With Oral Oncolytic Therapy. , 2017, Journal of oncology practice.

[20]  J. Browne,et al.  The experiences of professionals with using information from patient-reported outcome measures to improve the quality of healthcare: a systematic review of qualitative research , 2014, BMJ quality & safety.

[21]  P. Esper Identifying strategies to optimize care with oral cancer therapy. , 2013, Clinical journal of oncology nursing.

[22]  Joanne Greenhalgh,et al.  Implementing patient-reported outcomes assessment in clinical practice: a review of the options and considerations , 2012, Quality of Life Research.

[23]  Yves Rosseel,et al.  lavaan: An R Package for Structural Equation Modeling , 2012 .

[24]  G. Bonsel,et al.  Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L) , 2011, Quality of Life Research.

[25]  C. Spitzer,et al.  A 4-item measure of depression and anxiety: validation and standardization of the Patient Health Questionnaire-4 (PHQ-4) in the general population. , 2010, Journal of affective disorders.

[26]  R. Hays,et al.  Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. , 2008, Journal of clinical epidemiology.

[27]  C. Pipper,et al.  [''R"--project for statistical computing]. , 2008, Ugeskrift for laeger.

[28]  Douglas G Altman,et al.  The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. , 2014, International journal of surgery.

[29]  Xianggui Qu,et al.  Multivariate Data Analysis , 2007, Technometrics.

[30]  A. Mehnert,et al.  Die deutsche Version des NCCN Distress-Thermometers , 2006 .

[31]  Daniel J. Mundfrom,et al.  Minimum Sample Size Recommendations for Conducting Factor Analyses , 2005 .

[32]  L. Giustini,et al.  Quality of life (QOL) assessment with EORTC QLQ-C30 in daily clinical practice , 2005 .

[33]  G. Robert,et al.  Diffusion of innovations in service organizations: systematic review and recommendations. , 2004, The Milbank quarterly.

[34]  H. Chochinov,et al.  Dignity in the terminally ill: a developing empirical model. , 2002, Social science & medicine.

[35]  D. Cella,et al.  Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system , 1996, Quality of Life Research.

[36]  D. Osoba,et al.  The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. , 1993, Journal of the National Cancer Institute.

[37]  D. Tulsky,et al.  The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. , 1993, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[38]  Jacob Cohen Statistical Power Analysis for the Behavioral Sciences , 1969, The SAGE Encyclopedia of Research Design.

[39]  A. Mehnert,et al.  Assessment of patients' dignity in cancer care: preliminary psychometrics of the German version of the Patient Dignity Inventory (PDI-G). , 2014, Journal of pain and symptom management.

[40]  P. Bentler,et al.  Cutoff criteria for fit indexes in covariance structure analysis : Conventional criteria versus new alternatives , 1999 .