Patient-reported outcome measures for clinical decision-making in outpatient follow-up: validity and reliability of a renal disease questionnaire

Abstract

Background Patient-reported outcome measures are increasingly used by clinicians to support communication in telephone- or face-to-face consultations with patients. A renal disease questionnaire has been developed, but not sufficiently evaluated through clinimetrics in clinical setting. Hence, we aimed to evaluate the content validity, construct validity and the test–retest reliability of a renal disease questionnaire to be used for clinical decision-making. Methods A content, construct validity and test–retest reliability study was conducted in 3 nephrology outpatient clinics in Central Denmark Region, Denmark. Content validity (face validity, comprehensibility and relevance) was assessed among 8 patients and 6 clinicians. Reliability was assessed by asking outpatients with chronic kidney disease to complete the questionnaire twice. Reliability was assessed by kappa statistics and agreement by percentage. Construct validity was determined using 4 a priori defined hypotheses and comparing 2 known groups. Results Five new domains emerged, 6 items were rephrased and 3 items were removed following the content validity test. A total of 160 patients completed the questionnaire with median 8 days (IQR 2 days) between assessments. The test–retest reliability parameters of the single items in the questionnaire were substantial to almost perfect as all the observed weighted kappa values ranged from 0.61 to 0.91, 95% CI (0.34 to 0.95). In total, 61% of the single items showed almost perfect agreement. In total, 3 of the 4 hypotheses were accepted and 44% of the items showed satisfying known-group discriminative validity. Conclusion A renal disease questionnaire used for clinical decision-making in outpatient follow-up showed acceptable content validity and substantial to almost perfect reliability. Sufficient construct validity was not established. Incorporating the questionnaire into routine clinical practice may improve the evaluation of disease burden in patients with chronic kidney disease. Plain English summary We ask patients with chronic kidney disease (CKD) in Central Region Denmark to complete a questionnaire before each outpatient visit. The answers they provide are used to support communication with their health care provider. A questionnaire requires testing to ensure it can accurately capture important information about patient’s symptoms and quality of life. When questionnaires are used to support communication between patients and health care professionals, they need to have good measurement properties. This means they need to be: (1) trustworthy, (2) relevant to a patient’s health condition, (3) consistent and produce stable results every time. We explored the measurement properties of a questionnaire designed to be used in the face-to face outpatient visits for patients with CKD. We found that the questionnaire captured consistent and stable results. Using this questionnaire may help health care professionals to assess the patients´ burden of symptoms with a more patient-centered approach. Potentially, the use of the questionnaire will increase the patients´ ability to cope with their symptoms and strengthen patients´ involvement in the clinical decisions concerning their treatment.

Prevalence and Severity of Lower Gastrointestinal Symptoms amongst Non-Dialysis Chronic Kidney Disease Patients: A Systematic Review and Meta-Analysis

“…The vast majority of studies reported data collected in CKD G4–5 patients (30 studies), whereas far fewer studies reported data on GI symptomatology in the early stages of CKD (6 in G1–2 [ 9 , 32 , 33 , 34 , 35 , 36 ]; 10 in G3 [ 9 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 ]). Subgroup characteristics were described in Supplementary Materials, Results S1 .…”

“…Data on self-reported constipation prevalence in CKD were provided in 24 studies, of which 22 were included in the meta-analyses below ( Figure 2 ). They were conducted primarily in the WHO Western Pacific (9 studies [ 24 , 26 , 35 , 37 , 42 , 55 , 56 , 58 , 64 ]) and European (8 studies [ 23 , 28 , 30 , 31 , 38 , 44 , 53 , 62 , 65 ]) Regions. Data were collected using authors’ questionnaires/during anamnesis in the case of 8 studies, and using validated questionnaires: renal version of the Patient Outcome Scale—symptom module (POS-S Renal; 5 studies [ 24 , 27 , 31 , 35 , 64 ]); Integrated Palliative Care Outcome Scale (IPOS)-Renal (3 studies [ 26 , 37 , 39 ]); Dialysis Symptom Index (DSI) (3 studies [ 23 , 53 , 57 , 58 ]); Memorial Symptom Assessment Scale–Short Form (MSAS-SF; 2 studies [ 44 , 62 ]).…”

“…A total of 4 studies were included in the prevalence analysis for the CKD G3 subgroup [ 35 , 37 , 38 , 39 ]. The observed prevalence ranged from 13 to 43% mainly due to between-study variance (τ 2 = 0.13; I 2 = 77%).…”

“…A total of 22 studies enrolling 2878 patients were included in the analysis for the CKD G4–5 subgroup [ 24 , 26 , 27 , 28 , 29 , 30 , 31 , 35 , 37 , 38 , 39 , 42 , 44 , 53 , 55 , 56 , 57 , 58 , 62 , 64 , 65 , 66 ]. The observed prevalence ranged from 15 up to 100%.…”

“…We did not identify any study reporting the prevalence of functional diarrhea in CKD. Studies reporting self-reported diarrhea were conducted primarily in the WHO Western Pacific (7 studies [ 24 , 35 , 37 , 42 , 58 , 64 , 67 ]) and European (6 studies [ 30 , 31 , 38 , 53 , 62 , 65 ]) Regions, whereas only one study each was conducted in the African (Nigeria [ 43 ]) and Eastern Mediterranean (Saudi Arabia [ 68 ]) Regions.…”