A question prompt sheet for adult patients with chronic kidney disease

Participants and settings

Eligible participants were at least 18 years of age, English-speaking, with moderate to advanced CKD (eGFR <60 ml/min/1.73 m²), receiving chronic dialysis, or with a kidney transplant and had visited the outpatient nephrology clinic at the Edward Hines, Jr. United States Veterans Affairs (VA) Hospital between April 1^st and October 31^st, 2014. Though the target population for the QPS was patients with moderate disease, those with more severe CKD were included to obtain valuable insight about information patients wished they had known earlier and because a significant portion of CKD patients are referred to nephrologists with advanced disease [24]. During phase 1, the eligible patient pool was stratified by race, ethnicity and gender to oversample for women, African Americans, and Hispanics, allowing for representation of their CKD information needs. The pool of women and minority patients was exhausted early on in phase 2, limiting further stratification.

The Modification of Diet in Renal Disease equation estimating glomerular filtration rate (eGFR) was used to classify CKD according to conventional CKD stages [25]. Patients who were cognitively impaired (Six Item Screener) [26], unaware of their CKD diagnosis, or participating in another VA study were excluded. Eligible participants were mailed an information sheet describing the study and then received a telephone call one week later to screen for eligibility. The Hines VA Institutional Review Board (IRB) approved the study. All participants provided verbal informed consent.

Phase 1 data collection

In Phase 1, semi-structured telephone interviews were conducted to identify patients’ CKD information needs, and to begin formulating questions that patients believed were important to ask providers. Interviews included 17 open- and 15 closed-ended questions, as previously described (Additional file 1) [6]. Open-ended questions assessed overall CKD information needs, as well as probed for 9 specific domains of CKD care (e.g., diagnosis, cause, disease progression, management, prevention, self-care practices, relationship between CKD and comorbid conditions, complications, and treatment options). Another open-ended question regarding the optimal time for dialysis and transplant education was asked to assess patients’ preference for timing of this important discussion. One female nephrologist trained in qualitative research (S.L.) conducted all interviews. Given that patients provided verbal consent via telephone instead of written consent, the IRB did not permit audio-recording of the telephone interviews. Thus, hand-written notes were taken that represented patients’ responses verbatim and/or through close paraphrase and then converted into transcriptions of the interview dialogue, as is standard practice in qualitative research methods [27]. Mean interview time was 39 min (range: 19–74 min).

Phase 1 data analysis

Qualitative data (e.g., transcriptions of interviewee responses to open-ended questions) were analyzed using a thematic approach. After completing each interview, two investigators (S.L. and E.G.) routinely debriefed to identify emerging themes pertaining to patients’ CKD information needs and to register patients’ specific CKD questions into a temporary item bank. The process of developing the 67-item QPS is depicted in Fig. 1.

The debriefing process led to identification of 98 patient questions that were organized into CKD domains of care. Domains and questions were refined using an inductive, thematic approach to analyze participant responses. Thematic analysis entailed searching interview transcripts for repetition and patterns of key concepts and terms [28]. Next, all interview transcripts were re-examined as individual files (within-case) and as a list of all participant responses to each open-ended question (across-cases) to ascertain any questions or themes that might have previously been missed [29]. An additional 12 questions were identified during this process. We adapted language from published QPSs to prepare two different introductory paragraphs, explaining the QPS purpose and instructions on its use [22, 30].

The 6-person multidisciplinary research team comprised of four nephrologists, one internist and health communication expert, and one social scientist reviewed the QPS draft to improve organization, clarify question wording, and remove items that were repetitive or too-narrowly focused for the general CKD population. After refinement, the QPS included 67 questions. Several repetitive items were deliberately retained to assess patient preference in wording in Phase 2. Means and proportions for closed-ended questions were calculated with SPSS version 22 (Chicago, IL USA) in both phases.

Phase 2 data collection

In Phase 2, semi-structured telephone interviews were conducted to refine and reduce items from the phase 1 QPS. The QPS was mailed to a new pool of eligible patients. During the interview, participants were asked to rate the importance of asking each QPS question on a 5-point Likert Scale, anchored by ‘not at all’ and ‘entirely’, and to obtain open-ended feedback on all items. Open-ended feedback was obtained to assess the clarity of question wording, suggestions for improving wording, preference between repetitive questions, input on the overall list organization, and suggestions for additional questions to add or questions to cut. Participants also provided their preference between the two introductory statements and for one comprehensive QPS or different, albeit overlapping QPSs tailored to CKD severity (e.g., general CKD, dialysis and kidney transplant). Fifteen closed-ended questions assessed patients’ willingness to use a CKD-QPS and self-reported demographic characteristics. Two female interviewers (S.L., H.K.) trained in qualitative data collection and without previous encounters with participants conducted the interviews. Patients’ question ratings and open-ended responses were documented with verbatim handwritten notes. Mean interview time was 52 min (range: 19–122 min).

Phase 2 data analysis

Phase 2 QPS development is depicted in Fig. 2. Qualitative and quantitative data were analyzed together. Means for each item’s Likert score were generated. Open-ended responses were analyzed in an iterative manner using the same thematic approach as described above, until reaching saturation. Debriefing sessions and data collection occurred concomitantly, and newly generated questions were asked in subsequent interviews. For example, many patients reported finding several preliminary items repetitive; therefore, subsequent participants were asked which of those questions they most preferred.

Three key members of the multidisciplinary team, 2 nephrologists and 1 social scientist, met once to perform interim analyses for quality assurance, and assess for adequate participant representation and data saturation [31]. No questions were eliminated at that time. The three investigators agreed that data saturation occurred after approximately 40–45 interviews, but additional interviews were conducted to confirm patients’ preferences.

Regardless of CKD severity, participants generally rated all questions highly (e.g., ‘very’ or ‘entirely’ important), which limits the usefulness of mean ratings, underscores the importance of qualitative feedback, and limits the ability to perform meaningful CKD severity subgroup analyses. Generally, items were cut when they scored less than a mean of 3.75 because those items all generated primarily negative patient responses. This resulted in the elimination of fifteen items. Among items scoring above 3.75, eighteen items were removed from the list because the item received negative patient responses or was repetitive with a more preferred question.

Examples of repetitive questions included: ‘What food should I eat?” versus “What food should I avoid?” Patients preferred items on what to avoid rather than the alternate. Examples of negative comments resulting in item elimination included: the answer to the question was obvious (e.g., “Why do you take blood and urine tests so often?”), the item was too specific (e.g., “What is the difference between an AVF, an AVG, and catheter?”), the question undermined providers’ management (e.g., “Do any of my medications or doses need to be changed?”), and that providers cannot offer a meaningful response (e.g., “Did I do something to cause kidney disease?”). If two repetitive questions were equally liked by patients (e.g., “What happens if I do not do dialysis or transplant” versus “Will I die if I do not do dialysis or kidney transplant?”), we retained the question that would elicit a more thorough provider explanation. Analyses of patients’ preferences resulted in elimination of 33 questions to yield a 34-item CKD-QPS.

Refinement step 1: 6-person multidisciplinary team review

Next, the list was reviewed by the 6-person multidisciplinary research team to assess question wording, repetitiveness, and anticipated provider responses. This step served to optimize readability and ensure that each question would elicit a meaningful provider response. Two questions were eliminated by the team, yielding a 32-item QPS.

Refinement step 2: readability assessment

The readability of the QPS overall and specific items was assessed using two online tools (Gunning Fog Index, and Flesch-Kincaid Grade Level Score) estimating the amount of formal education required to comprehend the printed material [32].

Refinement step 3: feedback from the National Kidney Disease Education Program (NKDEP) Coordinating Panel

To further validate the instrument, the QPS was then reviewed by the NKDEP Coordinating Panel, which consists of individuals who are actively engaged in improving CKD detection and treatment. Based on their expert opinion, we further revised item wording and eliminated repetitive questions. One question that was previously removed from the list due to low rating (“How can I have kidney disease when I feel fine and make a lot of urine?”) was rephrased and re-inserted (“How can I have kidney disease when I feel fine?”). Two dialysis-related questions (“How long will it be before I need dialysis and transplant?” and “When do I have to start dialysis?”) were combined into one item (“Will I need dialysis and transplant? When?”). Another question that scored highly (“How can I get a kidney transplant outside of the VA?”) was deleted to improve generalizability of the QPS. The final QPS included 31-items.

Participant characteristics

Four hundred forty-six patients were invited to participate and 213 participants were reached by phone. Of those, 18 were ineligible and among the 195 individuals, 68 were not interested, 62 did not schedule an interview, and 85 participated (Phase 1 = 32, Phase 2 = 53) (participation rate 44 %). Patients who declined participation reported that they were: not interested, did not have time, or did not want to do a telephone interview.

Patients’ unmet information needs

After completing Phase 2 interviews, the two highest rated questions (that have since been minimally revised), referred to managing chronic conditions: “How do my CKD and other health problems (i.e., diabetes, hypertension, heart disease) affect each other?” and “What health problems can kidney disease cause?”).

Patients desired a CKD-QPS

Only ten patients were not ‘very’ or ‘completely’ willing to use the QPS. Some of these patients offered a rationale for their reluctance, including their: desire to first evaluate the final QPS, ability to remember their own questions, or ability to “handle it all” without a QPS. Despite patients’ enthusiasm for using a QPS, only 35 % of patients reported making their own list of questions in preparation for healthcare visits.

Desire for different CKD-QPSs

The final QPS

Based on the readability assessments, the final overall QPS scored at a 4^th to 5^th grade reading level. Few individual items scored higher because they included multisyllabic, albeit essential, CKD-related terminology (e.g., peritoneal dialysis, hemodialysis).