Johnston, Bradley C.*; Donen, Rachel‡; Pooni, Amrita§; Pond, Julia||; Xie, Feng†; Giglia, Lucy||; Kam, April||; Bhamber, Amanpaul§; Bami, Karan§; Patel, Yashesh§; Guyatt, Gordon H.†
Pediatric acute diarrhea presents clinically as a change in normal bowel habits, including a substantial increase in stool frequency and/or a decrease in stool consistency. Severity can be related to the child's age, nutritional status, and the underlying cause of diarrhea. Acute diarrhea is most frequently a result of a gastrointestinal infection, which is often accompanied by vomiting, fever, and dehydration. When diarrhea is accompanied by these symptoms, it is often referred to as acute gastroenteritis.
A number of outcomes are important in evaluating the effect of interventions for acute gastroenteritis. In some situations, the most compelling evidence of an intervention's effect may be a reduction in mortality (oral rehydration after severe dehyration), morbidity (possibly probiotics for reducing duration of symptoms), or frequency of disease occurrence (vaccine agents for preventing gastroenteritis). Alternatively, clinicians frequently rely on direct physiological or biochemical measures of disease severity and the way therapies influence these measures, for example, stool output and indicators of dehydration severity related to gastroenteritis, such as electrolyte levels.
Patient-reported outcomes (PROs) are patients’ own assessment of their health. They include the ability to function normally and to be free of pain and physical, emotional, and social limitations or dysfunction. Sometimes, results from PRO measures and other outcome measures may suggest discrepant conclusions: physiologic measurements may change without people feeling better or an intervention may ameliorate symptoms without a measurable change in physiologic function (1–5).
Most trials in pediatric diarrhea have evaluated short-term clinical disease activity (eg, duration of diarrhea, incidence of diarrhea), laboratory outcomes (eg, pathogen elimination: rotavirus, Clostridium difficile), or a composite of these endpoints (6). Few if any trials have used a health-related quality of life (HRQL) instrument as either their primary or secondary outcome. Given that acute gastroenteritis can lead to significant functional disability, especially when accompanied by vomiting, fever, and dehydration, future trials should consider evaluating outcomes that may be of greater importance to parents and children (functional status, HRQL) (6).
PRO measures such as HRQL cannot be directly measured in infants and toddlers; however, parents are in a position to provide information on the effect on young children, and rotavirus gastroenteritis in children up to 36 months of age may affect parents’ HRQL (7).
The aim of the study was to develop a conceptual framework specific to pediatric acute gastroenteritis (PAG)-HRQL. To do so, we conducted interviews and focus groups with parents of children (3 months–5 years) presenting to a local emergency department (ED) with an initial diagnosis of gastroenteritis. We used results to develop a conceptual framework for measurement of HRQL in PAG.
Definition of PAG
For the purposes of the present study, we defined PAG according to the definition used by the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Infectious Disease as a decrease in the consistency of stools (loose or liquid) and/or an increase in the frequency of evacuations (typically ≥3 in 24 hours), with or without fever or vomiting (8).
1. Parents of children (3 months–5 years) who present to the ED with a diagnosis of PAG (diarrhea with or without vomiting)
2. Consent to participate in individual interviews or in focus group discussion (see Appendix 1, http://links.lww.com/MPG/A177)
1. Children admitted to the hospital as result of severe PAG (major dehydration requiring extended clinical observation)
2. Children with diarrhea for >13 days (suggestive of chronic or persistent diarrhea)
3. Children with serious chronic disease (eg, global developmental delay, immune, cardiac, gastrointestinal).
Between March 2010 and April 2011, research assistants, emergency pediatricians, and nurses recruited participants from the ED at McMaster University in Hamilton, Ontario, Canada. When candidates were identified, the students and staff assisting the study introduced themselves, provided an overview of the study, explained what would be required of potential participants (eg, 30-minute–1-hour interview), and obtained informed consent. For those who consented, their contact information was forwarded to 2 investigators (B.C.J., R.D.) and participants were contacted via telephone within 48 hours after leaving the ED. We recruited parents for interviews or focus groups while their child still had PAG symptoms or within 2 weeks of PAG resolution. Using a prespecified screening form (Appendix 2, http://links.lww.com/MPG/A178), each consenting participant was screened to ensure that their children met eligibility criteria; if eligible we arranged an interview or focus group.
Interviews and Focus Groups
We conducted interviews (in-person and telephone) and focus groups (in-person) with consenting parents. Discussion was semistructured and conducted with the aim of creating a relaxed and comfortable environment for participants. An experienced qualitative researcher (R.D.) conducted the individual interviews and moderated the focus groups with assistance of a second researcher (B.C.J.) who recorded field notes and also asked questions.
Discussions began by asking parents to provide a description of the general demeanor of their son or daughter. Subsequently, we asked parents to list all their child's symptoms, to describe each symptom, and to recall the order of symptom appearance. We then elicited how each symptom was bothersome to the parent and why, followed by how their child's gastroenteritis negatively affected the parent's quality of life (eg, enquiring about how the child's gastroenteritis affected their physical health or function with respect to disruption of daily routine and activities). To explore how gastroenteritis influenced the life of their child, we queried parents about the perceived quality of life impairment in their child, based on changes in the child's behavior.
Interviews and focus group discussions were recorded in their entirety and transcribed verbatim. Fictitious names were used to help ensure participant confidentiality and privacy. One investigator (R.D.) analyzed the first 4 interviews using content analysis methods to identify themes and subthemes that described how HRQL, for both parent and child, was negatively affected by PAG. This involved the examination of text from the transcripts to organize the key ideas into themes and subthemes and coding the data to a provisional schema using the National Institute of Health's Patient-reported Outcomes Measurement Information System domain framework (9,10). To further refine the structure of the framework, a steering committee (B.C.J., F.X., G.H.G., J.P., L.G., R.D.) consisting of experts in quality of life, qualitative data analysis, and child health reviewed the initial framework and provided comments or suggestions.
After the steering committee reached a consensus regarding the preliminary framework, we used the QRS NVivo 8 software program (QRS International [Americas] Inc, Burlington, MA) on an ongoing basis to improve the reliability of the data analysis, to detect any opposing perspectives, and to perform an analysis across cases. Using the software, 2 investigators (B.C.J., R.D.) independently coded the first 5 interviews. Based on differences in coding, or gaps in information, the 2 investigators met to resolve any discrepancies, seeking to reach consensus on a coding framework that would inform subsequent interviews. Any unresolved discrepancies were adjudicated by a third, more experienced, HRQL researcher (G.H.G.).
Once a consensus was reached on a coding framework, one investigator (R.D.) coded the remaining interviews. To allow the framework to be continually developed and revised, and to inform subsequent interview guides, after 9 interviews/focus groups had been completed, investigators (B.C.J., G.H.G., R.D.) met to discuss the expanding list of codes seeking to collapse or consolidate related components. The steering committee then reviewed the HRQL framework and provided further comments and suggestions. Subsequently, interviews continued until the major themes and subthemes became saturated (ie, the same themes and subthemes continued to reemerge). Once saturation was reached, the study was closed and all data were transcribed, coded, and analyzed.
A priori, we sought to explore the effect on HRQL among mothers versus fathers, households with an annual income of <$50,000 versus ≥$50,000 Canadian, parents having had previous children with a diagnostic impression of acute gastroenteritis, single- versus 2-parent homes, and children (as perceived by the parents) requiring oral versus intravenous (IV) rehydration.
A total of 25 parents, 20 to 47 years of age (mean 32.4, standard deviation 6.95) of whom 20 (80%) were men and 5 (20%) were women, participated in interviews (n = 16) or focus groups (n = 4). As a result of the difficulties with recruitment, each of the focus groups was small with only 2 to 3 participants per group. Participants were mostly of white descent, 22 (88%); 2 (8%) were single parents. Parents represented 21 children, ranging in age from 5 to 69 months (mean 27.1, standard deviation 17.79). Twelve (57%) children were girls and 9 (43%) were boys. Treatment in the emergency room consisted of oral rehydration for 17 (81%) and IV rehydration for 4 (19%) children, with antiemetic (eg, ondansetron) provided to 9 (43%) children (Tables 1 and 2).
Based on the list of codes, an overall conceptual framework for a HRQL instrument was developed. For children, the final PAG-specific HRQL conceptual framework includes 2 domains containing 14 items. The 2 domains are physical health and emotional health. Physical health is divided into 2 subdomains: symptoms (diarrhea, vomiting, retching, lethargy, pain, nausea) and function (eating, sleep, normal routine). Emotional health consists of 1 subdomain: function (clingy, irritable, embarrassed, frightened, sad) (Fig. 1). For parents, the final PAG-specific HRQL conceptual framework includes 3 domains and 13 items. The 3 domains are physical health, emotional health, and social health. Physical health consists of 2 subdomains: function (sleep, daily activities in the home, daily activities outside the home) and symptoms (fatigue). Emotional health consists of 1 subdomain: function (worried, upset, frustrated, stressed, guilt, embarrassed, helpless). Social health also consists of 1 subdomain: function (interaction with immediate family, interaction with friends and extended family) (Fig. 2).
Physical Symptoms: Child
Among the symptoms that children displayed, parents reported that 6 occurred frequently (diarrhea, vomiting, retching, lethargy, pain, nausea). In addition to these symptoms, parents also described signs and symptoms of fever and dehydration; however, from parent reports, it was often unclear whether each of these were present, and when they were it was unclear how severe each of these were and the degree to which each affected HRQL. The following is a description of each of the domains and subdomains particular to both the child and parent framework. Tables 3 and 4 presents a list of quotations particular to each of the items.
All 21 children had diarrhea and parents reported that diarrhea was associated with lethargy, pain, and embarrassment for their children. For most, diarrhea was quite severe: “…diarrhea like non-stop.” One parent described their child's diarrhea as explosive: “…diarrhea all up her back and neck. So it was really bad.”
Vomiting and Retching
Nineteen of 21 children had vomiting, often accompanied by retching. Vomiting and retching were significantly associated with a feeling of discomfort, crying, disturbed sleep, dehydration, and lethargy: “I heard her cough in bed, but it sounded funny so I walked in and it just reeked. And she had vomited everywhere, on herself and kind of fallen right back asleep in it.” Vomiting was often followed by retching “…sort of vomit once and then retch two or three times a few minutes later.”
Lethargy was a part of the clinical picture for all children. Parents indicated that their children displayed a lack of energy, often appearing weak and tired. Children were not animated and were generally uninterested in playing. One parent described her child as “lifeless and not responding.”
Children experienced pain associated with diaper rash, sore buttocks, headache, sore eyes, and stomach cramps. One mother indicated “every time she had diarrhea… you could feel her stomach kind of contracting and she was crying, like it was really painful for her.”
Many parents described their children as having signs and symptoms of nausea: “You could tell by her face. She’d just get up and make this face and sometimes she’d say, ‘Uh oh’ or run to the bathroom.”
Physical Function: Child
Children generally had a lack of appetite. One mother indicated that “he didn’t go near his food,” whereas another parent reported that her child would not eat the child's favorite food “no, not even crackers; he would have a bite of cracker and he would say that it was disgusting.”
Sleep was interrupted or altered as a result of diarrhea, vomiting, retching, and stomach cramps. Children cried for parents at night and frequently slept more during the days: “He was just wanting to lay around and sleep. He was napping during the day which he hasn’t done since he was two….” In some instances children slept for most of the day.
The child's daily activities including their normal routine (eg, day care, school, outdoor activity, play group, extracurricular activity) were often disrupted. One child “missed 6 days of pre-school,” whereas another parent indicated that “…the only time we went outside the house was to get to the vehicle to go to the hospital.”
Emotional Function: Child
Parents regularly talked about how their child was more clingy than normal, in many cases constantly seeking comfort, always wanting to be carried, held, and cuddled, often only wanting their mother. For example “once she was sick she just wanted you to sit and cuddle” and “she would cry and get up and follow me to the kitchen if I didn’t carry her.”
As compared with when children were healthy, parents spoke of how their children were more agitated, angry, bothered, cranky, fussy, crying, and whiny. They were often upset when they could not be with their mother and many would be abnormally fussy or angry when the parent would try to give fluids or food: “You put him down and he's crying… screaming crying, he wants to be right back up with you.”
A number of parents perceived that their children were embarrassed, as one child “kept apologizing when she had diarrhea” and another child “didn’t quite make it to the bathroom… he was quite devastated…. I think he was embarrassed.”
Many parents perceived that their child was scared, afraid, screaming, nervous, or startled: “I think when he threw up the first time, because it was very sudden, I think it startled him. He was crying really bad and I think it startled him because it came out so fast….” For the 4 children who needed IV rehydration, parents described how their child was frightened: “…hiding with her arm and whining a bit. I talked to her and she seemed to be scared, probably, definitely.”
Parents commonly indicated that they perceived that their child was sad as a result of not being able to attend daycare or preschool, or because they missed their friends and were lonely: “She was sad. She’d keep asking to go over [to daycare] and she’d say ‘I want to see her, I want to see her.’ I said ‘you’re sick honey, you can’t see her.’ After awhile she kind of understood, but she missed her friends.” Two parents reported that their child was sad because they were not feeling well.
Physical Function: Parent
Parent sleep was commonly interrupted or altered as a result of hearing their child crying, screaming, or vomiting: “…violently throwing up through the night and then she started diarrhea as well. So we were up with her all night….” After gastroenteritis symptoms began, parents regularly had a hard time sleeping or falling back to sleep because of worry for their child or as a result of their partner waking up.
Daily Activities—In the Home
Routine activities such as preparing meals, house cleaning, and personal hygiene were disrupted as a result of constant child care. Parents were often faced with more diaper changes and laundry: “…seven loads of laundry in two days which is the most I have ever done in my life….” Parents also indicated that any personal time they were used to having was limited or absent.
Daily Activities—Outside the Home
Activities outside the home including errands, shopping, outdoor activities, personal activities, taking other kids to daycare or school as well were disrupted as was work attendance: “My husband and I ended up missing work.”
Physical Symptoms: Parent
Parents were often tired from physical and emotional demands of child care including the child always wanting to be held or with mother, constantly cleaning exudates or changing the child's diaper or clothes, and the lack of sleep: “…you’re both completely exhausted and there's nobody else, you know, there's no third parent that has slept–got their eight, nine hours.” Many parents spoke of having to take care of >1 family member who had gastroenteritis and, in a number of instances, feeling fatigued as a result of getting sick themselves.
Emotional Function: Parent
Parents described a sense of anxiety, nervousness, panic, and fear. These feelings were associated with not knowing what was wrong with their child, concern that their child would get dehydrated, and constantly waking up at night because of worry for their child: “It puts more worry onto yourself. You’re constantly thinking about it….you always have the worst thing in your mind….”
Parents generally felt upset and described this feeling in different ways including anger (because of lack of control of the situation), as well as feeling bothered and sad: “…it's just your heart, you just feel this hurt, you just feel so sad, like oh my god I wish I could make you feel better.” A few parents cried and one described a feeling of depression as a result of their child's sickness.
Parents often shared that, as a result of the sudden onset, perceived severity, and duration of their child's gastroenteritis, they felt frustrated that they could not help their child, irritated by the a lack of sleep and the vomitus or stools on both their child and themselves needing to be cleaned: “I got puked on, I got the diarrhea by changing the diapers on me. It was not pleasant. Very frustrated…it just wouldn’t stop....” Parents also felt frustrated when their child would not eat or drink.
A considerable number of parents, both staying at home and employed outside the home, felt a sense of stress as a result of feeling fatigued and still having responsibilities, planning care for child(ren), and modifying the activities of the child(ren): “…and I mean it's stressful to have a sick kid. Stressful to have a sick kid with a brother who's active and you’re not.” In a number of instances, parents had 2 children sick at once, adding to their distress.
Some parents felt guilty when they had to leave their child or when they could not make their child feel better: “I went to work the one day. Oh ya, I felt guilty leaving him… you think mommy should be there when you are sick.” A few parents described a feeling of guilt because of believing that they may have been responsible for their child getting sick (eg, because did not wipe hands properly in restaurant).
Some parents felt a sense of embarrassment as a result of not bringing their child to the hospital sooner or because they felt incompetent with their child care abilities: “At one point I was crying because I was embarrassed. I felt inadequate. They said I couldn’t keep her hydrated enough at home and I had to bring her back to the hospital.”
Parents often felt helpless, confused, desperate, incompetent, a lack of control, lost, and overwhelmed. Parents described a feeling of trying everything to help their child but feeling like nothing worked. One parent suggested “…to see your kid sick and not be able to do anything for her, it's draining, such a feeling of helplessness. I couldn’t fix her, I couldn’t help her.”
Social Function: Parent
Interaction With Immediate Family
Parents reported that they spent less time with their spouses and their other children, and that normal family activities were interrupted or cancelled. When families had other children, these children sometimes missed their activities inside and outside of the home. In some instances, parents believed that the burden of care was a result of their child's acute gastroenteritis led to more conflict within the family: “My husband and I were definitely shorter with each other, since I was tired….”
Interaction With Friends and Extended Family
Interaction with friends and extended family was impeded including get-togethers with friends and extended family being cancelled. A couple of parents felt a lack of support from their extended family with one mother sharing that there was “no family support… we had to do everything on our own.”
Based on the conceptual framework for both child and parent (Figs. 1 and 2), we have developed 2 questionnaires. Each question was assigned a response option ranging from 1 (none/not at all) to 7 (extremely severe) (see Appendix 1 and 2, http://links.lww.com/MPG/A177, http://links.lww.com/MPG/A178).
Differences emerged from the data regarding quality of life effect between mothers and fathers. In comparing physical function components, most mothers reported that their ability to sleep, or complete daily activities inside and outside the home, was extremely limited and as a result mothers were often fatigued. This was a result of the increased amount of child care, as well as the sick child always wanting their mother's attention. One mother reported that whenever she had to use the washroom, she had to bring her daughter with her. Another mother described her shower experience: “Even when I had a shower, she was in the bathroom and she was sticking her head in the shower to watch.” Similarly, fathers reported that their ability to sleep and complete daily activities was limited; however, unlike the mother whose physical function was affected by both the physical and emotional needs of the child, the effect on the fathers’ life was almost exclusively related to his child's physical needs (eg, diaper or linen changes) or as a result of attending to tasks that his partner or wife normally took care of (eg, groceries, housecleaning).
Both mothers and fathers experienced a range of negative emotions (eg, worry, upset, frustration, stress, guilt, helplessness), as described in Figure 2; however, only mothers declared a feeling of embarrassment (n = 4). The mothers’ experience of embarrassment seemed to be related to the notion that they, as mothers, were the primary caregivers and were somehow expected to know how to treat all symptoms of gastroenteritis, no matter the severity. Each mother shared a sense of failure as a mother and as a result a feeling of embarrassment. Regarding the depth of emotions described, fathers conveyed the emotional effect of their child's acute gastroenteritis with less expression and detail, then all mothers. A number of mothers, for example, cried during their interview as they recalled their experience and used language such as “…being at the hospital waiting and praying. Thinking, I’m going to die, I’ll get a heart attack….” A second example involves parents’ experience of guilt. The only guilt trigger reported by fathers was their belief that they may be responsible for the child getting sick because they did not wipe down a high chair well enough at a restaurant or because, before changing their child's diaper, they did not properly clean a change table in a public washroom. For mothers, examples of guilt triggers ranged from not getting housework done, to feeling guilty when other family members got sick, to pinning the child down to give fluids, and to having to go to work and be away from the sick child.
Five households in our study had incomes of $50,000 or less. Irrespective of income, parents did not appear to perceive the experience as financially bothersome, but did notice some extra costs (eg, pedialyte, diapers) at the time. Regarding HRQL of parents having had previous children with acute gastroenteritis, 3 mothers and 1 father reported having previous experience. The 3 mothers all had a similar negative emotional effect to other mothers. The lone father having previously experienced caring for a child with acute gastroenteritis had relaxed coping style that seemed to help reduce his emotional effect from the experience: “I’m pretty laid back as it is, so…everything that happened to our older son was a big deal, and now you know how to react to things a lot easier, just because we’ve gone through it before.” We found no differences in HRQL in children based on the method of rehydration (those requiring oral vs IV rehydration).
Based on interviews and focus groups involving 25 parents of children with acute gastroenteritis, we have developed a conceptual framework for quality of life instruments specific to PAG in children 3 months to 5 years. The child-specific HRQL framework is based on the child's signs and symptoms as well as changes in behavior, as observed and reported by parents. For children, the conceptual framework includes 2 domains (physical and emotional health), 3 subdomains, and 14 items (Fig. 1). For parents, the HRQL framework includes 3 domains (physical, emotional, and social health), 4 subdomains, and 13 items. Based on the each conceptual model, we have developed a HRQL questionnaire for both the parent and child (as completed by parent proxy; Appendix 1 and 2, http://links.lww.com/MPG/A177, http://links.lww.com/MPG/A178.
The development of quality of life instruments for acute conditions is a relatively new area of research. At least 2 previous studies involving the development of proxy-reported quality of life measures for acute recurrent illnesses in children have been reported. Although these studies appear to have compelling measurement properties (eg, validity, responsiveness), these studies appear to have placed little emphasis on developing a comprehensive conceptual framework through the use of focus groups and caregiver interviews as a basis for instrument development (11,12).
Only 1 earlier study of 17 parents of children 2 to 36 months of age with rotavirus gastroenteritis presenting to an ED and outpatient clinic in North Carolina (7) has used qualitative methods to assess the effect of PAG on families. Parents in the present study participated in interviews or focus groups and completed a questionnaire. The authors found that child gastroenteritis had a considerable effect on the physical and emotional function of parents. Parents reported missed or limited opportunity for work, sleep, meal preparation, and household chores. Parents were worried by the severity of their child's illness as well as their child's behavior (irritable, clingy, lethargic). In addition, parents felt stressed, fatigued, and frustrated as a result of not being able to do more to relieve their child's suffering. Our focus groups and interviews with parents yielded each of these themes as evidenced in our framework and preliminary questionnaire specific to parents. Similarly, a recent Canadian study evaluated the effect of rotavirus-associated gastroenteritis in children (younger than 36 months of age) on HRQL and the cost-effectiveness of rotavirus vaccines. By estimating the quality-adjusted life-years lost to rotavirus gastroenteritis and HRQL using 2 common generic measures (Health Utilities Index and the EQ-5D), results indicated that acute gastroenteritis had predominantly affected the domains of emotion, pain, and discomfort in children and the domains of usual activities, pain/discomfort, and anxiety in parents (13).
Our study has a number of limitations. First, because the parent's subjective well-being as well as their perception of the child's well-being is influenced by many factors unrelated to the disease process or treatment (eg, medical care systems, access to medical care, education, income), our findings may not fully reflect quality of life issues in other regions or settings such as lower-income countries in which the burden of PAG is greatest. Differences in cultural backgrounds as well as differences in the medical care system, or lack of access to medical care, may impart different quality of life issues. Second, although we recruited a diverse sample of 25 parents with respect to age and education, our sample included only 5 fathers, 5 households with an annual income of <$50,000, 4 households having had previous children with a diagnosis of acute gastroenteritis, and 4 children requiring IV rehydration. Just 1 subgroup, HRQL in mothers versus fathers, revealed a substantial difference; however, as a result of the limited sample for each of these subgroups, our framework may be limited in its ability to explore any true differences that may exist between each of these subgroups. Although we anticipated potential differences in caregiver coping in single- versus 2-parent homes, our sample only included 2 participants from single-parent homes. Third, given that some parents were interviewed postsymptom resolution, these parents may have underestimated the effect of PAG on HRQL issues relative to what they experienced during the PAG event. Fourth, given that children 3 months to 5 years of age do not have the capacity to provide their own HRQL data, our use of parents as a proxy for child-specific HRQL may provide limited insight into HRQL issues of the children. The child-specific framework is based on parent perception. Given that some authors have suggested that 6 to 12 interviews will provide a fairly solid understanding of a given phenomena when directly exploring perceptions of a given group (14–16), it may be that more interviews are required if a phenomena needs to be indirectly understood such as HRQL of a child, as reported by parents. We have conducted 25 interviews and based on our data, no new themes or subthemes emerged in the last 5 interviews around child-specific HRQL issues. This suggests that relative to our sample, we achieved a point of saturation and our findings are representative of HRQL issues in children.
We identified areas in which PAG has a major effect on HRQL in both parents and children, most prominently in physical symptoms, restrictions in physical function, and disturbed emotional function. This framework has provided the appropriate basis for the development of PAG-specific HRQL questionnaires included in online-only Appendixes 1 and 2, http://links.lww.com/MPG/A177, http://links.lww.com/MPG/A178.
The authors thank Stacy McKerracher for kind support in helping provide access to McMaster University's emergency department; Dr Rajesh Gupta for feedback on the draft manuscript; and Dr Anne Klassen for valuable advice throughout development of this framework, including assistance with NVivo software.