From qualitative data to a measurement instrument: A clarification and elaboration of choices made in the development of the Patient Scale of the Patient and Observer Scar Assessment Scale (POSAS) 3.0.

PURPOSE: To clarify and elaborate on the choices that were made in the development of the Patient Scale of the Patient and Observer Scar Assessment Scale 3.0 (POSAS 3.0), based upon the rich information obtained from patients during focus groups and pilot tests. METHODS: The discussions described in this paper are a reflection of the focus group study and pilot tests that were conducted in order to develop the Patient Scale of the POSAS3.0. The focus groups took place in the Netherlands and Australia and included 45 participants. Pilot tests were performed with 15 participants in Australia, the Netherlands, and the United Kingdom. RESULTS: We discussed the selection, wording and merging of 17 included items. Additionally, the reason for exclusion of 23 characteristics are given. CONCLUSION: Based upon the unique and rich material of patient input obtained, two versions of the Patient Scale of the POSAS3.0 were developed: the Generic version, and the Linear scar version. The discussions and decisions taken during the development are informative for a good understanding of the POSAS 3.0 and are indispensable as a background for future translations and cross-cultural adaptations.

Development of the Patient Scale of the Patient and Observer Scar Assessment Scale (POSAS) 3.0: a qualitative study.

PURPOSE: The Patient and Observer Scar Assessment Scale (POSAS) is widely used for measurements of scar quality. This encompasses visual, tactile and sensory characteristics of the scar. The Patient Scale of previous POSAS versions was lacking input from patients. Therefore, the aim of this study was to develop the POSAS3.0, Patient Scale with involvement of adults patients with all scar types, complying with the highest clinimetric standards. METHODS: From February 2018 to April 2019, a series of six focus group interviews were performed in the Netherlands and Australia to identify scar quality characteristics that adults with scars consider to be important. All focus groups were transcribed, anonymized and analysed using a thematic analysis. Relevant characteristics were formulated into items, resulting in a Dutch and English version of the Patient Scale. These drafts were pilot tested in Australia, the Netherlands and the United Kingdom, and refined accordingly. RESULTS: A total of 21 relevant scar quality characteristics were identified during the focus groups. Two distinct versions of the POSAS3.0, Patient Scale were developed. The Generic version contains 16 items and can be used for all scar types, except linear scars. The Linear Scar version of the Patient Scale contains the same 16 items, with an extra item referring to the widening of scar margins. All included items are rated on a verbal rating scale with five response options. CONCLUSION: Two versions of the POSAS3.0 Patient Scale were developed. Further field tests are being performed to establish the measurement properties and scoring algorithm of the scales.

Team dynamics and clinician's experience influence decision-making during Upper-GI multidisciplinary team meetings: A multiple case study.

Background: The probability of undergoing treatment with curative intent for esophagogastric cancer has been shown to vary considerately between hospitals of diagnosis. Little is known about the factors that attribute to this variation. Since clinical decision making (CDM) partially takes place during an MDTM, the aim of this qualitative study was to assess clinician's perspectives regarding facilitators and barriers associated with CDM during MDTM, and second, to identify factors associated with CDM during an MDTM that may potentially explain differences in hospital practice. Methods: A multiple case study design was conducted. The thematic content analysis of this qualitative study, focused on 16 MDTM observations, 30 semi-structured interviews with clinicians and seven focus groups with clinicians to complement the collected data. Interviews were transcribed ad verbatim and coded. Results: Factors regarding team dynamics that were raised as aspects attributing to CDM were clinician's personal characteristics such as ambition and the intention to be innovative. Clinician's convictions regarding a certain treatment and its outcomes and previous experiences with treatment outcomes, and team dynamics within the MDTM influenced CDM. In addition, a continuum was illustrated. At one end of the continuum, teams tended to be more conservative, following the guidelines more strictly, versus the opposite in which hospitals tended towards a more invasive approach maximizing the probability of curation. Conclusion: This study contributes to the awareness that variation in team dynamics influences CDM during an MDTM.

Clinical variation in the organization of clinical pathways in esophagogastric cancer, a mixed method multiple case study.

BACKGROUND: Among esophagogastric cancer patients, the probability of having undergone treatment with curative intent has been shown to vary, depending on the hospital of diagnosis. However, little is known about the factors that contribute to this variation. In this study, we sought to understand the organization of clinical pathways and their association with variation in practice. METHODS: A mixed-method study using quantitative and qualitative data was conducted. Quantitative data were obtained from the Netherlands Cancer Registry (e.g., outpatient clinic consultations and diagnostic procedures). For qualitative data, thematic content analysis was performed using semi-structured interviews (n = 30), observations of outpatient clinic consultations (n = 26), and multidisciplinary team meetings (MDTM, n = 16) in eight hospitals, to assess clinicians' perspectives regarding the clinical pathways. RESULTS: Quantitative analyses showed that patients more often underwent surgical consultation prior to the MDTM in hospitals associated with a high probability of receiving treatment with curative intent, but more often consulted with a geriatrician in hospitals associated with a low probability of such treatment. The organization of clinical pathways was analyzed quantitatively at three levels: regional, local, and patient levels. At a regional level, hospitals differed in terms of the number of patients discussed during the MDTM. At the local level, the revision of radiological images and restaging after neoadjuvant treatment varied. At the patient level, some hospitals routinely conduct fitness tests, whereas others estimated the patient's physical fitness during an outpatient clinic consultation. Few clinicians performed a standard geriatric consultation in older patients to assess their mental fitness and frailty. CONCLUSION: Surgical consultation prior to MDTM was more often conducted in hospitals associated with a high probability of receiving treatment with curative intent, whereas a geriatrician was consulted more often in hospitals associated with a low probability of receiving such treatment.

A longitudinal mixed methods study on changes in body weight, body composition, and lifestyle in breast cancer patients during chemotherapy and in a comparison group of women without cancer: study protocol.

BACKGROUND: More than 60% of women diagnosed with early stage breast cancer receive (neo)adjuvant chemotherapy. Breast cancer patients receiving chemotherapy often experience symptoms such as nausea, vomiting and loss of appetite that potentially affect body weight and body composition. Changes in body weight and body composition may detrimentally affect their quality of life, and could potentially increase the risk of disease recurrence, cardiovascular disease and diabetes. To date, from existing single method (quantitative or qualitative) studies is not clear whether changes in body weight and body composition in breast cancer patients are treatment related because previous studies have not included a control group of women without breast cancer. METHODS: We therefore developed the COBRA-study (Change Of Body composition in BReast cancer: All-in Assessment-study) to assess changes in body weight, body composition and related lifestyle factors such as changes in physical activity, dietary intake and other behaviours. Important and unique features of the COBRA-study is that it used I) a "Mixed Methods Design", in order to quantitatively assess changes in body weight, body composition and lifestyle factors and, to qualitatively assess how perceptions of women may have influenced these measured changes pre-, during and post-chemotherapy, and II) a control group of non-cancer women for comparison. Descriptive statistics on individual quantitative data were combined with results from a thematic analysis on the interviews- and focus group data to understand patients' experiences before, during and after chemotherapy. DISCUSSION: The findings of our mixed methods study, on chemotherapy treated cancer patients and a comparison group, can enable healthcare researchers and professionals to develop tailored intervention schemes to help breast cancer patients prevent or handle the physical and mental changes they experience as a result of their chemotherapy. This will ultimately improve their quality of life and could potentially reduce their risk for other co-morbidity health issues such as cardiovascular disease and diabetes.

Perceptions of Dutch health care professionals on weight gain during chemotherapy in women with breast cancer.

PURPOSE: Dutch Health care professionals (HCPs) provide little information concerning health risks associated with weight gain during chemotherapy for breast cancer. Women with breast cancer have specified the need for more information on nutrition and physical activity to deal with weight gain. The aims of this study were to assess the perceptions of Dutch HCPs on weight gain during chemotherapy and in addition evaluate whether and what kind of information on dietary intake and physical activity HCPs provide to prevent/treat weight gain during (neo)adjuvant chemotherapy. METHODS: A qualitative study was conducted using semi-structured interviews with 34 HCPs involved in breast cancer care: general practitioners, oncologists, specialized nurses, and dieticians. RESULTS: To date, little information about nutrition, physical activity, and weight gain is given during chemotherapy because it is not part of most HCPs' training, it is not included in the guidelines and it is not the best time to bring up information in the opinion of HCPs. Weight gain was perceived as just a matter of a few kilos and not an important health issue during treatment. All HCPs felt it is better that women themselves addressed their weight gain after chemotherapy. CONCLUSION: More knowledge about health risks associated with chemotherapy-induced weight gain and how to combat these issues needs to be made readily available to the HCPs and should become part of their training. Existing patient guidelines should include information on how to prevent and/or reduce weight gain through self-management of nutrition intake and physical activity during and post chemotherapy.

COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study.

BACKGROUND: Content validity is the most important measurement property of a patient-reported outcome measure (PROM) and the most challenging to assess. Our aims were to: (1) develop standards for evaluating the quality of PROM development; (2) update the original COSMIN standards for assessing the quality of content validity studies of PROMs; (3) develop criteria for what constitutes good content validity of PROMs, and (4) develop a rating system for summarizing the evidence on a PROM's content validity and grading the quality of the evidence in systematic reviews of PROMs. METHODS: An online 4-round Delphi study was performed among 159 experts from 21 countries. Panelists rated the degree to which they (dis)agreed to proposed standards, criteria, and rating issues on 5-point rating scales ('strongly disagree' to 'strongly agree'), and provided arguments for their ratings. RESULTS: Discussion focused on sample size requirements, recording and field notes, transcribing cognitive interviews, and data coding. After four rounds, the required 67% consensus was reached on all standards, criteria, and rating issues. After pilot-testing, the steering committee made some final changes. Ten criteria for good content validity were defined regarding item relevance, appropriateness of response options and recall period, comprehensiveness, and comprehensibility of the PROM. DISCUSSION: The consensus-based COSMIN methodology for content validity is more detailed, standardized, and transparent than earlier published guidelines, including the previous COSMIN standards. This methodology can contribute to the selection and use of high-quality PROMs in research and clinical practice.

Tools for a systematic appraisal of integrated community-based approaches to prevent childhood obesity.

BACKGROUND: Evaluation and monitoring methods are often unable to identify crucial elements of success or failure of integrated community-wide approaches aiming to tackle childhood overweight and obesity, yet difficult to determine in complex programmes. Therefore, we aimed to systematically appraise strengths and weaknesses of such programmes and to assess the usefulness of the appraisal tools used. METHODS: To identify strengths and weaknesses of the integrated community-based approaches two tools were used: the Good Practice Appraisal tool for obesity prevention programmes, projects, initiatives and intervention (GPAT), a self-administered questionnaire developed by the WHO; and the OPEN tool, a structured list of questions based on the EPODE theory, to assist face-to-face interviews with the principle programme coordinators. The strengths and weaknesses of these tools were assessed with regard to practicalities, quality of acquired data and the appraisal process, criteria and scoring. RESULTS: Several strengths and weaknesses were identified in all the assessed integrated community-based approaches, different for each of them. The GPAT provided information mostly on intervention elements whereas through the OPEN tool information on both the programme and intervention levels were acquired. CONCLUSION: Large variability between integrated community-wide approaches preventing childhood obesity in the European region was identified and therefore each of them has different needs. Both tools used in combination seem to facilitate comprehensive assessment of integrated community-wide approaches in a systematic manner, which is rarely conducted. Nonetheless, the tools should be improved in line to their limitations as recommended in this manuscript.

Perspectives of obese children and their parents on lifestyle behavior change: a qualitative study.

BACKGROUND: In order to improve and optimize future behavioral family lifestyle intervention programs, more information on the perceptions of obese children and their parents of these programs is needed. As such, the aim of this qualitative study is 1) to explore the expectations of obese children and their parents in relation to lifestyle interventions; 2) to identify barriers to making lifestyle changes that parents and children face within their social context (within the family, at school and amongst friends and peers) as well as the things that facilitate these changes and 3) to identify the needs of obese children and their parents in the context of a lifestyle intervention. METHODS: A qualitative study using semi-structured interviews was conducted. Interviewees were participants in a lifestyle intervention program in the Netherlands. RESULTS: Eighteen children (mean age 10 years) and 24 parents were interviewed. The respondents expected to lose weight by being physically active or by eating healthily. Parents struggled with adopting and adhering to new rules and the absence of support of family members. Children struggled with inconsistent parenting and a lack of support from their parents. Bullying experienced at school impeded the children in their ability to make the necessary changes. Support from peers, on the other hand, stimulated their progress. Parents identified the need for the general practitioner to discuss overweight in a non-offensive way and to show an interest in the process of weight loss. CONCLUSIONS: Participants in a lifestyle behavior intervention program benefit from parental support and help from their (extended) family, peers and friends. They would also profit from the sustained involvement of their general practitioner in assisting in the maintenance of lifestyle behavior changes.

A qualitative study of the anticipated barriers and facilitators to the implementation of a lifestyle intervention in the Dutch construction industry.

BACKGROUND: Lifestyle interventions have proven effective for lowering a cardiovascular risk profile by improving lifestyle behaviors, blood glucose and blood cholesterol levels. However, implementation of lifestyle interventions is often met with barriers. This qualitative study sought to determine anticipated barriers and facilitators to the nationwide implementation of an effective lifestyle intervention in the construction industry in the Netherlands. METHODS: Prior to implementation, focus groups were held with 8 lifestyle counselors and semi-structured interviews with 20 employees of the construction industry, 4 occupational physicians, 4 medical assistants, and 1 manager of an occupational health service. The transcripts were coded by two coders and analyzed by constant comparison. RESULTS: Hypothetical employee willingness to sign up for the intervention was facilitated by a high level of perceived risk, perceived added value of the intervention, and perceived social support. It was hampered by a preference for independence and perceived interference with their work. All professionals named a lack of time as an anticipated barrier to implementation. Lifestyle counselors suggested several strategies to improve the proficiency of their counseling technique, such as training in small groups and a continuous stream of employee referrals. Occupational physicians thought they would be hampered in screening employees and referring them to a lifestyle counselor by the perception that addressing employee lifestyles was not their task, and by a counter-productive relationship with other stakeholders. The manager addressed financial incentives and a good intervention fit with the current approach of the OHS. CONCLUSION: The findings suggest that employees can be motivated to sign up for a lifestyle intervention by tailoring the implementation strategy to various subgroups within the target group. Occupational physicians can be motivated to refer employees for the intervention by making a referral personally and professionally rewarding.

[A qualitative study of Falls Efficacy Scale-International/Hips. What do we measure?]. / Een kwalitatieve studie naar de Falls Efficacy Scale-International/Hips. Is meten weten?

OBJECTIVE: Pilot-testing a new instrument: the Falls Efficacy Scale-International/Hips (FES-I/Hips). This instrument is intended to measure 'Fear of Falling' (FoF). To the current instrument, the Falls Efficacy Scale-International, are four questions added for patients who are rehabilitating in a nursing home. It is pretested and used in the HIPS-study. METHODS: Qualitative exploratory study with interviews in a Three Step Test Interview (TSTI) protocol. Respondents (N = 12) were asked to think aloud while completing the questionnaire. RESULTS: The instruction how to complete the questionnaire is well understood by patients but was not properly used by them. The questionnaire contains questions with difficult words and questions which are no longer relevant. There are six "two-in-one questions" that cause confusion. CONCLUSION: Use of the standard instruction when completing the FES-I/Hips can lead to underreporting of FoF. Adaptation of certain items may improve content validity. Further psychometric studies are recommended to determine whether the proposed adjustments are appropriate.

A local consensus process making use of focus groups to enhance the implementation of a national integrated health care standard on obesity care.

BACKGROUND: Recent guidelines on obesity management promote integrated care. There is little knowledge about local opportunities and barriers, faced by health care professionals and patients, that affect implementation of an integrated national health care standard in a local setting. Our aim is to understand experiences and expectations of health care professionals and patients as part of the local implementation process. METHODS: Eight focus groups and two interviews have been conducted among 24 patients (60+) and 29 professionals from seven different care disciplines. RESULTS: Both patients and professionals have identified serious barriers to implement the national standard: older adults do not feel taken seriously and experience lacking support from professionals. Professionals give contradictory advice and recommendations do not match needs of older adults. Professionals actually feel reluctant to discuss weight-related topics due to several reasons: they do not consider obesity being a chronic disease, lack of qualifications to support self-management and perceived lack of awareness and motivation among patients. CONCLUSION: Focus groups have proven their value to ascertain the opportunities and barriers older adults and professionals foresee while improving obesity care in order to meet the standards as required in a national guideline. Our research provides an emerging picture of health care professionals and patients having contradictory views and expectations about 'the others' role and their notions on the capability to intervene on patient's weight problems. Without this emerging picture, we would have missed important information on barriers to overcome. The likelihood of successful implementation would then have been small.