Test-Retest Reliability and Clinical and Research Validity of the 'Quality of Life Impact and Concerns' (QoLI&C) Measure.

Hip dysplasia is a significant public health issue, representing the single largest cause for total hip arthroplasty in young adults. To gain insight into patient concerns and the impact of hip dysplasia on young adults, we developed a patient-centred outcome measure, the 'Quality of Life Impact and Concerns' (QoLI&C) measure. This short report provides additional evidence on test-retest reliability and suggests refinements to the measure to enhance its research and clinical utility.

An exploration of physical activity experiences throughout the Huntington's disease journey: supporting development of theoretically underpinned complex interventions.

PURPOSE: Huntington's disease is an autosomal dominant neurodegenerative disease. Progressive physical, behavioural and cognitive impairments cause loss of independent function. Physical activity interventions are important components of comprehensive intervention strategies and may help alter the functional decline trajectory. Qualitative research has an important role to play in developing theoretically sound, well-defined physical activity interventions in Huntington's disease. MATERIALS AND METHODS: Eight focus groups were conducted with people with prodromal to late stage Huntington's disease, caregivers (family members/formal), and healthcare professionals. An analytical coding framework was developed from the data and Levanthal's self-regulation model to assist analysis. RESULTS AND CONCLUSIONS: Key themes were identified: evolving representations of Huntington's disease and physical activity; varying social environment of the person with Huntington's disease and the impact on physical activity; achieving physical activity participation while coping with the nuances of Huntington's disease. Levanthal's model facilitated understanding of physical activity experiences, however with progression, self-regulation of activities needs to become more collaborative with caregivers. A modified self-regulation model specific to physical activity in Huntington's disease is presented. Using a novel approach to generate new understanding of physical activity across the Huntington's disease lifespan facilitated development of an original and significant theoretical foundation to underpin development of a range of much needed physical activity and exercise interventions in Huntington's disease.Implications for rehabilitationSocial and familial context of individuals with HD is a key consideration for health care professionals supporting physical activity participation.Strategies such as using physical activity as a way of achieving control and adjusting expectations can help people with HD to continue to be active.People with HD adapt physical activity from high level to more functional activities with symptom progression.

The outcomes of Perthes' disease.

AIMS: To identify a suite of the key physical, emotional, and social outcomes to be employed in clinical practice and research concerning Perthes' disease in children. METHODS: The study follows the guidelines of the COMET-Initiative (Core Outcome Measures in Effectiveness Trials). A systematic review of the literature was performed to identify a list of outcomes reported in previous studies, which was supplemented by a qualitative study exploring the experiences of families affected by Perthes' disease. Collectively, these outcomes formed the basis of a Delphi survey (two rounds), where 18 patients with Perthes' disease, 46 parents, and 36 orthopaedic surgeons rated each outcome for importance. The International Perthes Study Group (IPSG) (Dallas, Texas, USA (October 2018)) discussed outcomes that failed to reach any consensus (either 'in' or 'out') before a final consensus meeting with representatives of surgeons, patients, and parents. RESULTS: In total, 23 different outcome domains were identified from the systematic review, and a further ten from qualitative interviews. After round one of the Delphi survey, participants suggested five further outcome domains. A total of 38 outcomes were scored in round two of the Delphi. Among these, 16 outcomes were scored over the prespecified 70% threshold for importance (divided into six main categories: adverse events; life impact; resource use; pathophysiological manifestations; death; and technical considerations). Following the final consensus meeting, 14 outcomes were included in the final Core Outcome Set (COS). CONCLUSION: Core Outcome Sets (COSs) are important to improve standardization of outcomes in clinical research and to aid communication between patients, clinicians, and funding bodies. The results of this study should be a catalyst to develop high-quality clinical research in order to determine the optimal treatments for children with Perthes' disease. Cite this article: Bone Joint J 2020;102-B(5):611-617.

Exploring how to evaluate a qualitative patient-centered outcome measure: literature review and illustrative example - a Perthes child-friendly measure.

PURPOSE: To explore the question of 'how to evaluate a qualitative patient-centred outcome measure', comprising predominantly open-ended items, including perhaps emojis, story writing and/or pictures, in a way that does not compromise the strictures of the qualitative paradigm, doing so in a credible and authoritative manner. The paper aims to promote debate and discussion in the measurement validation community. METHODS: Comprehensive literature review of three electronic databases (PubMed; SCOPUS; Web of Science/Knowledge) and searches of three outcome-focused journals. RESULTS: The vast majority (>90%) of the papers only used qualitative methods in the initial, in particular, content validation of a measure and then used (quantitative) psychometric validation procedures.  The remaining papers comprised articles that were either methodologically or methods focused and the role of qualitative research.  A number of key issues are raised, inter alia: giving primacy to the patient's perspective; exploring the meaning and interpretation respondents place on the concept and possible items in a measure; prioritising maximising meaningful discrimination from the respondent's perspective; ensuring face and content validity and relevance of items in the item content pool; and using appropriate qualitative methods, for example, concept elicitation, "think-aloud" and cognitive interviews and expert respondent panels/judges. This approach is applied to validate a child-friendly outcome measure for children with Perthes disease, a paediatric hip condition presenting primarily amongst male children aged 5-8 years. CONCLUSIONS: The core messages are to: (i) not force validation of a qualitative outcome measure into psychometric validation; but (ii) retain full adherence to the principles of the qualitative paradigm and employ procedures drawn from that paradigm. In this manner, primary emphasis would lie on issues of meaningfulness, face and content validity, the meaning of item and measure scores to respondents and, for a child-friendly measure, the child-friendliness of the measure.

Development and validation of a patient-centered outcome measure for young adults with pediatric hip conditions: the "Quality of Life, Concerns and Impact Measure".

Purpose: To develop and validate a patient-centered, evaluative outcome measure to assess patient-significant and identified impacts of the three pediatric hip conditions (the "Quality of Life, Concerns and Impact Measure" (QoLC&I)), for use by patients and clinicians in discussions over treatment options and the evaluation of treatment and post-operative rehabilitation. Patients and methods: The measure was developed through a qualitative study, via two web-based forums (patient narratives, n=84) and one specialist orthopedic adult hip clinic (conducting interviews, n=38). The draft (1) measure was piloted in an asynchronous web-based discussion group forum; following revision, it was piloted with a group of clinicians and patients to assess its patient and clinical utility, face and content validity. The final, refined prototype measure (QoLC&I, draft 3) was subjected to psychometric evaluation. Results: A total of 230 patients provided useable data for the psychometric analysis: 70% (160) had a confirmed diagnosis of Developmental Dysplasia of the Hip, 15% (35) Perthes, 11% (26) Slipped Upper Femoral Epiphyses; 4% (9) PHC not stated. The scale showed good acceptability (few missing items, good spread, low floor/ceiling effects), relevance (76% stating they would find the measure useful in their discussions with clinicians), and good internal consistency (Cronbach's α=0.98; average ICC=0.98). Hypotheses on convergent validity (with the General Health Questionnaire, to measure depression, and the International Hip Outcome Tool Short Form, to measure quality of life) and divergent validity (with the General Self-Efficacy Scale, to measure coping) were confirmed. Conclusion: The 64-item QoL&CI measure is a practical and valid measure addressing areas of clinical and patient significance and has potential value to assist patients and clinicians in discussions about treatment choices and treatment progress. Future research will address further psychometric testing (test-retest validity and responsiveness to change), in additional sites, and embedding the measure into clinical practice.

Perspectives on the Social, Physical, and Emotional Impact of Living With Perthes' Disease in Children and Their Family: A Mixed Methods Study.

Aim. To determine the social, physical, and emotional impact of living with Perthes' disease on affected children and their family (caregivers). Patients and Methods. Through a mixed methods approach, we interviewed 18 parents and explored the perspectives of 12 children affected by Perthes' disease (mean = 7.1 years, SD = ±4.1 years) using a survey tool. Thematic analysis of parents' interviews provided an insight into disease-specific factors influencing patients and family's daily life activities. Using the childhood survey tool, good and bad day scores were analyzed using MANOVA (multivariate analysis of variance). Results. Thematic analysis of the parent interviews (main themes n = 4) identified a marked effect of the disease on many facets of the child's life, particularly pain and the impact on sleep, play, and school attendance. In addition, the interviews identified a negative effect on the family life of the parents and siblings. Children indicated that activities of daily living were affected even during "good days" (P < .05), but pain was the key limiting factor. Conclusion. Perthes' disease negatively affects the social, physical, and emotional well-being of children and their family. These findings provide outcome domains that are important to measure in day-to-day care and add in-depth insight into the challenges caused by this disease for health care professionals involved in clinical management.

Psycho-social impact of developmental dysplasia of the hip and of differential access to early diagnosis and treatment: A narrative study of young adults.

OBJECTIVES: Symptomatic developmental dysplasia of the hip can present in the young, active adult patient and can lead to severe pain and disability at a young age. The overall aim of the study was to deepen the understanding of the impact of developmental dysplasia of the hip on young adults' quality of life and psycho-social well-being, focusing on how differential access to early diagnosis impacted the trajectory of the disease and treatment options. METHODS: We conducted semi-structured interviews and gathered online stories from 97 participants. A narrative and thematic analysis was used to integrate the dataset producing a multi-dimensional view. RESULTS: A narrative plot showing how events unfolded over time was identified for each participant. Two common plots were identified: Plot 1 focused around those participants who received a prompt diagnosis and were treated within 12 months of diagnosis (n = 22) and Plot 2 focused around those who experienced a late/delayed diagnosis (mean = 8 years; range = 12-364 months) (n = 75) and thus delayed treatment. Participants in Plot 2 became more debilitated over time and experienced chronic hip pain for a prolonged period before an accurate diagnosis and/or intervention was made. It was clear from the narratives when pain persists over time, participants' quality of life and psycho-social well-being were affected. CONCLUSIONS: Developmental dysplasia of the hip is an under-recognised condition; more research is needed to develop a clear clinical picture that can be used to alert frontline health professionals to the potential for developmental dysplasia of the hip so that they can promptly diagnose patients and refer them to specialist centres. Patients can also experience a profound impact on their quality of life and psycho-social well-being. Patients actively seek information from support groups about all aspects of their condition. Further research is required to determine the long-term impact of developmental dysplasia of the hip to develop evidence-based information for clinicians and patients.

Soluble interleukin-6 receptor mediated fatigue highlights immunological heterogeneity of patients with early breast cancer who undergo radiation therapy.

PURPOSE: This study aimed to explore the associations between dose-volume parameters of localized breast irradiation, longitudinal interleukin-6 soluble receptor (sIL-6R), and leukocyte counts as markers of an immune-mediated response and fatigue as a centrally-driven behavior. METHODS AND MATERIALS: This prospective cohort study recruited 100 women who were diagnosed with stage 0-IIIa breast cancer, prescribed 40 Gy in 15 fractions over 3 weeks adjuvant radiation therapy, and had no prior or concurrent chemotherapy. Dose-volume parameters were derived from treatment plans and related to serum sIL-6R concentrations, leukocyte counts, and a validated measure of self-reported fatigue at baseline, after 10 and 15 fractions, and 4 weeks after radiation therapy. RESULTS: sIL-6R concertation was significantly higher in patients with a total volume of tissue irradiated within the 50% isodose >2040 cm3 (P = .003). When controlling for body mass index, this result only remained significant after treatment. The volume of liver irradiated within the 10% isodose correlated with the sIL-6R concentration during and after radiation therapy (ρ = .3-.4; P = .03-.007). The 38% of the cohort that was classified as fatigued had a higher mean sIL-6sR concentration at all observation points, but the differences were only statistically significant during radiation therapy: Mean (standard deviation [SD]) after 15 fractions for fatigued patients was 47.6 ng/dL (11.2 SD) versus 41.6 ng/dL (11.4 SD) for nonfatigued patients (P = .01). Cohort leukocyte counts and leukocyte subsets decreased consistently from baseline and the values for the fatigued group were 4% lower at baseline and between 7% and 9% lower during and after treatment compared with those of the nonfatigued group but the differences were not statistically significant. CONCLUSIONS: This is the first study to show that localized irradiation induces increased systemic sIL-6R during treatment in participants who reported elevated levels of fatigue before, during, and after treatment. This behavioral response appears to reflect a variation in innate host immunity, which then mediates the cellular and/or psychological stress of radiation therapy.

The outcomes of Perthes' disease of the hip: a study protocol for the development of a core outcome set.

BACKGROUND: Perthes' disease is an idiopathic osteonecrosis of a developmental hip that is most frequent in Northern Europe. Currently, the absence of a common set of standardised outcomes makes comparisons between studies of different interventions challenging. This study aims to summarise the outcomes used in clinical research of interventions for Perthes' disease and define a set of core outcomes (COS) to ensure that the variables of primary importance are measured and reported in future research studies investigating Perthes' disease. METHODS: A systematic review of the current literature will be used to identify a list of outcomes reported in previous studies. Additional important outcomes will be sought by interviewing a group of children with Perthes' disease, adults who were treated with the disease in infancy and parents of children with the disease. This list will then be evaluated by experts in Perthes' disease using a Delphi survey divided into two rounds to ascertain the importance of each outcome. The final outcomes list obtained from the Delphi survey will be then discussed during a consensus meeting of representative key stakeholders in order to define the COS to be reported in future clinical trials related to Perthes' disease. DISCUSSION: The absence of high-quality research and clear guidelines concerning the management of Perthes' disease is, at least in part, due to the difficulties in the comparing the results from previous studies. The development of a COS seeks to standardise outcomes collected in future research studies to enable comparisons between studies to be made and to facilitate meta-analyses of results. TRIAL REGISTRATION: Core Outcome Measures in Effectiveness Trials Initiative (COMET), 1003 . Registered on 20 July 2017. Prospero International Prospective Register of Systematic Reviews, CRD 42017069742 . Registered on 10 July 2017.

Experiences of young women living with developmental dysplasia of the hip: insight into their experiences of surgery and recovery.

OBJECTIVE: To explore the experiences of young women with developmental dysplasia of the hip explicating the impact of peri-acetabular osteotomy surgery and recovery in the short and longer term. DESIGN: Postings of five, selected women on an online active message board aimed at women with developmental dysplasia of the hip were analysed. Interest lay on their postings after they had had peri-acetabular osteotomy surgery. Data analysis was performed through the approach of interpretive phenomenological analysis. RESULTS: The time length of the postings for the cases ranged from 1 year to 6 years, and the number of postings varied substantially, from 48 to 591. Two major concepts were prominent across participants' accounts. The first concept, 'body image', centred on affects on the women's self-esteem and body image. The second, 'the long road to recovery', highlighted 'the emotional and physical battle of learning to walk' and concerns with 'saving my joints'. CONCLUSION: Developmental dysplasia of the hip potentially provides a critical case for exploration of the process of how a disability can affect confidence, self-esteem and body image. Recovery from this condition requires enormous effort, resilience and commitment from the women.

Psychological and immunological characteristics of fatigued women undergoing radiotherapy for early-stage breast cancer.

PURPOSE: The amelioration of fatigue in radiotherapy patients is limited by an equivocal aetiology and uncertainty regarding who is likely to experience significant fatigue. The research objective was to characterise fatigue in women undergoing radiotherapy for breast cancer, in order to evaluate associations with elevations in anxiety, depression and a marker of systemic inflammation. METHODS: Participants comprised 100 women, diagnosed with stages 0-IIA breast cancer and prescribed with 40 Gy in 15 fractions over 3 weeks. Fatigue was assessed at baseline between 10 and 22 days before radiotherapy, after 10 and 15 fractions of radiotherapy and 4 weeks after the completion of radiotherapy, using the Functional Assessment of Chronic Illness Therapy Fatigue Subscale. Psychological status was self-reported using the Hospital Anxiety and Depression Scale. Sera concentrations of interleukin-6-soluble receptor were established via enzyme-linked immunosorbent assay. The contributions of pretreatment factors to fatigue were analysed using multivariable regression. RESULTS: Thirty-eight percent of participants experienced significant fatigue during radiotherapy, with the remainder little are affected. After controlling for baseline fatigue, anxiety before treatment was the strongest unique predictor of subsequent fatigue. During radiotherapy, interleukin-6-soluble receptor was significantly elevated in the fatigued group compared to the non-fatigued group (p = 0.01). This association was not mediated by depression. CONCLUSIONS: The data are consistent with the concept that psychological distress prior to radiotherapy relates to a distinct immunological and behavioural response during radiotherapy. Patients reporting elevated anxiety should benefit from interventions that appropriately address the underlying psychological distress and have the potential to ameliorate disabling treatment-related fatigue.

Enhancing health literacy and behavioural change within a tele-care education and support intervention for people with type 2 diabetes.

BACKGROUND: Behavioural change interventions for persons with chronic illness draw on a variety of theoretical approaches including motivational interviewing and shared decision making. Health literacy provides an additional, potentially powerful explanatory framework to guide research and practice. OBJECTIVE: To examine the changes in the depth and detail of diabetes-related knowledge and confidence for persons with type 2 diabetes. DESIGN: Two-year, prospective, observational study, using questionnaire data at two time points (baseline and 2 years later) and in-depth interviews with a theoretically selected subsample. SETTING AND PARTICIPANTS: A total of 319 patients initially recruited from a deprived urban area in north-west England. INTERVENTION: Dedicated tele-carer education and support, tailored to the individual circumstances of the patient. MAIN OUTCOME MEASURES: Perceptions of confidence, levels of empowerment, learning for self-care and most helpful aspects of the intervention. RESULTS: Over 90% expressed confidence in keeping their blood sugar controlled, and high levels of perceived empowerment (mean = 4.25; 95% CI, 4.17-4.33) were found. Changes in the depth and detail of diabetes-related knowledge and confidence, from the specific to the more general, were observed and enhanced competence in translating knowledge into practice. DISCUSSION AND CONCLUSIONS: The intervention, built within a developed working partnership between tele-carer and patient, operated at two levels: health literacy, enhancing knowledge, developing personal skills and enabling self-control; and socio-psychological behavioural change, tailored to individuals within their socio-economic environments, enabling increased motivation and supportive problem-solving. Both approaches find reflection in the findings and provide powerful explanatory lenses to interrogate the data.

An exploratory study of young women adjusting to developmental dysplasia of the hip and deciding on treatment choices.

OBJECTIVE: To explore the experiences of young women adjusting to living with developmental dysplasia of the hip (DDH) and deciding on treatment choices. METHODS: Exploratory study of a set of online postings from one message board aimed at women with DDH. Postings of five, purposively selected users were explored from first posting to the time of their peri-acetabular osteotomy surgery. Data analysis was performed through the approach of interpretive phenomenological analysis. RESULTS: Two major concepts were prominent across participants' accounts; first, 'challenging the life course and identity as a young woman' and second, 'saving my joints'. Central was the women's description of how the diagnosis of DDH challenged the way they viewed themselves as young women. Once the women began to understand the long-term implications of having DDH they all began a quest to save their 'native joint', delaying the need for an artificial joint for as long as possible. CONCLUSION: The findings demonstrate the personal nature and diversity of the journeys the women followed. DDH potentially provides a critical case for exploration of the process of adjustment, as its treatment pathway and rehabilitation are lengthy and both physically and emotionally demanding.

The realisation of patient-centred care during a 3-year proactive telephone counselling self-care intervention for diabetes.

OBJECTIVE: To explore the way that patient-centred care is realised within a tele-carer behavioural change intervention. METHOD: In-depth, semi-structured interviews undertaken at years 1 and 3 with a purposively selected sample from the intervention group within a 3-year randomised controlled trial (RCT) of a telephone-based education and support for persons with type 2 diabetes, and interviews with the non-medically trained tele-carers and supervising diabetes specialist nurse. RESULTS: A four-phased flow of the patient-centred interactions was identified, which evolved over the process of the intervention. Initially, attention centred on building a picture for and of the patient and assessing their knowledge base. Later, focus moved towards understanding diabetes from the patient's perspective and advice-giving became more individualised. Throughout, the interaction dynamics varied for patients. CONCLUSION: This study provides insight into the development of patient-centred behaviours over time and the influence of patients on tele-carer communication styles. PRACTICE IMPLICATION: When adopting a patient-centred approach, tele-carers need to be flexible and recognise that patients vary in their knowledge, skills and psychological adaption to diabetes. Continuity of care and consistent contact is pivotal to patients being able to move through the various phases of their illness trajectory and make the transition towards improved self-care management.

Tailoring advice and optimizing response: a case study of a telephone-based support for patients with type 2 diabetes.

BACKGROUND AND AIMS: Health care increasingly incorporates telephone counselling, but the dynamics of interactions supporting its delivery are not well understood. This paper explores how advice was packaged and received by participants with type 2 diabetes within the context of a Pro-Active Call-Centre Treatment Support (PACCTS) system delivered to provide diabetes self-care training over the telephone. METHODS: The data relate to nine participants who formed part of the qualitative evaluation within the intervention arm of a randomized controlled trial (n = 591) of PACCTS. One consultation call between the tele-carer and the participant was tape recorded towards the end of the 3-year study and each participant was interviewed by telephone within 24 hours of the consultation. The nine calls and interviews were transcribed and analysed using the constant comparative method. RESULTS: The type of advice the participants received was packaged in six forms: advice as explanation, general information-giving, generic advice, advice in the form of practitioner self-disclosure, personalized advice and responsive advice. Variation was evident in terms of the nature of advice provided, level of generality, form and context. CONCLUSIONS: As the participants had to make multiple behavioural changes over time, advice needed to be delivered, reiterated and reinforced to achieve understanding and uptake. The more specific and personalized the information and advice, the more likely it was for the participant to give a positive and engaged response. Seizing every opportunity to deliver good quality personalized and/or responsive advice is essential in order to facilitate effective behavioural change.

Exploring patient perceptions of movement through the stages of change model within a diabetes tele-care intervention.

Achieving strict control of diabetes is challenging for many patients and most need regularly to depend on ongoing support from health care professionals. One approach that might successfully provide this in a cost-effective and acceptable way is the delivery of advice and support over the telephone (tele-care). To date the process and effects of tele-care have however rarely been studied. This article explores the potential of one behavioural model, the trans-theoretical stages of change model (TTM), to understand and theorize about behaviour change for this chronic disease. Case study data are drawn from a wider randomized controlled trial (RCT) set up to assess the effectiveness of a pro-active call centre-based stepped treatment support to people with type 2 diabetes. The case study demonstrates the relevance and importance of the TTM model in this area. Different experiential and behavioural processes were of particular significance and held different meanings for the various change groups.

Pro-active call center treatment support (PACCTS) to improve glucose control in type 2 diabetes: a randomized controlled trial.

OBJECTIVE: To determine whether Pro-Active Call Center Treatment Support (PACCTS), using trained nonmedical telephonists supported by specially designed software and a diabetes nurse, can effectively improve glycemic control in type 2 diabetes. RESEARCH DESIGN AND METHODS: A randomized controlled implementation trial of 1-year duration was conducted in Salford, U.K. The trial comprised 591 randomly selected individuals with type 2 diabetes. By random allocation, 197 individuals were assigned to the usual care (control) group and 394 to the PACCTS (intervention) group. Lifestyle advice and drug treatment in both groups followed local guidelines. PACCTS patients were telephoned according to a protocol with the frequency of calls proportional to the last HbA(1c) level. The primary outcome was absolute reduction in HbA(1c), and the secondary outcome was the proportion of patients reducing HbA(1c) by at least 1%. RESULTS: A total of 332 patients (84%) in the PACCTS group and 176 patients (89%) in the control group completed the study. Final HbA(1c) values were available in 374 patients (95%) in the PACCTS group and 180 patients (92%) in the usual care group. Compared with usual care, HbA(1c) improved by 0.31% (95% CI 0.11-0.52, P = 0.003) overall in the PACCTS patients. For patients with baseline HbA(1c) >7%, the improvement increased to 0.49% (0.21-0.77, P < 0.001), whereas in patients with baseline HbA(1c) <7% there was no change. The difference in the proportions of patients achieving a >/=1% reduction in HbA(1c) significantly favored the PACCTS intervention: 10% (4-16, P < 0.001) overall and 15% (7-24, P < 0.001) for patients with baseline HbA(1c) >7%. CONCLUSIONS: In an urban Caucasian trial population with blood glucose HbA(1c) >7%, PACCTS facilitated significant improvement in glycemic control. Further research should extend the validity of findings to rural communities and other ethnic groups, as well as to smoking and lipid and blood pressure control.

Acceptability and satisfaction with a telecarer approach to the management of type 2 diabetes.

OBJECTIVE: To examine patients' views of the acceptability of and satisfaction with telephone care center support provided to improve blood glucose control in type 2 diabetes. RESEARCH DESIGN AND METHODS: The Pro-Active Call-Center Treatment Support (PACCTS) Trial randomized patients from 47 general practices in a deprived urban area in northwest England to usual care or to proactive call center support in addition to usual care. Satisfaction with care was assessed in all 591 patients at baseline and the end of the study using the Diabetes Satisfaction and Treatment Questionnaire (DTSQ). Acceptability was assessed in 394 intervention patients after at least three proactive calls from the call center and at the end of the trial. A purposive sample of 25 patients took part in in-depth semistructured interviews. RESULTS: The response rates to the questionnaires were 79% (DTSQ) and 65% (acceptability). Persons receiving the intervention continued to report high levels of satisfaction with their treatment (95% CI 32.3-33.2 at 1 year), and >90% strongly agreed or agreed that the telecarer approach was acceptable. Qualitative comments pointed to the importance of a personalized service; increased feelings of well-being, including confidence and self-control; help with problem-solving; and patients developing rapport and a strong bond with the telecarers. CONCLUSIONS: A personalized PACCTS approach is acceptable to patients. A service giving priority to the interpersonal dimension leads to increased commitment from patients to improve long-term glycemic control.