"It's about how you take in things with your brain" - young people's perspectives on mental health and help seeking: an interview study.

INTRODUCTION: Poor mental health in young people has become a growing problem globally over the past decades. However, young people have also been shown to underutilize available healthcare resources. The World Health Organisation (WHO) has formulated guidelines for youth-friendly health services (YFHSs) to increase youth participation in healthcare. Still, little is known about how young people using these services perceive mental health, indicating a knowledge gap concerning the subjective evaluation of their mental health. AIM: To investigate how young people visiting youth health clinics (YHC) perceive the concept of mental health and factors they view as central to maintaining mental health. METHODS: In total 21 interviews were carried out, 16 in 2018, and 5 in 2023 to assure no changes in findings after the COVID-19 pandemic. Subjects were recruited during visits to youth health clinics (YHCs) in mid-Sweden and were aged 15-23 years. Recruitment strived to achieve heterogeneity in the sample concerning gender, sexual orientation, gender identity and age. Interviews were transcribed and analysed using qualitative content analysis. FINDINGS: Findings of the analysis revealed two themes, "Mental health is helped and hindered by the surroundings" and "Mental health is difficult to understand and difficult to achieve". The participants described their health as highly dependent on their social surroundings, and that these are important to maintaining health but may also affect health negatively. They described mixed experiences of the health care services and mentioned prerequisites for seeking care for mental health problems such as accessibility and respect for their integrity, including the right to turn down offered treatment. The informants also viewed mental health as an ongoing undertaking that one must work for, and that it is sometimes difficult to know what constitutes mental health. They also expressed a need from healthcare services to enquire about their health, and to show an active interest in how they are doing. CONCLUSIONS: Findings underline the need of young people's individual needs to be met in the healthcare system and their vulnerability to their social surroundings. Health status assessments in young people should consider social and individual factors to fully capture mental health.

Quality of life assessments in clinical practice using either the EORTC-QLQ-C30 or the SEIOQL-DW: a randomized study.

BACKGROUND: Effective patient-physician communication can improve patient understanding, agreement on treatment and adherence. This may, in turn, impact on clinical outcomes and patient quality of life (QoL). One way to improve communication is by using patient-reported outcome measures (PROMs). Heretofore, studies of the impact of using PROMs in clinical practice have mostly evaluated the use of standardized PROMs. However, there is reason to believe that individualized instruments may be more appropriate for this purpose. The aim of this study is to compare the effectiveness of the standardized QoL-instrument, the European Organization for Research and Treatment of Cancer Quality of Life C-30 (EORTC-QOL-C30) and the individualized QoL instrument, the Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW), in clinical practice. METHODS: In a prospective, open-label, controlled intervention study at two hospital out-patient clinics, 390 patients with gastrointestinal cancer were randomly assigned either to complete the EORTC-QOL-C30 or the SEIQoL-DW immediately before the consultation, with their responses being shared with their physician. This was repeated in 3-5 consultations over a period of 4-6 months. The primary outcome measure was patients' health-related QoL, as measured by FACIT-G. Patients' satisfaction with the consultation and survival were secondary outcomes. RESULTS: There was no significant difference between the groups with regard to study outcomes. Neither intervention instrument resulted in any significant changes in health-related QoL, or in any of the secondary outcomes, over time. This may reflect either a genuine lack of effect or sub-optimization of the intervention. Since there was no comparison to standard care an effect in terms of lack of deterioration over time cannot be excluded. CONCLUSIONS: Future studies should focus on the implementation process, including the training of physicians to use the instruments and their motivation for doing so. The effects of situational use of standardized or individualized instruments should also be explored. The effectiveness of the different approaches may depend on contextual factors including physician and patient preferences.

Pretend Play as an Intervention for Children With Cancer: A Feasibility Study.

Children with cancer suffer from symptoms and burdensome treatments that often cause distress to children and their families. Mortality is one aspect of cancer diagnosis, while another is the quality of life and well-being during and after the treatment. By supporting children's communication, self-efficacy and coping ability in the care situation, children are given the possibilities for increased independence and participation and are allowed to develop an influence over their care. The aim of this study was to develop and evaluate the feasibility and acceptability of an adult-facilitated pretend play intervention for children with cancer. Five children with ongoing treatment for cancer were invited to a play intervention that consisted of six to eight sessions of structured pretend play aimed at increasing participation, independence, and well-being. A mixed method design was used to evaluate the feasibility and acceptability of the play intervention. Measures were collected before and after interventions, and in conjunction with every play session. Results suggest that the children enjoyed the play intervention. Findings indicate small improvements regarding self-efficacy in care situations and equal or increased quality of life for participants. A main finding was that no adverse events or increased worrying was reported in conjunction with play sessions. Therefore, the intervention is regarded as safe, feasible, and acceptable as reported by participants and their primary caregivers and a possible means of increasing participation and independence in children with a cancer diagnosis.

The utility/futility of medications for neuropathic pain - an observational study.

Background and aims The RELIEF (Real Life) study by AstraZeneca was designed as an observational study to validate a series of Patient Reported Outcome (PRO) questionnaires in a mixed population of subjects with neuropathic pain (NP) coming from diabetes, neurology and primary care clinics. This article is an analysis of a subset of the information to include the medications used and the effects of pharmacological treatment over 6 months. The RELIEF study was performed during 2010-2013. Methods Subjects were recruited from various specialty clinics and one general practice clinic across Canada. The subjects were followed for a total of 2 years with repeated documentation of their status using 10 PROs. A total of 210 of the recruited subjects were entered into the data base and analyzed. Of these, 123 had examination-verified painful diabetic neuropathy (PDN) and 87 had examination-verified post-traumatic neuropathy (PTN). To evaluate the responsiveness of the PROs to change, several time points were included and this study focusses primarily on the first 6 months. Subjects also maintained a diary to document all medications, both for pain and other medical conditions, including all doses, start dates and stop dates, that could be correlated to changes in the PRO parameters. Results RELIEF was successful in being able to correlate the validity of the PROs and this data was used for further AstraZeneca Phase 1, 2, and 3 clinical trials of NP. To our surprise, there was very little change in pain and low levels of patient satisfaction with treatment during the trial. Approximately 15% of the subjects reported improvement, 8% worsening of pain, the remainder reported pain unchanged despite the use of multiple medications at multiple doses, alone or in combination with frequent changes of medications and doses over the study. Those taking predominantly NSAIDs (COX-inhibitors) did no worse than those taking the standard recommended medications against NP. Conclusions Since this is a real-life study, it reflects the clinical utility of a variety of internationally recommended medications for the treatment of NP. In positive clinical trials of these medications in selected "ideal" subjects, the effects are not overwhelming - 30% are 50% improved on average. This study shows that in the real world the results are not nearly as positive and reflects information from non-published negative clinical trials. Implications We still do not have very successful medications for NP. Patients probably differ in many respects from those subjects in clinical trials. This is not to negate the use of recommended medications for NP but an indication that success rates of treatment are likely to be worse than the data coming from those trials published by the pharmaceutical industry.

International Society for Quality of Life Research commentary on the draft European Medicines Agency reflection paper on the use of patient-reported outcome (PRO) measures in oncology studies.

In 2014, the European Medicines Agency (EMA) released for comment a draft reflection paper on the use of patient-reported outcome (PRO) measures in oncology studies. A twelve-member International Society for Quality of Life Research (ISOQOL) taskforce was convened to coordinate the ISOQOL response. Twenty-one ISOQOL members provided detailed comments and suggestions on the paper: 81 % from academia and 19 % from industry. Taskforce members consolidated and further refined these comments and shared the recommendations with the wider ISOQOL membership. A final response was submitted to the EMA in November 2014. The impending publication of the EMA reflection paper presents a valuable opportunity for ISOQOL to comment on the current direction of EMA PRO guidance and strategy. The EMA paper, although focused on cancer, could serve as a model for using PROs in other conditions, as it provides a useful update surrounding some of the design issues common to all trial research including PRO endpoints. However, we believe there are a number of additional areas in need of greater consideration. The purpose of this commentary is therefore to highlight the strengths of this timely and potentially useful document, but also to outline areas that may warrant further discussion.

Health care professionals’ perspectives on automated multi-dose drug dispensing / Perspectivas de los profesionales de la salud sobre la dispensación de medicamentos en multi-dosis automatizadas

Background: During the 1980s, manual repackaging of multi-dose medications from pharmacies in Sweden was successively substituted with automated multi-dose drug dispensing (MDD). There are few studies evaluating the consequences of automated MDD with regard to patient safety, and those that investigate this issue are not very extensive. Objectives: To investigate Swedish health care professionals’ perceived experience of automated MDD and its effects on patient adherence and patient safety. Methods: Three questionnaire forms, one for physicians, nurses, and assistant nurses/nursing assistants, were developed based on reviews of the literature and pilot testing of the questions in the intended target groups. The target groups were health professionals prescribing or administrating MDD to patients. A sample (every sixth municipality) was drawn from the sampling frame of Swedish municipalities, resulting in 40 municipalities, about 14% of all municipalities in Sweden. Email addresses of general practitioners were obtained from county councils, while the municipalities assisted in getting contact details for nurses, assistant nurses and nursing assistants. A total of 915 questionnaires were distributed electronically to physicians, 515 to nurses, and 4,118 to assistant nurses/nursing assistants. The data were collected in September and October 2012. Results: The response rate among physicians, nurses and assistant nurses/nursing assistants was 31%, 43% and 23%, respectively. The professionals reported that automated MDD reduces duplication of medication, contributes to correct dosages, helps patients take their medication at the right time, and reduces confusion among patients. Fifteen per cent of the physicians and about onethird of the nurses and assistant nurses/nursing assistants reported that generic substitution makes it more difficult for the patient to identify the various medicines available in the sachets. The physicians did, however, note that prescribing medicine to patients with automated MDD is complicated and can be a risk for patient safety. Both physicians and nurses requested more information on and training in automated MDD. They also asked for more medication reviews. Conclusions: The professionals generally had a positive attitude to automated MDD with regard to improved medication adherence, but said they believed that the electronic prescribing system posed a safety risk for patients (AU)

Antecedentes: Durante los años 1980s, el re-embalaje manual de medicamentos en las farmacias suecas fue gradualmente substituido por la dispensación multi-dosis automatizada (MDD). Hay pocos estudios que evalúen las consecuencias del MDD automatizado en relación a la seguridad del paciente, y los que lo han hecho no eran muy extensivos. Objetivos: Investigar las percepciones de los profesionales de salud suecos del MDD automatizado y sus efectos en la adherencia y seguridad del paciente. Métodos: Basándose en la literatura, se desarrollaron tres cuestionarios, para médicos, enfermeras y auxiliares de enfermería, y se pilotaron en cada uno de los tres grupos. Los grupos diana eran profesionales que prescribían o administraban MDD a pacientes. Se extrajo una muestra /una de cada seis) municipios del marco mostral de municipios de Suecia, obteniéndose 40 municipios, cerca del 40% de todos los que hay en Suecia. Se obtuvieron las direcciones de correo electrónico de los consejos de condado, mientras que los ayuntamientos ayudaron a conseguir los contactos de enfermeras y auxiliares de enfermería. Se distribuyeron electrónicamente un total de 915 cuestionarios a médicos, 515 a enfermeras y 4118 a auxiliares de enfermería. Los datos fueron recogidos entre septiembre y octubre de 2012. Resultados: La tasa de respuesta entre médicos, enfermeras y auxiliares de enfermería fue del 31%, 43% y 23%, respectivamente. Los profesionales reportaron que los MDD reducen la duplicidad e medicamentos, contribuye a la correcta dosificación, ayuda a los pacientes a tomar la medicación a la hora correcta, y reduce la confusión entre los pacientes. Un 15% de médicos y cerca de un tercio de enfermeras y auxiliares reportaron que la sustitución genérica hace más difícil al paciente identificar los varios medicamentos en los sobres. Sin embargo, los médicos apuntaron que prescribir medicamentos en MDD automatizado es complicado y puede ser de riesgo para la seguridad de los pacientes. Tanto médicos como enfermeras pidieron más información y entrenamiento sobre MDD automatizados. También pidieron más revisiones de la medicación. Conclusiones: Los profesionales en general tienen una actitud positiva hacia los MDD automatizados en cuento a la mejora de la adherencia a medicación, pero dicen que creen que la l sistema de prescripción electrónica ha creado un riesgo para los pacientes (AU)

Comparison of two instruments for measurement of quality of life in clinical practice--a qualitative study.

BACKGROUND: The study aimed to investigate the meaning patients assign to two measures of quality of life: the Schedule for Evaluation of Individual Quality of Life Direct Weighting (SEIQoL-DW) and the SEIQoL-DW Disease Related (DR) version, in a clinical oncology setting. Even though the use of quality of life assessments has increased during the past decades, uncertainty regarding how to choose the most suitable measure remains. SEIQoL-DW versions assesses the individual's perception of his or her present quality of life by allowing the individual to nominate the domains to be evaluated followed by a weighting procedure resulting in qualitative (domains) as well as quantitative outcomes (index score). METHODS: The study applied a cross-sectional design with a qualitative approach and collected data from a purposeful sample of 40 patients with gastrointestinal cancer. Patients were asked to complete two measures, SEIQoL-DW and the SEIQoL-DR, to assess quality of life. This included nomination of the areas in life considered most important and rating of these areas; after completion patients participated in cognitive interviews around their selections of areas. Interviews were audiotaped and transcribed verbatim which was followed by analysis using a phenomenographic approach. RESULTS: The analyses of nominated areas of the two measures resulted in 11 domains reflecting what patients perceived had greatest impact on their quality of life. Analysis of the cognitive interviews resulted in 16 thematic categories explaining the nominated domains. How patients reflected around their quality of life appeared to differ by version (DW vs. DR). The DW version more often related to positive aspects in life while the DR version more often related to negative changes in life due to having cancer. CONCLUSIONS: The two SEIQoL versions tap into different concepts; health-related quality of life, addressing losses and problems related to having cancer and, quality of life, more associated with aspects perceived as positive in life. The SEIQoL-DR and the SEIQoL-DW are recommended in clinical practice to take both negative and positive aspects into account and acting on the problems of greatest importance to the patient.

Phases in development of an interactive mobile phone-based system to support self-management of hypertension.

Hypertension is a significant risk factor for heart disease and stroke worldwide. Effective treatment regimens exist; however, treatment adherence rates are poor (30%-50%). Improving self-management may be a way to increase adherence to treatment. The purpose of this paper is to describe the phases in the development and preliminary evaluation of an interactive mobile phone-based system aimed at supporting patients in self-managing their hypertension. A person-centered and participatory framework emphasizing patient involvement was used. An interdisciplinary group of researchers, patients with hypertension, and health care professionals who were specialized in hypertension care designed and developed a set of questions and motivational messages for use in an interactive mobile phone-based system. Guided by the US Food and Drug Administration framework for the development of patient-reported outcome measures, the development and evaluation process comprised three major development phases (1, defining; 2, adjusting; 3, confirming the conceptual framework and delivery system) and two evaluation and refinement phases (4, collecting, analyzing, interpreting data; 5, evaluating the self-management system in clinical practice). Evaluation of new mobile health systems in a structured manner is important to understand how various factors affect the development process from both a technical and human perspective. Forthcoming analyses will evaluate the effectiveness and utility of the mobile phone-based system in supporting the self-management of hypertension.

Developing an interactive mobile phone self-report system for self-management of hypertension. Part 2: content validity and usability.

Self-management support tools using technology may improve adherence to hypertension treatment. There is a need for user-friendly tools facilitating patients' understanding of the interconnections between blood pressure, wellbeing and lifestyle. This study aimed to examine comprehension, comprehensiveness and relevance of items, and further to evaluate the usability and reliability of an interactive hypertension-specific mobile phone self-report system. Areas important in supporting self-management and candidate items were derived from five focus group interviews with patients and healthcare professionals (n = 27), supplemented by a literature review. Items and response formats were drafted to meet specifications for mobile phone administration and were integrated into a mobile phone data-capture system. Content validity and usability were assessed iteratively in four rounds of cognitive interviews with patients (n = 21) and healthcare professionals (n = 4). Reliability was examined using a test-retest. Focus group analyses yielded six areas covered by 16 items. The cognitive interviews showed satisfactory item comprehension, relevance and coverage; however, one item was added. The mobile phone self-report system was reliable and perceived easy to use. The mobile phone self-report system appears efficiently to capture information relevant in patients' self-management of hypertension. Future studies need to evaluate the effectiveness of this tool in improving self-management of hypertension in clinical practice.

Developing an interactive mobile phone self-report system for self-management of hypertension. Part 1: patient and professional perspectives.

Low adherence remains a struggle in hypertension management, despite improvement efforts. Presuming that increased patient participation is a possible approach, we collaborated with patients and healthcare professionals to design a self-report system to support self-management. The study aimed to explore and describe relevant aspects of hypertension and hypertension treatment, for use in the development of an interactive mobile phone self-report system. It further aimed to suggest which clinical measures, lifestyle measures, symptoms and side-effects of treatment would be meaningful to include in such a system. Five focus group interviews were performed with 15 patients and 12 healthcare professionals, and data was analysed using thematic analysis. Patients suggested trust, a good relationship with caregivers, and well-being as important aspects of hypertension self-management. Furthermore, they regarded blood pressure, dizziness, stress, headache and tiredness as important outcomes to include. Patients sought to understand interconnections between symptoms and variations in blood pressure, whilst healthcare professionals doubted patients' ability to do so. Healthcare professionals emphasized accessibility, clear and consistent counselling, complication prevention and educational efforts. The study presents aspects of importance for follow-up to understand the interplay between blood pressure and daily life experiences for patients with hypertension.

Health care professionals' perspectives on automated multi-dose drug dispensing.

BACKGROUND: During the 1980s, manual repackaging of multi-dose medications from pharmacies in Sweden was successively substituted with automated multi-dose drug dispensing (MDD). There are few studies evaluating the consequences of automated MDD with regard to patient safety, and those that investigate this issue are not very extensive. OBJECTIVES: To investigate Swedish health care professionals' perceived experience of automated MDD and its effects on patient adherence and patient safety. METHODS: Three questionnaire forms, one for physicians, nurses, and assistant nurses/nursing assistants, were developed based on reviews of the literature and pilot testing of the questions in the intended target groups. The target groups were health professionals prescribing or administrating MDD to patients. A sample (every sixth municipality) was drawn from the sampling frame of Swedish municipalities, resulting in 40 municipalities, about 14% of all municipalities in Sweden. Email addresses of general practitioners were obtained from county councils, while the municipalities assisted in getting contact details for nurses, assistant nurses and nursing assistants. A total of 915 questionnaires were distributed electronically to physicians, 515 to nurses, and 4,118 to assistant nurses/nursing assistants. The data were collected in September and October 2012. RESULTS: The response rate among physicians, nurses and assistant nurses/nursing assistants was 31%, 43% and 23%, respectively. The professionals reported that automated MDD reduces duplication of medication, contributes to correct dosages, helps patients take their medication at the right time, and reduces confusion among patients. Fifteen per cent of the physicians and about one-third of the nurses and assistant nurses/nursing assistants reported that generic substitution makes it more difficult for the patient to identify the various medicines available in the sachets. The physicians did, however, note that prescribing medicine to patients with automated MDD is complicated and can be a risk for patient safety. Both physicians and nurses requested more information on and training in automated MDD. They also asked for more medication reviews. CONCLUSIONS: The professionals generally had a positive attitude to automated MDD with regard to improved medication adherence, but said they believed that the electronic prescribing system posed a safety risk for patients.

Barriers against psychosocial communication: oncologists' perceptions.

PURPOSE: To explore oncologists' psychosocial attitudes and beliefs and their perceptions regarding barriers against psychosocial communication. METHODS: A questionnaire was distributed to oncologists in Sweden (n = 537). Questions covered demography, the Physician Psychosocial Beliefs Scale (PPBS), and barriers against psychosocial communication. Stepwise multiple regression was used to determine what factors contribute the most to the PPBS score and the total number of barriers and barriers affecting clinical practice, respectively. Spearman rank-order correlation was used to determine correlation between PPBS score and number of barriers. RESULTS: Questionnaire response rate was 64%. Mean PPBS value was 85.5 (range, 49 to 123; SD, 13.0). Most oncologists (93%) perceived one or more barriers in communicating psychosocial aspects with patients. On average, five different communication barriers were perceived, of which most were perceived to affect clinical practice. These barriers included insufficient consultation time, lack of resources for taking care of problems discovered, and lack of methods to evaluate patients' psychosocial health in clinical practice. There was a positive correlation (rs = 0.490; P < .001) between the PPBS score and the number of perceived barriers (ie, less psychosocially oriented oncologists perceived more barriers). Oncologists with supplementary education with a psychosocial focus perceived fewer barriers/barriers affecting clinical practice (P < .001 and P = .001, respectively) and were more psychosocially oriented (P = .001). CONCLUSION: Oncologists perceive many different barriers affecting psychosocial communication in clinical practice. Interventions aiming to improve psychosocial communication must therefore be multifaceted and individualized to clinics and individual oncologists. It is important to minimize barriers to facilitate optimal care and treatment of patients with cancer.

Different perspectives on communication quality and emotional functioning during routine oncology consultations.

OBJECTIVE: To determine quality of communication in routine oncology consultations from patient, physician, and observer perspectives, and to determine agreement of emotional function content in consultations from these three perspectives. METHODS: In total, 69 consultations were included. Perceived quality of communication and whether or not emotional functioning had been discussed was evaluated with patient- and physician-reported questionnaires. Observer perspective was evaluated by content analysis of audio records of the consultations. Agreement between perspectives was analyzed and means compared using linear mixed models. RESULTS: The patients' ratings of communication quality differed significantly from those of both the physician and observer. Observer and physician scores did not differ significantly. Physicians rated emotional functioning as discussed more often than was reported from patient and observer perspectives. CONCLUSION: The patients' view of the quality of communication differed from that of the physician and observer. Whether emotional functioning was discussed or not was also perceived differently by patients, physicians, and observer. PRACTICE IMPLICATIONS: The underpinnings and implications of these results need to be further explored regarding how to move toward a higher degree of shared understanding, where different perspectives are more in alignment, and how to develop more valid methods for evaluating communication.

Experiences of a nationwide web-based system: reporting dispensing errors in Swedish pharmacies.

OBJECTIVES: To design and evaluate a national web-based dispensing error reporting system for all Swedish pharmacies, replacing the currently used paper-based system. METHODS: A working group designed the new system. The number of reports before (1999-2003) and after (2004-2005) introduction was studied in a descriptive analysis. The completeness of reports was evaluated through the study of 100 randomly selected reports from the third quarter of 2003 and 2004 from each system. Evaluation was done by chi-square analysis; P>0.05. Perceptions on introduction were collected in semi-structured interviews (working group and one assistant) and subjected to descriptive analysis. KEY FINDINGS: Reported error rate per 100,000 dispensed items was 12.9 pre- and 21.4 post implementation. Completeness-analysis revealed that information was more comprehensively reported in the new system. A significant difference existed in the extent to which incidents were described as well as details provided of the medicine and the patient. According to the interviewees, users initially found the web-based system difficult to handle. It took more than 6 months to change this perception. CONCLUSIONS: Introducing a web-based system for reporting dispensing errors had an impact on quantity of reports and completeness. Time and patience was needed to implement the changes.

Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1--eliciting concepts for a new PRO instrument.

The importance of content validity in developing patient reported outcomes (PRO) instruments is stressed by both the US Food and Drug Administration and the European Medicines Agency. Content validity is the extent to which an instrument measures the important aspects of concepts that developers or users purport it to assess. A PRO instrument measures the concepts most significant and relevant to a patient's condition and its treatment. For PRO instruments, items and domains as reflected in the scores of an instrument should be important to the target population and comprehensive with respect to patient concerns. Documentation of target population input in item generation, as well as evaluation of patient understanding through cognitive interviewing, can provide the evidence for content validity. Developing content for, and assessing respondent understanding of, newly developed PRO instruments for medical product evaluation will be discussed in this two-part ISPOR PRO Good Research Practices Task Force Report. Topics include the methods for generating items, documenting item development, coding of qualitative data from item generation, cognitive interviewing, and tracking item development through the various stages of research and preparing this tracking for submission to regulatory agencies. Part 1 covers elicitation of key concepts using qualitative focus groups and/or interviews to inform content and structure of a new PRO instrument. Part 2 covers the instrument development process, the assessment of patient understanding of the draft instrument using cognitive interviews and steps for instrument revision. The two parts are meant to be read together. They are intended to offer suggestions for good practices in planning, executing, and documenting qualitative studies that are used to support the content validity of PRO instruments to be used in medical product evaluation.

Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2--assessing respondent understanding.

The importance of content validity in developing patient reported outcomes (PRO) instruments is stressed by both the US Food and Drug Administration and the European Medicines Agency. Content validity is the extent to which an instrument measures the important aspects of concepts developers or users purport it to assess. A PRO instrument measures the concepts most relevant and important to a patient's condition and its treatment. For PRO instruments, items and domains as reflected in the scores of an instrument should be important to the target population and comprehensive with respect to patient concerns. Documentation of target population input in item generation, as well as evaluation of patient understanding through cognitive interviewing, can provide the evidence for content validity. Part 1 of this task force report covers elicitation of key concepts using qualitative focus groups and/or interviews to inform content and structure of a new PRO instrument. Building on qualitative interviews and focus groups used to elicit concepts, cognitive interviews help developers craft items that can be understood by respondents in the target population and can ultimately confirm that the final instrument is appropriate, comprehensive, and understandable in the target population. Part 2 details: 1) the methods for conducting cognitive interviews that address patient understanding of items, instructions, and response options; and 2) the methods for tracking item development through the various stages of research and preparing this tracking for submission to regulatory agencies. The task force report's two parts are meant to be read together. They are intended to offer suggestions for good practice in planning, executing, and documenting qualitative studies that are used to support the content validity of PRO instruments to be used in medical product evaluation.

Comparing two versions of the Schedule for Evaluation of Individual Quality of Life in patients with advanced cancer.

BACKGROUND: The aim was to compare two individualized patient reported outcomes or the Schedule for the Evaluation of Individual Quality of Life - Direct Weighting (SEIQoL-DW) measuring quality of life in general, and the disease-related version (SEIQoL-DR) measuring quality of life related to disease. Both instruments have been used in clinical practice settings within oncology. The instruments were compared with regard to feasibility, the areas nominated by patients as important and patients' ratings of how they were doing in these areas (Index scores). MATERIAL AND METHODS: The study included 40 patients with gastrointestinal cancer. All patients completed both versions of the instrument on a touch screen computer in relation to a medical consultation. Firstly, the participants were invited to nominate the five domains she/he currently considered to be most important in life. Secondly, they were asked to rate how they were doing in each of these domains. Finally, they were asked to quantify the relative importance of each area. Cohen's effect sizes were calculated to illuminate the clinical importance of mean value differences. RESULTS: Both instruments took less than ten minutes to complete and the procedure was considered feasible by both patients and interviewers. The proportion of patients nominating the same areas in the two versions did not differ, however, the SEIQoL-DW Index score was significantly higher than the corresponding score for the SEIQoL-DR. The detected difference in the mean score measured by effect size was medium. CONCLUSION: The magnitude of the effect size of the difference in Index score imply that the two versions tap into different constructs, i.e. quality of life (QoL) versus health-related QoL (HRQL), supporting the construct validity of the two versions of the instrument. The SEIQoL-DW and the SEIQoL-DR should be considered as complementary rather than interchangeable when used in patients with cancer.

Swedish students' and preceptors' perceptions of what students learn in a six-month advanced pharmacy practice experience.

OBJECTIVE: To identify what pharmacy students learn during the 6-month advanced pharmacy practice experience (APPE) in Sweden. METHODS: Semi-structured interviews were conducted with 18 pharmacy APPE students and 17 pharmacist preceptors and analyzed in a qualitative directed content analysis using a defined workplace learning typology for categories. RESULTS: The Swedish APPE provides students with task performance skills for work at pharmacies and social and professional knowledge, such as teamwork, how to learn while in a work setting, self-evaluation, understanding of the pharmacist role, and decision making and problem solving skills. Many of these skills and knowledge are not accounted for in the curricula in Sweden. Using a workplace learning typology to identify learning outcomes, as in this study, could be useful for curricula development. CONCLUSIONS: Exploring the learning that takes place during the APPE in a pharmacy revealed a broad range of skills and knowledge that students acquire.

Communication analysis in oncology care. Performance of a combination of a content analysis system and a global scale.

OBJECTIVE: The aim was to assess the feasibility and reliability of Velikova's Content Analysis System (VCAS) and the Medical Interaction Process System (MIPS) global scale for evaluation of communication in oncology care. METHODS: Seventy routine physician consultations with gastro-intestinal (GI) cancer patients were audio-recorded. Two coders applied VCAS and MIPS global scale to the consultations. VCAS captures aspects of communication like symptoms, side effects, functional issues (e.g. emotional, social, physical), health-related quality of life and medical decision making. MIPS global scale measures the total impression of the consultation, e.g. patient centredness and psychosocial focus. RESULTS: In total, 61 of 70 consultations were coded. The coding took twice the consultations' actual durations in minutes for VCAS. The time for coding MIPS global scale equalled the consultations length. However, the coder had then listened to the consultation twice before, coding for VCAS. Cohen's kappa for all aspects measured by VCAS varied between 0.20 and 1, mean 0.80. One category (Info on test) had a kappa of 0.20, the other categories were all above 0.60. Weighted Kappa for MIPS global scale varied between 0.25 and 0.73, mean 0.42. CONCLUSIONS: VCAS and MIPS global scale is a feasible combination of tools for evaluating patient-physician communication regarding content, medical decision making and global aspects of communication. VCAS showed high reliability. The MIPS global scale showed lower reliability, due to its sensitivity to the individual coders' unique values, common for all global scales. Further development of the combination of content and global instruments would be valuable.

Reducing dispensing errors in Swedish pharmacies: the impact of a barrier in the computer system.

BACKGROUND: Since 2004, a web-based reporting system enables monitoring of dispensing errors in all Swedish pharmacies. The adoption of this system was followed by an overall increase in reports, mainly explained by the dispensing of medicines of improper strength. In 2006 an intervention was implemented, aimed at reducing these errors. The objective of this study was to assess the impact of the intervention on the number of errors. METHODS: Monthly data on the reported number of dispensing errors from July 2004 until December 2007 were used. These were analysed in total and subdivided by type and cause of error. A time-series design was applied, and linear segmented regression analysis used to analyse whether changes in slope or level occurred; shifts in intercept or slope where p<0.01 were considered as statistically significant. RESULTS: The intervention coincided with a distinct decrease in error reports and a statistically significant change in slope that switched from a slight increase, 0.09, to a decrease, -0.26 (p = 0.0035). Medicines dispensed with wrong strength also displayed a significant change in slope, from 0.08 to -0.27 (p<0.0001), as well as dispensing errors caused by registration failure, that is, failure of the registration of a prescription in pharmacy computers, which changed from 0.05 to -0.29 (p<0.0001). CONCLUSION: The intervention was associated with a decrease in the number of reports on drugs dispensed with the wrong strength, but also had a decreasing effect on errors caused by registration failure and on the dispensing errors in total as well.