Development and implementation of a tool for measuring the training effectiveness of the patient-centered consultation model.

Background: The patient-centered consultation model comprises four elements: exploring health, illness and disease experiences, understanding the whole person, finding common ground, and enhancing the patient-doctor relationship. This method is taught at the course in general practice at Copenhagen University. The aim of the study was to develop a simple tool consisting of a questionnaire about the patient-centered elements and a test video consultation. The outcome is the change in the students' ability to identify these elements. Used as a pre-course and post-course test it can inform the teachers which elements of the patient-centered consultation need intensifying in the teaching. Methods: The students from a course in general practice volunteered to participate in all steps of the development. They took part in individual interviews to select items from an already existing questionnaire (DanSCORE). The preliminary questionnaire was tested for face and content validity, pilot-tested and tested for test-retest reliability. All video consultations were transcribed and assessed for patient-centered elements through a conversation analysis. The videos showed medical students seeing real patients. Results: The preliminary version of the questionnaire (called DanOBS) had 23 items. In the subsequent interviews, items were reduced to 17, each with three response options. After a pilot test, the questionnaire was further reduced to 13 items, all strictly relevant to the model and with two response options. The final questionnaire had acceptable test-retest reliability. The number of test consultation videos underwent a reduction from six videos to one. Conclusions: The DanOBS combined with a test video consultation, used as a pre-and post-course test demonstrates for teachers which elements in the patient-centered consultation need to be intensified in the teaching.

Did psychosocial status, sociodemographics and smoking status affect non-attendance in control participants in the Danish Lung Cancer Screening Trial? A nested observational study.

OBJECTIVES: We investigated if psychosocial status, sociodemographics and smoking status affected non-attendance in the control group in the randomised Danish Lung Cancer Screening Trial (DLCST). DESIGN AND SETTING: This study was an observational study nested in the DLCST. Due to large non-attendance in the control group in the second screening round we made an additional effort to collect questionnaire data from non-attenders in this group in the third screening round. We used a condition-specific questionnaire to assess psychosocial status. We analysed the differences in psychosocial status in the third and preceding rounds between non-attenders and attenders in the control group in multivariable linear regression models adjusted for sociodemographics and smoking status reported at baseline. Differences in sociodemographics and smoking status were analysed with χ2 tests (categorical variables) and t-tests (continuous variables). PRIMARY OUTCOME MEASURE: Primary outcome was psychosocial status. PARTICIPANTS: All control persons participating in the third screening round in the DLCST were included. RESULTS: Non-attenders in the third round had significantly worse psychosocial status than attenders in the scales: 'behaviour' 0.77 (99% CI 0.18 to 1.36), 'self-blame' 0.59 (99% CI 0.14 to 1.04), 'focus on airway symptoms' 0.22 (99% CI 0.08 to 0.36), 'stigmatisation' 0.51 (99% CI 0.16 to 0.86), 'introvert' 0.56 (99% CI 0.23 to 0.89) and 'harms of smoking' 0.35 (99% CI 0.11 to 0.59). Moreover, non-attenders had worse scores than attendees in the preceding screening rounds. Non-attenders also reported worse sociodemographics at baseline. CONCLUSIONS: Non-attenders had a significantly worse psychosocial status and worse sociodemographics compared with attenders. The results of our study contribute with evidence of non-response and attrition driven by psychosocial status, which in turn may be influenced by the screening intervention itself. This can be used to adjust cancer screening trial results for bias due to differential non-attendance. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov Protocol Registration System (NCT00496977).

Consequences of screening in cervical cancer: development and dimensionality of a questionnaire.

BACKGROUND: Cervical cancer screening will inevitably lead to unintentional harmful effects e.g. detection of indolent pathological conditions defined as overdetection or overdiagnosis. Overdiagnosis often leads to overutilisation, overtreatment, labelling and thereby negative psychosocial consequences. There is a lack of adequate psychosocial measures when it comes to measurement of the harms of medical screening. However, the Consequences of Screening questionnaire (COS) has been found relevant and comprehensive with adequate psychometric properties in breast and lung cancer screening. Therefore, the aim of the present study was to extend the Consequences of Screening Questionnaire for use in cervical cancer screening by testing for content coverage, dimensionality, and reliability. METHODS: In interviews, the suitability, content coverage, and relevance of the COS were tested on participants in cervical screening. The results were thematically analysed to identify the key consequences of abnormal screening results. Item Response Theory and Classical Test Theory were used to analyse data. Dimensionality, invariance, and reliability were established by item analysis, examining the fit between item responses and Rasch models. RESULTS: All COS items were found relevant by the interviewees and the ten COS constructs were confirmed each to be unidimensional in the Rasch models. Ten new themes specifically relevant for participants having abnormal cervical screening result were extracted from the interviews: 'Uncertainty about the screening result', 'Uncertainty about future pregnancy', 'Change in body perception', 'Change in perception of own age', 'Guilt', 'Fear and powerlessness', 'Negative experiences from the pelvic examination', 'Negative experiences from the examination', 'Emotional reactions' and 'Sexuality' Altogether, 50 new items were generated: 10 were single items. Most of the remaining 40 items were confirmed to fit Rasch models measuring ten different constructs. However, the two items in the scale 'Change in perception of own age' both possessed differential item functioning in relation to time, which can bias longitudinal repeated measurement. CONCLUSIONS: The reliability and the dimensionality of a condition-specific measure with high content validity for women having an abnormal cervical cancer screening results have been demonstrated. This new questionnaire called Consequences Of Screening in Cervical Cancer (COS-CC) covers in two parts the psychosocial experience in cervical cancer screening.

Diabetic complications do not hamper improvement of health-related quality of life over the course of treatment of diabetic foot ulcers - the Eurodiale study.

AIMS: Diabetic complications, and in particular diabetic foot ulcers (DFUs), are associated with low health-related quality of life (HRQoL). We evaluated whether the presence of diabetic complications also influenced the improvement of HRQoL during DFU treatment. METHODS: 1088 patients presenting for DFU treatment at the centers participating in the Eurodiale study were followed prospectively up to one year. HRQoL was measured both at presentation and after healing or at end of follow up, using EQ-5D: a standardized instrument consisting of five domains and a summary index. The influence of diabetic comorbidity on the course of HRQoL was evaluated for each of the EQ-5D outcomes in multi-level linear regression analyses, adjusting for baseline characteristics. RESULTS: HRQoL improved in all EQ-5D outcomes over the course of treatment for those DFUs that healed. The few significant differences in the development of HRQoL between patients with and without comorbidity showed a more beneficial development for patients with comorbidity in DFUs that did not heal or healed slowly. CONCLUSIONS: Comorbidity does not hamper improvement of HRQoL in DFU treatment. On the contrary, HRQoL improved sometimes more in patients with certain comorbidity with hard-to-heal ulcers.

[Lung cancer screening with low dose CT requires careful consideration].

Results from the American National Lung Screening Trial (NLST) show a significant reduction in lung cancer and all-cause mortality in a high risk population screened with annual low-dose CT. Handling of pulmonary nodules, false positive tests, overdiagnosis, psychosocial consequences and cost-efficiency etc. are all aspects that require careful consideration. This paper gives an overview of the current knowledge on these issues. Before a recommendation can be made, we need an overall evaluation of both the benefits and harms in CT screening for lung cancer.

[Lung cancer screening with low-dose CT - Danish and international results].

Lung cancer is the cancer type that causes the largest number of deaths in Denmark. With advances in medical imaging and widespread use of computed tomography (CT), it is possible to detect even small abnormalities in lung tissue. This has led to a great interest in lung cancer screening with low-dose CT and launching of randomised screening trials worldwide. This paper gives an overview of the current lung cancer screening trials in Denmark and internationally and focuses on main lung cancer findings and mortality results.

Health-related quality of life predicts major amputation and death, but not healing, in people with diabetes presenting with foot ulcers: the Eurodiale study.

OBJECTIVE: Low health-related quality of life (HRQoL) has been consistently reported to be associated with poor prognosis for a variety of health outcomes in various settings. We aimed to evaluate whether HRQoL in patients presenting with new diabetic foot ulcers (DFUs) has prognostic significance for ulcer healing, major amputation, and death. RESEARCH DESIGN AND METHODS: We followed 1,088 patients with new DFUs presenting for treatment at one of the 14 centers in 10 European countries participating in the Eurodiale (European Study Group on Diabetes and the Lower Extremity) study, prospectively until healing (76.9%), major amputation (4.6%), or death (6.4%) up to a maximum of 1 year. At baseline, patient and ulcer characteristics were recorded as well as EQ-5D, a standardized instrument consisting of five domains and a visual analog scale for use as a measure of HRQoL. The prognostic influence of the EQ-5D domains was evaluated in multivariable Cox regression analyses on the time-to-event data, adjusting for baseline clinical characteristics of the ulcer and comorbidities. RESULTS: While predictive effects of HRQoL, adjusted for possible confounders, were absent for healing, decreased HRQoL, especially in the physical domains, was statistically significant for major amputation (mobility, self-care, usual activities) and death (self-care, usual activities, pain/discomfort). CONCLUSIONS: Low HRQoL appears to be predictive for major amputation and death, but high HRQoL does not increase healing. Future studies into the influence of HRQoL on ulcer outcome are important in attempts to decrease treatment failure and mortality.

The development and validation of a multidimensional sum-scaling questionnaire to measure patient-reported outcomes in acute respiratory tract infections in primary care: the acute respiratory tract infection questionnaire.

OBJECTIVE: Patient-reported outcomes are seldom validated measures in clinical trials of acute respiratory tract infections (ARTIs) in primary care. We developed and validated a patient-reported outcome sum-scaling measure to assess the severity and functional impacts of ARTIs. METHODS: Qualitative interviews and field testing among adults with an ARTI were conducted to ascertain a high degree of face and content validity of the questionnaire. Subsequently, a draft version of the Acute Respiratory Tract Infection Questionnaire (ARTIQ) was statistically validated by using the partial credit Rasch model to test dimensionality, objectivity, and reliability of items. Test of known groups' validity was conducted by comparing participants with and without an ARTI. RESULTS: The final version of the ARTIQ consisted of 38 items covering five dimensions (Physical-upper, Physical-lower, Psychological, Sleep, and Medicine) and five single items. All final dimensions were confirmed to fit the Rasch model, thus enabling sum-scaling of responses. The ARTIQ scores in participants with an ARTI were significantly higher than in those without ARTI (known groups' validity). CONCLUSION: A self-administered, multidimensional, sum-scaling questionnaire with high face and content validity and adequate psychometric properties for assessing severity and functional impacts from ARTIs in adults is available to clinical trials and audits in primary care.

[Too many difficult words in printed communications from the health-care system to laypeople]. / For mange svære ord i skriftlig kommunikation fra sundhedsvæsenet.

INTRODUCTION: It is vital that patients understand the language used in leaflets in medicine packages and in information for participation in medical research. The aim of the study was to determine the proportion of Danes with reading skills corresponding to 9-10 years of schooling who understand the language used by health-care professionals in materials targeted at laypeople. MATERIAL AND METHODS: Based on a study of ordinary citizens' understanding of the language used in printed communication from Danish authorities we tested the words used in printed matters from the health-care system; specifically information forms and questionnaires from research protocols submitted to the local ethics committee. In addition 44 students from adult learning centres were asked to comment on their understanding of words via individual interviews about patient leaflets from medicine packages. In total 143 common words were selected and tested with 404 other students. A word would be considered difficult if less than 90% of the students understood its meaning. RESULTS: Of the 143 words, 14 (10%) were understood correctly by less than 10% of the students, 33 (23%) by 10-25%, 46 (32%) by 25-50%, and 50 (35%) by more than half. No words were understood by 90% or more. CONCLUSION: Ordinary words are difficult to understand when used in a medical context. Our study did not identify any rule or principle to predict which words laypeople understand. Consequently printed communications from the health-care system to laypeople must be pre-tested by end users to ensure comprehension.

CT screening for lung cancer brings forward early disease. The randomised Danish Lung Cancer Screening Trial: status after five annual screening rounds with low-dose CT.

BACKGROUND: The effects of low-dose CT screening on disease stage shift, mortality and overdiagnosis are unclear. Lung cancer findings and mortality rates are reported at the end of screening in the Danish Lung Cancer Screening Trial. METHODS: 4104 men and women, healthy heavy smokers/former smokers were randomised to five annual low-dose CT screenings or no screening. Two experienced chest radiologists read all CT scans and registered the location, size and morphology of nodules. Nodules between 5 and 15 mm without benign characteristics were rescanned after 3 months. Growing nodules (>25% volume increase and/or volume doubling time<400 days) and nodules >15 mm were referred for diagnostic workup. In the control group, lung cancers were diagnosed and treated outside the study by the usual clinical practice. RESULTS: Participation rates were high in both groups (screening: 95.5%; control: 93.0%; p<0.001). Lung cancer detection rate was 0.83% at baseline and mean annual detection rate was 0.67% at incidence rounds (p=0.535). More lung cancers were diagnosed in the screening group (69 vs. 24, p<0.001), and more were low stage (48 vs 21 stage I-IIB non-small cell lung cancer (NSCLC) and limited stage small cell lung cancer (SCLC), p=0.002), whereas frequencies of high-stage lung cancer were the same (21 vs 16 stage IIIA-IV NSCLC and extensive stage SCLC, p=0.509). At the end of screening, 61 patients died in the screening group and 42 in the control group (p=0.059). 15 and 11 died of lung cancer, respectively (p=0.428). CONCLUSION: CT screening for lung cancer brings forward early disease, and at this point no stage shift or reduction in mortality was observed. More lung cancers were diagnosed in the screening group, indicating some degree of overdiagnosis and need for longer follow-up.

Paracetamol for feverish children: parental motives and experiences.

OBJECTIVE: The sale of paracetamol products for children is increasing, and more children are accidentally given overdoses, even though the use of paracetamol against fever is still under discussion. This study explores Danish parents' use of paracetamol for feverish children and their motives for this use. DESIGN: A cross-sectional survey using structured interviews. Setting. Four general practices located in city, suburb, and rural area. SUBJECTS: A total of 100 Danish parents with at least one child under the age of 10 years. MAIN OUTCOME MEASURES: Number of parents administering paracetamol to feverish children, situations triggering medication of a child, parental views regarding fever and effects of paracetamol, and sources of information on fever treatment. RESULTS: Three in four parents use paracetamol for feverish children, mainly to reduce temperature, to decrease pain, and to help the child fall asleep. Highly educated parents medicate more often than less educated. Parents often fear fever but this does not clearly affect their use of paracetamol. Many parents believe in perceived beneficial effects of paracetamol, such as increased appetite and well-being, better sleep, and prevention of fever seizures. These expectations of paracetamol influence parental use of the drug. Parents' main source of information on fever and paracetamol is their general practitioner (GP). CONCLUSIONS: Danish parents regularly treat feverish children with paracetamol. Although parents contact their GP for advice on fever treatment, paracetamol is sometimes given to children on vague indications. Clearer information for parents on when to give paracetamol as fever treatment may help regulate its use.

Consequences of screening in lung cancer: development and dimensionality of a questionnaire.

OBJECTIVE: The objective of this study was to extend the Consequences of Screening (COS) Questionnaire for use in a lung cancer screening by testing for comprehension, content coverage, dimensionality, and reliability. METHODS: In interviews, the suitability, content coverage, and relevance of the COS were tested on participants in a lung cancer screening program. The results were thematically analyzed to identify the key consequences of abnormal and false-positive screening results. Item Response Theory and Classical Test Theory were used to analyze data. Dimensionality, objectivity, and reliability were established by item analysis, examining the fit between item responses and Rasch models. RESULTS: Eight themes specifically relevant for participants in lung cancer screening results were identified: "self-blame,""focus on symptoms,""stigmatization,""introvert,""harm of smoking,""impulsivity,""empathy," and "regretful of still smoking." Altogether, 26 new items for part I and 16 new items for part II were generated. These themes were confirmed to fit a partial-credit Rasch model measuring different constructs including several of the new items. CONCLUSION: In conclusion, the reliability and the dimensionality of a condition-specific measure with high content validity for persons having abnormal or false-positive lung cancer screening results have been demonstrated. This new questionnaire called Consequences of Screening in Lung Cancer (COS-LC) covers in two parts the psychosocial experience in lung cancer screening. Part I: "anxiety,""behavior,""dejection,""sleep,""self-blame,""focus on airway symptoms,""stigmatization,""introvert," and "harm of smoking." Part II: "calm/relax,""social network,""existential values,""impulsivity,""empathy," and "regretful of still smoking."

General practitioners' experiences with provision of healthcare to patients with self-reported multiple chemical sensitivity.

OBJECTIVE: To describe general practitioners' (GPs') evaluation of and management strategies in relation to patients who seek medical advice because of multiple chemical sensitivity (MCS). DESIGN: A nationwide cross-sectional postal questionnaire survey. The survey included a sample of 1000 Danish GPs randomly drawn from the membership list of GPs in the Danish Medical Association. SETTING: Denmark. RESULTS: Completed questionnaires were obtained from 691 GPs (69%). Within the last 12 months 62.4% (n = 431) of the GPs had been consulted by at least one patient with MCS. Of these, 55.2% of the GPs evaluated the patients' complaints as chronic and 46.2% stated that they were rarely able to meet the patients' expectations for healthcare. The majority, 73.5%, had referred patients to other medical specialties. The cause of MCS was perceived as multi-factorial by 64.3% of the GPs, as somatic/biologic by 27.6%, and as psychological by 7.2%. Partial or complete avoidance of chemical exposures was recommended by 86.3%. Clinical guidelines, diagnostic tools, or more insight in the pathophysiology were requested by 84.5% of the GPs. CONCLUSION: Despite the lack of formal diagnostic labelling the patient with MCS is well known by GPs. The majority of the GPs believed that MCS primarily has a multi-factorial explanation. However, perceptions of the course of the condition and management strategies differed, and many GPs found it difficult to meet the patients' expectations for healthcare. The majority of the GPs requested more knowledge and clinical guidelines for the management of this group of patients.

The Danish randomized lung cancer CT screening trial--overall design and results of the prevalence round.

INTRODUCTION: Lung cancer screening with low dose computed tomography (CT) has not yet been evaluated in randomized clinical trials, although several are underway. METHODS: In The Danish Lung Cancer Screening Trial, 4104 smokers and previous smokers from 2004 to 2006 were randomized to either screening with annual low dose CT scans for 5 years or no screening. A history of cigarette smoking of at least 20 pack years was required. All participants have annual lung function tests, and questionnaires regarding health status, psychosocial consequences of screening, smoking habits, and smoking cessation. Baseline CT scans were performed in 2052 participants. Pulmonary nodules were classified according to size and morphology: (1) Nodules smaller than 5 mm and calcified (benign) nodules were tabulated, (2) Noncalcified nodules between 5 and 15 mm were rescanned after 3 months. If the nodule increased in size or was larger than 15 mm the participant was referred for diagnostic workup. RESULTS: At baseline 179 persons showed noncalcified nodules larger than 5 mm, and most were rescanned after 3 months: The rate of false-positive diagnoses was 7.9%, and 17 individuals (0.8%) turned out to have lung cancer. Ten of these had stage I disease. Eleven of 17 lung cancers at baseline were treated surgically, eight of these by video assisted thoracic surgery resection. CONCLUSIONS: Screening may facilitate minimal invasive treatment and can be performed with a relatively low rate of false-positive screen results compared with previous studies on lung cancer screening.

Consequences of Screening in Breast Cancer (COS-BC): development of a questionnaire.

OBJECTIVE: The aims of the study were to translate and adapt both the negative and positive items of the Psychological Consequences Questionnaire (PCQ) into Danish and to test the translated version for comprehension, suitability, and content coverage by developing new items in a setting of false-positive screening mammography. DESIGN: The translation was carried out following an internationally accepted method involving two panels: bilingual and lay. SUBJECTS: The suitability and the content coverage of the PCQ were tested in six group interviews. Participants in the interviews were women who had had a false-positive screening mammography. They were grouped according to additional examinations they experienced following abnormal screening mammography. The audio-recordings from the group interviews were thematically analysed to identify the key consequences of abnormal and false-positive screening mammography. RESULTS: Fifteen new items were generated to cover the negative psychosocial consequences of abnormal and false-positive screening mammography comprehensively. Five new items were produced that concerned the consequences of screening mammography during the period after being declared "free from" suspicion of cancer. Three items from the PCQ were deleted because they were judged by interviewees to be irrelevant. Response options for the positive items were changed to allow responses in both positive and negative directions. CONCLUSION: Because of the major changes to both parts of the PCQ the measure derived from this study should be regarded as a new questionnaire with two parts: Consequences Of Screening in Breast Cancer (COS-BC). Part II focuses on the long-term consequences of a false-positive screening mammography.

Validation of a condition-specific measure for women having an abnormal screening mammography.

OBJECTIVES: The aim of this study is to assess the validity of a new condition-specific instrument measuring psychosocial consequences of abnormal screening mammography (PCQ-DK33). METHODS: The draft version of the PCQ-DK33 was completed on two occasions by 184 women who had received an abnormal screening mammography and on one occasion by 240 women who had received a normal screening result. Item Response Theories and Classical Test Theories were used to analyze data. Construct validity, concurrent validity, known group validity, objectivity and reliability were established by item analysis examining the fit between item responses and Rasch models. RESULTS: Six dimensions covering anxiety, behavioral impact, sense of dejection, impact on sleep, breast examination, and sexuality were identified. One item belonging to the dejection dimension had uniform differential item functioning. Two items not fitting the Rasch models were retained because of high face validity. A sick leave item added useful information when measuring side effects and socioeconomic consequences of breast cancer screening. Five "poor items" were identified and should be deleted from the final instrument. CONCLUSIONS: Preliminary evidence for a valid and reliable condition-specific measure for women having an abnormal screening mammography was established. The measure includes 27 "good" items measuring different attributes of the same overall latent structure-the psychosocial consequences of abnormal screening mammography.

Measuring the psychosocial consequences of screening.

The last three decades have seen a dramatic rise in the implementation of screening programmes for cancer in industrialised countries. However, in contrast to screening for infectious diseases, most cancer screening programmes only have the potential to reduce mortality; they cannot lower the incidence of cancer in a population. In fact, most cancer screening programmes have been shown to increase the incidence of the disease as a consequence of over-diagnosis. A further dilemma of cancer screening programmes is that they do not distinguish between healthy people and those with disease. Rather, they identify a continuum of disease severity. Consequently, many healthy people who have abnormal screening tests are wrongly diagnosed. Indeed, studies have demonstrated that for each screening-prevented death from cancer, at least 200 false-positive results are given. Therefore, screening has the potential to be harmful as well as beneficial. The psychosocial consequences of false-positive screening results cannot be determined by diagnostic tests or by other technical means. Instead, patient reported outcome measures must be employed. To measure the outcomes of screening accurately and comprehensively patient reported outcome measures have to capture; the nature and extent of the psychosocial consequences and how these change over time. The outcome measures used must have high content validity and their psychometric properties should be determined prior to their use in the specific population. In particular it is important to establish unidimensionality, additivity and item ordering through the application of Item Response Theory.

Development and validation of a quality of life questionnaire for patients with colostomy or ileostomy.

BACKGROUND: Quality of life of stoma patients is increasingly being addressed in clinical trials. However, the instruments used in the majority of these studies have not been validated specifically for stoma patients. The aim of this paper is to describe the development and validation of a quality-of-life instrument, "Stoma-QOL", specifically for patients with colostomy or ileostomy. METHODS: Potential items were formulated in English on the basis of the results of a series of semi-structured interviews with 169 adult stoma patients. The process resulted in a preliminary 37-item version, which was translated into French, German, Spanish and Danish, and administered repeatedly to 182 patients with colostomy or ileostomy. A psychometric selection of items was performed through Rasch Analysis. The measurement properties of the final questionnaire version were subsequently tested. RESULTS: The 20 items in the final questionnaire covered four domains--sleep, sexual activity, relations to family and close friends, and social relations to other than family and close friends. These items were found to define a unidimensional variable according to Rasch specifications (Infit MNSQ < 1.3). Internal consistency reliability calculated as Cronbach's alpha was 0.92, i.e., highly reliable. Spearman's correlation coefficients of scores across times of administration was > 0.88 (p < 0.01), indicating a high test-retest reliability. Item calibrations by country calculated as ICC were 0.81 (0.67-0.91 95% CI), confirming cross-cultural comparability across the European countries included in the study. CONCLUSION: Given the adequacy of the metric properties of the Stoma-QOL suggested by the psychometric analyses, this study confirms the suitability of the instrument in clinical practice and in clinical research.