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.

[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.

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.

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."

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.

The adequacy of measurement of short and long-term consequences of false-positive screening mammography.

OBJECTIVES: The aim of this study is to review quantitative studies on women's experiences of consequences of false-positive screening mammography to assess the adequacy of the most frequently used instruments for measuring short-term and long-term psychological consequences. METHODS: Relevant papers reporting quantitative studies on consequences of false-positive screening mammography were identified using MEDLINE, CINAHL, EMBASE and PsycInfo databases. Articles citing development and psychometric properties of the most frequently used measures were also retrieved. Finally, the review focused on studies that had used at least one of the most frequently used measures. RESULTS: Twenty-three relevant studies were identified. The most commonly used measures were the General Health Questionnaire (GHQ), the Hospital Anxiety and Depression Scale (HADS), the Psychological Consequences Questionnaire (PCQ) and the State-Trait Anxiety Inventory (STAI). One or more of these was used in 17 of the 23 studies. CONCLUSIONS: The GHQ, the HADS and the STAI have problems with language, content relevance, and content coverage in studies of false-positive screening mammography. These instruments should not be used to measure psychological consequences of any kind of cancer screening. The PCQ is an adequate questionnaire for measuring short-term consequences, and the PCQ is preferable to other measures because of its higher sensitivity. However, there is little evidence that the PCQ is able to adequately detect all long-term consequences of screening mammography. Given the inadequacy of the measurement instruments used, any current conclusions about the long-term consequences of false-positive results of screening mammography must remain tentative.

The effect of low-level laser therapy on musculoskeletal pain: a meta-analysis.

A meta-analysis was undertaken of low-level laser therapy (LLLT) on musculoskeletal pain. A literature search revealed 23 LLLT trials and of these 17 were controlled trials. Ten were double blind and 7 were insufficiently blinded. Within the studies identified pain was assessed by visual analogue scale or by "some other indices of pain". Nine double-blind trials and 4 controlled trials presented results in a form which allowed pooling of data. In the double-blind trials, the mean difference in pain between LLLT and placebo was 0.3% (S.E.(d) 4.6%, confidence limits -10.3-10.9%). In the insufficiently blinded trials the mean difference in pain was 9.5% (S.E.(d) 4.5%, confidence limits -2.9-21.8%). We conclude that LLLT has no effect on pain in musculoskeletal syndromes.