SEARCH · PubMed Health

Results for “Internal validation”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 469 records · Page 26Linked to original sources

PubMedDate not supplied

[The stress index: proposed method for risk assessment of stress and burnout in health care settings].

To assess the risk from exposure to stress and burnout in health care workers, a pilot study was planned to compare and integrate the information based on the risk evaluation obtained through different parameters that can be quantified and elaborated to produce a numerical index, called the "Stress Index", and the subjective symptoms from the individual workers. For these purposes, three internationally validated questionnaires were administered: the Job Content Questionnaire, the State-Trait Anxiety Inventory and the Maslach Burnout Inventory. The study considered six different Units from three divisions of Internal Medicine of a large public hospital in Northern Italy, and a total group of 228 health care workers employed in the six units. The results showed an association between the Stress Index scores and the scores from the questionnaires. In particular, in the two units with the highest levels of the index, a significantly higher unbalance between job demand and decision latitude was observed, together with the highest levels of state and trait anxiety and of depersonalization, indicating higher burnout levels.

Burnout, Professional↗

PubMed2001

A food frequency questionnaire for youth: psychometric analysis and summary of eating habits in adolescents.

PURPOSE: To examine the reliability and validity of the Eating Habits Questionnaire (EHQ) for adolescents and assess eating habits in the context of the Food Pyramid. METHODS: Subjects were 446 students (81.2% female) attending three middle schools (sixth to eighth grades). Over half (56.9%) were African-American. Reliability was assessed with 48-h and 2-week retests on two subsamples (n = 62) and validity was assessed by comparison with three 24-h recalls on an additional subsample (n = 24) and by factor analysis. The EHQ is a self-administered questionnaire consisting of 83 food items and questions assessing food habits and food preparation style. RESULTS: Internal validity, determined with factor analysis, found that 10 factors explained 81.3% of the variance in eating habits. Overall perfect agreement between food groups reported on the 24-h recall and on the EHQ was 56%. Internal consistency, assessed by Cronbach alpha, ranged from .60 to .89. Test-retest correlations were highest at 48 h, ranging from .46 to .85 for the 10 factors. Adolescents ate more servings of fats and sugars (11.2) and meats (6.0) and fewer breads (5.2) and vegetables (1.6) than recommended in Food Pyramid guidelines. In addition, subjects consumed more high-fat protein than low-fat protein servings. CONCLUSIONS: The EHQ is a valid and reliable food frequency questionnaire that has been tested with African-American and white adolescents in the Southeast. It showed that adolescents consume higher than recommended daily servings of fats, sweets, and meats and lower than recommended servings of vegetables and breads.

Adolescent↗

PubMed1998

Behavioral disorders in Alzheimer disease: a transcultural perspective.

OBJECTIVES: To compare 2 samples of patients with Alzheimer disease (AD), from Italy and the United States, in order to determine transcultural differences in the manifestation of noncognitive symptoms. To analyze the concurrent validity, internal consistency reliability, between-rater reliability, and test-retest reliability of the Neuropsychiatric Inventory Scale (NPI). METHODS: The NPI was given to 50 Italian and 50 US patients with AD. To demonstrate the validity and reliability of the Italian version of the instrument, several different methods of analysis were used. The total score on the NPI and the score of single items in the different stages of the disease were compared in the 2 samples of patients. RESULTS: A high level of internal consistency reliability was confirmed, the between-rater reliability was very high, and the test-retest reliability was significantly correlated. Apathy was the most frequently recorded behavior in the Italian sample. Five of 10 NPI item scores showed a significant relation with the Mini-Mental State Examination scores in both samples. The Italian patients showed an increasing and significantly higher mean NPI total score at all levels of dementia severity when compared with the US patients. The scores on some NPI subscales, such as apathy, aberrant motor behavior, disinhibition, and agitation, were significant higher in Italian patients at different levels of severity covarying with educational level. CONCLUSIONS: These results indicate that NPI is a reliable instrument with which to study transcultural differences in the presentation of neuropsychiatric disturbances in patients with AD. The described similar pattern of behaviors between Italians and US patients with AD suggests a biological origin of the disorders. However, cultural influences must be taken in account when the focus of the study is on psychopathological aspects of dementia.

Aged↗

PubMed1985

A psychometric assessment of Hare's checklist for psychopathy on an English prison population.

The research scale for psychopathy developed by Hare (1980) represents an important recent advance in the assessment of this disorder in that it emphasizes objectivity and reliability. This study compares the factor structure of the scale derived from an English prison sample with the original Canadian sample in order to assess the cross-cultural generalizability of the checklist and reassess the factorial basis of the scale. Results from the first analysis indicate substantial correspondence between psychopathy factors derived from English and Canadian analyses. Results of a second analysis suggest that four main clusters of traits (emotional detachment, superficial relationships, egocentricity, and impulsivity) are centrally important in the identification of psychopathy. Results of further psychometric analyses suggest increasing the scale's validity by deleting several items having little in common with the main features of psychopathy. It is concluded that Hare's checklist is both applicable to an English population and internally valid, and that future research may usefully investigate correlates of each of the four psychopathy factors.

Adult↗

PubMed1999

The psychometric properties of the diabetes management self-efficacy scale for patients with type 2 diabetes mellitus.

This article summarizes the development and validation of a scale to measure the level of self-efficacy of patients with type 2 diabetes mellitus. Self-efficacy is described as people's belief in their capability to organize and execute the course of action required to deal with prospective situations. This self-efficacy scale was developed based on the self-care activities these patients have to carry out in order to manage their diabetes. The following psychometric properties of this scale were established: content validity, construct validity, internal consistency and stability. The original scale contained 42 items. A panel of five experts in diabetes and four self-efficacy experts evaluated the original scale two times for relevance and clarity. This content validity procedure resulted in a final scale which consisted of 20 items. Subsequently, patients with type 2 diabetes were asked to complete this 20-item scale and further tests were done with the 94 usable responses. Factor analysis identified four factors, all of which were related to clusters of self-care activities used to manage diabetes which comprised this scale. The internal consistency of the total scale was alpha=0.81 and the test-retest reliability with a 5-week time interval was r=0.79 (P < 0.001).

Adult↗

PubMed2000

Pretreatment nomogram for predicting the outcome of three-dimensional conformal radiotherapy in prostate cancer.

PURPOSE: Several studies have defined risk groups for predicting the outcome after external-beam radiotherapy of localized prostate cancer. However, most models formed patient risk groups, and none of these models considers radiation dose as a predictor variable. The purpose of this study was to develop a nomogram to improve the accuracy of predicting outcome after three-dimensional conformal radiotherapy. MATERIALS AND METHODS: This study was a retrospective, nonrandomized analysis of patients treated at the Memorial Sloan-Kettering Cancer Center between 1988 and 1998. Clinical parameters of the 1,042 patients included stage, biopsy Gleason score, pretreatment serum prostate-specific antigen (PSA) level, whether neoadjuvant androgen deprivation therapy was administered, and the radiation dose delivered. Biochemical (PSA) treatment failure was scored when three consecutive rises of serum PSA occurred. A nomogram, which predicts the probability of remaining free from biochemical recurrence for 5 years, was validated internally on this data set using a bootstrapping method and externally using a cohort of patients treated at the Cleveland Clinic, Cleveland, OH. RESULTS: When predicting outcomes for patients in the validation data set from the Cleveland Clinic, the nomogram had a Somers' D rank correlation between predicted and observed failure times of 0.52. Predictions from this nomogram were more accurate (P<.0001) than the best of seven published risk stratification systems, which achieved a Somers' D coefficient of 0.47. CONCLUSION: The development process illustrated here produced a nomogram that seems to predict more accurately than other available systems and may be useful for treatment selection by both physicians and patients.

Aged↗

PubMed2004

A clinical prediction rule for diagnosing severe acute respiratory syndrome in the emergency department.

BACKGROUND: Accurate, objective models of triage for patients with suspected severe acute respiratory syndrome (SARS) could assess risks and improve decisions about isolation and inpatient treatment. OBJECTIVE: To develop and validate a clinical prediction rule for identifying patients with SARS in an emergency department setting. DESIGN: Retrospective analysis using a 2-step coefficient-based multivariable logistic regression scoring method with internal validation by bootstrapping. SETTING: 2 hospitals in Hong Kong. PARTICIPANTS: 1274 consecutive patients from 1 hospital and 1375 consecutive patients from another hospital. MEASUREMENTS: Points were assigned on the basis of history, physical examination, and simple investigations obtained at presentation. The outcome measure was a final diagnosis of SARS, as confirmed by World Health Organization laboratory criteria. RESULTS: Predictors for SARS on the basis of history (step 1) included previous contact with a patient with SARS and the presence of fever, myalgia, and malaise. Age 65 years and older and younger than 18 years and the presence of sputum, abdominal pain, sore throat, and rhinorrhea were inversely related to having SARS. In step 2, haziness or pneumonic consolidation on chest radiographs and low lymphocyte and platelet counts, in addition to a positive contact history and fever were associated with a higher probability of SARS. A high neutrophil count, the extremes of age, and sputum production were associated with a lower probability of SARS. In the derivation sample, the observed incidence of SARS was 4.4% for those assigned to the low-risk group (in steps 1 or 2); in the high-risk group, incidence of SARS was 21.0% for quartile 1, 39.5% for quartile 2, 61.2% for quartile 3, and 79.7% for quartile 4. This prediction rule achieved an optimism-corrected sensitivity of 0.90, a specificity of 0.62, and an area under the receiver-operating characteristic curve of 0.85. LIMITATIONS: The prediction rule may not apply to isolated cases occurring during an interepidemic period. Generalizability of the findings should be confirmed in other SARS-affected countries and should be prospectively validated if SARS returns. CONCLUSIONS: Our findings suggest that a simple model that uses clinical data at the time of presentation to an emergency department during an acute outbreak predicted the incidence of SARS and provided good diagnostic utility.

Adult↗

PubMedDate not supplied

[Tyrer's Brief Scale for Anxiety used with outpatients. First validation in the French language].

The brief scale for anxiety of Tyrer is a subdivision of the comprehensive psychopathological scale. We studied a serie of 105 anxious outpatients treated for chronic or reactive anxiety, without depressive or psychotic symptoms. We confirm its sensitivity to change, prove its concurrent validity in regard to the Hamilton anxiety rating scale and demonstrate that the brief scale for anxiety is a reliable instrument to assess anxiety with outpatients. Nevertheless the assessment of its internal validity raises the question of the item's selection at the time of the elaboration of the rating scales according to the scale's purpose. Indeed, must we attempt to register all the symptoms of the anxious syndrome, with the risk of including less specific items? Or must we choose the most characteristic and specific items with the risk of obtaining a more reductionist inventory, but more reliable in a "transnosographic" perspective?

Adult↗

PubMed1999

Development and validation of a core outcome measure for palliative care: the palliative care outcome scale. Palliative Care Core Audit Project Advisory Group.

OBJECTIVES: To develop an outcome measure for patients with advanced cancer and their families which would cover more than either physical symptoms or quality of life related questions. To validate the measure in various specialist and non-specialist palliative care settings throughout the UK. DESIGN: A systematic literature review of measures appropriate for use in palliative care settings was conducted. In conjunction with a multidisciplinary project advisory group, questions were chosen for inclusion into the scale based on whether they measured aspects of physical, psychological, or spiritual domains pertinent to palliative care, and whether similar items had shown to be valid as part of another measure. A staff completed version was developed to facilitate data collection on all patients throughout their care, and a patient completed version was designed to enable the patient to contribute to the assessment of their outcomes when possible. A full validation study was conducted to evaluate construct validity, internal consistency, responsiveness to change over time, and test-retest reliability. Assessments were timed. SETTING: Eight centres in England and Scotland providing palliative care, including inpatient care, outpatient care, day care, home care, and primary care. PATIENTS: A total of 450 patients entered care during the study period. Staff collected data routinely on patients in care long enough to be assessed (n = 337). Of these, 262 were eligible for patient participation; 148 (33%) went on to complete a questionnaire. MAIN MEASURES: The Palliative Care Outcome Scale (POS), the European Organisation for Research on Cancer Treatment, and the Support Team Assessment Schedule. RESULTS: The POS consists of two almost identical measures, one of which is completed by staff, the other by patients. Agreement between staff and patient ratings was found to be acceptable for eight out of 10 items at the first assessment. The measure demonstrated construct validity (Spearman rho = 0.43 to 0.80). Test/re-test reliability was acceptable for seven items. Internal consistency was good (Cronbach's alpha = 0.65 (patients), 0.70 (staff)). Change over time was shown, but did not reach statistical significance. The questionnaire did not take more than 10 minutes to complete by staff or patients. CONCLUSION: The POS has acceptable validity and reliability. It can be used to assess prospectively palliative care for patients with advanced cancer.

England↗

PubMed2006

Explanatory and pragmatic perspectives regarding idiopathic physical symptoms and related syndromes.

In recent years, research-methods literature mainly addressing controlled clinical trials has arisen regarding explanatory and pragmatic treatment trials. Explanatory trials tend to examine causal mechanisms and questions of efficacy and value internal validity (creating optimal study conditions) over generalizability (using study results to understand treatment effects in real-life patient populations). In contrast, pragmatic trials value "external relevance" (generalizability) of study results over "internal elegance" so that clinicians and health policymakers can better understand how treatments might impact their patients and policies. This review draws inspiration from these contrasting explanatory and pragmatic perspectives and develops them for clinical and research pertaining to idiopathic physical symptoms and related syndromes (eg, somatization disorder, chronic fatigue syndrome, multiple chemical sensitivities, irritable bowel syndrome). Explanatory and pragmatic perspectives are used to examine these idiopathies with regard to causation, case definition, labels, and treatment. It is concluded that idiopathic symptom syndromes are fundamentally pragmatic clinical and research challenges. For epidemiologic and methodologic reasons, the complex explanations for these syndromes remain largely elusive. Even so, scientific and clinical pragmatism offers the opportunity to reduce disagreement between competing medical disciplines and between clinicians and affected patients with regard to irreconcilable etiologic questions and to remain evidence-based in the care of patients.

Anxiety Disorders↗

PubMed2006

Fast-track failure after cardiac surgery: development of a prediction model.

OBJECTIVE: Risk factors for unsuccessful fast-tracking of cardiac surgery patients have not been collectively defined in the literature. The aim of this study was to determine risk factors for fast-track failure and incorporate them into a predictive fast-track failure score. DESIGN: Prospective observational study. SETTING: Cardiothoracic Department of St Mary's Hospital, London. PATIENTS: Data were collected from April 2003 to April 2005 including 1,084 patients undergoing heart surgery who were admitted into the fast-track unit. INTERVENTIONS: Multifactorial logistic regression was used to develop a propensity score for estimating the likelihood of fast-track failure. MEASUREMENTS AND MAIN RESULTS: One hundred and sixty-nine patients failed fast-track management (15.6%). Independent predictors for fast-track failure were impaired left ventricular function with or without recent acute coronary syndrome (odds ratios 2.89 and 1.65 respectively), re-do operation (one, two, or more vs. none, odds ratio 1.75, 7.98), extracardiac arteriopathy (odds ratio 2.63), preoperative intra-aortic balloon pump (odds ratio 3.09), raised serum creatinine in micromol/L (120-150, >150 vs. <120, odds ratio 1.57, 11.24), and nonelective (odds ratio 3.43) and complex surgery (odds ratio 2.70). Model validation showed very good discrimination (area under the curve = 0.815) and calibration (ĉ statistic = 8.527, p = .129). CONCLUSIONS: The fast-track failure score incorporates several preoperative factors and has been successfully internally validated; after undergoing external validation and possible recalibration it may be used as a tool to facilitate planning and flow of cardiac surgery patients, based on the predicted probability of failure. Application of this score may limit fast-track failure rates and help to reduce morbidity and cost.

Aged↗

PubMed2005

Measuring diabetes self-care: a psychometric analysis of the Self-Care Inventory-Revised with adults.

OBJECTIVE: To examine psychometric properties of the Self-Care Inventory-revised (SCI-R), a self-report measure of perceived adherence to diabetes self-care recommendations, among adults with diabetes. RESEARCH DESIGN AND METHODS: We used three data sets of adult type 1 and type 2 diabetic patients to examine psychometric properties of the SCI-R. Principal component and factor analyses examined whether a general factor or common factors were present. Associations with measures of theoretically related concepts were examined to assess SCI-R concurrent and convergent validity. Internal reliability coefficients were calculated. Responsiveness was assessed using paired t tests, effect size, and Guyatt's statistic for type 1 patients who completed psychoeducation. RESULTS: Principal component and factor analyses identified a general factor but no consistent common factors. Internal consistency of the SCI-R was alpha = 0.87. Correlation with a measure of frequency of diabetes self-care behaviors was r = 0.63, providing evidence for SCI-R concurrent validity. The SCI-R correlated with diabetes-related distress (r = -0.36), self-esteem (r = 0.25), self-efficacy (r = 0.47), depression (r = -0.22), anxiety (r = -0.24), and HbA(1c) (r = -0.37), supporting construct validity. Responsiveness analyses showed SCI-R scores improved with diabetes psychoeducation with a medium effect size of 0.62 and a Guyatt's statistic of 0.85. CONCLUSIONS: The SCI-R is a brief, psychometrically sound measure of perceptions of adherence to recommended diabetes self-care behaviors of adults with type 1 or type 2 diabetes.

Adult↗

PubMed2002

Standardization using the harmonically weighted ratios: internal and external comparisons.

Standardization of rates is a basic tool for epidemiologists. The most frequently used methods are the 'direct standardization' (with summary index of comparative mortality figure, CMF) and the 'indirect standardization' (with summary index of standardized mortality ratio, SMR). The CMF facilitates a valid comparison between populations or across time periods, yet, it suffers from the problem of instability. By contrast, the SMR is stable and can be used for external comparison. However, it cannot guarantee a valid internal comparison. In this paper, the author proposes a new standardized measure, the 'harmonically weighted ratio' (HWR). The HWR can be used for external as well as internal comparisons--with the assumption of rate-ratio homogeneity, or with heterogeneity but dominance of one population over another. Simulation shows that its performance in terms of pairwise comparisons is the best among the three methods or compares favourably to that of the SMR. The author also examines the behaviours of the HWR when used for hypothesis testing (the 'HWR test'). The HWR can be considered for standardization when the purpose of the standardization is solely for comparison and when the universe of the comparisons can be clearly defined.

Adolescent↗

PubMed1984

[Evaluation of the level of dependency of persons placed in establishments for chronic patients. Development of a survey instrument and studies of validity, pertinence and performance].

With the aim to achieve a more equitable budgetary allocation to nursing homes, an instrument for the evaluation of the patients' dependency has been developed and tested in 55 institutions, for a total of about 23000 observations. Statistical analyses show that the internal validity of the gathered data is quite good. The tool criteria are judged relevant by experts, and the tool performance is adequate: its use should permit the constitution of groups (clustering) of nursing homes homogeneous from the point of view of their nursing care load.

Data Collection↗

PubMed2001

Evaluation of male sexual function by the International Index of Erectile Function after deep dorsal vein arterialization of the penis.

PURPOSE: The objective of vascular surgery for erectile dysfunction is to provide long-term improvement of erectile function. We evaluated that claim after deep dorsal vein arterialization by a cross-sectional study of multifaceted male sexual function with the validated International Index of Erectile Function (IIEF). MATERIALS AND METHODS: We performed a mail survey of male sexual function after deep dorsal vein arterialization in 68 consecutive literate men who underwent surgery between 1984 and 1998 for severe erectile dysfunction. The IIEF questionnaire and a questionnaire on patient characteristics were answered in a self-administered and nominative manner. Scores of the responders pertaining to the 5 domains of male sexuality were compared with those of the control groups used for the psychometric validation of the IIEF. RESULTS: Of the patients 38 (55.9%) with a mean age plus or minus standard deviation of 46.5 +/- 11.9 years responded. Mean followup was 61.2 +/- 34.7 months. Compared to controls with erectile dysfunction controls men who underwent deep dorsal vein penile arterialization had significantly higher scores for erectile function, sexual desire, orgasmic function, intercourse satisfaction and overall satisfaction. Conversely compared with normal controls these patients reported significantly lower erectile function, orgasmic function, intercourse satisfaction and overall satisfaction scores, whereas sexual desire scores were similar in the 2 groups. No correlations were noted of the 5 IIEF domains with the duration of followup after arterialization. When erectile function scores were graded, 25.0% and 28.1% of patients reported no and or mild dysfunction, respectively, while 15.6% still complained of severe erectile dysfunction. CONCLUSIONS: Long-term improvement in the various aspects of male sexual function was observed after deep dorsal vein penile arterialization in a significant proportion of patients.

Coitus↗

PubMed1998

Analyzing the time and value of housestaff inpatient work.

OBJECTIVE: To determine time allocation and the perceived value to education and patient care of the weekday activities of internal medicine housestaff on inpatient rotations and to compare the work activities of interns and residents. DESIGN: An observational study. We classified activities along five dimensions (association, location, activity, time, and value), developed a computer-assisted self-interview survey, and demonstrated its face and content validity, internal consistency, and interrater reliability. Subjects were assigned survey computers for 5 consecutive weekdays over a 24-week period, into which they entered data when prompted several times a day. SETTING: The medical service of a university-affiliated Veterans Administration Medical Center. PARTICIPANTS: Sixty housestaff (36 interns, 24 residents) rotating on the inpatient wards. MEASUREMENTS AND MAIN RESULTS: We analyzed activities according to content (direct patient care, indirect patient care, education), association, and location. Likert-scale ratings of perceived value to education and patient care were also obtained. Housestaff provided complete responses to 3,812 (95%) of 3,992 prompts by a median of 11 seconds; 93% of responses were logically consistent across the measured dimensions. Housestaff spent more time in indirect patient care (56%) than in direct patient care (14%) or educational activities (45%). Formal educational activities had the highest educational value (66 on 0-100 scale), and direct care had the highest value to patient care (81). Over 30% of time was spent in administrative activities, which had low educational value(40). Compared with residents, interns allocated significantly less time to educational activities (38% vs 57%) and more time to lower-value activities such as documentation (19% vs 12%). CONCLUSIONS: Improved data collection methods demonstrate that housestaff in our program, particularly interns, spend much of their workday in activities that are low in educational and patient care value. Selective elimination or delegation of such activities would preserve higher-value experiences during reductions in overall inpatient training time. Planners can use automated random sampling to guide the rational redesign of housestaff work.

Confidence Intervals↗

PubMed2002

Evaluation of anesthesia residents using mannequin-based simulation: a multiinstitutional study.

BACKGROUND: Anesthesia simulators can generate reproducible, standardized clinical scenarios for instruction and evaluation purposes. Valid and reliable simulated scenarios and grading systems must be developed to use simulation for evaluation of anesthesia residents. METHODS: After obtaining Human Subjects approval at each of the 10 participating institutions, 99 anesthesia residents consented to be videotaped during their management of four simulated scenarios on MedSim or METI mannequin-based anesthesia simulators. Using two different grading forms, two evaluators at each department independently reviewed the videotapes of the subjects from their institution to score the residents' performance. A third evaluator, at an outside institution, reviewed the videotape again. Statistical analysis was performed for construct- and criterion-related validity, internal consistency, interrater reliability, and intersimulator reliability. A single evaluator reviewed all videotapes a fourth time to determine the frequency of certain management errors. RESULTS: Even advanced anesthesia residents nearing completion of their training made numerous management errors; however, construct-related validity of mannequin-based simulator assessment was supported by an overall improvement in simulator scores from CB and CA-1 to CA-2 and CA-3 levels of training. Subjects rated the simulator scenarios as realistic (3.47 out of possible 4), further supporting construct-related validity. Criterion-related validity was supported by moderate correlation of simulator scores with departmental faculty evaluations (0.37-0.41, P < 0.01), ABA written in-training scores (0.44-0.49, < 0.01), and departmental mock oral board scores (0.44-0.47, P < 0.01). Reliability of the simulator assessment was demonstrated by very good internal consistency (alpha = 0.71-0.76) and excellent interrater reliability (correlation = 0.94-0.96; P < 0.01; kappa = 0.81-0.90). There was no significant difference in METI versus MedSim scores for residents in the same year of training. CONCLUSIONS: Numerous management errors were identified in this study of anesthesia residents from 10 institutions. Further attention to these problems may benefit residency training since advanced residents continued to make these errors. Evaluation of anesthesia residents using mannequin-based simulators shows promise, adding a new dimension to current assessment methods. Further improvements are necessary in the simulation scenarios and grading criteria before mannequin-based simulation is used for accreditation purposes.

Anaphylaxis↗

PubMed2004

An alternative trial design to overcome validity and recruitment problems in primary care research.

BACKGROUND: Although the randomized controlled trial is widely accepted as the best design to investigate new interventions, conducting a trial in primary care may present researchers with many methodological problems. OBJECTIVE: Our aim was to present an alternative trial design to overcome internal validity and recruitment problems. METHODS: In a randomized controlled trial, fatigued employees absent from work were selected among the population of an occupational health service in the South of The Netherlands. Patients randomly assigned to the experimental condition received cognitive behavioural therapy by a research GP near their home address, whereas patients in the control group received no intervention. We describe our considerations for building an alternative design. Research GPs and patients were recruited separately for the study. The pre-randomization design was applied. RESULTS: Nine research GPs performed all the interventions. Seventy-six experimental patients and 75 control patients were selected for study participation. Of these, only six patients in the experimental group and seven patients in the control group withdrew from the study at some point during follow-up. CONCLUSION: Results suggest that recruitment and randomization procedures in the alternative design served their purpose well. The alternative design proposed here might have several advantages compared with conventional trial procedures. However, our design is not widely applicable and there are ethical aspects involved that should be considered. Researchers should address their creativity when trying to minimize the problems they may encounter in designing a study.

Absenteeism↗