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1.  Feasibility of Collecting Diary Data From Asthma Patients Through Mobile Phones and SMS (Short Message Service): Response Rate Analysis and Focus Group Evaluation From a Pilot Study 
Background
Self-management of asthma may improve asthma outcomes. The Internet has been suggested as a tool for the monitoring and self-management of asthma. However, in a recent study we found that a Web interface had some disadvantages and that users stopped using the application after a short while.
Objective
The primary objective of this study was to evaluate, from a user perspective, the feasibility of using short message service (SMS) for asthma diary data collection through mobile phones. The secondary objective was to investigate patient compliance with an SMS diary, as measured by response rates over time.
Methods
The study included quantitative response rate data, based on SMS collection, and qualitative data from a traditional focus group setting. In a period of 2 months, the participants received 4 SMS messages each day, including a medication reminder, a request to enter peak flow, data on sleep loss, and medication dosage. Participants were asked to reply to a minimum of 3 of the messages per day. Diary inputs were collected in a database and the response rate per patient was expressed as the number of diary inputs (SMS replies) divided by diary requests (product of number of days in the study and the number of diary questions per day) for each participant. After the study period, the participants were invited to a focus group interview addressing the participants' attitudes to their disease, their experience with the SMS asthma diary, and their future expectations from the SMS asthma diary.
Results
Twelve patients with asthma (6 males, 6 females) participated in the data collection study. The median age was 38.5 (range: 13 – 57) years. The median response rate per patient was 0.69 (range: 0.03 – 0.98), ie, half the participants reported more than about two thirds of the requested diary data. Furthermore, response rates were relatively steady during the study period with no signs of decreasing usage over time. From the subsequent focus group interview with 9 users we learned that, in general, the participants were enthusiastic about the SMS diary – it became an integrated part of their everyday life. However, the participants wished for a simpler diary with only one SMS message to respond to and a system with a Web interface for system customization and graphical display of diary data history.
Conclusion
This study suggests that SMS collection of asthma diary data is feasible, and that SMS may be a tool for supporting the self-management of asthma (and possibly other chronic diseases) in motivated and self-efficacious patients because mobile phones are a part of people's everyday lives and enable active requests for data wherever the patient is. The combination of SMS data collection and a traditional Web page for data display and system customization may be a better and more usable tool for patients than the use of Web-based asthma diaries which suffer from high attrition rates.
doi:10.2196/jmir.6.4.e42
PMCID: PMC1550628  PMID: 15631966
Internet; cellular phone; asthma; disease management; patient compliance; focus groups; qualitative research
2.  Assessing Time Diary Quality for Older Couples: An Analysis of the Panel Study of Income Dynamics’ Disability and Use of Time (DUST) Supplement 
Annals of economics and statistics  2012;105-106:271-289.
Using same-day diaries from 394 older couples in the Panel Study of Income Dynamics (PSID), this paper develops and explores several new measures of diary quality. Two overarching questions are explored: 1) How do diary quality measures reflecting the data collection process enhance understanding of time use in later life? and 2) How well do same-day diaries from couples match up in terms of husbands’ and wives’ reports of time spent (actively engaged) together? We found a summary measure of diary quality indicated only 13.8% of diaries were lower quality. Lower quality diaries were more likely to be obtained from older adults (ages 70+ vs. 50–69) and first (vs. second) interviews. Joint activities from diaries of lower quality were less likely than those from higher quality diaries to be matched to an activity on a spouse’s same-day diary. However, such a measure did not predict time spent in common activities nor did its inclusion have any effect on predictors of time use. We also found that among activities described as joint by at least one respondent, up to 76% had a matching record in the spouse’s diary. The quality of matches appeared to be quite good, with the majority of matched activities having overlapping times reported by spouses and being described as joint by both spouses. Very similar estimates of joint time were reported by husbands and wives (about 5–5½ hours). Implications of findings for future methodological and substantive investigations are discussed.
PMCID: PMC3613756  PMID: 23560241
Time use; survey methods; data quality
3.  Physicians’ Use of Patients’ Daily Reports of Quality of Life to Evaluate Treatment Response in Phase I Cancer Trials*# 
Journal of cancer therapy  2012;3(5):582-588.
For cancer patients on Phase I trials, one of the most important physician decisions is whether or not patients are deriving benefit from therapy. With an increasing number of cytostatic treatment agents, the criteria to determine patient response to Phase I treatment has become harder to define. Physicians are increasingly looking to patient-reported outcomes (PROs) such as quality of life (QOL) to help evaluate treatment response. Electronic daily diary (EDD) devices can be used by patients to report their QOL over extended periods of time, thereby providing a more accurate picture of how patients are affected by treatment on a daily basis. However, questions remain about how to integrate this patient-reported information into decisions about Phase I treatment. This study investigated how physicians use patients’ daily QOL reports to evaluate patient response to Phase I treatment. Data were collected over a 4-month period from Phase I patients (N = 30) and physicians (N = 3) in an NCI-designated comprehensive cancer center. Patients completed daily QOL reports using EDD devices and physicians were provided with a summary of patients’ QOL before each visit. After the visit, doctors recorded their treatment decision and also rated the importance of four biomedical factors (Toxicity, Imaging, Labs, and Performance Status) and QOL in their treatment decision for that visit. Although physicians rated QOL as being very important in evaluating treatment response, in practice, when predictors of their decisions were analyzed, results showed they relied exclusively on biomedical data (Toxicity, Imaging) to make Phase I treatment decisions. Questions remain about the utility and effective integration of QOL and biomedical data in clinical decision-making processes in Phase I clinical trials.
doi:10.4236/jct.2012.35074
PMCID: PMC3777632  PMID: 24058742
Patient-Reported Outcomes; Quality of Life; Clinical Trials; Quality of Life; Treatment Decision-Making
4.  Subcutaneous treprostinil is well tolerated with infrequent site changes and analgesics 
Pulmonary Circulation  2013;3(3):611-621.
Continuous prostanoid infusions are recommended for patients with advanced pulmonary arterial hypertension. Infusion site pain has discouraged some physicians from considering subcutaneous (SQ) treprostinil therapy even though it has safety and convenience advantages over intravenous epoprostenol. We conducted a 1-year prospective study of patients utilizing SQ treprostinil. We provided counseling on infrequent site changes and a written analgesic protocol including narcotics. After placement of a new site, subjects recorded daily pain scores and analgesic use. Twenty-six of 29 patients consented, including 4 patients who had recently started therapy. They returned 203 diaries, and we captured every site change in a diary. Sixteen subjects returned 8 or fewer diaries during 12 months, and 20% of diaries documented only mild discomfort. The majority of diaries documented brief periods of severe pain, but this had generally abated by day 7. Contrary to published guidelines, infusion site pain was independent of treprostinil dose in a rigorous analysis. There were 3 significant local reactions but no systemic illness. No subject discontinued SQ treprostinil because of site discomfort. Subjects reported satisfaction with their treatment using a validated assessment, and quality-of-life scores were favorable. A strategy emphasizing infrequent site changes and early analgesia can facilitate use of SQ treprostinil. These data may allow physicians to consider treprostinil earlier in the treatment algorithm for this fatal disease.
doi:10.1086/674304
PMCID: PMC4070817  PMID: 24618545
5.  Performance of Electronic Diaries in Diabetes Clinical Trials Measured Through Overall Satisfaction of Site Coordinators 
Background
Clinical trials are increasingly being designed to collect data directly from patients through the use of paper diaries or electronic diaries (e-diaries). E-diaries can be advantageous over paper diaries, but actual benefits may depend on the particular features of a given e-diary. The objective of this study was to determine which e-diary system features are most important to consider when selecting such a tool.
Methods
A 42-question survey was distributed to 295 site coordinators participating in four diabetes clinical trials, using e-diary systems provided by three different vendors. The survey gathered information about the site coordinators' experience with the e-diary system used. Analyses included a comparison of global satisfaction rating scores and individual survey item responses among the different e-diaries utilized and correlation of individual survey items with the global satisfaction rating for each system.
Results
The survey was completed by 131 site coordinators (44% response rate). Mean global satisfaction rating scores varied from 3.4 to 7.2 (p < 0.0001). Individual survey items such as technical problems that cannot be resolved easily, the ability of the help line to fully address problems, and organization and user-friendliness of the e-diary's data management Web site were most closely correlated with the global satisfaction rating. The site coordinators' prior e-diary experience and years of job experience did not significantly correlate with the global satisfaction rating.
Conclusions
This survey highlights features of e-diaries for sponsors to consider in clinical trials, including the importance of minimizing technical problems, assessing vendors' help line capabilities, and choosing an e-diary system with an efficient and user-friendly data-management Web site.
PMCID: PMC2769627  PMID: 19885115
clinical trials; diabetes; electronic diary; patient diary
6.  Sore Throats in Adults: Who Sees a Doctor? 
Canadian Family Physician  1982;28:453-458.
In a study looking at the relationship of life stress events to health status, 500 individuals randomly selected from family practices in Hamilton, Ontario were asked to keep a health diary for three days every two weeks over a two year period. The compliance with diary keeping was remarkably high (85%), partly due to a novel method of reinforcing compliance. The present study involved reviewing these health diaries for symptoms of sore throat during the three month period January to March 1979. Over 2,700 diaries representing 8,148 person/days were reviewed; 48% recorded at least one symptom and 5.2% of all diaries recorded sore throat on at least one day. Eight to 16% of those individuals recording sore throat as a symptom contacted a health professional and/or took prescribed drugs.
Although the group under study included only adults, the low medical contact rate of patients with sore throats raises questions about the effectiveness of any approach to sore throat/pharyngitis adopted in office practice.
PMCID: PMC2306388  PMID: 21286075
7.  Validation of an asthma quality of life diary in a clinical trial. 
Thorax  1995;50(7):724-730.
BACKGROUND--Quality of life (QOL) is commonly measured in asthma clinical trials by a questionnaire given before and after treatment. A structured asthma QOL daily diary provides more restricted information but on a daily basis. The validity and use of such a QOL diary was examined in a clinical trial in which two asthma treatments were compared. METHODS--The effects of low dose inhaled steroid (400 micrograms beclomethasone dipropionate, BDP) combined with the long acting beta 2 agonist salmeterol (100 micrograms) (n = 220) was compared with high dose inhaled steroid (1000 micrograms BDP) (n = 206) in asthmatic outpatients in a double blind, parallel group study. Outcome measures consisted of a combined diary for peak expiratory flow (PEF) rate, symptoms, and problems, and an asthma-specific QOL questionnaire, the Living with Asthma Questionnaire. RESULTS--The QOL diary correlated with the QOL questionnaire for both cross sectional and longitudinal assessments. Cross sectional correlations with PEF were higher for the QOL questionnaire than the QOL diary, but longitudinal correlations with PEF were higher for the diary than the questionnaire. Treatment with low dose steroid/salmeterol compared with high dose steroid produced better lung function, better QOL as measured by diary, and reduced night time wakenings, but treatment differences were not obtained with the QOL questionnaire nor for daytime symptoms. Diary assessed QOL was a better predictor of low PEF than diary assessed symptoms. Compliance with diary completion was good but there were floor or ceiling effects in the QOL diary records of about 25% of patients. CONCLUSIONS--Structured QOL diaries are valid instruments that appear to be more responsive to longitudinal change in clinical trials than a QOL questionnaire, but QOL questionnaires provide a more sensitive cross sectional measure of disease severity. Floor and ceiling effects are found in some patients' QOL diaries which limit their usefulness. QOL diary problem events occur during the troughs of a peak flow graph, while symptoms are more widely distributed with respect to peak flow.
PMCID: PMC474643  PMID: 7570405
8.  Sleeping Well, Aging Well: A Descriptive and Cross-Sectional Study of Sleep in “Successful Agers” 75 and Older 
Objectives
To examine diary-based, laboratory-based, and actigraphic measures of sleep in a group of healthy older women and men (≥75 years of age) without sleep/wake complaints and to describe sleep characteristics which may be correlates of health-related quality of life in old age.
Design
Cross-sectional, descriptive study.
Setting
University-based sleep and chronobiology program.
Intervention
None.
Participants
Sixty-four older adults (30 women, 34 men; mean age 79)
Measurements
We used diary-, actigraphic-, and laboratory-based measures of sleep, health-related quality of life, mental health, social support, and coping strategies. We used two-group t-tests to compare baseline demographic and clinical measures between men and women, followed by ANOVA on selected EEG measures to examine first-night effects as evidence of physiological adaptability. Finally, we examined correlations between measure of sleep and health-related quality of life.
Results
We observed that healthy men and women aged 75 and older can experience satisfactory nocturnal sleep quality and daytime alertness, especially as reflected in self-report and diary-based measures. Polysomnography (psg) suggested the presence of a first-night effect, especially in men, consistent with continued normal adaptability in this cohort of healthy older adults. Continuity and depth of sleep in older women were superior to that of men. Diary-based measures of sleep quality (but not psg measures) correlated positively (small to moderate effect sizes) with physical and mental health-related quality of life.
Conclusions
Sleep quality and daytime alertness in late life may be more important aspects of successful aging than previously appreciated. Good sleep may be a marker of good functioning across a variety of domains in old age. Our observations suggest the need to study interventions which protect sleep quality in older adults to determine if doing so fosters continued successful aging.
doi:10.1097/JGP.0b013e3181557b69
PMCID: PMC2772651  PMID: 18070833
sleep; successful aging; aging; health-related quality of life
9.  Development and Testing of a Multidimensional iPhone Pain Assessment Application for Adolescents with Cancer 
Background
Pain is one of the most common and distressing symptoms reported by adolescents with cancer. Despite advancements in pain assessment and management research, pain due to cancer and/or its treatments continues to be poorly managed. Our research group has developed a native iPhone application (app) called Pain Squad to tackle the problem of poorly managed pain in the adolescent with cancer group. The app functions as an electronic pain diary and is unique in its ability to collect data on pain intensity, duration, location, and the impact pain has on an adolescent’s life (ie, relationships, school work, sleep, mood). It also evaluates medications and other physical and psychological pain management strategies used. Users are prompted twice daily at configurable times to complete 20 questions characterizing their pain and the app transmits results to a database for aggregate reporting through a Web interface. Each diary entry represents a pain case filed by an adolescent with cancer and a reward system (ie, moving up through law-enforcement team ranks, built-in videotaped acknowledgements from fictitious officers) encourages consistent use of the diary.
Objective
Our objective was to design, develop, and test the usability, feasibility, compliance, and satisfaction of a game-based smartphone pain assessment tool for adolescents with cancer.
Methods
We used both low- and high-fidelity qualitative usability testing with qualitative semi-structured, audio-taped interviews and iterative cycles to design and refine the iPhone based Pain Squad app. Qualitative thematic analysis of interviews using constant comparative methodology captured emergent themes related to app usability. Content validity was assessed using question importance-rating surveys completed by participants. Compliance and satisfaction data were collected following a 2-week feasibility trial where users were alarmed to record their pain twice daily on the app.
Results
Thematic analysis of usability interviews showed the app to be appealing overall to adolescents. Analyses of both low- and high-fidelity testing resulted in minor revisions to the app to refine the theme and improve its usability. Adolescents resoundingly endorsed the game-based nature of the app and its virtual reward system. The importance of app pain diary questions was established by content validity analysis. Compliance with the app, assessed during feasibility testing, was high (mean 81%, SD 22%) and adolescents from this phase of the study found the app likeable, easy to use, and not bothersome to complete.
Conclusions
A multifaceted usability approach demonstrated how the Pain Squad app could be made more appealing to children and adolescents with cancer. The game-based nature and built-in reward system of the app was appealing to adolescents and may have resulted in the high compliance rates and satisfaction ratings observed during clinical feasibility testing.
doi:10.2196/jmir.2350
PMCID: PMC3636147  PMID: 23475457
neoplasms; pain; child; adolescent; youth; cellular phone; game
10.  In-Clinic Use of Electronic Pain Diaries: Barriers of Implementation Among Pain Physicians 
Objectives
The aim of this study was to examine barriers to the use of electronic diaries within the clinic setting and to determine outcome differences between patients who used electronic diaries to monitor their progress with summary data feedback and patients who monitored their progress with paper diaries without summary data feedback.
Methods
One hundred thirty-four (n=134) chronic pain patients were asked to monitor their pain, mood, activity interference, medication use, and pain location on either a paper or electronic diary immediately before each monthly clinic visit for 10 months. Patients and their treating physicians in the electronic diary group (n=67) were able to observe changes in their ratings while patients using the paper diaries (n=67) had no feedback about their data entry.
Results
Most participants believed that completing pain diaries was beneficial, yet only 23% of patients in the experimental condition felt that the data from the electronic diaries improved their care and less than 15% believed that their doctor made a change in their treatment based on the summary diary information.
Conclusion
In general, treating physicians were positive about the use of electronic diaries, although they admitted that they did not regularly incorporate the summary data in their treatment decision-making either because they forgot or they were too busy. Future studies in understanding barriers to physicians’ and patients’ use of diary data to impact treatment outcome are needed in order to improve care for persons with chronic pain.
doi:10.1016/j.jpainsymman.2009.12.021
PMCID: PMC2934898  PMID: 20580526
Electronic diaries; PDA; chronic pain; treatment helpfulness; barriers; patient satisfaction
11.  Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study 
Aims:
To evaluate the efficacy and tolerability of flexible-dose fesoterodine in subjects with overactive bladder (OAB) who were dissatisfied with previous tolterodine treatment.
Methods:
This was a 12-week, open-label, flexible-dose study of adults with OAB (≥ 8 micturitions and ≥ 3 urgency episodes per 24 h) who had been treated with tolterodine (immediate- or extended-release) for OAB within 2 years of screening and reported dissatisfaction with tolterodine treatment. Subjects received fesoterodine 4 mg once daily for 4 weeks; thereafter, daily dosage was maintained at 4 mg or increased to 8 mg based on the subject’s and physician’s subjective assessment of efficacy and tolerability. Subjects completed 5-day diaries, the Patient Perception of Bladder Condition (PPBC) and the Overactive Bladder Questionnaire (OAB-q) at baseline and week 12 and rated treatment satisfaction at week 12 using the Treatment Satisfaction Question (TSQ). Safety and tolerability were assessed.
Results:
Among 516 subjects treated, approximately 50% opted for dose escalation to 8 mg at week 4. Significant improvements from baseline to week 12 were observed in micturitions, urgency urinary incontinence episodes, micturition-related urgency episodes and severe micturition-related urgency episodes per 24 h (all p< 0.0001). Approximately 80% of subjects who responded to the TSQ at week 12 reported satisfaction with treatment; 38% reported being very satisfied. Using the PPBC, 83% of subjects reported improvement at week 12 with 59% reporting improvement ≥ 2 points. Significant improvements from baseline (p< 0.0001) exceeding the minimally important difference (10 points) were observed in OAB-q Symptom Bother and Health-Related Quality of Life (HRQL) scales and all four HRQL domains. Dry mouth (23%) and constipation (5%) were the most common adverse events; no safety issues were identified.
Conclusion:
Flexible-dose fesoterodine significantly improved OAB symptoms, HRQL, and rates of treatment satisfaction and was well tolerated in subjects with OAB who were dissatisfied with prior tolterodine therapy.
doi:10.1111/j.1742-1241.2009.02035.x
PMCID: PMC2705818  PMID: 19348029
12.  Professional Caregivers’ Perceptions on how Persons with Mild Dementia Might Experience the Usage of a Digital Photo Diary 
The Open Nursing Journal  2012;6:20-29.
Cognitive impairments influence the possibility of persons with dementia to remember daily events and maintain a sense of self. In order to address these problems a digital photo diary was developed to capture information about events in daily life. The device consisted of a wearable digital camera, smart phone with Global Positioning System (GPS) and a home memory station with computer for uploading the photographs and touch screen. The aim of this study was to describe professional caregiver’s perceptions on how persons with mild dementia might experience the usage of this digital photo diary from both a situation when wearing the camera and a situation when viewing the uploaded photos, through a questionnaire with 408 respondents. In order to catch the professional caregivers’ perceptions a questionnaire with the semantic differential technique was used and the main question was “How do you think Hilda (the fictive person in the questionnaire) feels when she is using the digital photo diary?”. The factor analysis revealed three factors; Sense of autonomy, Sense of self-esteem and Sense of trust. An interesting conclusion that can be drawn is that professional caregivers had an overall positive view of the usage of digital photo diary as supporting autonomy for persons with mild dementia. The meaningfulness of each situation when wearing the camera and viewing the uploaded pictures to be used in two different situations and a part of an integrated assistive device has to be considered separately. Individual needs and desires of the person who is living with dementia and the context of each individual has to be reflected on and taken into account before implementing assistive digital devices as a tool in care.
doi:10.2174/1874434601206010020
PMCID: PMC3322432  PMID: 22509232
“Ageing in place”; assistive digital device; dementia; factor analysis; perceptions.
13.  Collecting household water usage data: telephone questionnaire or diary? 
Background
Quantitative Microbial Risk Assessment (QMRA), a modelling approach, is used to assess health risks. Inputs into the QMRA process include data that characterise the intensity, frequency and duration of exposure to risk(s). Data gaps for water exposure assessment include the duration and frequency of urban non-potable (non-drinking) water use. The primary objective of this study was to compare household water usage results obtained using two data collection tools, a computer assisted telephone interview (CATI) and a 7-day water activity diary, in order to assess the effect of different methodological survey approaches on derived exposure estimates. Costs and logistical aspects of each data collection tool were also examined.
Methods
A total of 232 households in an Australian dual reticulation scheme (where households are supplied with two grades of water through separate pipe networks) were surveyed about their water usage using both a CATI and a 7-day diary. Householders were questioned about their use of recycled water for toilet flushing, garden watering and other outdoor activities. Householders were also questioned about their water use in the laundry. Agreement between reported CATI and diary water usage responses was assessed.
Results
Results of this study showed that the level of agreement between CATI and diary responses was greater for more frequent water-related activities except toilet flushing and for those activities where standard durations or settings were employed. In addition, this study showed that the unit cost of diary administration was greater than for the CATI, excluding consideration of the initial selection and recruitment steps.
Conclusion
This study showed that it is possible to successfully 'remotely' coordinate diary completion providing that adequate instructions are given and that diary recording forms are well designed. In addition, good diary return rates can be achieved using a monetary incentive and the diary format allows for collective recording, rather than an individual's estimation, of household water usage. Accordingly, there is merit in further exploring the use of diaries for collection of water usage information either in combination with a mail out for recruitment, or potentially in the future with Internet-based recruitment (as household Internet uptake increases).
doi:10.1186/1471-2288-9-72
PMCID: PMC2777918  PMID: 19900290
14.  Phenomenologic analysis of healthcare worker perceptions of intensive care unit diaries 
Critical Care  2013;17(1):R13.
Introduction
Studies have reported associations between diaries kept for intensive care unit (ICU) patients and long-term quality-of-life and psychological outcomes in patients and their relatives. Little was known about perceptions of healthcare workers reading and writing in the diaries. We investigated healthcare worker perceptions the better to understand their opinions and responses to reading and writing in the diaries.
Methods
We used a phenomenologic approach to conduct a qualitative study of 36 semistructured interviews in a medical-surgical ICU in a 460-bed tertiary hospital.
Results
Two domains of perception were assessed: reading and writing in the diaries. These two domains led to four main themes in the ICU workers' perceptions: suffering of the families; using the diary as a source of information for families but also as generating difficulties in writing bad news; determining the optimal interpersonal distance with the patient and relatives; and using the diary as a tool for constructing a narrative of the patient's ICU stay.
Conclusions
The ICU workers thought that the diary was beneficial in communicating the suffering of families while providing comfort and helping to build the patient's ICU narrative. They reported strong emotions related to the diaries and a perception of intruding into the patients' and families' privacy when reading the diaries. Fear of strong emotional investment may adversely affect the ability of ICU workers to perform their duties optimally. ICU workers are in favor of ICU diaries, but activation by the diaries of emotions among younger ICU workers may require specific support.
doi:10.1186/cc11938
PMCID: PMC4056037  PMID: 23336394
15.  Measuring patients' attitudes to care across the primary/secondary interface: the development of the patient career diary 
Quality in Health Care : QHC  1999;8(3):154-160.
Background - A growing number of new ways of organising services across the primary/secondary interface are being introduced and evaluated. The principal motive for such reorganisation is to improve the efficiency of health care. However, unless the impact of the new services on patients is investigated and taken into account, it is possible that patients' reactions could be negative, a factor that could lead to unexpected consequences in the use and costs of services. Objective - To develop a measure of patients' attitudes towards care across the interface between primary and secondary care. Design - Generation of questions to be included in the measure from a qualitative study of patients' experiences of care across the interface; administration of pilot versions of the measure to samples of patients referred to secondary care; refinement of questions guided by analysis of response patterns, principal components analysis and internal consistency; administration of the final version of the patient career diary in complete form retrospectively to patients referred to secondary care, and one section alone to patients attending outpatient departments for follow up appointments. Face validity was assessed by analysis of open comments in a sample of 50 diaries, and review of the diary by 34 health professionals. Construct validity was assessed by investigation of levels of correlation between components of each section of the diary and the components of the healthcare section overall. Setting - In the final field test, patients were attending various hospital services, including cardiology, dermatology, neurology, gynaecology, general surgery, general medicine, ophthalmology, trauma and orthopaedics, and gastroenterology. Results - The final version of the diary included 109 questions in seven sections: general practitioner (GP) visits and referral, other GP visits, first outpatient visit, other outpatient visits, inpatient stay and discharge, care after discharge, and care overall. Response rates were poor for retrospective completion of the entire diary, but excellent when a section was given separately. Principal components analysis confirmed that components relating to issues identified as important to patients in the qualitative study had been included in the diary. Levels of internal consistency were good, and comments of patients and health professionals supported validity. Conclusion - The patient career diary is a valid and reliable measure of patients' attitudes to care across the interface. It should be given in sections to ensure adequate response rates, and is suitable for use in the evaluation or quality of patterns of care across the interface. In future, the impact on patients of new ways of organising services across the interface should be investigated by use of measures such as the patient career diary.
PMCID: PMC2483654  PMID: 10847871
16.  IBS Patients Show Frequent Fluctuations between Loose/Watery and Hard/Lumpy Stools: Implications for Treatment 
The American journal of gastroenterology  2011;107(2):10.1038/ajg.2011.358.
Aims
To determine how variable stool consistency is in patients with irritable bowel (IBS) and assess the relationship between stool consistency and gastrointestinal symptoms.
Methods
Individuals with a physician diagnosis of IBS were recruited by advertisement. Enrollment questionnaires included the Rome III Diagnostic Questionnaire and IBS Symptom Severity Scale. Then 185 patients meeting Rome criteria for IBS rated the consistency (using the Bristol Stool Scale) of each bowel movement (BM) for 90 days and whether the BM was accompanied by pain, urgency, or soiling. Each night they transferred BM ratings from a paper diary to an internet form and also reported the average daily intensity of abdominal pain, bloating, bowel habit dissatisfaction, and life interference of bowel symptoms. Only the longest sequence of consecutive days of diary data was used in analysis (average of 73 days).
Results
Patients were 89% female with average age 36.6 years. 78% had both loose/watery and hard/lumpy stools; the average was 3 fluctuations between these extremes per month. The proportion of loose/watery stools correlated r=.78 between the first and second months and the proportion of hard/lumpy stools correlated r=.85 between months. Loose/watery stools were associated with more BM-related pain, urgency, and soiling than hard/lumpy or normal stools; however, IBS-C patients had significantly more BM-unrelated abdominal pain, bloating, dissatisfaction with bowel habits, and life interference than IBS-D. Questionnaires overestimated the frequency of abnormal stool consistency and gastrointestinal symptoms compared to diaries.
Conclusions
Stool consistency varies greatly within individuals. However, stool patterns are stable within an individual from month to month. The paradoxical findings of greater symptom severity after individual loose/watery BMs vs. greater overall symptom severity in IBS-C implies different physiological mechanisms for symptoms in constipation compared to diarrhea. Daily symptom monitoring is more sensitive and reliable than a questionnaire.
doi:10.1038/ajg.2011.358
PMCID: PMC3855407  PMID: 22068664
17.  A High-Level Specification for Adaptive Ecological Momentary Assessment: Real-time Assessment of Drug Craving, Use and Abstinence 
In psychological research, efforts to capture day-today human experience traditionally relied on pen-and-paper diaries and questionnaires. Some current studies, however, incorporate handheld computers, which provide researchers with many options and advantages in addition to providing more reliable data. One advantage of using handheld computers is the programmability of the electronic diary, which, compared to old-fashioned paper diaries, affords the researchers with a wealth of possibilities. An important possibility is to construct a built-in mechanism in the computer-administered questionnaires that would allow transparent branching, in which question presentation is contingent on participants’ answers to previous questions. The major hurdle in implementing such an approach is the limitations of the platform used for such assessments: inexpensive “low-end” handheld devices. We propose a high-level specification which enables non-programming researchers to “branch” their questionnaires without modifications to the source code in a highly user-friendly fashion, with backtracking capability and very modest hardware requirements. A finite state automaton approach was implemented, we believe for the first time, to create an auto-trigger mechanism for the real-time evaluation of the conditions. This solution provides our investigators with the capacity to administer efficient assessments that are dynamically customized to reflect participants’ behaviors without the need for any post-production programming.
PMCID: PMC1560797  PMID: 16779081
18.  Measuring the value of older people's production: a diary study 
Background
The productive capacity of retired people is usually not valued. However, some retirees produce much more than we might expect. This diary-based study identifies the activities of older people, and suggests some value mechanisms. One question raised is whether it is possible to scale up this diary study into a larger representative study.
Methods
Diaries kept for one week were collected among 23 older people in the north of Sweden. The texts were analysed with a grounded theory approach; an interplay between ideas and empirical data.
Results
Some productive activities of older people must be valued as the opportunity cost of time or according to the market value, and others must be valued with the replacement cost. In order to make the choice between these methods, it is important to consider the societal entitlement. When there is no societal entitlement, the first or second method must be used; and when it exists, the third must be used.
Conclusions
An explicit investigation of the content of the entitlement is needed to justify the choice of valuation method for each activity. In a questionnaire addressing older people's production, each question must be adjusted to the type of production. In order to fully understand this production, it is important to consider the degree of free choice to conduct an activity, as well as health-related quality of life.
doi:10.1186/1472-6963-12-4
PMCID: PMC3295658  PMID: 22230745
old; production; entitlement; intergenerational fairness; informal care
19.  Improving Diabetes Care for Young People With Type 1 Diabetes Through Visual Learning on Mobile Phones: Mixed-Methods Study 
Background
Only 17% of Norwegian children and adolescents with diabetes achieve international treatment goals measured by glycated hemoglobin (HbA1c). Classic patient–physician consultations seem to be poorly adapted to young children. New strategies that are better attuned to young people to improve support of adolescents’ self-management of diabetes need to be tested and evaluated.
Objective
(1) To explore how applications for mobile phones can be used in follow-up of adolescents with type 1 diabetes, and (2) to use the findings to guide further development of the applications and as a basis for future studies.
Method
We pilot tested two mobile phone applications: (1) an application that contained a picture-based diabetes diary to record physical activity and photos taken with the phone camera of food eaten, where the phone also communicated with the glucometer by Bluetooth technology to capture blood glucose values, and (2) a Web-based, password-secured and encrypted short message service (SMS), based on access using login passwords received via SMS to be used by participants to send messages to their providers when they faced obstacles in everyday life, and to send educational messages to the participants. At the end of the 3-month pilot study, 12 participants (7 girls and 5 boys ) aged 13–19 years completed semistructured interviews. The participants had a mean HbA1c value of 8.3 (SD 0.3), mean age of 16.2 (SD 1.7) years, mean body mass index of 23.3 (SD 3.2) kg/m2, and mean diabetes duration of 7.5 (SD 4.6) years. We applied three additional measurements: change in metabolic control as measured by HbA1c, the System Usability Scale, and diabetes knowledge.
Results
From the interviews, three main categories emerged: visualization, access, and software changes. Participants appreciated the picture-based diary more than the SMS solution. Visualization of cornerstones in diabetes self-care (ie, diet, insulin dosage, physical activity, and pre- and postprandial glucose measurements all transformed into one picture) in the mobile diary was found to be an important educational tool through reflections in action. This led to a change in participants’ applied knowledge about the management of their disease. Additional measurements supplemented and supported the qualitative findings. However, changes in HbA1c and participants’ theoretical knowledge as tested by a 27-item questionnaire, based on a national health informatics’ diabetes quiz, before and after the intervention were not statistically significant (P = .38 and P = .82, respectively, paired-samples t test). Participants suggested additional functionality, and we will implement this in the design of the next software generation.
Conclusion
Participants reported an increased understanding of applied knowledge, which seem to positively affect diabetes self-care. Visual impressions seem well adapted to the maturation of the adolescent brain, facilitating the link between theoretical knowledge and executive functions. SMS gave the adolescents a feeling of increased access and security. Participants gave valuable input for further development of these applications.
doi:10.2196/jmir.2155
PMCID: PMC3803161  PMID: 22868871
Diabetes; adolescents; user-centered design; education; eHealth; mHealth; mobile phones; short message service; SMS; qualitative research; triangulation of methods
20.  Validity of coital diaries in a feasibility study for the Microbicides Development Programme trial among women at high risk of HIV/AIDS in Mwanza, Tanzania 
Sexually Transmitted Infections  2007;83(6):490-497.
Objectives
To compare coital diaries and face‐to‐face interviews (FFIs) in measuring sexual behaviour among women at high risk of HIV. To assess the effect of differing levels of support from researchers on reporting in coital diaries and FFIs.
Methods
Three groups of 50 women were randomly selected from a cohort of food and recreational facility workers participating in a microbicide trial feasibility study and received differing levels of researcher support. Minimum support involved delivering and collecting coital diaries weekly; medium support included a weekly FFI and discussion of concerns; intensive support also included an unscheduled mid‐week visit when diaries were checked and concerns addressed. All respondents participated in an exit FFI, including questions on sexual behaviour over the four‐week study period and study acceptability.
Results
Sexual behaviours were generally reported more frequently in coital diaries than weekly or exit interviews. Vaginal and anal sex, male and female condom use, vaginal cleaning and lubrication, sex during menstruation and sex with irregular and regular partners were reported more frequently in coital diaries than exit interviews. In coital diaries, level of support was associated with reporting of vaginal sex and cleaning. In exit interviews, support level was associated with reporting of vaginal sex, vaginal cleaning and sex with regular, irregular and commercial partners. Women with minimum support reported least satisfaction with the research process. Women with intensive support were most likely to report that they informed someone about their study participation and that they completed diaries daily.
Conclusion
Compared with FFIs, coital diaries resulted in higher reporting of socially stigmatised activities, and sexual behaviour reporting varied less by level of support. More researcher support enhanced study acceptability.
doi:10.1136/sti.2007.024810
PMCID: PMC2598720  PMID: 17660325
sexual behaviour research methods; microbicides; diaries; HIV; developing countries
21.  Interactive Multimodal Ambulatory Monitoring to Investigate the Association between Physical Activity and Affect 
Although there is a wealth of evidence that physical activity has positive effects on psychological health, a large proportion of people are inactive. Data regarding counts, steps, and movement patterns are limited in their ability to explain why people remain inactive. We propose that multimodal ambulatory monitoring, which combines the assessment of physical activity with the assessment of psychological variables, helps to elucidate real world physical activity. Whereas physical activity can be monitored continuously, psychological variables can only be assessed at discrete intervals, such as every hour. Moreover, the assessment of psychological variables must be linked to the activity of interest. For example, if an inactive and overweight person is physically active once a week, psychological variables should be assessed during this episode. Linking the assessment of psychological variables to episodes of an activity of interest can be achieved with interactive monitoring. The primary aim of our interactive multimodal ambulatory monitoring approach was to intentionally increase the number of e-diary assessments during “active” episodes. We developed and tested an interactive monitoring algorithm that continuously monitors physical activity in everyday life. When predefined thresholds are surpassed, the algorithm triggers a signal for participants to answer questions in their electronic diary. Using data from 70 participants wearing an accelerative device for 24 h each, we found that our algorithm quadrupled the frequency of e-diary assessments during the activity episodes of interest compared to random sampling. Multimodal interactive ambulatory monitoring appears to be a promising approach to enhancing our understanding of real world physical activity and movement.
doi:10.3389/fpsyg.2012.00596
PMCID: PMC3554220  PMID: 23355828
ambulatory monitoring; e-diary; interactive assessment; physical activity
22.  Sleep, Mood, and Quality of Life in Patients Receiving Treatment for Lung Cancer 
Oncology nursing forum  2013;40(5):441-451.
Purpose/Objectives
To distinguish relationships among subjective and objective characteristics of sleep, mood, and quality of life (QOL) in patients receiving treatment for lung cancer.
Design
Descriptive, correlational study.
Setting
Two ambulatory oncology clinics.
Sample
35 patients with lung cancer.
Methods
The following instruments were used to measure the variables of interest: Pittsburgh Sleep Quality Index (PSQI), Hospital Anxiety and Depression Scale, Functional Assessment of Cancer Treatment–Lung (FACT-L), a sleep diary, and a motionlogger actigraph.
Main Research Variables
Sleep, mood, and QOL.
Findings
Significant differences were found between sleep diary and actigraph measures of sleep efficiency (p = 0.002), sleep latency (p = 0.014), sleep duration (p < 0.001), and wake after sleep onset (p < 0.001). Poor sleepers (PSQI score greater than 5) were significantly different from good sleepers (PSQI score of 5 or lower) on sleep diary measures of sleep efficiency and sleep latency and the FACT-L lung cancer symptom subscale, but not on mood or actigraphy sleep measures.
Conclusions
Although patients with lung cancer may report an overall acceptable sleep quality when assessed by a single question, those same patients may still have markedly increased sleep latencies or reduced total sleep time. The findings indicate the complexity of sleep disturbances in patients with lung cancer. Lung cancer symptoms had a stronger association with sleep than mood. Research using prospective methods will help to elucidate their clinical significance.
Implications for Nursing
Patients receiving treatment for lung cancer are at an increased risk for sleep disturbances and would benefit from routine sleep assessment and management. In addition, assessment and management of common symptoms may improve sleep and, ultimately, QOL.
Knowledge Translation
A high frequency of sleep disturbances in patients receiving treatment for lung cancer was evident, and poor sleepers had lower QOL. Sleep disturbances may be more related to lung cancer symptoms than anxiety or depression. Improving lung cancer symptoms such as dyspnea may improve sleep.
doi:10.1188/13.ONF.441-451
PMCID: PMC4080434  PMID: 23989018
23.  Urinary incontinence self-report questions: reproducibility and agreement with bladder diary 
International urogynecology journal  2011;22(12):10.1007/s00192-011-1503-3.
Introduction and hypothesis This study aims to measure self-report urinary incontinence questions' reproducibility and agreement with bladder diary.
Methods Data were analyzed from the Reproductive Risk of Incontinence Study at Kaiser. Participating women reporting at least weekly incontinence completed self-report incontinence questions and a 7-day bladder diary. Self-report question reproducibility was assessed and agreement between self-reported and diary-recorded voiding and incontinence frequency was measured. Test characteristics and area under the curve were calculated for self-reported incontinence types using diary as the gold standard.
Results Five hundred ninety-one women were included and 425 completed a diary. The self-report questions had moderate reproducibility and self-reported and diary-recorded incontinence and voiding frequencies had moderate to good agreement. Self-reported incontinence types identified stress and urgency incontinence more accurately than mixed incontinence.
Conclusions Self-report incontinence questions have moderate reproducibility and agreement with diary, and considering their minimal burden, are acceptable research tools in epidemiologic studies.
doi:10.1007/s00192-011-1503-3
PMCID: PMC3807739  PMID: 21796472
Reproducibility of results; Sensitivity and specificity; Stress urinary incontinence; Urinary incontinence, classification; Urgency urinary incontinence
24.  Sacral Nerve Stimulation For Urinary Urge Incontinence, Urgency-Frequency, Urinary Retention, and Fecal Incontinence 
Executive Summary
Objective
The aim of this review was to assess the effectiveness, safety, and cost of sacral nerve stimulation (SNS) to treat urinary urge incontinence, urgency-frequency, urinary retention, and fecal incontinence.
Background: Condition and Target Population
Urinary urge incontinence, urgency-frequency, urinary retention, and fecal incontinence are prevalent, yet rarely discussed, conditions. They are rarely discussed because patients may be uncomfortable disclosing their symptoms to a health professional or may be unaware that there are treatment options for these conditions. Briefly, urge incontinence is an involuntary loss of urine upon a sudden urge. Urgency-frequency is an uncontrollable urge to void, which results in frequent, small-volume voids. People with urgency-frequency may or may not also experience chronic pelvic pain. Urinary retention refers to the inability to void despite having the urge to void. It can be caused by a hypocontractile detrusor (weak or no bladder muscle contraction) or obstruction due to urethral overactivity. Fecal incontinence is a loss of voluntary bowel control.
The prevalence of urge incontinence, urgency-frequency, and urinary retention in the general population is 3.3% to 8.2%, and the prevalence of fecal incontinence is 1.4% to 1.9%. About three-quarters of these people will be successfully treated by behaviour and/or drug therapy. For those who do not respond to these therapies, the options for treatment are management with diapers or pads, or surgery. The surgical procedures are generally quite invasive, permanent, and are associated with complications. Pads and/or diapers are used throughout the course of treatment as different therapies are tried. Patients who respond successfully to treatment may still require pads or diapers, but to a lesser extent.
The Technology Being Reviewed: Sacral Nerve Stimulation
Sacral nerve stimulation is a procedure where a small device attached to an electrode is implanted in the abdomen or buttock to stimulate the sacral nerves in an attempt to manage urinary urge incontinence, urgency-frequency, urinary retention, and fecal incontinence. The device was originally developed to manage urinary urge incontinence; however, it has also been used in patients with urgency-frequency, urinary retention, and fecal incontinence. SNS is intended for patients who are refractory to behaviour, drug, and/or interventional therapy.
There are 2 phases in the SNS process: first, patients must undergo a test stimulation phase to determine if they respond to sacral nerve stimulation. If there is a 50% or greater improvement in voiding function, then the patient is considered a candidate for the next phase, implantation.
Review Strategy
The standard Medical Advisory Secretariat search strategy was used to locate international health technology assessments and English-language journal articles published from 2000 to November 2004. The Medical Advisory Secretariat also conducted Internet searches of Medscape (1) and the manufacturer’s website (2) to identify product information and recent reports on trials that were unpublished but that were presented at international conferences. In addition, the Web site Current Controlled Trials (3) was searched for ongoing randomized controlled trials (RCTs) investigating the role of sacral nerve stimulation in the management of voiding conditions.
Summary of Findings
Four health technology assessments were found that reviewed SNS in patients with urge incontinence, urgency-frequency, and/or urinary retention. One assessment was found that reviewed SNS in patients with fecal incontinence. The assessments consistently reported that SNS was an effective technology in managing these voiding conditions in patients who did not respond to drug or behaviour therapy. They also reported that there was a substantial complication profile associated with SNS. Complication rates ranged from 33% to 50%. However, none of the assessments reported that they found any incidences of permanent injury or death associated with the device.
The health technology assessments for urge incontinence, urgency-frequency, and urinary retention included (RCTs (level 2) as their primary source of evidence for their conclusions. The assessment of fecal incontinence based its conclusions on evidence from case series (level 4). Because there was level 2 data available for the use of SNS in patients with urinary conditions, the Medical Advisory Secretariat chose to review thoroughly the RCTs included in the assessments and search for publications since the assessments were released. However, for the health technology assessment for fecal incontinence, which contained only level 4 evidence, the Medical Advisory Secretariat searched for studies on SNS and fecal incontinence that were published since that assessment was released.
Urge Incontinence
Two RCTs were identified that compared SNS to no treatment in patients with refractory urge incontinence. Both RCTs reported significant improvements (> 50% improvement in voiding function) in the SNS group for number of incontinence episodes per day, number of pads used per day, and severity of incontinence episodes.
Urgency-Frequency (With or Without Chronic Pelvic Pain)
One RCT was identified that compared SNS to no treatment in patients with refractory urgency-frequency. The RCT reported significant improvements in urgency-frequency symptoms in the SNS group (average volume per void, detrusor pressure). In addition to the RCT, 1 retrospective review and 2 prospective case series were identified that measured pelvic pain associated with urgency-frequency in patients who underwent SNS. All 3 studies reported a significant decrease in pain at median follow-up.
Urinary Retention
One RCT was identified that compared SNS to no treatment in patients with refractory urinary retention. The RCT reported significant improvements in urinary retention in the SNS group compared to the control group for number of catheterizations required and number of voids per day. In addition to this RCT, 1 case series was also identified investigating SNS in women with urinary retention. This study also found that there were significant improvements in urinary retention after the women had received the SNS implants.
Fecal Incontinence
Three case series were identified that investigated the role of SNS in patients with fecal incontinence. All 3 reported significant improvements in fecal incontinence symptoms (number of incontinent episodes per week) after the patients received the SNS implants.
Long-Term Follow-up
None of the studies identified followed patients until the point of battery failure. Of the 6 studies identified describing the long-term follow-up of patients with SNS, follow-up periods ranged from 1.5 years to over 5 years. None of the long-term follow-up studies included patients with fecal incontinence. All of the studies reported that most of the patients who had SNS had at least a 50% improvement in voiding function (range 58%–77%). These studies also reported the number of patients who had their device explanted in the follow-up period. The rates of explantation ranged from 12% to 21%.
Safety, Complications, and Quality of Life
A 33% surgical revision rate was reported in an analysis of the safety of 3 RCTs comparing SNS to no treatment in patients with urge incontinence, urgency-frequency, or urinary retention. The most commonly reported adverse effects were pain at the implant site and lead migration. Despite the high rate of surgical revision, there were no reports of permanent injury or death in any of the studies or health technology assessments identified. Additionally, patients consistently said that they would recommend the procedure to a friend or family member.
Economic Analysis
One health technology assessment and 1 abstract were found that investigated the costing factors pertinent to SNS. The authors of this assessment did their own “indicative analysis” and found that SNS was not more cost-effective than using incontinence supplies. However, the assessment did not account for quality of life. Conversely, the authors of the abstract found that SNS was more cost-effective than incontinence supplies alone; however, they noted that in the first year after SNS, it is much more expensive than only incontinence supplies. This is owing to the cost of the procedure, and the adjustments required to make the device most effective. They also noted the positive effects that SNS had on quality of life.
Conclusions and Implications
In summary, there is level 2 evidence to support the effectiveness of SNS to treat people with urge incontinence, urgency-frequency, or urinary retention. There is level 4 evidence to support the effectiveness of SNS to treat people with fecal incontinence.
To qualify for SNS, people must meet the following criteria:
Be refractory to behaviour and/or drug therapy
Have had a successful test stimulation before implantation; successful test stimulation is defined by a 50% or greater improvement in voiding function based on the results of a voiding diary. Test stimulation periods range from 3 to 7 days for patients with urinary dysfunctions, and from 2 to 3 weeks for patients with fecal incontinence.
Be able to record voiding diary data, so that clinical results of the implantation can be evaluated.
Patients with stress incontinence, urinary retention due to obstruction and neurogenic conditions (such as diabetes with peripheral nerve involvement) are ineligible for sacral nerve stimulation.
Physicians will need to learn how to use the InterStim System for Urinary Control. Requirements for training include these:
Physicians must be experienced in the diagnosis and treatment of lower urinary tract disorders and should be trained in the implantation and use of the InterStim System for Urinary Control.
Training should include the following:
Participation in a seminar or workshop that includes instructional and laboratory training on SNS. This seminar should include a review of the evidence on SNS with emphasis on techniques to prevent adverse events.
Completion of proctoring by a physician experienced in SNS for the first 2 test stimulations and the first 2 implants
PMCID: PMC3382408  PMID: 23074472
25.  The Influence of Hormonal Contraception on Mood and Sexual Interest among Adolescents 
Archives of sexual behavior  2008;37(4):605-613.
Mood and sexual interest changes are commonly cited reasons for discontinuing hormonal contraceptives. Data, however, are inconsistent and limited to adult users. We examined associations of hormonal contraceptive use with mood and sexual interest among adolescents. We recruited 14-17 year old women primary care clinics and followed them longitudinally for up to 41 months. Participants completed face-to-face interviews quarterly and two 12 week periods of daily diary collection per year. On daily diaries, participants recorded positive mood, negative mood, and sexual interest. We classified 12 week diary periods as “stable OCP use,” “non-use,” “initiated use,” “stopped use,” and “DMPA use” based on self-report of oral contraceptive pill (OCP) use and depot medroxyprogesterone acetate (DMPA) use from medical charts. Diary periods were the unit of analysis. Participants could contribute more than one diary period. We analyzed data using linear models with a random intercept and slope across weeks in a diary period, an effect for contraceptive group, and an adjustment for age at the start of a diary period. Mean weekly positive mood was higher in diary periods characterized by stable OCP use, compared to other groups. Mean weekly negative mood was lower in diary periods characterized by stable OCP use and higher in periods characterized by DMPA use. Periods characterized by stable OCP use additionally showed less mood variation than other groups. Changes in mood among adolescent hormonal contraceptive users differed from those anticipated for adult users. Attention to adolescent-specific changes in mood and sexual interest may improve contraceptive adherence.
doi:10.1007/s10508-007-9302-0
PMCID: PMC3020653  PMID: 18288601
adolescent; oral contraceptives; sexual interest; sexual desire; mood; daily diaries; depot medroxyprogesterone acetate

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