To design a Bayesian random effects model for pooling binary outcome data from cluster randomized trials (CRTs) with individually randomized trials (IRTs) and then use this model to determine if hip protectors decrease the risk of hip fracture in elderly nursing home residents.
Study Design and Setting
Eight electronic databases were searched; abstracts and papers were reviewed in duplicate. Randomized controlled trials of hip protectors in nursing homes were included. The pooled mean odds ratio (OR) of a hip fracture in an individual allocated to hip protectors with 95% credibility interval (CRI) was calculated.
We included four trials of 1,922 individuals (including three CRTs). The pooled OR of an elderly nursing home resident sustaining one or more hip fractures with hip protector allocation was 0.40 (95% CRI 0.25, 0.61). The model was robust in multiple sensitivity analyses assuming alternative intracluster correlation coefficient values.
The Bayesian approach may be used in meta-analyses of IRTs and CRTs. Using this approach, we have determined that hip protectors decrease the risk of hip fracture in elderly nursing home residents. Methodologic limitations of the included trials and a possible herd effect in CRTs may have influenced these results.
PMID: 17346606 CAMSID: cams6239
Meta-analysis; Randomized controlled trials; Bayesian; Osteoporosis; Hip fracture; Hip protectors
To determine the level of exposure to hip protectors and barriers to their use in nursing homes.
Design, Setting, and Participants
We conducted a written survey of 160 staff (including administrators) in 5 nursing homes in the Hamilton-Wentworth region, Ontario, Canada.
The results of primary analyses were expressed as percentage of respondents.
Among respondents of respective institutions, the rate of prior exposure to hip protectors varied from 40.9% to 100.0% and the rate of prior experience applying these devices varied from 14.3% to 80.0%. The most frequently cited main barriers to the use of hip protectors in long-term care facilities included physicians not thinking to prescribe them, expense, lack of evidence of benefit in this population, wearer discomfort, and wearer removal. A lack of staff time to apply these devices was rarely cited. The majority of staff believed that nursing home residents with a prior history of fracture, those who fall frequently, or those who are unsteady on their feet should wear hip protectors.
The exposure of surveyed nursing home staff to hip protectors was variable but most agreed that residents who are at increased risk of hip fracture should wear them. Some identified barriers to the use of hip protectors in long-term care facilities were physicians not thinking to prescribe them, expense, lack of evidence of benefit in this population, wearer discomfort, and wearer removal. Such barriers need to be addressed for hip protector implementation strategies to be successful in nursing homes.
PMID: 17498606 CAMSID: cams6238
Hip protectors; hip fracture; nursing home
Family physicians’ personal and practice characteristics may influence how osteoporosis is managed. Thus, we evaluated the impact of family physicians’ personal and practice characteristics on the appropriate use of bone mineral density testing and osteoporosis therapy.
The physician questionnaire assessed 13 personal and practice characteristics of the physicians. The patient questionnaire was used to collect data to ascertain how family physicians managed osteoporosis. A total of 225 family physicians from 7 provinces across Canada completed both the physician and patient questionnaires. The family physicians evaluated a total of 5601 patients. The generalized estimating equations technique was utilized to model the associations between family physicians’ personal and practice characteristics and appropriate use of bone mineral density testing and osteoporosis therapy. Odds ratios (OR) and corresponding 95% confidence intervals (CI) are reported.
Findings indicated that female family physicians have higher odds of administering appropriate bone density testing compared to male family physicians (OR: 1.28; 95% CI: 1.05, 1.55), and that physicians who have hospital privileges (OR: 0.77; 95% CI: 0.62, 0.97) and who graduated more recently from medical school (OR: 0.87; 95% CI: 0.77, 0.99) have lower odds of administering appropriate bone mineral density tests. Physicians who use electronic health records have higher odds of administering appropriate therapy (OR: 1.30; 95% CI: 1.06, 1.59) as compared to physicians who do not use them.
Several family physicians’ personal and practice characteristics are associated with appropriate utilization of bone mineral density testing and therapy. The education of both clinicians and policy makers regarding these new insights may translate to enhanced individual practices and an improved overall health care system to optimize the environment for managing osteoporosis.
PMID: 19534577 CAMSID: cams6205
Patients with dementia have increased healthcare utilization and often have comorbid chronic conditions. It is not clear if the increase in utilization is driven by dementia, the comorbidities or both. The objective of this study was to describe the number and types of comorbid conditions in a population-based cohort of older adults with dementia and how the level of comorbidity impacts dementia-related and non-dementia-related health service utilization.
This study is a retrospective cohort study using multiple linked administrative databases to examine health service utilization and costs of 100,630 community-living older adults living with pre-existing dementia in Ontario, Canada. Comorbid conditions and health service utilization were measured using administrative data (physician visits, emergency department visits, hospitalizations, and homecare contacts).
Nearly all, 96.3 %, had at least one comorbid condition, while 18.4 % had five or more comorbid conditions. The most common comorbid conditions were hypertension (77.8 %), and arthritis (66.2 %). All types of utilization increased consistently with the number of comorbid conditions. The average number of dementia-related services tended to be similar across all levels of comorbidity while the average number of non-dementia related visits tended to increase with the level of comorbidity.
Comorbidities in community-living older adults with dementia are common and account for a substantial proportion of health service use and costs in this population. Our results suggest that comprehensive programs that take a holistic view to identify the needs of patients in the context of other comorbidities are required for persons with dementia living in the community.
Electronic supplementary material
The online version of this article (doi:10.1186/s12877-016-0351-x) contains supplementary material, which is available to authorized users.
Dementia; Community-living older adults; Health service utilization; Health service costs; Comorbidity
Supplemental Digital Content is available in the text.
To determine whether clinical outcomes differed by occurrence of severe hypertension in the international CHIPS trial (Control of Hypertension in Pregnancy Study), adjusting for the interventions of “less tight” (target diastolic blood pressure [dBP] 100 mm Hg) versus “tight” control (target dBP 85 mm Hg). In this post-hoc analysis of CHIPS data from 987 women with nonsevere nonproteinuric preexisting or gestational hypertension, mixed effects logistic regression was used to compare the following outcomes according to occurrence of severe hypertension, adjusting for allocated group and the influence of baseline factors: CHIPS primary (perinatal loss or high-level neonatal care for >48 hours) and secondary outcomes (serious maternal complications), birth weight <10th percentile, preeclampsia, delivery at <34 or <37 weeks, platelets <100×109/L, elevated liver enzymes with symptoms, maternal length of stay ≥10 days, and maternal readmission before 6 weeks postpartum. Three hundred and thirty-four (34.1%) women in CHIPS developed severe hypertension that was associated with all outcomes examined except for maternal readmission (P=0.20): CHIPS primary outcome, birth weight <10th percentile, preeclampsia, preterm delivery, elevated liver enzymes (all P<0.001), platelets <100×109/L (P=0.006), and prolonged hospital stay (P=0.03). The association between severe hypertension and serious maternal complications was seen only in less tight control (P=0.02). Adjustment for preeclampsia (464, 47.3%) did not negate the relationship between severe hypertension and the CHIPS primary outcome (P<0.001), birth weight <10th percentile (P=0.005), delivery at <37 (P<0.001) or <34 weeks (P<0.001), or elevated liver enzymes with symptoms (P=0.02). Severe hypertension is a risk marker for adverse maternal and perinatal outcomes, independent of BP control or preeclampsia co-occurrence.
Clinical Trial Registration—
URL: http://pre-empt.cfri.ca/. Unique identifier: ISRCTN 71416914. URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01192412.
antihypertensive therapy; hypertension; labetalol; methyldopa; pregnancy
For women with chronic or gestational hypertension in CHIPS (Control of Hypertension In Pregnancy Study, NCT01192412), we aimed to examine whether clinical predictors collected at randomization could predict adverse outcomes.
Material and methods
This was a planned, secondary analysis of data from the 987 women in the CHIPS Trial. Logistic regression was used to examine the impact of 19 candidate predictors on the probability of adverse perinatal (pregnancy loss or high level neonatal care for >48 h, or birthweight <10th percentile) or maternal outcomes (severe hypertension, preeclampsia, or delivery at <34 or <37 weeks). A model containing all candidate predictors was used to start the stepwise regression process based on goodness of fit as measured by the Akaike information criterion. For face validity, these variables were forced into the model: treatment group (“less tight” or “tight” control), antihypertensive type at randomization, and blood pressure within 1 week before randomization. Continuous variables were represented continuously or dichotomized based on the smaller p‐value in univariate analyses. An area‐under‐the‐receiver‐operating‐curve (AUC ROC) of ≥0.70 was taken to reflect a potentially useful model.
Point estimates for AUC ROC were <0.70 for all but severe hypertension (0.70, 95% CI 0.67–0.74) and delivery at <34 weeks (0.71, 95% CI 0.66–0.75). Therefore, no model warranted further assessment of performance.
CHIPS data suggest that when women with chronic hypertension develop an elevated blood pressure in pregnancy, or formerly normotensive women develop new gestational hypertension, maternal and current pregnancy clinical characteristics cannot predict adverse outcomes in the index pregnancy.
Preexisting hypertension; chronic hypertension; gestational hypertension; prediction; adverse outcome; maternal; perinatal
Supplemental Digital Content is available in the text.
The CHIPS randomized controlled trial (Control of Hypertension in Pregnancy Study) found no difference in the primary perinatal or secondary maternal outcomes between planned “less tight” (target diastolic 100 mm Hg) and “tight” (target diastolic 85 mm Hg) blood pressure management strategies among women with chronic or gestational hypertension. This study examined which of these management strategies is more or less costly from a third-party payer perspective. A total of 981 women with singleton pregnancies and nonsevere, nonproteinuric chronic or gestational hypertension were randomized at 14 to 33 weeks to less tight or tight control. Resources used were collected from 94 centers in 15 countries and costed as if the trial took place in each of 3 Canadian provinces as a cost-sensitivity analysis. Eleven hospital ward and 24 health service costs were obtained from a similar trial and provincial government health insurance schedules of medical benefits. The mean total cost per woman–infant dyad was higher in less tight versus tight control, but the difference in mean total cost (DM) was not statistically significant in any province: Ontario ($30 191.62 versus $24 469.06; DM $5723, 95% confidence interval, −$296 to $12 272; P=0.0725); British Columbia ($30 593.69 versus $24 776.51; DM $5817; 95% confidence interval, −$385 to $12 349; P=0.0725); or Alberta ($31 510.72 versus $25 510.49; DM $6000.23; 95% confidence interval, −$154 to $12 781; P=0.0637). Tight control may benefit women without increasing risk to neonates (as shown in the main CHIPS trial), without additional (and possibly lower) cost to the healthcare system.
Clinical Trial Registration—
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01192412.
blood pressure; cost analysis; health policy; hypertension; pregnancy; randomized controlled trials
The pan-Canadian Oncology Drug Review (pCODR) makes recommendations to Canada's provinces and territories (except Quebec) to guide their cancer drug funding decisions. The objective of this paper is to explore, using an economic perspective and the pCODR as an example, the challenges associated with striving to simultaneously achieve the goals of maximizing health benefits with available resources and improving access to a more consistent standard of care across Canada. The first challenge concerns how to interpret the goals in order to determine how resources should be allocated to achieve each goal. The second challenge relates to whether, if pursued simultaneously, both goals can be achieved to the same extent that each goal could have been achieved alone with the same available resources. Regarding the first challenge, we illustrate that, due to a lack of definitional clarity, it is difficult to determine exactly how resources should be allocated in order to achieve the goal of improving access to a more consistent standard of care across Canada. Regarding the second challenge, we illustrate that choosing to strive for both of the pCODR goals simultaneously will likely be associated with tradeoffs in the extent to which one or both goals can be achieved (relative to what could have been achieved for each goal alone with the same available resources). We suggest that, if the pCODR and the provincial drug plan decision-makers it supports want to strive for both goals simultaneously, they must prioritize the goals and explicitly identify the tradeoffs associated with the prioritization. This will ensure that the consequences of striving to simultaneously achieve both goals are explicit, transparent, and predictable for provincial drug plan decision-makers, physicians, patients, caregivers, and society as a whole.
resource allocation; health technology assessment; oncology; cancer; pan-Canadian oncology drug review (pCODR); drug reimbursement; drug funding; health policy
The current landscape of a rapidly aging population accompanied by multiple chronic conditions presents numerous challenges to optimally support the complex needs of this group. Mobile health (mHealth) technologies have shown promise in supporting older persons to manage chronic conditions; however, there remains a dearth of evidence-informed guidance to develop such innovations.
The purpose of this study was to conduct a scoping review of current practices and recommendations for designing, implementing, and evaluating mHealth technologies to support the management of chronic conditions in community-dwelling older adults.
A 5-stage scoping review methodology was used to map the relevant literature published between January 2005 and March 2015 as follows: (1) identified the research question, (2) identified relevant studies, (3) selected relevant studies for review, (4) charted data from selected literature, and (5) summarized and reported results. Electronic searches were conducted in 5 databases. In addition, hand searches of reference lists and a key journal were completed. Inclusion criteria were research and nonresearch papers focused on mHealth technologies designed for use by community-living older adults with at least one chronic condition, or health care providers or informal caregivers providing care in the home and community setting. Two reviewers independently identified articles for review and extracted data.
We identified 42 articles that met the inclusion criteria. Of these, described innovations focused on older adults with specific chronic conditions (n=17), chronic conditions in general (n=6), or older adults in general or those receiving homecare services (n=18). Most of the mHealth solutions described were designed for use by both patients and health care providers or health care providers only. Thematic categories identified included the following: (1) practices and considerations when designing mHealth technologies; (2) factors that support/hinder feasibility, acceptability, and usability of mHealth technologies; and (3) approaches or methods for evaluating mHealth technologies.
There is limited yet increasing use of mHealth technologies in home health care for older adults. A user-centered, collaborative, interdisciplinary approach to enhance feasibility, acceptability, and usability of mHealth innovations is imperative. Creating teams with the required pools of expertise and insight regarding needs is critical. The cyclical, iterative process of developing mHealth innovations needs to be viewed as a whole with supportive theoretical frameworks. Many barriers to implementation and sustainability have limited the number of successful, evidence-based mHealth solutions beyond the pilot or feasibility stage. The science of implementation of mHealth technologies in home-based care for older adults and self-management of chronic conditions are important areas for further research. Additionally, changing needs as cohorts and technologies advance are important considerations. Lessons learned from the data and important implications for practice, policy, and research are discussed to inform the future development of innovations.
Telemedicine; Mobile health; Health Plan Implementations; Evaluation Studies as Topic; Design; mHealth Innovations; Frail Elderly; Older Adults; Multiple Chronic Conditions; Home Care Services; Scoping Review; Communication; Information Communication Technologies
Few studies have examined the effectiveness of community-based self-management interventions in older adults with type 2 diabetes mellitus (T2DM) and multiple chronic conditions (MCC). The objectives of this study were to examine the feasibility of implementation in practice (primary) and the feasibility of study methods and potential effectiveness (secondary) of the Aging, Community and Health—Community Partnership Program, a new 6-month interprofessional, nurse-led program to promote diabetes self-management in older adults (>65 years) with T2DM and MCC.
This study used a prospective one-group pre-test/post-test design. Participants were recruited from a specialized diabetes clinic. They received a median of three in-home/clinic visits by certified diabetes educators (CDEs) and attended a median of three group wellness sessions provided by the CDEs in partnership with a community-based seniors’ association. The primary outcome was the feasibility of the program (acceptability, fidelity, implementation barriers/facilitators). Secondary outcomes included the feasibility of the study methods (recruitment/retention rates and procedures, eligibility criteria, data collection and analysis methods) and potential effectiveness of the program based on 6-month changes in self-reported outcomes including self-management behavior (diet, exercise, self-monitoring), health status (quality of life, mental health), and costs of service use. Analysis of feasibility outcomes was primarily based on descriptive statistics. The potential effectiveness of the program was explored using different tests, with the results expressed using descriptive statistics and effect estimates (95 % confidence intervals).
In total, 45 (88 %) of 51 eligible persons consented to participate. Of these, 37 (82 %) completed the 6-month follow-up. Participants and providers viewed the program as acceptable and feasible. Participants had a higher SF-12 physical component summary score at 6 months compared with baseline (mean score difference 3.0, 95 % CI 0.2–5.8). Median costs for diabetes care increased over 6 months (reflecting inclusion of program costs), while other service costs either decreased or remained unchanged.
This study offers preliminary evidence that the program was feasible to deliver and acceptable to participants and providers. Initial results suggest that the program may improve physical functioning. A randomized controlled trial is feasible, with some adaptations to the program and study methods that were identified from this feasibility study.
Clinicaltrials.gov identifier: NCT01880476
Electronic supplementary material
The online version of this article (doi:10.1186/s40814-016-0063-1) contains supplementary material, which is available to authorized users.
Nurse-led intervention; Older adults; Feasibility study; Diabetes self-management; Community-based care; Interdisciplinary
Patient decision aids (P‐DAs) inform medical decision making, but longer term effects are unknown. This article describes extended follow‐up from a thyroid cancer treatment P‐DA trial.
In this single‐center, parallel‐design randomized controlled trial conducted at a Canadian tertiary/quaternary care center, early‐stage thyroid cancer patients from a P‐DA trial were contacted 15 to 23 months after randomization/radioactive iodine (RAI) decision making to evaluate longer term outcomes. It was previously reported that the use of the computerized P‐DA in thyroid cancer patients considering postsurgical RAI treatment significantly improved medical knowledge in comparison with usual care alone. The P‐DA and control groups were compared for the following outcomes: feeling informed about the RAI treatment choice, decision satisfaction, decision regret, cancer‐related worry, and physician trust. In a subgroup of 20 participants, in‐depth interviews were conducted for a qualitative analysis.
Ninety‐five percent (70 of 74) of the original population enrolled in follow‐up at a mean of 17.1 months after randomization. P‐DA users perceived themselves to be significantly more 1) informed about the treatment choice (P = .008), 2) aware of options (P = .009), 3) knowledgeable about treatment benefits (P = .020), and 4) knowledgeable about treatment risks/side effects (P = .001) in comparison with controls. There were no significant group differences in decision satisfaction (P = .142), decision regret (P = .199), cancer‐related worry (P = .645), mood (P = .211), or physician trust (P = .764). In the qualitative analysis, the P‐DA was perceived to have increased patient knowledge and confidence in decision making.
The P‐DA improved cancer survivors’ actual and long‐term perceived medical knowledge with no adverse effects. More research on the long‐term outcomes of P‐DA use is needed. Cancer 2015;121:3717–3726. © 2015 American Cancer Society.
In this extended follow‐up study of a randomized controlled trial of a thyroid cancer treatment patient decision aid, patient decision aid users perceive themselves to be significantly more informed about the choice of radioactive iodine treatment, although their decision satisfaction and regret are not significantly different from those of controls not exposed to the patient decision aid. Patient decision aid utilization has no significant negative impact on cancer‐related worry, mood, or trust in the treating physician in long‐term follow‐up.
decision aids; decision making; decision support techniques; iodine radioisotopes; patient satisfaction; qualitative research; thyroid cancer
Infant behavioral sleep problems are common, with potential negative consequences. We conducted a randomized controlled trial to assess effects of a sleep intervention comprising a two-hour group teaching session and four support calls over 2 weeks. Our primary outcomes were reduced numbers of nightly wakes or parent report of sleep problem severity. Secondary outcomes included improvement in parental depression, fatigue, sleep, and parent cognitions about infant sleep.
Two hundred thirty five families of six-to-eight month-old infants were randomly allocated to intervention (n = 117) or to control teaching sessions (n = 118) where parents received instruction on infant safety. Outcome measures were observed at baseline and at 6 weeks post intervention. Nightly observation was based on actigraphy and sleep diaries over six days. Secondary outcomes were derived from the Multidimensional Assessment of Fatigue Scale, Center for Epidemiologic Studies Depression Measure, Pittsburgh Sleep Quality Index, and Maternal (parental) Cognitions about Infant Sleep Questionnaire.
One hundred eight intervention and 107 control families provided six-week follow-up information with complete actigraphy data for 96 in each group: 96.9 % of intervention and 97.9 % of control infants had an average of 2 or more nightly wakes, a risk difference of −0.2 % (95 % CI: −1.32, 0.91). 4 % of intervention and 14 % of control infants had parent-assessed severe sleep problems: relative risk 0.3, a risk difference of −10 % (CI: 0.11, 0.84-16.8 to −2.2). Relative to controls, intervention parents reported improved baseline-adjusted parental depression (CI: −3.7 to −0.4), fatigue (CI: −5.74 to −1.68), sleep quality (CI: −1.5 to −0.2), and sleep cognitions: doubts (CI: −2.0 to −0.6), feeding (CI: − 2.1 to - 0.7), anger (CI: − 1.8 to - 0.4) and setting limits (CI: −3.5 to −1.5).
The intervention improved caregivers' assessments of infant sleep problem severity and parental depression, fatigue, sleep, and sleep cognitions compared with controls.
Randomized controlled trial; Multi-component intervention; Behavioral sleep problems; Infants; Actigraphy; Diaries; Parents
Women with recurrent ovarian cancer depend on their physicians to provide them with information about their diagnosis and available treatment options if they wish to participate in the process of choosing the treatment. There is no information on how oncologists give information to women during the physician–patient encounter at the time the disease recurs.
To explore from the oncologists' perspective (i) the extent to which oncologists provide their own patients who are experiencing their first recurrence of ovarian cancer with the same information about management options, and (ii) any explicit or implicit criteria they use to decide whether and how to tailor the information to individual patients.
We adopted a qualitative, exploratory descriptive approach to begin to understand oncologists' perspectives on how they gave information to patients within the context of their clinical practice. Individual interviews were used to identify themes related to the study objectives.
Fifteen gynaecologic and five medical oncologists participated. Theme 1 describes the extent to which oncologists give information to their patients in the same way or in different ways. This section describes how the same oncologist may modify the depth of information transfer based on several factors. Theme 2 focuses on the factors that influence what information is given. For example, the amount and type of information given is based on the oncologist's on‐going assessment of how the patient is assimilating the information shared during the medical encounter, the oncologists' perception of their relationship with the patient and the oncologist's assessment of what role they should take in decision making. Theme 3 involves the factors that influenced how information is given. For example, the information shared may vary based on the oncologist's perception of the patient's vitality, the patient's comprehension of the information, the patient's emotional well‐being. In addition, the oncologist may make the information relevant for the patient by using analogies. Different types of information may be shared based on the oncologist's perception of patient‐ or family‐initiated question. The information relay may be curtailed based on competing demands for the oncologist.
Discussion and Conclusions
Oncologists provide women with information on their disease status, their treatment options and the side effects of treatment. The oncologists use perceptions to determine what information and how to provide information. The question this paper raises is whether the oncologist's perceptions reflect the individual patient's information and decision‐making needs.
information giving; oncologist perspective; ovarian cancer; qualitative
Patient decision aids (P-DAs) are used to inform patients about healthcare choices, but there is limited knowledge about their longer term effects, beyond the time period of decision-making.
We developed a computerized P-DA that explains the choice of radioactive iodine (RAI) adjuvant treatment or no RAI, for patients with low risk papillary thyroid cancer after total thyroidectomy. The original protocol for a randomized controlled trial, comparing the use of the P-DA (with usual care) to usual care alone, has been published in Trialshttp://www.trialsjournal.com/content/11/1/81. We found that P-DA (with usual care) significantly improved patients’ medical knowledge at the time of decision-making (primary outcome) compared to usual care alone (control). In this update, we present the protocol for an extended follow-up study (15 to 23 months post-randomization), including qualitative and quantitative methods. The patient outcomes evaluated using quantitative questionnaires include: the degree to which patients feel well-informed about their RAI treatment choice, decision satisfaction, decision regret, cancer-related worry, mood, and trust in the treating physician. The qualitative component explores the experiences of RAI treatment decision-making, treatment satisfaction, and trial participation in a representative subgroup of patients. Extended follow-up study results will be described for the entire study population, and data will be compared between the P-DA and control groups.
Result and Conclusion
This mixed methods extended follow-up study will provide data on long term outcomes, relating to the use of a computerized P-DA in decision-making about adjuvant RAI treatment in early stage papillary thyroid cancer.
Our results are intended to inform future research in this area, particularly relating to long term effects of the use of P-DAs in making healthcare choices.
Clinicaltrials.gov identifier NCT01083550, registered 24 February 2010 and last updated 5 January 2015
Papillary thyroid cancer; Decision aid; Knowledge translation; Patient satisfaction
We have shown in a randomized controlled trial that a computerized patient decision aid (P-DA) improves medical knowledge and reduces decisional conflict, in early stage papillary thyroid cancer patients considering adjuvant radioactive iodine treatment. Our objectives were to examine the relationship between participants’ baseline information preference style and the following: 1) quantity of detailed information obtained within the P-DA, and 2) medical knowledge.
We randomized participants to exposure to a one-time viewing of a computerized P-DA (with usual care) or usual care alone. In pre-planned secondary analyses, we examined the relationship between information preference style (Miller Behavioural Style Scale, including respective monitoring [information seeking preference] and blunting [information avoidance preference] subscale scores) and the following: 1) the quantity of detailed information obtained from the P-DA (number of supplemental information clicks), and 2) medical knowledge. Spearman correlation values were calculated to quantify relationships, in the entire study population and respective study arms.
In the 37 P-DA users, high monitoring information preference was moderately positively correlated with higher frequency of detailed information acquisition in the P-DA (r = 0.414, p = 0.011). The monitoring subscale score weakly correlated with increased medical knowledge in the entire study population (r = 0.268, p = 0.021, N = 74), but not in the respective study arms. There were no significant associations with the blunting subscale score.
Individual variability in information preferences may affect the process of information acquisition from computerized P-DA’s. More research is needed to understand how individual information preferences may impact medical knowledge acquisition and decision-making.
Electronic supplementary material
The online version of this article (doi:10.1186/s12911-015-0168-0) contains supplementary material, which is available to authorized users.
Cancer; Patient decision aid; Behaviour; Health information; Decision making; Consumer health information; Information seeking behaviors
The Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS) showed no benefit in the reduction of major neonatal mortality/morbidity or neurodevelopment at 2 and 5 years of age. Using the data from the randomized controlled trial and its follow-up, the aim of this study was to evaluate the association between gestational ages at birth in children exposed to single versus multiple courses of antenatal corticosteroid (ACS) therapy in utero and outcomes at 5 years of age.
A total of 1719 children, with the breakdown into groupings of <30, 30–36, and ≥ 37 weeks gestation at birth, contributed to the primary outcome: death or survival with a disability in one of the following domains: neuromotor, neurosensory, and neurobehavioral/emotional disability and were included in this analysis.
Gestational age at birth was strongly associated with the primary outcome, p < 0.001. Overall, the interaction between ACS groups and gestational age at birth was not significant, p = 0.064. Specifically, in the 2 preterm categories, there was no difference in the primary outcome between single vs. multiple ACS therapy. However, for infants born ≥37 weeks gestation, there was a statistically significant increase in the risk of the primary outcome in multiple ACS therapy, 48/213 (22.5%) compared to 38/249 (15.3%) in the single ACS therapy; OR = 1.69 [95% CI: 1.04, 2.77]; p = 0.037.
Preterm birth (<37 weeks gestation) remained the primary factor contributing to an adverse outcome regardless of the number of courses of ACS therapy. Children born ≥ 37 weeks and exposed to multiple ACS therapy may have an increased risk of neurodevelopmental/neurosensory impairment by 5 years of age. To optimize outcomes for infants/children, efforts in reducing the incidence of preterm birth should remain the primary focus in perinatal research.
This study has been registered at (identifier NCT00187382)
Electronic supplementary material
The online version of this article (doi:10.1186/1471-2393-14-272) contains supplementary material, which is available to authorized users.
Preterm birth; Long-term neurodevelopmental outcomes; Antenatal corticosteroids; Gestational age at birth
Twin birth is associated with a higher risk of adverse perinatal outcomes than singleton birth. It is unclear whether planned cesarean section results in a lower risk of adverse outcomes than planned vaginal delivery in twin pregnancy.
We randomly assigned women between 32 weeks 0 days and 38 weeks 6 days of gestation with twin pregnancy and with the first twin in the cephalic presentation to planned cesarean section or planned vaginal delivery with cesarean only if indicated. Elective delivery was planned between 37 weeks 5 days and 38 weeks 6 days of gestation. The primary outcome was a composite of fetal or neonatal death or serious neonatal morbidity, with the fetus or infant as the unit of analysis for the statistical comparison.
A total of 1398 women (2795 fetuses) were randomly assigned to planned cesarean delivery and 1406 women (2812 fetuses) to planned vaginal delivery. The rate of cesarean delivery was 90.7% in the planned-cesarean-delivery group and 43.8% in the planned-vaginal-delivery group. Women in the planned-cesarean-delivery group delivered earlier than did those in the planned-vaginal-delivery group (mean number of days from randomization to delivery, 12.4 vs. 13.3; P = 0.04). There was no significant difference in the composite primary outcome between the planned-cesarean-delivery group and the planned-vaginal-delivery group (2.2% and 1.9%, respectively; odds ratio with planned cesarean delivery, 1.16; 95% confidence interval, 0.77 to 1.74; P = 0.49).
In twin pregnancy between 32 weeks 0 days and 38 weeks 6 days of gestation, with the first twin in the cephalic presentation, planned cesarean delivery did not significantly decrease or increase the risk of fetal or neonatal death or serious neonatal morbidity, as compared with planned vaginal delivery. (Funded by the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00187369; Current Controlled Trials number, ISRCTN74420086.)
PMID: 24088091 CAMSID: cams3905
Context Promoting patient participation in treatment decision making is of increasing interest to researchers, clinicians and policy makers. Decision aids (DAs) are advocated as one way to help achieve this goal. Despite their proliferation, there has been little agreement on criteria or standards for evaluating these tools. To fill this gap, an international collaboration of researchers and others interested in the development, content and quality of DAs have worked over the past several years to develop a checklist and, based on this checklist, an instrument for determining whether any given DA meets a defined set of quality criteria.
Objective/Methods In this paper, we offer a framework for assessing the conceptual clarity and evidence base used to support the development of quality criteria/standards for evaluating DAs. We then apply this framework to assess the conceptual clarity and evidence base underlying the International Patient Decision Aids Standards (IPDAS) checklist criteria for one of the checklist domains: how best to present in DAs probability information to patients on treatment benefits and risks.
Conclusion We found that some of the central concepts underlying the presenting probabilities domain were not defined. We also found gaps in the empirical evidence and theoretical support for this domain and criteria within this domain. Finally, we offer suggestions for steps that should be undertaken for further development and refinement of quality standards for DAs in the future.
decision aids; quality standards IPDAS; shared decision making
Shared decision making is now making inroads in health care professionals’ continuing education curriculum, but there is no consensus on what core competencies are required by clinicians for effectively involving patients in health-related decisions. Ready-made programs for training clinicians in shared decision making are in high demand, but existing programs vary widely in their theoretical foundations, length, and content. An international, interdisciplinary group of 25 individuals met in 2012 to discuss theoretical approaches to making health-related decisions, compare notes on existing programs, take stock of stakeholders concerns, and deliberate on core competencies. This article summarizes the results of those discussions. Some participants believed that existing models already provide a sufficient conceptual basis for developing and implementing shared decision making competency-based training programs on a wide scale. Others argued that this would be premature as there is still no consensus on the definition of shared decision making or sufficient evidence to recommend specific competencies for implementing shared decision making. However, all participants agreed that there were 2 broad types of competencies that clinicians need for implementing shared decision making: relational competencies and risk communication competencies. Further multidisciplinary research could broaden and deepen our understanding of core competencies for shared decision making training.
PMID: 24347105 CAMSID: cams3819
shared decision making; education; patient-centered care; implementation science; theory; risk communication
Many common diseases affecting the airways are characterized by airway inflammation. The measurement of this inflammation has a significant role in the management of these diseases. Quantitative sputum cell counts provide a measurement of the type and severity of inflammation present. Sputum cell counts are used in routine clinical practice in some centres but their use is not widespread. The present study used a standardized questionnaire to determine both patients’ and physicians’ attitudes toward the use of sputum cell counts. The use of sputum cell counts was well accepted by patients and physicians. Ninety per cent of patients were satisfied with the test. Sixty per cent of family physicians were satisfied with the test and 80% were in favour of it being funded by the government. The authors recommend more widespread use of sputum cell counts to guide the management of airway diseases.
Asthma; Bronchitis; Patient satisfaction; Sputum cell counts; Willingness to pay
Objective To identify patients’ and physicians’ perceptions of physician‐related verbal and nonverbal facilitators and barriers to patient involvement in treatment decision making (TDM) occurring during clinical encounters for women with early stage breast cancer (ESBC).
Methods Eligible women were offered treatment options including surgery and adjuvant therapy. Eligible physicians provided care for women with ESBC in either a teaching hospital or an academic cancer centre. In Phase 1, women were interviewed 1–2 weeks after their initial consultation. In Phase 2, women and their physicians were interviewed separately while watching their own consultation on a digital video disk. All interviews were audiotaped, transcribed and analysed.
Results Forty women with ESBC and six physicians participated. Patients and physicians identified thirteen categories of physician facilitators of women’s involvement. Of these, seven categories were frequently identified by women: conveyed a rationale for patient involvement in TDM; explained the risk of cancer recurrence; explained treatment options; enhanced patient understanding of information; gave time for TDM; offered a treatment recommendation; and made women feel comfortable. Physicians described similar information‐giving facilitators but less often mentioned other facilitators. Few physician barriers to women’s involvement in TDM were identified.
Conclusions Women with ESBC and cancer physicians shared some views of how physicians involve patients in TDM, although there were important differences. Physicians may underestimate the importance that women’s place on understanding the rationale for their involvement in TDM and on feeling comfortable during the consultation.
breast cancer; treatment decision making
Decision aids help physicians convey information to patients and enable patients to be involved in the decision-making process. There is a lack of use of decision aids in the orthopedic literature. The purpose of this study was to develop a decision board to elicit preferences for treatment of displaced femoral neck fractures in patients over 60 years old.
Materials and Methods:
We developed a decision board presenting descriptions and potential outcomes and complications of two treatment options, hemiarthroplasty (HA) and internal fixation (IF), for displaced femoral neck fractures. Five orthopedic surgeons evaluated the face and content validity of the decision board and 10 volunteers completed “scope tests” to determine the comprehensibility. We then presented the decision board to 108 study participants faced with the scenario of sustaining a displaced femoral neck fracture. Participants stated their preference for operative procedure and described the reasons for their choices.
The decision board achieved good face and content validity. All participants in the scope tests appropriately switched their preference to the other modality when probabilities were altered. Most participants found the decision board easy to understand and helpful in making an informed decision. Also, most participants were satisfied with the amount of information presented and with the use of the decision board as a decision making tool. Sixty-one participants (56%) chose IF as their operative procedure of choice quoting less blood loss, shorter operative time, and less invasiveness as the top factors that contributed to this choice. Participants who preferred HA (44%) did so primarily due to the lower re-operation rate.
The decision board is a useful and reliable tool to inform patients about the treatment options for displaced femoral neck fractures. They should be utilized by surgeons to incorporate patients’ preferences into the decision-making process.
Decision aid; decision board; femoral neck fracture; hemiarthroplasty; internal fixation
To garner Canadian physicians’ opinions on strategies to reduce hip fractures in long-term care (LTC) facilities, focusing on secondary prevention.
A cross-sectional survey using a mailed, self-administered, written questionnaire.
Family physician members of the Ontario Long-Term Care Association (n = 165) and all actively practising geriatricians registered in the Canadian Medical Directory (n = 81).
MAIN OUTCOME MEASURES
The strength of recommendations for fracture-reduction strategies in LTC and barriers to implementing these strategies.
Of the 246 physicians sent the questionnaire, 25 declined study materials and were excluded. Of the 221 remaining, 120 responded for a response rate of 54%. About two-thirds of respondents were family physicians (78 of 120) and the rest were mostly geriatricians. Most respondents strongly recommended the following secondary prevention strategies for use in LTC after hip fracture: calcium, vitamin D, oral aminobisphosphonates, physical therapy, and environmental modification (such as handrails). Most respondents either did not recommend or recommended limited use of etidronate, intravenous bisphosphonates, calcitonin, raloxifene, testosterone (for hypogonadal men), and teriparatide. Postmenopausal hormone therapy was discouraged or not recommended by most respondents. Support was mixed for the use of hip protectors, B vitamins, and folate. Barriers to implementation identified by most respondents included a lack of strong evidence of hip fracture reduction (for B vitamins and folate, cyclic etidronate, and testosterone), side effects (for postmenopausal hormone therapy), poor compliance (for hip protectors), and expense (for intravenous bisphosphonates and teriparatide). Some respondents cited side effects or poor compliance as barriers to using calcium and potent oral bisphosphonates.
Canadian physicians favour the use of calcium, vitamin D, potent oral bisphosphonates, physical therapy, and evironmental modifications for LTC residents after hip fracture. Further study at the clinical and administrative levels is required to find ways to overcome the specific barriers to implementation and effectiveness of these interventions.
Concern has been growing in the academic literature and popular media about the licensing, introduction and adoption of surgical devices before full effectiveness and safety evidence is available to inform clinical practice. Our research will seek empirical survey evidence about the roles, responsibilities, and information and policy needs of the key stakeholders in the introduction into clinical practice of new surgical devices for pelvic floor surgery, in terms of the underlying ethical principals involved in the economic decision-making process, using the example of pelvic floor procedures.
Our study involves three linked case studies using, as examples, selected pelvic floor surgery devices representing Health Canada device safety risk classes: low, medium and high risk. Data collection will focus on stakeholder roles and responsibilities, information and policy needs, and perceptions of those of other key stakeholders, in seeking and using evidence about new surgical devices when licensing and adopting them into practice. For each class of device, interviews will be used to seek the opinions of stakeholders. The following stakeholders and ethical and economic principles provide the theoretical framework for the study:
Stakeholders - federal regulatory body, device manufacturers, clinicians, patients, health care institutions, provincial health departments, and professional societies. Clinical settings in two centres (in different provinces) will be included.
Ethics - beneficence, non-maleficence, autonomy, justice.
Economics - scarcity of resources, choices, opportunity costs.
For each class of device, responses will be analysed to compare and contrast between stakeholders. Applied ethics and economic theory, analysis and critical interpretation will be used to further illuminate the case study material.
The significance of our research in this new area of ethics will lie in providing recommendations for regulatory bodies, device manufacturers, clinicians, health care institutions, policy makers and professional societies, to ensure surgical patients receive sufficient information before providing consent for pelvic floor surgery. In addition, we shall provide a wealth of information for future study in other areas of surgery and clinical management, and provide suggestions for changes to health policy.
Patients with early stage papillary thyroid carcinoma (PTC), are faced with the decision to either to accept or reject adjuvant radioactive iodine (RAI) treatment after thryroidectomy. This decision is often difficult because of conflicting reports of RAI treatment benefit and medical evidence uncertainty due to the lack of long-term randomized controlled trials.
We report the protocol for a parallel, 2-arm, randomized trial comparing an intervention group exposed to a computerized decision aid (DA) relative to a control group receiving usual care. The DA explains the options of adjuvant radioactive iodine or no adjuvant radioactive iodine, as well as associated potential benefits, risks, and follow-up implications. Potentially eligible adult PTC patient participants will include: English-speaking individuals who have had recent thyroidectomy, and whose primary tumor was 1 to 4 cm in diameter, with no known metastases to lymph nodes or distant sites, with no other worrisome features, and who have not received RAI treatment for thyroid cancer. We will measure the effect of the DA on the following patient outcomes: a) knowledge about PTC and RAI treatment, b) decisional conflict, c) decisional regret, d) client satisfaction with information received about RAI treatment, and e) the final decision to accept or reject adjuvant RAI treatment and rationale.
This trial will provide evidence of feasibility and efficacy of the use of a computerized DA in explaining complex issues relating to decision making about adjuvant RAI treatment in early stage PTC.
Clinical Trials.gov Identifier: NCT01083550