Prospective surveillance and targeted physiotherapy for arm morbidity after breast cancer surgery: a pilot randomized controlled trial.

OBJECTIVE: To evaluate prospective surveillance and targeted physiotherapy (PSTP) compared to education (EDU) on the prevalence of arm morbidity and describe the associated program cost. DESIGN: Pilot randomized single-blinded controlled trial. SETTING: Urban with assessments and treatment delivered in hospitals. PARTICIPANTS: Women scheduled for breast cancer surgery. INTERVENTIONS: Participants were randomly assigned (1:1) to PSTP ( n = 21) or EDU ( n = 20) and assessed presurgery and 12 months postsurgery. All participants received usual care, namely, preoperative education and provision of an education booklet with postsurgical exercises. The PSTP group was monitored for arm morbidity every three months and referred for physiotherapy if arm morbidity was identified. The EDU group received three education sessions on nutrition, stress and fatigue management. MAIN OUTCOME MEASURES: Arm morbidity was based on changes in the surgical arm(s) from presurgery in four domains: (1) shoulder range of motion, (2) strength, (3) volume, and (4) upper body function. Complex arm morbidity indicated ≥2 domains impaired. Second, the cost of the PSTP program was described. RESULTS: At 12 months, 18 (49%) participants (10 PSTP and 8 EDU) had arm morbidity, with EDU participants presenting more complex arm morbidity compared to PSTP participants. PSTP participants attended 4.4 of 5 assessments with 90% retention. The PSTP program cost was $150 covered by the Health Care Provider and the Patient Out-of-Pocket Travel cost was CAN$40. CONCLUSION: Our results suggest that PSTP is feasible among women with breast cancer for early identification of arm morbidity. A larger study is needed to determine the cost and effectiveness benefits.

Development of a Chronic Disease Management Program for Stroke Survivors Using Intervention Mapping: The Stroke Coach.

OBJECTIVE: To describe the systematic development of the Stroke Coach, a theory- and evidence-based intervention to improve control of lifestyle behavior risk factors in patients with stroke. DESIGN: Intervention development. SETTING: Community. PARTICIPANTS: Individuals who have had a stroke. INTERVENTIONS: We used intervention mapping to guide the development of the Stroke Coach. Intervention mapping is a systematic process used for intervention development and composed of steps that progress from the integration of theory and evidence to the organization of realistic strategies to facilitate the development of a practical intervention supported by empirical evidence. Social cognitive theory was the underlying premise for behavior change, whereas control theory methods were directed toward sustaining the changes to ensure long-term health benefits. Practical evidence-based strategies were linked to behavioral determinants to improve stroke risk factor control. MAIN OUTCOME MEASURES: Not applicable. RESULTS: The Stroke Coach is a patient-centered, community-based, telehealth intervention to promote healthy lifestyles after stroke. Over 6 months, participants receive seven 30- to 60-minute telephone sessions with a lifestyle coach who provides education, facilitates motivation for lifestyle modification, and empowers participants to self-management their stroke risk factors. Participants also receive a self-management manual and a self-monitoring kit. CONCLUSIONS: Through the use of intervention mapping, we developed a theoretically sound and evidence-grounded intervention to improve risk factor control in patients with stroke. If empirical evaluation of the Stroke Coach produces positive results, the next step will be to develop an implementation intervention to ensure successful uptake and delivery of the program in community and outpatient settings.

Users' guide to the surgical literature: how to assess a noninferiority trial.

SUMMARY: A well-planned randomized controlled trial (RCT) is the most optimal study design to determine if a novel surgical intervention is any different than a prevailing one. Traditionally, when we want to show that a new surgical intervention is superior to a standard one, we analyze data from an RCT to see if the null hypothesis of "no difference" can be rejected (i.e., the 2 surgical interventions have the same effect). A noninferiority RCT design seeks to determine whether a new intervention is not worse than a prevailing (standard) one within an acceptable margin of risk or benefit, referred to as the "noninferiority margin." In the last decade, we have observed an increase in the publication of noninferiority RCTs. This article explores this type of study design and discusses the tools that can be used to appraise such a study.

Users' guide to the surgical literature: how to assess an article about harm in surgery.

CLINICALSCENARIO: You are a new plastic surgeon in the community and you are referred a patient interested in breast reconstruction. The patient is a 35-year-old female school teacher who had a bilateral prophylactic mastectomy 2 years earlier, as she was a BRCA gene carrier. Since she is of a petite build with very little subcutaneous tissue or extra skin in the lower abdomen, you decide that she is not a suitable candidate for an abdomen-based autologous tissue reconstruction. You recommend the technique of tissue expansion and silicone gel implants. She is concerned, however, about the possibility of anaplastic large cell lymphoma (ALCL) developing in her breasts. She read in a magazine recently that ALCL, an unusual form of breast cancer, has been occurring in patients who have breast implants. She is very concerned that she might be at risk and asks for your opinion as to whether she should proceed with the procedure or not.

Risks and benefits of screening asymptomatic women for ovarian cancer: a systematic review and meta-analysis.

OBJECTIVE: We performed a systematic review and meta-analysis to quantify risks and benefits of screening asymptomatic women for ovarian cancer. METHODS: We searched MEDLINE, EMBASE, CINAHL, and Cochrane CENTRAL, without language restrictions, from January 1, 1979 to February 5, 2012. Eligible studies randomly assigned asymptomatic women to screening or usual care. Two reviewers independently screened studies for eligibility, extracted data using a standardized, piloted extraction form, and assessed bias and strength of inference for each outcome using the GRADE framework. Chance-corrected agreement was calculated at each step, and disagreements were resolved through consensus. RESULTS: Ten randomized trials proved eligible. Screening did not reduce all-cause mortality (relative risk (RR)=1.0, 95% confidence interval (CI) 0.96-1.06), ovarian cancer specific mortality (RR=1.08, 95% CI 0.84-1.38), or risk of diagnosis at an advanced stage (RR of diagnosis at FIGO stages III-IV=0.86, 95% CI 0.68-1.11). Transvaginal ultrasound resulted in a mean of 38 surgeries per ovarian cancer detected (95% CI 15.7-178.1) while screening with CA-125 led to 4 surgeries per ovarian cancer detected (95% CI 2.7-4.5). Surgery was associated with severe complications in 6% of women (95% CI 1%-11%). Quality of life was not affected by screening; however, women with false-positive results had increased cancer-specific distress compared to those with normal results (odds ratio (OR)=2.22, 95% CI 1.23-3.99). CONCLUSIONS: Screening asymptomatic women for ovarian cancer does not reduce mortality or diagnosis at an advanced stage and is associated with unnecessary surgery.

The Author Truncation "et al." in Article References: An Anachronism That Needs to Change.

Background: Valuable research requires contribution from many experts; however, the "et al." truncation often keeps all individuals from being acknowledged. The adoption of a new citation rule (list all authors up to 30, followed by et al.) would allow more authors to be acknowledged. The purpose of this study was to (1) explore the citation styles of the top 10 Plastic Surgery, Surgery, and Medical journals and (2) compare the number of extra pages required, and the number of additional authors acknowledged when the "new rule" is implemented. Methods: The top 10 journals in Plastic Surgery, Surgery, and Medicine were identified. The citation styles used in each of the journals were reviewed and the reference list from a recently published article was extracted. The original reference list was used to create an Extended Reference List using the new rule. Results: Most journals implemented "et al." when seven or more authors were listed. Ten articles required additional pages to accommodate the Extended Reference List. When the "et al." truncation was introduced after 30 authors, there was an almost 100% chance of all authors being included. The adoption of this rule rarely resulted in the need for additional pages, especially within Plastic Surgery. Conclusions: In a time of electronic publishing, where constraints such as article and journal page length should not be important factors, all authors should be recognized. The use of the "et al." truncation should be discouraged by all individuals involved in the production and publication of research. Scenario You are asked by the Editor-in-Chief of your specialty's journal to review an article in your area of expertise. You gladly accept the task. One of the questions you are required to answer in your review is whether the authors of the submitted manuscript have missed any important articles in their references. As you are the recognized expert in this field, you glance at the references to see if a key article you published 3 years earlier has been included. The first author of that article was a junior resident in your service and the research was done under your supervision. To their credit, the authors included the said article, but you are dismayed that the reference does not include your name. It includes only the names of the first three authors, all junior residents in your service. Your name, and the names of many others, are lost in the et al. truncation.

Contexte: Une recherche intéressante nécessite la contribution de nombreux experts; cependant, le raccourci « et coll. ¼ empêche souvent la reconnaissance de toutes les personnes. L'adoption d'une nouvelle règle de référencement (énumérer tous les auteurs jusqu'à 30, suivi de et coll.) permettrait de reconnaître davantage d'auteurs. L'objectif de cette étude était de 1) explorer les styles de référence des 10 principaux journaux de chirurgie plastique, chirurgie et médecine, et 2) comparer le nombre de pages supplémentaires requises et le nombre d'auteurs supplémentaires identifiés quand la « nouvelle règle ¼ est appliquée. Méthodes: Les 10 principaux journaux de chirurgie plastique, chirurgie et médecine ont été identifiés. Les styles de référencement utilisés dans chacun de ces journaux ont été revus et la liste des références d'un article récemment publié a été extraite. La liste de références originale a servi à créer une liste de références étendue selon la nouvelle règle. Résultats: La majorité des journaux a utilisé « et coll. ¼ quand 7 auteurs ou plus étaient cités. Dix articles ont nécessité des pages supplémentaires pour accueillir la liste de références étendue. Quand le raccourci « et coll. ¼ était introduit avec le seuil de 30 auteurs, il y avait pratiquement 100 % de chances d'avoir inclus tous les auteurs. L'adoption de cette règle a rarement entraîné le besoin de pages supplémentaires, en particulier dans Plastic Surgery. Conclusions: À l'époque de l'édition électronique où des contraintes telles que la longueur d'un article et le nombre de pages ne devraient pas être des facteurs importants, tous les auteurs devraient être reconnus. L'utilisation du raccourci « et coll. ¼ devrait être découragée par tous ceux qui sont impliqués dans la production et la publication de recherches.

Telehealth coaching to improve self-management for secondary prevention after stroke: A randomized controlled trial of Stroke Coach.

BACKGROUND: Stroke Coach is a lifestyle coaching telehealth program to improve self-management of stroke risk factors. AIMS: To examine the efficacy of Stroke Coach on lifestyle behavior and risk factor control among community-living stroke survivors within one-year post stroke. METHODS: Participants were randomized to Stroke Coach or an attention control Memory Training group. Lifestyle behavior was measured using the Health Promoting Lifestyle Profile II. Secondary outcomes included specific behavioral and cardiometabolic risk factors, health-related quality of life (HRQoL), cognitive status, and depressive symptoms. Measurements were taken at baseline, post-intervention (6 months), and retention (12 month). Linear mixed-effects models were used to test the study hypotheses (p < 0.05). All analyses were intention-to-treat. RESULTS: The mean age of the Stroke Coach (n = 64) and Memory Training (n = 62) groups was 67.2 and 69.1 years, respectively. The majority of participants (n = 100) had mild stroke (modified Rankin Scale = 1 or 2), were active, with controlled blood pressure (mean = 129/79 mmHg) at baseline. At post-intervention, there were no significant differences in lifestyle (b = -2.87; 95%CI - 8.03 to 2.29; p = 0.28). Glucose control, as measured by HbA1c (b = 0.17; 95%CI 0.17 to 0.32; p = 0.03), and HRQoL, measured using SF-36 Physical Component Summary (b = -3.05; 95%CI -5.88 to -0.21; p = 0.04), were significantly improved in Stroke Coach compared to Memory Training, and the improvements were maintained at retention. CONCLUSION: Stroke Coach did not improve lifestyle behavior; however, there were improvements to HbA1c and HRQoL among community-living stroke survivors with mild stroke-related disability. (ClinicalTrials.gov identifier: NCT02207023).

A multicentered, randomized, controlled trial comparing radioguided seed localization to standard wire localization for nonpalpable, invasive and in situ breast carcinomas.

BACKGROUND: Studies suggest radioguided seed localization (RSL) yields fewer positive margins than wire-guided localization (WL). The goal of this study is to determine whether RSL is superior to WL. METHODS: Women with confirmed invasive or ductal carcinoma in situ (DCIS) undergoing localization and breast conserving surgery were enrolled. Outcomes measured include positive margin and reoperation rates, specimen weight, operative and localization times, and surgeon and radiologist ranking of procedural difficulty. RESULTS: Randomization was centralized, concealed, and stratified by surgeon with 153 patients in the WL group and 152 in RSL group. Localizations were performed using either ultrasound (70%) or mammographic guidance (30%). Pathology was either DCIS (18%) or invasive carcinoma (82%). Procedures were performed at 3 sites, by 7 surgeons. Only difference found for patient and tumor characteristics was more multifocal disease in RSL group. Using intention-to-treat analysis, there were no differences in positive margins rates for RSL (10.5%) and WL (11.8%), (P=.99) or for positive or close margins (<1 mm) (RSL 19% and WL 22%; P=.61). Mean operative time (minutes) was shorter for RSL (RSL 19.4 vs WL 22.2; P<.001). Specimen volume, weight, reoperation and localization times were similar. Surgeons ranked the seed technique as easier (P=.008), while radiologists ranked them similarly. Patient's pain rankings during wire localization were higher (P=.038). CONCLUSIONS: In contrast to other trials positive margin and reoperation rates were similar for RSL and WL. However, for RSL operative times were shorter, and the technique was preferred by surgeons, making it an acceptable method for localization.

Dose-dependent development of depressive symptoms during adjuvant interferon-{alpha} treatment of patients with malignant melanoma.

BACKGROUND: Adjuvant IFN-α treatment for patients with malignant melanoma is often complicated by depression. The influence of dosage, however, is unknown. OBJECTIVE: The authors sought to elucidate this dosage effect. METHOD: Using the Zung Self-Rating Depression Scale and the German Bf-S Self-Rating (Affectivity) Scale, the authors prospectively compared the frequency and severity of IFN-α-induced depressive symptoms between a group of 29 patients receiving low-dose and 17 patients getting high-dose induction therapy for 4 weeks. RESULTS: Patients receiving high-dose induction treatment had significantly higher depression scores after 4 weeks, and significantly more patients in the high-dose group developed depression. CONCLUSION: The authors concluded that frequency and severity of IFN-α-associated depression during melanoma treatment are dose-dependent.

Knowledge to action: a challenge for neck pain treatment.

SYNOPSIS: For clinicians, systematic reviews can enhance incorporation into practice of the large volumes of information emerging from research on effectiveness and risks. But we believe that these reviews are most useful with simplified tools to facilitate translation of this knowledge into practice. We provide a "Neck Care Tool Kit" that gives a diagrammatic approach to prioritizing intervention. The evidence from a series of 11 systematic reviews by the Cervical Overview Group is depicted in decision flow-charts and tables to enhance clinical interpretation of the overview findings. On simple visual inspection of symbols in a table, the reader can establish where there is evidence of benefit or no benefit, the strength of the recommendation, and if these data represent short- or long-term findings. Where possible, we guide clinicians to dosage of specific treatment methods. There is no consensus as to which outcome measures to prioritize among the large number in use. This clinical commentary guides clinicians to view the evidence in enough detail to integrate it into their clinical practice environment. We conclude by delineating research gaps and proposing future research directions. LEVEL OF EVIDENCE: Therapy, level 5.

Measurement properties of the neck disability index: a systematic review.

STUDY DESIGN: Systematic review of clinical measurement. OBJECTIVE: To find and synthesize evidence on the psychometric properties and usefulness of the neck disability index (NDI). BACKGROUND: The NDI is the most commonly used outcome measure for neck pain, and a synthesis of knowledge should provide a deeper understanding of its use and limitations. METHODS AND MEASURES: Using a standard search strategy (1966 to September 2008) and 4 databases (Medline, CINAHL, Embase, and PsychInfo), a structured search was conducted and supplemented by web and hand searching. In total, 37 published primary studies, 3 reviews, and 1 in-press paper were analyzed. Pairs of raters conducted data extraction and critical appraisal using structured tools. Ranking of quality and descriptive synthesis were performed. RESULTS: Horizon estimation suggested the potential for 1 missed paper. The agreement between raters on quality assessments was high(kappa = 0.82). Half of the studies reached a quality level greater than 70%. Failures to report clear psychometric objectives/hypotheses or to rationalize the sample size were the most common design flaws. Studies often focused on less clinically applicable properties, like construct validity or group reliability, than transferable data, like known group differences or absolute reliability (standard error of measurement [SEM] or minimum detectable change [MDC]). Most studies suggest that the NDI has acceptable reliability, although intraclass correlation coefficients (ICCs) range from 0.50 to 0.98. Longer test intervals and the definition of stable can influence reliability estimates. A number of high-quality published (Korean, Dutch, Spanish, French, Brazilian Portuguese) and commercially supported translations are available. The NDI is considered a 1-dimensional measure that can be interpreted as an interval scale. Some studies question these assumptions. The MDC is around 5/50 for uncomplicated neck pain and up to 10/50 for cervical radiculopathy. The reported clinically important difference (CID) is inconsistent across different studies ranging from 5/50 to 19/50. The NDI is strongly correlated (>0.70) to a number of similar indices and moderately related to both physical and mental aspects of general health. CONCLUSION: The NDI has sufficient support and usefulness to retain its current status as the most commonly used self-report measure for neck pain. More studies of CID in different clinical populations and the relationship to subjective/work/function categories are required.

Alignment differs between patellofemoral osteoarthritis cases and matched controls: An upright 3D MRI study.

Patellofemoral (PF) osteoarthritis (OA) is a prevalent and clinically important knee OA subgroup. Malalignment may be an important risk factor for PF OA. However, little is known about alignment in PF OA, particularly in an upright, weightbearing environment. Using a vertically-oriented open-bore MR scanner, we evaluated 3D knee alignment in 15 PF OA cases and 15 individually matched asymptomatic controls. We imaged one knee per participant while they stood two-legged at four flexion angles (0°, 15°, 30°, 45°), and also while they stood one-legged at 30° knee flexion. We calculated 3D patellofemoral and tibiofemoral alignment. Using mixed effects models, four of the five patellofemoral measures differed by group. For key measures, PF OA patellae were 6.6° [95%CI 5.0, 8.2] more laterally tilted, 2.4 mm [1.3, 3.5] more laterally translated, and at least 3.7 mm [0.2, 7.2] more proximally translated compared to controls (more with knees flexed). Alignment did not differ between two-legged stance and one-legged stance in either group. Statement of Clinical Significance: Our study demonstrated significant and clinically relevant differences in alignment between PF OA cases and controls in upright standing and squatting positions. Our findings were similar to those in previous studies of PF OA using traditional MR scanners in supine positions, supporting the clinical usefulness of existing methods aimed at identifying individuals who may benefit from interventions designed to correct malalignment. © 2019 The Authors. Journal of Orthopaedic Research® Published by Wiley Periodicals, Inc. on behalf of the Orthopaedic Research Society. 9999:1-9, 2019.

Measurement properties of the Wheelchair Skills Test for scooters among experienced users.

PURPOSE: To investigate the score distribution, reliability, and validity of the objective Wheelchair Skills Test (WST) for scooter users. METHOD: A study using a test-retest design was conducted with 20 people who had mobility limitations that prevented them from ambulating more than one city block without a mobility aid, and who had owned a scooter for ≥3 months. Objective scooter skills, confidence, and physical accessibility were measured at both time points, while anxiety, depression, visual attention and task switching, functional independence, and visual acuity were measured only at baseline. RESULTS: The mean total WST scores at Time 1 and Time 2 were 86.3% and 87.5%. The WST ICC was 0.889. The WST had a SEM of 2.50 and a Cronbach's alpha of 0.74. The total WST scores were significantly correlated with total subjective WST-Q scores (r = 0.547, p = 0.013), scooter confidence (r = 0.466, p = 0.038), and were affected by gender (p = 0.005). CONCLUSION: The WST for scooters has good test-retest reliability and generally varies as anticipated with other measures. Although further study is needed, the WST for scooters appears to have promise for use in research and clinical practice. Implications for Rehabilitation It is important to understand the measurement properties of the tools we use in rehabilitation so the results can be interpreted correctly. As scooter use increases, better measurement of skills is required.

Support service utilization and out-of-pocket payments for health services in a population-based sample of adults with neurological conditions.

BACKGROUND: Social support can help to deal with the consequences of neurological conditions and promote functional independence and quality of life. Our aim was to evaluate the impact of neurological conditions on the use of support and health-care services in a population-based sample of community-dwelling adults with neurological conditions. METHODS: Data were from the Survey of Living with Neurological Conditions in Canada, which was derived from a representative sample of household residents. Formal and informal support received and out-of-pocket payments were assessed by personal interviews. Logistic regression was used to explore the association between support service utilization and six common neurological conditions (Stroke, Parkinson's disease, Alzheimer's disease/dementias, traumatic brain injury, spinal cord injury and multiple sclerosis) with stroke as the reference category. RESULTS: The sample contained 2,410 respondents and equate to an estimated 459,770 when sample weights were used. A larger proportion of people within each of the neurological conditions received informal support than formal support (at least twice as much). Samples with the non-stroke conditions were more likely to receive formal assistance for personal (odds ratios 2.7 to 5.6; P < 0.05) and medical (odds ratios 2.4 to 4.4; P < 0.05) care compared to the stroke group. Also, the non-stroke conditions were more likely to receive informal assistance (odds ratios 2.7 to 17.9; P < 0.05) and less likely to make out-of-pocket payments for rehabilitation therapy (odds ratios 0.2 to 0.3; P < 0.05) than the stroke group. The Alzheimer's disease/dementia group had the highest proportion who received formal and informal support services. CONCLUSIONS: Our findings suggest that Canadians with neurological conditions receive more informal assistance than formal assistance. Furthermore, it appears that stroke survivors receive less support services, while those with Alzheimer's disease/dementia receive the most compared to other adult neurological conditions. Such data can help inform the development of support services in the community.

A telehealth intervention to promote healthy lifestyles after stroke: The Stroke Coach protocol.

Rationale Recurrent stroke is prevalent and associated with high mortality rates, disability, and social and economic costs. Adequate management of risk factors may reduce recurrent stroke; however, many stroke survivors have poor control of risk factors. We have developed a theoretically sound and evidence-based lifestyle modification program called the Stroke Coach, a telephone-based self-management program to improve control of risk factors. Hypothesis Individuals who participate in Stroke Coach will achieve more lifestyle improvements than individuals in an attention controlled Memory Training Program. Design In this single blind randomized controlled trial, 126 community-living stroke survivors will be randomized to Stroke Coach or the attention control group. Participants randomized to the six-month Stroke Coach will receive seven telephone lifestyle coaching sessions, self-management education and practice, and a self-monitoring kit, comprised of a health report card, with blood pressure and activity monitors. Study Outcomes The primary outcome will be measured using the Health Promoting Lifestyle Profile II. Secondary outcomes include behavioral and physiological risk factors, quality of life, cognitive status, health and social service use. Measurements will be taken at baseline, immediately after the intervention and six-month post-intervention. Summary The results of this trial will add to our understanding of the use of self-management to improve control of risk factors, and may facilitate the development of a larger trial evaluating the effect of Stroke Coach on endpoints such as recurrent stroke or cardiac events as the primary outcome.

A Systematic Review and Meta-Analysis of Subsequent Malignant Neoplasm Risk After Radioactive Iodine Treatment of Thyroid Cancer.

Background: The potential risk of subsequent malignant neoplasms (SMNs) after radioactive iodine (RAI) treatment of thyroid cancer (TC) is an important concern. Methods: A systematic review was updated comparing the risk of SMNs in TC patients treated with RAI to TC patients without RAI. Six electronic databases were searched (up to March, 2018), supplemented with a hand search. Two reviewers independently screened citations, reviewed full-text papers, and critically appraised/abstracted data. Random-effects meta-analyses were conducted using crude data and data statistically adjusted for confounders. The outcomes were any SMN and specific SMNs for which sufficient data were available. Results: In total, 3506 unique electronic search citations and 93 full-text papers were examined, including 17 studies (3 systematic reviews and 14 original studies). Published knowledge syntheses were limited by inclusion of small numbers of studies, with two systematic reviews suggesting an increased risk of any SMN and one meta-analysis suggesting a reduced risk of breast SMN after RAI treatment. In a meta-analysis of crude data, the risk ratio of any SMN in RAI-treated TC patients was 0.98 ([confidence interval (CI) 0.76-1.27]; n = 10 studies of 65,539 individuals, heterogeneity Q = 64.26, degrees of freedom [df] = 9, p < 0.001, I2 = 85.99). The pooled risk ratio for any SMN, adjusted for confounders, was 1.16 ([CI 0.97-1.39]; n = 6 studies, data from at least 11,241 TC patients, Q = 10.86, df = 5, p = 0.054, I2 = 53.96). In secondary analyses examining specific SMNs, although relatively rare, the risk of subsequent leukemia was increased, but the risk of multiple myeloma was reduced in RAI-treated TC patients. There was no significant increased relative risk of breast cancer, salivary cancer, or combined hematologic malignancies according to RAI treatment status. Conclusions: The body of evidence on whether 131I treatment of thyroid cancer is associated with the primary outcome of any SMN is highly heterogeneous and complex. More research examining the long-term risk of specific SMNs after 131I treatment is needed.

A comprehensive appropriateness of prescribing questionnaire was validated by nominal consensus group.

OBJECTIVE: To develop and validate a comprehensive Appropriateness of Prescribing Evaluation Questionnaire (APEQ) suitable for human and computer use. STUDY DESIGN AND SETTING: This study was part of an ongoing research program examining the effectiveness and cost-effectiveness of computerized prescribing decision support for providers, patients, and drug policy. A nominal group consensus process involved physicians, both primary care physicians and specialists, pharmacists, drug plan managers, patients, patient advocates, and pharmaceutical industry. Structured case scenarios of musculoskeletal problems were used to evaluate APEQ's validity and responsiveness. RESULTS: Seventeen panelists evaluated 72 patient scenarios in two rounds. Their ratings of appropriateness, assessed by ANOVA, showed significant agreement with the experts' scores in the two rounds, which evaluated appropriateness and responsiveness, respectively. Interrater and intrarater agreement was moderate to good. CONCLUSION: This formal assessment suggests that APEQ has reasonable validity, reliability, and responsiveness. Such tools could be very useful in e-prescribing and e-claims reimbursement environments and should be further explored.

BLISS index for analyzing knee osteoarthritis trials data.

OBJECTIVES: Different pain thresholds were investigated, using the WOMAC Pain Scale (WOMAC-P) to determine if they could differentiate between treatment groups (hylan G-F 20 vs. appropriate care) at low and very low levels of state attainment in patients with knee osteoarthritis (OA). A method, termed the BLISS (Bellamy et al. Low Intensity Symptom State-attainment) Index, for analyzing OA knee clinical trials data, was proposed. STUDY DESIGN AND SETTING: Five analyses were performed: time to first BLISS day, BLISS days over 12 months, patients with a BLISS response at month 12, patients with a BLISS response at any time, and number of BLISS periods over 12 months. For each analysis, five levels of WOMAC-P were examined:

Feasibility of a Systematic, Comprehensive, One-to-One Training (SCOOT) program for new scooter users: study protocol for a randomized control trial.

BACKGROUND: Mobility scooters can facilitate community participation among individuals with mobility limitations. However, accidents are a serious concern with scooter use. Scooter training has been recommended to improve safety, but there are currently few validated programs available. Therefore, we developed a Systematic, Comprehensive, One-to-One Training (SCOOT) program for scooter users. We will conduct a study to evaluate the outcomes produced by the provision SCOOT. METHODS: This feasibility study will use a mixed-methods, rater-blinded, randomized control trial, with a two-step wedge design. The study has two arms: an immediate intervention group, which will receive the intervention directly after baseline assessments, and a delayed intervention group, which will receive the intervention after a 6-week period. Forty participants, who will be stratified based on whether or not participants have previously held a driver's license, will be randomly assigned to each arm. The intervention for this study consists of 6 weeks of one-to-one scooter training by an experienced occupational therapist, who will provide training once or twice per week over the 6 weeks. The primary outcome measure is subjective scooter skills, measured using the Wheelchair Skills Test for scooters. Secondary outcomes include objective scooter skills, confidence, mobility, and satisfaction with selected participation activities. Descriptive measures include cognitive status, functional status, hearing, vision, physical accessibility of the home and community, and visual attention and task switching. Qualitative interviews will be conducted with the first ten willing participants from each group to learn about their scooter use and experiences with SCOOT. DISCUSSION: The results of this study will inform a larger randomized control trial. If the intervention is proven to be effective in this larger study, it may have important implications for policy and practice. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02696213 . Registered on 23 February 2016.