Resultados de la cirugía laparoscópica comparada con la cirugía abierta en el cáncer colorrectal. Revisión sistemática

Determinar el efecto de la cirugía laparoscópica versus cirugía abierta sobre la supervivencia en el manejo de pacientes del cáncer colorectal.

The Health Education Impact Questionnaire (heiQ): An outcomes and evaluation measure for patient education and self-management interventions for people with chronic conditions

Objective: This paper describes the development and validation of the Health Education Impact Questionnaire (heiQ). The aim was to develop a user-friendly, relevant, and psychometrically sound instrument for the comprehensive evaluation of patient education programs, which can be applied across a broad range of chronic conditions.

Methods: Item development for the heiQ was guided by a Program Logic Model, Concept Mapping, interviews with stakeholders and psychometric analyses. Construction (N = 591) and confirmatory (N = 598) samples were drawn from consumers of patient education programs and hospital outpatients. The properties of the heiQ were investigated using item response theory and structural equation modeling.

Results: Over 90 candidate items were generated, with 42 items selected for inclusion in the final scale. Eight independent dimensions were derived: Positive and Active Engagement in Life (five items, Cronbach's alpha (α) = 0.86); Health Directed Behavior (four items, α = 0.80); Skill and Technique Acquisition (five items, α = 0.81); Constructive Attitudes and Approaches (five items, α = 0.81); Self-Monitoring and Insight (seven items, α = 0.70); Health Service Navigation (five items, α = 0.82); Social Integration and Support (five items, α = 0.86); and Emotional Wellbeing (six items, α = 0.89).

Conclusion:The heiQ has high construct validity and is a reliable measure of a broad range of patient education program benefits.

Practice Implications: The heiQ will provide valuable information to clinicians, researchers, policymakers and other stakeholders about the value of patient education programs in chronic disease management.

Pilot Study of clinician attitudes to insulin pump therapy: international differences and the need for a greater understanding of the patient perspective

OBJECTIVES: To identify and survey health care professionals (HCPs) attitudes to insulin pump therapy (CSII).

METHODS: Eight specialists were interviewed to explore the attitudes and beliefs about CSII. Responses were analysed thematically and used to inform the design of a new 22-item questionnaire: the Attitudes to Pump Therapy (APT) Survey. The APT was pilottested among 95 HCPs (54% male; 75.5% diabetologists/DSNs, 13.8% general practitioners) at the International Diabetes Federation (IDF) conference, 2006. Results were analysed using non-parametric statistics with bonferroni correction.

RESULTS: Analyses of interview data identified 9 themes: biomedical, perceived control of care/diabetes, technology, quality of life, financial resources, training, education & support, suitability, and evidence-base. Items were designed to reflect these themes with responses scored on a 5-point Likert scale (strongly agree—strongly disagree). No statistically significant differences
were found by gender, HCP speciality, country (and continent) of origin or proportion of patients using CSII. Most notable differences were found in relation to gross domestic product (GDP) and the potential for pump therapy to achieve tight blood glucose control (lower GDP = more agreement: p = 0.001), and result in diabetic ketoacidosis (DKA) (lower GDP = less agreement: p < 0.005). Ranked mean scores showed a split between biomedical/clinical items (N = 11) and items concerned with patient experience (N = 11). Attitudes about biomedical/clinical issues were generally clear (i.e. for 7/11 items, the mean score was “agree”) but less decisive about patient experience (i.e. for 8/11 items, the mean score was “neither agree nor disagree”).

CONCLUSION: Few subgroup differences existed, but those that did may be explained by lack of access to treatment (directly corresponding to GDP). Clinicians’ were generally clear in their attitudes regarding biomedical aspects but less so regarding patient experience. Research focusing on patient-reported outcomes is likely to offer clinicians a greater understanding of the patients’ perspective of insulin pump therapy.

Patient and practitioner compliance with silicone hydrogel and daily disposable lens replacement in the United States

Objective: The objectives of this study were to assess current recommendations for replacement frequency (RF) of silicone hydrogel (SH) and daily disposable (DD) lenses, to determine compliance with these recommendations, and to investigate the reasons given for noncompliance.

Methods: A package containing 20 patient surveys was sent to 309 eye care practitioners (ECPs) in the United States who had agreed to participate in the study. One thousand eight hundred fifty-nine completed surveys were received from 158 ECPs and 1,654 surveys were eligible for analysis. Questions related to patient demographics, lens type, lens wearing patterns, the ECP instructions for RF, and the actual patient reported RF. ECPs were asked to provide lens information and their recommendation for RF after the surveys had been completed and sealed in envelopes. All responses were anonymous.

Results: Sixty-six percent of patients were women and their mean age was 34 ± 12 years. Eighty-eight percent of lenses were worn for daily wear, 12.8 ± 3.2 hours a day, 6.2 ± 1.5 days a week. Lens type distribution was 16% DD, 45% 2 week (2W) SH, and 39% 1 month (1M) SH. ECP recommendations for RF varied according to the lens type; 1% of 1M (95% CI 0.2-1.7), 4% of DD (95% CI 2.1-7.2), and 18% of 2W (95% CI 15.1-20.7) patients were given instructions that did not conform to the manufacturers' recommended RF (MRRF). When considering only those patients who were given the correct instructions for RF, 38% were not compliant with the MRRF; noncompliance rates varied according to the lens type and were 12% for DD (95% CI 8.6-17.2), 28% for 1M (95% CI 24.9-32.1), and 52% for 2W (95% CI 47.8-55.8). The most frequent reasons for over wearing lenses were forgetting which day to replace lenses (51%) and to save money (26%). Fifty-three percent believed that a reminder system would aid compliance; the most popular methods being a cell phone reminder or text message (29%) and a nominated day each week or month (26%). Discussions between the ECPs and the patients were more extensive for patients who were compliant with the MRRF.

Conclusions: ECPs recommended RFs more frequently with DD and 1M SH lenses than with 2W SH lenses, consistent with manufacturers' recommendations. Patients were less compliant with RF than ECPs for all lens types investigated. Patients were most compliant with RF when wearing DD lenses and least compliant when wearing 2W SH lenses. Better communication facilitated greater compliance with RF. More than half of those not replacing lenses, when recommended, reported that this was because they forgot which day to replace their lenses.

Measurement issues in the evaluation of chronic disease self-management programs

Objectives: 

Self-reported access to and quality of healthcare for diabetes : Do the severely obese experience equal access?

Background: Given reported pejorative views that health professionals have about patients who are severely obese, we examined the self-reported views of the quality and availability of diabetes care from the perspective of adults with type 2 diabetes (T2DM), stratified by body mass index (BMI). Methods: 1795 respondents to the Diabetes MILES - Australia national survey had T2DM. Of these, 530 (30%) were severely obese (BMI ≥35 kg/m2) and these participants were matched with 530 controls (BMI <35 kg/m2). Data regarding participants' self-reported interactions with health practitioners and services were compared. Results: Over 70% of participants reported that their general practitioner was the professional they relied on most for diabetes care. There were no betweengroup differences in patient-reported availability of health services, quality of interaction with health practitioners, resources and support for selfmanagement, or access to almost all diabetes services. Discussion: Participants who were severely obese did not generally report greater difficulty in accessing diabetes care.

Chemosensory science in the context of cancer treatment: implications for patient care

Introduction: This collaborative commentary brings together both clinical and sensory science perspectives in an effort to explain the mechanisms of cancer treatment and the ensuing implications for the sensorium. Strategy: This paper makes the distinction between food hedonics and true chemosensory effects in the cancer context and describes the adverse effects cancer and its treatment have on the eating and drinking experience, including gastronomic, nutritional and emotional implications. Results from a prospective breast cancer cohort study, conducted by an interdisciplinary team of nurses, medical oncologists, dietitians and sensory science researchers shed new light on specific sensory symptomatology associated with chemotherapy treatment and the implications this has for informing reliable pre-treatment patient education. Findings: Two conceptual models are posed as frameworks for better understanding the determinants and consequences of altered eating and drinking experiences during chemotherapy, as well as the link between patient-reported symptoms and chemosensory or hedonic disturbances. Discussion: Application of evidence of cancer treatment and its sensory effects in the patient treatment context continues to be a challenge for cancer clinicians, especially where standardised testing of taste and smell function are not able to be practically administered. Conclusions: Recommendations are made for further research and practice pursuits to underpin improved food enjoyment and dietary quality throughout the cancer trajectory. Clinician education of sensory science is also encouraged.

The 45 year old health check - feasibility and impact on practices and patient behaviour

Background: The 45 year old health check (MBS item 717) for patients aged 45-49 years was introduced in 2006. This study evaluated its impact on preventive care and patient reported risk factors. Methods: A quantitative and qualitative study was conducted in eight general practices in Sydney, New South Wales. It involved follow up surveys of 118 patients taken both before the check and 3 months after. Practice staff were trained and supported to conduct the health checks and appropriate interventions. Results: There was ambivalence among some of the general practitioners toward the health check, but most found it feasible. The reported frequency of GP advice relating to each of the SNAP (smoking, nutrition, alcohol, and physical activity) risk factors increased; patient referrals, however, were infrequent. Patients' readiness to change their diet and exercise habits improved as a result of the check, with respondents showing an increase in both the consumption of vegetables and the frequency of physical activity. There was no change in body mass index, smoking or alcohol consumption. Discussion: The health check was associated with a short term improvement in diet and physical activity behaviours. Mechanisms to enhance referral need to be developed.

Zinc supplementation for the prevention of type 2 diabetes mellitus in adults with insulin resistance

BackgroundDiabetes is associated with long-term damage, dysfunction and failure of various organs, especially the eyes, kidneys, nerves, heart and blood vessels. The risk of developing type 2 diabetes increases with age, obesity and lack of physical activity. Insulin resistance is a fundamental aspect of the aetiology of type 2 diabetes. Insulin resistance has been shown to be associated with atherosclerosis, dyslipidaemia, glucose intolerance, hyperuricaemia, hypertension and polycystic ovary syndrome. The mineral zinc plays a key role in the synthesis and action of insulin, both physiologically and in diabetes mellitus. Zinc seems to stimulate insulin action and insulin receptor tyrosine kinase activity.ObjectivesTo assess the effects of zinc supplementation for the prevention of type 2 diabetes mellitus in adults with insulin resistance.Search methodsThis review is an update of a previous Cochrane systematic review published in 2007. We searched the Cochrane Library (2015, Issue 3), MEDLINE, EMBASE, LILACS and the ICTRP trial register (frominception toMarch 2015). There were no language restrictions. We conducted citation searches and screened reference lists of included studies.Selection criteriaWe included studies if they had a randomised or quasi-randomised design and if they investigated zinc supplementation compared with placebo or no intervention in adults with insulin resistance living in the community.Data collection and analysisTwo review authors selected relevant trials, assessed risk of bias and extracted data.Main resultsWe included three trials with a total of 128 participants in this review. The duration of zinc supplementation ranged between four and 12 weeks. Risk of bias was unclear for most studies regarding selection bias (random sequence generation, allocation concealment) and detection bias (blinding of outcome assessment). No study reported on our key outcome measures (incidence of type 2 diabetes mellitus, adverse events, health-related quality of life, all-cause mortality, diabetic complications, socioeconomic effects). Evaluation of insulin resistance as measured by the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) showed neutral effects when comparing zinc supplementation with control (two trials; 114 participants). There were neutral effects for trials comparing zinc supplementation with placebo for total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol and triglycerides (2 studies, 70 participants). The one trial comparing zinc supplementation with exercise also showed neutral effects for total cholesterol, HDL and LDL cholesterol, and a mean difference in triglycerides of -30 mg/dL (95% confidence interval (CI) -49 to -10) in favour of zinc supplementation (53 participants). Various surrogate laboratory parameters were also analysed in the included trials.Authors'conclusionsThere is currently no evidence on which to base the use of zinc supplementation for the prevention of type 2 diabetes mellitus. Future trials should investigate patient-important outcome measures such as incidence of type 2 diabetes mellitus, health-related quality of life, diabetic complications, all-cause mortality and socioeconomic effects.

Prosthetic rehabilitation of a patient with gastroesophageal reflux disease: 4-year followup

The gastroesophageal reflux disease (GERD) is one of the main causes of dental erosion. The aim of this case presented is to describe the prosthetic rehabilitation of a patient with GERD after 4 years of followup. A 33-year-old male patient complained about tooth sensitivity. The lingual surface of the maxillary anterior teeth and the cusps of the upper and lower posterior teeth presented wear. It was suspected that the feeling of heartburn reported by the patient associated with the intake of sports supplements (isotonics) was causing gastroesophageal changes. The patient was referred to a gastroenterologist and was diagnosed with GERD. Dental treatment was performed with metal-free crowns and porcelain veneers after medical treatment of the disease. With the change in eating habits, the treatment of GERD and lithium disilicate ceramics provided excellent cosmetic results after 4 years and the patient reported satisfaction with the treatment.

Subjective cognitive complaints one year after ceasing adjuvant endocrine treatment for early-stage breast cancer

Background:In the BIG 1-98 trial objective cognitive function improved in postmenopausal women 1 year after cessation of adjuvant endocrine therapy for breast cancer. This report evaluates changes in subjective cognitive function (SCF).Methods:One hundred postmenopausal women, randomised to receive 5 years of adjuvant tamoxifen, letrozole, or a sequence of the two, completed self-reported measures on SCF, psychological distress, fatigue, and quality of life during the fifth year of trial treatment (year 5) and 1 year after treatment completion (year 6). Changes between years 5 and 6 were evaluated using the Wilcoxon signed-rank test. Subjective cognitive function and its correlates were explored.Results:Subjective cognitive function and the other patient-reported outcomes did not change significantly after cessation of endocrine therapy with the exception of improvement for hot flushes (P=0.0005). No difference in changes was found between women taking tamoxifen or letrozole. Subjective cognitive function was the only psychosocial outcome with a substantial correlation between year 5 and 6 (Spearman's R=0.80). Correlations between SCF and the other patient-reported outcomes were generally low.Conclusion:Improved objective cognitive function but not SCF occur following cessation of adjuvant endocrine therapy in the BIG 1-98 trial. The substantial correlation of SCF scores over time may represent a stable attribute.British Journal of Cancer advance online publication, 24 April 2012; doi:10.1038/bjc.2012.156 www.bjcancer.com.

Validity and responsiveness of the Core Outcome Measures Index (COMI) for the neck

Patient-orientated outcome questionnaires are essential to evaluate treatment success. To compare different treatments, hospitals, and surgeons, standardised questionnaires are required. The present study examined the validity and responsiveness of the Core Outcome Measurement Index for neck pain (COMI-neck), a short, multidimensional outcome instrument.

The effects of excluding patients from the analysis in randomised controlled trials: meta-epidemiological study

OBJECTIVE: To examine whether excluding patients from the analysis of randomised trials are associated with biased estimates of treatment effects and higher heterogeneity between trials. DESIGN: Meta-epidemiological study based on a collection of meta-analyses of randomised trials. DATA SOURCES: 14 meta-analyses including 167 trials that compared therapeutic interventions with placebo or non-intervention control in patients with osteoarthritis of the hip or knee and used patient reported pain as an outcome. METHODS: Effect sizes were calculated from differences in means of pain intensity between groups at the end of follow-up, divided by the pooled standard deviation. Trials were combined by using random effects meta-analysis. Estimates of treatment effects were compared between trials with and trials without exclusions from the analysis, and the impact of restricting meta-analyses to trials without exclusions was assessed. RESULTS: 39 trials (23%) had included all patients in the analysis. In 128 trials (77%) some patients were excluded from the analysis. Effect sizes from trials with exclusions tended to be more beneficial than those from trials without exclusions (difference -0.13, 95% confidence interval -0.29 to 0.04). However, estimates of bias between individual meta-analyses varied considerably (tau(2)=0.07). Tests of interaction between exclusions from the analysis and estimates of treatment effects were positive in five meta-analyses. Stratified analyses indicated that differences in effect sizes between trials with and trials without exclusions were more pronounced in meta-analyses with high between trial heterogeneity, in meta-analyses with large estimated treatment benefits, and in meta-analyses of complementary medicine. Restriction of meta-analyses to trials without exclusions resulted in smaller estimated treatment benefits, larger P values, and considerable decreases in between trial heterogeneity. CONCLUSION: Excluding patients from the analysis in randomised trials often results in biased estimates of treatment effects, but the extent and direction of bias is unpredictable. Results from intention to treat analyses should always be described in reports of randomised trials. In systematic reviews, the influence of exclusions from the analysis on estimated treatment effects should routinely be assessed.

Structural equation modeling of the medical outcome study: Short Form 36 (SF-36)

The factorial validity of the SF-36 was evaluated using confirmatory factor analysis (CFA) methods, structural equation modeling (SEM), and multigroup structural equation modeling (MSEM). First, the measurement and structural model of the hypothesized SF-36 was explicated. Second, the model was tested for the validity of a second-order factorial structure, upon evidence of model misfit, determined the best-fitting model, and tested the validity of the best-fitting model on a second random sample from the same population. Third, the best-fitting model was tested for invariance of the factorial structure across race, age, and educational subgroups using MSEM.^ The findings support the second-order factorial structure of the SF-36 as proposed by Ware and Sherbourne (1992). However, the results suggest that: (a) Mental Health and Physical Health covary; (b) general mental health cross-loads onto Physical Health; (c) general health perception loads onto Mental Health instead of Physical Health; (d) many of the error terms are correlated; and (e) the physical function scale is not reliable across these two samples. This hierarchical factor pattern was replicated across both samples of health care workers, suggesting that the post hoc model fitting was not data specific. Subgroup analysis suggests that the physical function scale is not reliable across the "age" or "education" subgroups and that the general mental health scale path from Mental Health is not reliable across the "white/nonwhite" or "education" subgroups.^ The importance of this study is in the use of SEM and MSEM in evaluating sample data from the use of the SF-36. These methods are uniquely suited to the analysis of latent variable structures and are widely used in other fields. The use of latent variable models for self reported outcome measures has become widespread, and should now be applied to medical outcomes research. Invariance testing is superior to mean scores or summary scores when evaluating differences between groups. From a practical, as well as, psychometric perspective, it seems imperative that construct validity research related to the SF-36 establish whether this same hierarchical structure and invariance holds for other populations.^ This project is presented as three articles to be submitted for publication. ^

Patient-rated Outcomes of Lumbar Fusion in Patients with Degenerative Disease of the Lumbar Spine: Does Age Matter?

Introduction: Current demographic changes are characterized by population aging, such that the surgical treatment of degenerative spine conditions in the elderly is gaining increasing relevance. However, there is a general reluctance to consider spinal fusion procedures in this patient age group due to the increased likelihood of complications. The aim of this study was to assess the patient-rated outcome and complication rates associated with lumbar fusion procedures in three different age groups. Methods: This was a retrospective analysis of prospectively collected data from consecutive patients who underwent first-time, one to three level posterior instrumented fusion between 2004 and 2011, due to degenerative disease of the lumbar spine. Data were obtained from our Spine Surgery Outcomes Database (linked to the International Spine Tango Register). Before surgery, patients completed the multidimensional Core Outcome Measures Index (COMI), and at 3 and 12 months after surgery they completed the COMI and rated the Global Treatment Outcome (GTO) and their satisfaction with care. Patients were divided into three groups according to their age: younger (≥50y <65y; n = 317), older (≥65y <80y; n = 350), and geriatric (≥ 80y; n = 40). Results: 707 consecutive patients were included. The preoperative comorbidity status differed significantly (p < 0.0001) between the age groups, with the highest scores in the geriatric group. General medical complications during surgery were lower in the younger age group (7%) than in the older (13.4%; p = 0.006) and geriatric groups (17.5%; p = 0.007). Duration of hospital stay was longer (p = 0.006) in the older group (10.8 ± 3.7 days) than the younger (10.0 ± 3.6 days) group. There were no significant group differences (p>0.05) for any of the COMI domains covering pain, function, symptom specific well-being, general quality of life, and social and work disability at either 3 months’ or 12 months’ follow-up. Similarly, there were no differences (p>0.05) between the age groups for GTO and patient-rated satisfaction at either follow-up. Conclusions: Preoperative comorbidity and general medical complications during lumbar fusion for degenerative disorders of the lumbar spine are both greater in geriatric patients than in younger patients. However, patient-rated outcome is as good in the elderly as it is in younger age groups. These data suggest that geriatric age per se is not a contraindication to instrumented fusion for lumbar degenerative disease.