The effect of cognitive behavioral therapy for insomnia on sleep and glycemic outcomes in people with type 2 diabetes: A randomized controlled trial.

STUDY OBJECTIVES: Investigate whether aiding sleep by online cognitive behavioral therapy for insomnia (CBT-I) can improve glycemic and metabolic control, mood, quality of life (QoL) and insomnia symptoms in people with type 2 diabetes and assess the mediating role of lifestyle factors. METHODS: Adults with type 2 diabetes and insomnia symptoms were randomly assigned to CBT-I or care as usual. At baseline, three and six months we assessed HbA1c as primary outcome and glycemic control, metabolic outcomes, sleep, mood and QoL as secondary outcomes. Mixed models were used to determine within-person and between-persons differences in outcomes and mediation analysis for lifestyle factors. RESULTS: We randomized 29 participants to CBT-I and 28 to care as usual. Intention-to-treat analysis showed no significant differences in glycemic control, metabolic outcomes, anger, distress or QoL, but showed a significantly larger decrease in insomnia (-1.37(2.65: 0.09)) and depressive symptoms (-0.92(-1.77: 0.06)) and increase in BMI (0.29 kg/m2(0.00:0.57)) in the intervention compared to the control group. Only half of the intervention participants completed the CBT-I. Per protocol analysis showed a not statistically significant decrease in HbA1c (-2.10 mmol/l(-4.83:0.63)) and glucose (-0.39 mmol/l(-1.19:0.42)), metabolic outcomes and increase in QoL. Furthermore, the intervention group showed a significant decrease in insomnia (-2.22(-3.65: 0.78)) and depressive symptoms (-1.18(-2.17: 0.19)) compared to the control group. Lifestyle factors partially mediated the effect of the intervention. CONCLUSIONS: CBT-I might improve insomnia symptoms and mood, and perhaps improves glycemic control, albeit not significant, in people with type 2 diabetes and insomnia symptoms, compared to care as usual.

GPs' awareness of pregnancy: trends and association with hazardous medication use.

BACKGROUND: GPs have been shown to be important providers of medical care during pregnancy, however, little evidence exists on their awareness of pregnancy when prescribing medication to women. AIM: To assess GPs' awareness of pregnancy and its association with prescribing medication with potential safety risks. DESIGN AND SETTING: Population-based study using confirmed pregnancy records linked to GP records from the PHARMO Perinatal Research Network. METHOD: GPs' awareness of pregnancy, defined as the presence of a pregnancy confirmation in the GP information system during pregnancy, was assessed from 2004 to 2020. GP prescriptions of medication with potential safety risks were selected during pregnancy and its association with GPs' awareness of pregnancy was assessed using multivariable logistic regression. RESULTS: A pregnancy confirmation was present in the GP records for 48% (n = 67 496/140 976) of selected pregnancies, increasing from 28% (n = 34/121) in 2004 to 63% in 2020 (n = 5763/9124). During 3% (n = 4489/140 976) of all pregnancies, the GP prescribed highly hazardous medication with teratogenic effects that should have been (temporarily) avoided. Pregnancy was GP confirmed for only 13% (n = 585/4489) at the first occurrence of such a prescription. Comparative analyses showed that women without a pregnancy confirmation were 59% more likely to be prescribed this highly hazardous medication (odds ratio [OR] 1.59, 95% confidence interval [CI] = 1.49 to 1.70) compared with those with a confirmed pregnancy. CONCLUSION: Results of this study indicate a potential issue with GP awareness about pregnancy status at the time medication with potential safety risks is prescribed. Although pregnancy registration by GPs improved over the years, inadequate use still seems to be made of the available information systems for appropriate drug surveillance.

Validation of an Announced Telephone Pill Count Compared to a Home-Visit Pill Count in People With Type 2 Diabetes or Cardiovascular Disease.

We aimed to assess the validity of an announced telephone pill count in people with type 2 diabetes or cardiovascular disease by comparing this method to a home-visit pill count. We also assessed whether a second telephone pill count improved accuracy. People aged ≥35 years using oral type 2 diabetes or cardiovascular disease medication were included. Thirty-four participants completed a telephone pill count followed by a home-visit pill count, and a subsample of this population (n = 11) completed a second telephone pill count. Scatterplots were used for a visual representation of the number of pills counted with both methods, intraclass correlation coefficients for agreement, and Bland-Altman plots for absolute differences and outliers. A total of 203 pill counts were conducted. The study population consisted of 53% men, with a mean age of 69.6 (±9.2) years and an average of 6.1 (±2.8) medication prescriptions per participant. Scatterplots showed that pills counted with both methods were mostly scattered around the y = x equation. Agreement between the first telephone pill count and home-visit pill count was high, with intraclass correlation coefficients of 0.96 (medication count level) and 0.98 (individual level). No learning effects were observed in the subsample (n = 11), the intraclass correlation coefficient for the first telephone pill count was 0.88 versus 0.89 for the second telephone pill count. Bland-Altman plots indicated high agreement between the two methods. An announced telephone pill count is considered a valid alternative for a home-visit pill count in people with type 2 diabetes or cardiovascular disease. A single pill count appears sufficient.

Identification of frailty in primary care: accuracy of electronically derived measures.

BACKGROUND: Routinely collected clinical data based on electronic medical records could be used to define frailty. AIM: To estimate the ability of four potential frailty measures that use electronic medical record data to identify older patients who were frail according to their GP. DESIGN AND SETTING: This retrospective cohort study used data from 36 GP practices in the Dutch PHARMO Data Network. METHOD: The measures were the Dutch Polypharmacy Index, Charlson Comorbidity Index (CCI), Chronic Disease Score (CDS), and Frailty Index. GPs' clinical judgement of patients' frailty status was considered the reference standard. Performance of the measures was assessed with the area under the receiver operating characteristic curve (AUC). Analyses were done in the total population and stratified by age and sex. RESULTS: Of 31 511 patients aged ≥65 years, 3735 (11.9%) patients were classified as frail by their GP. The CCI showed the highest AUC (0.79, 95% confidence interval [CI] = 0.78 to 0.80), followed by the CDS (0.69, 95% CI = 0.68 to 0.70). Overall, the measures showed poorer performance in males and females aged ≥85 years than younger age groups (AUC 0.55-0.58 in females and 0.57-0.60 in males). CONCLUSION: This study showed that of four frailty measures based on electronic medical records in primary care only the CCI had an acceptable performance to assess frailty compared with frailty assessments done by professionals. In the youngest age groups diagnostic performance was acceptable for all measures. However, performance declined with older age and was least accurate in the oldest age group, thereby limiting the use in patients of most interest.

The Effect of a Screening and Treatment Program for the Prevention of Fractures in Older Women: A Randomized Pragmatic Trial.

Population screening for fracture risk may reduce the fracture incidence. In this randomized pragmatic trial, the SALT Osteoporosis Study (SOS), we studied whether screening for fracture risk and subsequent treatment in primary care can reduce fractures compared with usual care. A total of 11,032 women aged 65 to 90 years with ≥1 clinical risk factor for fractures were individually randomized to screening (n = 5575) or usual care (n = 5457). Participants in the screening group underwent a screening program, including bone densitometry and vertebral fracture assessment. Participants with a high 10-year fracture probability (FRAX) or a vertebral fracture were offered treatment with anti-osteoporosis medication by their general practitioner. Incident fractures as reported by questionnaires were verified with medical records. Follow-up was completed by 94% of the participants (mean follow-up = 3.7 years). Of the 5575 participants in the screening group, 1417 (25.4%) had an indication for anti-osteoporosis medication. Screening and subsequent treatment had no statistically significant effect on the primary outcome fracture (hazard ratio [HR] = 0.97; 95% confidence interval [CI] 0.87-1.08), nor on the secondary outcomes osteoporotic fractures (HR = 0.91; 95% CI 0.81-1.03), major osteoporotic fractures (HR = 0.91; 95% CI 0.80-1.04), hip fractures (HR = 0.91; 95% CI 0.71-1.15), falls (odds ratio [OR] = 0.91; 95% CI 0.72-1.15), or mortality (HR = 1.03; 95% CI 0.91-1.17). Post hoc explorative finding suggested that screening might be most effective after a recent fracture (HR = 0.65; 95% CI 0.44-0.96 for major osteoporotic fractures and HR = 0.38; 95% CI 0.18-0.79 for hip fractures). The results of this study might have been compromised by nonparticipation and medication nonadherence in the screening group. Overall, this study does not provide sufficient indications to consider screening for fracture prevention. However, we cannot exclude its clinical relevance to reduce (major) osteoporotic fractures and hip fractures because of the relatively small number of women with a treatment indication in the intervention group. © 2019 The Authors. Journal of Bone and Mineral Research Published by Wiley Periodicals, Inc.

Identification of drug-related problems of elderly patients discharged from hospital.

BACKGROUND: Drug-related problems (DRP) following hospital discharge are common among elderly patients using multiple drugs for the treatment of chronic diseases. The aim of this study was to investigate the occurrence of DRP in these patients using a specific tool for the identification of DRP by community pharmacists. METHODS: An observational study involving 340 patients aged over 60 years using at least five prescription drugs and discharged from hospital. The occurrence of DRP was assessed by means of an identification tool specifically developed for use by community pharmacists, including a semistructured patient interview and a checklist of common DRP. RESULTS: In total, 992 potential DRP were observed in the 340 patients (mean 2.9 ± 1.7). No drug prescribed but clear indication, an unnecessarily long duration of treatment, dose too low, and incorrect drug selection were the DRP most commonly observed. Ten percent of DRP occurring in 71 patients were drug-drug interactions. The number of DRP was related to the number of drugs prescribed. Frequently occurring DRP found using the patient interview were fear of side effects and no or insufficient knowledge of drug use. Medication of patients discharged from the pulmonary department and of those with type 2 diabetes was particularly associated with occurrence of DRP. CONCLUSION: Following hospital discharge, DRP occur frequently among elderly patients using five or more drugs for the treatment of chronic disease. The number of DRP increased with the number of drugs used. An important task for community pharmacists is to identify, resolve, and prevent the occurrence of DRP among this patient group. Since DRP are associated with an increased risk of hospital readmissions, morbidity, and mortality, it is very important to develop intervention strategies to resolve and prevent DRP.

Variation in the location of the shoe sole flexion point influences plantar loading patterns during gait.

BACKGROUND: Several footwear design characteristics are known to have detrimental effects on the foot. However, one characteristic that has received relatively little attention is the point where the sole flexes in the sagittal plane. Several footwear assessment forms assume that this should ideally be located directly under the metarsophalangeal joints (MTPJs), but this has not been directly evaluated. The aim of this study was therefore to assess the influence on plantar loading of different locations of the shoe sole flexion point. METHOD: Twenty-one asymptomatic females with normal foot posture participated. Standardised shoes were incised directly underneath the metatarsophalangeal joints, proximal to the MTPJs or underneath the midfoot. The participants walked in a randomised sequence of the three shoes whilst plantar loading patterns were obtained using the Pedar® in-shoe pressure measurement system. The foot was divided into nine anatomically important masks, and peak pressure (PP), contact time (CT) and pressure time integral (PTI) were determined. A ratio of PP and PTI between MTPJ2-3/MTPJ1 was also calculated. RESULTS: Wearing the shoe with the sole flexion point located proximal to the MTPJs resulted in increased PP under MTPJ 4-5 (6.2%) and decreased PP under the medial midfoot compared to the sub-MTPJ flexion point (-8.4%). Wearing the shoe with the sole flexion point located under the midfoot resulted in decreased PP, CT and PTI in the medial and lateral hindfoot (PP: -4.2% and -5.1%, CT: -3.4% and -6.6%, PTI: -6.9% and -5.7%) and medial midfoot (PP: -5.9% CT: -2.9% PTI: -12.2%) compared to the other two shoes. CONCLUSION: The findings of this study indicate that the location of the sole flexion point of the shoe influences plantar loading patterns during gait. Specifically, shoes with a sole flexion point located under the midfoot significantly decrease the magnitude and duration of loading under the midfoot and hindfoot, which may be indicative of an earlier heel lift.

Definitions, variants, and causes of nonadherence with medication: a challenge for tailored interventions.

BACKGROUND: Nonadherence with medication is a complex and multidimensional health care problem. The causes may be related to the patient, treatment, and/or health care provider. As a consequence, substantial numbers of patients do not benefit optimally from pharmacotherapy, resulting in increased morbidity and mortality as well as increased societal costs. Several interventions may contribute to improved adherence. However, most interventions have only a modest effect. Thus, despite the many efforts made, there has been little progress made as yet in tackling the problem of nonadherence. METHODS: This paper summarizes the definitions and taxonomy of adherence with medication, as well as types and causes of nonadherence. In addition, interventions aimed at improvement of adherence are discussed. CONCLUSION: There is not just one solution for the nonadherence problem that fits all patients. Most interventions to improve adherence are aimed at all patients regardless of whether they are adherent or not. Recently, a number of tailored interventions have been described in the literature. Modern techniques are useful. Electronic pill boxes combined with Short Message Service reminders are specifically designed to improve unintentional adherence and have resulted in an increase in refill adherence in diabetic patients with suboptimal adherence. Tailored Internet interventions are a possibility for influencing patient drug-taking behavior and show promising results. Tailored counseling interventions targeted at the underlying causes of nonadherence seem an attractive method for supporting patients with their use of drugs. However, despite the plausible theoretical framework, data on long-term health effects of the various interventions are not available. To improve adherence effectively, there is a need for a tailored approach based on the type and cause of nonadherence and the specific needs of the patient.

Process evaluation of podiatric treatment of patients with forefoot pain.

BACKGROUND: Foot pain is a common problem for people aged 50 and over and occurs more often in women than in men. About 60% of the foot problems are forefoot problems and slightly more than half of these patients seek medical help, mainly in the form of podiatric care. Podiatric treatment of forefoot problems is known to be heterogeneous. The aims of the present study are to describe the podiatric treatment of patients with forefoot pain and to evaluate the podiatric examination and treatment using an expert panel. METHOD: We invited twenty-five randomly selected subjects with forefoot problems who had received podiatric treatment in a pragmatic randomised clinical trial to participate in an analysis of their treatment by an expert panel. The panel retrospectively established the cause of the foot problem as well as the therapeutic goals and evaluated the treatment. These findings were compared to those reported by the treating podiatrist. RESULTS: Two fundamentally different approaches were found in approach of podiatric examination; a functional approach (n =13) and a non-functional approach (n =12). In nine cases the expert panel agreed with the cause recorded by the podiatrist. In five other cases the expert panel concluded that the treatment of the podiatrist was not consistent with the cause of the problem recorded by the podiatrist. Of the 10 patients for whom the podiatrist had recorded to have given shoe advice, only two were able to recollect the proper advice. Three patients did not remember receiving advice at all. CONCLUSION: In this study almost half of the podiatrists worked according to a non-functional approach where the other half (like the expert panel) chose a functional strategy that analyses the underlying problem. Fundamental differences in treatment plans and thus heterogeneous treatments could be a consequence.

Treatment of forefoot problems in older people: study protocol for a randomised clinical trial comparing podiatric treatment to standardised shoe advice.

BACKGROUND: Foot problems in general and forefoot problems in particular can lead to a decrease in mobility and a higher risk of falling. Forefoot problems increase with age and are more common in women than in men. Around 20% of people over 65 suffer from non-traumatic foot problems and 60% of these problems are localised in the forefoot. Little is known about the best way to treat forefoot problems in older people. The aim of this study is to compare the effects of two common modes of treatment in the Netherlands: shoe advice and podiatric treatment. This paper describes the design of this study. METHODS: The study is designed as a pragmatic randomised clinical trial (RCT) with 2 parallel intervention groups. People aged 50 years and over who have visited their general practitioner (GP) with non traumatic pain in the forefoot in the preceding year and those who will visit their GP during the recruitment period with a similar complaint will be recruited for this study. Participants must be able to walk unaided for 7 metres and be able to fill in questionnaires. Exclusion criteria are: rheumatoid arthritis, neuropathy of the foot or pain caused by skin problems (e.g. warts, eczema). Inclusion and exclusion criteria will be assessed by a screening questionnaire and baseline assessment. Those consenting to participation will be randomly assigned to either a group receiving a standardised shoe advice leaflet (n = 100) or a group receiving podiatric treatment (n = 100). Primary outcomes will be the severity of forefoot pain (0-10 on a numerical rating scale) and foot function (Foot Function 5-pts Index and Manchester Foot Pain and Disability Index). Treatment adherence, social participation and quality of life will be the secondary outcomes. All outcomes will be obtained through self-administered questionnaires at the start of the study and after 3, 6, 9 and 12 months. Data will be analysed according to the "intention-to-treat" principle using multilevel level analysis. DISCUSSION: Strength of this study is the comparison between two common primary care treatments for forefoot problems, ensuring a high external validity of this trial. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR2212.