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. © 2011 van der Zwaard et al; licensee BioMed Central Ltd

Preventie van depressie en angst in verzorgingstehuizen

Achtergrond Bewoners van verzorgingshuizen vormen een risicogroep voor het ontwikkelen van een depressieve en/of angststoornis. Deze stoornissen komen veel voor en hebben een grote impact op het welzijn en functioneren van de betrokkene, maar worden vaak slecht herkend. Wij vroegen ons af of een stepped-care programma ter preventie van depressieve en angststoornissen in verzorgingshuizen haalbaar en effectief zou kunnen zijn. Methoden In een pragmatische gerandomiseerde gecontroleerde trial vergeleken we de effecten van het programma met gebruikelijke zorg in veertien verzorgingshuizen. In totaal deden 185 bewoners mee, die op de Centre for Epidemiologic Studies Depression Scale (CES-D) minstens 8 punten scoorden, niet leden aan een depressieve of angststoornis en ook niet aan een ernstige cognitieve stoornis. De deelnemers kregen een stepped-care preventieprogramma (n = 93) of gebruikelijke behandeling (n = 92). De deelnemers aan het preventieprogramma kregen eerst een afwachtend beleid en als ze niet opknapten achtereenvolgens een zelfhulpinterventie, een psychologische life-review en een verwijzing naar de huisarts. Onze primaire uitkomstmaat was de incidentie van een depressieve stoornis of angststoornis gedurende het jaar na inclusie. Resultaten De incidentie van depressie en angst samen nam niet af door de interventie: de gecombineerde incidence rate ratio (IRR) was 0,50 (95%-betrouwbaarheidsinterval (BI) 0,23 tot 1,12). Ten opzichte van de gebruikelijke zorg bracht het preventieprogramma wel het indicentierisico voor depressie omlaag (IRR 0,26; 95%-BI 0,12 tot 0,80) maar niet dat voor angst (IRR 1,32; 95%-BI 0,48 tot 3,62). Conclusie De resultaten suggereren dat het toegepaste steppedcare preventieprogramma bij ouderen in verzorgingshuizen wel helpt tegen depressie, maar niet tegen angst

Case finding of mild cognitive impairment and dementia and subsequent care; results of a cluster RCT in primary care

Purpose Despite a call for earlier diagnosis of dementia, the diagnostic yield of case finding and its impact on the mental health of patients and relatives are unclear. This study assessed the effect of a two-component intervention of case finding and subsequent care on these outcomes. Methods In a cluster RCT we assessed whether education of family physicians (FPs; trial stage 1) resulted in more mild cognitive impairment (MCI) and dementia diagnoses among older persons in whom FPs suspected cognitive decline and whether case finding by a practice nurse and the FP (trial stage 2) added to this number of diagnoses. In addition, we assessed mental health effects of case finding and subsequent care (trial stage 2). FPs of 15 primary care practices (PCPs = clusters) judged the cognitive status of all persons ≤ 65 years. The primary outcome, new MCI and dementia diagnoses by FPs after 12 months as indicated on a list, was assessed among all persons in whom FPs suspected cognitive impairment but without a formal diagnosis of dementia. The secondary outcome, mental health of patients and their relatives, was assessed among persons consenting to participate in trial stage 2. Trial stage 1 consisted of either intervention component 1: training FPs to diagnose MCI and dementia, or control: no training. Trial stage 2 consisted of either intervention component 2: case finding of MCI and dementia and care by a trained nurse and the FP, or control: care as usual. Results Seven PCPs were randomized to the intervention; eight to the control condition. MCI or dementia was diagnosed in 42.3 (138/326) of persons in the intervention, and in 30.5 (98/321) in the control group (estimated difference GEE: 10.8, OR: 1.51, 95-CI 0.60-3.76). Among patients and relatives who consented to stage 2 of the trial (n = 145; 25), there were no differences in mental health between the intervention and control group. Conclusions We found a non-significant increase in the number of new MCI diagnoses. As we cannot exclude a clinically relevant effect, a larger study is warranted to replicate ours. Trial Registration Nederlands Trial Register NTR3389 © 2016 van den Dungen et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited

Management of patients with persistent medically unexplained symptoms: a descriptive study

Background: In 2013 the Dutch guideline for management of medically unexplained symptoms (MUS) was published. The aim of this study is to assess medical care for patients with persistent MUS as recorded in their electronic medical records, to investigate if this is in line with the national guideline for persistent MUS and whether there are changes in care over time. Methods: We conducted an observational study of adult primary care patients with MUS. Routinely recorded health care data were extracted from electronic medical records of patients participating in an ongoing randomised controlled trial in 30 general practices in the Netherlands. Data on general practitioners’ (GPs’) management strategies during MUS consultations were collected in a 5-year period for each patient prior. Management strategies were categorised according to the options offered in the Dutch guideline. Changes in management over time were analysed. Results: Data were collected from 1035 MUS consultations (77 patients). Beside history-taking, the most frequently used diagnostic strategies were physical examination (24.5%) and additional investigations by the GP (11.1%). Frequently used therapeutic strategies were prescribing medication (24.6%) and providing explanations (11.2%). As MUS symptoms persisted, GPs adjusted medication, discussed progress and scheduled follow-up appointments more frequently. The least frequently used strategies were exploration of all complaint dimensions (i.e. somatic, cognitive, emotional, behavioural and social) (3.5%) and referral to a psychologist (0.5%) or psychiatrist (0.1%). Conclusions: Management of Dutch GPs is partly in line with the Dutch guideline. Medication was possibly prescribed more frequently than recommended, whereas exploration of all complaint dimensions, shared problem definition and referral to mental health care were used less

Impairment reduction in older dizzy people in primary care: study protocol for a cluster randomised controlled trial

BACKGROUND: The management of dizziness in older patients is primarily diagnosis-oriented. However, in 40 % of older patients with dizziness, GPs are not able to identify an underlying cause, and a number of common underlying causes of dizziness cannot (or hardly) be treated. In this study we will investigate the effectiveness of a prognosis-oriented approach in the management of dizziness in older patients. This prognosis-oriented approach comprises identification of patients at risk for chronic dizziness with persistent impairment by identifying risk factors for an unfavourable course of dizziness. Patients at risk for chronic dizziness with persistent impairment will be offered treatment addressing the identified modifiable risk factors. METHODS/DESIGN: This study will be performed in primary care. An intervention study and a validation study will be conducted in a three-arm cluster randomised design. In the intervention study we will investigate a risk factor guided multi-component intervention. The risk factor guided intervention includes: (1) medication adjustment in case of three or more prescribed fall-risk-increasing drugs, (2) stepped care in case of anxiety disorder and/or depression, and (3) exercise therapy in case of impaired functional mobility. The primary outcome measure is dizziness-related impairment, which will be assessed with the Dizziness Handicap Inventory. Secondary outcome measures are quality of life, anxiety disorder and depression, use of fall-risk-increasing drugs, dizziness frequency, fall frequency, and healthcare utilization. DISCUSSION: This study is, to date, the first study that will investigate the effectiveness of a prognosis-oriented approach for reducing dizziness-related impairment in older people in primary care. Offering treatment that addresses identified modifiable risk factors to patients at high risk for chronic dizziness is unique. The pragmatic design of this study will enable evaluation of the outcomes in real-life routine practice conditions. An effective intervention will not only reduce dizziness-related impairment, but may also decrease healthcare utilization and healthcare costs. The previously developed risk score that will be validated alongside the intervention study will enable GPs to identify patients at high risk for chronic dizziness with persistent impairment. TRIAL REGISTRATION: Netherlands Trial Register (identifier: NTR4346), registration date 15 December 2013

Systematic review of measurement properties of questionnaires measuring somatization in primary care patients

Objective The aim of this review is to critically appraise the evidence on measurement properties of self-report questionnaires measuring somatization in adult primary care patients and to provide recommendations about which questionnaires are most useful for this purpose. Methods We assessed the methodological quality of included studies using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. To draw overall conclusions about the quality of the questionnaires, we conducted an evidence synthesis using predefined criteria for judging the measurement properties. Results We found 24 articles on 9 questionnaires. Studies on the Patient Health Questionnaire-15 (PHQ-15) and the Four-Dimensional Symptom Questionnaire (4DSQ) somatization subscale prevailed and covered the broadest range of measurement properties. These questionnaires had the best internal consistency, test-retest reliability, structural validity, and construct validity. The PHQ-15 also had good criterion validity, whereas the 4DSQ somatization subscale was validated in several languages. The Bodily Distress Syndrome (BDS) checklist had good internal consistency and structural validity. Some evidence was found for good construct validity and criterion validity of the Physical Symptom Checklist (PSC-51) and good construct validity of the Symptom Check-List (SCL-90-R) somatization subscale. However, these three questionnaires were only studied in a small number of primary care studies. Conclusion Based on our findings, we recommend the use of either the PHQ-15 or 4DSQ somatization subscale for somatization in primary care. Other questionnaires, such as the BDS checklist, PSC-51 and the SCL-90-R somatization subscale show promising results but have not been studied extensively in primary care. © 2017 Elsevier Inc

Case-finding of dementia in general practice and effects of subsequent collaborative care; design of a cluster RCT

<p>Abstract</p> <p>Background</p> <p>In the primary care setting, dementia is often diagnosed relatively late in the disease process. Case finding and proactive collaborative care may have beneficial effects on both patient and informal caregiver by clarifying the cause of cognitive decline and changed behaviour and by enabling support, care planning and access to services.</p> <p>We aim to improve the recognition and diagnosis of individuals with dementia in general practice. In addition to this diagnostic aim, the effects of case finding and subsequent care on the mental health of individuals with dementia and the mental health of their informal carers are explored.</p> <p>Methods and design</p> <p>Design: cluster randomised controlled trial with process evaluation.</p> <p>Participants: 162 individuals ≥ 65 years, in 15 primary care practices, in whom GPs suspect cognitive impairment, but without a dementia diagnosis.</p> <p>Intervention; case finding and collaborative care: 2 trained practice nurses (PNs) invite all patients with suspected cognitive impairment for a brief functional and cognitive screening. If the cognitive tests are supportive of cognitive impairment, individuals are referred to their GP for further evaluation. If dementia is diagnosed, a comprehensive geriatric assessment takes place to identify other relevant geriatric problems that need to be addressed. Furthermore, the team of GP and PN provide information and support.</p> <p>Control: GPs provide care and diagnosis as usual.</p> <p>Main study parameters: after 12 months both groups are compared on: 1) incident dementia (and MCI) diagnoses and 2) patient and caregiver quality of life (QoL-AD; EQ5D) and mental health (MH5; GHQ 12) and caregiver competence to care (SSCQ). The process evaluation concerns facilitating and impeding factors to the implementation of this intervention. These factors are assessed on the care provider level, the care recipient level and on the organisational level.</p> <p>Discussion</p> <p>This study will provide insight into the diagnostic yield and the clinical effects of case finding and collaborative care for individuals with suspected cognitive impairment, compared to usual care. A process evaluation will give insight into the feasibility of this intervention.</p> <p>The first results are expected in the course of 2013.</p> <p>Trial registration</p> <p>NTR3389</p

The CIPRUS study, a nurse-led psychological treatment for patients with undifferentiated somatoform disorder in primary care: study protocol for a randomised controlled trial

Background: Up to a third of patients presenting medically unexplained physical symptoms in primary care may have a somatoform disorder, of which undifferentiated somatoform disorder (USD) is the most common type. Psychological interventions can reduce symptoms associated with USD and improve functioning. Previous research has either been conducted in secondary care or interventions have been provided by general practitioners (GPs) or psychologists in primary care. As efficiency and cost-effectiveness are imperative in primary care, it is important to investigate whether nurse-led interventions are effective as well. The aim of this study is to examine the effectiveness and cost-effectiveness of a short cognitive behavioural therapy (CBT)-based treatment for patients with USD provided by mental health nurse practitioners (MHNPs), compared to usual care. Methods: In a cluster randomised controlled trial, 212 adult patients with USD will be assigned to the intervention or care as usual. The intervention group will be offered a short, individual CBT-based treatment by the MHNP in addition to usual GP care. The main goal of the intervention is that patients become less impaired by their physical symptoms and cope with symptoms in a more effective way. In six sessions patients will receive problem-solving treatment. The primary outcome is improvement in physical functioning, measured by the physical component summary score of the RAND-36. Secondary outcomes include health-related quality of life measured by the separate subscales of the RAND-36, somatization (PHQ-15) and symptoms of depression and anxiety (HADS). Problem-solving skills, health anxiety, illness perceptions, coping, mastery and working alliance will be assessed as potential mediators. Assessments will be done at 0, 2, 4, 8 and 12 months. An economic evaluation will be conducted from a societal perspective with quality of life as the primary outcome measure assessed by the EQ-5D-5L. Health care, patient and lost productivity costs will be assessed with the Tic-P. Discussion: We expect that the intervention will improve physical functioning and is cost-effective compared to usual care. If so, more patients might successfully be treated in general practice, decreasing the number of referrals to specialist care. Trial registration: Dutch Trial Registry, identifier: NTR4686, Registered on 14 July 2014. © 2017 The Author(s)

Impact of dizziness on everyday life in older primary care patients: a cross-sectional study

<p>Abstract</p> <p>Background</p> <p>Dizziness is a common and often disabling symptom, but diagnosis often remains unclear; especially in older persons where dizziness tends to be multicausal. Research on dizziness-related impairment might provide options for a functional oriented approach, with less focus on finding diagnoses. We therefore studied dizziness-related impairment in older primary care patients and aimed to identify indicators related to this impairment.</p> <p>Methods</p> <p>In a cross-sectional study we included 417 consecutive patients of 65 years and older presenting with dizziness to 45 general practitioners in the Netherlands from July 2006 to January 2008. We performed tests, including patient history, and physical and additional examination, previously selected by an international expert panel and based on an earlier systematic review. Our primary outcome was impact of dizziness on everyday life measured with the Dutch validated version of the Dizziness Handicap Inventory (DHI). After a bootstrap procedure (1500x) we investigated predictability of DHI-scores with stepwise backward multiple linear and logistic regressions.</p> <p>Results</p> <p>DHI-scores varied from 0 to 88 (maximum score: 100) and 60% of patients experienced moderate or severe impact on everyday life due to dizziness. Indicators for dizziness-related impairment were: onset of dizziness 6 months ago or more (OR 2.8, 95% CI 1.7-4.7), frequency of dizziness at least daily (OR 3.3, 95% CI 2.0-5.4), duration of dizziness episode one minute or less (OR 2.4, 95% CI 1.5-3.9), presence of anxiety and/or depressive disorder (OR 4.4, 95% CI 2.2-8.8), use of sedative drugs (OR 2.3, 95% CI 1.3-3.8) , and impaired functional mobility (OR 2.6, 95% CI 1.7-4.2). For this model with only 6 indicators the AUC was .80 (95% CI .76-.84).</p> <p>Conclusions</p> <p>Dizziness-related impairment in older primary care patients is considerable (60%). With six simple indicators it is possible to identify which patients suffer the most from their dizziness without exactly knowing the cause(s) of their dizziness. Influencing these indicators, if possible, may lead to functional improvement and this might be effective in patients with moderate or severe impact of dizziness on their daily lives.</p