OBJECTIVES: to determine (cost)-effectiveness of a stepped-care intervention programme among subjects ≥75 years who screened positive for depressive symptoms in general practice. DESIGN: the... Show moreOBJECTIVES: to determine (cost)-effectiveness of a stepped-care intervention programme among subjects ≥75 years who screened positive for depressive symptoms in general practice. DESIGN: the pragmatic cluster-randomised controlled trial with 12-month follow-up. SETTING: sixty-seven Dutch general practices. SUBJECTS: two hundred and thirty-nine subjects ≥75 years screened positive for untreated depressive symptoms (15-item Geriatric Depression Scale ≥5). METHODS: usual care (34 practices, 118 subjects) was compared with the stepped-care intervention (33 practices, 121 subjects) consisting of three steps: individual counselling; Coping with Depression course; and-if indicated-referral back to general practitioner to discuss further treatment. Measurements included severity of depressive symptoms [Montgomery-Åsberg Depression Rating Scale (MADRS)], quality of life, mortality and costs. RESULTS: at baseline subjects mostly were mildly/moderately depressed. At 6 months MADRS scores had improved more in the usual care than the intervention group (-2.9 versus -1.1 points, P = 0.032), but not at 12 months (-3.1 versus -4.6, P = 0.084). No significant differences were found within two separate age groups (75-79 years and ≥80 years). In intervention practices, 83% accepted referral to the stepped-care programme, and 19% accepted course participation. The control group appeared to have received more psychological care. CONCLUSIONS: among older subjects who screened positive for depressive symptoms, an offered stepped-care intervention programme was not (cost)-effective compared with usual care, possibly due to a low uptake of the course offer.Trial registration: www.controlled-trials.com/ISRCTN 71142851v. Show less
BACKGROUND Screening can increase detection of clinically relevant depressive symptoms, but screen-positive persons are not necessarily willing to accept a subsequent unsolicited treatment offer.... Show moreBACKGROUND Screening can increase detection of clinically relevant depressive symptoms, but screen-positive persons are not necessarily willing to accept a subsequent unsolicited treatment offer. Our objective was to explore limiting and motivating factors in accepting an offer to join a "coping with depression" course, and perceived needs among persons aged ≥75 years who screened positive for depressive symptoms in general practice. METHODS In a randomized controlled trial, in which 101 persons who had screened positive for depressive symptoms were offered a "coping with depression" course, a sample of 23 persons were interviewed, of whom five (22%) accepted the treatment offer. Interview transcripts were coded independently by two researchers. RESULTS All five individuals who accepted a place on the course felt depressed and/or lonely and had positive expectations about the course. The main reasons for declining to join the course were: not feeling depressed, or having negative thoughts about the course effect, concerns about group participation, or about being too old to change and learn new things. Although perceived needs to relieve depressive symptoms largely matched the elements of the course, most of those who had been screened were not (yet) prepared to accept an intervention offer. Many expressed the need to discuss this treatment decision with their general practitioner. CONCLUSIONS Although the unsolicited treatment offer closely matched the perceived needs of people screening positive for depressive symptoms, only those who combined feelings of being depressed or lonely with positive expectations about the offered course accepted it. Treatment should perhaps be more individually tailored to the patient's motivational stage towards change, a process in which general practitioners can play an important role. Show less
Weele, G.M. van der; Jong, R. de; Waal, M.W.M. de; Spinhoven, P.; Rooze, H.A.H.; Reis, R.; ... ; Mast, R.C. van der 2012
Many rating scales can be self-administered or interviewer-administered, and the influence of administration method on scores is unclear. We aimed to study this influence on scores of the Geriatric... Show moreMany rating scales can be self-administered or interviewer-administered, and the influence of administration method on scores is unclear. We aimed to study this influence on scores of the Geriatric Depression Scale (GDS-15), used as a screening instrument in general practice. In two general practices 376 registered patients aged 75years and older were asked to participate. Exclusion criteria were dementia and current treatment for depression. GDS-15 was administered twice within 1month: self-administered by mail, and interviewer-administered during home visits. The sequence of administering the methods was different for the two practices. We analyzed differences in total and item GDS-scores. Of 141 subjects that participated (response rate 55%) 59 were men (42%). Mean age was 81.4years (SD 4.8). When GDS-15 was self-administered, 33 subjects (23.4%) left items unanswered. There were no items unanswered when GDS-15 was interviewer-administered. On average the self-administered total GDS-scores were 0.70 points higher than interviewer-administered scores (CI95%=0.41; 0.98), with a large range of variation in the scores (limits of agreement -2.69 to 4.08). Item-item comparisons showed high percentages of agreement. Chance-corrected agreement (kappa) was moderate to fair, but three items showed only slight agreement (kappa values <0.21). In conclusion, compared to interviewer-administered scores, scores on self-administered GDS-15 were higher. The method of administration should be taken into account when interpreting scores. Show less
Drewes, Y.M.; Gussekloo, J.; Meer, V. van der; Rigter, H.; Dekker, J.H.; Goumans, M.J.B.M.; ... ; Assendelft, W.J.J. 2012
BACKGROUND: Sciatica is a common condition worldwide that is characterized by radiating leg pain and regularly caused by a herniated disc with nerve root compression. Sciatica patients with... Show moreBACKGROUND: Sciatica is a common condition worldwide that is characterized by radiating leg pain and regularly caused by a herniated disc with nerve root compression. Sciatica patients with persisting leg pain after six to eight weeks were found to have similar clinical outcomes and associated costs after prolonged conservative treatment or surgery at one year follow-up. Guidelines recommend that the team of professionals involved in sciatica care and patients jointly decide about treatment options, so-called interprofessional shared decision making (SDM). However, there are strong indications that SDM for sciatica patients is not integrated in daily practice. We designed a study aiming to explore the barriers and facilitators associated with the everyday embedding of SDM for sciatica patients. All related relevant professionals and patients are involved to develop a tailored strategy to implement SDM for sciatica patients. METHODS: The study consists of two phases: identification of barriers and facilitators and development of an implementation strategy. First, barriers and facilitators are explored using semi-structured interviews among eight professionals of each (para)medical discipline involved in sciatica care (general practitioners, physical therapists, neurologists, neurosurgeons, and orthopedic surgeons). In addition, three focus groups will be conducted among patients. Second, the identified barriers and facilitators will be ranked using a questionnaire among a representative Dutch sample of 200 GPs, 200 physical therapists, 200 neurologists, all 124 neurosurgeons, 200 orthopedic surgeons, and 100 patients. A tailored team-based implementation strategy will be developed based on the results of the first phase using the principles of intervention mapping and an expert panel. DISCUSSION: Little is known about effective strategies to increase the uptake of SDM. Most implementation strategies only target a single discipline, whereas multiple disciplines are involved in SDM among sciatica patients. The results of this study can be used as an example for implementing SDM in other patient groups receiving multidisciplinary complex care (e.g., elderly) and can be generalized to other countries with similar context, thereby contributing to a worldwide increase of SDM in preference sensitive choices. Show less
Background Surgery is sometimes recommended for persistent lateral elbow pain where other less invasive interventions have failed. Objectives To determine the benefits and safety of surgery for... Show moreBackground Surgery is sometimes recommended for persistent lateral elbow pain where other less invasive interventions have failed. Objectives To determine the benefits and safety of surgery for lateral elbow pain. Search strategy We searched CENTRAL (The Cochrane Library), MEDLINE, EMBASE, CINAHL and Web of Science unrestricted by date or language (to 15 December 2010). Selection criteria Randomised and controlled clinical trials assessing a surgical intervention compared with no treatment or another intervention including an alternate surgical intervention, in adults with lateral elbow pain. Data collection and analysis Two authors independently selected trials for inclusion, assessed risk of bias and extracted data. Main results We included five trials involving 191 participants with persistent symptoms of at least five months duration and failed conservative treatment. Three trials compared two different surgical procedures and two trials compared surgery to a non-surgical treatment. All trials were highly susceptible to bias. Meta-analysis was precluded due to differing comparator groups and outcome measures. One trial (24 participants) reported no difference between open extensor carpi radialis brevis (ECRB) surgery and radiofrequency microtenotomy, although reanalysis found that pain was significantly lower in the latter group at three weeks (MD-2.80 points on 10 point scale, 95% CI-5.07 to -0.53). One trial (26 participants) reported no difference between open ECRB surgery and decompression of the posterior interosseous nerve in terms of the number of participants with improvement in pain pain on activity, or tenderness on palpation after an average of 31 months following surgery. One trial (45 participants) found that compared with open release of the ERCB muscle, percutaneous release resulted in slightly better function. One trial (40 participants) found comparable results between open surgical release of the ECRB and botulinum toxin injection at two years, although we could not extract any data for this review. One trial (56 participants) found that extracorporeal shock wave therapy (ESWT) improved pain at night compared with percutaneous tenotomy at 12 months (MD 5 points on 100 point VAS, 95% CI 1.12 to 8.88), but there were no differences in pain at rest or pain on applying pressure. Authors' conclusions Due to a small number of studies, large heterogeneity in interventions across trials, small sample sizes and poor reporting of outcomes, there was insufficient evidence to support or refute the effectiveness of surgery for lateral elbow pain. Further well-designed randomised controlled trials and development of standard outcome measures are needed. Show less
Rubinstein, S.M.; Middelkoop, M. van; Assendelft, W.J.J.; Boer, M.R. de; Tulder, M.W. van 2011
Background Many therapies exist for the treatment of low-back pain including spinal manipulative therapy (SMT), which is a worldwide, extensively practiced intervention. Objectives To assess the... Show moreBackground Many therapies exist for the treatment of low-back pain including spinal manipulative therapy (SMT), which is a worldwide, extensively practiced intervention. Objectives To assess the effects of SMT for chronic low-back pain. Search strategy An updated search was conducted by an experienced librarian to June 2009 for randomised controlled trials (RCTs) in CENTRAL (The Cochrane Library 2009, issue 2), MEDLINE, EMBASE, CINAHL, PEDro, and the Index to Chiropractic Literature. Selection criteria RCTs which examined the effectiveness of spinal manipulation or mobilisation in adults with chronic low-back pain were included. No restrictions were placed on the setting or type of pain; studies which exclusively examined sciatica were excluded. The primary outcomes were pain, functional status and perceived recovery. Secondary outcomes were return-to-work and quality of life. Data collection and analysis Two review authors independently conducted the study selection, risk of bias assessment and data extraction. GRADE was used to assess the quality of the evidence. Sensitivity analyses and investigation of heterogeneity were performed, where possible, for the meta-analyses. Main results We included 26 RCTs (total participants = 6070), nine of which had a low risk of bias. Approximately two-thirds of the included studies (N = 18) were not evaluated in the previous review. In general, there is high quality evidence that SMT has a small, statistically significant but not clinically relevant, short-term effect on pain relief (MD: -4.16, 95% CI -6.97 to -1.36) and functional status (SMD: -0.22, 95% CI -0.36 to -0.07) compared to other interventions. Sensitivity analyses confirmed the robustness of these findings. There is varying quality of evidence (ranging from low to high) that SMT has a statistically significant short-term effect on pain relief and functional status when added to another intervention. There is very low quality evidence that SMT is not statistically significantly more effective than inert interventions or sham SMT for short-term pain relief or functional status. Data were particularly sparse for recovery, return-to-work, quality of life, and costs of care. No serious complications were observed with SMT. Authors' conclusions High quality evidence suggests that there is no clinically relevant difference between SMT and other interventions for reducing pain and improving function in patients with chronic low-back pain. Determining cost-effectiveness of care has high priority. Further research is likely to have an important impact on our confidence in the estimate of effect in relation to inert interventions and sham SMT, and data related to recovery. Show less
BACKGROUND: Despite the availability of effective therapies, asthma remains a source of significant morbidity and use of health care resources. The central research question of the ACCURATE trial... Show moreBACKGROUND: Despite the availability of effective therapies, asthma remains a source of significant morbidity and use of health care resources. The central research question of the ACCURATE trial is whether maximal doses of (combination) therapy should be used for long periods in an attempt to achieve complete control of all features of asthma. An additional question is whether patients and society value the potential incremental benefit, if any, sufficiently to concur with such a treatment approach. We assessed patient preferences and cost-effectiveness of three treatment strategies aimed at achieving different levels of clinical control:1. sufficiently controlled asthma2. strictly controlled asthma3. strictly controlled asthma based on exhaled nitric oxide as an additional disease marker DESIGN: 720 Patients with mild to moderate persistent asthma from general practices with a practice nurse, age 18-50 yr, daily treatment with inhaled corticosteroids (more then 3 months usage of inhaled corticosteroids in the previous year), will be identified via patient registries of general practices in the Leiden, Nijmegen, and Amsterdam areas in The Netherlands. The design is a 12-month cluster-randomised parallel trial with 40 general practices in each of the three arms. The patients will visit the general practice at baseline, 3, 6, 9, and 12 months. At each planned and unplanned visit to the general practice treatment will be adjusted with support of an internet-based asthma monitoring system supervised by a central coordinating specialist nurse. Patient preferences and utilities will be assessed by questionnaire and interview. Data on asthma control, treatment step, adherence to treatment, utilities and costs will be obtained every 3 months and at each unplanned visit. Differences in societal costs (medication, other (health) care and productivity) will be compared to differences in the number of limited activity days and in quality adjusted life years (Dutch EQ5D, SF6D, e-TTO, VAS). This is the first study to assess patient preferences and cost-effectiveness of asthma treatment strategies driven by different target levels of asthma control. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR1756. Show less
Blom, J.W.; Ruijter, W. de; Witteman, J.C.M.; Assendelft, W.J.J.; Breteler, M.M.B.; Hofman, A.; Gussekloo, J. 2011
There are indications that in persons of older age, systolic blood pressure (SBP) is no longer associated with mortality. This raises the question whether the predictive value of SBP changes from... Show moreThere are indications that in persons of older age, systolic blood pressure (SBP) is no longer associated with mortality. This raises the question whether the predictive value of SBP changes from younger to older age groups. Analysis in the Rotterdam Study, a population-based prospective cohort study among 4,612 participants aged ≥55 years without previous cardiovascular disease and with a median follow-up of 14.9 (interquartile range, 11.1-15.8) years. Within four age groups (55-64, 65-74, 75-84, ≥85 years), the predictive value of baseline SBP for mortality was studied. From age 55 to ≥85 years, risk of all-cause mortality associated with SBP ≥160 mmHg decreased from HR 1.7 (95%CI 1.2-2.2) to HR 0.7 (95%CI 0.4-1.1), p for trend <0.001. For participants with SBP 140-159 mmHg, the risk decreased from HR 1.2 (95%CI 0.9-1.5) to HR 0.7 (95%CI 0.5-1.1), p for trend <0.001. Analyses in the 5-year age groups showed an increased risk with higher SBPs up to age 75 years. After 75 years, a trend towards SBP no longer being associated with an increased mortality risk was seen in our study. These findings need to be considered with recently reported beneficial effects of antihypertensive treatment in this age group. Show less
Meer, V. van der; Hout, W.B. van den; Bakker, M.J.; Rabe, K.F.; Sterk, P.J.; Assendelft, W.J.J.; ... ; SMASHING Self-Management Asthma 2011
PURPOSE: Our purpose was to investigate the feasibility of pharmacy-initiated pharmacogenetic (PGt) screening in primary care with respect to patient willingness to participate, quality of DNA... Show morePURPOSE: Our purpose was to investigate the feasibility of pharmacy-initiated pharmacogenetic (PGt) screening in primary care with respect to patient willingness to participate, quality of DNA collection with saliva kits, genotyping, and dispensing data retrieved from the pharmacy. METHODS: Polypharmacy patients aged >60 years who used at least one drug with Anatomical Therapeutic Chemical (ATC) code N06AA01-N06AX19 (antidepressants), A02BC01-A02BC05 (proton-pump inhibitors), N05AA01-N05AH04 (antipsychotics), or C07AB02 (metoprolol) in the preceding 2 years were randomly selected. DNA was collected with saliva kits and genotyped for CYP2D6 and CYP2C19 with the AmpliChip. Pharmacy dispensing records were retrieved and screened for drugs interacting with the patient's CYP2D6 and CYP2C19 genotype by using the evidence-based PGt guidelines from the Dutch Pharmacogenetics Working Group. RESULTS: Out of the 93 invited patients, 54 (58.1%) provided informed consent. Nine saliva samples (16.7%) contained too little DNA. Call rates for CYP2D6 and CYP2C19 were 93.3% and 100%, respectively. Frequencies of genotype-predicted phenotype were 2.4%, 38.1%, 54.8%, and 4.8% for CYP2D6 poor metabolizers (PM), intermediate metabolizers (IM), extensive metabolizers (EM), and ultrarapid metabolizers (UM) respectively. For CYP2C19 genotype-predicted phenotype, frequencies were 2.2%, 15.6%, and 82.2% for PM, IM, and EM, respectively. CONCLUSIONS: This study shows that pharmacy-initiated PGt screening is feasible for a primary care setting. Show less
Study Design. Systematic review of interventions. Objective. To assess the effects of spinal manipulative therapy SMT) for chronic low-back pain. Summary of Background Data. SMT is one of the many... Show moreStudy Design. Systematic review of interventions. Objective. To assess the effects of spinal manipulative therapy SMT) for chronic low-back pain. Summary of Background Data. SMT is one of the many therapies for the treatment of low-back pain, which is a worldwide, extensively practiced intervention. Methods. Search methods. An experienced librarian searched for randomized controlled trials RCTs) in multiple databases up to June 2009. Selection criteria. RCTs that examined manipulation or mobilization in adults with chronic low-back pain were included. The primary outcomes were pain, functional status, and perceived recovery. Secondary outcomes were return-to-work and quality of life. Data collection and analysis. Two authors independently conducted the study selection, risk of bias assessment, and data extraction. GRADE was used to assess the quality of the evidence. Results. We included 26 RCTs total participants = 6070), 9 of which had a low risk of bias. Approximately two-thirds of the included studies N = 18) were not evaluated in the previous review. There is a high-quality evidence that SMT has a small, significant, but not clinically relevant, short-term effect on pain relief mean difference -4.16, 95% confidence interval -6.97 to -1.36) and functional status standardized mean difference -0.22, 95% confidence interval -0.36 to -0.07) in comparison with other interventions. There is varying quality of evidence that SMT has a significant short-term effect on pain relief and functional status when added to another intervention. There is a very low-quality evidence that SMT is not more effective than inert interventions or sham SMT for short-term pain relief or functional status. Data were particularly sparse for recovery, return-to-work, quality of life, and costs of care. No serious complications were observed with SMT. Conclusions. High-quality evidence suggests that there is no clinically relevant difference between SMT and other interventions for reducing pain and improving function in patients with chronic low-back pain. Determining cost-effectiveness of care has high priority. Show less
Objectives: this study investigates the predictive value of multimorbidity for the development of disability in the general population of very old people and the role of cognitive impairment in... Show moreObjectives: this study investigates the predictive value of multimorbidity for the development of disability in the general population of very old people and the role of cognitive impairment in this association. Design: the Leiden 85-plus Study (1997-2004) is an observational prospective cohort study with 5 years of follow-up. Setting: general population of the city of Leiden, the Netherlands. Subjects: population based sample of 594 participants aged 85 years. Methods: disability in activities of daily living (ADL) was measured annually for 5 years with the Groningen Activity Restriction Scale (range 9-36, 9 = optimal). Multimorbidity is defined as the presence of two or more chronic diseases at age 85 years. Cognitive function was measured at baseline with the mini-mental state examination (MMSE). Results: at baseline participants with multimorbidity had higher ADL disability scores compared with those without [median 11 inter-quartile range (IQR 9-16) versus 9 (IQR 9-13) ADL points, Mann-Whitney U test P < 0.001]. Stratified into four MMSE groups, ADL disability increased over time in all groups, even in participants without multimorbidity (P trend < 0.001). Multimorbidity predicted accelerated increase in ADL disability in participants with MMSE of 28-30 points (n = 205, 0.67 points/year, P < 0.001), but not in participants with lower MMSE scores (all P > 0.100). Conclusion: the predictive value of multimorbidity for the increase in ADL disability varies with cognitive function in very old people. In very old people with good cognitive function, multimorbidity predicts accelerated increase in ADL disability. This relation is absent in very old people with cognitive impairment. Show less
