Sally Green

Cochrane handbook for systematic reviews of interventions

The Cochrane Handbook for Systematic Reviews of Interventions is the official document that describes in detail the process of preparing and maintaining Cochrane systematic reviews on the effects of healthcare interventions.

Developing theory-informed behaviour change interventions to implement evidence into practice: a systematic approach using the Theoretical Domains Framework

BackgroundThere is little systematic operational guidance about how best to develop complex interventions to reduce the gap between practice and evidence. This article is one in a Series of articles documenting the development and use of the Theoretical Domains Framework (TDF) to advance the science of implementation research.MethodsThe intervention was developed considering three main components: theory, evidence, and practical issues. We used a four-step approach, consisting of guiding questions, to direct the choice of the most appropriate components of an implementation intervention: Who needs to do what, differently? Using a theoretical framework, which barriers and enablers need to be addressed? Which intervention components (behaviour change techniques and mode(s) of delivery) could overcome the modifiable barriers and enhance the enablers? And how can behaviour change be measured and understood?ResultsA complex implementation intervention was designed that aimed to improve acute low back pain management in primary care. We used the TDF to identify the barriers and enablers to the uptake of evidence into practice and to guide the choice of intervention components. These components were then combined into a cohesive intervention. The intervention was delivered via two facilitated interactive small group workshops. We also produced a DVD to distribute to all participants in the intervention group. We chose outcome measures in order to assess the mediating mechanisms of behaviour change.ConclusionsWe have illustrated a four-step systematic method for developing an intervention designed to change clinical practice based on a theoretical framework. The method of development provides a systematic framework that could be used by others developing complex implementation interventions. While this framework should be iteratively adjusted and refined to suit other contexts and settings, we believe that the four-step process should be maintained as the primary framework to guide researchers through a comprehensive intervention development process.

Physical Therapy for Patellofemoral Pain A Randomized, Double-Blinded, Placebo-Controlled Trial

Background Although physical therapy forms the mainstay of nonoperative management for patellofemoral pain, its efficacy has not been established. Hypothesis Significantly more pain relief will be achieved from a 6-week regimen of physical therapy than from placebo treatment. Study Design Multicenter, randomized, double-blinded, placebo-controlled trial. Methods Seventy-one subjects, 40 years of age or younger with patellofemoral pain of 1 month or longer, were randomly allocated to a physical therapy or placebo group. A standardized treatment program consisted of six treatment sessions, once weekly. Physical therapy included quadriceps muscle retraining, patellofemoral joint mobilization, and patellar taping, and daily home exercises. The placebo treatment consisted of sham ultrasound, light application of a nontherapeutic gel, and placebo taping. Results Sixty-seven participants completed the trial. The physical therapy group (N = 33) demonstrated significantly greater reduction in the scores for average pain, worst pain, and disability than did the placebo group (N = 34). Conclusions A six-treatment, 6-week physical therapy regimen is efficacious for alleviation of patellofemoral pain.

Systematic review of randomised controlled trials of interventions for painful shoulder: selection criteria, outcome assessment, and efficacy

Abstract Objective: To review the efficacy of common interventions for shoulder pain. Design: All randomised controlled trials of non-steroidal anti-inflammatory drugs, intra-articular and subacromial glucocorticosteroid injection, oral glucocorticosteroid treatment, physiotherapy, manipulation under anaesthesia, hydrodilatation, and surgery for shoulder pain that were identified by computerised and hand searches of the literature and had a blinded assessment of outcome were included. Main outcome measures: Methodological quality (score out of 40), selection criteria, and outcome measures. Effect sizes were calculated and combined in a pooled analysis if study population, end point, and intervention were comparable. Results: Thirty one trials met inclusion criteria. Mean methodological quality score was 16.8 (9.5-22). Selection criteria varied widely, even for the same diagnostic label. There was no uniformity in the outcome measures used, and their measurement properties were rarely reported. Effect sizes for individual trials were small (range −1.4 to 3.0). The results of only three studies investigating “rotator cuff tendinitis” could be pooled. The only positive finding was that subacromial steroid injection is better than placebo in improving the range of abduction (weighted difference between means 35° (95% confidence interval 14 to 55)). Conclusions: There is little evidence to support or refute the efficacy of common interventions for shoulder pain. As well as the need for further well designed clinical trials, more research is needed to establish a uniform method of defining shoulder disorders and developing outcome measures which are valid, reliable, and responsive in affected people. Key messages This systematic review found little evidence to support the use of any of the common interventions in managing shoulder pain There is currently no uniformity in the way shoulder disorders are labelled or defined Measurement of outcome varies widely between clinical trials and, in general, the reliability, validity, and responsiveness of these outcome measures are not established Further clinical trials are needed to determine the optimal treatment strategies for shoulder pain

A systematic review of physical interventions for patellofemoral pain syndrome

ObjectivePhysical interventions (nonpharmacological and nonsurgical) are the mainstay of treatment for patellofemoral pain syndrome (PFPS). Physiotherapy is the most common of all physical interventions and includes specific vastus medialis obliquus or general quadriceps strengthening and/or realignment procedures (tape, brace, stretching). These treatments appear to be based on sound theoretical rationale and have attained widespread acceptance, but evidence for the efficacy of these interventions is not well established. This review will present the available evidence for physical interventions for PFPS. Data SourcesComputerized bibliographic databases (MEDLINE, Current Contents, CINAHL) were searched, including the keywords “patellofemoral,” “patella,” and “anterior knee pain,” combined with “treatment,” “rehabilitation,” and limited to clinical trials through October 2000. Study SelectionThe critical eligibility criteria used for inclusion were that the study be a controlled trial, that outcome assessments were adequately described, and that the treatment was a nonpharmacological, nonsurgical physical intervention. ResultsOf the 89 potentially relevant titles, 16 studies were reviewed and none of these fulfilled all of the requirements for a randomized, controlled trial. Physiotherapy interventions were evaluated in eight trials, and the remaining eight trials examined different physical interventions. Significant reductions in PFPS symptoms were found with a corrective foot orthosis and a progressive resistance brace, but there is no evidence to support the use of patellofemoral orthoses, acupuncture, low-level laser, chiropractic patellar mobilization, or patellar taping. Overall the physiotherapy interventions had significant beneficial effects but these interventions were not compared with a placebo control. There is inconclusive evidence to support the superiority of one physiotherapy intervention compared with others. ConclusionsThe evidence to support the use of physical interventions in the management of PFPS is limited. There appears to be a consistent improvement in short-term pain and function due to physiotherapy treatment, but comparison with a placebo group is required to determine efficacy, and further trials are warranted for the other interventions.

Screening for prostate cancer: an updated Cochrane systematic review

• To determine whether screening for prostate cancer reduces prostate cancer‐specific mortality, impact on all‐cause mortality and patient health‐related quality of life.

The Effect of Provider Case Volume on Cancer Mortality: Systematic Review and Meta‐Analysis

The authors systematically reviewed the association between provider case volume and mortality in 101 publications involving greater than 1 million patients with esophageal, gastric, hepatic, pancreatic, colon, or rectal cancer, of whom more than 70,000 died. The majority of studies addressed the relation between hospital surgical case volume and short‐term perioperative mortality. Few studies addressed surgeon case volume or evaluated long‐term survival outcomes. Common methodologic limitations were failure to control for potential confounders, post hoc categorization of provider volume, and unit of analysis errors. A significant volume effect was evident for the majority of gastrointestinal cancers; with each doubling of hospital case volume, the odds of perioperative death decreased by 0.1 to 0.23. The authors calculated that between 10 and 50 patients per year, depending on cancer type, needed to be moved from a “low‐volume” hospital to a “high‐volume” hospital to prevent 1 additional volume‐associated perioperative death. Despite this, approximately one‐third of all analyses did not find a significant volume effect on mortality. The heterogeneity of results from individual studies calls into question the validity of case volume as a proxy for care quality, and leads the authors to conclude that more direct quality measures and the validity of their use to inform policy should also be explored. CA Cancer J Clin 2009;59:192–211.

Paradoxical response to nebulised salbutamol in wheezy infants, assessed by partial expiratory flow-volume curves.

Lower airway responses to nebulised bronchodilators were studied in 18 chronically or recurrently wheezy infants, aged 3-15 months, by means of partial forced expiratory flow-volume manoeuvres performed with an inflatable jacket. Maximum flow at functional residual capacity (FRC) (VmaxFRC) was used as the index of intrathoracic airways function. Peak expiratory flow rate was also measured. Baseline airways resistance and lung volume were determined during quiet breathing in an infant whole body plethysmograph. Measurements were made on separate days before and after nebulised salbutamol 2.5 mg with nebulised saline as control. The results were paradoxical: there was no change in VmaxFRC after saline, but a significant decline in VmaxFRC was found after salbutamol. Peak expiratory flow remained unchanged. These observations suggest that under conditions of forced expiration intrathoracic airways function may be further impaired by nebulised bronchodilator treatment in wheezy infants. When nebulised bronchodilator drugs are used to treat severe airways obstruction in infancy, careful monitoring is essential.

Efficacy of standardised manual therapy and home exercise programme for chronic rotator cuff disease: randomised placebo controlled trial.

Objective To investigate the efficacy of a programme of manual therapy and exercise treatment compared with placebo treatment delivered by physiotherapists for people with chronic rotator cuff disease. Design Randomised, participant and single assessor blinded, placebo controlled trial. Setting Metropolitan region of Melbourne, Victoria, Australia. Participants 120 participants with chronic (>3 months) rotator cuff disease recruited through medical practitioners and from the community. Interventions The active treatment comprised a manual therapy and home exercise programme; the placebo treatment comprised inactive ultrasound therapy and application of an inert gel. Participants in both groups received 10 sessions of individual standardised treatment over 10 weeks. For the following 12 weeks, the active group continued the home exercise programme and the placebo group received no treatment. Main outcome measures The primary outcomes were pain and function measured by the shoulder pain and disability index, average pain on movement measured on an 11 point numerical rating scale, and participants’ perceived global rating of overall change. Results 112 (93%) participants completed the 22 week trial. At 11 weeks no difference was found between groups for change in shoulder pain and disability index (3.6, 95% confidence interval −2.1 to 9.4) or change in pain (0.7, −0.1 to 1.5); both groups showed significant improvements. More participants in the active group reported a successful outcome (defined as “much better”), although the difference was not statistically significant: 42% (24/57) of active participants and 30% (18/61) of placebo participants (relative risk 1.43, 0.87 to 2.34). The active group showed a significantly greater improvement in shoulder pain and disability index than did the placebo group at 22 weeks (between group difference 7.1, 0.3 to 13.9), although no significant difference existed between groups for change in pain (0.9, −0.03 to 1.7) or for the percentage of participants reporting a successful treatment outcome (relative risk 1.39, 0.94 to 2.03). Several secondary outcomes favoured the active group, including shoulder pain and disability index function score, muscle strength, interference with activity, and quality of life. Conclusion A standardised programme of manual therapy and home exercise did not confer additional immediate benefits for pain and function compared with a realistic placebo treatment that controlled for therapists’ contact in middle aged to older adults with chronic rotator cuff disease. However, greater improvements were apparent at follow-up, particularly in shoulder function and strength, suggesting that benefits with active treatment take longer to manifest. Trial registration Clinical trials NCT00415441.

Evaluation of a Theory-Informed Implementation Intervention for the Management of Acute Low Back Pain in General Medical Practice: The IMPLEMENT Cluster Randomised Trial

Introduction This cluster randomised trial evaluated an intervention to decrease x-ray referrals and increase giving advice to stay active for people with acute low back pain (LBP) in general practice. Methods General practices were randomised to either access to a guideline for acute LBP (control) or facilitated interactive workshops (intervention). We measured behavioural predictors (e.g. knowledge, attitudes and intentions) and fear avoidance beliefs. We were unable to recruit sufficient patients to measure our original primary outcomes so we introduced other outcomes measured at the general practitioner (GP) level: behavioural simulation (clinical decision about vignettes) and rates of x-ray and CT-scan (medical administrative data). All those not involved in the delivery of the intervention were blinded to allocation. Results 47 practices (53 GPs) were randomised to the control and 45 practices (59 GPs) to the intervention. The number of GPs available for analysis at 12 months varied by outcome due to missing confounder information; a minimum of 38 GPs were available from the intervention group, and a minimum of 40 GPs from the control group. For the behavioural constructs, although effect estimates were small, the intervention group GPs had greater intention of practising consistent with the guideline for the clinical behaviour of x-ray referral. For behavioural simulation, intervention group GPs were more likely to adhere to guideline recommendations about x-ray (OR 1.76, 95%CI 1.01, 3.05) and more likely to give advice to stay active (OR 4.49, 95%CI 1.90 to 10.60). Imaging referral was not statistically significantly different between groups and the potential importance of effects was unclear; rate ratio 0.87 (95%CI 0.68, 1.10) for x-ray or CT-scan. Conclusions The intervention led to small changes in GP intention to practice in a manner that is consistent with an evidence-based guideline, but it did not result in statistically significant changes in actual behaviour. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN012606000098538