Reliability and validity of assessment methods available in primary care for bladder outlet obstruction and benign prostatic obstruction in men with lower urinary tract symptoms: a systematic review.

OBJECTIVES: To systematically review the literature regarding the reliability and validity of assessment methods available in primary care for bladder outlet obstruction or benign prostatic obstruction in men with lower urinary tract symptoms (LUTS). DESIGN: Systematic review with best evidence synthesis. SETTING: Primary care. PARTICIPANTS: Men with LUTS due to bladder outlet obstruction or benign prostatic obstruction. REVIEW METHODS: PubMed, Ebsco/CINAHL and Embase databases were searched for studies on the validity and reliability of assessment methods for bladder outlet obstruction and benign prostatic obstruction in primary care. Methodological quality was assessed with the COSMIN checklist. Studies with poor methodology were excluded from the best evidence synthesis. RESULTS: Of the 5644 studies identified, 61 were scored with the COSMIN checklist, 37 studies were included in the best evidence synthesis, 18 evaluated bladder outlet obstruction and 17 benign prostatic obstruction, 2 evaluated both. Overall, reliability was poorly evaluated. Transrectal and transabdominal ultrasound showed moderate to good validity to evaluate bladder outlet obstruction. Measured prostate volume with these ultrasound methods, to identify benign prostatic obstruction, showed moderate to good accuracy, supported by a moderate to high level of evidence. Uroflowmetry for bladder outlet obstruction showed poor to moderate diagnostic accuracy, depending on used cut-off values. Questionnaires were supported by high-quality evidence, although correlations and diagnostic accuracy were poor to moderate compared with criterion tests. Other methods were supported by low level evidence. CONCLUSION: Clinicians in primary care can incorporate transabdominal and transrectal ultrasound or uroflowmetry in the evaluation of men with LUTS but should not solely rely on these methods as the diagnostic accuracy is insufficient and reliability remains insufficiently researched. Low-to-moderate levels of evidence for most assessment methods were due to methodological shortcomings and inconsistency in the studies. This highlights the need for better study designs in this domain.

Is behavioral graded activity cost-effective in comparison with manual therapy for patients with subacute neck pain? An economic evaluation alongside a randomized clinical trial.

STUDY DESIGN: An economic evaluation alongside a randomized controlled trial comparing behavioral graded activity (BGA) with manual therapy (MT). OBJECTIVE: To evaluate the cost-effectiveness of BGA in comparison with MT for patients with subacute neck pain from a societal perspective. SUMMARY OF BACKGROUND DATA: Neck pain is common and poses an important socioeconomic burden to society. Data on the cost-effectiveness of treatments for neck pain are scarce. METHODS: A randomized clinical trial was conducted, involving 146 patients with subacute nonspecific neck pain. The BGA program can be described as a time-contingent increase in activities from baseline toward predetermined goals. MT consists of specific spinal mobilization techniques and exercises. Clinical outcomes included recovery, pain, disability, and quality-adjusted life-years (QALYs). Costs were measured from a societal perspective using cost diaries. The follow-up period was 52 weeks. Multiple imputation was used for missing cost and effect data. Uncertainty surrounding cost differences and incremental cost-effectiveness ratios was estimated using bootstrapping. Cost-effectiveness planes and cost-effectiveness acceptability (CEA) curves were estimated. RESULTS: BGA had no significant effect on recovery or QALYs gained in comparison with MT but pain and disability did improve significantly in the BGA group in comparison with the MT group. Total societal costs in the BGA group were nonsignificantly higher than in the MT group. Cost-effectiveness analyses showed that BGA is not cost-effective in comparison with MT for recovery and QALYs gained. Substantial investments are needed to reach a 0.95 probability that BGA is cost-effective in comparison with MT for pain and disability. CONCLUSION: On the basis of the data presented, we consider BGA not cost-effective in comparison with MT.

Added value of qualitative studies in the development of health related patient reported outcomes such as the Pain Coping and Cognition List in patients with sub-acute neck pain.

Psychometric analyses, such as factor analysis, internal consistency and construct validity analysis, are well known and frequently applied methods in the development of health related patient reported outcomes. These statistical indexes shed very little light on how respondents interpret individual items, or on the meaning of their responses. In this study, the Pain Coping and Cognition List (PCCL), a quantitatively validated psychological questionnaire developed to assess chronic pain, has been subjected to a qualitative research method: the Three Step Test Interview (TSTI), an observational technique that aims to identify problems with self reported questionnaires. It consists of three phases: 1) concurrent thinking aloud; 2) a retrospective interview; 3) a semi-structured interview. Participants with sub-acute neck pain distinguished six different types of problems: long complicated formulations, composite questions, irrelevant questions, lacking frame of reference, problematic words, and wrongly interpreted questions. This study illustrates that qualitative methods have an added value when developing self-report questionnaires because some of the problems that were highlighted that cannot be identified using quantitative methods only. Therefore, we recommend that a full qualitative study should be an integral part of the development of questionnaires. The TSTI method is very useful for this purpose.

Comparison of the effectiveness of a behavioural graded activity program and manual therapy in patients with sub-acute neck pain: design of a randomized clinical trial.

The objective is to present the design of a randomized clinical trial (RCT) on the effectiveness and cost effectiveness of a behavioural graded activity programme compared with manual therapy in patients with sub-acute neck pain. Sub-acute is defined as pain existing for 4-12 weeks. The behavioural graded activity programme is a time-contingent increase in activities from baseline towards pre-determined goals. Manual therapy consists mainly of specific spinal mobilization techniques and exercises. The primary outcomes are global perceived effect and functional status. Secondary outcomes are kinesiophobia, distress, coping, depression and somatization. The intensity and persistence of the pain and its interference with activities are also assessed. Direct and indirect costs are measured by means of cost diaries. Measurements take place at baseline and 6 and 12 weeks after randomization. To assess the long-term effect, measurements will also take place after 6 and 12 months. Finally some challenges are discussed concerning the use of a behavioural graded activity programme, manual therapy and outcomes.